174 research outputs found
Recommendations for optimising pilot and feasibility work in surgery
BackgroundSurgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. MethodsThe findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS.ResultsThe synthesis informed development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS are not currently optimised. The four root causes identified include issues relating to i) understanding the full scope of PAFS; ii) design and conduct of PAFS; iii) reporting of PAFS; and iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform development of a practical guidance tool for surgeons and study teams to improve research practice.ConclusionsOptimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our ‘Top Tips’ guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.<br/
Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer:the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial
A mixed methods approach to assess the reliability of a test for the success of blinding in a surgical randomised controlled trial (RCT)
Patient-reported outcome measures for post-mastectomy breast reconstruction:A systematic review of development and measurement properties
Understanding stage of innovation of invasive procedures and devices:Protocol for a systematic review and thematic analysis
INTRODUCTION: Surgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. METHODS AND ANALYSIS: A systematic review is being conducted. Ovid MEDLINE and Embase databases were searched from their inception until July 2021 using an iteratively developed strategy based on the concepts of stage of innovation, invasive procedures or devices and guidance. Articles were included if they described an approach to evaluating surgical innovations in stages, described a method for determining stage of innovation, described indicators of stage of innovation, defined stages or described potential sources of stage-related information. Conference abstracts and non-English language articles were excluded. Other articles were detected from citations within included articles and suggestions from experts in surgical innovation. Data will be extracted regarding approaches to evaluating surgical innovations, methods for determining stage of innovation, indicators of stage of innovation, definitions of stages and potential sources of stage-related information. A thematic analysis will be conducted, and findings summarised in a narrative report. ETHICS AND DISSEMINATION: Ethical approval will not be required. This systematic review will be published in a peer-reviewed journal and presented at appropriate conferences. PROSPERO REGISTRATION NUMBER: CRD42021270812
Sample size calculations for cluster randomised controlled trials with a fixed number of clusters
Background\ud
Cluster randomised controlled trials (CRCTs) are frequently used in health service evaluation. Assuming an average cluster size, required sample sizes are readily computed for both binary and continuous outcomes, by estimating a design effect or inflation factor. However, where the number of clusters are fixed in advance, but where it is possible to increase the number of individuals within each cluster, as is frequently the case in health service evaluation, sample size formulae have been less well studied. \ud
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Methods\ud
We systematically outline sample size formulae (including required number of randomisation units, detectable difference and power) for CRCTs with a fixed number of clusters, to provide a concise summary for both binary and continuous outcomes. Extensions to the case of unequal cluster sizes are provided. \ud
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Results\ud
For trials with a fixed number of equal sized clusters (k), the trial will be feasible provided the number of clusters is greater than the product of the number of individuals required under individual randomisation () and the estimated intra-cluster correlation (). So, a simple rule is that the number of clusters () will be sufficient provided: \ud
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> x \ud
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Where this is not the case, investigators can determine the maximum available power to detect the pre-specified difference, or the minimum detectable difference under the pre-specified value for power. \ud
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Conclusions\ud
Designing a CRCT with a fixed number of clusters might mean that the study will not be feasible, leading to the notion of a minimum detectable difference (or a maximum achievable power), irrespective of how many individuals are included within each cluster. \ud
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Patient experiences of an electronic PRO tailored feedback system for symptom management following upper gastrointestinal cancer surgery
Purpose
Complications following upper gastrointestinal (UGI) surgery are common. Symptom-monitoring following discharge is not standardized. An electronic patient-reported outcome (ePRO) system providing feedback to patients and clinicians could support patients and improve outcomes. Little is known about patients’ experiences of using such systems. This qualitative sub-study explored patients’ perspectives of the benefits of using a novel ePRO system, developed as part of the mixed methods eRAPID pilot study, to support recovery following discharge after UGI surgery.
Methods
Patients completed the online ePRO symptom-report system post-discharge. Weekly interviews explored patients’ experiences of using ePRO, the acceptability of feedback generated and its value for supporting their recovery. Interviews were audio-recorded and targeted transcriptions were thematically analysed.
Results
Thirty-five interviews with 16 participants (11 men, mean age 63 years) were analysed. Two main themes were identified: (1) reassurance and (2) empowerment. Feelings of isolation were common; many patients felt uninformed regarding their expectations of recovery and whether their symptoms warranted clinical investigation. Participants were reassured by tailored feedback advising them to contact their care team, alleviating their anxiety. Patients reported feeling empowered by the ePRO system and in control of their symptoms and recovery.
Conclusion
Patients recovering at home following major cancer surgery regarded electronic symptom-monitoring and feedback as acceptable and beneficial. Patients perceived that the system enhanced information provision and provided a direct link to their care team. Patients felt that the system provided reassurance at a time of uncertainty and isolation, enabling them to feel in control of their symptoms and recovery
Remote assessment of surgical site infection (SSI) using patient-taken wound images:Development and evaluation of a method for research and routine practice
Men’s knowledge and attitudes towards dietary prevention of a prostate cancer diagnosis:a qualitative study
BACKGROUND: Prostate cancer (PC) incidence and progression may be influenced by dietary factors, but little is known about the acceptability of dietary modification to men at increased risk of PC. Qualitative interviews with men participating in the ProDiet study were undertaken to explore the feasibility of implementing dietary interventions for the prevention of prostate cancer. METHODS: An interview study nested within the ProDiet randomised feasibility trial of dietary interventions to prevent a PC diagnosis. Men (n = 133) who previously participated in community based prostate specific antigen (PSA) testing without PC but who were at increased risk of the disease were randomly allocation to both lycopene (lycopene or placebo capsules or lycopene rich diet) and green tea (green tea or placebo capsules or green tea drink) for 6 months. Semi-structured interviews were conducted with participants shortly after randomisation, to investigate attitudes towards dietary modification for PC prevention and dietary information. Interviews were audio-recorded, transcribed and analysed to identify common themes. RESULTS: Interviews were conducted with 21 participants aged 52-72 years with PSA levels between 2.5 and 2.95 ng/ml, or a negative prostate biopsy result. Most men identified the major causes of cancer in general to include diet, environment, ageing and genetic factors. This contrasted sharply with men’s uncertainty about PC aetiology, and the function of the prostate. Men were confused by conflicting messages in the media about dietary practices to promote health overall, but were positive about the potential of lycopene and green tea in relation to PC prevention, valuing their natural components. Furthermore these men wanted tailored dietary advice for PC prevention from their clinicians, whom they considered a trusted source of information. CONCLUSION: Men at elevated risk of PC reported uncertainty about PC aetiology and the role of diet in PC prevention, but enthusiasm for dietary modifications that were perceived as ‘simple’ and ‘natural’. The men looked to clinicians to provide consistent disease specific dietary advice. These factors should be taken into consideration by clinicians discussing elevated PSA results with patients and those planning to embark on future trials investigating dietary modification interventions for the prevention of a PC diagnosis
Development of a ‘universal-reporter’ outcome measure (UROM) for patient and healthcare professional completion:a mixed methods study demonstrating a novel concept for optimal questionnaire design
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