Perspectives on Participation in Clinical Trials Among Individuals With Pain, Depression, and/or Anxiety: An ACTTION Scoping Review

Ferguson, McKenzie C; McNicol, Ewan D; Kleykamp, Bethea A.; Sandoval, Karin E.; Haroutounian, Simon; Holzer, Katherine J.; Kerns, Robert D.; Veasley, Christin; Turk, Dennis C.; Dworkin, Robert H.

doi:10.1016/j.jpain.2022.09.001

Cited by 6 publications

(10 citation statements)

References 41 publications

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“…), 94 along with preliminary findings from a systematic review on patient perspectives as participants in clinical pain trials (M.F.). 63 Presentations are available on the IMMPACT web site, http://www.immpact.org/meetings/Immpact25/background25.html .…”

Section: Methodsmentioning

confidence: 99%

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Haroutounian,

Holzer,

Kerns

et al. 2023

Pain

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In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

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Section: Methodsmentioning

confidence: 99%

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Haroutounian,

Holzer,

Kerns

et al. 2023

Pain

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“…Patients are often influenced by close relationships when facing a decision to participate in a clinical trial. In a review of the medical literature on clinical trial participation among patients with chronic pain, participants ranked professional rapport with research staff among the top three motivations (along with access to treatment and altruism) for trial participation ( 9 ). Specifically, they stated that they were strongly motivated by research team members who were good listeners, empathic, trustworthy, and socio-demographically representative of the patient population ( 9 ).…”

Section: Introductionmentioning

confidence: 99%

“…Among healthy volunteers in phase I trials, monetary compensation is a commonly cited—sometimes deciding—influence on the choice to participate ( 23 ). Although less motivating, monetary compensation may still play a role in the decision to participate in later phase trials ( 9 , 11 , 12 , 23 ). A nested sub-study provided a window into the effect of monetary compensation on recruitment in a population dealing with pain ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

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Recruitment and retention of clinical trial participants: understanding motivations of patients with chronic pain and other populations

Anastasi,

Capili,

Norton

et al. 2024

Front. Pain Res.

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This paper aims to present and discuss the issues, challenges, and strategies related to recruitment and retention in clinical trials involving participants with chronic pain. The randomized controlled clinical trial (RCT) is widely regarded as the gold standard for evaluating clinical interventions. However, it is crucial to acknowledge and address the challenges associated with recruiting and retaining participants. To prioritize the experience of the study population, targeted outreach strategies and a patient-centric approach are necessary. Researchers should consider incorporating recruitment and retention strategies during the study design phase. Implementing multi-pronged recruitment methods, leveraging relationships with community providers, and involving representatives of the patient population are helpful approaches. Effective communication and maintaining a professional environment are vital for optimizing engagement and supporting the successful execution of clinical trials involving participants with chronic pain.

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“…This approach can help develop useful, inclusive and equitable metrics and help apply them universally in clinical studies, subsequently allowing meaningful aggregation and meta-analysis. Recommendations on how to incorporate these approaches in pain studies are emerging [14,15].…”

mentioning

confidence: 99%

Peri‐operative mental health and pain after surgery: cause, consequence or coincidence?

Haroutounian,

Holzer

2024

Anaesthesia

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Perspectives on Participation in Clinical Trials Among Individuals With Pain, Depression, and/or Anxiety: An ACTTION Scoping Review

Cited by 6 publications

References 41 publications

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations

Recruitment and retention of clinical trial participants: understanding motivations of patients with chronic pain and other populations

Peri‐operative mental health and pain after surgery: cause, consequence or coincidence?

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