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Errors of omission: Why we are deeply concerned about research on autism therapies


Kristen Bottema-Beutel

Associate professor, Boston University


Shannon Crowley

Graduate student, Boston University


Micheal Sandbank

Assistant professor, University of Texas at Austin


Tiffany Woynaroski

Assistant professor, Vanderbilt University

Last year, we completed a project to determine whether psychoeducational therapies for young autistic children are effective. Initially, we were excited: We had been able to track down 150 studies completed over the past five decades comparing treatment and control groups. Locating such a large number of studies would usually allow for a high degree of confidence in our conclusions.

As part of our protocol, we rated and summarized the rigor of the studies and planned to do a statistical analysis of only those that we deemed to be high quality. We quickly became disappointed, however: Across intervention types, there were too few high-quality studies for us to compute reliable statistics.

Inspired by conversations and social-media interactions with fellow autism researcher Michelle Dawson, we conducted two follow-up analyses, scrutinizing the ethical conduct of researchers who authored the studies we had compiled. One focused on the researchers’ disclosure of conflicts of interest (COIs), and the other on their reporting of adverse events. The results only deepened our concerns about how scientists conduct and report their research on autism interventions for young children.

Altogether, our analyses revealed three ethical problems: Most studies are poorly designed, fail to disclose COIs and lack attention to adverse outcomes. Disclosing COIs and taking steps to mitigate the biases they may introduce will lead to better-quality research and instill greater trust from the autism community. Proactively measuring and reporting adverse outcomes will enable families to adequately weigh the potential benefits of interventions against any potential negative consequences.

Conflict resolution:

We found that 70 percent of studies were co-authored by a researcher with a COI, which we defined as any situation in which a person holds a vested interest that might bias a study’s outcome. For example, a researcher who provides an intervention for profit stands to benefit from evidence suggesting the method is effective. That researcher’s interest in fairly evaluating the intervention conflicts with his potential for financial gain.

Having COIs does not necessarily constitute ethical misconduct, but failing to disclose them might — especially if a journal requires it. We found that only 6 percent of the studies with COIs had actually reported them.

One conflict we found especially worrisome was when the investigator was the developer of the intervention. Developers stand to gain from career advancement, training others to use their intervention via for-profit workshops and selling manuals describing the intervention. However, none of the studies we evaluated had disclosed this particular COI, even though most interventions were studied by the same researchers who had developed them.

We surmise that the low quality of autism-intervention research to date is related to this paucity of COI reporting. Biases associated with having COIs may lead autism-intervention researchers to make questionable methodological decisions that compromise research integrity and quality. For instance, a researcher with a COI may choose a flawed study design in which participants are not randomly assigned to treatment and control groups, or may use a measure that is vulnerable to placebo effects. These types of flaws increase the likelihood of getting favorable results, even when the interventions are not actually effective. COIs may also bias researchers’ interpretations of their results, leading them to claim their studies provide strong evidence of effectiveness when in fact the results are mixed.

Additionally, when researchers collectively and routinely fail to disclose COIs, there is no pressure from either the research community or the autism community to reckon with the effects these COIs may have. Essentially, COIs have remained out of sight and out of mind for many researchers — meaning that the problems they introduce are not being addressed.

Unfortunately, it is not always clear what constitutes a COI; there is no exhaustive list of the kinds of relationships that should be considered as such. We therefore urge researchers to think carefully about any potential COIs that they or their team members may have and to disclose them. Such disclosures may compel researchers to design unbiased studies and to be clear about how they prevented their COIs from influencing their research results (such as by excluding themselves from data collection and statistical analysis).

Facing adversity:

Our other follow-up looked at the extent to which autism-intervention researchers measured and reported adverse events, adverse effects and harms. Adverse events include any occurrence of psychological or physical distress; other adverse outcomes that might be reasonably attributed to an intervention are deemed adverse effects. Harms refer to adverse events that remain long after an intervention has ended. For example, if a child develops a fever while receiving an intervention, researchers should document this as an adverse event. If a child breaks her arm on a play structure during an intervention session, this should be reported as an adverse effect. If a child becomes fearful of a particular toy used during an intervention and remains afraid of it several years later, this should be recorded as a harm.

We found that, similar to COIs, adverse events are rarely reported. Only 7 percent of the 150 studies we examined mentioned adverse events. None mentioned harms, nor described systematic procedures for measuring adverse events.

Because autism research has a history of using punishments that induce pain as an intervention strategy — some of the first behavioral therapists gave electric shocks or slaps to children to discourage certain behaviors — we believe it is especially important for autism-intervention researchers to proactively monitor adverse outcomes. Although contemporary interventions tend not to use punishment, unintended negative consequences are still possible.

To get some insight into these unintended consequences, we compiled a list of the adverse effects reported in the literature, along with any reported reasons for a participant’s withdrawal that met the definition of an adverse effect but were not labeled as such. We also scrutinized results indicating that children had less optimal outcomes when they received the treatment of interest than when they were in a control condition.

The adverse effects we identified included major and minor physical trauma, child distress and dislike of the intervention, caregiver anxiety and stress, and poorer outcomes in several areas, such as social communication, restricted and repetitive behavior, language, play and social-emotional behavior. The majority of the participants in the studies we reviewed likely did not experience adverse effects, but our findings still suggest researchers should monitor for and record them.

We were not able to find any data on the potential harms of autism interventions, but many autistic adults have expressed that they experienced harm — even trauma — as a result of the interventions they received as children. Researchers should conduct follow-up evaluations of study participants long after interventions are over, to document possible harms that arise or persist over time.

We hope that bringing these issues to light will lead to greater awareness of these pitfalls, improve researcher practices and ultimately lead to better services to support autistic children and their families.

Kristen Bottema-Beutel is associate professor of teaching, curriculum and society at Boston College in Massachusetts. Shannon Crowley is a doctoral candidate in the curriculum and instruction program at Boston College. Micheal Sandbank is assistant professor of special education at the University of Texas at Austin. Tiffany Woynaroski is assistant professor of hearing and speech sciences at Vanderbilt University Medical Center in Nashville, Tennessee.

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If you have any questions about this Notice of Privacy Practices, please contact our Privacy Officer, by telephone at (704) 824-7800 or in writing at 2675 Court Drive, Gastonia, NC 28054.
This Notice of Privacy Practices describes how we may use and disclose your protected health information to carry out treatment, payment or health care operations and for other purposes that are permitted or required by law. It also describes your rights to access and control your protected health information. Protected health information is information about you, including demographic information, that may identify you and that relates to your past, present or future physical or mental health or condition and related health care services.


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Your protected health information may be used and disclosed by our office staff others outside of our office who are involved in your care and treatment for the purpose of providing health care services to you.
Your protected health information may also be used and disclosed to pay your health care bills and to support the operation of our practice.
Following are examples of the types of uses and disclosures of your protected health information that we are permitted to make. These examples are not meant to be exhaustive, but to describe the types of uses and disclosures that may be made by our office.

1. Treatment: We will use and disclose your protected health information to provide, coordinate, or manage your health care and any related services. This includes the coordination or management of your health care with another provider.
For example, we would disclose your protected health information, as necessary, to a home health agency that provides care to you. We will also disclose protected health information to other healthcare providers who may be treating you.
For example, your protected health information may be provided to a physician to whom you have been referred to ensure that the physician has the necessary information to diagnose or treat you. In addition, we may disclose your protected health information from time-to-time to other health care providers (e.g., a specialist or laboratory) who become involved in your care by providing assistance with your health care diagnosis or treatment to us.
2. Payment: We may use and disclose protected health information about you so that the treatment and services you receive at Compleat KiDZ may be billed to and payment may be collected from you, an insurance company, or a third party. This may include certain activities that your health insurance plan may undertake before it approves or pays for the health care services we recommend for you such as: making a determination of eligibility or coverage for insurance benefits, and reviewing services provided to you for medical necessity. For example, if you have a back injury, we may need to give your health plan information about your condition, supplies used, and services you received.
3. Healthcare Operations: We may use or disclose, as needed, your protected health information for healthcare operations. These uses and disclosures are necessary to run Compleat KiDZ and make sure that all of our patients receive quality care. For example, we ma)'use protected health information to review our treatment and services and to evaluate the performance of our staff in caring for you. We may also combine protected health information about many patients to decide what additional services Compleat KiDZ should offer, what services are not needed, and whether certain new treatments are effective. We may also disclose information to doctors, nurses, technicians, medical students, and other personnel for review and learning purposes, we may remove information that identifies you from this set of protected health information so others may use it to study health care and health care delivery without learning the identities of specific patients.
We may share your protected health information with third party "business associates" that perform various activities (for example, billing or transcription services) for our practice. Whenever an arrangement between our practice and a business associate involves the use or disclosure of your protected health information, we will have a written contract that contains terms that will protect the privacy of your protected health information.
We may use and / or disclose protected health information to contact you to, remind you about an appointment you have for treatment or medical care.
We may use or disclose your protected health information, as necessary, to provide you with information about treatment alternatives or other health--related benefits and services that may be of interest to you. You may contact our Privacy Officer to request that these materials not be sent to you.
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(v) Abuse or Neglect: We may disclose your protected health information to a public health authority that is authorized by law to receive reports of child abuse or neglect. In addition, we may disclose your protected health information if we believe that you have been a victim of abuse, neglect or domestic violence to the governmental entity or agency authorized to receive such information. In this case, the disclosure will be made consistent with the requirements of applicable federal and state laws.

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(viii) Research: We may disclose your protected health information to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your protected health information.

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(xi) Workers' Compensation: We may disclose your protected health information as authorized to comply with workers' compensation laws and other similar legally established programs.
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Unless you object, we may disclose to a member of your family, a relative, a close friend or any other person you identify, your protected health information that directly relates to that person's involvement in your health care. If you are unable to agree or object to such a disclosure, we may disclose such information as necessary if we determine that it is in your best interest based on our professional judgment. We may use or disclose protected health information to notify or assist in notifying a family member, personal representative or any other person that is responsible for your care of your location, general condition or death. Finally, we may use or disclose your protected health information to an authorized public or private entity to assist in disaster relief efforts and to coordinate uses and disclosures to family or other individuals involved in your health care.
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You may request a restriction by making your request in writing to our Privacy Officer. In your request, you must tell us (1) what information you want to limit; (2) whether you want to limit our use, disclosure, or both; and (3) to whom you want the limits to apply, for example, disclosures to your spouse.
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You may contact our Privacy Officer at (704) 824-7800 for further information about the complaint process.

This notice was published and becomes effective on August l, 2011.