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To establish whether items included in instruments published in the last decade assessing risk of bias of randomized controlled trials (RCTs) are indeed addressing risk of bias.We searched Medline, Embase, Web of Science, and Scopus from 2010 to October 2021 for instruments assessing risk of bias of RCTs. By extracting items and summarizing their essential content, we generated an item list. Items that two reviewers agreed clearly did not address risk of bias were excluded. We included the remaining items in a survey in which 13 experts judged the issue each item is addressing: risk of bias, applicability, random error, reporting quality, or none of the above.Seventeen eligible instruments included 127 unique items. After excluding 61 items deemed as clearly not addressing risk of bias, the item classification survey included 66 items, of which the majority of respondents deemed 20 items (30.3%) as addressing risk of bias; the majority deemed 11 (16.7%) as not addressing risk of bias; and there proved substantial disagreement for 35 (53.0%) items.Existing risk of bias instruments frequently include items that do not address risk of bias. For many items, experts disagree on whether or not they are addressing risk of bias.

Objectives (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process. Data Sources Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases. Study Selection Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation. Data extraction (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct. Data Synthesis Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains. Conclusions Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Objective This study aimed to verify a possible relationship between shoulder disability and shoulder pain intensity and the variables related to cervical-spine dysfunction, and determine which of these can differentiate moderate to severe shoulder pain (>4 on a numerical rating scale [NRS]) from mild shoulder pain (≤4 on the NRS) in individuals with subacromial impingement symptoms. Methods One hundred and forty volunteers with shoulder pain were evaluated. Demographic information and variables related to the shoulder and neck were collected. Self-reported pain and disability of the shoulder and cervical spine were measured using the Shoulder Pain and Disability Index (SPADI) and Neck Disability Index (NDI) questionnaires, respectively. An NRS was used to measure pain in the shoulder and cervical spine. A purposeful modeling strategy was used to determine the best model to predict shoulder disability and shoulder pain (dependent variables). Multiple logistic regression analysis followed by receiver operating curve analysis was used to determine which variables better differentiated moderate to severe shoulder pain from mild shoulder pain. Results Variables such as Neck Disability Index (NDI) score (β = 1.09, P = .00) and age (β = −0.19, P = .03) were associated with the total SPADI score. Neck pain was significantly associated with shoulder pain (β = 0.40, P = .00). The combination of variables predicting moderate to severe shoulder pain was total SPADI score (odds ratio [OR] = 1.15, P = .003), neck pain (OR = 3.20, P = .04), and age (OR = 1.01, P = .05). Conclusion Our results demonstrate the important connection between shoulder- and neck-related symptoms in individuals with subacromial impingement symptoms.

Context Idiopathic pulmonary fibrosis (IPF) is a progressive, incurable interstitial lung disease with heavy symptom burden and poor quality of life. The last year of life is characterized by increased acute care utilization and hospital deaths. Clinical guidelines recommend early integration of palliative care but are rarely implemented. In 2012, we reorganized our clinic into a multidisciplinary team comprising two pulmonologists (expertise in interstitial lung disease and palliative respiratory care, respectively), nurse, respiratory therapist, physiotherapist, and a dietitian. We adopted an early integrated palliative approach with a focus on early symptom management and advance care planning starting at the first clinic visit. We designed a Multidisciplinary collaborative (MDC) care model with emphasis on community-based care to manage patients in their homes and support caregivers. Objectives Exploratory analysis of this model's association with acute care utilization in the last year of life and location of death was undertaken. Methods Data from deceased IPF patients before and after 2012 (non-MDC and MDC care model, respectively) were collected, and statistical analysis was performed. Results Patients in MDC care were 24.2 times less likely to have respiratory-related emergency room visits (95% CI: 3.12–187.44, P = 0.002), 2.32 times less likely to have respiratory-related hospitalizations (95% CI: 0.95–5.6, P = 0.064). The odds of achieving a home or hospice death in MDC care were 9.2 times compared to non-MDC care, who die mostly in the hospital (95% CI: 1.14–75, P = 0.037). Conclusions MDC care model for IPF was associated with reduced health care use in the last year of life and more home deaths.

Purpose Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation tool that can be used to influence cortical brain activity to induce measurable behavioral changes. Although there is growing evidence that tDCS combined with behavioural language therapy could boost language recovery in patients with post-stroke aphasia, there is great variability in patient characteristics, treatment protocols, and outcome measures in these studies that poses challenges for analyzing the evidence. The purpose of this study is to critically analyze the methodological rigor of the evidence regarding the use of tDCS for post-stroke anomia. Method This critical review was conducted by searching four databases (MEDLINE, EMBase, PsycINFO, and CINAHL). Nineteen studies fully met the inclusion criteria. Three critical appraisal tools and Robey and Schultz’s (1998) five- phase model for conducting clinical outcome research were adopted to evaluate and analyze the current level of evidence. Methodological issues of the studies were also identified. Results The current level of evidence for using tDCS for anomia is at the pre-efficacy level with emerging evidence at the efficacy level. Lack of proper evaluation of carry-over effects in cross-over studies, lack of or unclear randomization, allocation concealment, and incomplete data handling were the main methodological issues that could threaten the validity of the tDCS for anomia studies. Conclusions Several methodological issues have been identified in pre-efficacy studies that pose challenges in determining whether tDCS is a beneficial adjunct to behavioral aphasia therapy. Future studies need to improve the quality of the methods used to investigate the effect of tDCS for anomia.

Objective To identify, synthesize, and categorize the methodological issues faced by the rehabilitation field. Data Sources A scoping review was conducted using studies identified in MEDLINE, the Cochrane Library, EMBASE, Web of Science, Scopus, Physiotherapy Evidence Database, and Google Scholar up to August 2018. Study Selection We included all type of publications describing methodological issues in rehabilitation research where rehabilitation is described as a multimodal process. The methodological issues have been categorized and classified. Data Extraction The synthesis included qualitative and quantitative analysis. To focus the attention on rehabilitation, we post hoc divided in “specific issues” (highly related to, even if not exclusive of, rehabilitation research) and “generic issues” (common in biomedical research). Data Synthesis Seventy-one publications were included: 68% were narrative reviews, 15% systematic reviews, 7% editorials, 4% meta-epidemiologic studies, and 5% others. Specific methodological issues include the following: problematic application of randomized controlled trials (32%), absent definition of core outcome sets (28%), poor interventions description (22%), weak methodological (conducting) and reporting quality (21%), scarce clinical practice applicability (14%), lack of blinding assessor (10%), inadequate randomization methods or inadequate allocation concealment (8%), and inadequate participants description and recruitment (8%). “Generic” issues included the following: data and statistical description (31%), authors’ methodological training (7%), peer review process (6%, n=4), funding declaration (6%), ethical statement (3%), protocol registration (3%), and conflict of interest declaration (1%). Conclusions Methodological and reporting issues might influence the quality of the evidence produced in rehabilitation research. The next steps to move forward in the field of rehabilitation could be to evaluate the influence of all these issues on the validity of trial results through meta-epidemiologic studies and to develop specific checklists to provide guidance to authors to improve the reporting and conduct of trials in this field.

Background There are insufficient studies providing Minimal Clinically Important Difference (MCID) for outcomes related to temporomandibular disorders (TMD). Objectives (1) To provide the MCID of outcomes related to TMD using the Global Rating of Change Scale (GRCS) as an anchor. (2) To verify which outcomes can predict a moderate or large response to the treatment. Study design Secondary analysis of a randomized controlled trial in subjects with TMD. Methods Sixty-one women with TMD were divided into intervention and control groups. Visual Analogue Scale (VAS), Headache Impact Test (HIT-6), pressure pain thresholds (PPTs) of masticatory muscles, Mandibular Function Impairment Questionnaire (MFIQ), and Craniocervical Flexion Test (CCFT) were collected at baseline and 5-weeks follow-up. Results Participants were divided based on their response to the treatment, according to the GRCS. MCID values were provided for subjects that moderately or largely improved to the treatment. MCID was between 0 and 1.90 for orofacial pain, around 2 points for the MFIQ, between 3 and 6.26 points for the HIT-6, around 0.2 kg/cm2 for the PPTs on masticatory muscles, around 2.5 mm for MMO and between 60 and 68 points for CCFT. Orofacial pain and HIT-6 were the most discriminative variables at determining whether patients would largely/moderately improve or would not improve after treatment. Conclusions The values of MCID could be used as guidance for both clinical practice and research. Pain intensity and headache impact were the most predictive outcomes for improvement of the general health status of women with TMD.

Background Although electromyography (EMG) has been used extensively in dentistry to assess masticatory muscle impairments in several conditions, especially temporomandibular disorders (TMDs), many investigators have questioned its psychometric properties and accuracy in diagnosing TMD. Types of Studies Reviewed The authors conducted a systematic review to analyze the literature critically and determine the accuracy of EMG in diagnosing TMDs. They conducted an electronic search of MEDLINE, Embase, all Evidence-Based Medicine Reviews, Allied and Complementary Medicine, Ovid HealthSTAR and SciVerse Scopus. The authors selected abstracts that fulfilled the inclusion criteria, retrieved the original articles, verified the inclusion criteria and hand searched the articles' references. They used a methodological tool (Quality Assessment of Diagnostic Accuracy Studies [QUADAS]) to evaluate the quality of the selected articles. Results The electronic database search resulted in a total of 130 articles. The authors selected eight articles as potentially meeting eligibility for the review. Of these eight articles, only two fulfilled the study inclusion criteria, and the authors analyzed them. Investigators in both studies reported low sensitivity (values ranged from 0.15 to 0.40 in one study and a mean of 0.69 in the second study). In addition, investigators in the two studies reported contradictory levels of specificity (values ranged from 0.95 to 0.98 in one study, and the mean value in the second study was 0.67). The likelihood ratios and predictive values were not helpful in diagnosing TMD by means of EMG. The quality of the two studies was poor on the basis of the QUADAS checklist. Clinical Implications The authors of this systematic review found no evidence to support the use of EMG for the diagnosis of TMD.

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results.

Context Cancer pain is prevalent, yet patients do not receive best care despite widely available evidence. Although national cancer control policies call for education, effectiveness of such programs is unclear and best practices are not well defined. Objectives To examine existing evidence on whether knowledge translation (KT) interventions targeting health care providers, patients, and caregivers improve cancer pain outcomes. Methods A systematic review and meta-analysis were undertaken to evaluate primary studies that examined effects of KT interventions on providers and patients. Results Twenty-six studies met the inclusion criteria. Five studies reported interventions targeting health care providers, four focused on patients or their families, one study examined patients and their significant others, and 16 studies examined patients only. Seven quantitative comparisons measured the statistical effects of interventions. A significant difference favoring the treatment group in least pain intensity (95% confidence interval [CI]: 0.44, 1.42) and in usual pain/average pain (95% CI: 0.13, 0.74) was observed. No other statistical differences were observed. However, most studies were assessed as having high risk of bias and failed to report sufficient information about the intervention dose, quality of educational material, fidelity, and other key factors required to evaluate effectiveness of intervention design. Conclusion Trials that used a higher dose of KT intervention (characterized by extensive follow-up, comprehensive educational program, and higher resource allocation) were significantly more likely to have positive results than trials that did not use this approach. Further attention to methodological issues to improve educational interventions and research to clarify factors that lead to better pain control are urgently needed.

Armijo-Olivo SL, Fuentes JP, Major PW, Warren S, Thie NM, Magee DJ. Is maximal strength of the cervical flexor muscles reduced in patients with temporomandibular disorders? Objective To determine whether there was a difference in maximal cervical flexor muscle strength in subjects with temporomandibular disorders (mixed and myogenous) compared with healthy subjects. Design Cross-sectional study. Setting Orthopedics/sports laboratory at the University of Alberta. Participants Subjects (N=149) of whom 50 were healthy, 54 had myogenous temporomandibular disorders (TMD), and 45 had mixed TMD. Interventions Not applicable. Main Outcome Measures Maximal cervical flexor strength, pain. Results There was no statistically significant difference in maximal cervical flexor strength among groups ( P >.05). Subjects' body weight was significantly associated with strength. No significant association between jaw disability with maximal cervical flexor strength was found. A significant but weak association between neck disability and maximal cervical flexors strength was found. Conclusions These results indicated that strength evaluation is one of several assessment factors that need to be addressed when evaluating musculoskeletal painful conditions such as TMD and neck disorders, but strength evaluation cannot be considered as a direct measure of disability. Future studies should explore evaluation of strength in other muscular groups such as cervical extensors, rotators, and lateral flexors, and also under different conditions such as rapid movements, and in patients with more severe jaw disability.

Proprioceptive neuromuscular facilitation (PNF) techniques are a group of therapeutic procedures that may be used to cause relaxation of muscles. Studies have found controversial results when applying these techniques. The aim of the present study was to evaluate the effectiveness of masticatory muscle relaxation through the use of the contract–relax technique (CR) when compared with the agonist contract–antagonist relax technique (AC). A convenience sample of 30 students was recruited for this study. The CR and the AC techniques were applied to the subjects in order to cause relaxation of the masticatory muscles. Electromyography activity of all muscles was registered. Two way ANOVA with repeated measures analysis demonstrated that both the AC technique and the CR technique did not decrease the EMG activity of masticatory muscles ( P > 0.05 ). Instead, both techniques caused an increase in electromyographic activity of the masticatory muscles. Based on the results obtained from this study, both the CR and the AC techniques were not effective in causing relaxation of the masticatory muscles. The purported physiological mechanisms of PNF techniques, which stated that they act through reciprocal inhibition and autogenic inhibition causing muscular relaxation, are not supported by this study.

Background The authors aimed to describe how often and by what means investigators assessed the risk of bias of clinical trials in systematic reviews of oral health interventions and to identify factors associated with risk of bias assessments. Methods The authors selected therapeutic oral health systematic reviews published from 1991 through 2014. They extracted data related to the tools used for risk of bias assessment of primary studies and data related to other review characteristics. They descriptively analyzed the data and used multivariate logistic regression. Results The authors identified 1,114 oral health systematic reviews (130 Cochrane reviews and 984 non-Cochrane reviews). The investigators of the primary studies assessed risk of bias in 61.4% of the reviews, and the risk of bias assessments occurred more often in Cochrane reviews than in non-Cochrane reviews (100% versus 56.3%; P Conclusions The investigators of primary studies did not undertake risk of bias assessment in a considerable portion of non-Cochrane oral health systematic reviews. The investigators of reviews published in dental journals were less likely to assess risk of bias than the investigators of reviews published in nondental journals. The results of this study provide evidence of the need for improving the conduct and reporting of oral health systematic reviews with respect to risk of bias assessment. Practical Implications Clinicians should determine to what extent the findings of a systematic review are valid on the basis of whether the investigators assessed and considered risk of bias during the interpretation of findings.

P. Manns 1, V. Ezeugwu2, S. Armijo-Olivo 3, J. Vallance 4, G. Healy 5,6,7 1 University of Alberta, Physical Therapy, Edmonton, Canada; 2 University of Alberta, Faculty of Rehabilitation Medicine, Edmonton, Canada; 3 Rehabilitation Research Centre, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada; 4 Athabasca University, Medicine Hat, Canada; 5 The University of Queensland, School of Population Health, Brisbane, Australia; 6 Baker IDI Heart and Diabetes Institute, Melbourne, Australia, Australia; 7 Curtin University, School of Physiotherapy, Perth, Australia