A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials

Phelps, Emma; Tutton, Elizabeth; Griffin, Xavier L; Baird, Janis

doi:10.1016/j.socscimed.2020.112961

Cited by 22 publications

(47 citation statements)

References 52 publications

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“…Documenting initial impressions allowed for early familiarisation and preliminary coding of our data and provided a mechanism for highlighting key issues with recruitment to the Trial Management Group and recruitment sites throughout data collection. A secondary analysis was then conducted where the ndings from both studies were mapped onto the themes identi ed in the Phelp's systematic review, [1] with particular attention given to identifying themes relating to optimising recruitment.…”

Section: Discussionmentioning

confidence: 99%

“…Failing to reach recruitment targets can have signi cant cost implications if funding is stopped or extensions are required and trials that do not recruit to target are underpowered to detect an effect. [1] Trials of surgical interventions, especially those that compare surgical and non-surgical interventions recruitment challenges, due to the irreversibility of surgical treatments and issues with surgeon equipoise. [2,3] The stakes are particularly high for trials of rare fractures or injuries, where there is an added impetus to recruit as many eligible patients as possible.…”

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confidence: 99%

“…[3][4][5] A mixed methods systematic review synthesised the evidence on recruitment to surgical trials from the patient perspective. [1] The review, which included 34 papers (11 quantitative and 21 qualitative) concluded that whether a patient chooses to participate or not in a RCT is in uenced by multiple inter-related factors such as patients' perceptions of the risk and bene ts of participation and their treatment preferences. The authors recommended that future trials consider a patient-centred approach to trial recruitment that tailors information to the individual patient.…”

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confidence: 99%

“…For recruitment to be effective it is also important to take stock of staff's experiences of recruitment to ensure that future strategies for improving recruitment consider not only what is important to patients, but the practicalities of recruiting patients in a complex healthcare system. [1] We present the ndings of two qualitative process evaluations undertaken during the PRESTO (Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture Treatment Outcomes) feasibility study [6] and ACTIVE (Articular type C pilon fracture Trial comparing Internal Versus External xation) trial's internal pilot. The main a priori research question for both process evaluations was how to best optimise recruitment by exploring patients, surgeons and local recruiting staffs' views and experiences of the interventions and trial processes.…”

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confidence: 99%

“…The main a priori research question for both process evaluations was how to best optimise recruitment by exploring patients, surgeons and local recruiting staffs' views and experiences of the interventions and trial processes. In this paper we draw on the work of Phelps et al [1] and use the ndings from our two process evaluations to highlight how recruitment to future orthopaedic RCTs may be improved from the perspective of trial recruiters and patients.…”

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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

Scantlebury

McDaid

Brealey

et al. 2021

Preprint

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Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries, or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design: Two qualitative process evaluations of a United Kingdom-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting: NHS secondary care organisations throughout the United Kingdom. Interviews were undertaken via telephone. Participants: 37 trial recruiters (surgeons, physiotherapists, research nurses) and 22 patients were interviewed. Patients included those who agreed to participate in the ACTIVE and PRESTO studies and patients that declined participation in the ACTIVE study. Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registries: ACTIVE: (ISRCTN98152560) PRESTO: (ISRCTN12094890)

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

Scantlebury

McDaid

Brealey

et al. 2021

Preprint

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What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research

Berwanger,

Merz

2024

Ethics & Human Research

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We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

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Patient preferences and decision‐making when considering surgery for musculoskeletal disorders: A mixed methods systematic review

Healy

Dorflinger

Michaleff

et al. 2022

Musculoskeletal Care

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Introduction:The burden of Musculoskeletal disorders (MSD) is large. Surgery is an important management option but the factors that shape patients' surgical decisions are not well understood. As prior reviews have explored only single data types or conditions, a mixed methods appraisal across the musculoskeletal spectrum was undertaken. Methods:A mixed-methods systematic, convergent segregated approach was used, with PubMed, Cumulated Index to Nursing and Allied Health Literature (CINHAL), Embase and PsycINFO searched to identify studies of adult patients' decisions about whether to undergo surgery. A narrative synthesis was conducted, with identified themes integrated across quantitative, qualitative and mixed-methods studies.Results: Forty-six studies were included (24 quantitative, 19 qualitative and three mixed methods), with four decision-making themes identified (symptoms, sociodemographic and health factors, information and perceptions). Decision-making involves a complex interaction of individual sociodemographic, health and symptom information, integrated with individual perceptions of candidacy and surgical expectations. While most studies investigated hip and knee surgery, across all included conditions, patients are more likely to favour surgery if symptoms and/or dysfunction are higher, and if perceptions of surgical candidacy and processes (outcomes, inconvenience, and risk) are favourable. Other factors including age, general health, race, financial context, professional and non-professional communication, and information sources also impact decision-making but exert a less consistent impact upon the propensity to prefer surgery. Conclusion:Patients are more likely to choose surgery for MSD when they have higher levels of symptoms or dysfunction and positive perceptions of surgical suitability and expectations. Other factors important to individuals, have a less consistent impact upon the propensity to prefer surgery. These findings have potential to aid the efficient referral of patients to orthopaedics. More research is needed to validate these findings across the spectrum of MSD.This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials

Cited by 22 publications

References 52 publications

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research

Patient preferences and decision‐making when considering surgery for musculoskeletal disorders: A mixed methods systematic review

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