Dataset Information

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

ABSTRACT:

Background

Randomised controlled trials in surgery can be a challenge to design and conduct, especially when including a non-surgical comparison. As few as half of initiated surgical trials reach their recruitment target, and failure to recruit is cited as the most frequent reason for premature closure of surgical RCTs. The aim of this qualitative evidence synthesis was to identify and synthesise findings from qualitative studies exploring the challenges in the design and conduct of trials directly comparing surgical and non-surgical interventions.

Methods

A qualitative evidence synthesis using meta-ethnography was conducted. Six electronic bibliographic databases (Medline, Central, Cinahl, Embase and PsycInfo) were searched up to the end of February 2018. Studies that explored patients' and health care professionals' experiences regarding participating in RCTs with a surgical and non-surgical comparison were included. The GRADE-CERQual framework was used to assess confidence in review findings.

Results

In total, 3697 abstracts and 49 full texts were screened and 26 published studies reporting experiences of patients and healthcare professionals were included. The focus of the studies (24/26) was primarily related to the challenge of recruitment. Two studies explored reasons for non-compliance to treatment allocation following randomisation. Five themes related to the challenges to these types of trials were identified: (1) radical choice between treatments; (2) patients' discomfort with randomisation: I want the best treatment for me as an individual; (3) challenge of equipoise: patients' a priori preferences for treatment; (4) challenge of equipoise: clinicians' a priori preferences for treatment and (5) imbalanced presentation of interventions.

Conclusion

The marked dichotomy between the surgical and non-surgical interventions was highlighted in this review as making recruitment to these types of trials particularly challenging. This review identified factors that increase our understanding of why patients and clinicians may find equipoise more challenging in these types of trials compared to other trial comparisons. Trialists may wish to consider exploring the balance of potential factors influencing patient and clinician preferences towards treatments before they start recruitment, to enable issues specific to a particular trial to be identified and addressed. This may enable trial teams to make more efficient considered design choices and benefit the delivery of such trials.

SUBMITTER: Davies L

PROVIDER: S-EPMC8495989 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundRandomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians' difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians' reported intentions compared with their actual practices.Methods and findingsSix pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded. Interviews revealed that clinicians' sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician's expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving their communication skills. However, the frequency of occurrence of equipoise issues across the RCTs suggests that the findings are likely to be reflective of clinical recruiters' practices more widely.ConclusionsCommunicating equipoise is a challenging process that is easily disrupted. Clinicians' personal views about trial treatments encroached on their ability to convey equipoise to patients. Clinicians should be encouraged to reflect on personal biases and be mindful of the common ways in which these can arise in their discussions with patients. Common pitfalls that recurred irrespective of RCT context indicate opportunities for specific training in communication skills that would be broadly applicable to a wide clinical audience.

Project description:BackgroundA multicentre feasibility trial (MIAMI), comparing outcomes and quality of life of women with multiple ipsilateral breast cancer randomised to therapeutic mammoplasty or mastectomy, was conducted from September 2018 to March 2020. The MIAMI surgical trial aimed to investigate recruitment of sufficient numbers of women. Multidisciplinary teams at 10 breast care centres in the UK identified 190 with MIBC diagnosis; 20 were eligible for trial participation but after being approached only four patients were recruited. A nested qualitative study sought to understand the reasons for this lack of recruitment.MethodsInterviews were conducted from November 2019 to September 2020 with 17 staff from eight hospital-based breast care centres that recruited and attempted to recruit to MIAMI; and seven patients from four centres, comprising all patients who were recruited to the trial and some who declined to take part. Interviews were audio-recorded, anonymised and analysed using thematic methods of building codes into themes and sub-themes using the process of constant comparison.ResultsOverarching themes of (1) influences on equipoise and recruitment and (2) effects of a lack of equipoise were generated. Within these themes, health professional themes described the barriers to recruitment as 'the treatment landscape has changed', 'staff preferences and beliefs' which influenced equipoise and patient advice; and how different the treatments were for patients. Patient themes of 'altruism and timing of trial approach', 'influences from consultants and others' and 'diagnostic journey doubts' all played a part in whether patients agreed to take part in the trial.ConclusionsBarriers to recruiting to breast cancer surgical trials can be significant, especially where there are substantial differences between the treatments being offered and a lack of equipoise communicated by healthcare professionals to patients. Patients can become overwhelmed by numerous requests for participation in research trials and inappropriate timing of trial discussions. Alternative study designs to the gold standard randomised control trial for surgical interventions may be required to provide the high-quality evidence on which to base practice.Trial registrationISRCTN ( ISRCTN17987569 ) registered on April 20, 2018, and ClinicalTrials.gov ( NCT03514654 ).

Project description:INTRODUCTION:Living with an altered facial appearance as a result of treatment for cancer requires considerable psychological adjustment. As such it is essential that health care professionals understand the lived experience of people affected. This systematic review provides a meta-ethnography of studies that have explored the experience of changed facial appearance as a result of cancer. METHODS:A search of four databases (Web of Science, CINAHL, PsycInfo, and Scopus) took place using terms relating to qualitative research, cancer, and changed facial appearance. Thirteen studies were identified, appraised, and included in the synthesis. The findings and interpretations within the studies were subject to meta-ethnography procedures so as to elicit novel cross-cutting themes. FINDINGS:The experience of changed facial appearance after cancer was clustered into three contexts. In the context of the disease, subthemes were the primacy of survival, the changing relationship with the disease, and the impact of the care team on the experience of changed appearance. In the context of the social world, subthemes were positive reactions, negative reactions, and coping strategies. In the context of the self, subthemes were the self under attack, self-to-self relating, the self in the world, and rebuilding the self. CONCLUSIONS:The findings indicate that health care professionals must conduct holistic assessments, so as to fully recognize and where necessary address the impact upon self. The meta-ethnography shows that the experience of facial appearance change following cancer is complex and requires awareness of a number of theoretical areas including identity construction, social support, stigmatization, and the specific literature on visible difference. Statement of contribution What is already known on this subject? Changed facial appearance after cancer can cause significant social difficulties and impact on the sense of self. The experience of managing the specific dual challenges of cancer and altered facial appearance is not clearly understood. Recent studies that have focused specifically on the experience of changes in appearance after cancer have been limited in scope and transferability. What does this study add? To our knowledge, this is the first meta-ethnography to bring together the literature on the impact of altered facial appearance following cancer. Patients may feel unable to talk about appearance with health care professionals because it is seen as a frivolous issue. Clinicians should facilitate open, person-centred opportunities for patients to discuss the impact of changed appearance and where necessary facilitate access to support.

Project description:BackgroundUrinary tract infections (UTIs) are a common and significant problem for patients, clinicians, and healthcare services. Recurrent UTIs (rUTIs) are common, with a 3% prevalence in the UK. Although acute UTIs have a significant negative impact on the lives of patients, evidence of the impact of rUTIs is limited. To enhance shared decision-making around rUTI management, it is important to understand both the patients' and healthcare professionals' (HCPs') perspectives. The objective of this qualitative evidence synthesis is to understand patients' and HCPs' experiences and views in the management of rUTIs.MethodsA qualitative evidence synthesis (QES) was performed that included primary qualitative studies involving patients with rUTIs or primary care HCPs who manage patients with rUTIs, up to June 2022. The following databases were searched: MEDLINE, Embase, CINAHL, PsycInfo, ASSIA, Web of Science, Cochrane Database of Systematic Reviews, Epistemonikos, Cochrane Central Registry of Controlled Trials, OpenGrey, and the Health Management Information Consortium (HMIC). The QES was prospectively registered on PROSPERO (CRD42022295662). Reciprocal translation was conducted and developed into a line of argument synthesis. We appraised the confidence in our review findings by using GRADE-CERQual.ResultsTwelve studies were included in the final review; ten of those included patients, and three included HCPs (one study included both). Our review demonstrates that women with rUTIs have a unique experience, but it is generally of a chronic condition with significant impacts on numerous aspects of their lives. Antibiotics can be "transformative", but patients have serious concerns about their use and feel non-antibiotic options need further research and discussion. HCPs share similar views about the impacts of rUTIs and concerns about antibiotic use and find the management of rUTIs to be complex and challenging. Based on our GRADE-CERQual assessment of the review findings, we have moderate confidence in those related to patients and low confidence in those related to HCPs. New conceptual models for both patients and HCPs are presented.ConclusionsThis review has significant clinical implications. Patients require information on antibiotic alternative acute and preventative treatments for rUTIs, and this is not currently being addressed. There are communication gaps around the impact of rUTIs on patients, their perceived expectation for antibiotics, and the reasons for treatment failure. Further development of current clinical guidance and a patient decision aid would help address these issues.