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MOOSE Checklist Infliximab Reduces Hospitalizations and Surgery

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MOOSE Checklist Infliximab Reduces Hospitalizations and Surgery Systematic reviews and meta-analyses of observational studies (MOOSE): Checklist. MOOSE Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease: a systematic review and meta‐analysis. Criteria Brief description of how the criteria were handled in the meta‐analysis Reporting of background should include √ Problem definition Hospitalization and surgery are markers of inflammatory bowel disease (IBD) severity and significantly contribute to the high economic burden of IBD. √ Hypothesis statement Infliximab therapy was suggested to reduce the rate of serious complications in IBD (hospitalization and surgery rate). √ Description of study outcomes We aimed to perform a systematic review and meta‐analysis of all studies (observational and experimental) that evaluated patients with IBD treated with infliximab and incidence of hospitalizations and surgery. Secondary outcome described in Methods section. √ Type of exposure or intervention Infliximab (any dose or regimen) used √ Type of study designs used All studies (observational and experimental) √ Study population Adult patients (aged 18 years or older) with IBD, irrespective of IBD severity, baseline diseases and risk factors. Reporting of search strategy should include √ Qualifications of searchers The credentials of investigators are indicated in the author list. 1 √ Search strategy, including time PubMed, from inception – April 2012. period included in the synthesis and keywords Cochrane Library, from inception – April 2012. Web of Science® – with Conference Proceedings, from inception – April 2012. Search strings are supplied in appendix √ Databases and registries Medline through PubMed, CENTRAL at Cochrane Library and searched Web of Science® – with Conference Proceedings. √ Search software used, name and No software was involved in search method version, including special features √ Use of hand searching We performed handsearch of references from obtained studies. √ List of citations located and those Present in the flowchart. excluded, including justifications √ Method of addressing articles No language restrictions were applied. published in languages other than English √ Method of handling abstracts and Abstracts contained pretended data. unpublished studies √ Description of any contact with We did not contact any author. authors Reporting of methods should include √ Description of relevance or Detailed inclusion and exclusion criteria were described in the appropriateness of studies Methods section. assembled for assessing the hypothesis to be tested √ Rationale for the selection and Authors extracted data from study design, location, time‐ coding of data frame of study, patients’ characteristics, drugs used and its assessment, studies’ primary outcome, data of required outcomes and estimates adjustments. √ Assessment of confounding We made subgroup analysis according to IBD type and we explored different sources of heterogeneity. 2 √ Assessment of study quality, Quality of reporting was analyzed using a qualitative including blinding of quality classification according to risk of bias (high, unclear or low assessors; stratification or risk). regression on possible predictors of study results For observational studies we used a 6‐items classification based on MOOSE, QATSO and STROBE. This system was adapted from previous published systematic review. For RCTs we adopted Cochrane Collaboration’s Tool for assessing risk bias. √ Assessment of heterogeneity Statistical heterogeneity was evaluated using I2 statistics. √ Description of statistical methods Description of methods of meta‐analyses, subgroup analyses, in sufficient detail to be NNT calculations and assessment of publication bias are replicated present in Methods section. √ Provision of appropriate tables We provided 1 flowchart figure and 2 figures with forest plots and graphics of outcomes. For supplementary section we provided 4 figures with quality appraisal graphs (2 for RCTs and 2 for observational studies). We supplied 2 tables with studies characteristics: one for RCTs and one for observational studies. Reporting of results should include √ Graph summarizing individual Figure 2 and 3. study estimates and overall estimate √ Table giving descriptive Table 1 and 2. information for each study included √ Results of sensitivity/subgroup Figure 2 and 3. testing √ Indication of statistical 95% confidence intervals were presented with all summary uncertainty of findings estimates and I2 values. Reporting of discussion should include √ Quantitative assessment of bias Quality of studies and the potential impact of bias in results were discussed. Subgroups analyses for surgery rate indicate that CD patients are more likely to benefit with infliximab 3 treatment. √ Justification for exclusion We excluded studies that did not evaluate pretended outcomes or infliximab therapy, studies that included pediatric population and case‐series studies or studies with a sample size population smaller that pre‐established. √ Assessment of quality of included Overall quality of included studies was considered to be good. studies The higher risk of bias was found for potential selective reporting and failure to describe withdrawals in RCTs and presentation of unadjusted risk estimates in observational studies. Reporting of conclusions should include √ Consideration of alternative We discussed the limitations inherent to individual studies explanations for observed results (selective reporting, unadjusted risk estimates) and meta‐ analysis (pooling data of studies with different designs, settings and baseline morbidities and heterogeneous risk for hospitalizations and surgery) that could bias observed results. √ Generalization of the conclusions Our results suggest an important role of infliximab treatment in hospitalization and surgery (at least for CD patients) risk reduction. √ Guidelines for future research Specific designed prospective long‐term effectiveness studies are required to establish definite conclusions and to better estimate the true magnitude of this impact. Future studies should also use active controls to inform comparative effectiveness. √ Disclosure of funding source Disclosure of funding source was made. 4 Systematic reviews and meta-analyses of randomized controlled trials (PRISMA): Checklist. PRISMA Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease: a systematic review and meta-analysis. Section/topic # Checklist item Page TITLE Title 1 Identify the report as a systematic review, meta-analysis, or both. Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease: a systematic 1 review and meta-analysis. ABSTRACT Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. OBJECTIVE: To systematically review interventional and observational studies evaluating patients with inflammatory bowel disease (IBD) treated with infliximab to estimate their risk of hospitalizations and surgery. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline through PubMed, Cochrane Library and Web of Science® with Conference Proceedings from inception to April 2012. Systematic reviews and references of retrieved articles were comprehensively searched. 2, 3 STUDY SELECTION: Two reviewers independently selected clinical trials and observational studies evaluating IBD patients treated with infliximab and reporting on hospitalization and/or surgery rate, and retrieved studies’ characteristics and data estimates. DATA SYNTHESIS: Primary and secondary outcomes were incidence of hospitalization and surgery. Analyses were carried according to study design (randomized clinical trials – RCTs, and observational studies) and IBD type (Crohn’s 5 disease [CD] and ulcerative colitis [UC]). Random-effects meta-analysis was used to derive pooled and 95% confidence intervals estimates of odds ratios (OR). Heterogeneity was assessed with I2 test. RESULTS: Twenty-seven eligible studies were included (9 RCTs and 18 observational studies). Infliximab significantly reduced hospitalization risk, both in pooled RCTs (OR 0.51, 95% CI 0.40-0.65; I2=0%) and observational studies’ results (OR 0.29, 95% CI 0.19-0.43; I2=87%), without differences between CD and UC patients. Infliximab also significantly reduced surgery risk in pooled RCTs results (OR 0.36, 95% CI 0.18-0.71; I2=65%), both in CD and UC patients. Pooled estimate from observational studies favored infliximab for CD (OR 0.30, 95% CI 0.18-0.49; I2=78%), but not for UC patients. CONCLUSIONS: The best evidence available points towards a reduction of the risk of hospitalization and surgery requirement in IBD patients treated with infliximab. This impact is clinically and economically relevant because hospitalization and surgery are considered to be markers of disease severity and significantly contribute to the total direct costs associated with IBD. INTRODUCTION Rationale 3 Describe the rationale for the review in the context of what is already known. The requirement for hospitalization and surgery are both currently thought to be markers of IBD severity. Furthermore, medical and surgical hospitalizations positivity impact significantly on the globally high economic
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