Exclusion criterion: learning disability

Abstract

In 2013 the UK Department of Health commissioned an independent Confidential Inquiry into the premature deaths of people with learning disabilities.1Heslop P Blair P Fleming P Hoghton M Marriott A Russ L Confidential Inquiry into premature deaths of people with learning disabilities (CIPOLD).http://www.bristol.ac.uk/media-library/sites/cipold/migrated/documents/fullfinalreport.pdfDate: 2013Date accessed: November 3, 2019Google Scholar In response, the Learning Disabilities Mortality Review (LeDeR) programme, the first of its kind globally, was carried out by the Healthcare Quality Improvement Partnership on behalf of the UK National Health Service. The LeDeR programme had two aims: to improve the quality of health and social care, and to reduce premature mortality and health inequalities for people with learning disabilities.2Parkin E Kennedy S Bate A Long R Hubble S Powell A Learning disability—overview of policy and services. House of Commons Library, London2018Google Scholar It identified 1311 premature deaths between July, 2016, and November, 2017, highlighting the importance of prevention, early identification, and treatment for this population.3National Health Service EnglandThe learning disabilities mortality review (LeDeR) programme.http://www.bristol.ac.uk/media-library/sites/sps/leder/leder_annual_report_2016-2017.pdfDate: December, 2017Date accessed: November 3, 2019Google Scholar Clinical research-related recommendations proposed the need to improve care through research and specialist training, with a special focus on pneumonia and sepsis; 272 (47%) of the 576 stated causes of premature deaths were attributed to respiratory and circulatory diseases.3National Health Service EnglandThe learning disabilities mortality review (LeDeR) programme.http://www.bristol.ac.uk/media-library/sites/sps/leder/leder_annual_report_2016-2017.pdfDate: December, 2017Date accessed: November 3, 2019Google Scholar In April, 2019, we reviewed the 26 293 studies in England that are recorded in the National Institute for Health Research (NIHR) portfolio, to determine the inclusion of people with learning disabilities. This portfolio includes all high-quality clinical research studies that are eligible for support from the NIHR Clinical Research Network. We discovered that 15 853 (60·3%) of the studies excluded learning disability groups, none of the studies investigating pneumonia or sepsis included learning disability groups, and only 368 (1·4%) of all studies were specifically related to learning disabilities. Given the vast number of studies, we only perused the study titles and inclusion and exclusion criteria, and might thus have overlooked other relevant information. In addition, our restricted search terms (“learning di”, ‘autism’, ‘ASD’, ‘Down syndrome’, ‘Williams syndrome’, ‘Asperger’, ‘Fragile X’, and ‘cerebral palsy’) might not encompass all learning disabilities; in fact, the definition of learning disability remains inconsistent.4Russell A Bryant L House A Identifying people with a learning disability: an advanced search for general practice.Br J Gen Pract. 2017; 67: e842-e850Crossref PubMed Scopus (14) Google Scholar Therefore, our findings could underestimate exclusion in the NIHR portfolio, justifying the need for further investigation. The LeDeR programme identified health and care disparities associated with premature deaths in people with learning disabilities. This finding mirrors the poor access of this population to the clinical research that should lead to better health outcomes. It is irrefutable that ethical principles, such as the Declaration of Helsinki, are put forward to protect vulnerable groups such as people with learning disabilities.5World Medical AssociationWorld Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.JAMA. 2013; 310: 2191-2194Crossref PubMed Scopus (12289) Google Scholar However, such principles might inadvertently create barriers for access to research. Based on our initial findings in the NIHR portfolio, a review of ethical barriers and a more active involvement of research funding organisations to scrutinise the justifications behind this exclusion might be warranted. RH, HM, and JP report salary support from the UK National Institute for Health Research (NIHR) Clinical Research Network, and JP reports salary support from the NIHR Applied Research Collaboration and an NIHR Programme Grant for Applied Research (award RP-PG-0616-20003). All other authors declare no competing interests. The views expressed are those of the authors and not necessarily those of the NIHR, National Health Service, or Department of Health and Social Care.