SYSTEMATIC REVIEW PROTOCOL FOR ANIMAL INTERVENTION STUDIES FORMAT BY SYRCLE (WWW.SYRCLE.NL) VERSION 2.0 (DECEMBER 2014) Item Section/Subsection/Item # A. General 1.
Title of the review
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Authors (names, affiliations, contributions)
Description Two types of maxillo-mandibular fixation systems: a systematic review of animal studies Felipe Perraro Sehn (1) Bianca Marigliani (2) Anna Maria Buehler (3)
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Funding sources/sponsors
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Conflicts of interest Date and location of protocol registration Registration number (if applicable) Stage of review at time of registration Full text analysis and data extraction B. Objectives Background There are many possibilities to treat mandible fractures, What is already known about this and one of them is the use of absorbable system. disease/model/intervention? Why is it However, the complete knowledge about the reason and important to do this review? their consequences is still not recognized. Research question Specify the disease/health problem of interest Maxillo-mandibular fractures or osteotomies Specify the population/species Animals with maxilla-mandibular fractures or osteotomy studied Specify the intervention/exposure Absorbable fixation system Specify the control population Metallic fixation system 1º) Complete or incomplete healing of the fractured/osteotomyzed bone fragments; 2º) Histological (new bone formation) and histomorphometrical (bone to Specify the outcome measures screw contact) behavior of fixation system; 3º) Degradable time of absorbable fixation system; 4º) Side effects of using absorbable fixation system The use of absorbable fixation system promotes similar State your research question (based osteosynthesis to that carried out by metal fixing systems on items 11-15) in maxillo-mandibular fractures/osteotomies in animals? C. Methods Search and study identification
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X (1) University of São Paulo (2) Federal University of São Paulo (3) Oswaldo Cruz German Hospital Mabel Figueiró (1) (1) University of São Paulo Felipe Perraro Sehn:
[email protected] FAPESP São Paulo Research Foundation - Process nº 2014/23710-6 None
Other contributors (names, affiliations, contributions) Contact person + e-mail address
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Check for approval
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Identify literature databases to search (e.g. Pubmed, Embase, Web of science)
XMEDLINE via PubMed XSCOPUS XEMBASE □Other, namely: Cochrane; Lilacs; Ebscohost □Specific journal(s), namely:
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Define electronic search strategies (e.g. use the step by step search guide15 and animal search filters20, 21)
When available, please add a supplementary file containing your search strategy: [insert file name]
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Identify other sources for study identification
XReference lists of included studies □Books □Reference lists of relevant reviews □Conference proceedings, namely: □Contacting authors/ organisations, namely: □Other, namely:
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Define search strategy for these other Screening the reference lists for relevant titles and sources screening the abstracts of these relevant titles Study selection Define screening phases (e.g. pre1º) screening based on title and abstract screening based on title/abstract, full 2º) full-text screening of the eligible articles text screening, both) Specify (a) the number of reviewers At screening phase, two reviewers will screen all articles per screening phase and (b) how (FPS and BM). Differences will be solved through discrepancies will be resolved discussion or by consulting a third investigator. Define all inclusion and exclusion criteria based on: Inclusion criteria: “in vivo” pre-clinical studies Exclusion criteria: “ex vivo” pre-clinical studies; “in vitro” Type of study (design) pre-clinical studies and biomechanical studies; clinical studies (humans) Inclusion criteria: all animals, ages and genders Type of animals/population (e.g. age, Exclusion criteria: clinicals (humans), “in vitro” and “ex gender, disease model) vivo” studies Inclusion criteria: use of absorbable fixation system versus Type of intervention (e.g. dosage, metallic fixations systems at maxillo-mandibular area timing, frequency) Exclusion criteria: other types fixations system (steel wires) and others areas Inclusion criteria: 1º) Complete or incomplete healing of the fractured/osteotomyzed bone fragments; 2º) Histological (new bone formation) and histomorphometrical (bone to screw contact) behavior of Outcome measures fixation system; 3º) Degradable time of absorbable fixation system; 4º) Side effects of using absorbable fixation system Exclusion criteria: no relevant outcome measure Inclusion criteria: all languages Language restrictions Exclusion criteria: none Inclusion criteria: all publications dates Publication date restrictions Exclusion criteria: none Other NA Sort and prioritize your exclusion Selection phase:
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criteria per selection phase
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1. Review 2. No full paper (abstract, comment) 3. Data published in duplicate 4. Human 5. Not in vivo (e.g. ex vivo/in vitro/in sillico) 6. No comparison absorbable X metallic system
Study characteristics to be extracted (for assessment of external validity, reporting quality) Study ID (e.g. authors, year) Authors, title, year, language, contact author e-mail Number of animals in experimental and control groups, presence of control group, study period, place of fracture or osteotomy, presence of semi-rigid fixation, type of Study design characteristics (e.g. materials, radiographical evaluation, feed restriction, experimental groups, number of histomorphometrical data (new bone formation, animals) connective tissue, bone to screw contact), data from stimulating factors, adverse effects, re-interventions, drug used, power calculation reported Animal model characteristics (e.g. Animal species, age, weight, gender species, gender, disease induction) Intervention characteristics (e.g. Type of fixation system, duration of surgical time, type and intervention, timing, duration) side of semi-rigid fixation Timing of data collection, histomorphometrical data (new Outcome measures bone formation, connective tissue, bone to screw contact), presence of semi-rigid fixation number of animals excluded from statistical analysis, Other (e.g. drop-outs) reason for excluding animals Assessment risk of bias (internal validity) or study quality Specify (a) the number of reviewers a) 3 reviewers. The criteria will be independently assessed assessing the risk of bias/study quality by Felipe Perraro Sehn, Bianca Marigliani and Anna Maria in each study and (b) how Buehler; b) Discrepancies will be resolved by discussion discrepancies will be resolved
XBy use of SYRCLE's Risk of Bias tool □By use of SYRCLE’s Risk of Bias tool, adapted as follows: □By use of CAMARADES' study quality checklist, e.g □By use of CAMARADES' study quality checklist, adapted
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Define criteria to assess (a) the internal validity of included studies (e.g. selection, performance, detection and attrition bias) and/or (b) other study quality measures (e.g. reporting quality, power)
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as follows:
□Other criteria, namely:
Collection of outcome data Timing of data collection: continuous, units: days or months Histomorphometrical data: continuous, unit: percentage and standard deviation Presence of semi-rigid fixation: dichotomous, unit: yes or no (only for discussion)
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For each outcome measure, define the type of data to be extracted (e.g. continuous/dichotomous, unit of measurement)
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Methods for data extraction/retrieval (e.g. first extraction from graphs using Extraction from text and tables. a digital screen ruler, then contacting Contacting authors by e-mail in case of missing data. authors)
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Specify (a) the number of reviewers Two reviewers (FPS and BM) will extract all data. extracting data and (b) how Discrepancies will be resolved by discussion discrepancies will be resolved Data analysis/synthesis Specify (per outcome measure) how you are planning to combine/compare Meta-analysis the data (e.g. descriptive summary, meta-analysis) A minimum of 5 articles per outcome measure is required. Specify (per outcome measure) how it No restrictions in terms of heterogeneity will be applied, will be decided whether a metainstead, sources of heterogeneity will be investigated analysis will be performed through sensitivity and subgroup analysis. If a meta-analysis seems feasible/sensible, specify (for each outcome measure): The effect measure to be used (e.g. Timing of data collection: mean difference mean difference, standardized mean Histomorphometrical data: mean difference difference, risk ratio, odds ratio) The statistical model of analysis (e.g. Fixed effects model random or fixed effects model) The statistical methods to assess Q heterogeneity (e.g. I2, Q) Animal species (mouse vs. rat vs. pig etc) Which study characteristics will be Gender (male vs. female vs. mixed) examined as potential source of Timing of data collection heterogeneity (subgroup analysis) Histomorphometrical analysing method Any sensitivity analyses you propose Effect of possible interactions by species and quality to perform If studies report data for a series of time points, we will Other details meta-analysis (e.g. pool the data of different time points to correct for correction for multiple testing, repeated measurements of dependent variables. We will correction for multiple use of control correct for repeated use of the same control group by group) dividing the number of animals in the control group by the number of comparisons made. The method for assessment of Funnel plot and, if possible, trim and fill publication bias
Final approval by (names, affiliations):
Felipe Perraro Sehn, University of São Paulo Bianca Marigliani, Federal University of São Paulo Anna Maria Buehler, Oswaldo Cruz German Hospital
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Date: April, 16, 2016
