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Double blindedness in a fully remote trial

Double blindedness in a fully remote trial



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We are planning to do a fully remote clinical trial to test an online intervention for depression. We will be using a self-rated PHQ-9 at base-line, post intervention, and 90 days follow-up to test the efficacy of the intervention.

The participants wouldn't know if they are assigned to the experimental or the control group (so it is definitely single-blind). Since there is no investigator who will be assessing the depression severity, there is no source of any human bias there (since double-blind trials are designed to eliminate investigator bias).

I was wondering if this can be called a double-blind study. I have seen other fully remote trials with a similar design but they haven't mentioned the term double-blind anywhere. Considering the fact that it is the gold standard, I am surprised that investigators did not mention it in their paper. That is the source of my confusion.

Any thoughts are welcome. Thanks in advance.


Double blind basically consists when the patient does not know to which condition it belongs (control, treatment A, treatment B) and the professional does not know to which group he/she is administering the treatment (control, treatment A, treatment B).

The double-blind designation is not based on the fact that the initial level of depression is not assessed. (I guess you know it and it has been erroneously specified in the question).

In online studies this denomination is not usually used although of course it is not incompatible. (The issue is that this denomination is not usually used because the trial is not common either).

In short I do not see problem with the double blind designation.

On the other hand, it would be necessary to pay close attention to the clinical level and the characteristics of the intervention (you do not specify, is the intervention also remote?).

In any case sounds very interesting.


If the investigator knows what group the subject is in and then has any interaction with the subject, it is not double blind since the investigator can, potentially unintentionally, influence the subject. The fact that the measures are objective is irrelevant.


16 Advantages and Disadvantages of a Double-Blind Study

A double-blind study uses a format where neither the participants nor the researchers know who receives a specific treatment. This procedure is useful because it prevents bias from forming in the achievable results. It is used most often when there is a direct need to understand the benefits of demand characteristics against the placebo effect.

What is unique about the placebo effect is that a person receives an inert substance that has no medical benefit. Participants believe that it is real medicine because a double-blind study wouldn’t inform anyone who gets the actual drug being studied. Researchers don’t receive that information either.

That means the results between the two groups can get compared to see if the effects of the drug are better than that of the placebo. It can also be a way to check for the development of side effects.

Several double-blind study advantages and disadvantages are worth reviewing when considering this format.

List of the Advantages of a Double-Blind Study

1. Three groups are typically part of a double-blind study.
The typical double-blind study project will involve three groups of participants. You’ll have the treatment group, the placebo, group, and a control group. The first two receive the item in question based on their name, although only the administrator knows for certain who is getting what since researchers are kept in the dark. The control group doesn’t receive anything because it serves as the baseline against which the other two sets of results get compared.

When people in the placebo group improve more than the control group, then it shows a belief that the product works. If the treatment group shows better results than those who receive a placebo, then you know the medication worked.

2. It avoids deception in the research process.
One of the criticized shortcomings of this approach is the fact that no one knows if the items they take or use is real or a placebo. The solution is to create two placebo subgroups where one is told that it is real medicine and the other is told it isn’t, which means researchers would need to deceive one set of participants. That process would violate the principles of informed consent.

The double-blind structure avoids this issue by providing complete information to all participants without letting on who receives the actual product getting studied.

3. It reduces the issue of experimenter bias.
Using double-blind procedures can minimize the potential effects of research bias when collecting data. This issue often occurs when experimenters knowingly or unknowingly influence the results during information gathering or product administration during the project. There can also be subjective feelings that drive specific decisions that would occur if less information was present in the study.

By limiting the potential influences that could impact the collected data, the final results produced by the research or experiment has more validity.

4. The results of a double-blind project can get duplicated.
One of the reasons why a double-blind study is considered a best practice is because the results offer the potential for duplication. Other researchers can follow the same protocols for administering placebos and the item being examined against a control group. If the results are similar, then it adds even more validity to the ability of a product or service to provide benefits. When duplication doesn’t happen, then the information from both studies can get compared to see what may have created a divergence in the data.

5. Double-blind assignment factors are randomized.
No one knows who is going to be part of what group at the beginning of a double-blind study. The only participant group that knows they aren’t part of the placebo or target group are those who provide the control baselines. When looking at an intervention-based process, the fact that random assignment occurs for willing participants works to reduce the influence of confounding variables in the material.

6. High levels of control are part of the research process.
The context of a double-blind research study allows administrators to manipulate variables so that the setting allows for direct observation. Control factors that could influence the environment can get added or removed to assist with the limitation of outside factors that would potentially change the data. This process allows for an accurate analysis of the collected data to ensure the authenticity of the results gets verified.

7. It is a process that’s usable in multiple industries.
The double-blind study might be used primarily by the pharmaceutical industry because it can look directly at the impact of medication, but any field can use the processes to determine the validity of an idea. Agriculture, biology, chemistry, engineering, and social sciences all use these structures as a way to provide validation for a theory or idea.

List of the Disadvantages of a Double-Blind Study

1. It doesn’t reflect real-life circumstances.
When a patient receives a pill after going to the doctor, they are told that the product is actual medicine intended to provide specific results. When participants receive something in a double-blind placebo study, then each person gets told explicitly that the item in question might be real medicine or a placebo. That leads to a different set of expectations that can influence the results of the work in adverse ways.

These artificial environments can cause an over-manipulation of the variables to produce circumstances that fall outside of the study’s parameters. When situations don’t feel realistic to a participant, then the quality of the data decreases exponentially.

2. Active placebos can interfere with the results.
Double-blind studies respond to the objections of researchers unintentionally when communicating information about the results of a pill being authentic or a placebo. Objections to the pill offering this information don’t exist with this structure. Although both items look identical, the real medication provides biological effects. Even if the results aren’t measurable, the individuals can feel the impact of the medicine on their bodies.

This outcome may cause them to conclude that they are in the treatment group. That means some participants have a higher positive expectancy than those who don’t feel those effects. It is a disadvantage that can lead to a misinterpretation of the results being experienced in real-time.

3. It is not always possible to complete a double-blind study.
There are times when a double-blind study is not possible. Any experiments that look at types of psychotherapy don’t benefit as an example because it would be impossible to keep participants in the dark about who receives treatment and who didn’t get the stated therapy. It only works when there is a way to provide two identical processes without clear communication about who receives the authentic item and who receives the placebo.

4. We do not fully understand the strength of the placebo effect.
Research published by Science Translational Medicine in 2014 found that the simple act of taking a pill can establish a placebo effect for people. A migraine was being tested in this study. The control group took nothing, while the placebo group took a medication clearly labeled as “placebo.” Then one group took a migraine drug labeled with its name. Those who took the placebo had results that were 50% effective when reducing pain during a migraine effect.

The placebo effect can stimulate the brain into believing that the body is being healed, creating a natural mechanism that encourages better health. The presence of this effect doesn’t indicate the success or failure of a medication or another process in a double-blind study. It may be an indication that the group receiving the placebo has a powerful internal mechanism that provides self-healing.

5. Some people can have a negative response to a placebo.
There can be times when an individual doesn’t have a response to the placebo at all. When that outcome occurs, then the effects of a process or medication can receive a direct comparison to see if the real product is useful. Some people can have an adverse reaction to the placebo, even producing unwanted side effects as if they were taking a real medication. It all depends on how each person feels.

A study involving people with asthma showed that using a placebo inhaler caused patients to do no better on breathing tests than sitting and doing nothing. When researchers asked how they felt about using the product, they reported that the placebo was just as effective as the regular medicine they used.

6. Randomization must use a structured process to be useful.
The most common example of using randomization when assigning people to a group in a double-blind study is to flip a coin. It is an action that’s random and cannot be predicted, which means it is likely to be a 50/50 scenario over time as it gets tossed frequently. Assigning people who come to a specific location based on a day of the week can influence the results of the study unintentionally because there are other dynamics that control the behavior. That bias would be in the data without anyone recognizing its presence since it was placed there in the initial design.

7. Most double-blind studies are too small to provide a representative sample.
Winchester Hospital, which is a division of Beth Israel Lahey Health in Massachusetts, says that a good double-blind study should enroll at least 100 individuals, “preferably as many as 300.” Effective treatments can prove themselves in small trials, but research requires more people to establish patterns so that results can be verified. Even when you have hundreds, or sometimes thousands, of participants in this work, the results might not extrapolate to the general population.

There were more than 4,100 trials in progress for pain treatments in 2011, but the only new approvals given were for formulations or updated dosages for existing medications. Even when drugs get into the third phase of testing, the product only has a 60% chance to continue moving forward. Divergent results often create failure.

8. It doesn’t work well for functional disorders.
The highest response rates for a placebo occur when researchers are looking into functional disorders like Irritable Bowel Syndrome. It also happens when there are imprecise endpoint measurements, as with Crohn’s disease. People who have other immune-response conditions like rheumatoid arthritis. The FDA even notes that the placebo response is steadily growing in the general population.

This disadvantage creates another limitation where the structure of a double-blind study may not provide useful information.

9. Double-blind studies are an expensive effort to pursue.
A double-blind study takes several months to complete so that researchers can look at each possible variable. It may be necessary to complete several efforts using different groups to collect enough data. When corporations look at the cost of these efforts, it can be an expense that reaches several million dollars before its completion. Government studies can quickly reach $1 billion or more, depending on the extent of the work and the industry or product under consideration.

When the Tufts Center for the Study of Drug Development looked at the cost of creating and bringing a new drug to the market, the expense was pegged at $2.6 billion. That’s why new prescription medicines are so expensive. Even the clinical trials for FDA approval have an average cost of $19 million.

Double-blind placebo studies are often called the gold standard for testing medications. This description is at its most powerful when studying new psychiatric medications since the placebo effect is a psychological benefit. It is a process that improves on the experiments that compare the response of someone taking a pill with those who do not.

Since no one knows who is getting what in a double-blind study, the danger of a researcher accidentally communicating non-verbally about the expectation of an item to work or not gets eliminated.

When reviewing these double-blind study advantages and disadvantages, the benefits that come from this process can only be achieved when structures that counter the potential negatives are in place. It gives us a baseline from which to work, but there are no guarantees that results are achievable.


Attention: Change Blindness and Inattentional Blindness

Visual Attention versus Visual Experience

CB and IB can be regarded as two forms of the perceptual failure created by the diversion of attentional resources. They can be distinguished at the functional level by the type of information involved (second- or first-order information, respectively). They also appear to be distinguished by the type of attention involved (focused or diffuse) and the kinds of operations (e.g., comparison) associated with these. This division may correspond to the two modes sometimes proposed for conscious visual experience: an object mode associated with focused attention and a background mode operating as default. Beyond this, however, only partial and tentative conclusions can be drawn regarding the issue of how visual attention relates to conscious visual experience.

In the case where attention of any kind is absent, there does not appear to be any conscious experience of stimuli (second-order quantities for focused attention first-order quantities for diffuse). However, results still point to a considerable amount of processing being carried out. For example, work on IB indicates that unattended – and therefore unseen – items can influence the perception of attended items. Similarly, some models of CB posit low-level representations with a degree of detail and feature binding (proto-objects) that are formed in the absence of this kind of attention.

It is worth pointing out that observers in IB experiments often report that they can detect something about the nonselected stimuli, even though they cannot always identify it. Importantly, this kind of experience is found only in those experiments involving superimposed or interspersed stimuli for dichoptically presented stimuli, there is a complete absence of perception of the nonselected event. This suggests that in the superimposed and interspersed conditions diffuse attention is given to nonselected events, with the main event given focused attention. If so, this would suggest that identification and localization may require more focused attention (or related resource), and that both diffuse and focused attention may be allocated simultaneously to different stimuli.

This proposal would be consistent with work on CB. Focused attention is needed only for the perception of complex quantities such as change background items not given focused attention might still be seen, but only in regards to detection and perhaps a limited form of identification based on relatively fragmented pieces of static items.


Aims and objectives

The aim of this research project is to investigate the impact of combined working memory training and tDCS protocols in individuals following a brain injury in terms of the training gains, change in objective measures of working memory, mood and fatigue, as well as participants’ perceptions of day-to-day memory function and subjective benefit of the training program.

Specifically, our primary objective is to determine if the combination of tDCS and working memory training is superior to working memory training alone to improve working memory function in an n-back task in an ABI population. The key secondary objectives are to determine if the combination of brain stimulation with working memory training can:

boost performance in other cognitive domains (attention, executive functions)

lengthen improvement duration to 1 month

increase improvement magnitude

To address the above questions, we will use a randomized clinical trial, assessor- and patient-blinded with two parallel groups and a simple randomization with a 1:1 allocation ratio.


Clinical Trials & Behavioral Studies

The Department of Psychiatry and Behavioral Sciences welcomes research participants ages 12 to 70 to enroll in studies aimed at improving the diagnosis and treatment of schizophrenia, bipolar disorder, Alzheimer’s disease, depression and anxiety. Browse the entries below and call the associated telephone numbers to learn how you can volunteer to help advance our understanding of psychiatric illness.

If you have questions, please call the Clinical Research Program office at 312-503-9100.

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less&hellip

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust lamotrigine in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

  • 3 overnight visits during pregnancy and 2 postpartum,
  • expert evaluation, mood assessments, and blood draws, and
  • to compensate for your time and effort, you will receive between $100 and $150 for each completed overnight visit.
  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lamotrigine (Lamictal) and planning to continue to take it during pregnancy and postpartum.

Participation involves one overnight visit per trimester and two postpartum. Each visit includes expert evaluation, mood assessments, and blood draws. To compensate for your time and effort you will be eligible to receive up to $750 for your participation in the study. Validation for on-site parking will be provided.

  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lithium (Lithium Carbonate) and plan to continue taking it during and after pregnancy.

The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

fluid) during pregnancy and postpartum. Taking the same medication dose when you are pregnant may result in

an amount of drug in your blood that is different than when you are not pregnant. We will also study the impact

of genetic factors on the amount of drug in your blood. Drug metabolism (how medications are broken down,

absorbed, and removed from the body) differs among people because of their unique genetic make-up, which can

cause medications to be metabolized faster or slower. This means that when two people with different genetic

backgrounds take the same dose, the concentration of the medicine in their blood can vary dramatically.

Changes in antidepressant concentrations are important to monitor because a decrease in the blood level of the

drug may result in the antidepressant becoming ineffective and an increase in mood symptoms or recurrence of

depression may occur. An increase in antidepressant concentration may lead to side effects. We aim to better

understand the course of these changes across pregnancy and postpartum and determine how n woman’s genetic

makeup affects these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of


Resources for Distance Service Delivery

Note: Due to the urgency to share the information, some of the documents may not be fully accessible. For accessible version of the documents, please contact the publisher and/or author of the resources.

Click each topic for more information:

How VR Agencies are Responding - Effective Practices

Electronic Signatures
  1. Washington State DSB COVID-19 Agreements for Signatures and Extension Documentation: Washington State’s Department of Services for the Blind (DSB) has allowed staff to accept written or verbal agreement in place of a signature on Applications, extensions for Eligibility Determination, extensions for Individual Plans for Employment, and Individual Plans for Employment as a result of the COVID-19 crisis
  2. Arizona VR-Acceptable Signature Requirements During RSA Approved Special Circumstances
  3. Minnesota Blind - Dealing with Electronic Signatures
  4. U.S. Department of Veterans Affairs: VRE Signature Guidance COVID-19 Veteran program Participants: Although not a part of the State public VR program, the VA’s Federal VR and Employment program has modified their requirements for wet signatures during the COVID-19 crisis. This is an excellent example of a VR program responding to the need presented by the pandemic.
  5. Utah Permissions for Verbal and Written Signature Consent
  6. Utah Guidance for Documenting Verbal/Written Signature Consent
  7. Colorado VR-Electronic Signature Policy and Procedure
  8. California VR Electronic Signature Policy-Interim Email
  9. Michigan Bureau of Services for Blind Persons-COVID-19 Signature Policy
  10. 10/27/20 California DORS-Interim Policy Using Email for Electronic Signatures-Revised
Service Provision Vendors/Staff
  1. Texas Workforce Commission-VR Provider Resources This link directs you to the TWC-VR provider resources website page and includes instructions for temporary exceptions to certain requirements in the VR Providers Manual, and archived notices to providers.
  2. Nebraska General-Virtual Pre-ETS Guidance to Staff
  3. Nebraska Commission for the Blind-Services Provided
  4. Maryland DORS Guidance on the use of Teleconferencing to Provide Services
  • NC Blind Remote Pre-ETS Activities Weeks 1-3
  • March Newsletter
  • April Newsletter
  • NC Blind-Remote Pre-ETS Activities Week 4
  • NC Blind-Remote Pre-ETS Activities Week 5
  • NC Blind-Remote Pre-ETS Activities Week 6
  • NC Blind-Remote Pre-ETS Activities Week 7
  • NC Blind-Remote Pre-ETS Activities Week 8
  • NC Blind-Remote Pre-ETS Activities Week 9
  • NC Blind-Remote Pre-ETS Activities Week 10
  • NC Blind-Remote Pre-ETS Activities Week 11
  • NC Blind-Remote Pre-ETS Activities Week 12
  • NC Blind-Remote Pre-ETS Activities Week 13

Indiana VR Communications

  • Virtual teaching is taking place with various courses throughout the agency. Clients receive material delivery prior to virtual sessions for courses such as cooking, orientation and mobility, Braille lessons. So, similar format is being prepared for Summer Pre-Ets course curriculum. Students will be sent "package of materials" prior to scheduled virtual session. Parents, family or caregivers can be paid to be the "hands on coach" = financial incentive for meeting demand for coaches and helps with families who are frustrated with what little school systems provide.
Webinars
Other

Resources related to Teleworking and Telecounseling

  1. New Jersey Blind Telework PowerPoint
    This PowerPoint was developed by New Jersey Blind to give instruction to staff about teleworking. This covers the new normal, ideas for delivery of client services, professional development links and more.
  2. Sample Telework Agreement-Minnesota
  3. Indiana VR - Supervision within a Virtual Environment
  4. Utah VR Supervisory Telework Guidance
  5. Utah VR Counselor Telecommuting Guidance
  6. Idaho General - Meaningfull Work Ideas
  1. SHRM-Coronavirus and Teleworking: Tips for Preparing Your Workforce
  2. Ergonomic and Safety tips when working from home
  3. Technical Assistance Guide on Telecommuting in the Workplace A Corporate Partner Benefit of the National Business & Disability Council (NBDC) at The Viscardi Center August 2015
  4. Telework.gov: Guide to Telework in the Federal Government
  5. Virginia Commonwealth University (VCU) has a Telecommuting Resources page
  6. Tips for working remotely and combatting stress
  7. Got kids try these tips for working from home while they're with you
  8. NPR-For these federal employees telework means productivity is up and backlog is down
  9. Stanford-Parenting in the COVID-19 Era: Work-Life Balance Turning into Whack-A-Mole
  10. Mayo Clinic Tips for Coping During Telework
  1. Telecounseling Resource Collection: Developed by the Center for Innovative Training in Vocational Rehabilitation at George Washington University, this collection of resources and guidelines may be helpful when working with clients remotely.
  2. Utilizing Telerehabilitation to Deliver Vocational Rehabilitation Services Remotely as an Alternative to Traditional Counseling
  3. Studies on Video Counseling
    A randomized trial of web-based videoconferencing for substance abuse counseling
  4. Developing a Virtual Reality-Based Vocational Rehabilitation Training Program for Patients with Schizophrenia
  5. The Use of Videoconferencing for Persons with Chronic Conditions – A Systematic Review is a literature review conducted on the issue and may be of help for rehabilitation professionals interested in research on videoconferencing to deliver counseling services.
  6. Telerehabilitation Clinical and Vocational Applications for Assistive Technology: Research, Opportunities and Challenges
  7. Veterans Administration VR Tele-counseling Factsheet
  8. VA announces fully capable Tele-counseling service within its Vocational Rehabilitation and Employment Program
  9. Distance Check ins-Tips for Rehab Counselors Working from Home (by Kristen Dietart, CRC)

    Telehealth Resources

  1. E-Counseling in Psychosocial Cancer Care: A Survey of Practice, Attitudes, and Training Among Providers
  2. The Use of Video Conferencing for Persons with Chronic Conditions: A Systematic Review
  3. A Mobile Phone–Based Intervention to Improve Mental Health Among Homeless Young Adults: Pilot Feasibility Trial
  4. Human-Centered Design of Video-Based Health Education: An Iterative, Collaborative, Community-Based Approach
  5. APA's guidelines for tele-psychological practice
  6. TeleMental Health Institute
  7. Best Practices for an Online World
  8. Avoiding a Disconnect with Telemental Health
    This article discusses how telemental health can help practices run more smoothly and efficiently, increase access to needed treatment for individuals in remote areas, and expand the reach of the professional services psychotherapists offer.
  9. Should a clinician use telehealth to see patients while traveling?
    Practitioners must ensure they follow APA's Ethics Code when using telepsychology with clients.
  10. Practicing Telehealth
    The ethical and legal ways to treat your patients from afar.
  11. Limited Time APA Information On Tele-psychological Services
    The content on this webpage, usually reserved for paid members, is being made available to all readers during the COVID-19 crisis to aid the psychology community in their ever-vigilant effort to improve lives.

Online Training Options for VR Staff

The WINTAC website has a number of pre-recorded training sessions that are provided through a Training Management System. Click this link for WINTAC Training. A WINTAC user account is required to access all trainings.You will find instructions to set up that account in the first paragraph on that page. Topic areas covered within this portion of the website include: intro to WIOA performance, internal controls, order of selection and promising practices, apprenticeship strategies, career pathways, and many more.

In addition, the WINTAC Pre-employment transition services pre-recorded webinars can be found at this link. WINTAC Pre-ETS Webinars

IMPORTANT NOTE: In light of the recent flexibilities that went into effect on February 28th, the webinars have not been updated to reflect the new policy interpretation. It will be important for staff to have an understanding of those changes when watching the webinars. Here is a link to the Federal Register PDF. Federal Register Pre-ETS Flexibilities Notice of Interpretation

Finally, there are several training resources around the common performance accountability system and the RSA-911 Case Service Report webinars. Click here for the link

These short training videos, each under 10 minutes in length, provide VR professionals with short, direct, and relevant training materials on using The Career Index Plus’ multitude of features.

The National Rehabilitation Information Center is a library and information center focusing on disability and rehabilitation research. Click this link

Online courses, webinars, and programs can help you stay mentally engaged. Many of these learning tools also offer continuing education credits which can be applied toward certifications, memberships, and professional licensing.

WorkforceGPS, Employment and Training Administration, U.S. Department of Labor | Published 3/5/2020 | WorkforceGPS, Employment and Training Administration, U.S. Department of Labor.

The Disability and Employment eLearning Task Force in collaboration with the Employment and Training Administration (ETA) is developing eLearning Training Modules to help support the professional development needs of the workforce development staff across the country. eLearning Modules: - Module 1: Serving Individuals with Disabilities – A Day in the Life of an American Job Center (March 2020) - Module 2: Working Across Partners – A Day in the Life of an American Job Center (To Be Released during April, 2020) - Module 3: Providing Inclusive Business Services – A Day in the Life of an American Job Center (To Be Released during May, 2020)

  1. Ethics and Self-care: Why is professional self-care an ethical practice?
    This is a one-hour webcast on ethics and self-care made possible by the George Washington University Center for Innovative Training in Vocational Rehabilitation. Dr. Rob Froehlich and Dr. Maureen McGuire-Kuletz will discuss why professional self-care is an ethical practice and some strategies you can use in your own self-care routines.
  2. CIT-VR Telehealth Resources during the COVID-19 Outbreak
  3. Work Incentives Planning and Assistance National Training and Data Center

Two new online training are available on SSI Work Incentives Series: The Student Earned Income Exclusion (SEIE) and Impairment Related Work Expenses (IWRE) and Blind Work Expenses (BWE). Set up a myNTC account to access myNTC account. Each training is worth three continuing education credits and they are worth two clock hours if you are interested in CRC credits.

A webinar covering current legal and regulatory factors, obstacles and solutions of interjurisdictional telepsychology practice, and ASPPB's Psychology Interjurisdictional Compact (PSYPACT) Initiative.

This presentation provides practical considerations for using phone apps. It introduces a competency-based framework for including phone apps in clinical practice and provides specific and practical ways in which phone apps can be used in practice.

APA’s Continuing Education (CE) Office has curated a list of telehealth courses. More resources are being developed on a regular basis.

HKNC is offering professional learning courses, free of charge, up to May 31, 2020. We know that you are most likely sheltering at home and practicing social distancing due to COVID-19, and we hope these resources are helpful in supporting the needs of individuals who are deaf-blind. Continuing Education Credits (CEUs) are offered with many of our courses. Click to access the class catalogue. All courses are asynchronous and designed to learn at your own pace. Click to access other resources and training tools. Contact the HKNC
Regional Representative for your state, for the coupon code. Click for the information for the field offices for reference.

Provides online continuing education courses for rehabilitation counselors. Course bundles, unlimited subscriptions, and course packages are available for cost.

Provides a variety of multimedia online counseling CEUs via on-demand and live webinar courses for a fee. Although the mental health and rehabilitation counseling courses available through this organization are written to the CRCC standards for post-approval, three CEU courses are pre-approved each year by CRCC.

The American Counseling Association offers select sessions/courses that are approved by the CRCC. Members receive discounted rates. A limited number of free courses are available.

Offers a variety of home study courses for CRC renewal for a fee. Welcomes the opportunity to answer questions by offering three contact options (online “contact us” web portal, email at [email protected], toll free phone 800-230-2263)

The Commission on Rehabilitation Counselor Certification offers an extensive online course catalog. Individual course fees or an annual plan option is available.

Courses have been pre-approved by the Commission for Rehabilitation Counselor. A limited number of free courses are available. Certification and are available online 24/7 and are interactive. Courses and transcripts are accessible for 1 year from date of purchase.

Several free webinars related to vocational rehabilitation are available. Must read the fine print to determine if CRC credit given.

Courses cover a variety of topics. Individual and bundle packages are available for purchase in traditional print format or PDF format. Bundle packages can be tailored to suit needs.

A limited number of free CEU courses are valid for CRC renewal. 9.5 hours of approved credits for the 2019 KT Online Conference are pre-approved through October 27,2020. Listen to the YouTube presentations and complete and submit the evaluation to receive the verification of completion form. Once you submit the evaluation, the evaluation will be checked. The verification of completion form will be sent via email within a day or two.

Offers CRC continuing education units for $4.00 per Continuing Education Credit Hour or by membership for $95 per year. A limited number of courses are free.

Free continuing education units available. Each course lists the amount of CRC credit available.

CRCs can receive post-approval CE credits for completing fee based and free courses offered. Approval of post-education must be completed through the Commission on Rehabilitation Counselor Certification (CRCC) online portal. Please see the CRCC Criteria for Certification Renewal and Continuing Education Manual for specific information about continuing education approval.

The University of Wisconsin-Stout VRI offers free webcasts worth one CRC.

Provides a variety of continuing education courses via live webinars, on-demand recorded webinars, and other online continuing education course content for a fee.

Organization offers a limited number of free training and cost-based CEU courses for credit.

Remote delivery of services by Topic area

    When deciding on what online resources you will use, here are some thoughts for consideration.

  • Make sure the curriculum or activities the providers use are consistent, and that VR (you) approves of the activities they are doing/curriculum they are using.
  • Determine the method you will use to ensure documentation of student attendance and progress.
  • For those students who are not able to access the internet or participate remotely, the VR counselor or provider will want to circle back around with those students and ensure services are provided in another format if they need them, once they get back to school.

  • Explore-Work - This option was developed by WINTAC as a resource for you when delivering Pre-ETS for students remotely. Explore-Work has the option for the student to choose either the VR counselor or provider to be receiving email notices of student progress from the site.
  • Pathways to the Future (West Virginia) This includes sample lesson plans and detailed curricula for students with disabilities that schools,VR, or other partners could use in delivering any of the five required Pre-ETS services. We advise that you thoroughly review these to see what activities you would approve your vendors using.
  • GCFLearnFree.org program

GCFLearnFree.org offers more than 200 topics, including more than 7,000 lessons, more than 1,000 videos, and more than 50 interactive links and games, completely free. We advise that you thoroughly review these to see what activities you would approve your vendors using.

  • New Course: Connecting with Employers and Families - Now Online
    Connecting with Employers and Families! Employers and families are critical partners throughout the transition planning process. Students need support making connections with businesses and employers in their community. Their families bring a unique perspective on their son or daughter’s abilities, preferences, strengths, and challenges. Engaging families and employers in meaningful ways will improve the delivery of pre-ETS. Two video lessons address how to collaborate effectively with these stakeholders. These lessons include: Best practices, Practical tips and strategies, How to overcome common barriers and concerns, Examples of successful collaboration, and featured videos of families and employers sharing their perspectives
  • New Course: Instruction in Self-Advocacy
    Click here to explore the course!
    Are you looking for strategies that empower students to speak up for themselves, understand their strengths and weaknesses, know what they need to succeed, and how to communicate these needs to others? Have you been searching for information on how to equip students to actively participate and have input on life decisions? Understanding the elements of self-advocacy will help you in preparing students to take on current and future challenges. Instruction in self-advocacy gives students the confidence to ask for the tools they need to be successful in the real world. Our new self-advocacy course will help Pre-ETS providers assist students in becoming strong and effective advocates. In these lessons you will -discover the importance of students acquiring self-advocacy skills for successful adult outcomes, identify the key self-advocacy skills and understand the elements of self-advocacy. You will also find seven video activities that support the development of self-advocacy skills. Each activity includes a featured video of individuals sharing their self-advocacy stories and experiences.

    3.26.20 WINTAC Webinar - WINTAC Pre-ETS Discussion with States

No Barriers podcasts-We are all facing unprecedented times. Embrace adaptation to help break through your barriers and come out on the other side stronger than ever. The Alchemy Series to get to podcasts and episode specific tip sheets to maximize learning Tips Sheets

    Implementation of Section 511 Requirements

RSA is currently awaiting clearance to address the issue of the delay in providing career counseling and information and referral (CC&I&R) services due to the pandemic and how that delay affects the ability of the 14c employer to be in compliance with annual CC&I&R timeframes. Once we have the answer to this question, we will post it on our website immediately.

    Remote Training or Technical Assistance

  • The WINTAC Service Integration/Alignment Team is available for remote technical assistance and training in the areas of WIOA implementation related to customer service in the collaborative workforce environment
  • Logistics for remote training or technical assistance arranged by contacting Doug Keast [email protected]
  • For Counselor/Staff Training, will engage a combination of

  • The IRT and WIOA: The Strategy and Its Relevance – recorded Training A strategy that can facilitate WIOA’s customer service vision in a remote service environment.
  • Assessing WIOA Service Integration: The Integration Continuum – recorded training
  • The IRT and WIOA: The Strategy and Its Relevance – recorded Training
  • Career Services in the American Job Center – recorded training
  • Career Pathways - A Roadmap for Innovation and Integration – recorded training
  • Career Pathways Checklist – WINTAC has developed this review to help your agency determine where it is positioned with regard to providing career counseling and rehabilitation services within a Career Pathways structure. This checklist includes a broad-range perspective that supports agencies in providing services for the people (and industries) they serve. Numerous resources are also included.
  • WIOA Implementation Checklist - Implementing WIOA according to its vision in the act and in RSA TAC 15-01 with regard to service alignment and integration with the other Core and Required partners is a multi-step process. From a customer service standpoint, the nature and impact of the services provided and received have as much to do with how state and local partners work together as the guidance for implementation itself. To support your agency in this process, WINTAC has created a checklist to assist with your ongoing review of this implementation.
  • COVID-19 FAQ - WIOA Performance Accountability Provisions
    The Office of Special Education and Rehabilitative Services’ Rehabilitation Services Administration (RSA) announced the U.S. Department of Education has released an initial frequently-asked questions document related to implementing performance accountability provisions under title I of the Workforce Innovation and Opportunity Act (WIOA) as State Vocational Rehabilitation (VR) agencies seek to provide continuity of operations for individuals with disabilities in the COVID-19 environment.
  • COVID-19 FAQ - VR Administrative and Program Requirements
    The Rehabilitation Services Administration (RSA), within the U.S. Department of Education’s (Department) Office of Special Education and Rehabilitative Services, issues this Questions and Answers document in response to inquiries concerning the administration of the State Vocational Rehabilitation (VR) Services, American Indian Vocational Rehabilitation Services (AIVRS), and Randolph-Sheppard programs as grantees seek to provide continuity of operations for individuals with disabilities in the current COVID-19 environment. Regarding data collection and reporting, this FAQ includes responses to questions on the implementation of PD 19-03 (RSA-911) and the effects of COVID-19 on the Statistical Adjustment Model.
  • WINTAC hosted a panel discussion related to COVID-19 data integrity strategies on May 19, 2020. Four State VR agencies were invited to discuss their policies and procedures specifically around providing services remotely while maintaining data integrity and confidentiality. Access the recorded webinar and additional information here.

The role of Labor Market Information (LMI) in the VR Process will be more important than ever in the coming months. Now is the time to train on using LMI Resources and to educate yourself and your clients on higher education, labor rights, and other LMI related topics during this pandemic.


Supplementary Material

1. Li Q , Guan X , Wu P , et al. Early transmission dynamics in Wuhan, China, of novel coronavirus–infected pneumonia. N Engl J Med 2020 382: 1199 - 1207 .

2. Vincent MJ , Bergeron E , Benjannet S , et al. Chloroquine is a potent inhibitor of SARS coronavirus infection and spread. Virol J 2005 2: 69 - 69 .

3. Yao X , Ye F , Zhang M , et al. In vitro antiviral activity and projection of optimized dosing design of hydroxychloroquine for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clin Infect Dis 2020 March 9 (Epub ahead of print).

4. Liu J , Cao R , Xu M , et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov 2020 6: 16 - 16 .

5. Pastick KA , Okafor EC , Wang F , et al. Review: hydroxychloroquine and chloroquine for treatment of SARS-CoV-2 (COVID-19). Open Forum Infect Dis 2020 7: ofaa130 - ofaa130 .

6. Geleris J , Sun Y , Platt J , et al. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. N Engl J Med 2020 382: 2411 - 2418 .

7. Mehra MR , Desai SS , Ruschitzka F , Patel AN . Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis. Lancet 2020 May 22 (Epub ahead of print).

8. Rosenberg ES , Dufort EM , Udo T , et al. Association of treatment with hydroxychloroquine or azithromycin with in-hospital mortality in patients with COVID-19 in New York State. JAMA 2020 May 11 (Epub ahead of print).

9. Burke RM , Midgley CM , Dratch A , et al. Active monitoring of persons exposed to patients with confirmed COVID-19 — United States, January–February 2020. MMWR Morb Mortal Wkly Rep 2020 69: 245 - 246 .

10. Park SY , Kim YM , Yi S , et al. Coronavirus disease outbreak in call center, South Korea. Emerg Infect Dis 2020 April 23 (Epub ahead of print).

11. Lee SH , Son H , Peck KR . Can post-exposure prophylaxis for COVID-19 be considered as an outbreak response strategy in long-term care hospitals? Int J Antimicrob Agents 2020 April 17 (Epub ahead of print).

12. Lother SA , Abassi M , Agostinis A , et al. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth 2020 May 7 (Epub ahead of print).

13. Harris PA , Taylor R , Minor BL , et al. The REDCap Consortium: building an international community of software platform partners. J Biomed Inform 2019 95: 103208 - 103208 .

14. Al-Kofahi M , Jacobson P , Boulware DR , et al. Finding the dose for hydroxychloroquine prophylaxis for COVID-19 the desperate search for effectiveness. Clin Pharmacol Ther 2020 April 28 (Epub ahead of print).

15. Council of State and Territorial Epidemiologists. Interim-20-ID-01: standardized surveillance case definition and national notification for 2019 novel coronavirus disease (COVID-19). 2020 (https://www.cste.org/resource/resmgr/2020ps/Interim-20-ID-01_COVID-19.pdf).

16. McMichael TM , Currie DW , Clark S , et al. Epidemiology of Covid-19 in a long-term care facility in King County, Washington. N Engl J Med 2020 382: 2005 - 2011 .

17. CDC COVID-19 Response Team. Characteristics of health care personnel with COVID-19 — United States, February 12–April 9, 2020. MMWR Morb Mortal Wkly Rep 2020 69: 477 - 481 .


The New Nuremberg Trials 2021 | BREAKING-NEWS.CA

Fuellmich and his team present the faulty PCR test and the order for doctors to label any comorbidity death as a Covid death as fraud. The PCR test was never designed to detect pathogens and is 100% faulty at 35 cycles. All the PCR tests overseen by the CDC are set at 37 to 45 cycles. The CDC admits that any tests over 28 cycles are not admissible for a positive reliable result. This alone invalidates over 90% of the alleged covid cases / ”infections” tracked by the use of this faulty test.

In addition to the flawed tests and fraudulent death certificates, the “experimental” vaccine itself is in violation of Article 32 of the Geneva Convention. Under Article 32 of the 1949 Geneva Convention IV, “mutilation and medical or scientific experiments not necessitated by the medical treatment of a protected person” are prohibited. According to Article 147, conducting biological experiments on protected persons is a grave breach of the Convention.

The “experimental” vaccine is in violation of all 10 of the Nuremberg Codes which carry the death penalty for those who seek to violate these International Laws.

The “vaccine” fails to meet the following five requirements to be considered a vaccine and is by definition a medical “experiment” and trial:

Provides immunity to the virus
This is a “leaky” gene therapy that does not provide immunity to Covid and claims to reduce symptoms yet double-vaccinated are now 60% of the patients requiring ER or ICU with covid infections.

Protects recipients from getting the virus
This gene-therapy does not provide immunity and double-vaccinated can still catch and spread the virus.

Reduces deaths from the virus infection
This gene-therapy does not reduce deaths from the infection. Double-Vaccinated infected with Covid have also died.

Reduces circulation of the virus
This gene-therapy still permits the spread of the virus as it offers zero immunity to the virus.

Reduces transmission of the virus
This gene-therapy still permits the transmission of the virus as it offers zero immunity to the virus.

The following violations of the Nuremberg Code are as follows:

Nuremberg Code #1: Voluntary Consent is Essential

No person should be forced to take a medical experiment without informed consent. Many media, political and non-medical persons are telling people to take the shot. They offer no information as to the adverse effects or dangers of this gene-therapy. All you hear from them is – “ safe and effective” and “ benefits outweigh the risks.” Countries are using lockdowns, duress and threats to force people to take this vaccine or be prohibited to participate in free society under the mandate of a Vaccine Passport or Green Pass. During the Nuremberg trials, even the media was prosecuted and members were put to death for lying to the public, along with many of the doctors and Nazis found guilty of Crimes Against Humanity.

Nuremberg Code #2: Yield Fruitful Results Unprocurable By Other Means

As listed above, the gene-therapy does not meet the criteria of a vaccine and does not offer immunity to the virus. There are other medical treatments that yield fruitful results against Covid such as Ivermectin, Vitamin D, Vitamin C, Zinc and boosted immune systems for flu and colds.

Nuremberg Code #3: Base Experiments on Results of Animal Experimentation and Natural History of Disease

This gene therapy skipped animal testing and went straight to human trials. In mRNA research that Pfizer used – a candidate study on mRNA with rhesus macaques monkeys using BNT162b2 mRNA and in that study all the monkeys developed pulmonary inflammation but the researchers considered the risk low as these were young healthy monkeys from the age of 2-4. Israel has used Pfizer and the International Court of Law has accepted a claim for 80% of the recipients having pulmonary inflammation from being injected with this gene-therapy. Despite this alarming development Pfizer proceeded to develop their mRNA for Covid without animal testing.

Nuremberg Code #4: Avoid All Unnecessary Suffering and Injury

Since the rollout of the experiment and listed under the CDC VAERS reporting system over 4,000 deaths and 50,000 vaccine injuries have been reported in America. In the EU over 7,000 deaths and 365,000 vaccine injuries have been reported. This is a grievous violation of this code.

Nuremberg Code #5: No Experiment to be Conducted if There’s Reason to Think Injury or Death Will Occur

See #4, based on fact-based medical data this gene-therapy is causing death and injury. Past research on mRNA also shows several risks that have been ignored for this current trial gene-experiment. A 2002 study on SARS-CoV-1 spike proteins showed they cause inflammation, immunopathology, blood clots, and impede Angiotensin 2 expression. This experiment forces the body to produce this spike-protein inheriting all these risks.

Nuremberg Code #6: Risk Should Never Exceed the Benefit

Covid-19 has a 98-99% recovery rate. The vaccine injuries, deaths and adverse side-effects of mRNA gene-therapy far exceed this risk. The use of “leaky” vaccines was banned for agriculture use by the US and EU due to the Marek Chicken study that shows ‘hot-viruses’ and variants emerge… making the disease even more deadly. Yet, this has been ignored for human use by the CDC knowing fully the risk of new deadlier variants emerge from leaky vaccinations. The CDC is fully aware that the use of leaky vaccines facilitates the emergence of hot (deadlier)strains. Yet they’ve ignored this when it comes to human

Nuremberg Code #7: Preparation Must Be Made Against Even Remote Possibility of Injury, Disability or Death

There were no preparations made. This gene therapy skipped animal trials. The pharmaceutical companies’ own Phase 3 human clinical trials will not conclude until 2022 /2023. These vaccines were approved under an Emergency Use only act and forced on a misinformed public. They are NOT FDA-approved.

Nuremberg Code #8: Experiment Must Be Conducted by Scientifically Qualified Persons

Politicians, media and actors claiming that this is a safe and effective vaccine are not qualified. Propaganda is not medical science. Many retail outlets such as Walmart & drive-through vaccine centers are not qualified to administer experimental medical gene-therapies to the uninformed public.

Nuremberg Code #9: Anyone Must Have the Freedom to Bring the Experiment to an End At Any Time

Despite the outcry of over 85,000 doctors, nurses, virologists and epidemiologists – the experiment is not being ended. In fact, there are currently many attempts to change laws in order to force vaccine compliance. This includes mandatory and forced vaccinations. Experimental ‘update’ shots are planned for every 6 months without any recourse to the growing number of deaths and injuries already caused by this experiment. These ‘update’ shots will be administered without any clinical trials. Hopefully this new Nuremberg Trial will put an end to this crime against humanity.

Nuremberg Code #10: The Scientist Must Bring the Experiment to an End At Any Time if There’s Probable Cause of it Resulting in Injury or Death

It is clear in the statistical reporting data that this experiment is resulting in death and injury yet all the politicians, drug companies and so-called experts are not making any attempt to stop this gene-therapy experiment from inflicting harm on a misinformed public.

What can you do to help put an end to this crime against humanity? Share this information. Hold your politicians, media, doctors and nurses accountable – that if they are complicit in this crime against humanity they too are subject to the laws set forth in the Geneva Convention and Nuremberg Code and can be tried, found guilty and put to death. Legal proceedings are moving forward, evidence has been collected and a large growing body of experts are sounding the alarm.

Visit the Covid Committee website at: https://corona-ausschuss.de/ and if you have been affected by this crime, report the event, persons involved, and as much detail to the following website:

Crimes against humanity affect us all. They are a crime against you, your children, your parents, your grandparents, your community and your country and your future.


Telemedicine in Age-Related Macular Degeneration (AMD)

AMD affects 15 million Americans, with 200,000 new advanced cases diagnosed each year. AMD is the leading cause of blindness in this country, from either the &ldquodry&rdquo or &ldquowet&rdquo advanced forms. At present, there is no treatment for dry AMD. Besides blindness, AMD has other indirect complications such as depression, social dependency, and the risk of fall and injury. The prevalence of this disease is expected to grow substantially as life expectancy continues to increase and record numbers of Baby Boomers enter their senior years. The total direct cost of AMD is $220 billion per year and is expected to increase

1.5 fold. The Age-Related Eye Disease Study (AREDS) showed that specific vitamin supplementation protocols can reduce the risk of progression from intermediate to late AMD by

25% which in turn could lower the cost of AMD 17.6% if fully implemented. To accomplish this, it is crucial to perform large scale population screening to identify the individuals with early- or intermediate-stage of AMD and better predict those at risk of developing late AMD, but such a system is currently not available. Although articles have been published on automatic AMD pathology detection, none of these systems are available for screening due to lack of validation and commercial readiness. Considering this urgent need, we aim to develop an automated tool for AMD screening and prediction, and make it widely available in both urban and remote/rural areas and for large-scale screening through a telemedicine platform, and thereby prevent blindness. To establish the feasibility of our proposed telemedicine solution, patients are invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved camera at their own doctor&rsquos office. The photos will then be transmitted securely and analyzed by computer (telemedicine) for presence of absence of AMD. If sufficient accuracy by the automatic system can be established compared to expert human diagnosis, a larger scale study will be carried out.

Eligibility:

Inclusion Criteria:

- Subjects with AMD will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent

Exclusion Criteria:

- Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery.


Contents

The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy. [10] Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, [11] and in education. [12] [13] [14] Later, in the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman [15] and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments. [16]

The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", which described a Medical Research Council investigation. [17] [18] [19] One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT. [20]

Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s. [21]

By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine. [22] As of 2004, more than 150,000 RCTs were in the Cochrane Library. [20] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. [1] [4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.

Although the principle of clinical equipoise ("genuine uncertainty within the expert medical community. about the preferred treatment") common to clinical trials [23] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. [24] For another, "collective equipoise" can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). [25] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical "for most therapeutic trials." [26] [27]

Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally that is, they do not understand the difference between research and treatment. [28] [29] Further research is necessary to determine the prevalence of and ways to address this "therapeutic misconception". [29]

The RCT method variations may also create cultural effects that have not been well understood. [30] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.

Trial registration Edit

In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. [31] However, trial registration may still occur late or not at all. [32] [33] Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication. [34]

By study design Edit

One way to classify RCTs is by study design. From most to least common in the healthcare literature, the major categories of RCT study designs are: [35]

    – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention. [36][37] – over time, each participant receives (or does not receive) an intervention in a random sequence. [38][39] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention. [40][41] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).

An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. [35]

By outcome of interest (efficacy vs. effectiveness) Edit

RCTs can be classified as "explanatory" or "pragmatic." [42] Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. [42] In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions in this way, pragmatic RCTs can "inform decisions about practice." [42]

By hypothesis (superiority vs. noninferiority vs. equivalence) Edit

Another classification of RCTs categorizes them as "superiority trials", "noninferiority trials", and "equivalence trials", which differ in methodology and reporting. [43] Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. [43] Some RCTs are noninferiority trials "to determine whether a new treatment is no worse than a reference treatment." [43] Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other. [43]

The advantages of proper randomization in RCTs include: [44]

  • "It eliminates bias in treatment assignment," specifically selection bias and confounding.
  • "It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors."
  • "It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance."

There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations this may be a simple random assignment of patients to any of the groups at equal probabilities, may be "restricted", or may be "adaptive." A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random "systematic" methods of group assignment, such as alternating subjects between one group and the other, can cause "limitless contamination possibilities" and can cause a breach of allocation concealment. [45]

However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect. [46]

Procedures Edit

The treatment allocation is the desired proportion of patients in each treatment arm.

An ideal randomization procedure would achieve the following goals: [47]

  • Maximize statistical power, especially in subgroup analyses. Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure [48] ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment). [49]
  • Minimize selection bias. This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms. A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).
  • Minimize allocation bias (or confounding). This may occur when covariates that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an "accidental bias" [44][50] ). If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be biased if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).

However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.

Simple Edit

This is a commonly used and intuitive procedure, similar to "repeated fair coin-tossing." [44] Also known as "complete" or "unrestricted" randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects. [51]

Restricted Edit

To balance group sizes in smaller RCTs, some form of "restricted" randomization is recommended. [51] The major types of restricted randomization used in RCTs are:

  • Permuted-block randomization or blocked randomization: a "block size" and "allocation ratio" (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block. [45] For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with "stratified randomization", for example by center in a multicenter trial, to "ensure good balance of participant characteristics in each group." [4] A special case of permuted-block randomization is random allocation, in which the entire sample is treated as one block. [45] The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias. [47] Another disadvantage is that "proper" analysis of data from permuted-block-randomized RCTs requires stratification by blocks. [51]
  • Adaptive biased-coin randomization methods (of which urn randomization is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented. [45] The methods are thought to be less affected by selection bias than permuted-block randomization. [51]

Adaptive Edit

At least two types of "adaptive" randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:

  • Covariate-adaptive randomization, of which one type is minimization: The probability of being assigned to a group varies in order to minimize "covariate imbalance." [51] Minimization is reported to have "supporters and detractors" [45] because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors. [4]
  • Response-adaptive randomization, also known as outcome-adaptive randomization: The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable. [51] Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail. [52]

Allocation concealment Edit

"Allocation concealment" (defined as "the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study") is important in RCTs. [53] In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient. [45] Such practices introduce selection bias and confounders (both of which should be minimized by randomization), possibly distorting the results of the study. [45] Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded. Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.

Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE) sequentially numbered containers pharmacy controlled randomization and central randomization. [45] It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. [54] On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective. [55]

Sample size Edit

The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small. [56]

An RCT may be blinded, (also called "masked") by "procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received." [55] Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., physical therapy), participants cannot be blinded to the intervention.

Traditionally, blinded RCTs have been classified as "single-blind", "double-blind", or "triple-blind" however, in 2001 and 2006 two studies showed that these terms have different meanings for different people. [57] [58] The 2010 CONSORT Statement specifies that authors and editors should not use the terms "single-blind", "double-blind", and "triple-blind" instead, reports of blinded RCT should discuss "If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how." [4]

RCTs without blinding are referred to as "unblinded", [59] "open", [60] or (if the intervention is a medication) "open-label". [61] In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective [55] for example, in an RCT of treatments for multiple sclerosis, unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial. [62] In pragmatic RCTs, although the participants and providers are often unblinded, it is "still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes." [42]

The types of statistical methods used in RCTs depend on the characteristics of the data and include:

  • For dichotomous (binary) outcome data, logistic regression (e.g., to predict sustained virological response after receipt of peginterferon alfa-2a for hepatitis C[63] ) and other methods can be used.
  • For continuous outcome data, analysis of covariance (e.g., for changes in blood lipid levels after receipt of atorvastatin after acute coronary syndrome[64] ) tests the effects of predictor variables.
  • For time-to-event outcome data that may be censored, survival analysis (e.g., Kaplan–Meier estimators and Cox proportional hazards models for time to coronary heart disease after receipt of hormone replacement therapy in menopause[65] ) is appropriate.

Regardless of the statistical methods used, important considerations in the analysis of RCT data include:

  • Whether an RCT should be stopped early due to interim results. For example, RCTs may be stopped early if an intervention produces "larger than expected benefit or harm", or if "investigators find evidence of no important difference between experimental and control interventions." [4]
  • The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called "intention-to-treat analysis" is used). A "pure" intention-to-treat analysis is "possible only when complete outcome data are available" for all randomized subjects [66] when some outcome data are missing, options include analyzing only cases with known outcomes and using imputed data. [4] Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to. [4]
  • Whether subgroup analysis should be performed. These are "often discouraged" because multiple comparisons may produce false positive findings that cannot be confirmed by other studies. [4]

The CONSORT 2010 Statement is "an evidence-based, minimum set of recommendations for reporting RCTs." [67] The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on "individually randomised, two group, parallel trials" which are the most common type of RCT. [1]

For other RCT study designs, "CONSORT extensions" have been published, some examples are:

  • Consort 2010 Statement: Extension to Cluster Randomised Trials [68]
  • Consort 2010 Statement: Non-Pharmacologic Treatment Interventions [69][70]

Relative importance and observational studies Edit

Two studies published in The New England Journal of Medicine in 2000 found that observational studies and RCTs overall produced similar results. [71] [72] The authors of the 2000 findings questioned the belief that "observational studies should not be used for defining evidence-based medical care" and that RCTs' results are "evidence of the highest grade." [71] [72] However, a 2001 study published in Journal of the American Medical Association concluded that "discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common" between observational studies and RCTs. [73]

Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:

  • If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs. [74]
  • RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. [75][76] One example is combination chemotherapy including cisplatin for metastatictesticular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study. [76][77]

Interpretation of statistical results Edit

Like all statistical methods, RCTs are subject to both type I ("false positive") and type II ("false negative") statistical errors. Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. [78] Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many "negative" RCTs were too small to make definitive conclusions about the negative results, [79] by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations. [80]

Peer review Edit

Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet. [81]

RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:

  • As of 1998, the National Health and Medical Research Council of Australia designated "Level I" evidence as that "obtained from a systematic review of all relevant randomised controlled trials" and "Level II" evidence as that "obtained from at least one properly designed randomised controlled trial." [82]
  • Since at least 2001, in making clinical practice guideline recommendations the United States Preventive Services Task Force has considered both a study's design and its internal validity as indicators of its quality. [83] It has recognized "evidence obtained from at least one properly randomized controlled trial" with good internal validity (i.e., a rating of "I-good") as the highest quality evidence available to it. [83]
  • The GRADE Working Group concluded in 2008 that "randomised trials without important limitations constitute high quality evidence." [84]
  • For issues involving "Therapy/Prevention, Aetiology/Harm", the Oxford Centre for Evidence-based Medicine as of 2011 defined "Level 1a" evidence as a systematic review of RCTs that are consistent with each other, and "Level 1b" evidence as an "individual RCT (with narrow Confidence Interval)." [85]

Notable RCTs with unexpected results that contributed to changes in clinical practice include:

  • After Food and Drug Administration approval, the antiarrhythmic agentsflecainide and encainide came to market in 1986 and 1987 respectively. [86] The non-randomized studies concerning the drugs were characterized as "glowing", [87] and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989. [86] In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality. [88] Sales of the drugs then decreased. [86]
  • Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent myocardial infarction. [87] In 2002 and 2004, however, published RCTs from the Women's Health Initiative claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease. [65][89] Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied. [90][91] The use of hormone replacement therapy decreased after publication of the RCTs. [92]

Many papers discuss the disadvantages of RCTs. [75] [93] [94] Among the most frequently cited drawbacks are:

Time and costs Edit

RCTs can be expensive [94] one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million, [95] for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a "net benefit to society at 10-years" of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product. [95]

The conduct of an RCT takes several years until being published thus, data is restricted from the medical community for long years and may be of less relevance at time of publication. [96]

It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions. [75] [94]

Interventions to prevent events that occur only infrequently (e.g., sudden infant death syndrome) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies. [75]

Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation whereas the case report, for example, can detail many aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up). [96]

Conflict of interest dangers Edit

A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded "without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised." [97]

Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. [98] A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs "are more likely to be associated with statistically significant pro-industry findings." [99] These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. [100] One possible reason for the pro-industry results in industry-funded published RCTs is publication bias. [99] Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval. [101]

Ethics Edit

If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes "obvious" that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.

Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size however, these approaches are controversial in the scientific community and must be handled with care. [102]

Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue. Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.

Transport science Edit

Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials. [103] Graham-Rowe and colleagues [104] reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 "quality levels". They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.

Dr. Steve Melia [105] took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated. He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:

  1. Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)
  2. Is applied in a context or setting similar to that which applies to the control group
  3. Can be isolated from other activities—and the purpose of the study is to assess this isolated effect
  4. Has a short timescale between its implementation and maturity of its effects

And the causal mechanisms:

  1. Are either known to the researchers, or else all possible alternatives can be tested
  2. Do not involve significant feedback mechanisms between the intervention group and external environments
  3. Have a stable and predictable relationship to exogenous factors
  4. Would act in the same way if the control group and intervention group were reversed

Criminology Edit

A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. [106] The authors classified the studies they found into five categories: "policing", "prevention", "corrections", "court", and "community". [106] Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required "passing sentences that would randomly assign offenders to programmes") and therefore that experiments with quasi-experimental design are still necessary. [107]

Education Edit

RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. [108] For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. [109] Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19. [110]

A 2018 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the "unique time period assessment bias", the "background traits remain constant assumption", the "average treatment effects limitation", the "simple treatment at the individual level limitation", the "all preconditions are fully met assumption", the "quantitative variable limitation" and the "placebo only or conventional treatment only limitation". [111]

  1. ^ abc Schulz KF, Altman DG, ((Moher D for the CONSORT Group)) (2010). "CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials". Br Med J. 340: c332. doi:10.1136/bmj.c332. PMC2844940 . PMID20332509. CS1 maint: multiple names: authors list (link)
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  3. Chalmers TC, Smith H Jr, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A (1981). "A method for assessing the quality of a randomized control trial". Controlled Clinical Trials. 2 (1): 31–49. doi:10.1016/0197-2456(81)90056-8. PMID7261638.
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  5. "Randomised controlled trial". National Institute for Health and Care Excellence, London, UK. 2019 . Retrieved 3 June 2019 .
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  7. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J. 340: c869. doi:10.1136/bmj.c869. PMC2844943 . PMID20332511.
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  9. Hannan EL (June 2008). "Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations". JACC. Cardiovascular Interventions. 1 (3): 211–7. doi: 10.1016/j.jcin.2008.01.008 . PMID19463302.
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  11. Ranjith G (2005). "Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial". Psychother Psychosom. 74 (6): 387, author reply 387–8. doi:10.1159/000087787. PMID16244516. S2CID143644933.
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  13. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1976). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design". Br J Cancer. 34 (6): 585–612. doi:10.1038/bjc.1976.220. PMC2025229 . PMID795448.
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  15. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1977). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples". Br J Cancer. 35 (1): 1–39. doi:10.1038/bjc.1977.1. PMC2025310 . PMID831755.
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  29. ^ According to Denis Conniffe:

Ronald A. Fisher was "interested in application and in the popularization of statistical methods and his early book Statistical Methods for Research Workers, published in 1925, went through many editions and motivated and influenced the practical use of statistics in many fields of study. His Design of Experiments (1935) [promoted] statistical technique and application. In that book he emphasized examples and how to design experiments systematically from a statistical point of view. The mathematical justification of the methods described was not stressed and, indeed, proofs were often barely sketched or omitted altogether . a fact which led H. B. Mann to fill the gaps with a rigorous mathematical treatment in his well known treatise, Mann (1949)."


Placebos

Humans are marvelously complicated, which makes them difficult to work with as subjects for an experiment. For instance, when you give a subject an experimental medication and they exhibit signs of improvement, what is the reason? It could be the medicine, but there could also be some psychological effects. When someone thinks they are being given something that will make them better, sometimes they will get better. This is known as the placebo effect.

To mitigate any psychological effects of the subjects, sometimes a placebo is given to the control group. A placebo is designed to be as close to the means of administration of the experimental treatment as possible. But the placebo is not the treatment. For example, in the testing of a new pharmaceutical product, a placebo could be a capsule that contains a substance that has no medicinal value. By use of such a placebo, subjects in the experiment would not know whether they were given medication or not. Everyone, in either group, would be as likely to have psychological effects of receiving something that they thought was medicine.


Clinical Trials & Behavioral Studies

The Department of Psychiatry and Behavioral Sciences welcomes research participants ages 12 to 70 to enroll in studies aimed at improving the diagnosis and treatment of schizophrenia, bipolar disorder, Alzheimer’s disease, depression and anxiety. Browse the entries below and call the associated telephone numbers to learn how you can volunteer to help advance our understanding of psychiatric illness.

If you have questions, please call the Clinical Research Program office at 312-503-9100.

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less&hellip

We are working to understand how physiological changes during pregnancy and postpartum affect the metabolism of lamotrigine (Lamictal). Changes in the metabolism of lamotrigine have the potential to lead to less than therapeutic drug levels, which may cause an increase in mood symptoms. Participating in this study may help researchers better understand how to adjust lamotrigine in pregnancy and postpartum, which will in turn help reduce the recurrence of symptoms.

  • 3 overnight visits during pregnancy and 2 postpartum,
  • expert evaluation, mood assessments, and blood draws, and
  • to compensate for your time and effort, you will receive between $100 and $150 for each completed overnight visit.
  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lamotrigine (Lamictal) and planning to continue to take it during pregnancy and postpartum.

Participation involves one overnight visit per trimester and two postpartum. Each visit includes expert evaluation, mood assessments, and blood draws. To compensate for your time and effort you will be eligible to receive up to $750 for your participation in the study. Validation for on-site parking will be provided.

  • pregnancy planning or less than 27 weeks pregnant,
  • between the ages of 18 and 45, and
  • taking lithium (Lithium Carbonate) and plan to continue taking it during and after pregnancy.

The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the

blood changes due to the physiological changes in the body (i.e., increased metabolism, hormones, and body

fluid) during pregnancy and postpartum. Taking the same medication dose when you are pregnant may result in

an amount of drug in your blood that is different than when you are not pregnant. We will also study the impact

of genetic factors on the amount of drug in your blood. Drug metabolism (how medications are broken down,

absorbed, and removed from the body) differs among people because of their unique genetic make-up, which can

cause medications to be metabolized faster or slower. This means that when two people with different genetic

backgrounds take the same dose, the concentration of the medicine in their blood can vary dramatically.

Changes in antidepressant concentrations are important to monitor because a decrease in the blood level of the

drug may result in the antidepressant becoming ineffective and an increase in mood symptoms or recurrence of

depression may occur. An increase in antidepressant concentration may lead to side effects. We aim to better

understand the course of these changes across pregnancy and postpartum and determine how n woman’s genetic

makeup affects these changes. Our overall goal is to develop guidelines to optimize antidepressant treatment of


Resources for Distance Service Delivery

Note: Due to the urgency to share the information, some of the documents may not be fully accessible. For accessible version of the documents, please contact the publisher and/or author of the resources.

Click each topic for more information:

How VR Agencies are Responding - Effective Practices

Electronic Signatures
  1. Washington State DSB COVID-19 Agreements for Signatures and Extension Documentation: Washington State’s Department of Services for the Blind (DSB) has allowed staff to accept written or verbal agreement in place of a signature on Applications, extensions for Eligibility Determination, extensions for Individual Plans for Employment, and Individual Plans for Employment as a result of the COVID-19 crisis
  2. Arizona VR-Acceptable Signature Requirements During RSA Approved Special Circumstances
  3. Minnesota Blind - Dealing with Electronic Signatures
  4. U.S. Department of Veterans Affairs: VRE Signature Guidance COVID-19 Veteran program Participants: Although not a part of the State public VR program, the VA’s Federal VR and Employment program has modified their requirements for wet signatures during the COVID-19 crisis. This is an excellent example of a VR program responding to the need presented by the pandemic.
  5. Utah Permissions for Verbal and Written Signature Consent
  6. Utah Guidance for Documenting Verbal/Written Signature Consent
  7. Colorado VR-Electronic Signature Policy and Procedure
  8. California VR Electronic Signature Policy-Interim Email
  9. Michigan Bureau of Services for Blind Persons-COVID-19 Signature Policy
  10. 10/27/20 California DORS-Interim Policy Using Email for Electronic Signatures-Revised
Service Provision Vendors/Staff
  1. Texas Workforce Commission-VR Provider Resources This link directs you to the TWC-VR provider resources website page and includes instructions for temporary exceptions to certain requirements in the VR Providers Manual, and archived notices to providers.
  2. Nebraska General-Virtual Pre-ETS Guidance to Staff
  3. Nebraska Commission for the Blind-Services Provided
  4. Maryland DORS Guidance on the use of Teleconferencing to Provide Services
  • NC Blind Remote Pre-ETS Activities Weeks 1-3
  • March Newsletter
  • April Newsletter
  • NC Blind-Remote Pre-ETS Activities Week 4
  • NC Blind-Remote Pre-ETS Activities Week 5
  • NC Blind-Remote Pre-ETS Activities Week 6
  • NC Blind-Remote Pre-ETS Activities Week 7
  • NC Blind-Remote Pre-ETS Activities Week 8
  • NC Blind-Remote Pre-ETS Activities Week 9
  • NC Blind-Remote Pre-ETS Activities Week 10
  • NC Blind-Remote Pre-ETS Activities Week 11
  • NC Blind-Remote Pre-ETS Activities Week 12
  • NC Blind-Remote Pre-ETS Activities Week 13

Indiana VR Communications

  • Virtual teaching is taking place with various courses throughout the agency. Clients receive material delivery prior to virtual sessions for courses such as cooking, orientation and mobility, Braille lessons. So, similar format is being prepared for Summer Pre-Ets course curriculum. Students will be sent "package of materials" prior to scheduled virtual session. Parents, family or caregivers can be paid to be the "hands on coach" = financial incentive for meeting demand for coaches and helps with families who are frustrated with what little school systems provide.
Webinars
Other

Resources related to Teleworking and Telecounseling

  1. New Jersey Blind Telework PowerPoint
    This PowerPoint was developed by New Jersey Blind to give instruction to staff about teleworking. This covers the new normal, ideas for delivery of client services, professional development links and more.
  2. Sample Telework Agreement-Minnesota
  3. Indiana VR - Supervision within a Virtual Environment
  4. Utah VR Supervisory Telework Guidance
  5. Utah VR Counselor Telecommuting Guidance
  6. Idaho General - Meaningfull Work Ideas
  1. SHRM-Coronavirus and Teleworking: Tips for Preparing Your Workforce
  2. Ergonomic and Safety tips when working from home
  3. Technical Assistance Guide on Telecommuting in the Workplace A Corporate Partner Benefit of the National Business & Disability Council (NBDC) at The Viscardi Center August 2015
  4. Telework.gov: Guide to Telework in the Federal Government
  5. Virginia Commonwealth University (VCU) has a Telecommuting Resources page
  6. Tips for working remotely and combatting stress
  7. Got kids try these tips for working from home while they're with you
  8. NPR-For these federal employees telework means productivity is up and backlog is down
  9. Stanford-Parenting in the COVID-19 Era: Work-Life Balance Turning into Whack-A-Mole
  10. Mayo Clinic Tips for Coping During Telework
  1. Telecounseling Resource Collection: Developed by the Center for Innovative Training in Vocational Rehabilitation at George Washington University, this collection of resources and guidelines may be helpful when working with clients remotely.
  2. Utilizing Telerehabilitation to Deliver Vocational Rehabilitation Services Remotely as an Alternative to Traditional Counseling
  3. Studies on Video Counseling
    A randomized trial of web-based videoconferencing for substance abuse counseling
  4. Developing a Virtual Reality-Based Vocational Rehabilitation Training Program for Patients with Schizophrenia
  5. The Use of Videoconferencing for Persons with Chronic Conditions – A Systematic Review is a literature review conducted on the issue and may be of help for rehabilitation professionals interested in research on videoconferencing to deliver counseling services.
  6. Telerehabilitation Clinical and Vocational Applications for Assistive Technology: Research, Opportunities and Challenges
  7. Veterans Administration VR Tele-counseling Factsheet
  8. VA announces fully capable Tele-counseling service within its Vocational Rehabilitation and Employment Program
  9. Distance Check ins-Tips for Rehab Counselors Working from Home (by Kristen Dietart, CRC)

    Telehealth Resources

  1. E-Counseling in Psychosocial Cancer Care: A Survey of Practice, Attitudes, and Training Among Providers
  2. The Use of Video Conferencing for Persons with Chronic Conditions: A Systematic Review
  3. A Mobile Phone–Based Intervention to Improve Mental Health Among Homeless Young Adults: Pilot Feasibility Trial
  4. Human-Centered Design of Video-Based Health Education: An Iterative, Collaborative, Community-Based Approach
  5. APA's guidelines for tele-psychological practice
  6. TeleMental Health Institute
  7. Best Practices for an Online World
  8. Avoiding a Disconnect with Telemental Health
    This article discusses how telemental health can help practices run more smoothly and efficiently, increase access to needed treatment for individuals in remote areas, and expand the reach of the professional services psychotherapists offer.
  9. Should a clinician use telehealth to see patients while traveling?
    Practitioners must ensure they follow APA's Ethics Code when using telepsychology with clients.
  10. Practicing Telehealth
    The ethical and legal ways to treat your patients from afar.
  11. Limited Time APA Information On Tele-psychological Services
    The content on this webpage, usually reserved for paid members, is being made available to all readers during the COVID-19 crisis to aid the psychology community in their ever-vigilant effort to improve lives.

Online Training Options for VR Staff

The WINTAC website has a number of pre-recorded training sessions that are provided through a Training Management System. Click this link for WINTAC Training. A WINTAC user account is required to access all trainings.You will find instructions to set up that account in the first paragraph on that page. Topic areas covered within this portion of the website include: intro to WIOA performance, internal controls, order of selection and promising practices, apprenticeship strategies, career pathways, and many more.

In addition, the WINTAC Pre-employment transition services pre-recorded webinars can be found at this link. WINTAC Pre-ETS Webinars

IMPORTANT NOTE: In light of the recent flexibilities that went into effect on February 28th, the webinars have not been updated to reflect the new policy interpretation. It will be important for staff to have an understanding of those changes when watching the webinars. Here is a link to the Federal Register PDF. Federal Register Pre-ETS Flexibilities Notice of Interpretation

Finally, there are several training resources around the common performance accountability system and the RSA-911 Case Service Report webinars. Click here for the link

These short training videos, each under 10 minutes in length, provide VR professionals with short, direct, and relevant training materials on using The Career Index Plus’ multitude of features.

The National Rehabilitation Information Center is a library and information center focusing on disability and rehabilitation research. Click this link

Online courses, webinars, and programs can help you stay mentally engaged. Many of these learning tools also offer continuing education credits which can be applied toward certifications, memberships, and professional licensing.

WorkforceGPS, Employment and Training Administration, U.S. Department of Labor | Published 3/5/2020 | WorkforceGPS, Employment and Training Administration, U.S. Department of Labor.

The Disability and Employment eLearning Task Force in collaboration with the Employment and Training Administration (ETA) is developing eLearning Training Modules to help support the professional development needs of the workforce development staff across the country. eLearning Modules: - Module 1: Serving Individuals with Disabilities – A Day in the Life of an American Job Center (March 2020) - Module 2: Working Across Partners – A Day in the Life of an American Job Center (To Be Released during April, 2020) - Module 3: Providing Inclusive Business Services – A Day in the Life of an American Job Center (To Be Released during May, 2020)

  1. Ethics and Self-care: Why is professional self-care an ethical practice?
    This is a one-hour webcast on ethics and self-care made possible by the George Washington University Center for Innovative Training in Vocational Rehabilitation. Dr. Rob Froehlich and Dr. Maureen McGuire-Kuletz will discuss why professional self-care is an ethical practice and some strategies you can use in your own self-care routines.
  2. CIT-VR Telehealth Resources during the COVID-19 Outbreak
  3. Work Incentives Planning and Assistance National Training and Data Center

Two new online training are available on SSI Work Incentives Series: The Student Earned Income Exclusion (SEIE) and Impairment Related Work Expenses (IWRE) and Blind Work Expenses (BWE). Set up a myNTC account to access myNTC account. Each training is worth three continuing education credits and they are worth two clock hours if you are interested in CRC credits.

A webinar covering current legal and regulatory factors, obstacles and solutions of interjurisdictional telepsychology practice, and ASPPB's Psychology Interjurisdictional Compact (PSYPACT) Initiative.

This presentation provides practical considerations for using phone apps. It introduces a competency-based framework for including phone apps in clinical practice and provides specific and practical ways in which phone apps can be used in practice.

APA’s Continuing Education (CE) Office has curated a list of telehealth courses. More resources are being developed on a regular basis.

HKNC is offering professional learning courses, free of charge, up to May 31, 2020. We know that you are most likely sheltering at home and practicing social distancing due to COVID-19, and we hope these resources are helpful in supporting the needs of individuals who are deaf-blind. Continuing Education Credits (CEUs) are offered with many of our courses. Click to access the class catalogue. All courses are asynchronous and designed to learn at your own pace. Click to access other resources and training tools. Contact the HKNC
Regional Representative for your state, for the coupon code. Click for the information for the field offices for reference.

Provides online continuing education courses for rehabilitation counselors. Course bundles, unlimited subscriptions, and course packages are available for cost.

Provides a variety of multimedia online counseling CEUs via on-demand and live webinar courses for a fee. Although the mental health and rehabilitation counseling courses available through this organization are written to the CRCC standards for post-approval, three CEU courses are pre-approved each year by CRCC.

The American Counseling Association offers select sessions/courses that are approved by the CRCC. Members receive discounted rates. A limited number of free courses are available.

Offers a variety of home study courses for CRC renewal for a fee. Welcomes the opportunity to answer questions by offering three contact options (online “contact us” web portal, email at [email protected], toll free phone 800-230-2263)

The Commission on Rehabilitation Counselor Certification offers an extensive online course catalog. Individual course fees or an annual plan option is available.

Courses have been pre-approved by the Commission for Rehabilitation Counselor. A limited number of free courses are available. Certification and are available online 24/7 and are interactive. Courses and transcripts are accessible for 1 year from date of purchase.

Several free webinars related to vocational rehabilitation are available. Must read the fine print to determine if CRC credit given.

Courses cover a variety of topics. Individual and bundle packages are available for purchase in traditional print format or PDF format. Bundle packages can be tailored to suit needs.

A limited number of free CEU courses are valid for CRC renewal. 9.5 hours of approved credits for the 2019 KT Online Conference are pre-approved through October 27,2020. Listen to the YouTube presentations and complete and submit the evaluation to receive the verification of completion form. Once you submit the evaluation, the evaluation will be checked. The verification of completion form will be sent via email within a day or two.

Offers CRC continuing education units for $4.00 per Continuing Education Credit Hour or by membership for $95 per year. A limited number of courses are free.

Free continuing education units available. Each course lists the amount of CRC credit available.

CRCs can receive post-approval CE credits for completing fee based and free courses offered. Approval of post-education must be completed through the Commission on Rehabilitation Counselor Certification (CRCC) online portal. Please see the CRCC Criteria for Certification Renewal and Continuing Education Manual for specific information about continuing education approval.

The University of Wisconsin-Stout VRI offers free webcasts worth one CRC.

Provides a variety of continuing education courses via live webinars, on-demand recorded webinars, and other online continuing education course content for a fee.

Organization offers a limited number of free training and cost-based CEU courses for credit.

Remote delivery of services by Topic area

    When deciding on what online resources you will use, here are some thoughts for consideration.

  • Make sure the curriculum or activities the providers use are consistent, and that VR (you) approves of the activities they are doing/curriculum they are using.
  • Determine the method you will use to ensure documentation of student attendance and progress.
  • For those students who are not able to access the internet or participate remotely, the VR counselor or provider will want to circle back around with those students and ensure services are provided in another format if they need them, once they get back to school.

  • Explore-Work - This option was developed by WINTAC as a resource for you when delivering Pre-ETS for students remotely. Explore-Work has the option for the student to choose either the VR counselor or provider to be receiving email notices of student progress from the site.
  • Pathways to the Future (West Virginia) This includes sample lesson plans and detailed curricula for students with disabilities that schools,VR, or other partners could use in delivering any of the five required Pre-ETS services. We advise that you thoroughly review these to see what activities you would approve your vendors using.
  • GCFLearnFree.org program

GCFLearnFree.org offers more than 200 topics, including more than 7,000 lessons, more than 1,000 videos, and more than 50 interactive links and games, completely free. We advise that you thoroughly review these to see what activities you would approve your vendors using.

  • New Course: Connecting with Employers and Families - Now Online
    Connecting with Employers and Families! Employers and families are critical partners throughout the transition planning process. Students need support making connections with businesses and employers in their community. Their families bring a unique perspective on their son or daughter’s abilities, preferences, strengths, and challenges. Engaging families and employers in meaningful ways will improve the delivery of pre-ETS. Two video lessons address how to collaborate effectively with these stakeholders. These lessons include: Best practices, Practical tips and strategies, How to overcome common barriers and concerns, Examples of successful collaboration, and featured videos of families and employers sharing their perspectives
  • New Course: Instruction in Self-Advocacy
    Click here to explore the course!
    Are you looking for strategies that empower students to speak up for themselves, understand their strengths and weaknesses, know what they need to succeed, and how to communicate these needs to others? Have you been searching for information on how to equip students to actively participate and have input on life decisions? Understanding the elements of self-advocacy will help you in preparing students to take on current and future challenges. Instruction in self-advocacy gives students the confidence to ask for the tools they need to be successful in the real world. Our new self-advocacy course will help Pre-ETS providers assist students in becoming strong and effective advocates. In these lessons you will -discover the importance of students acquiring self-advocacy skills for successful adult outcomes, identify the key self-advocacy skills and understand the elements of self-advocacy. You will also find seven video activities that support the development of self-advocacy skills. Each activity includes a featured video of individuals sharing their self-advocacy stories and experiences.

    3.26.20 WINTAC Webinar - WINTAC Pre-ETS Discussion with States

No Barriers podcasts-We are all facing unprecedented times. Embrace adaptation to help break through your barriers and come out on the other side stronger than ever. The Alchemy Series to get to podcasts and episode specific tip sheets to maximize learning Tips Sheets

    Implementation of Section 511 Requirements

RSA is currently awaiting clearance to address the issue of the delay in providing career counseling and information and referral (CC&I&R) services due to the pandemic and how that delay affects the ability of the 14c employer to be in compliance with annual CC&I&R timeframes. Once we have the answer to this question, we will post it on our website immediately.

    Remote Training or Technical Assistance

  • The WINTAC Service Integration/Alignment Team is available for remote technical assistance and training in the areas of WIOA implementation related to customer service in the collaborative workforce environment
  • Logistics for remote training or technical assistance arranged by contacting Doug Keast [email protected]
  • For Counselor/Staff Training, will engage a combination of

  • The IRT and WIOA: The Strategy and Its Relevance – recorded Training A strategy that can facilitate WIOA’s customer service vision in a remote service environment.
  • Assessing WIOA Service Integration: The Integration Continuum – recorded training
  • The IRT and WIOA: The Strategy and Its Relevance – recorded Training
  • Career Services in the American Job Center – recorded training
  • Career Pathways - A Roadmap for Innovation and Integration – recorded training
  • Career Pathways Checklist – WINTAC has developed this review to help your agency determine where it is positioned with regard to providing career counseling and rehabilitation services within a Career Pathways structure. This checklist includes a broad-range perspective that supports agencies in providing services for the people (and industries) they serve. Numerous resources are also included.
  • WIOA Implementation Checklist - Implementing WIOA according to its vision in the act and in RSA TAC 15-01 with regard to service alignment and integration with the other Core and Required partners is a multi-step process. From a customer service standpoint, the nature and impact of the services provided and received have as much to do with how state and local partners work together as the guidance for implementation itself. To support your agency in this process, WINTAC has created a checklist to assist with your ongoing review of this implementation.
  • COVID-19 FAQ - WIOA Performance Accountability Provisions
    The Office of Special Education and Rehabilitative Services’ Rehabilitation Services Administration (RSA) announced the U.S. Department of Education has released an initial frequently-asked questions document related to implementing performance accountability provisions under title I of the Workforce Innovation and Opportunity Act (WIOA) as State Vocational Rehabilitation (VR) agencies seek to provide continuity of operations for individuals with disabilities in the COVID-19 environment.
  • COVID-19 FAQ - VR Administrative and Program Requirements
    The Rehabilitation Services Administration (RSA), within the U.S. Department of Education’s (Department) Office of Special Education and Rehabilitative Services, issues this Questions and Answers document in response to inquiries concerning the administration of the State Vocational Rehabilitation (VR) Services, American Indian Vocational Rehabilitation Services (AIVRS), and Randolph-Sheppard programs as grantees seek to provide continuity of operations for individuals with disabilities in the current COVID-19 environment. Regarding data collection and reporting, this FAQ includes responses to questions on the implementation of PD 19-03 (RSA-911) and the effects of COVID-19 on the Statistical Adjustment Model.
  • WINTAC hosted a panel discussion related to COVID-19 data integrity strategies on May 19, 2020. Four State VR agencies were invited to discuss their policies and procedures specifically around providing services remotely while maintaining data integrity and confidentiality. Access the recorded webinar and additional information here.

The role of Labor Market Information (LMI) in the VR Process will be more important than ever in the coming months. Now is the time to train on using LMI Resources and to educate yourself and your clients on higher education, labor rights, and other LMI related topics during this pandemic.


Contents

The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy. [10] Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, [11] and in education. [12] [13] [14] Later, in the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman [15] and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments. [16]

The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", which described a Medical Research Council investigation. [17] [18] [19] One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT. [20]

Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s. [21]

By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine. [22] As of 2004, more than 150,000 RCTs were in the Cochrane Library. [20] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. [1] [4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.

Although the principle of clinical equipoise ("genuine uncertainty within the expert medical community. about the preferred treatment") common to clinical trials [23] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. [24] For another, "collective equipoise" can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). [25] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical "for most therapeutic trials." [26] [27]

Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally that is, they do not understand the difference between research and treatment. [28] [29] Further research is necessary to determine the prevalence of and ways to address this "therapeutic misconception". [29]

The RCT method variations may also create cultural effects that have not been well understood. [30] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.

Trial registration Edit

In 2004, the International Committee of Medical Journal Editors (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. [31] However, trial registration may still occur late or not at all. [32] [33] Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication. [34]

By study design Edit

One way to classify RCTs is by study design. From most to least common in the healthcare literature, the major categories of RCT study designs are: [35]

    – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention. [36][37] – over time, each participant receives (or does not receive) an intervention in a random sequence. [38][39] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention. [40][41] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).

An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. [35]

By outcome of interest (efficacy vs. effectiveness) Edit

RCTs can be classified as "explanatory" or "pragmatic." [42] Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. [42] In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions in this way, pragmatic RCTs can "inform decisions about practice." [42]

By hypothesis (superiority vs. noninferiority vs. equivalence) Edit

Another classification of RCTs categorizes them as "superiority trials", "noninferiority trials", and "equivalence trials", which differ in methodology and reporting. [43] Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. [43] Some RCTs are noninferiority trials "to determine whether a new treatment is no worse than a reference treatment." [43] Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other. [43]

The advantages of proper randomization in RCTs include: [44]

  • "It eliminates bias in treatment assignment," specifically selection bias and confounding.
  • "It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors."
  • "It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance."

There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations this may be a simple random assignment of patients to any of the groups at equal probabilities, may be "restricted", or may be "adaptive." A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random "systematic" methods of group assignment, such as alternating subjects between one group and the other, can cause "limitless contamination possibilities" and can cause a breach of allocation concealment. [45]

However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect. [46]

Procedures Edit

The treatment allocation is the desired proportion of patients in each treatment arm.

An ideal randomization procedure would achieve the following goals: [47]

  • Maximize statistical power, especially in subgroup analyses. Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure [48] ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment). [49]
  • Minimize selection bias. This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms. A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).
  • Minimize allocation bias (or confounding). This may occur when covariates that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an "accidental bias" [44][50] ). If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be biased if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).

However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.

Simple Edit

This is a commonly used and intuitive procedure, similar to "repeated fair coin-tossing." [44] Also known as "complete" or "unrestricted" randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects. [51]

Restricted Edit

To balance group sizes in smaller RCTs, some form of "restricted" randomization is recommended. [51] The major types of restricted randomization used in RCTs are:

  • Permuted-block randomization or blocked randomization: a "block size" and "allocation ratio" (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block. [45] For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with "stratified randomization", for example by center in a multicenter trial, to "ensure good balance of participant characteristics in each group." [4] A special case of permuted-block randomization is random allocation, in which the entire sample is treated as one block. [45] The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias. [47] Another disadvantage is that "proper" analysis of data from permuted-block-randomized RCTs requires stratification by blocks. [51]
  • Adaptive biased-coin randomization methods (of which urn randomization is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented. [45] The methods are thought to be less affected by selection bias than permuted-block randomization. [51]

Adaptive Edit

At least two types of "adaptive" randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:

  • Covariate-adaptive randomization, of which one type is minimization: The probability of being assigned to a group varies in order to minimize "covariate imbalance." [51] Minimization is reported to have "supporters and detractors" [45] because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors. [4]
  • Response-adaptive randomization, also known as outcome-adaptive randomization: The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable. [51] Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail. [52]

Allocation concealment Edit

"Allocation concealment" (defined as "the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study") is important in RCTs. [53] In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient. [45] Such practices introduce selection bias and confounders (both of which should be minimized by randomization), possibly distorting the results of the study. [45] Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded. Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.

Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE) sequentially numbered containers pharmacy controlled randomization and central randomization. [45] It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. [54] On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective. [55]

Sample size Edit

The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small. [56]

An RCT may be blinded, (also called "masked") by "procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received." [55] Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., physical therapy), participants cannot be blinded to the intervention.

Traditionally, blinded RCTs have been classified as "single-blind", "double-blind", or "triple-blind" however, in 2001 and 2006 two studies showed that these terms have different meanings for different people. [57] [58] The 2010 CONSORT Statement specifies that authors and editors should not use the terms "single-blind", "double-blind", and "triple-blind" instead, reports of blinded RCT should discuss "If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how." [4]

RCTs without blinding are referred to as "unblinded", [59] "open", [60] or (if the intervention is a medication) "open-label". [61] In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective [55] for example, in an RCT of treatments for multiple sclerosis, unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial. [62] In pragmatic RCTs, although the participants and providers are often unblinded, it is "still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes." [42]

The types of statistical methods used in RCTs depend on the characteristics of the data and include:

  • For dichotomous (binary) outcome data, logistic regression (e.g., to predict sustained virological response after receipt of peginterferon alfa-2a for hepatitis C[63] ) and other methods can be used.
  • For continuous outcome data, analysis of covariance (e.g., for changes in blood lipid levels after receipt of atorvastatin after acute coronary syndrome[64] ) tests the effects of predictor variables.
  • For time-to-event outcome data that may be censored, survival analysis (e.g., Kaplan–Meier estimators and Cox proportional hazards models for time to coronary heart disease after receipt of hormone replacement therapy in menopause[65] ) is appropriate.

Regardless of the statistical methods used, important considerations in the analysis of RCT data include:

  • Whether an RCT should be stopped early due to interim results. For example, RCTs may be stopped early if an intervention produces "larger than expected benefit or harm", or if "investigators find evidence of no important difference between experimental and control interventions." [4]
  • The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called "intention-to-treat analysis" is used). A "pure" intention-to-treat analysis is "possible only when complete outcome data are available" for all randomized subjects [66] when some outcome data are missing, options include analyzing only cases with known outcomes and using imputed data. [4] Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to. [4]
  • Whether subgroup analysis should be performed. These are "often discouraged" because multiple comparisons may produce false positive findings that cannot be confirmed by other studies. [4]

The CONSORT 2010 Statement is "an evidence-based, minimum set of recommendations for reporting RCTs." [67] The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on "individually randomised, two group, parallel trials" which are the most common type of RCT. [1]

For other RCT study designs, "CONSORT extensions" have been published, some examples are:

  • Consort 2010 Statement: Extension to Cluster Randomised Trials [68]
  • Consort 2010 Statement: Non-Pharmacologic Treatment Interventions [69][70]

Relative importance and observational studies Edit

Two studies published in The New England Journal of Medicine in 2000 found that observational studies and RCTs overall produced similar results. [71] [72] The authors of the 2000 findings questioned the belief that "observational studies should not be used for defining evidence-based medical care" and that RCTs' results are "evidence of the highest grade." [71] [72] However, a 2001 study published in Journal of the American Medical Association concluded that "discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common" between observational studies and RCTs. [73]

Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:

  • If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs. [74]
  • RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. [75][76] One example is combination chemotherapy including cisplatin for metastatictesticular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study. [76][77]

Interpretation of statistical results Edit

Like all statistical methods, RCTs are subject to both type I ("false positive") and type II ("false negative") statistical errors. Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. [78] Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many "negative" RCTs were too small to make definitive conclusions about the negative results, [79] by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations. [80]

Peer review Edit

Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet. [81]

RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:

  • As of 1998, the National Health and Medical Research Council of Australia designated "Level I" evidence as that "obtained from a systematic review of all relevant randomised controlled trials" and "Level II" evidence as that "obtained from at least one properly designed randomised controlled trial." [82]
  • Since at least 2001, in making clinical practice guideline recommendations the United States Preventive Services Task Force has considered both a study's design and its internal validity as indicators of its quality. [83] It has recognized "evidence obtained from at least one properly randomized controlled trial" with good internal validity (i.e., a rating of "I-good") as the highest quality evidence available to it. [83]
  • The GRADE Working Group concluded in 2008 that "randomised trials without important limitations constitute high quality evidence." [84]
  • For issues involving "Therapy/Prevention, Aetiology/Harm", the Oxford Centre for Evidence-based Medicine as of 2011 defined "Level 1a" evidence as a systematic review of RCTs that are consistent with each other, and "Level 1b" evidence as an "individual RCT (with narrow Confidence Interval)." [85]

Notable RCTs with unexpected results that contributed to changes in clinical practice include:

  • After Food and Drug Administration approval, the antiarrhythmic agentsflecainide and encainide came to market in 1986 and 1987 respectively. [86] The non-randomized studies concerning the drugs were characterized as "glowing", [87] and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989. [86] In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality. [88] Sales of the drugs then decreased. [86]
  • Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent myocardial infarction. [87] In 2002 and 2004, however, published RCTs from the Women's Health Initiative claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease. [65][89] Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied. [90][91] The use of hormone replacement therapy decreased after publication of the RCTs. [92]

Many papers discuss the disadvantages of RCTs. [75] [93] [94] Among the most frequently cited drawbacks are:

Time and costs Edit

RCTs can be expensive [94] one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million, [95] for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a "net benefit to society at 10-years" of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product. [95]

The conduct of an RCT takes several years until being published thus, data is restricted from the medical community for long years and may be of less relevance at time of publication. [96]

It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions. [75] [94]

Interventions to prevent events that occur only infrequently (e.g., sudden infant death syndrome) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies. [75]

Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation whereas the case report, for example, can detail many aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up). [96]

Conflict of interest dangers Edit

A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded "without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised." [97]

Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. [98] A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs "are more likely to be associated with statistically significant pro-industry findings." [99] These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. [100] One possible reason for the pro-industry results in industry-funded published RCTs is publication bias. [99] Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval. [101]

Ethics Edit

If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes "obvious" that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.

Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size however, these approaches are controversial in the scientific community and must be handled with care. [102]

Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue. Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.

Transport science Edit

Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials. [103] Graham-Rowe and colleagues [104] reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 "quality levels". They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.

Dr. Steve Melia [105] took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated. He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:

  1. Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)
  2. Is applied in a context or setting similar to that which applies to the control group
  3. Can be isolated from other activities—and the purpose of the study is to assess this isolated effect
  4. Has a short timescale between its implementation and maturity of its effects

And the causal mechanisms:

  1. Are either known to the researchers, or else all possible alternatives can be tested
  2. Do not involve significant feedback mechanisms between the intervention group and external environments
  3. Have a stable and predictable relationship to exogenous factors
  4. Would act in the same way if the control group and intervention group were reversed

Criminology Edit

A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. [106] The authors classified the studies they found into five categories: "policing", "prevention", "corrections", "court", and "community". [106] Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required "passing sentences that would randomly assign offenders to programmes") and therefore that experiments with quasi-experimental design are still necessary. [107]

Education Edit

RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. [108] For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. [109] Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19. [110]

A 2018 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the "unique time period assessment bias", the "background traits remain constant assumption", the "average treatment effects limitation", the "simple treatment at the individual level limitation", the "all preconditions are fully met assumption", the "quantitative variable limitation" and the "placebo only or conventional treatment only limitation". [111]

  1. ^ abc Schulz KF, Altman DG, ((Moher D for the CONSORT Group)) (2010). "CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials". Br Med J. 340: c332. doi:10.1136/bmj.c332. PMC2844940 . PMID20332509. CS1 maint: multiple names: authors list (link)
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  3. Chalmers TC, Smith H Jr, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A (1981). "A method for assessing the quality of a randomized control trial". Controlled Clinical Trials. 2 (1): 31–49. doi:10.1016/0197-2456(81)90056-8. PMID7261638.
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  5. "Randomised controlled trial". National Institute for Health and Care Excellence, London, UK. 2019 . Retrieved 3 June 2019 .
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  7. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J. 340: c869. doi:10.1136/bmj.c869. PMC2844943 . PMID20332511.
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  9. Hannan EL (June 2008). "Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations". JACC. Cardiovascular Interventions. 1 (3): 211–7. doi: 10.1016/j.jcin.2008.01.008 . PMID19463302.
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  11. Ranjith G (2005). "Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial". Psychother Psychosom. 74 (6): 387, author reply 387–8. doi:10.1159/000087787. PMID16244516. S2CID143644933.
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  13. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1976). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design". Br J Cancer. 34 (6): 585–612. doi:10.1038/bjc.1976.220. PMC2025229 . PMID795448.
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  15. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1977). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples". Br J Cancer. 35 (1): 1–39. doi:10.1038/bjc.1977.1. PMC2025310 . PMID831755.
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  17. Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H (2004). "Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial". Lancet. 364 (9429): 141–8. doi:10.1016/S0140-6736(04)16626-9. PMID15246726. S2CID24361586.
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  19. Dunn PM (January 1997). "James Lind (1716-94) of Edinburgh and the treatment of scurvy". Arch. Dis. Child. Fetal Neonatal Ed. 76 (1): F64–5. doi:10.1136/fn.76.1.f64. PMC1720613 . PMID9059193.
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  21. Charles Sanders Peirce and Joseph Jastrow (1885). "On Small Differences in Sensation". Memoirs of the National Academy of Sciences. 3: 73–83. http://psychclassics.yorku.ca/Peirce/small-diffs.htm
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  23. Hacking, Ian (September 1988). "Telepathy: Origins of Randomization in Experimental Design". Isis. A Special Issue on Artifact and Experiment. 79 (3): 427–451. doi:10.1086/354775. JSTOR234674. MR1013489. S2CID52201011.
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  25. Stephen M. Stigler (November 1992). "A Historical View of Statistical Concepts in Psychology and Educational Research". American Journal of Education. 101 (1): 60–70. doi:10.1086/444032. S2CID143685203.
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  27. Trudy Dehue (December 1997). "Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design" (PDF) . Isis. 88 (4): 653–673. doi:10.1086/383850. PMID9519574. S2CID23526321.
  28. ^ Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." Statistical Science 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.
  29. ^ According to Denis Conniffe:

Ronald A. Fisher was "interested in application and in the popularization of statistical methods and his early book Statistical Methods for Research Workers, published in 1925, went through many editions and motivated and influenced the practical use of statistics in many fields of study. His Design of Experiments (1935) [promoted] statistical technique and application. In that book he emphasized examples and how to design experiments systematically from a statistical point of view. The mathematical justification of the methods described was not stressed and, indeed, proofs were often barely sketched or omitted altogether . a fact which led H. B. Mann to fill the gaps with a rigorous mathematical treatment in his well known treatise, Mann (1949)."


Attention: Change Blindness and Inattentional Blindness

Visual Attention versus Visual Experience

CB and IB can be regarded as two forms of the perceptual failure created by the diversion of attentional resources. They can be distinguished at the functional level by the type of information involved (second- or first-order information, respectively). They also appear to be distinguished by the type of attention involved (focused or diffuse) and the kinds of operations (e.g., comparison) associated with these. This division may correspond to the two modes sometimes proposed for conscious visual experience: an object mode associated with focused attention and a background mode operating as default. Beyond this, however, only partial and tentative conclusions can be drawn regarding the issue of how visual attention relates to conscious visual experience.

In the case where attention of any kind is absent, there does not appear to be any conscious experience of stimuli (second-order quantities for focused attention first-order quantities for diffuse). However, results still point to a considerable amount of processing being carried out. For example, work on IB indicates that unattended – and therefore unseen – items can influence the perception of attended items. Similarly, some models of CB posit low-level representations with a degree of detail and feature binding (proto-objects) that are formed in the absence of this kind of attention.

It is worth pointing out that observers in IB experiments often report that they can detect something about the nonselected stimuli, even though they cannot always identify it. Importantly, this kind of experience is found only in those experiments involving superimposed or interspersed stimuli for dichoptically presented stimuli, there is a complete absence of perception of the nonselected event. This suggests that in the superimposed and interspersed conditions diffuse attention is given to nonselected events, with the main event given focused attention. If so, this would suggest that identification and localization may require more focused attention (or related resource), and that both diffuse and focused attention may be allocated simultaneously to different stimuli.

This proposal would be consistent with work on CB. Focused attention is needed only for the perception of complex quantities such as change background items not given focused attention might still be seen, but only in regards to detection and perhaps a limited form of identification based on relatively fragmented pieces of static items.


Aims and objectives

The aim of this research project is to investigate the impact of combined working memory training and tDCS protocols in individuals following a brain injury in terms of the training gains, change in objective measures of working memory, mood and fatigue, as well as participants’ perceptions of day-to-day memory function and subjective benefit of the training program.

Specifically, our primary objective is to determine if the combination of tDCS and working memory training is superior to working memory training alone to improve working memory function in an n-back task in an ABI population. The key secondary objectives are to determine if the combination of brain stimulation with working memory training can:

boost performance in other cognitive domains (attention, executive functions)

lengthen improvement duration to 1 month

increase improvement magnitude

To address the above questions, we will use a randomized clinical trial, assessor- and patient-blinded with two parallel groups and a simple randomization with a 1:1 allocation ratio.


The New Nuremberg Trials 2021 | BREAKING-NEWS.CA

Fuellmich and his team present the faulty PCR test and the order for doctors to label any comorbidity death as a Covid death as fraud. The PCR test was never designed to detect pathogens and is 100% faulty at 35 cycles. All the PCR tests overseen by the CDC are set at 37 to 45 cycles. The CDC admits that any tests over 28 cycles are not admissible for a positive reliable result. This alone invalidates over 90% of the alleged covid cases / ”infections” tracked by the use of this faulty test.

In addition to the flawed tests and fraudulent death certificates, the “experimental” vaccine itself is in violation of Article 32 of the Geneva Convention. Under Article 32 of the 1949 Geneva Convention IV, “mutilation and medical or scientific experiments not necessitated by the medical treatment of a protected person” are prohibited. According to Article 147, conducting biological experiments on protected persons is a grave breach of the Convention.

The “experimental” vaccine is in violation of all 10 of the Nuremberg Codes which carry the death penalty for those who seek to violate these International Laws.

The “vaccine” fails to meet the following five requirements to be considered a vaccine and is by definition a medical “experiment” and trial:

Provides immunity to the virus
This is a “leaky” gene therapy that does not provide immunity to Covid and claims to reduce symptoms yet double-vaccinated are now 60% of the patients requiring ER or ICU with covid infections.

Protects recipients from getting the virus
This gene-therapy does not provide immunity and double-vaccinated can still catch and spread the virus.

Reduces deaths from the virus infection
This gene-therapy does not reduce deaths from the infection. Double-Vaccinated infected with Covid have also died.

Reduces circulation of the virus
This gene-therapy still permits the spread of the virus as it offers zero immunity to the virus.

Reduces transmission of the virus
This gene-therapy still permits the transmission of the virus as it offers zero immunity to the virus.

The following violations of the Nuremberg Code are as follows:

Nuremberg Code #1: Voluntary Consent is Essential

No person should be forced to take a medical experiment without informed consent. Many media, political and non-medical persons are telling people to take the shot. They offer no information as to the adverse effects or dangers of this gene-therapy. All you hear from them is – “ safe and effective” and “ benefits outweigh the risks.” Countries are using lockdowns, duress and threats to force people to take this vaccine or be prohibited to participate in free society under the mandate of a Vaccine Passport or Green Pass. During the Nuremberg trials, even the media was prosecuted and members were put to death for lying to the public, along with many of the doctors and Nazis found guilty of Crimes Against Humanity.

Nuremberg Code #2: Yield Fruitful Results Unprocurable By Other Means

As listed above, the gene-therapy does not meet the criteria of a vaccine and does not offer immunity to the virus. There are other medical treatments that yield fruitful results against Covid such as Ivermectin, Vitamin D, Vitamin C, Zinc and boosted immune systems for flu and colds.

Nuremberg Code #3: Base Experiments on Results of Animal Experimentation and Natural History of Disease

This gene therapy skipped animal testing and went straight to human trials. In mRNA research that Pfizer used – a candidate study on mRNA with rhesus macaques monkeys using BNT162b2 mRNA and in that study all the monkeys developed pulmonary inflammation but the researchers considered the risk low as these were young healthy monkeys from the age of 2-4. Israel has used Pfizer and the International Court of Law has accepted a claim for 80% of the recipients having pulmonary inflammation from being injected with this gene-therapy. Despite this alarming development Pfizer proceeded to develop their mRNA for Covid without animal testing.

Nuremberg Code #4: Avoid All Unnecessary Suffering and Injury

Since the rollout of the experiment and listed under the CDC VAERS reporting system over 4,000 deaths and 50,000 vaccine injuries have been reported in America. In the EU over 7,000 deaths and 365,000 vaccine injuries have been reported. This is a grievous violation of this code.

Nuremberg Code #5: No Experiment to be Conducted if There’s Reason to Think Injury or Death Will Occur

See #4, based on fact-based medical data this gene-therapy is causing death and injury. Past research on mRNA also shows several risks that have been ignored for this current trial gene-experiment. A 2002 study on SARS-CoV-1 spike proteins showed they cause inflammation, immunopathology, blood clots, and impede Angiotensin 2 expression. This experiment forces the body to produce this spike-protein inheriting all these risks.

Nuremberg Code #6: Risk Should Never Exceed the Benefit

Covid-19 has a 98-99% recovery rate. The vaccine injuries, deaths and adverse side-effects of mRNA gene-therapy far exceed this risk. The use of “leaky” vaccines was banned for agriculture use by the US and EU due to the Marek Chicken study that shows ‘hot-viruses’ and variants emerge… making the disease even more deadly. Yet, this has been ignored for human use by the CDC knowing fully the risk of new deadlier variants emerge from leaky vaccinations. The CDC is fully aware that the use of leaky vaccines facilitates the emergence of hot (deadlier)strains. Yet they’ve ignored this when it comes to human

Nuremberg Code #7: Preparation Must Be Made Against Even Remote Possibility of Injury, Disability or Death

There were no preparations made. This gene therapy skipped animal trials. The pharmaceutical companies’ own Phase 3 human clinical trials will not conclude until 2022 /2023. These vaccines were approved under an Emergency Use only act and forced on a misinformed public. They are NOT FDA-approved.

Nuremberg Code #8: Experiment Must Be Conducted by Scientifically Qualified Persons

Politicians, media and actors claiming that this is a safe and effective vaccine are not qualified. Propaganda is not medical science. Many retail outlets such as Walmart & drive-through vaccine centers are not qualified to administer experimental medical gene-therapies to the uninformed public.

Nuremberg Code #9: Anyone Must Have the Freedom to Bring the Experiment to an End At Any Time

Despite the outcry of over 85,000 doctors, nurses, virologists and epidemiologists – the experiment is not being ended. In fact, there are currently many attempts to change laws in order to force vaccine compliance. This includes mandatory and forced vaccinations. Experimental ‘update’ shots are planned for every 6 months without any recourse to the growing number of deaths and injuries already caused by this experiment. These ‘update’ shots will be administered without any clinical trials. Hopefully this new Nuremberg Trial will put an end to this crime against humanity.

Nuremberg Code #10: The Scientist Must Bring the Experiment to an End At Any Time if There’s Probable Cause of it Resulting in Injury or Death

It is clear in the statistical reporting data that this experiment is resulting in death and injury yet all the politicians, drug companies and so-called experts are not making any attempt to stop this gene-therapy experiment from inflicting harm on a misinformed public.

What can you do to help put an end to this crime against humanity? Share this information. Hold your politicians, media, doctors and nurses accountable – that if they are complicit in this crime against humanity they too are subject to the laws set forth in the Geneva Convention and Nuremberg Code and can be tried, found guilty and put to death. Legal proceedings are moving forward, evidence has been collected and a large growing body of experts are sounding the alarm.

Visit the Covid Committee website at: https://corona-ausschuss.de/ and if you have been affected by this crime, report the event, persons involved, and as much detail to the following website:

Crimes against humanity affect us all. They are a crime against you, your children, your parents, your grandparents, your community and your country and your future.


16 Advantages and Disadvantages of a Double-Blind Study

A double-blind study uses a format where neither the participants nor the researchers know who receives a specific treatment. This procedure is useful because it prevents bias from forming in the achievable results. It is used most often when there is a direct need to understand the benefits of demand characteristics against the placebo effect.

What is unique about the placebo effect is that a person receives an inert substance that has no medical benefit. Participants believe that it is real medicine because a double-blind study wouldn’t inform anyone who gets the actual drug being studied. Researchers don’t receive that information either.

That means the results between the two groups can get compared to see if the effects of the drug are better than that of the placebo. It can also be a way to check for the development of side effects.

Several double-blind study advantages and disadvantages are worth reviewing when considering this format.

List of the Advantages of a Double-Blind Study

1. Three groups are typically part of a double-blind study.
The typical double-blind study project will involve three groups of participants. You’ll have the treatment group, the placebo, group, and a control group. The first two receive the item in question based on their name, although only the administrator knows for certain who is getting what since researchers are kept in the dark. The control group doesn’t receive anything because it serves as the baseline against which the other two sets of results get compared.

When people in the placebo group improve more than the control group, then it shows a belief that the product works. If the treatment group shows better results than those who receive a placebo, then you know the medication worked.

2. It avoids deception in the research process.
One of the criticized shortcomings of this approach is the fact that no one knows if the items they take or use is real or a placebo. The solution is to create two placebo subgroups where one is told that it is real medicine and the other is told it isn’t, which means researchers would need to deceive one set of participants. That process would violate the principles of informed consent.

The double-blind structure avoids this issue by providing complete information to all participants without letting on who receives the actual product getting studied.

3. It reduces the issue of experimenter bias.
Using double-blind procedures can minimize the potential effects of research bias when collecting data. This issue often occurs when experimenters knowingly or unknowingly influence the results during information gathering or product administration during the project. There can also be subjective feelings that drive specific decisions that would occur if less information was present in the study.

By limiting the potential influences that could impact the collected data, the final results produced by the research or experiment has more validity.

4. The results of a double-blind project can get duplicated.
One of the reasons why a double-blind study is considered a best practice is because the results offer the potential for duplication. Other researchers can follow the same protocols for administering placebos and the item being examined against a control group. If the results are similar, then it adds even more validity to the ability of a product or service to provide benefits. When duplication doesn’t happen, then the information from both studies can get compared to see what may have created a divergence in the data.

5. Double-blind assignment factors are randomized.
No one knows who is going to be part of what group at the beginning of a double-blind study. The only participant group that knows they aren’t part of the placebo or target group are those who provide the control baselines. When looking at an intervention-based process, the fact that random assignment occurs for willing participants works to reduce the influence of confounding variables in the material.

6. High levels of control are part of the research process.
The context of a double-blind research study allows administrators to manipulate variables so that the setting allows for direct observation. Control factors that could influence the environment can get added or removed to assist with the limitation of outside factors that would potentially change the data. This process allows for an accurate analysis of the collected data to ensure the authenticity of the results gets verified.

7. It is a process that’s usable in multiple industries.
The double-blind study might be used primarily by the pharmaceutical industry because it can look directly at the impact of medication, but any field can use the processes to determine the validity of an idea. Agriculture, biology, chemistry, engineering, and social sciences all use these structures as a way to provide validation for a theory or idea.

List of the Disadvantages of a Double-Blind Study

1. It doesn’t reflect real-life circumstances.
When a patient receives a pill after going to the doctor, they are told that the product is actual medicine intended to provide specific results. When participants receive something in a double-blind placebo study, then each person gets told explicitly that the item in question might be real medicine or a placebo. That leads to a different set of expectations that can influence the results of the work in adverse ways.

These artificial environments can cause an over-manipulation of the variables to produce circumstances that fall outside of the study’s parameters. When situations don’t feel realistic to a participant, then the quality of the data decreases exponentially.

2. Active placebos can interfere with the results.
Double-blind studies respond to the objections of researchers unintentionally when communicating information about the results of a pill being authentic or a placebo. Objections to the pill offering this information don’t exist with this structure. Although both items look identical, the real medication provides biological effects. Even if the results aren’t measurable, the individuals can feel the impact of the medicine on their bodies.

This outcome may cause them to conclude that they are in the treatment group. That means some participants have a higher positive expectancy than those who don’t feel those effects. It is a disadvantage that can lead to a misinterpretation of the results being experienced in real-time.

3. It is not always possible to complete a double-blind study.
There are times when a double-blind study is not possible. Any experiments that look at types of psychotherapy don’t benefit as an example because it would be impossible to keep participants in the dark about who receives treatment and who didn’t get the stated therapy. It only works when there is a way to provide two identical processes without clear communication about who receives the authentic item and who receives the placebo.

4. We do not fully understand the strength of the placebo effect.
Research published by Science Translational Medicine in 2014 found that the simple act of taking a pill can establish a placebo effect for people. A migraine was being tested in this study. The control group took nothing, while the placebo group took a medication clearly labeled as “placebo.” Then one group took a migraine drug labeled with its name. Those who took the placebo had results that were 50% effective when reducing pain during a migraine effect.

The placebo effect can stimulate the brain into believing that the body is being healed, creating a natural mechanism that encourages better health. The presence of this effect doesn’t indicate the success or failure of a medication or another process in a double-blind study. It may be an indication that the group receiving the placebo has a powerful internal mechanism that provides self-healing.

5. Some people can have a negative response to a placebo.
There can be times when an individual doesn’t have a response to the placebo at all. When that outcome occurs, then the effects of a process or medication can receive a direct comparison to see if the real product is useful. Some people can have an adverse reaction to the placebo, even producing unwanted side effects as if they were taking a real medication. It all depends on how each person feels.

A study involving people with asthma showed that using a placebo inhaler caused patients to do no better on breathing tests than sitting and doing nothing. When researchers asked how they felt about using the product, they reported that the placebo was just as effective as the regular medicine they used.

6. Randomization must use a structured process to be useful.
The most common example of using randomization when assigning people to a group in a double-blind study is to flip a coin. It is an action that’s random and cannot be predicted, which means it is likely to be a 50/50 scenario over time as it gets tossed frequently. Assigning people who come to a specific location based on a day of the week can influence the results of the study unintentionally because there are other dynamics that control the behavior. That bias would be in the data without anyone recognizing its presence since it was placed there in the initial design.

7. Most double-blind studies are too small to provide a representative sample.
Winchester Hospital, which is a division of Beth Israel Lahey Health in Massachusetts, says that a good double-blind study should enroll at least 100 individuals, “preferably as many as 300.” Effective treatments can prove themselves in small trials, but research requires more people to establish patterns so that results can be verified. Even when you have hundreds, or sometimes thousands, of participants in this work, the results might not extrapolate to the general population.

There were more than 4,100 trials in progress for pain treatments in 2011, but the only new approvals given were for formulations or updated dosages for existing medications. Even when drugs get into the third phase of testing, the product only has a 60% chance to continue moving forward. Divergent results often create failure.

8. It doesn’t work well for functional disorders.
The highest response rates for a placebo occur when researchers are looking into functional disorders like Irritable Bowel Syndrome. It also happens when there are imprecise endpoint measurements, as with Crohn’s disease. People who have other immune-response conditions like rheumatoid arthritis. The FDA even notes that the placebo response is steadily growing in the general population.

This disadvantage creates another limitation where the structure of a double-blind study may not provide useful information.

9. Double-blind studies are an expensive effort to pursue.
A double-blind study takes several months to complete so that researchers can look at each possible variable. It may be necessary to complete several efforts using different groups to collect enough data. When corporations look at the cost of these efforts, it can be an expense that reaches several million dollars before its completion. Government studies can quickly reach $1 billion or more, depending on the extent of the work and the industry or product under consideration.

When the Tufts Center for the Study of Drug Development looked at the cost of creating and bringing a new drug to the market, the expense was pegged at $2.6 billion. That’s why new prescription medicines are so expensive. Even the clinical trials for FDA approval have an average cost of $19 million.

Double-blind placebo studies are often called the gold standard for testing medications. This description is at its most powerful when studying new psychiatric medications since the placebo effect is a psychological benefit. It is a process that improves on the experiments that compare the response of someone taking a pill with those who do not.

Since no one knows who is getting what in a double-blind study, the danger of a researcher accidentally communicating non-verbally about the expectation of an item to work or not gets eliminated.

When reviewing these double-blind study advantages and disadvantages, the benefits that come from this process can only be achieved when structures that counter the potential negatives are in place. It gives us a baseline from which to work, but there are no guarantees that results are achievable.


Telemedicine in Age-Related Macular Degeneration (AMD)

AMD affects 15 million Americans, with 200,000 new advanced cases diagnosed each year. AMD is the leading cause of blindness in this country, from either the &ldquodry&rdquo or &ldquowet&rdquo advanced forms. At present, there is no treatment for dry AMD. Besides blindness, AMD has other indirect complications such as depression, social dependency, and the risk of fall and injury. The prevalence of this disease is expected to grow substantially as life expectancy continues to increase and record numbers of Baby Boomers enter their senior years. The total direct cost of AMD is $220 billion per year and is expected to increase

1.5 fold. The Age-Related Eye Disease Study (AREDS) showed that specific vitamin supplementation protocols can reduce the risk of progression from intermediate to late AMD by

25% which in turn could lower the cost of AMD 17.6% if fully implemented. To accomplish this, it is crucial to perform large scale population screening to identify the individuals with early- or intermediate-stage of AMD and better predict those at risk of developing late AMD, but such a system is currently not available. Although articles have been published on automatic AMD pathology detection, none of these systems are available for screening due to lack of validation and commercial readiness. Considering this urgent need, we aim to develop an automated tool for AMD screening and prediction, and make it widely available in both urban and remote/rural areas and for large-scale screening through a telemedicine platform, and thereby prevent blindness. To establish the feasibility of our proposed telemedicine solution, patients are invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved camera at their own doctor&rsquos office. The photos will then be transmitted securely and analyzed by computer (telemedicine) for presence of absence of AMD. If sufficient accuracy by the automatic system can be established compared to expert human diagnosis, a larger scale study will be carried out.

Eligibility:

Inclusion Criteria:

- Subjects with AMD will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent

Exclusion Criteria:

- Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery.


Supplementary Material

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Placebos

Humans are marvelously complicated, which makes them difficult to work with as subjects for an experiment. For instance, when you give a subject an experimental medication and they exhibit signs of improvement, what is the reason? It could be the medicine, but there could also be some psychological effects. When someone thinks they are being given something that will make them better, sometimes they will get better. This is known as the placebo effect.

To mitigate any psychological effects of the subjects, sometimes a placebo is given to the control group. A placebo is designed to be as close to the means of administration of the experimental treatment as possible. But the placebo is not the treatment. For example, in the testing of a new pharmaceutical product, a placebo could be a capsule that contains a substance that has no medicinal value. By use of such a placebo, subjects in the experiment would not know whether they were given medication or not. Everyone, in either group, would be as likely to have psychological effects of receiving something that they thought was medicine.


Watch the video: Color Blind Test - Do You See Color Like Everyone Else? (August 2022).