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)

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Other contributors (names, affiliations, contributions) Contact person + e-mail address

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Funding sources/sponsors

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Conflicts of interest Date and location of protocol registration Registration number (if applicable)

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Stage of review at time of registration

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Description Effects of selective serotonin reuptake inhibitors on skeletal muscle of rodents: A systematic review. Diego Visco, Graduate Program in Physical Therapy, Federal University of Pernambuco, Brazil: study design, data extraction analysis, writing manuscript Wenicios Chaves, Undergraduate In Nutrition, Federal University of Pernambuco, Brazil, data extraction analysis, writing manuscript Kelli Nogueira Ferraz-Pereira, Graduate Program in Nutrition, editing manuscript, statistics Ana Elisa Toscano, Phd, Graduate Program in Nutrition, Physical Activity and Phenotypic Plasticity, Federal University of Pernambuco, Brazil, data extraction analysis, writing manuscript, third acessor data Raul Manhães-de-Castro, Phd, Gradute Program of Nutrition, Federal University of Pernambuco, Brazil, editing manuscript

[email protected] National Council for Scientific and Technological Development (CNPq) none December, 2016 Pernambuco, Brazil. Formal screening of search results against eligibility criteria

B. Objectives Background

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11. 12.

The pharmacological manipulation of Selective Serotonin Reuptake Inhibitors (SSRIs) during a critical period of What is already known about this development can modified the important regulatory disease/model/intervention? Why is it functions of the serotoninergic system and induced important to do this review? changes in embryogenesis and morphogenesis. Facilitate or inhibit the action of this system can inducing changes on morphology and properties of skeletal muscle. Research question Specify the disease/health problem of Muscle skeletal outcomes of Selective serotonin reuptake interest inhibitors exposure. Specify the population/species Rodents studied

Check for approval

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Specify the intervention/exposure

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Specify the control population

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Specify the outcome measures State your research question (based on items 11-15) C. Methods Search and study identification

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Exposure for any method to Selective serotonin reuptake inhibitors (SSRI) during pregnancy or before the birth. Exposure to a control during pregnancy or before the birth. The muscle skeletal properties Does selective serotonin reuptake inhibitors affect the skeletal muscle of rodents?

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Identify literature databases to search (e.g. Pubmed, Embase, Web of science)

□MEDLINE via PubMed □Web of Science □SCOPUS □EMBASE □Other, namely: LILACS, BIREME, Psyinfo, Scielo □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]

Identify other sources for study identification

□Reference lists of included studies □Books □Reference lists of relevant reviews □Conference proceedings, namely: □Contacting authors/ organisations, namely: □Other, namely:

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Screening the reference list for relevant titles and Define search strategy for these other subsequently the abstracts of these identified studies sources (same criteria as initial selection phase) Study selection Define screening phases (e.g. pre1) Title and abstract in relation to research question; screening based on title/abstract, full 2) Full text based on inclusion/ exclusion criteria text screening, both) Two Investigators independently screen for phases 1 and 2 Specify (a) the number of reviewers in the data bases; discrepancies that cannot be resolved per screening phase and (b) how by discussion will be resolved by an additional discrepancies will be resolved investigator. Define all inclusion and exclusion criteria based on: Inclusion criteria: primary, preclinical, controlled Type of study (design) Exclusion criteria: review, clinical, not controlled Inclusion criteria: rodents any sex, any age at testing Type of animals/population (e.g. age, Exclusion criteria: humans, other animals, genetic gender, disease model) mutation Inclusion criteria: Serotonin uptake inhibitors or control exposure prenatal, perinatal or early postnatal exposure, Type of intervention (e.g. dosage, any dosage timing, frequency) Exclusion criteria: non –SSRI, SSRI in combination with another drug, exposure from an environmental source Inclusion criteria: any method to assess muscle skeletal Outcome measures properties Exclusion criteria: other outcomes Language restrictions Inclusion criteria: all

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Publication date restrictions

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Other

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Sort and prioritize your exclusion criteria per selection phase

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Exclusion criteria: none Inclusion criteria: all Exclusion criteria: none Inclusion criteria: Exclusion criteria: Selection phase 1: 1. Not an original primary study 2. Not in vivo rodents study 3. No treatment with Serotonin uptake inhibitors. Selection phase: 1. No perinatal, prenatal, early postnatal exposure 2. No assessments of muscle skeletal properties 3. No control population

Study characteristics to be extracted (for assessment of external validity, reporting quality) Study ID (e.g. authors, year) Authors, years, title Numbers of groups Study design characteristics (e.g. Number of animals per group (total and per test( experimental groups, number of Number of litters per group animals) Little size Repeated measures / comparasion between groups Strain Sex Age Animal model characteristics (e.g. Age at testing species, gender, disease induction) Muscle Diet Weight Type of Serotonin uptake inhibitors Type of control Intervention characteristics (e.g. Age and duration of control intervention, timing, duration) Administration method Dosage Histological techniques Immunohistochemical test Outcome measures Enzyme Assays Muscle function Number of animal excluded from statistical analysis Other (e.g. drop-outs) reason for excluding Conflict of interest/ acknowledgements Assessment risk of bias (internal validity) or study quality Two reviewers (VISCO, CHAVES) will assess the risk of Specify (a) the number of reviewers assessing the risk of bias/study quality bias/study quality in each study. Discrepancies that in each study and (b) how cannot be resolved by discussion will be resolved by discrepancies will be resolved an additional investigator (TOSCANO).

□By 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 4

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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

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For each outcome measure, define the type of data to be extracted (e.g. continuous/dichotomous, unit of measurement)

Histological techniques (preferably continuous, but also scales) Immunohistochemical tests (preferably continuous, but also scale or dichotomous) Enzyme Assays (continuous)

Methods for data extraction/retrieval 1. Extract data from text/table (e.g. first extraction from graphs using 2. Extraction from graphs using a digital screen ruler. a digital screen ruler, then contacting 3. Contact Author for missing data. authors) Specify (a) the number of reviewers Two independent reviewers (VISCO and CHAVES)will extracting data and (b) how extract data from the included articles. discrepancies will be resolved Discrepancies will be resolved by discussion. Data analysis/synthesis Data are presented in tables (mean, CI/SD and number of animals per group) or in a descriptive summary, enabling Specify (per outcome measure) how comparison of results. you are planning to combine/compare A meta analysis is expected to be possible for at least one the data (e.g. descriptive summary, of the outcome measure. meta-analysis) For subgroup analysis preferably >3 independent articles are used. Specify (per outcome measure) how it A meta-analysis will be performed when >3 independent will be decided whether a metaarticles present data on comparable outcomes. analysis will be performed If a meta-analysis seems feasible/sensible, specify (for each outcome measure): We use mean difference if studies use the same The effect measure to be used (e.g. experimental test with the same scoring system but mean difference, standardized mean standardized mean difference if combining different tests difference, risk ratio, odds ratio) for one properties (e.g. muscle fiber type). The statistical model of analysis (e.g. Random Effects model. random or fixed effects model) The statistical methods to assess Review Manager will be used for statistical analysis, with heterogeneity (e.g. I2, Q) use of I2 for heterogeneity testing. Which study characteristics will be Type of SSRI examined as potential source of Muscle Properties. heterogeneity (subgroup analysis) Possible characteristics for the sensitivity analysis are: Any sensitivity analyses you propose animal strain, age, weight, type of control group, Type of to perform SSRI and muscle properties outcome measure. Other details meta-analysis (e.g. If necessary Correction of p-valeu for the number of correction for multiple testing, subgroup analyses by Bonferroni-Holmes correction. correction for multiple use of control Correction for multiple comparisons.

50.

group) The method for assessment of publication bias

Final approval by (names, affiliations):

If possible, using a funnel plot.

Date:

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