Humam Saltaji

Poor Reliability between Cochrane Reviewers and Blinded External Reviewers When Applying the Cochrane Risk of Bias Tool in Physical Therapy Trials

Objectives To test the inter-rater reliability of the RoB tool applied to Physical Therapy (PT) trials by comparing ratings from Cochrane review authors with those of blinded external reviewers. Methods Randomized controlled trials (RCTs) in PT were identified by searching the Cochrane Database of Systematic Reviews for meta-analysis of PT interventions. RoB assessments were conducted independently by 2 reviewers blinded to the RoB ratings reported in the Cochrane reviews. Data on RoB assessments from Cochrane reviews and other characteristics of reviews and trials were extracted. Consensus assessments between the two reviewers were then compared with the RoB ratings from the Cochrane reviews. Agreement between Cochrane and blinded external reviewers was assessed using weighted kappa (κ). Results In total, 109 trials included in 17 Cochrane reviews were assessed. Inter-rater reliability on the overall RoB assessment between Cochrane review authors and blinded external reviewers was poor (κ  =  0.02, 95%CI: −0.06, 0.06]). Inter-rater reliability on individual domains of the RoB tool was poor (median κ  = 0.19), ranging from κ  =  −0.04 (“Other bias”) to κ  =  0.62 (“Sequence generation”). There was also no agreement (κ  =  −0.29, 95%CI: −0.81, 0.35]) in the overall RoB assessment at the meta-analysis level. Conclusions Risk of bias assessments of RCTs using the RoB tool are not consistent across different research groups. Poor agreement was not only demonstrated at the trial level but also at the meta-analysis level. Results have implications for decision making since different recommendations can be reached depending on the group analyzing the evidence. Improved guidelines to consistently apply the RoB tool and revisions to the tool for different health areas are needed.

Indices to assess malocclusions in patients with cleft lip and palate

BACKGROUND Several indices are now available to assess the severity of the malocclusion in cleft lip and/or palate (CLP) patients; and although it has been quite some time since the introduction of these indices, there is no consensus as to which index should be used for CLP populations. OBJECTIVE To systematically review the available literature on the indices used to assess the occlusal schemes in dental models of CLP patients, with respect to the most commonly used index and the index that most fulfils the World Health Organization (WHO) criteria. SEARCH METHODS Ten electronic databases, grey literature, and reference list searches were conducted. SELECTION CRITERIA The inclusion criteria consisted of studies that aimed to assess a particular malocclusion index on study models of patients with CLP. DATA COLLECTION AND ANALYSIS Full articles were retrieved from abstracts/titles that appeared to have met the inclusion -exclusion criteria which were subsequently reviewed using more detailed criteria for a final selection decision. The Quality Assessment of Diagnostic Accuracy Studies tool was used to appraise the methodological quality of the finally included studies. Due to the heterogeneity of the data, only a qualitative analysis was performed. RESULTS A total of 13 studies met the inclusion -exclusion criteria. These studies revealed seven utilized indices, namely the GOSLON Yardstick, Five-Year-Old, Bauru-Bilateral Cleft Lip and Palate Yardstick, Huddart -Bodenham, Modified Huddart -Bodenham, EUROCRAN Yardstick, and GOAL Yardstick. The GOSLON Yardstick was the most commonly used index, and the Modified Huddart -Bodenham performed the best according to the WHO criteria. CONCLUSIONS Current evidence suggests that the Modified Huddart -Bodenham Index equalled or outperformed the rest of the indices on all the WHO criteria and that the GOSLON Yardstick was the most commonly used index, possibly due to a longer time in use. Therefore, the Modified Huddart -Bodenham could be considered as the standard to measure outcomes of patients with CLP.

PEDro or Cochrane to Assess the Quality of Clinical Trials? A Meta-Epidemiological Study.

Objective There is debate on how the methodological quality of clinical trials should be assessed. We compared trials of physical therapy (PT) judged to be of adequate quality based on summary scores from the Physiotherapy Evidence Database (PEDro) scale with trials judged to be of adequate quality by Cochrane Risk of Bias criteria. Design Meta-epidemiological study within Cochrane Database of Systematic Reviews. Methods Meta-analyses of PT trials were identified in the Cochrane Database of Systematic Reviews. For each trial PeDro and Cochrane assessments were extracted from the PeDro and Cochrane databases. Adequate quality was defined as adequate generation of random sequence, concealment of allocation, and blinding of outcome assessors (Cochrane criteria) or as trials with a PEDro summary score ≥5 or ≥6 points. We combined trials of adequate quality using random-effects meta-analysis. Results Forty-one Cochrane reviews and 353 PT trials were included. All meta-analyses included trials with PEDro scores ≥5, 37 (90.2%) included trials with PEDro scores ≥6 and only 22 (53.7%) meta-analyses included trials of adequate quality according to the Cochrane criteria. Agreement between PeDro and Cochrane was poor for PeDro scores of ≥5 points (kappa = 0.12; 95% CI 0.07 to 0.16) and slight for ≥6 points (kappa 0.24; 95% CI 0.16-0.32). When combining effect sizes of trials deemed to be of adequate quality according to PEDro or Cochrane criteria, we found that a substantial difference in the combined effect size (≥0.15) was evident in 9 (22%) out of the 41 meta-analyses for PEDro cutoff ≥5 and 10 (24%) for cutoff ≥6. Conclusions The PeDro and Cochrane approaches lead to different sets of trials of adequate quality, and different combined treatment estimates from meta-analyses of these trials. A consistent approach to assessing RoB in trials of physical therapy should be adopted.

Inconsistency in the items included in tools used in general health research and physical therapy to evaluate the methodological quality of randomized controlled trials: a descriptive analysis.

BackgroundAssessing the risk of bias of randomized controlled trials (RCTs) is crucial to understand how biases affect treatment effect estimates. A number of tools have been developed to evaluate risk of bias of RCTs; however, it is unknown how these tools compare to each other in the items included. The main objective of this study was to describe which individual items are included in RCT quality tools used in general health and physical therapy (PT) research, and how these items compare to those of the Cochrane Risk of Bias (RoB) tool.MethodsWe used comprehensive literature searches and a systematic approach to identify tools that evaluated the methodological quality or risk of bias of RCTs in general health and PT research. We extracted individual items from all quality tools. We calculated the frequency of quality items used across tools and compared them to those in the RoB tool. Comparisons were made between general health and PT quality tools using Chi-squared tests.ResultsIn addition to the RoB tool, 26 quality tools were identified, with 19 being used in general health and seven in PT research. The total number of quality items included in general health research tools was 130, compared with 48 items across PT tools and seven items in the RoB tool. The most frequently included items in general health research tools (14/19, 74%) were inclusion and exclusion criteria, and appropriate statistical analysis. In contrast, the most frequent items included in PT tools (86%, 6/7) were: baseline comparability, blinding of investigator/assessor, and use of intention-to-treat analysis. Key items of the RoB tool (sequence generation and allocation concealment) were included in 71% (5/7) of PT tools, and 63% (12/19) and 37% (7/19) of general health research tools, respectively.ConclusionsThere is extensive item variation across tools that evaluate the risk of bias of RCTs in health research. Results call for an in-depth analysis of items that should be used to assess risk of bias of RCTs. Further empirical evidence on the use of individual items and the psychometric properties of risk of bias tools is needed.

Le Fort III Distraction Osteogenesis Versus Conventional Le Fort III Osteotomy in Correction of Syndromic Midfacial Hypoplasia: A Systematic Review

PURPOSE It has been debated whether the Le Fort III procedure using distraction osteogenesis (LFIII-DO) reduces the risk of postintervention relapse compared with conventional Le Fort III (LFIII) osteotomy in the correction of syndromic midfacial hypoplasia. Our objective was to evaluate the short- and long-term stability of the bony structures after midfacial advancement using conventional LFIII osteotomy versus LFIII-DO in patients with syndromic midfacial hypoplasia. MATERIALS AND METHODS We performed a systematic review of the published data. An electronic search of 10 databases was performed from their inception through June 2012. The reference lists of the relevant publications were also reviewed. Studies were considered for inclusion if they were longitudinal clinical studies with follow-up periods of at least 1 year after surgery (LFIII group) or at the end of the consolidation period (LFIII-DO group). Study selection, risk of bias assessment, and data extraction were performed in duplicate. The methodologic and clinical heterogeneity across the studies precluded combining the findings using meta-analyses. RESULTS A total of 57 reports met the initial search criteria, and 12 reports were finally selected. The studies demonstrated a mean midfacial advancement of 8 to 12 mm in the LFIII group and 9 to 16 mm in the LFIII-DO group. For the LFIII group, horizontal short-term follow-up showed a maximal rate of relapse of 8.7 to 11.9% in 2 studies, with 1 study demonstrating a far more severe rate of maximal relapse of 50%. For the LFIII-DO procedure, the horizontal short-term relapse rate was 14.4% in 1 study, with the remainder demonstrating a rate of relapse of less than 10%. Moreover, 3 studies even showed additional advancement without any rate of relapse. CONCLUSIONS Current evidence suggests that conventional LFIII and LFIII-DO techniques can effectively advance the midface forward in patients with syndromic midfacial hypoplasia and have good to excellent stability, with a mild rate of relapse. However, the LFIII-DO technique appears to achieve a greater amount of advancement with a lower rate of relapse compared with the conventional LFIII technique.

The relationship between vertical facial morphology and overjet in untreated Class II subjects

OBJECTIVE To evaluate the association between vertical facial morphology and overjet in untreated Class II subjects. MATERIALS AND METHODS The lateral cephalograms of 140 untreated Class II subjects (68 males and 72 females) between 8 and 11 years of age were divided into three groups based on their overjet value as measured on study casts: Group I normal overjet (less than 3 mm), Group II increased overjet (more than 3 mm but less than or equal to 6 mm), and Group III extreme overjet (more than 6 mm). Mean values and standard deviations of 28 variables measured on lateral cephalograms were calculated. Differences between the three groups were tested using one-way analysis of variance (ANOVA), followed by Bonferroni tests. Additionally, cephalometric differences between groups and available normal values for the Syrian population were evaluated using an independent t-test. RESULTS Subjects with normal overjet showed a horizontal facial pattern and posterior inclination of the maxilla, whereas increased overjet subjects exhibited a neutral facial pattern. In contrast, subjects with extreme overjet had a vertical facial pattern and anterior inclination of the maxilla. The mandible was retrognathic and the maxilla was normally positioned in the three groups. CONCLUSIONS A positive association was found between the overjet and the tendency toward a hyperdivergent pattern.

Long-term skeletal stability after maxillary advancement with distraction osteogenesis in cleft lip and palate patients.

OBJECTIVE To systematically review the long-term skeletal stability after maxillary advancement with distraction osteogenesis (DO) in cleft lip and palate (CLP) patients. MATERIALS AND METHODS Electronic databases, grey literature, and reference list searches were conducted. The inclusion criteria were stability of maxillary advancement with distraction osteogenesis assessed at the posttreatment follow-up ≥ 1 year in CLP patients. Full articles were retrieved from abstracts or titles that appear to meet the inclusion criteria or lacked sufficient detail for immediate exclusion. Once full articles were collected, they were again reviewed considering more detailed inclusion criteria for a final selection decision. A methodologic quality assessment tool was utilized. RESULTS Thirty abstracts/titles met the initial search criteria, and 13 articles were finally selected. Overall, methodologic quality scores were high in only one randomized clinical trial. After maxillary advancement with DO in CLP patients, the long-term horizontal relapse in A-point was less than 15% in eight studies and between 20% and 25% in four studies. The study that was judged as a high-quality study reported 8.2% horizontal relapse in A-point. The relapse rate was higher in DO with external distracter device than DO with internal distracter device. CONCLUSIONS Current evidence suggests maxillary advancement with DO has good stability in CLP patients with moderate and severe maxillary hypoplasia.

Impact of Sense of Coherence on Oral Health Behaviors: A Systematic Review

Objectives The aim of this review was to critically analyze the empirical evidence on the association between Sense of Coherence (SOC) and oral health behaviors through a systematic approach. Methods A systematic search up to April 2015 was carried out using the following electronic bibliographic databases: PubMed, Ovid MEDLINE; ISI Web of Science; and Ovid PsychInfo. Studies were included if they evaluated the relationship between SOC and oral health behaviors including tooth cleaning, fluoride usage, dietary habits, dental attendance, and smoking. We excluded studies that only assessed the relationship between oral health status and SOC without evaluating oral health behaviors. The New Castle Ottawa (NOS) quality assessment checklist was employed to evaluate the methodological quality of included studies. Results Thirty-nine potential papers met the preliminary selection criteria and following a full-text review, 9 papers were finally selected for this systematic review. Results provided by the included studies indicated different levels of association between SOC and oral health behaviors. The most frequent behaviors investigated were tooth brushing and dental attendance pattern. The impact of SOC on performing positive oral health behaviors, to some extent, was related to demographic and socio-economic factors. In addition, mothers’ SOC influenced children’s oral health practices. Conclusions A more favorable oral health behavior was observed among those with a stronger SOC suggesting that the SOC can be a determinant of oral health-related behaviors including tooth brushing frequency, daily smoking, and dental attendance.

What is the influence of randomisation sequence generation and allocation concealment on treatment effects of physical therapy trials? A meta-epidemiological study.

Objective To determine if adequacy of randomisation and allocation concealment is associated with changes in effect sizes (ES) when comparing physical therapy (PT) trials with and without these methodological characteristics. Design Meta-epidemiological study. Participants A random sample of randomised controlled trials (RCTs) included in meta-analyses in the PT discipline were identified. Intervention Data extraction including assessments of random sequence generation and allocation concealment was conducted independently by two reviewers. To determine the association between sequence generation, and allocation concealment and ES, a two-level analysis was conducted using a meta-meta-analytic approach. Primary and secondary outcome measures association between random sequence generation and allocation concealment and ES in PT trials. Results 393 trials included in 43 meta-analyses, analysing 44 622 patients contributed to this study. Adequate random sequence generation and appropriate allocation concealment were accomplished in only 39.7% and 11.5% of PT trials, respectively. Although trials with inappropriate allocation concealment tended to have an overestimate treatment effect when compared with trials with adequate concealment of allocation, the difference was non-statistically significant (ES=0.12; 95% CI −0.06 to 0.30). When pooling our results with those of Nuesch et al, we obtained a pooled statistically significant value (ES=0.14; 95% CI 0.02 to 0.26). There was no difference in ES in trials with appropriate or inappropriate random sequence generation (ES=0.02; 95% CI −0.12 to 0.15). Conclusions Our results suggest that when evaluating risk of bias of primary RCTs in PT area, systematic reviewers and clinicians implementing research into practice should pay attention to these biases since they could exaggerate treatment effects. Systematic reviewers should perform sensitivity analysis including trials with low risk of bias in these domains as primary analysis and/or in combination with less restrictive analyses. Authors and editors should make sure that allocation concealment and random sequence generation are properly reported in trial reports.

A descriptive analysis of oral health systematic reviews published 1991-2012: cross sectional study.

Objectives To identify all systematic reviews (SRs) published in the domain of oral health research and describe them in terms of their epidemiological and descriptive characteristics. Design Cross sectional, descriptive study. Methods An electronic search of seven databases was performed from inception through May 2012; bibliographies of relevant publications were also reviewed. Studies were considered for inclusion if they were oral health SRs defined as therapeutic or non-therapeutic investigations that studied a topic or an intervention related to dental, oral or craniofacial diseases/disorders. Data were extracted from all the SRs based on a number of epidemiological and descriptive characteristics. Data were analysed descriptively for all the SRs, within each of the nine dental specialities, and for Cochrane and non-Cochrane SRs separately. Results 1,188 oral health (126 Cochrane and 1062 non-Cochrane) SRs published from 1991 through May 2012 were identified, encompassing the nine dental specialties. Over half (n = 676; 56.9%) of the SRs were published in specialty oral health journals, with almost all (n = 1,178; 99.2%) of the SRs published in English and almost none of the non-Cochrane SRs (n = 11; 0.9%) consisting of updates of previously published SRs. 75.3% of the SRs were categorized as therapeutic, with 64.5% examining non-drug interventions, while approximately half (n = 150/294; 51%) of the non-therapeutic SRs were classified as epidemiological SRs. The SRs included a median of 15 studies, with a meta-analysis conducted in 43.6%, in which a median of 9 studies/1 randomized trial were included in the largest meta-analysis conducted. Funding was received for 25.1% of the SRs, including nearly three-quarters (n = 96; 76.2%) of the Cochrane SRs. Conclusion Epidemiological and descriptive characteristics of the 1,188 oral health SRs varied across the nine dental specialties and by SR category (Cochrane vs. non-Cochrane). There is a clear need for more updates of SRs in all the dental specialties.