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.

Development of a single, practical measure of surgical site infection (SSI) for patient report or observer completion.

Background: Surgical site infections (SSIs) are the third most common hospital-associated infection and can lead to significant patient morbidity and healthcare costs. Identification of SSIs is key to surveillance and research but reliable assessment is challenging, particularly after hospital discharge when most SSIs present. Existing SSI measurement tools have limitations and their suitability for post-discharge surveillance is uncertain.

Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies.

Objectives: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking.

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

Background: Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information).

Methods: Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients.

Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life.

Objectives: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations.

Materials And Methods: A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization.

A Systematic Review of Patient-reported Outcomes in Randomized Controlled Trials of Unplanned General Surgery.

Unplanned general surgery represents a major workload and requires comprehensive evaluation with appropriate outcomes. This study aimed to summarize current reporting of patient-reported outcomes (PROs) in randomized clinical trials (RCTs) in unplanned general surgery. A systematic review identified RCTs reporting PROs in the commonest six areas of unplanned general surgery.

Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study.

Background: Randomised controlled trials (RCTs) in surgery can be challenging to conduct, and trials in the emergency surgical setting when patients have unplanned hospital admissions are particularly difficult. One area of challenge is capturing baseline patient-reported outcome (PRO) data. This study examined the feasibility and optimal methods for the collection of baseline and follow-up PRO data in the setting of unplanned surgical hospital admissions.

Role of information in preparing men for transrectal ultrasound guided prostate biopsy: a qualitative study embedded in the ProtecT trial.

Background: The histological diagnosis of prostate cancer requires a prostate needle biopsy. Little is known about the relationship between information provided to prepare men for transrectal ultrasound guided biopsy (TRUS-Bx) and how men experience biopsy. The objectives were a) to understand men's experiences of biopsy as compared to their expectations; and b) to propose current evidence-based information for men undergoing TRUS-Bx.

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.

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 is associated with prostate cancer risk.

Methods: We conducted a nested case-control study of 1,806 prostate-specific antigen (PSA)-detected prostate cancer cases and 12,005 controls in the ProtecT trial.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial.

Background: There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer.

Methods/design: A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study.

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.

Psychological impact of prostate biopsy: physical symptoms, anxiety, and depression.

Purpose: To investigate the psychological impact of prostate biopsy, including relationships between physical biopsy-related symptoms and anxiety and depression.

Patients And Methods: A prospective cohort of 1,147 men, nested within the Prostate Testing for Cancer and Treatment trial and recommended to receive prostate biopsy, completed questionnaires assessing physical and psychological harms after biopsy in the Prostate Biopsy Effects study. Psychological impact was measured using the Hospital Anxiety and Depression Scale, and scores were compared according to experiences of biopsy-related symptoms at biopsy, and at 7 and 35 days afterward, and in relation to biopsy results.

Men with prostate cancer make positive dietary changes following diagnosis and treatment.

Purpose: Few studies have measured dietary changes made among men diagnosed with prostate cancer (PC) without formal dietary interventions, yet they may offer insight into the needs of PC survivors. This study examined dietary changes in men before and after treatment for PC within the prostate testing for cancer and treatment randomized trial.

Methods: This was a prospective cohort study in community-based men aged 50-69 tested for PC in nine UK areas.

Behavior theory for dietary interventions for cancer prevention: a systematic review of utilization and effectiveness in creating behavior change.

Purpose: Theory-based approaches are now recommended to design and enact dietary interventions, but their use in cancer trials is unknown. This systematic review examined application of behavior theory to dietary interventions aimed at preventing cancer to improve the design and interpretation of trials.

Methods: Electronic databases were searched (inception-July 2011).

A cross-sectional analysis of the association between diet and insulin-like growth factor (IGF)-I, IGF-II, IGF-binding protein (IGFBP)-2, and IGFBP-3 in men in the United Kingdom.

Background: There is evidence of associations between insulin-like growth factor I (IGF-I), IGF-II, insulin-like binding protein-2 (IGFBP-2), IGFBP-3, and prostate cancer risk. This study examines the association between dietary factors associated with prostate cancer and serum levels of these peptides.

Methods: A cross-sectional analysis of self-reported 12-month dietary intake with serum IGF and IGFBP levels was performed using data from 1,798 subjects screened negative for prostate cancer as part of a UK multicenter trial comparing treatments for this condition.

Predictors of attendance for prostate-specific antigen screening tests and prostate biopsy.

Background: Little is known about factors influencing men's decisions to undergo screening and diagnostic tests for prostate cancer (PCa).

Objective: Identify predictors of attendance for prostate-specific antigen (PSA) testing and prostate biopsy.

Design, Setting, And Participants: Literature searches and interviews with men undergoing PSA testing and prostate biopsy formed the basis of a self-report questionnaire designed to identify predictors of health behaviour, which was completed by men eligible for PSA invitation and prostate biopsy.

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.

Prognostic value of changes in health-related quality of life scores during curative treatment for esophagogastric cancer.

Purpose: Accumulating evidence suggests that health-related quality of life (HRQL) data before treatment predict survival, but the prognostic value of changes in HRQL scores after treatment is unknown. The aim of this study was to explore whether changes in HRQL scores in esophagogastric cancer predict survival.

Patients And Methods: Consecutive patients undergoing curative treatment completed HRQL questionnaires (EORTC QLQ-C30) at baseline and after six months and were followed up for at least five years.

Prostate-specific antigen testing and prostate biopsy: are self-reported lower urinary tract symptoms and health-related quality of life associated with the decision to undergo these investigations?

Objective: To investigate whether men's self-reported health-related quality of life and lower urinary tract symptoms (LUTS) are associated with acceptance of prostate-specific antigen (PSA) testing and subsequent prostate biopsy.

Patients And Methods: In a prospective questionnaire study of men aged 50-69 years, nested within the primary-care-based Prostate testing for cancer and Treatment study in nine UK areas, the Hospital Anxiety and Depression Scale (HADS), 12-item Short Form Health Survey (SF-12) and a self-reported LUTS measure (ICSmaleSF) were completed immediately before having a PSA test or prostate biopsy, or after not responding to an invitation for a PSA test or refusing a biopsy. Analyses compared 348 men accepting or 232 not responding to invitations for PSA testing and 318 accepting or 48 refusing a prostate biopsy.

Patient-reported outcomes to evaluate surgery.

The role of patient-reported outcomes (PROs) in surgery evaluation is increasing. PROs include measures of health-related quality of life (HRQL), patient satisfaction and utility. It is hypothesized that they add to traditional end points by providing detailed assessment of the impact of surgery on patient well-being as well as assessing patient preferences.

Quality of life after surgery for colorectal cancer: clinical implications of results from randomised trials.

Goals Of Work: Health-related quality of life (HRQL) is an important outcome after surgery for colorectal cancer (CRC), and accurate assessment is required to fully inform clinical decision making. The purpose of this review is to summarise randomised surgical trials in CRC with robust HRQL to consider the role of HRQL in surgical decision making.

Materials And Methods: A systematic review in Medline and the Cochrane Controlled Trials Register identified randomised surgical trials with HRQL.