Patients' perspectives on opt-out consent for observational research: systematic review and focus group

Cardillo, Luca; Cahill, Fidelma; Wylie, Harriet; Williams, A. Jess; Zylstra, Janine; Davies, Andrew; Fullwood, Louise; Hemelrijck, Mieke Van

doi:10.12968/bjon.2018.27.22.1321

Cited by 13 publications

(8 citation statements)

References 36 publications

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“…Although an opt-out method of contacting patients such as described in this research can be ethically controversial and limited by government regulations in some jurisdictions, the literature shows that most patients consider it an acceptable approach. 18,128 3.5. Sample size Our review of chronic pain studies found small sample sizes to be problematic.…”

Section: Cohort Identification and Characterizationmentioning

confidence: 99%

Recruitment and retention for chronic pain clinical trials: a narrative review

Kennedy¹,

Nelson²,

Jerome³

et al. 2022

PR9

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Section: Cohort Identification and Characterizationmentioning

confidence: 99%

Recruitment and retention for chronic pain clinical trials: a narrative review

Kennedy¹,

Nelson²,

Jerome³

et al. 2022

PR9

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“…However, no patient to date has opted out. We have conducted qualitative research on patient preferences regarding opt out consent in our patient population [3], and hence we expect this number to remain extremely low.…”

Section: Construction and Contentmentioning

confidence: 99%

Guy’s cancer cohort – real world evidence for cancer pathways

et al. 2020

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Background: The burden of disease due to cancer remains substantial. Since the value of real-world evidence has also been recognised by regulatory agencies, we established a Research Ethics Committee (REC) approved research database for cancer patients (Reference: 18/NW/0297). Construction and content: Guy's Cancer Cohort introduces the concept of opt-out consent processes for research in a subset of oncology patients diagnosed and treated at a large NHS Trust in the UK. From April 2016 until March 2017, 1388 eligible patients visited Guy's and St Thomas' NHS Foundation Trust (GSTT) for breast cancer management. For urological cancers this number was 1757 and for lung cancer 677. The Cohort consists of a large repository of routinely collected clinical data recorded both retrospectively and prospectively. The database contains detailed clinical information collected at various timepoints across the treatment pathway inclusive of diagnostic data, and data on disease progression, recurrence and survival. Conclusions: Guy's Cancer Cohort provides a valuable infrastructure to answer a wide variety of research questions of a clinical, mechanistic, and supportive care nature. Clinical research using this database will result in improved patient safety and experience. Guy's Cancer Cohort promotes collaborative research and will accept applications for the release of anonymised datasets for research purposes.

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“…As described, methods for recruitment and retention are broadly categorized as active and passive methods, with active methods being preferable and having a lower participant burden. Using the example of sending introductory letters for the purpose of recruitment, active recruitment would entail the research team contacting potential participants after a predetermined number of days that would allow the patient to opt out of being approached ( 156 ). Passive recruitment would entail potential participants having to opt in and contact the research team directly to learn more, leaving the research team being unable to reach out otherwise.…”

Section: Toolkit: Suggested Enhancements For Research Protocol Implementationmentioning

confidence: 99%

Enhancing Recruitment and Retention of Minority Populations for Clinical Research in Pulmonary, Critical Care, and Sleep Medicine: An Official American Thoracic Society Research Statement

Thakur¹,

Lovinsky‐Desir²,

Appell³

et al. 2021

Am J Respir Crit Care Med

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Background: Well-designed clinical research needs to obtain information that is applicable to the general population. However, most current studies fail to include substantial cohorts of racial/ethnic minority populations. Such underrepresentation may lead to delayed diagnosis or misdiagnosis of disease, wide application of approved interventions without appropriate knowledge of their usefulness in certain populations, and development of recommendations that are not broadly applicable. Goals: To develop best practices for recruitment and retention of racial/ethnic minorities for clinical research in pulmonary, critical care, and sleep medicine. Methods: The American Thoracic Society convened a workshop in May of 2019. This included an international interprofessional group from academia, industry, the NIH, and the U.S. Food and Drug Administration, with expertise ranging from clinical and biomedical research to community-based participatory research methods and patient advocacy. Workshop participants addressed historical and current mistrust of scientific research, systemic bias, and social and structural barriers to minority participation in clinical research. A literature search of PubMed and Google Scholar was performed to support conclusions. The search was not a systematic review of the literature. Results: Barriers at the individual, interpersonal, institutional, and federal/policy levels were identified as limiting to minority participation in clinical research. Through the use of a multilevel framework, workshop participants proposed evidence-based solutions to the identified barriers. Conclusions: To date, minority participation in clinical research is not representative of the U.S. and global populations. This American Thoracic Society research statement identifies potential evidence-based solutions by applying a multilevel framework that is anchored in community engagement methods and patient advocacy.

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Patients' perspectives on opt-out consent for observational research: systematic review and focus group

Abstract: 1

Cited by 13 publications

References 36 publications

Recruitment and retention for chronic pain clinical trials: a narrative review

Recruitment and retention for chronic pain clinical trials: a narrative review

Guy’s cancer cohort – real world evidence for cancer pathways

Enhancing Recruitment and Retention of Minority Populations for Clinical Research in Pulmonary, Critical Care, and Sleep Medicine: An Official American Thoracic Society Research Statement

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