The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography

Davies, Loretta; Beard, David; Cook, Jonathan; Price, Andrew; Osbeck, Ida; Toyé, Francine

doi:10.1186/s13063-021-05403-5

Cited by 23 publications

(26 citation statements)

References 101 publications

(289 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Parents struggled with what they perceived was a severe injury and the stark contrast they faced between surgical and non-surgical treatment. Other studies amongst adults taking part in surgical trials identify participants often struggle to make a decision regarding trial inclusion, which is more marked when the injury is severe or there is a substantial difference between the treatments [ 17 , 18 ]. In this study parents believed that surgery would guarantee that their child’s arm would straighten.…”

Section: Discussionmentioning

confidence: 99%

Protecting my injured child: a qualitative study of parents’ experience of caring for a child with a displaced distal radius fracture

et al. 2022

View full text Add to dashboard Cite

Background Childhood fractures can have a significant impact on the daily lives of families affecting children’s normal activities and parent’s work. Wrist fractures are the most common childhood fracture. The more serious wrist fractures, that can look visibly bent, are often treated with surgery to realign the bones; but this may not be necessary as bent bones straighten in growing children. The children’s radius acute fracture fixation trial (CRAFFT) is a multicentre randomised trial of surgery versus a cast without surgery for displaced wrist fractures. Little is known about how families experience these wrist fractures and how they manage treatment uncertainty. This study aimed to understand families’ experience of this injury and what it is like to be asked to include their child in a clinical trial. Methods Nineteen families (13 mothers, 7 fathers, 2 children) from across the UK participated in telephone interviews. Interviews were audio recorded, transcribed and analysed using reflexive thematic analysis. Results Our findings highlight parents’ desire to be a good parent through the overarching theme “protecting my injured child”. To protect their child after injury, parents endeavoured to make the right decisions about treatment and provide comfort to their child but they experienced ongoing worry about their child’s recovery. Our findings show that parents felt responsible for the decision about their child’s treatment and their child’s recovery. They also reveal the extent to which parents worried about the look of their child’s wrist and their need for reassurance that the wrist was healing. Conclusion Our findings show that protecting their child after injury can be challenging for parents who need support to make decisions about treatment and confidently facilitate their child’s recovery. They also highlight the importance of providing information about treatments, acknowledging parents’ concerns and their desire to do the right thing for their child, reassuring parents that their child’s wrist will heal and ensuring parents understand what to expect as their child recovers.

show abstract

Section: Discussionmentioning

confidence: 99%

Protecting my injured child: a qualitative study of parents’ experience of caring for a child with a displaced distal radius fracture

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The importance of embracing uncertainty has been widely reported and discussed in the literature. 27 , 28 ‘Equipoise’ is a state of equilibrium, while ‘clinical equipoise’ refers to a state of genuine uncertainty regarding the effectiveness of different interventions. The belief in clinical equipoise has been shown to be key to participants' consent to randomization.…”

Section: Discussionmentioning

confidence: 99%

“…The belief in clinical equipoise has been shown to be key to participants' consent to randomization. 29 A comprehensive review by Davies et al 27 found that the a priori preferences for treatment of both patients and clinicians, as well as the imbalanced presentation of interventions were important themes relating to recruitment problems in clinical trials. While Rooshenas et al 28 investigated how clinicians conveyed equipoise in six clinical trials, finding that while clinicians intended to set their personal biases aside, equipoise was omitted or compromised in 46% of the recorded appointments.…”

Section: Discussionmentioning

confidence: 99%

A qualitative study exploring clinicians’ views on clinical trials in thumb carpometacarpal joint osteoarthritis

Dean

Srikesavan

Horton³

et al. 2022

Bone & Joint Open

Self Cite

View full text Add to dashboard Cite

Aims Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to ‘no treatment’ ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. Conclusion Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321–331.

show abstract

“…Despite practitioner intentions to set aside personal biases and neutrally convey trial arms, equipoise is commonly omitted or compromised in trial discussions [ 10 ]. Imbalanced presentation of trial arms can influence patient views towards trial arms and willingness to participate in a trial [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Patient and health practitioner views and experiences of a cancer trial before and during COVID-19: qualitative study

Sherratt

Fisher

Mathieson

et al. 2022

Trials

View full text Add to dashboard Cite

Background Understanding patient and health practitioner perspectives on clinical trials can inform opportunities to enhance trial conduct and design, and therefore patient experience. Patients with haematological cancers have faced additional risk and uncertainty during the pandemic but it is unclear how they and practitioners have experienced cancer trials during this period. In the context of a haemato-oncology trial (PETReA), we compared patient and practitioner views and experiences of PETReA before and during COVID-19. Methods Qualitative study embedded within PETReA. Semi-structured interviews (N=41) with patients and practitioners from 16 NHS sites before (n=17) and during the first wave of COVID-19 (n=24). Analysis drew on the framework approach. Results Practitioners acknowledged the need for the trial to continue during the pandemic but their treatment preferences altered, becoming more pronounced for patients who had a favourable response to induction treatment, while staying unchanged for patients with a less favourable response. Practitioners commented that COVID-19 meant the evidence base for the trial arms was lacking or mixed, but that it likely increased the risks of maintenance treatment for patients with a favourable response to induction treatment. While only one participant interviewed withdrew from PETReA during the pandemic, others said they would consider withdrawing if information that they were at increased risk of severe illness from COVID-19 became available. During COVID-19, patients described less frequent contact with the trial team, which left some feeling less clear about their trial pathway. However, several described having in-depth, collaborative discussions with practitioners about the risks and benefits of randomisation in the context of COVID-19. Patients valued these discussions and were reassured by the emphasis practitioners placed on patients being free to withdraw if circumstances changed, and this helped patients feel comfortable about continuing in PETReA. Conclusions The findings point to ways trial communication can support patients to feel comfortable about continuing in a trial during uncertain times, including adopting a more in-depth, collaborative exploration of the risks and benefits of trial arms with patients and emphasising voluntariness. The results are relevant to trialists recruiting patients who are clinically extremely vulnerable or are at increased risk of poor COVID-19 outcomes despite being vaccinated.

show abstract

The challenge of equipoise in trials with a surgical and non-surgical comparison: a qualitative synthesis using meta-ethnography

Cited by 23 publications

References 101 publications

Protecting my injured child: a qualitative study of parents’ experience of caring for a child with a displaced distal radius fracture

Protecting my injured child: a qualitative study of parents’ experience of caring for a child with a displaced distal radius fracture

A qualitative study exploring clinicians’ views on clinical trials in thumb carpometacarpal joint osteoarthritis

Patient and health practitioner views and experiences of a cancer trial before and during COVID-19: qualitative study

Contact Info

Product

Resources

About