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

Impact of question order on prioritisation of outcomes in the development of a core outcome set:A randomised controlled trial

Abstract Background Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeholders’ opinions of which outcomes to measure and report in trials of a particular condition or intervention. Research outside of Delphi surveys and COS development demonstrates that question order can affect response rates and lead to ‘context effects’, where prior questions determine an item’s meaning and influence responses. This study examined the impact of question order within a Delphi survey for a COS for oesophageal cancer surgery. Methods A randomised controlled trial was nested within the Delphi survey. Patients and health professionals were randomised to receive a survey including clinical and patient-reported outcomes (PROs), where the PRO section appeared first or last. Participants rated (1–9) the importance of 68 items for inclusion in a COS (ratings 7–9 considered ‘essential’). Analyses considered the impact of question order on: (1) survey response rates; (2) participants’ responses; and (3) items retained at end of the survey. Results In total, 116 patients and 71 professionals returned completed surveys. Question order did not affect response rates among patients, but fewer professionals responded when clinical items appeared first (difference = 31.3%, 95% confidence interval [CI] = 13.6–48.9%, P = 0.001). Question order led to different context effects within patients and professionals. While patients rated clinical items highly, irrespective of question order, more PROs were rated essential when appearing last rather than first (difference = 23.7%, 95% CI = 10.5–40.8%). Among professionals, the greatest impact was on clinical items; a higher percentage rated essential when appearing last (difference = 11.6%, 95% CI = 0.0–23.3%). An interaction between question order and the percentage of PRO/clinical items rated essential was observed for patients (P = 0.025) but not professionals (P = 0.357). Items retained for further consideration at the end of the survey were dependent on question order, with discordant items (retained by one question order group only) observed in patients (18/68 [26%]) and professionals (20/68 [29%]). Conclusions In the development of a COS, participants’ ratings of potential outcomes within a Delphi survey depend on the context (order) in which the outcomes are asked, consequently impacting on the final COS. Initial piloting is recommended with consideration of the randomisation of items in the survey to reduce potential bias. Trial registration The randomised controlled trial reported within this paper was nested within the development of a core outcome set to investigate processes in core outcome set development. Outcomes were not health-related and trial registration was not therefore applicable

Functional and quality of life outcomes of localised prostate cancer treatments (prostate testing for cancer and treatment [ProtecT] study)

Objective To investigate the functional and quality of life (QoL) outcomes of treatments for localised prostate cancer and inform treatment decision-making. Patients and Methods Men aged 50–69 years diagnosed with localised prostate cancer by prostate-specific antigen testing and biopsies at nine UK centres in the Prostate Testing for Cancer and Treatment (ProtecT) trial were randomised to, or chose one of, three treatments. Of 2565 participants, 1135 men received active monitoring (AM), 750 a radical prostatectomy (RP), 603 external-beam radiotherapy (EBRT) with concurrent androgen-deprivation therapy (ADT) and 77 low-dose-rate brachytherapy (BT, not a randomised treatment). Patient-reported outcome measures (PROMs) completed annually for 6 years were analysed by initial treatment and censored for subsequent treatments. Mixed effects models were adjusted for baseline characteristics using propensity scores. Results Treatment-received analyses revealed different impacts of treatments over 6 years. Men remaining on AM experienced gradual declines in sexual and urinary function with age (e.g., increases in erectile dysfunction from 35% of men at baseline to 53% at 6 years and nocturia similarly from 20% to 38%). Radical treatment impacts were immediate and continued over 6 years. After RP, 95% of men reported erectile dysfunction persisting for 85% at 6 years, and after EBRT this was reported by 69% and 74%, respectively (P < 0.001 compared with AM). After RP, 36% of men reported urinary leakage requiring at least 1 pad/day, persisting for 20% at 6 years, compared with no change in men receiving EBRT or AM (P < 0.001). Worse bowel function and bother (e.g., bloody stools 6% at 6 years and faecal incontinence 10%) was experienced by men after EBRT than after RP or AM (P < 0.001) with lesser effects after BT. No treatment affected mental or physical QoL. Conclusion Treatment decision-making for localised prostate cancer can be informed by these 6-year functional and QoL outcomes

Psychometric evaluation of a new patient-completed questionnaire for evaluating anal incontinence symptoms and impact on quality of life: The ICIQ-B

BACKGROUND: A psychometrically robust patient-completed questionnaire for anal incontinence, which reflects issues of importance to both clinicians and patients, was lacking for assessment purposes. OBJECTIVE: This study aimed to determine the psychometric properties of a new questionnaire developed to address this need, the International Consultation on Incontinence Questionnaire-Bowels module. DESIGN: Qualitative studies were used to refine the developmental version of the questionnaire. Quantitative studies were conducted to evaluate its psychometric properties. SETTINGS: Patients were invited to complete the questionnaire via postal administration. PATIENTS: Two hundred sixty-one patients with known bowel symptoms participated in the study (244 females, 17 males; mean age, 59.7 years (range, 24-92)). MAIN OUTCOME MEASURES: The aspects of validity were evaluated in comparison with available evidence, responses to existing instruments, and physiological findings. Reliability was assessed through repeat administration of the questionnaire and evaluation of internal consistency by the Cronbach α coefficient. Responsiveness following treatment was evaluated by the use of the Wilcoxon signed rank test. Exploratory factor analysis was used to derive the final version of the questionnaire with evidence from the above studies. RESULTS: The final questionnaire contains 17 questions arranged in 3 scored domains: bowel pattern, bowel control, and quality of life, with 4 unscored items included to evaluate important issues from a clinical or patient perspective. The questionnaire demonstrated acceptable validity, "good" to "very good" reliability, and reasonable response to changes in symptom and quality-of-life status following intervention. LIMITATIONS: Response rates varied according to location. CONCLUSIONS: The International Consultation on Incontinence Questionnaire Bowel module is a psychometrically robust, self-report instrument for the evaluation of anal incontinence and its impact on quality of life. It is suitable for use in individuals with anal incontinence of varying causes. It includes a scoring system for use in clinical practice and research. © The ASCRS 2011

A patient-centered approach to developing a comprehensive symptom and quality of life assessment of anal incontinence

PURPOSE: This study was designed to identify question items required for a comprehensive symptom and quality of life assessment for individuals with anal incontinence. METHODS: Three substudies addressed the goals: 1) convenience sample of clinical experts was asked to identify symptom items essential to characterize anal incontinence; 2) free-text comments by patients involved in a treatment intervention trial (Norton et al., Gastroenterology 2003;125:1320-9) underwent content analysis to highlight themes regarding life restriction caused by anal incontinence; and 3) qualitative interviews were conducted by using a grounded theory approach with symptomatic patients to identify issues causing impact on quality of life. Terminology for this condition was explored in the interviews to identify the most acceptable phraseology. Finally, the capability of existing anal incontinence questionnaires to capture and assess issues identified as important by patients was assessed. RESULTS: Seven clinical experts reached consensus that assessment should include the type, frequency and severity of incontinence, whether passive or associated with urgency, ability to delay and discriminate stool type, and "normal" bowel pattern. A total of 284 patients' comments were reviewed and 31 patients were interviewed, highlighting five key issues: unpredictability, toilet location, coping strategies, embarrassment, and social activity restriction. Assessment of available questionnaires for their inclusion of these themes indicates that none currently captures comprehensive information on these issues identified as important by patients. CONCLUSIONS: Fundamental issues as identified by patients are not currently represented in one overall comprehensive measure. The mixed method approach identified key issues to be assessed to ensure accurate symptomatic assessment and a comprehensive assessment of quality of life impact associated with anal incontinence. © 2007 American Society of Colon and Rectal Surgeons

Adherence to dietary and lifestyle recommendations and prostate cancer risk in the Prostate Testing for Cancer and Treatment (ProtecT) trial

BACKGROUND: The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) published eight recommendations for cancer prevention but they are not targeted at prostate cancer prevention. We investigated whether adherence to the WCRF/AICR recommendations and a prostate cancer dietary index are associated with prostate cancer risk. METHODS: We conducted a nested case-control study of 1,806 PSA-detected prostate cancer cases and 12,005 controls in the ProtecT trial. We developed a prostate cancer dietary index by incorporating three dietary factors most strongly associated with prostate cancer. Scores were computed to quantify adherence to the WCRF/AICR recommendations and the prostate cancer dietary index separately. RESULTS: The prostate cancer dietary index score was associated with decreased risk of prostate cancer (OR per 1 score increment: 0.91, 95% CI: 0.84, 0.99; p-trend=0.04) but the WCRF/AICR index score was not (OR: 0.99, 95% CI: 0.94, 1.05; p-trend=0.71). There was no heterogeneity in association by prostate cancer stage (p=0.81) or grade (p=0.61). Greater adherence to recommendations to increase plant foods (OR per 0.25 index score increment: 0.94; 95% CI: 0.89, 0.99; p-trend=0.02) and tomato products (OR adherence vs. non-adherence: 0.82; 95% CI: 0.70, 0.97; p=0.02) were inversely associated with overall prostate cancer risk. CONCLUSIONS: Adherence to the prostate cancer-specific dietary recommendations was associated with decreased risk of prostate cancer. High intake of plant foods and tomato products in particular may help protect against prostate cancer. IMPACT: Meeting the WCRF/AICR recommendations alone is insufficient for prostate cancer prevention. Additional dietary recommendations should be developed