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

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

A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

Background: Multiple studies are evaluating how to prevent SARS-CoV-2 infection. Interventions are wide ranging and include vaccines, prophylactic drugs, public health safety measures, and behavioural interventions. Heterogeneity in the outcomes measured and reported is leading to research waste and inefficiency, slowing worldwide identification and implementation of effective methods to prevent infection. A core outcome set (COS) for studies of interventions to prevent SARS-CoV-2 infection has recently been developed, identifying infection as a critical outcome to measure. This paper examines how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials and considers how this can be improved. Methods: We searched the Cochrane COVID-19 Study Register to identify and review SARS-CoV-2 infection outcomes in prevention trials, including the rationale for choice of outcome measurement. We included phase 3 and 4 trials of COVID-19 prevention interventions. Early phase trials and studies relating to the transmission, treatment or management of COVID-19 were excluded. Results: We identified 430 entries in the register, of which 199 unique prevention trials were included across eight settings and 12 intervention types. Fifteen (8%) trials did not include any SARS-CoV-2 infection outcomes. The remaining 184 (92%) studies included a total of 268 SARS-CoV-2 infection outcomes, of which 32 (17%) did not specify how infection would be measured. Testing (i.e. formal diagnostic test) as a standalone method for determining infection was used in 57 (31%) trials, whereas defining infection by symptoms alone was used in 16 (9%) trials. All other trials (n=79, 43%) included multiple infection outcomes, defined in different ways. Discussion: There is considerable variation in how SARS-CoV-2 infection is measured within and across different interventions and settings. Furthermore, few studies report the rationale for outcome selection and measurement. Better transparency and standardisation of SARS-CoV-2 infection measurement is needed for the findings from prevention trials to inform decision-making.</ns3:p

The importance of dietary change for men diagnosed with and at risk of prostate cancer:a multi-centre interview study with men, their partners and health professionals

BACKGROUND: The diagnosis of prostate cancer (PC) can provide a trigger for dietary change, and there is evidence that healthier diets may improve quality of life and clinical outcomes. However, men’s views about dietary change in PC survivorship are largely unknown. This multi-centre qualitative interview study explored men’s views about dietary change in PC survivorship, to better understand motivations for, and barriers to, achieving desired changes. The role of radical and active surveillance treatments on dietary change and the influence of men’s partners were examined. Focus groups also evaluated stakeholder opinion, including healthcare professionals, about the provision of dietary advice to PC patients. METHODS: A multi-centre interview study explored views about diet and motivations for, and barriers to, dietary change in men at elevated risk or diagnosed with PC following prostate specific antigen (PSA) testing. 58 men and 11 partners were interviewed. Interviews and focus groups were undertaken with 11 healthcare professionals, 5 patients and 4 partners to evaluate stakeholders’ opinions about the feasibility and acceptability of providing dietary advice to PC patients. Data were analysed using methods of constant comparison and thematic analysis. RESULTS: Over half of diagnosed men reported making dietary changes, primarily to promote general or prostate health or facilitate coping, despite their uncertainty about diet-PC links. Interest in dietary advice was high. Information needs varied depending on treatment received, with men on active surveillance more frequently modifying their diet and regarding this as an adjunct therapy. Men considered their partners integral to implementing changes. Provision of dietary advice to men diagnosed with PC was considered by healthcare professionals and men to be feasible and appropriate in the context of a holistic ‘care package’. CONCLUSIONS: Many men make positive dietary changes after PC diagnosis, which are perceived by men and their partners to bring psychological and general health benefits and could help future dietary intervention trials. Men and their partners desire more and better dietary information that may support PC survivorship, particularly among those embarking on active surveillance/monitoring programmes. There are opportunities for healthcare professionals to support PC patients both clinically and psychologically by the routine integration of healthy eating advice into survivorship care plans

A core outcome set for seamless, standardized evaluation of innovative surgical procedures and devices (COHESIVE):a patient and professional stakeholder consensus study

To develop a COS, an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques. SUMMARY OF BACKGROUND DATA: Agreement on the key outcomes to measure and report for safe and efficient surgical innovation is lacking, hindering transparency and risking patient harm. METHODS: (I) Generation of a list of outcome domains from published innovation-specific literature, policy/regulatory body documents, and surgeon interviews; (II) Prioritization of identified outcome domains using an international, multi-stakeholder Delphi survey; (III) Consensus meeting to agree the final COS. Participants were international stakeholders, including patients/public, surgeons, device manufacturers, regulators, trialists, methodologists, and journal editors. RESULTS: A total of 7972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. Four hundred ten international participants (220 professionals, 190 patients/public) completed at least one round 1 survey item, of which 153 (69.5%) professionals and 116 (61.1%) patients completed at least one round 2 item. Twelve outcomes were scored “consensus in” (“very important” by ≥70% of patients and professionals) and 20 “no consensus.” A consensus meeting, involving context: modifications, unexpected disadvantages, device problems, technical procedure completion success, patients’ experience relating to the procedure being innovative, surgeons’/operators’ experience. Other domains relate to intended benefits, whether the overall desired effect was achieved and expected disadvantages. CONCLUSIONS: The COS is recommended for use in all studies before definitive randomized controlled trial evaluation to promote safe, transparent, and efficient surgical innovation

Shared Learning Utilizing Digital Methods in Surgery to Enhance Transparency in Surgical Innovation:Protocol for a Scoping Review

BACKGROUND: Surgical innovation can lead to important improvements in patient outcomes. Currently, information and knowledge about novel procedures and devices are disseminated informally and in an unstandardized way (eg, through social media). This can lead to ineffective and inefficient knowledge sharing among surgeons, which can result in the harmful repetition of mistakes and delay in the uptake of promising innovation. Improvements are needed in the way that learning in surgical innovation is shared through the development of novel, real-time methods, informed by a contemporary and comprehensive investigation of existing methods. OBJECTIVE: The aim of this scoping review is to explore the application of existing digital methods for training/education and feedback to surgeons in the context of performing invasive surgical procedures. This work will (1) summarize existing methods for shared learning in surgery and how they are characterized and operationalized, (2) examine the impact of their application, and (3) explore their benefits and barriers to implementation. The findings of this scoping review will inform the development of novel, real-time methods to optimize shared learning in surgical innovation. METHODS: This study will adhere to the recommended guidelines for conducting scoping reviews. A total of 6 different searches will be conducted within multiple sources (2 electronic databases, journals, social media, gray literature, commercial websites, and snowball searches) to comprehensively identify relevant articles and data. Searches will be limited to articles published in the English language within the last 5 years. Wherever possible, a 2-stage study selection process will be followed whereby the eligibility of articles will be assessed through the title, abstract, and full-text screening independently by 2 reviewers. Inclusion criteria will be articles providing data on (1) fully qualified theater staff involved in performing invasive procedures, (2) one or more methods for shared learning (ie, digital means for training/education and feedback), and (3) qualitative or quantitative evaluations of this method. Data will be extracted (10% double data extraction by an independent reviewer) into a piloted proforma and analyzed using descriptive statistics, narrative summaries, and principles of thematic analysis. RESULTS: The study commenced in October 2021 and is planned to be completed in 2023. To date, systematic searches were applied to 2 electronic databases (MEDLINE and Web of Science) and returned a total of 10,093 records. The results of this scoping review will be published as open access in a peer-reviewed journal. CONCLUSIONS: This scoping review of methods for shared learning in surgery is, to our knowledge, the most comprehensive and up-to-date investigation that maps current information on this topic. Ultimately, efficient and effective sharing of information and knowledge of novel procedures and devices has the potential to optimize the evaluation of early-phase surgical research and reduce harmful innovation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/3754

Optimising recruitment and informed consent in randomised controlled trials:the development and implementation of the QuinteT Recruitment Intervention (QRI)

BACKGROUND: Pragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really important RCTs are not undertaken because recruitment is thought to be too difficult. The ‘QuinteT Recruitment Intervention’ (QRI) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment. This paper presents the development and implementation of the QRI. METHODS: The QRI developed iteratively as a complex intervention. It emerged from the National Institute for Health Research (NIHR) ProtecT trial and has been developed further in 13 RCTs. The final version of the QRI uses a combination of standard and innovative qualitative research methods with some simple quantification to understand recruitment and identify sources of difficulties. RESULTS: The QRI has two major phases: understanding recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator (CI) and the Clinical Trials Unit (CTU). The plan of action usually includes RCT-specific, as well as generic, aspects. The QRI can be used in two ways: it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start, or it can be applied to an ongoing RCT experiencing recruitment shortfalls, with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure. CONCLUSIONS: The QRI provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. It can facilitate recruitment to the most controversial and important RCTs. QRIs are likely to be of interest to the CIs and CTUs developing proposals for ‘difficult’ RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1391-4) contains supplementary material, which is available to authorized users