Reprint of: 'A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance'.

The UK Medical Research Council's widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

Randomized controlled trials comparing gastric bypass, gastric band, and sleeve gastrectomy: A systematic review examining validity and applicability to wider clinical practice.

Consideration of how applicable the results of surgical trials are to clinical practice is important to inform decision-making. Randomized controlled trials comparing at least two surgical interventions (of gastric bypass, gastric band, and sleeve gastrectomy) for severe and complex obesity were examined using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, to consider how applicable the trial results are to clinical practice, and the Risk of Bias 2 tool, to examine validity. MEDLINE, Embase, and CENTRAL databases were searched for studies published between November 2013 and June 2021, and 15 were identified. Using the PRagmatic Explanatory Continuum Indicator Summary-2 tool, three were classified as pragmatic, with good applicability to clinical practice. Ten had more explanatory domains but did include some pragmatic characteristics, and two were predominantly explanatory. This was due to some trial design features that would not be considered applicable to the wider clinical setting, including being single-centered, having prescribed intervention delivery methods, and intensive follow-up regimens. Only two trials had low risk of bias, of which one was considered pragmatic. Three had high risk of bias. Overall, few trials in bariatric surgery are pragmatic with low risk of bias. Well-designed pragmatic trials are needed to inform practice and reduce research waste.

Development and pilot testing of a patient-reported outcome measure to assess symptoms of parastomal hernia.

AIM: The aim was to develop and pilot a patient-reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH). METHODS: Standard questionnaire development was undertaken (phases 1-3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi-structured interviews with patients with a PSH and health professionals (phase 1). Domains were operationalized into items in a provisional questionnaire, and 'think-aloud' patient interviews explored face validity and acceptability (phase 2). The updated questionnaire was piloted in patients with a stoma who had undergone colorectal surgery and had a computed tomography scan available for review. Patient-reported symptoms were examined in relation to PSH (phase 3). Three sources determined PSH presence: (i) data about PSH presence recorded in hospital notes, (ii) independent expert review of the computed tomography scan and (iii) patient report of being informed of a PSH by a health professional. RESULTS: For phase 1, 169 and 127 domains were identified from 70 PROMs and 29 interviews respectively. In phase 2, 14 domains specific to PSH were identified and operationalized into questionnaire items. Think-aloud interviews led to three minor modifications. In phase 3, 44 completed questionnaires were obtained. Missing data were few: 5/660 items. PSH symptom scores associated with PSH presence varied between different data sources. The scale with the most consistent differences between PSH presence and absence and all data sources was the stoma appearance scale. CONCLUSION: A PROM to examine the symptoms of PSH has been developed from the literature and views of key informants. Although preliminary testing shows it to be understandable and acceptable it is uncertain if it is sensitive to PSH-specific symptoms and further psychometric testing is needed.

Real-time monitoring and feedback to improve shared decision-making for surgery (the ALPACA Study): protocol for a mixed-methods study to inform co-development of an inclusive intervention.

INTRODUCTION: High-quality shared decision-making (SDM) is a priority of health services, but only achieved in a minority of surgical consultations. Improving SDM for surgical patients may lead to more effective care and moderate the impact of treatment consequences. There is a need to establish effective ways to achieve sustained and large-scale improvements in SDM for all patients whatever their background. The ALPACA Study aims to develop, pilot and evaluate a decision support intervention that uses real-time feedback of patients' experience of SDM to change patients' and healthcare professionals' decision-making processes before adult elective surgery and to improve patient and health service outcomes. METHODS AND ANALYSIS: This protocol outlines a mixed-methods study, involving diverse stakeholders (adult patients, healthcare professionals, members of the community) and three National Health Service (NHS) trusts in England. Detailed methods for the assessment of the feasibility, usability and stakeholder views of implementing a novel system to monitor the SDM process for surgery automatically and in real time are described. The study will measure the SDM process using validated instruments (CollaboRATE, SDM-Q-9, SHARED-Q10) and will conduct semi-structured interviews and focus groups to examine (1) the feasibility of automated data collection, (2) the usability of the novel system and (3) the views of diverse stakeholders to inform the use of the system to improve SDM. Future phases of this work will complete the development and evaluation of the intervention. ETHICS AND DISSEMINATION: Ethical approval was granted by the NHS Health Research Authority North West-Liverpool Central Research Ethics Committee (reference: 21/PR/0345). Approval was also granted by North Bristol NHS Trust to undertake quality improvement work (reference: Q80008) overseen by the Consent and SDM Programme Board and reporting to an Executive Assurance Committee. TRIAL REGISTRATION NUMBER: ISRCTN17951423; Pre-results.

A systematic scoping review protocol to summarise and appraise the use of artificial intelligence in the analysis of digital videos of invasive general surgical procedures.

Background: Intraoperative video recordings are a valuable addition to operative written documentation. However, the review of these videos often requires surgical expertise and takes considerable time. While a large amount of work has been undertaken to understand the role of artificial intelligence (AI) in healthcare more generally, the application of these techniques to automate the analysis of surgical videos is currently unclear. In this systematic scoping review, we sought to give a contemporary overview of the use of AI research in the analysis of digital videos of invasive general surgical procedures. We will describe and summarise the study characteristics, purpose of the applications and stage of development, to ascertain how these techniques might be applied in future research and to identify gaps in current knowledge (e.g. uncertainties about the study methods). Methods: Systematic searches will be conducted in OVID Medline and Embase, using terms related to 'artificial intelligence', 'surgery' and 'video' to identify all potentially relevant studies published since 1st January 2012. All primary studies where AI has been applied to the analysis of videos (recorded by conventional digital cameras or laparoscopic or robotic-assisted technology) of general surgical procedures will be included. Data extraction will include study characteristics, governance, details of video datasets and AI models, measures of accuracy, validation and any reported limitations. Ethics and dissemination: No ethical approval is required as primary data will not be collected. The results will be disseminated at relevant conferences, on social media and published in a peer-reviewed journal.

Using trials of caloric restriction and bariatric surgery to explore the effects of body mass index on the circulating proteome.

Thousands of proteins circulate in the bloodstream; identifying those which associate with weight and intervention-induced weight loss may help explain mechanisms of diseases associated with adiposity. We aimed to identify consistent protein signatures of weight loss across independent studies capturing changes in body mass index (BMI). We analysed proteomic data from studies implementing caloric restriction (Diabetes Remission Clinical trial) and bariatric surgery (By-Band-Sleeve), using SomaLogic and Olink Explore1536 technologies, respectively. Linear mixed models were used to estimate the effect of the interventions on circulating proteins. Twenty-three proteins were altered in a consistent direction after both bariatric surgery and caloric restriction, suggesting that these proteins are modulated by weight change, independent of intervention type. We also integrated Mendelian randomisation (MR) estimates of the effect of BMI on proteins measured by SomaLogic from a UK blood donor cohort as a third line of causal evidence. These MR estimates provided further corroborative evidence for a role of BMI in regulating the levels of six proteins including alcohol dehydrogenase-4, nogo receptor and interleukin-1 receptor antagonist protein. These results indicate the importance of triangulation in interrogating causal relationships; further study into the role of proteins modulated by weight in disease is now warranted.

How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review.

INTRODUCTION: Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown. METHOD: A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted. RESULTS: From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9-49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews. CONCLUSION: Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs. PROSPERO REGISTRATION NUMBER: CRD42021287371.

Access to publicly funded weight management services in England using routine data from primary and secondary care (2007-2020): An observational cohort study.

BACKGROUND: Adults living with overweight/obesity are eligible for publicly funded weight management (WM) programmes according to national guidance. People with the most severe and complex obesity are eligible for bariatric surgery. Primary care plays a key role in identifying overweight/obesity and referring to WM interventions. This study aimed to (1) describe the primary care population in England who (a) are referred for WM interventions and (b) undergo bariatric surgery and (2) determine the patient and GP practice characteristics associated with both. METHODS AND FINDINGS: An observational cohort study was undertaken using routinely collected primary care data in England from the Clinical Practice Research Datalink linked with Hospital Episode Statistics. During the study period (January 2007 to June 2020), 1,811,587 adults met the inclusion criteria of a recording of overweight/obesity in primary care, of which 54.62% were female and 20.10% aged 45 to 54. Only 56,783 (3.13%) were referred to WM, and 3,701 (1.09% of those with severe and complex obesity) underwent bariatric surgery. Multivariable Poisson regression examined the associations of demographic, clinical, and regional characteristics on the likelihood of WM referral and bariatric surgery. Higher body mass index (BMI) and practice region had the strongest associations with both outcomes. People with BMI ≥40 kg/m2 were more than 6 times as likely to be referred for WM (10.05% of individuals) than BMI 25.0 to 29.9 kg/m2 (1.34%) (rate ratio (RR) 6.19, 95% confidence interval (CI) [5.99,6.40], p < 0.001). They were more than 5 times as likely to undergo bariatric surgery (3.98%) than BMI 35.0 to 40.0 kg/m2 with a comorbidity (0.53%) (RR 5.52, 95% CI [5.07,6.02], p < 0.001). Patients from practices in the West Midlands were the most likely to have a WM referral (5.40%) (RR 2.17, 95% CI [2.10,2.24], p < 0.001, compared with the North West, 2.89%), and practices from the East of England least likely (1.04%) (RR 0.43, 95% CI [0.41,0.46], p < 0.001, compared with North West). Patients from practices in London were the most likely to undergo bariatric surgery (2.15%), and practices in the North West the least likely (0.68%) (RR 3.29, 95% CI [2.88,3.76], p < 0.001, London compared with North West). Longer duration since diagnosis with severe and complex obesity (e.g., 1.67% of individuals diagnosed in 2007 versus 0.34% in 2015, RR 0.20, 95% CI [0.12,0.32], p < 0.001), and increasing comorbidities (e.g., 2.26% of individuals with 6+ comorbidities versus 1.39% with none (RR 8.79, 95% CI [7.16,10.79], p < 0.001) were also strongly associated with bariatric surgery. The main limitation is the reliance on overweight/obesity being recorded within primary care records to identify the study population. CONCLUSIONS: Between 2007 and 2020, a very small percentage of the primary care population eligible for WM referral or bariatric surgery according to national guidance received either. Higher BMI and GP practice region had the strongest associations with both. Regional inequalities may reflect differences in commissioning and provision of WM services across the country. Multi-stakeholder qualitative research is ongoing to understand the barriers to accessing WM services and potential solutions. Together with population-wide prevention strategies, improved access to WM interventions is needed to reduce obesity levels.

Novel methods to define invasive procedures at the end of life were developed to improve quality of end of life care research: a population-based cohort study in colorectal cancer.

BACKGROUND: Understanding the use of invasive procedures (IPs) at the end of life (EoL) is important to avoid undertreatment and overtreatment, but epidemiologic analysis is hampered by limited methods to define treatment intent and EoL phase. This study applied novel methods to report IPs at the EoL using a colorectal cancer case study. METHODS: An English population-based cohort of adult patients diagnosed between 2013 and 2015 was used with follow-up to 2018. Procedure intent (curative, noncurative, diagnostic) by cancer site and stage at diagnosis was classified by two surgeons independently. Joinpoint regression modeled weekly rates of IPs for 36 subcohorts of patients with incremental survival of 0-36 months. EoL phase was defined by a significant IP rate change before death. Zero-inflated Poisson regression explored associations between IP rates and clinical/sociodemographic variables. RESULTS: Of 87,731 patients included, 41,972 (48%) died. Nine thousand four hundred ninety two procedures were classified by intent (inter-rater agreement 99.8%). Patients received 502,895 IPs (1.39 and 3.36 per person year for survivors and decedents). Joinpoint regression identified significant increases in IPs 4 weeks before death in those living 3-6 months and 8 weeks before death in those living 7-36 months from diagnosis. Seven thousand nine hundred eight (18.8%) patients underwent IPs at the EoL, with stoma formation the most common major procedure. Younger age, early-stage disease, men, lower comorbidity, those receiving chemotherapy, and living longer from diagnosis were associated with IPs. CONCLUSION: Methods to identify and classify IPs at the EoL were developed and tested within a colorectal cancer population. This approach can be now extended and validated to identify potential undertreatment and overtreatment.

Further considerations for placebo controls in surgical trials.

The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.

Training surgeons to optimize communication and symptom management in patients with life-limiting conditions: systematic review.

BACKGROUND: Surgeons routinely care for patients with life-limiting illness, requiring communication and symptom management skills supported by appropriate training. The objective of this study was to appraise and synthesize studies that assessed surgeon-directed training interventions that aimed to optimize communication and symptom management for patients with life-limiting illness. METHODS: A PRISMA-concordant systematic review was undertaken. MEDLINE, Embase, Allied and Complementary Medicine Database (AMED), and the Cochrane Central Register of Controlled Trials were searched from inception until October 2022 for studies reporting on the evaluation of surgeon-training interventions intending to improve surgeons' communication or symptom management of patients with life-limiting disease. Data on the design, trainer and patient participants, and the intervention were extracted. Risk of bias was assessed. RESULTS: Of 7794 articles, 46 were included. Most studies employed a before-after approach (29 studies) and nine included control groups with five being randomized studies. General surgery was the most frequently included sub-specialty (22 studies). Trainers were described in 25 of 46 studies. Most training interventions aimed to improve communication skills (45 studies) and 13 different training interventions were described. Eight studies reported a measurable improvement in patient care, such as increased documentation of advance care discussions. Most study outcomes focused on surgeons' knowledge (12 studies), skills (21 studies), and confidence/comfort (18 studies) in palliative communication skills. Studies had a high risk of bias. CONCLUSION: Whilst interventions exist to improve the training of surgeons managing patients with life-threatening conditions, evidence is limited, and studies measure the direct impact on patient care insufficiently. Improved research is needed to lead to better methods for training surgeons to benefit patients.

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review.

BACKGROUND: Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of 'modifications', and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. METHODS: A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. RESULTS: Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. CONCLUSION: A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.

BACKGROUND/AIM: Clinical assessment of wounds for surgical site infection (SSI) after hospital discharge is challenging and resource intensive. Remote assessment using digital images may be feasible and expedite SSI diagnosis. Acceptable and accurate methods for this process are needed. This study developed and evaluated the feasibility, acceptability and usability of a method for patients to capture standardised wound images for remote wound assessment to detect SSI. MATERIALS AND METHODS: The work was conducted in two phases. Phase I involved: i) a review of literature to identify key components of photography relevant to taking wound images, ii) development of wound photography instructions for patients and a secure process for transmission of images using electronic survey software and iii) pre-testing of the photography instructions and processing method with a sample of 16 patients using cognitive interviews and observations. Phase II involved a prospective cohort study of 89 patients to evaluate the feasibility, acceptability and usability of the remote method following discharge from hospital after surgery. Quality of the images was assessed by three independent clinical reviewers. RESULTS: Some 21 key components for photographing wounds were identified from 11 documents. Of these, 16 were relevant to include in instructions for patients to photograph their wounds. Pre-testing and subsequent iterations improved understanding and ease of use of the instructions and the process for transmitting images. Fifty-two of 89 (58.4%) patients testing the method remotely took an image of their wound(s) and 46/52 (88.5%) successfully transmitted images. When it was possible to ascertain a reason for not taking/transmitting images, this was primarily health problems (n = 7) or lack of time/poor engagement with the study (n = 4) rather than problems relating to technology/competency (n = 2) or practical issues relating to the wound itself (n = 2). Eighty-seven (85.3%) of the 102 images received were evaluated to be of high quality and sufficient to remotely assess SSI by at least two independent reviewers. CONCLUSION: A simple, standardised and acceptable method for patients to take and transmit wound images suitable for remote assessment of SSI has been developed and tested and is now available for use in routine clinical care and research.

A standardized measurement instrument was recommended for evaluating operator experience in complex healthcare interventions.

OBJECTIVE: During development of complex surgical innovations, modifications occur to optimize safety and efficacy. Operators' experiences (how professionals feel undertaking the innovation) drive this process but comprehensive overviews of measures of this concept are lacking. This study identified and appraised measures to assess operators' experience of surgical innovation. STUDY DESIGN AND SETTING: There were three phases: (1) Literature reviews identified measures of operators' experience and concepts measured were extracted and grouped into domains. (2) Quality appraisal was conducted to assess content validity of identified instruments and was supported by COnsensus-based Standards for the selection of health Measurement Instruments methodology. Self-reported measurement instruments that had underdone formal development were eligible. Content validity was assessed using COnsensus-based Standards for the selection of health Measurement Instruments criteria for good content validity (rated sufficient/insufficient/indeterminate/inconsistent), informed by standards for measurement development and domains identified in phase 1. (3) Instruments determined suitable and of sufficient quality underwent supplemental appraisal in interviews with international multidisciplinary professionals and a focus group. RESULTS: Literature reviews identified 16 measurement instruments from 243 studies. Most assessed 'psychological' experiences and 'usability'. No instrument was specifically validated for innovative surgery. Three instruments were rated 'sufficient' (Surgery Task Load Index [SURG-TLX]) or 'indeterminate' (Spielberger State-Trait Anxiety Inventory, Imperial Stress Assessment Tool). Twenty professionals were interviewed (seven female; 15 specialties; six countries) and the focus group included 10 participants (four professionals, six researchers). The SURG-TLX was considered the most relevant, comprehensive, and comprehensible instrument. CONCLUSION: The SURG-TLX is preliminarily recommended to measure operators' experiences of innovation. Further work exploring its role and impact on surgical innovation is required.

A Core Outcome Set for Seamless, Standardized Evaluation of Innovative Surgical Procedures and Devices (COHESIVE): A Patient and Professional Stakeholder Consensus Study.

OBJECTIVE: 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, involvingcontext: 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.

What Are Patients Told About Innovative Surgical Procedures? A Qualitative Synthesis of 7 Case Studies in the United Kingdom.

OBJECTIVES: To investigate how information about innovative surgical procedures is communicated to patients. BACKGROUND: Despite the national and international guidance that patients should be informed whether a procedure is innovative and has uncertain outcomes, little is known about current practice. METHODS: This qualitative study followed 7 "case studies" of surgical innovation in hospitals across the United Kingdom. Preoperative interviews were conducted with clinician innovators (n=9), preoperative real-time consultations between clinicians and patients were audio-recorded (n=37). Patients were interviewed postoperatively (n=30). Data were synthesized using thematic analytical methods. RESULTS: Interviews with clinicians demonstrated strong intentions to inform patients about the innovative nature of the procedure in a neutral manner, although tensions between fully informing patients and not distressing them were raised. In the consultations, only a minority of clinicians actually made explicit statements about, (1) the procedure being innovative, (2) their limited clinical experience with it, (3) the paucity of evidence, and (4) uncertainty/unknown outcomes. Discussions about risks were generalized and often did not relate to the innovative component. Instead, all clinicians optimistically presented potential benefits and many disclosed their own positive beliefs. Postoperative patient interviews revealed that many believed that the procedure was more established than it was and were unaware of the unknown risks. CONCLUSIONS: There were contradictions between clinicians' intentions to inform patients about the uncertain outcomes of innovative and their actual discussions with patients. There is a need for communication interventions and training to support clinicians to provide transparent data and shared decision-making for innovative procedures.

Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.

Outcomes after Localized Prostate Cancer TreatmentDonovan et al. present the long-term patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial. Functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring are described. Over the trial period from 7 to 12 years, generic quality-of-life scores were similar among all groups, with varying degrees of impact on urinary leakage, sexual function, and fecal leakage depending on the treatment group.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations' policies in England and Wales.

OBJECTIVE: To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds). DESIGN: A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales. SETTING: NHS trusts in England and health boards in Wales, UK. PARTICIPANTS: Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review. RESULTS: From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure's novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon's experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included. CONCLUSIONS: Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients' and clinicians' views is required to address variability around information provision/consent for innovative procedures.

Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance.

BACKGROUND: The complexities associated with delivering randomised surgical trials, such as clustering effects, by centre or surgeon, and surgical learning, are well known. Despite this, approaches used to manage these complexities, and opinions on these, vary. Guidance documents have been developed to support clinical trial design and reporting. This work aimed to identify and examine existing guidance and consider its relevance to clustering effects and learning curves within surgical trials. METHODS: A review of existing guidelines, developed to inform the design and analysis of randomised controlled trials, is undertaken. Guidelines were identified using an electronic search, within the Equator Network, and by a targeted search of those endorsed by leading UK funding bodies, regulators, and medical journals. Eligible documents were compared against pre-specified key criteria to identify gaps or inconsistencies in recommendations. RESULTS: Twenty-eight documents were eligible (12 Equator Network; 16 targeted search). Twice the number of guidance documents targeted design (n/N=20/28, 71%) than analysis (n/N=10/28, 36%). Managing clustering by centre through design was well documented. Clustering by surgeon had less coverage and contained some inconsistencies. Managing the surgical learning curve, or changes in delivery over time, through design was contained within several documents (n/N=8/28, 29%), of which one provided guidance on reporting this and restricted to early phase studies only. Methods to analyse clustering effects and learning were provided in five and four documents respectively (N=28). CONCLUSIONS: To our knowledge, this is the first review as to the extent to which existing guidance for designing and analysing randomised surgical trials covers the management of clustering, by centre or surgeon, and the surgical learning curve. Twice the number of identified documents targeted design aspects than analysis. Most notably, no single document exists for use when designing these studies, which may lead to inconsistencies in practice. The development of a single document, with agreed principles to guide trial design and analysis across a range of realistic clinical scenarios, is needed.

A systematic review of robot-assisted cholecystectomy to examine the quality of reporting in relation to the IDEAL recommendations: systematic review.

INTRODUCTION: Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. METHODS: Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. RESULTS: Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. CONCLUSION: The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.