PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews Evidence in emergency non-trauma gastrointestinal surgery: synthesis of systematic reviews Jelena Savovic, Natalie Blencowe, Sean Strong, Ceri Rowlands, Laura Gould, Noah Howes, Daniel Stevens, John Mason, Katie Whale, Sarah Richards, Sanjeeva Kariyawasam, James Crichton, Jane Blazeby, Katy Chalmers, Victoria Pegna Citation Jelena Savovic, Natalie Blencowe, Sean Strong, Ceri Rowlands, Laura Gould, Noah Howes, Daniel Stevens, John Mason, Katie Whale, Sarah Richards, Sanjeeva Kariyawasam, James Crichton, Jane Blazeby, Katy Chalmers, Victoria Pegna. Evidence in emergency non-trauma gastrointestinal surgery: synthesis of systematic reviews. PROSPERO 2015:CRD Available from Review question(s) What interventions for treatment of anorectal (peranal) abscess are supported by robust evidence? What interventions for treatment of appendicitis are supported by robust evidence? What interventions for treatment of abdominal wall hernia are supported by robust evidence? What interventions for treatment of acute gallbladder disease are supported by robust evidence? What interventions for treatment of stomach and duodenum emergencies are supported by robust evidence? What interventions for treatment of small and large bowel emergencies are supported by robust evidence? What diagnostic procedures for diagnosing any of the above mentioned conditions of interest are supported by robust evidence? Is there robust cost-effectiveness evidence for interventions used to treat the above conditions of interest? Searches We searched Centre for Review and Dissemination Databases: DARE (Database of Abstracts of Reviews of Effects), NHS EED (NHS Economic Evaluation Database), HTA (Health Technology assessments), and PROSPERO systematic reviews register. In addition we also searched NICE (National Institute of Clinical Excellence) guidelines. We only searched for systematic reviews. We did not impose any language restrictions to the search. Full search strategy can be found in the accompanying document. Link to search strategy Types of study to be included a) Systematic reviews of randomized controlled trials and/or observational studies including patients presenting as an emergency with one of the conditions specified below. For the purposes of this overview of reviews, we defined a systematic review as one that made a documented attempt to identify studies addressing the research question of interest, and that may or may not contain a statistical summary of included studies (a meta-analysis). b) Systematic reviews of diagnostic studies, where diagnostic procedures assessed in the review are aimed at diagnosing patients presenting as an emergency with suspected eligible condition from the list specified below. c) Health economic evaluations of interventions for any of the listed conditions will also be included, but reviewed separately from the reviews of interventions and diagnostic studies. Economic evaluations studies will be eligible if Page: 1 / 6

2 they are based on data derived from either a single primary study or from a systematic review of interventions or diagnostic tests that have included eligible patients (i.e. patients presenting as an emergency with one of the specified conditions), and will exclude studies based on elective procedures or mixture of elective and emergency procedures. Condition or domain being studied Emergency surgery represents 50% of the surgical workload in the UK and accounts for approximately 14,000 admissions to intensive care units at a cost of 88 million pounds per year. A distinct subsection of emergency surgery can be defined as non-trauma gastrointestinal surgery, within which the most common presentations include perianal abscess, appendicitis, gallbladder disease, small/large bowel emergencies and abdominal wall herniae (based on data from Hospital Episodes Statistics, 2010). A recent report from the Royal College of Surgeons England (RCSEng) has highlighted that delivery of emergency surgical care is sub-optimal with a lack of financial investment and poor mortality and morbidity rates when compared to those of other healthcare economies3. Furthermore, the quality of nontrauma emergency surgical research is poor with many studies collecting data retrospectively and including only small numbers of patients and centres. Participants/ population We will include reviews and economic evaluation studies in adults, aged 16 years old and over, presenting as an emergency with one of the conditions specified below. Reviews which combined studies with adults and children will also be included, but purely pediatric reviews will be excluded (otherwise eligible reviews in children will be flagged in the citation database at the point of exclusion for future work in pediatric surgery). Systematic reviews that included a mixture of primary studies of both elective and emergency treatments (e.g. reviews including primary studies of patients presenting as an emergency as well as studies of patients needing elective/ scheduled treatment or diagnostic procedures) will be excluded. Eligible conditions for inclusion: Reviews (or economic evaluations) of studies including adults presenting as an emergency with one of the following six conditions will be included in the overview: appendicitis, abdominal wall hernia, gallbladder disease, stomach and duodenum emergencies, small and large bowel emergencies, and anorectal (perianal) abscess. Specific inclusion and exclusion criteria for each site or condition are as follows. Appendicitis: Patients presenting as an emergency with appendicitis, perforated appendix, appendix abscess or appendix mass treated with surgery or medical intervention. We will include patients undergoing an appendicectomy even if it was normal, or undergoing a diagnostic laparoscopy but no appendictomy. We will exclude malignant conditions of the appendix including carcinoid that were diagnosed pre operatively. Abdominal wall hernias: Patients requiring emergency treatment (or undergoing diagnostic procedures) for all types of groin herniae, including inguinal, femoral and obturator herniae. These may be primary, recurrent, unilateral or bilateral and for strangulated, incarcerated, obstructed or painful/tender herniae treated as an emergency. We will exclude reviews of any elective hernia repair and reviews of emergency non groin hernia surgery (umbilical, paraumbilical, spigelian, epigastric, incisional, hiatal and diagphragmatic). Gallbladder disease: Patients presenting as an emergency with sequelae of gallstones will be included. Specific diagnoses to be included are biliary colic, acute cholecystitis, empyema, mucocoele, pancreatitis, cholangitis or perforation of the gallbladder. Reviews of the treatment of patients with pancreatitis secondary to any cause other than gallstones will be excluded. Also excluded will be reviews solely reporting the elective treatment of gallstone disease. Reviews including a mixture of emergency and elective patients will be included only if data are presented separately. Similarly, if the review includes studies of patients with pancreatitis of mixed aetiologies (e.g. alcohol and gallstone induced pancreatitis), the review should only be included if the results can be extracted separately for the aetiology of interest. Stomach and duodenum emergencies: Patients presenting with upper GI emergencies requiring resection and repair, such as bleeding/perforation/bowel strangulation (e.g. due to peptic ulcer disease/acute gastric erosions, embolic disease or mechanical injury such as intusseception). Reviews assessing non-surgical management of the aforementioned conditions are also eligible. Upper GI bleeds from other causes such as alcoholic liver disease and varices, Mallory Weiss tears etc. will be excluded. If the review includes patients with upper GI bleeds of various Page: 2 / 6

3 etiologies it will only be included if the results are presented separately for different conditions (e.g. varices, Mallory Weiss, ulcers) in a way that the data for the conditions of interest are extractable, then the review should be included. If however the results for all these conditions are presented together, the review will be excluded. Conditions of the small and large bowel (jejunum to rectum): Patients admitted acutely to hospital with non-trauma emergency conditions of the small and large bowel (jejunum to rectum). The presentations or pathologies included are: obstruction (adhesions, carcinoma, volvulus, hernia, gallstone ileus, inflammatory stricture); bleeding (small or large bowel tumour, Meckel s diverticulum, inflammatory bowel disease, angiodysplasia, diverticular source); inflammatory complications of Meckel s diverticulum or appendix; inflammatory bowel disease; toxic mega-colon or colitis of any cause requiring operative management (bleeding, stricture, sepsis, peritonitis or refractory to medical treatment); complications of diverticular disease (diverticulitis, diverticular abscess, perforation, bleed, stricture) and large or small bowel ischaemia of any cause. Exclusions of note are small or large bowel tumours not causing significant bleeding or obstruction to warrant non-scheduled surgery, inflammatory bowel disease managed by medical therapy alone and pseudo-obstruction. Sepsis and bleeding conditions of unknown cause will also be excluded. Anorectal abscess: Patients presenting with the following eligible pathologies will be included: perianal abscess, ischiorectal abscess, intersphincteric abscess, supralevator abscess, submucosal abscess and anorectal abscess (generic term). We will exclude the following conditions: pilonidal abscess/cyst/fistula, fistulae of any sort, abscesses unrelated to the anus and/or rectum, haemorrhoids, rectal bleeding and anal fissure. Intervention(s), exposure(s) Interventions: a) Any treatment administered to patients with one of the conditions of interest and aimed at treating that condition will be included. Treatments do not have to be surgical. Interventions comparing different care pathways or organization of care will be excluded. b) Diagnostic tests and procedures applied to patients with any of the listed conditions for the purposes of diagnosing the said condition or its severity. We will exclude reviews that focus on surgical interventions for treating postoperative complications (even when requiring emergency treatment). We will also exclude reviews whose primary focus is on concomitant interventions, i.e. when the primary emergency condition has already been treated by another intervention. Comparator(s)/ control We will not restrict the inclusion of reviews based on the comparison intervention. Outcome(s) Primary outcomes Any efficacy, safety, process or cost outcomes will be eligible. There are no pre-specified primary or secondary outcomes. We will record all reported outcomes. We will record all reported outcomes. Secondary outcomes We will record all reported outcomes. Data extraction, (selection and coding) Screening of titles and abstracts for inclusion: Downloaded citations will be stored in a purpose-built Microsoft Access database, which will be used for screening titles and abstracts and where decisions on inclusion of each record will be stored. Titles and abstracts will be screened for relevant articles independently by two reviewers with clinical knowledge of the conditions of interest. Titles and abstracts with discrepant decisions will be re-screened by a third (more senior) reviewer whose decision will be final. Full papers will be obtained for screening for records that were judged as relevant by both reviewers, re-screened records judged relevant by the third reviewer, and records judged unclear based on title and abstracts. Page: 3 / 6

4 Study selection for inclusion in review: Two independent reviewers will assess full paper articles for inclusion based on pre-specified criteria. Disagreements will be discussed between two reviewers and if unresolved a senior reviewer will cast a final decision. Data Extraction: Data will be extracted by the first reviewer (with clinical expertise) on a pre-agreed and piloted paper extraction form and checked by the second reviewer. Any disagreements will be discussed between the first and the second reviewer until resolved, or by a discussion with a senior reviewer. The second reviewer will then enter the checked (and corrected if necessary) data into the database. Accuracy of data entry into the database will then be checked by another reviewer. Data to be extracted: Details regarding the journal and year of publication, country of review will be extracted. The type of article will be described as a systematic review, meta-analysis or health economic evaluation and the types of studies included within each review will be documented (for example RCT, cohort study, case series) as well as the number of each and number of participants (total and per study design if available). The disease area under investigation will be classified according to the six pre-specified categories. If the review relates to treatments, the nature of both interventions and comparators will also be documented. All reported outcomes will be recorded and categorised. Where meta-analyses are available we will extract: the number and design of of studies and participants included in each meta-analysis, outcome and its definition, timing of outcome, the effect estimate and confidence intervals; a measure of heterogeneity. We will also extract overall conclusions of the review. Risk of bias (quality) assessment Quality of included reviews will be assessed using the AMSTAR tool. Assessments will be done in duplicate by two reviewers at the time of data extraction. We have selected 4 key components from the 11 items to classify the findings from a review as at low, high, or unclear risk of bias. Findings from a systematic review will thus be classified as at high risk of bias if the literature search was not comprehensive, it did not assess the methodological quality of included studies, did not use methodological quality assessments appropriately in generating review conclusions, or if it used inappropriate statistical methods for meta-analysis. Findings will be classified as at low risk of bias if none of these deficiencies was observed and as at unclear risk of bias if insufficient details were provided to permit judgement on 1 or more of the 4 deficiencies. Strategy for data synthesis It is anticipated that only a descriptive analysis will be carried out. We intend to present results in descriptive tables by condition and intervention type, describing what studies were synthesized, quality of reviews, and the main findings. Analysis of subgroups or subsets Diagnostic and economic reviews will be presented (and published) separately from intervention review data. For intervention reviews we will present data separately for each condition. Within each condition we will present data separately according the nature of the intervention (e.g. we will present separately data that compares 2 surgical techniques and surgery versus medical therapy) Dissemination plans We plan to publish one overall paper describing the entire review presenting the overview of all identified reviews without detailed results. We will then published results of intervention overview for each of the 6 topics separately in more detail. Diagnostic and economic overview will be also published separately. Contact details for further information Dr Savovic School of Social and Community Medicine Canynge Hall 39 Whatley Road Bristol BS6 5UP Page: 4 / 6

5 Organisational affiliation of the review University of Bristol Review team Dr Jelena Savovic, University of Bristol Miss Natalie Blencowe, University of Bristol Mr Sean Strong, University of Bristol Mr Ceri Rowlands, North Bristol NHS Trust Dr Laura Gould, St George's Hospital, London Mr Noah Howes, University of Bristol Dr Daniel Stevens, University of Oxford Dr John Mason, University of Oxford Miss Katie Whale, University of Bristol Miss Sarah Richards, Royal United Hospital, Bath Mr Sanjeeva Kariyawasam, Australia Dr James Crichton, Musgrove Park Hospital Professor Jane Blazeby, University of Bristol Dr Katy Chalmers, University of Bristol Miss Victoria Pegna, University of Bristol Anticipated or actual start date 01 April 2014 Anticipated completion date 01 May 2015 Funding sources/sponsors This review is supported by: The Bristol Surgical Trials Centre (Royal College of Surgeons of England) NIHR CLAHRC West University Hospitals Bristol NHS Trust Conflicts of interest None known Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Digestive System Surgical Procedures; Emergency Service, Hospital; Humans Stage of review Ongoing Page: 5 / 6

6 Powered by TCPDF ( Date of registration in PROSPERO 27 January 2015 Date of publication of this revision 27 January 2015 DOI /CRD Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes No Data extraction Yes No Risk of bias (quality) assessment Yes No Data analysis No No PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 6 / 6