p.p1 medial compartment knee OA, published as

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5px Helvetica}span.s1 {font: 7.5px Helvetica}METHODSSearch strategyA systematic literature search was conducted, following the Preferred Reporting Items forSystematic Reviews and Meta-Analyses (PRISMA) group statement (Liberati et al.

, 2009). Thestudy protocol is registered in International prospective register of systematic reviews(PROSPERO), with registration number CRD42017070785(http://www.crd.york.ac.uk/prospero/.The Population, Intervention, Comparison and Outcome (PICO) framework was used todefine the search strategy (Schardt, Adams, Owens, Keitz, & Fontelo, 2007). Combinations ofkey words and specific subject headings related to knee osteoarthritis, external kneeadduction moment, biomechanics kinetics and kinematics and interventions to reducePhysiotherapy Research International Page 4 of 32dynamic loading of the knee (see Supplemental Table 1) were searched.

Boolean operators”OR” and “AND” were utilized to combine search terms. No restrictions were set for thesearches with respect to language or publication year. Two investigators (VF, RS) derived theBoolean phrase and completed the systematic search. Medline/Pubmed, CINAHL andScopus, were searched from their inception through May 31, 2017.

Eligibility criteriaThe articles from searching databases were collected and duplicates were removed andcross-checked between the researchers to ensure agreement. Two authors (VF, RS) reviewedthe titles and abstracts of all articles for eligibility based on the criteria list. When in doubt,full text articles were reviewed. Disagreements were resolved by discussion until consensuswas reached.

Studies to be included in this review, must have been peer-reviewed studies that examinedthe acute biomechanical effects of lateral wedged insoles in patients with medialcompartment knee OA, published as full text. There were no restrictions on design andseverity of knee OA. Studies must have investigated a lateral wedged insole, defined as anin-shoe orthotic device with an angle of inclination toward the lateral border of the foot. Norestrictions were made regarding the features of insoles (i.e., length: heel or full length) orpresence of concurrent arch support in the device. Only baseline data inferring theimmediate effects of lateral wedge insoles were used.

Studies must have included acomparison condition that could be the insole removed or neutral insole (without anyinclination). If studies included the two control conditions (neutral insole or insole removed),only the data from neutral insole were analyzed. If an article analyzed customizationintervention, but not provide individual results, the article was excluded.Systematic and narrative reviews were eligible for the purposes of manual reference listsearching only to identify any studies missed in the primary search. Studies were excluded ifthey did not include patients with osteoarthritis or osteoarthrosis, and if they wereabstracts, case reports, editorials, conference proceedings papers, study protocols orunpublished papers or without full-access.Data extractionFrom the full articles of the systematic review, the first author extracted into spreadsheetsall data concerning the characteristics of the individual trials and outcomes. A second author(RS) checked the data for accuracy.

The main data extracted were the study design, numberof patients, patient characteristics, type of insole, angle of lateral wedge, control condition,biomechanical outcome measures, statistical information and funding sources. Primaryoutcome variables of interest extracted included features of the external knee adductionmoment; the first peak EKAM, second peak EKAM, and KAAI.Assessment of risk of bias in included studiesThe risk of bias assessment was completed by one author (VF) and checked by a secondauthor (RS) using the Cochrane Risk of Bias assessment tool (Higgins et al., 2011). Eacharticle was graded (unclear, low or high risk of bias) based on selection bias (randomsequence generation and allocation concealment), detection bias (blinding of outcomePhysiotherapy Research International Page 6 of 32assessment), blinding of participants and personnel (performance bias), attrition bias(incomplete outcome data), reporting bias (selective reporting), and other bias. In case ofdisagreements, a common consensus was established and a third author (PR) was consultedif consensus could not be reached.

Data analysisStatistical information including descriptive (means, medians, standard deviations SDs,change scores) and inferential (P values, confidence interval CI) were extracted and crosscheckedby two authors (VF, RS). For the meta-analysis, standardized mean differences(SMDs) were calculated as the mean difference in EKAM change produced by the angle ofthe insole and the control (neutral insole or without insole) divided by the pooled standarddeviation of the measurement. Hence, a negative effect size indicated a beneficial effect forthe insole group. Meta-analysis was performed in Review Manager (RevMan) software(version 5.3, Cochrane Collaboration) using the inverse variance method, where thecontribution of effect sizes from individual studies is weighted on sample size. For studiesnot reporting sufficient data, and where the authors could not provide data, they werecalculated from other available data when possible (e.

g., from 95% CI or P values from ttests). It was decided to use a random effects model a priori to more conservatively estimatethe pooled effect of intervention.Heterogeneity was assessed using a ?2 test (Q value), its corresponding degrees of freedomand p value. The extent of heterogeneity was analyzed using Higgins’ I2 value (expressed as%).

Heterogeneity determine the percentage of total variation across studies that is due toheterogeneity rather than chance and examines the null hypothesis that all studies arePage 7 of 32 Physiotherapy Research Internationalevaluating the same effect (Higgins, Thompson, Deeks, & Altman, 2003). For theinterpretation of heterogeneity the values of 25%, 50%, and 75% were followed, whichrepresenting low, moderate, and high heterogeneity, respectively (Higgins et al., 2003). Therisk of small study effects was assessed using the Egger’s regression test (Higgins et al., 2011)and if present, adjustment was planned using a trim and fill method (Duval & Tweedie, 2000)with STATA software (version 12, StataCorp).


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