Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in?

McDonald, Katherine; Schwartz, Alan M.; Sabatello, Maya

doi:10.1016/j.dhjo.2022.101368

Cited by 17 publications

(15 citation statements)

References 34 publications

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“…Research has also shown that persons with IDs are often excluded from clinical studies (DeCormier Plosky et al 2022;McDonald et al 2022). Studies in persons with IDs are therefore a necessary desideratum in clinical research.…”

Section: Discussionmentioning

confidence: 99%

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Trauma treatment using Narrative Exposure Therapy adapted to persons with intellectual disabilities or severe chronic mental disorders – a randomised controlled pilot study with an embedded observational study

Mayer

Elbing

Ostermann

2023

J intellect Disabil Res

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BackgroundDespite an increased likelihood of experiencing traumatic events and increased vulnerability, there are only few publications on trauma therapy for persons with intellectual disabilities (IDs). This pilot study for the first time investigates the feasibility and effectiveness of Narrative Exposure Therapy (NET) within this target group modified by Plain Language.MethodsA group of n = 10 participants with ID dual diagnoses and another group of n = 5 participants with severe and chronic mental disorders were separately stratified and randomised, then forming together an intervention group (n = 7) and a waiting list control group (n = 8). All participants were treated with NET attuned to their communication abilities by using Plain Language. Primary outcome was the post‐traumatic stress measured with the Post‐Traumatic Symptom Scale‐10 before and after the intervention. In addition, the Adverse Childhood Experience Index was used for diagnostic purposes. Data were analysed using t‐test for repeated measures and analysis of covariance.ResultsNarrative Exposure Therapy and the randomised controlled trial study proved to be successfully conductible with participants with IDs in a congregated residential service. Although the corresponding effect size was high (partial eta square = 0.188), the between‐group difference was not significant (P = 0.12). Analysis of the observational study resulted in a highly significant improvement for participants with IDs (P < 0.001; Hedges' g = 2.36) and in a significant improvement in participants with severe and chronic mental disorders (P < 0.013; Hedges' g = 1.52). Additionally, the participants with IDs show a significantly better reduction of symptom burden (P = 0.03; partial eta square = 0.327).ConclusionsThe results provide a first evidence for a possible and successful implementation of NET modified in Plain Language for persons with IDs and complex mental health support needs. Completeness in responding to the items of Post‐Traumatic Symptom Scale‐10 and Adverse Childhood Experience Index indicates the suitability of these instruments for both groups of participants. Although the group difference in the randomised controlled trial failed to achieve statistical significance mainly due to the small sample size, the results of the embedded observational study are promising for the conduct of further studies with the modified NET.

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Section: Discussionmentioning

confidence: 99%

“…2022; McDonald et al . 2022). Studies in persons with IDs are therefore a necessary desideratum in clinical research.…”

Section: Discussionmentioning

confidence: 99%

Trauma treatment using Narrative Exposure Therapy adapted to persons with intellectual disabilities or severe chronic mental disorders – a randomised controlled pilot study with an embedded observational study

Mayer

Elbing

Ostermann

2023

J intellect Disabil Res

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“…There is growing evidence of the intentional and unintentional exclusion of people with an intellectual disability globally 14,15 and within the UK 16,17 from clinical studies targeting pharmacological and psychosocial interventions. Gatekeepers, clinicians, and researchers all hold perceptions of people with an intellectual disability not being able to participate in randomised control trials (RCTs).…”

Section: Identifying the Ethical And Methodological Reasons For Exclu...mentioning

confidence: 99%

“…However, such principles might inadvertently create barriers for access to research.' 17 McDonald et al 15 explored why people with an intellectual disability were excluded from the USA's National Institutes of Health (NIH)funded medical and behavioural clinical RCTs: in total there where 248 studies reviewed. The authors found that 25% of studies directly included adults with an intellectual disability.…”

Section: Identifying the Ethical And Methodological Reasons For Exclu...mentioning

confidence: 99%

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Why do we continue to exclude the most vulnerable in our society in diabetes research and education? Addressing the challenges presented by people with intellectual disability

Taggart

2024

Practical Diabetes

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People with an intellectual disability are more likely to develop diabetes compared to their non‐disabled peers. There has been a history of exclusion of people with an intellectual disability from diabetes research and education: we must now challenge this from a human rights perspective. In challenging these perceptions, we must identify the ethical and methodological reasons for exclusion and offer practical solutions to these challenges.These barriers to inclusion focus on three core areas. Firstly, individual factors concerning the person with the disability (can the person give their own informed consent, can the person read/write, completion of self‐report measures?). Secondly, factors concerning the methodology and design of the research study (can studies recruit the numbers needed, can people with intellectual disability understand/accept randomisation?). And, thirdly, system/organisational factors pertaining to the enablers/barriers to engaging in and completing research studies (buy‐in from senior managers, staff acting as gatekeepers, maternalistic attitudes held by gatekeepers, fidelity of intervention delivery).This Janet Kinson paper will explore these intentional and unintentional exclusion criteria that are so often applied to people with an intellectual disability in research trial studies. This paper will dispel the myths and offer solutions for including people with an intellectual disability in diabetes research and education. Using the UK national diabetes structured education programme, DESMOND, this paper will highlight the types of reasonable adjustments that can be made to adapt this programme suitable for adults with an intellectual disability: called DESMOND‐ID. This paper will demonstrate how, with reasonable adjustments, this newly‐adapted DESMOND‐ID education programme then can be tested within a National Institute for Health and Care Research clinical randomised control trial across the UK investigating the programme's clinical and cost‐effectiveness. Copyright © 2024 John Wiley & Sons.

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Expanding the Agenda for a More Just Genomics

Dolan,

Pacia,

Johnston

et al. 2024

Hastings Center Report

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The integration of genomics into public health and medicine is happening at a faster rate than the accrual of the capabilities necessary to ensure the equitable, global distribution of its clinical benefits. Uneven access to genetic testing and follow‐up care, unequal distribution of the resources required to access and participate in research, and underrepresentation of some descent groups in genetic and clinical datasets (and thus uncertain genetic results for some patients) are just some of the reasons to center justice in genomics. A more just genomics is an imperative rooted in the ethical obligations incurred by a publicly funded science that is reliant on human data. These features of genomics indebt the genomics enterprise and compel the expanded scope of responsibility proposed by the authors of this special report. The report begins to define justice in genomics for different stakeholder groups and proposes substantial shifts in power, resource distribution, scientific practice, and governance that could enable genomics to meet its obligations to humanity.

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Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in?

Cited by 17 publications

References 34 publications

Trauma treatment using Narrative Exposure Therapy adapted to persons with intellectual disabilities or severe chronic mental disorders – a randomised controlled pilot study with an embedded observational study

Trauma treatment using Narrative Exposure Therapy adapted to persons with intellectual disabilities or severe chronic mental disorders – a randomised controlled pilot study with an embedded observational study

Why do we continue to exclude the most vulnerable in our society in diabetes research and education? Addressing the challenges presented by people with intellectual disability

Expanding the Agenda for a More Just Genomics

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