- •Individuals with pain have challenges that affect trial participation.
- •Individuals with depression have challenges that affect trial participation.
- •Assessments of perspectives in underserved or marginalized populations are needed.
- •Trial design should promote facilitators and accommodate barriers.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- Factors limiting participation in arthritis self-management programmes: an exploration of barriers and patient preferences within a randomized controlled trial.Rheumatol Oxf Engl England;. 2013; 52: 472-479
- Depression and pain comorbidity: A literature review.Arch Intern Med. 2003; 163: 2433
- Exploring patients’ reasons for declining contact in a cognitive behavioural therapy randomised controlled trial in primary care.Br J Gen Pract. 2012; 62: e371-e377
- Self-management toolkit and delivery strategy for end-of-life pain: The mixed-methods feasibility study.Health Technol Assess Winch Engl. 2017; 21: 1-292
- An exploration of patients’ experiences of participation in a randomised controlled trial of the Manchester Acute Coronary Syndromes (MACS) decision rule.Emerg Med J BMJ Publishing Group;. 2017; 34: 593-598
- Comorbidity between pain and mental illness - Evidence of a bidirectional relationship.Eur J Pain. 2018; 22: 1304-1311
- Patients’ experience with non-surgical treatment for lumbar spinal stenosis: A qualitative study.Spine J. 2017; 18: 639-647
- From evidence to influence: Dissemination and implementation of scientific knowledge for improved pain research and management.Pain. 2018; 159: S56-S64
- Personal preferences for personalised trials among patients with chronic diseases: an empirical Bayesian analysis of a conjoint survey.BMJ Open. 2020; 10e036056
- Group cognitive behavioural therapy for women with depression: Pilot and feasibility study for a randomised controlled trial using mixed methods.BMC Psychiatry. 2011; 11: 82
- Clinical trials from the patient perspective: Survey in an online patient community.BMC Health Serv Res. 2017; 17: 166
- Enhancing patient engagement in Parkinson's disease mental health research.ProQuest Information & Learning. 2020; ([Internet]) (Available from:)https://login.libproxy.siue.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=2020-04049-039&site=ehost-live&scope=site
- Women's experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study.Pilot Feasibility Stud. 2018; 4: 168
- Considering the case for an antidepressant drug trial involving temporary deception: A qualitative enquiry of potential participants.BMC Health Serv Res. 2007; 7: 64
- At my own pace, space, and place: A systematic review of qualitative studies of enablers and barriers to telehealth interventions for people with chronic pain.Pain. 2022; 163: e165-e181
- Pivoting to virtual delivery for managing chronic pain with nonpharmacological treatments: Implications for pragmatic research.Pain. 2021; 162: 1591-1596
- A randomized survey of the public’s expectancies and willingness to participate in clinical trials of antidepressants versus psychotherapy for depression.Prim Care Companion CNS Disord. 2016; 18https://doi.org/10.4088/PCC.15m01879
- Patients’ treatment expectancies in clinical trials of antidepressants versus psychotherapy for depression: A study using hypothetical vignettes.Compr Psychiatry. 2013; 54: 28-33
- Patient and public involvement (PPI) in informing the osteoarthritis of the thumb therapy (OTTER) pilot trial: what matters most to people with thumb base osteoarthritis otter collaborations.Ann Rheum Dis [Internet]. 2013; 72: 778
- Participation in a single-blinded pediatric therapeutic strategy study for juvenile idiopathic arthritis: are parents and patient-participants in equipoise?.BMC Med Ethics. 2018; 19: 96
- Partnering with patients in clinical trials of pain treatments: A narrative review.Pain. 2022; 163: 1862-1873
- Confronting racism in all forms of pain research: A shared commitment for engagement, diversity, and dissemination.J Pain. 2022; 23: 913-928
- Factors affecting recruitment into depression trials: Systematic review, meta-synthesis and conceptual framework.J Affect Disord. 2015; 172: 274-290
- Patient engagement survey regarding future double-blinded, randomized controlled trial of tapering of chronic opioid therapy.J Prim Care Community Health. 2019; 10 (Thousand Oaks, California: Sage Publications Inc.N.PAG-N.PAG)
- Making pain research more inclusive: Why and how.J Pain. 2022; 23: 707-728
- Patient preference in clinical trials for headache medication: the patient's view.Cephalalgia. 2004; 24: 347-355
- Effect of group-based outpatient physical therapy on function after total knee replacement: Results from a multicenter randomized controlled trial.Arthritis Care Res. 2020; 72: 768-777
- Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial.J Affect Disord. 2017; 210: 151-157
- Confronting racism in all forms of pain research: Reframing study designs.J Pain. 2022; 23: 893-912
- PRE-EMPT trial collaborative group. Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.Trials. 2017; 18: 121
- The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study.Trials. 2016; 17: 364
- Confronting racism in pain research: A call to action.J Pain. 2022; (S1526590022000293)
- Establishing an updated core domain set for studies in juvenile idiopathic arthritis: A report from the OMERACT 2018 JIA workshop.J Rheumatol Canada;. 2019; 46: 1006-1013
- Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach.BMC Med Res Methodol. 2018; 18: 143
- QUALZICE: A QUALitative exploration of the experiences of the participants from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates.Trials. 2013; 14 (325–325)
- What can qualitative research do for randomised controlled trials? A systematic mapping review.BMJ Open. 2013; 3e002889
- Playing their parts”: The experiences of participants in a randomized sham-controlled acupuncture trial.J Altern Complement Med. 2008; 14 (New Rochelle, New York: Mary Ann Liebert, Inc.): 199-208
- Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.Trials. 2020; 21: 259
- Families’ views on the feasibility of a corticosteroid trial in JIA: A qualitative study.Pediatr Rheumatol. 2017; 15: 132
- Participant preferences for pharmacologic chronic pain treatment trial characteristics: An ACTTION adaptive choice-based conjoint study.J Pain United States;. 2016; 17: 1198-1206
- Identifying the primary outcome for a randomised controlled trial in rheumatoid arthritis: the role of a discrete choice experiment.J Foot Ankle Res. 2017; 10: 57
- Involving patients with depression in research: Survey of patients’ attitudes to participation.Br J Gen Pract. 2011; 61: e134-e141
- Do patient preferences for core outcome domains for chronic gout studies support the validity of composite response criteria?.Arthritis Care Res United States. 2013; 65: 1259-1264
- PRISMA extension for scoping reviews (PRISMA-ScR): Checklist and explanation.Ann Intern Med. 2018; 169: 467-473
- Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain.Pain United States;. 2008; 137: 276-285
- “You can't always get what you want”: from doctrine to practicability of study designs for clinical investigation in endometriosis.BMC Womens Health BioMed Central;. 2015; 15: 1-9
- Muscle biopsies in clinical trials for Duchenne muscular dystrophy - Patients’ and caregivers’ perspective.Neuromuscul Disord NMD England;. 2019; 29: 576-584
- Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses.BMJ Open. 2019; 9e031151
- Patient preference of pain measurements: a cross-sectional study based on chronic low back pain population in china.J Altern Complement Med N Y N. 2016; 22: A139
- U.S. Food & Drug Administration.FDA, 2014 ([cited 2022 Jan 7]. Available from:)Accessed November 14, 2022)
Clinical Trials: The Heart and Soul of Science [Internet]. The Louisiana Community Engagement Alliance against COVID-19 Disparities (LA-CEAL) [cited 2022 Jun 15]. Available from: https://www.youtube.com/watch?v=5j8Ppc4Ti8w. Accessed November 14, 2022.
- Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist [Internet].PRISMA, 2021 ([cited 2021 Nov 2]. Available from:)Accessed November 14, 2022)
- US Food and Drug Administration, Patient-Focused Drug Development Initiative.FDA, 2014 Oct (Available from:)Accessed November 14, 2022)
Publication stageIn Press Journal Pre-Proof
Conflict of Interest Statement: No authors have any conflicts of interest.