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Objective Summarize the evidence from randomized controlled trials and controlled trials that examined the effectiveness of electrotherapy in the treatment of patients with orofacial pain. Data Source Medline, Embase, CINAHL PLUS with Full text, Cochrane Library Trials, Web of Science, and Scopus. Review Methods A data search (last update, July 1, 2022) and a manual search were performed (October 5, 2022). Trials involving adults with orofacial pain receiving electrotherapy compared with any other type of treatment were included. The main outcome was pain intensity; secondary outcomes were mouth opening and tenderness. The reporting was based on the new PRISMA Guidelines. Results From the electronics databases and manual search 43 studies were included. Although this study was open to including any type of orofacial pain, only studies that investigated temporomandibular disorders were found. The overall quality of the evidence for pain intensity was very low. Although the results should be carefully used, transcutaneous electric nerve stimulation therapy showed to be clinically superior to placebo for reducing pain after treatment (2.63 [−0.48; 5.74]) and at follow-up (0.96 [−0.02; 1.95]) and reduce tenderness after treatment (1.99 [−0.33; 4.32]) and at follow-up (2.43 [−0.24; 5.10]) in subjects with mixed temporomandibular disorders. Conclusion The results of this systematic review support the use of transcutaneous electric nerve stimulation therapy for patients with mixed temporomandibular disorders to improve pain intensity, and tenderness demonstrating that transcutaneous electric nerve stimulation is superior to placebo. There is inconsistent evidence supporting the superiority of transcutaneous electric nerve stimulation against other therapies.

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.

Purpose: Trismus, or restricted mouth opening, is a common side effect of treatment for head and neck cancer. This scoping review examined the characteristics, extent, and nature of existing research on manual therapy and jaw-mobilizing devices to prevent and manage trismus related to head and neck cancer. Method: Six electronic databases were searched using the terms trismus, head and neck cancer, and physical therapy and the associated MeSH terms. The review focused on the factors related to intervention delivery: timing, adherence, completion rates, and adverse events. Results: Nine studies were included. Eight examined the use of a jaw-mobilizing device, and one explored the benefit of remote telephone support. Two studies involved cancer survivors at risk of trismus, five involved survivors with trismus, and two included survivors both with and at risk of trismus. No studies were found examining physiotherapist provision of manual therapy. Within-group comparisons supported the benefit of using a jaw-mobilizing device to manage trismus, whereas significant between-groups differences were found only in non-randomized controlled trials. Survivor symptoms and intervention burden were reported reasons for poor adherence and completion rates. Conclusions: No benefit was found for the use of jaw-mobilizing devices for the prevention of trismus. Given the potential of manual therapy to enhance outcomes, physical therapist–led research is warranted.

This protocol aims to guide the process to conduct a scoping review on noise and cognitive performance in developing the brain using functional MRI. This review benefits future research by providing a clear mapping of evidence. This protocol adhered to Arksey and O'Malley's scoping review methodological framework. A Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) extension for Scoping Reviews (PRISMA-ScR) was implemented to report the full scoping review. This protocol facilitated a well-structured mapping of evidence. The findings from scoping review will be made public through conferences and journal publications. Keywords: Scoping review protocol; Adolescents’ cognitive performance; Noise; functional MRI. eISSN: 2398-4287 © 2022. The Authors. Published for AMER ABRA cE-Bs by e-International Publishing House, Ltd., UK. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians/Africans/Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia. DOI: https://doi.org/10.21834/ebpj.v7i19.3256

A thorough knowledge of biases in intervention studies and how they influence study results is essential for the practice of evidence-based medicine. The objective of this review was to provide a basic knowledge and understanding of the concept of biases and associated influence of these biases on treatment effects, focusing on the area of rehabilitation research. This article provides a description of selection biases, confounding, and attrition biases. In addition, useful recommendations are provided to identify, avoid, or control these biases when designing and conducting rehabilitation trials. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used. If not addressed appropriately, biases related to intervention research are a threat to internal validity and consequently to external validity. By addressing these biases, ensuring appropriate randomization, allocation concealment, appropriate retention techniques to avoid dropouts, appropriate study design and statistical analysis, among others, will generate more accurate treatment effects. Based on their impact on clinical results, a proper understanding of these concepts is central for researchers, rehabilitation clinicians, and other stakeholders working on this field.

To determine the effectiveness of laser therapy for managing patients with orofacial pain (OFP). In addition, to determine which parameters provide the best treatment effects to reduce pain, improve function, and quality of life in adults with OFP.Systematic review. Searches were conducted in six databases; no date or language restrictions were applied. Studies involving adults with OFP treated with laser therapy were included. The risk of bias (RoB) was performed with the Revised Cochrane RoB-2. A meta-analysis was structured around the OFP type, and outcomes. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) assessed the overall certainty of the evidence.Eighty-nine studies were included. Most studies (Laser therapy was better than placebo to improve pain, MMO, protrusion, and tenderness. Also, it was better than occlusal splint to improve pain, but not better than TENS and medication.Implications for rehabilitationLaser therapy was found to be good in improving pain, maximal mouth opening, jaw protrusion, and tenderness at the end of the treatment.For patients with all types of temporomandibular disorders (TMDs) (myogenous, arthrogenous, and mixed), the following lasers and parameters are recommended: diode or gallium-aluminum-arsenide (GaAlAs) laser, wavelength of 400-800 or 800-1500 nm, and a dosage25 J/cm

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.

The objective of this study was to determine the association between biases related to attrition, missing data, and the use of intention to treat and changes in effect size estimates in physical therapy randomized trials. A meta-epidemiological study was conducted. A random sample of randomized controlled trials included in meta-analyses in the physical therapy discipline were identified. Data extraction including assessments of the use of intention to treat principle, attrition-related bias, and missing data was conducted independently by two reviewers. To determine the association between these methodological issues and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach. Three hundred ninety-three trials included in 43 meta-analyses, analyzing 44,622 patients contributed to this study. Trials that did not use the intention-to-treat principle (effect size = -0.13, 95% confidence interval = -0.26 to 0.01) or that were assessed as having inappropriate control of incomplete outcome data tended to underestimate the treatment effect when compared with trials with adequate use of intention to treat and control of incomplete outcome data (effect size = -0.18, 95% confidence interval = -0.29 to -0.08).Researchers and clinicians should pay attention to these methodological issues because they could provide inaccurate effect estimates. Authors and editors should make sure that intention-to-treat and missing data are properly reported in trial reports.

The objective of this review is to summarize the concept of clinical significance and associated methods focusing on the area of rehabilitation to provide a resource to rehabilitation researchers and clinicians. Studies were searched on electronic databases from inception until July 28, 2020, with no date or language limits. Manual searches as well as Scopus forward citation for relevant references were performed. Narrative synthesis of study results were performed. Definitions of the concepts related to clinical significance, ways of calculating, and interpreting each method were provided using rehabilitation examples. An explanation of methods to evaluate clinical significance (distribution, anchor and opinion-based methods) and their advantages and disadvantages were also provided. Considering the limitations of statistical significance in assuring meaningfulness of results, clinical interpretation of research outcomes and the report of clinical significance in intervention trials should be a priority in rehabilitation research. When possible, the use of multiple methods (distribution, anchor, and opinion-based) is recommended. Thus, clinical researchers are encouraged to present results in a manner that allow the rehabilitation professionals to easily interpret and implement those results in their clinical practice.

Bias is a systematic error that can cause distorted results leading to incorrect conclusions. Intervention bias (i.e., contamination bias, cointervention bias, compliance bias, and performance bias) and detection bias are the most common biases in rehabilitation research. A better understanding of these biases is essential at all stages of research to enhance the quality of evidence in rehabilitation trials. Therefore, this narrative review aims to provide insights to the readers, clinicians, and researchers about contamination, cointervention, compliance, performance, and detection biases and ways of recognizing and mitigating them. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used.This review provides several strategies to guard against the impact of bias on study results. Clinicians, researchers, and other stakeholders are encouraged to apply these recommendations when designing and conducting rehabilitation trials.

BACKGROUND The use of wearable inertial sensors has shown to be an easy-to-use and reliable option to objectively measure and monitor the range of motion (ROM) associated with each stage of the craniocervical flexion test (CCFT). However, previous research showed limitations when discriminating between each of the stages of the CCFT to standardize a set of ROM targets, since the instrumentation used only provided data of ROM on each of six pressure stages of the CCFT and the process of associating values of ROM and pressure was not automatically synchronized by a computer. OBJECTIVE The aim of the study is to develop a novel real-time, high-precision (Computer-based) time synchronization system to continuously record pressure and craniocervical flexion ROM during the CCFT in order to assess its feasibility on measuring and discriminating the values of ROM between different pressure levels. METHODS This is a descriptive, observational, cross-sectional study in a sample of asymptomatic participants in order to allow for the description of normative values of ROM and pressure during an ideal execution of the CCFT. All participants performed a testing procedure consisting on the performance of full-range craniocervical flexion and the CCFT. During the CCFT, a low-range pressure sensor and a wireless inertial sensor simultaneously registered data of pressure and ROM. A web application was developed using HTML and NodeJS technologies. It allowed for real-time synchronization of processing, visualization, and storage of data from both sensors at a frequency of 50Hz. A biofeedback computer screen allowed for real-time observation and assessment of the correct performance of the CFFT for both the examiner and the patient by observing pressure and ROM graphics at the same time. RESULTS A total of 45 participants successfully finished the study protocol (20 males, 25 females; mean [SD] age, 32 [11.48] years). One-way analyses of variance (ANOVAs) showed large effect significant interactions between pressure levels and the percentage of full craniocervical flexion ROM when considering the 6 pressure reference levels of the CCFT (P CONCLUSIONS The novel time synchronizing system developed in this study seems a feasible option for future research and clinical practice to provide real-time monitoring of both pressure and ROM through a computer screen high-precision feedback during the performance of the CCFT. The values of craniocervical flexion ROM presented in this study could serve as reference targets to further investigate the potential use of inertial sensor technology to assess or train deep cervical flexors. CLINICALTRIAL Not applicable

The quality of reporting of health economic evaluations for rehabilitation services has been questioned, limiting the ability to provide accurate recommendations for health decisions.To document current overall reporting quality of the published literature for economic evaluations of rehabilitation services using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), and to identify factors that could influence the quality of reporting.Electronic literature searches were performed using MEDLINE and the NHS Economic Evaluations DatabaseProspective rehabilitation economic evaluation articles from 2013 to 2020 were selected.Data were extracted by one reviewer and independently verified by a second reviewer.Title and abstracts of 3,454 papers were reviewed. 204 papers were selected for a full text screening. From those, 129 potential papers were identified to be included in this study.Only two databases were used in data collection, and papers were selected from 2013 to 2020 only.Inconsistent reporting in health economic evaluations of rehabilitation services has continued, despite the availability of the CHEERS checklist. The methods of the analyzed studies were frequently under-reported, thereby creating challenges in determining whether the results reported were valid.IMPLICATIONS FOR REHABILITATIONVariable quality of reporting has been identified in rehabilitation research assessing cost-effectiveness.To grow as an area of expertise, the field of rehabilitation must produce research demonstrating its cost-effectiveness.Both rehabilitation clinicians and funders would benefit from full and transparent information to identify optimal solutions for effective and efficient care.

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.

Background Sponsorship bias could affect research results to inform decision makers when using the results of these trials. The extent to which sponsorship bias affect results in the field of physical therapy has been unexplored in the literature. Therefore, the main aim of this study was to evaluate the influence of sponsorship bias on the treatment effects of randomized controlled trials in physical therapy area. Methods This was a meta-epidemiological study. A random sample of randomized controlled trials included in meta-analyses of physical therapy area were identified. Data extraction including assessments of appropriate influence of funders was conducted independently by two reviewers. To determine the association between biases related to sponsorship biases and effect sizes, a two-level analysis was conducted using a meta-meta-analytic approach. Results We analyzed 393 trials included in 43 meta-analyses. The most common sources of sponsorship for this sample of physical therapy trials were government (n = 205, 52%), followed by academic (n = 44, 11%) and industry (n = 39, 10%). The funding was not declared in a high percentage of the trials (n = 85, 22%). The influence of the trial sponsor was assessed as being appropriate in 246 trials (63%) and considered inappropriate/unclear in 147 (37%) of them. We have moderate evidence to say that trials with inappropriate/unclear influence of funders tended to have on average a larger effect size than those with appropriate influence of funding (effect size = 0.15; 95% confidence interval = -0.03 to 0.33). Conclusions Based on our sample of physical therapy trials, it seems that most of the trials are funded by either government and academia and a small percentage are funded by the industry. Treatment effect size estimates were on average 0.15 larger in trials with lack of appropriate influence of funders as compared with trials with appropriate influence of funding. Contrarily to other fields, industry funding was relatively small and their influence perhaps less marked. All these results could be explained by the relative youth of the field and/or the absence of clear industry interests. In front of the call for action by the World Health Organization to strengthen rehabilitation in health systems, these results raise the issue of the need of public funding in the field.

Objective Some recent studies suggest that double blinding should not be considered a validity criterion in randomized controlled trials (RCTs) on real-life circumstances. This study aims to assess whether blinding vs. nonblinding have been analyzed conceptually in the rehabilitation literature. Propositions on the role of blinding in RCTs on rehabilitation are presented based on the conceptual analysis. Design Study questions, literature search strategy, and inclusion and exclusion criteria for the original studies were formulated. A health science librarian carried out the literature search. Eligibility was assessed and data extraction was performed by two independent researchers. Results The literature search identified a total of 1052 citations, of which 13 studies fulfilled the inclusion criteria. None of the included studies answered our research questions, and thus we were unable to extract any relevant data. Conclusions The ideas on blinding vs. nonblinding in RCTs have not been considered in the rehabilitation research literature. This conceptual systematic review proposes that a physical therapy modality is a single core element, and when the study question is on effectiveness of this single core element itself, double blinding in an RCT is indicated. In all other RCTs in rehabilitation, double blinding is not indicated and double blinding should not be considered a criterion for the assessment of risk of bias.

BACKGROUND AND OBJECTIVES: Assessing changes in coverage, recall, review, conclusions and references not found when searching fewer databases. METHODS: In randomly selected 60 Cochrane reviews, we checked included study publications' coverage (indexation) and recall (findability) using different search approaches with MEDLINE, Embase, and CENTRAL and related them to authors' conclusions and certainty. We assessed characteristics of unfound references. RESULTS: Overall 1989/2080 included references, were indexed in ≥1 database (coverage = 96%). In reviews where using one of our search approaches would not change conclusions and certainty (n = 44-54), median coverage and recall were highest (range 87.9%-100.0% and 78.2%-93.3%, respectively). Here, searching ≥2 databases reached >95% coverage and ≥87.9% recall. In reviews with unchanged conclusions but less certainty (n = 2-8): 63.3%-79.3% coverage and 45.0%-75.0% recall. In reviews with opposite conclusions (n = 1-3): 63.3%-96.6% and 52.1%-78.7%. In reviews where a conclusion was no longer possible (n = 3-7): 60.6%-86.0% and 20.0%-53.8%. The 265 references that were indexed but unfound were more often abstractless (30% vs. 11%) and older (28% vs. 17% published before 1991) than found references. CONCLUSION: Searching ≥2 databases improves coverage and recall and decreases the risk of missing eligible studies. If researchers suspect that relevant articles are difficult to find, supplementary search methods should be used.

IntroductionNeck pain is a very common musculoskeletal disorder associated with high socioeconomic costs derived from work absenteeism and medical expenses. Previous studies have suggested that patients with neck pain of different origins present sensorimotor control impairments compared with the asymptomatic population. However, there is a small number of published studies focusing on these with conflicting results. In addition, the existing methodological limitations highlight the need for more and better quality studies. Moreover, longitudinal studies are necessary to investigate whether changes in pain or disability in individuals with chronic neck pain over time associate with changes in cervical sensorimotor control.Methods and analysisThis is a descriptive, observational, longitudinal, prospective study consecutively enrolling 52 patients with non-specific neck pain and 52 age-matched asymptomatic participants.Intensity of pain, neck disability, duration of symptoms, topography of pain and comorbidities will be registered at baseline. Sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns will be recorded as primary outcomes by means of inertial sensors during the following tests consecutively performed in two sessions separated by 12 months: (1) kinematics of planar movements, (2) kinematics of the craniocervical flexion movement, (3) kinematics during functional tasks and (4) kinematics of task-oriented neck movements in response to visual targets.Secondary outcomes will include: (1) Regular physical activity levels, (2) Kinesiophobia, (3) Symptoms related to central sensitisation and (4) The usability of the inertial measurement unit sensor technology.Ethics and disseminationThis study was approved by the Research Ethics Committee of CEU San Pablo University (495/21/39). Patients will be recruited after providing written informed consent and they will be able to withdraw their consent at any time. Only the study investigators will have access to the study data. The results will be disseminated through scientific publications, conferences and media.Trial registration numberNCT05032911.

Excessive masticatory muscle activity is generally present in awake bruxism, which is related to increased anxiety and stress. It has been hypothesized that biofeedback could potentially manage awake bruxism, however, its effectiveness has not been empirically analyzed in a systematic manner. Therefore, this systematic review was designed to determine the effectiveness of biofeedback compared to other therapies in adults with awake bruxism. Extensive searches in five databases looking for randomized controlled trials (RCTs) that included biofeedback to manage awake bruxism were targeted. The risk of bias (RoB) assessment was conducted using the Cochrane RoB-2 tool. Overall, four studies were included in this systematic review, all of which used the electromyographic activity of the masticatory muscles during the day and night as the main endpoint. Auditory and visual biofeedback could reduce the excessive level of masticatory muscle activity in a few days of intervention. The majority of the included studies had a high RoB and only one study had a low RoB. The standardization of the biofeedback protocols was also inconsistent, which makes it difficult to establish the ideal protocol for the use of biofeedback in awake bruxism. Thus, it is proposed that future studies seek to reduce methodological risks and obtain more robust samples.

BACKGROUND: One of the goals of Cochrane Rehabilitation is to strengthen methodology relevant to evidence-based clinical practice. Toward this goal, several research activities have been performed in rehabilitation literature: a scoping review listed the methodological issues in research, a study showed the low clinical replicability of randomized controlled trials, two systematic reviews showed the relevant items in reporting guidelines, and a series of articles discussed main methodological issues as a result of the first Cochrane Rehabilitation Methodological Meeting (Paris 2018). The need to improve the quality of conduct and reporting of research studies in rehabilitation emerged as a relevant task. The aim of this article is to present the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project to produce a specific reporting guideline in rehabilitation. METHODS: The project followed a combination of the CONsolidated Standards of Reporting Trials and EQUATOR Network methodologies. The project includes five phases. The first is kick-off, first consensus meeting and executive and advisory committee identification. The second is literature search and synthesis, where eight working groups will produce knowledge synthesis products (systematic or scoping reviews) to compile items relevant to reporting of randomized controlled trials in rehabilitation. The topics will be as follows: patient selection; blinding; treatment group; control group and co-interventions; attrition, follow-up, and protocol deviation; outcomes; statistical analysis and appropriate randomization; and research questions. The third is guidelines development, which means drafting of a document with the guidelines through a consensus meeting. The fourth is Delphi process consensus, a Delphi study involving all the rehabilitation research and methodological community. The fifth is final consensus meeting and publication. CONCLUSIONS: The RCTRACK will be an important contribution to the rehabilitation field and will impact several groups of rehabilitation stakeholders worldwide. The main goal is to improve the quality of the evidence produced in rehabilitation research. The RCTRACK also wants to improve the recognition and understanding of rehabilitation within Cochrane and the scientific and medical community at large. ispartof: AMERICAN JOURNAL OF PHYSICAL MEDICINE & REHABILITATION vol:99 issue:3 pages:210-215 ispartof: location:United States status: published

BACKGROUND Long-term therapy for psoriasis is impaired by gradual loss of effectiveness and treatment discontinuation. Identifying factors that affect biologic drug survival may help in treatment optimization. OBJECTIVES To identify factors that predicted biologic drug persistence or discontinuation in a real-life setting. METHODS We identified studies of biologic persistence in psoriasis through a comprehensive, systematic literature search using predefined search criteria. Studies were screened by title and abstract then further by full-text review. Hazard ratio (HR) data were extracted for all available predictive factors (HRs > 1 denoted biologic discontinuation, and HRs < 1 denoted biologic persistence). A meta-analysis of HRs (random-effects model) was used to assess any predictive factor included in at least two studies. RESULTS Sixteen cohort studies were included in the review, with a total of 32 194 patients. A meta-analysis was performed on 13 studies (n = 29 802): nine for female sex (n = 28 090), six for obesity (n = 9311) and six for psoriatic arthritis (n = 24 444). Obesity and female sex predicted treatment discontinuation, with HRs of 1.21 [95% confidence interval (CI) 1.10-1.32, I2 = 0%] and 1.22 (95% CI 1.07-1.38, I2 = 84%), respectively. Concomitant psoriatic arthritis predicted biologic persistence (HR 0.83, 95% CI 0.80-0.86, I2 = 0%). Female sex predicted biologic discontinuation due to side-effects, with a pooled HR of 2.16 (95% CI 1.39-3.35, I2 = 67%). Other reported predictive factors (smoking, metabolic syndrome, biologic naivety, age, Dermatology Life Quality Index, dyslipidaemia, high socioeconomic status and concomitant methotrexate) were insufficiently reported for meta-analysis. CONCLUSIONS Our meta-analysis demonstrates that female sex and obesity predict biologic discontinuation, and concomitant psoriatic arthritis predicts biologic survival. What's already known about this topic? Ineffectiveness is the main factor that causes drug discontinuation during long-term treatment of psoriasis. It is unclear which factors and comorbidities impact drug persistence. What does this study add? Female sex and obesity predict biologic discontinuation due to ineffectiveness and adverse events. Concomitant psoriatic arthritis is associated with improved drug persistence.

Purpose: Background: Evaluate whether the design of placebo control groups could produce different interpretations of the efficacy of manual therapy techniques. Methods: Nine databases were searched (EMBASE, CINAHL, PsycINFO, MEDLINE, PubMed, SCOPUS, WEB of SCIENCE, COCHRANE, and PEDro). Randomized placebo-controlled clinical trials that used manual therapy as a sham treatment on subjects suffering from pain were included. Data were summarized qualitatively, and meta-analyses were conducted with R. Results: 53 articles were included in the qualitative analysis and 48 were included in the quantitative analyses. Manipulation techniques did not show higher effectiveness when compared with all types of sham groups that were analyzed (SMD 0.28; 95%CI [−0.24; 0.80]) (SMD 0.28; 95%CI [−0.08; 0.64]) (SMD 0.42; 95%CI [0.16; 0.67]) (SMD 0.82; 95%CI [−0.57; 2.21]), raising doubts on their therapeutic effect. Factors such as expectations of treatment were not consistently evaluated, and analysis could help clarify the effect of different sham groups. As for soft tissue techniques, the results are stronger in favor of these techniques when compared to sham control groups (SMD 0.40; 95%CI [0.19, 0.61]). Regarding mobilization techniques and neural gliding techniques, not enough studies were found for conclusions to be made. Conclusions: The literature presents a lack of a unified placebo control group design for each technique and an absence of assessment of expectations. These two issues might account for the unclear results obtained in the analysis.

The need for home care services is expanding around the world with increased attention to the resources required to produce them. To assist decision making, there is a need to assess the cost-effectiveness of alternative programs within home care. Electronic searches were performed in five databases (before February 2020) identifying 3292 potentially relevant studies that assessed new or enhanced home care interventions compared with usual care for adults with an accompanying economic evaluation. From these, 133 articles were selected for full-text screening; 17 met the inclusion criteria and were analyzed. Six main areas of research were identified including the following: alternative nursing care (n = 4), interdisciplinary care coordination (n = 4), fall prevention (n = 4), telemedicine/remote monitoring (n = 2), restorative/reablement care (n = 2), and one multifactorial undernutrition intervention study. Risk of bias was found to be high/weak (n = 7) or have some concerns/moderate (n = 6) rating, in addition to inconsistent reporting of important information required for economic evaluations. Both health and cost outcomes had mixed results. Cost-effective interventions were found in two areas including alternative nursing care and reablement/restorative care. Clinicians and decision makers are encouraged to carefully evaluate the quality of the studies because of issues with risk of bias and incomplete reporting of economic outcomes.

To determine which factors influence and better differentiate between good and poor oral health-related quality of life (OHRQoL) in patients with myogenous TMD and which cut-off could predict a good/poor OHRQoL.Fifty-eight women with myogenous TMD were included. Factors of interest were collected (i.e., demographic variables, depression symptoms (Symptom Checklist-90 R (RDC/TMD)), pain intensity (Visual Analog Scale), jaw function (Mandibular Functional Limitation Questionnaire), and OHRQoL (Oral Health Impact Profile-14). A multivariable regression model, logistic regression, and receiver operating curve (ROC) analyses were conducted.Depression symptoms (β = 0.139) and jaw function (β = 0.478) were significantly associated with OHRQoL in the multivariable model. The best model to discriminate between good/poor OHRQoL included only jaw function (AUC = 0.90), with the best cut-off of 17 points (sensitivity: 0.93; specificity: 0.79).Depression symptoms and jaw function were significantly associated with OHRQoL. The best model and cut-off to discriminate good/poor OHRQoL included only jaw function.

To synthesize evidence on the effectiveness of mass media campaigns for the management of LBP on beliefs of the general public and health care providers, LBP-related disability, health utilization, and LBP clinical outcomes. Five electronic databases were searched from inception to December 17, 2019. Any studies evaluating the effectiveness of mass media campaigns for LBP were eligible. Primary outcome was general public LBP beliefs, while secondary outcomes included health care provider beliefs as well as LBP-related disability, health utilization, and clinical outcomes. The search resulted in 4,164 unique records, of which 18 studies were included. These 18 studies predominantly used quasi-experimental methods to evaluate seven LBP mass media campaigns conducted in seven countries. All studies evaluating LBP beliefs in the general public detected positive effects. Health care provider beliefs also consistently improved. Results for behavioural outcomes (disability behaviour and health utilization) were mixed and appeared dependent on campaign characteristics and local context. Mass media campaigns for LBP appear effective for improving beliefs of the general public and health care providers. Prospero CRD42018116797IMPLICATIONS FOR REHABILITATIONMass media campaigns about low back pain (LBP) appear effective for improving beliefs of the general public and health care providers, aligning beliefs with current evidence and self-management principles.Rehabilitation professionals should be aware of and seek to support public education initiatives in their communities related to LBP and other disabling health conditions.Rehabilitation professionals can highlight and reinforce campaign messages when providing education and reassurance to individual patients.Several campaign resources (i.e., posters, pamphlets, electronic resources, etc.) are available for rehabilitation professionals to use in their efforts to reduce disability related to LBP. Mass media campaigns about low back pain (LBP) appear effective for improving beliefs of the general public and health care providers, aligning beliefs with current evidence and self-management principles. Rehabilitation professionals should be aware of and seek to support public education initiatives in their communities related to LBP and other disabling health conditions. Rehabilitation professionals can highlight and reinforce campaign messages when providing education and reassurance to individual patients. Several campaign resources (i.e., posters, pamphlets, electronic resources, etc.) are available for rehabilitation professionals to use in their efforts to reduce disability related to LBP.

INTRODUCTION Attrition, missing data, compliance, and related biases can influence the magnitude of treatment effects in randomized controlled trials (RCTs). It is unclear which items should be considered when reporting and evaluating the influence of these biases in trial reports in the rehabilitation field. The aim was to describe which individual items considering attrition, missing data, compliance, and related biases are included in quality tools used in rehabilitation research. In addition, we aimed to determine whether the existing reporting guidelines, such as the CONSORT and its extensions include all relevant items related to these biases when reporting RCTs in the area of rehabilitation. EVIDENCE ACQUISITION Comprehensive literature searches and a systematic approach to identify tools and items looking at attrition, missing data, compliance and related biases in rehabilitation were performed. We extracted individual items linked to these biases from all quality tools. We calculated the frequency of quality items used across tools and compared them to those found in the CONSORT statement and its extensions. A list of items to be potentially added to the CONSORT statement was generated. EVIDENCE SYNTHESIS Three new tools to assess the conduct and reporting of trials in the rehabilitation field were found. From these tools, 28 items were used to evaluate the reporting as well as the conduct of trials considering attrition, missing data, compliance, and related biases in the rehabilitation field. However, our team found that some of these items lack specificity in the information required and therefore more research is needed to determine a core set of items used for reporting as well as assessing the risk of bias (RoB) of RCT in the rehabilitation field. CONCLUSIONS Although many items have been described by existing tools and the CONSORT statement (and its extensions) that deal with attrition, missing data, compliance, and related biases, several gaps in reporting were identified. It is crucial that future research investigate a core set of items to be used in the field of rehabilitation to facilitate the reporting as well as the conduct of RCTs.

OBJECTIVE To summarize evidence regarding the prevalence and incidence of low back pain and associated risk factors in nursing and medical students. TYPE: Systematic review and meta-analysis. LITERATURE SURVEY The protocol was registered with PROSPERO (CRD42015029729). Its reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Seven databases were searched until August 2020 to identify relevant studies. METHODOLOGY Two independent reviewers screened, extracted, and evaluated the risk of bias of the selected studies. Meta-analyses were used to estimate 12-month prevalence/incidence rates of low back pain and associated risk factors in these students. Levels of evidence for risk factors were determined by the updated Guidelines for Systematic Reviews in the Cochrane Collaboration Back Review Group. SYNTHESIS Sixteen studies involving 7072 students were included. The pooled 12-month prevalence rates of low back pain for nursing and medical students were 44% (95% confidence interval [95% CI]: 27%-61%) and 53% (95% CI: 44%-62%), respectively. The 12-month incidence of low back pain in nursing students ranged from 29% to 67%. No incidence rate was reported in medical students. Strong/moderate-quality evidence supported that final year of study (pooled odds ratio [OR] from five studies, 1.96, 95% CI: 1.13-3.40), anxiety (OR ranging from 3.12 to 4.61), or high mental pressure or psychological distress (OR ranging from 1.37 to 4.52) was associated with a higher 12-month low back pain prevalence in both student groups. Moderate-quality evidence suggested that prior history of low back pain (pooled OR from two studies: 3.46, 95% CI: 1.88-6.36) was associated with a higher 12-month low back pain incidence in nursing students. Similarly, moderate-quality evidence suggested that female medical students (pooled OR from two studies: 1.77, 95% CI: 1.09-2.86) demonstrated a higher 12-month low back pain prevalence than male counterparts. CONCLUSIONS Although it is impossible to alter nonmodifiable risk factors for low back pain, universities may develop and implement proper strategies to mitigate modifiable risk factors in these students.

Introduction Attrition, missing data, compliance, and related biases are three interrelated concepts. Previous research has found that these biases can affect the treatment estimates of randomized trials (RCTs). The extent to which the effects of attrition, missing data, compliance and related biases influence effect size estimates in rehabilitation as well as the effect of analytic strategies to mitigate these biases is unknown. Evidence acquisition To compile and synthetize the empirical evidence regarding the effects of attrition and compliance related biases on treatment effect estimates in rehabilitation RCTs. Electronic searches were conducted. Studies were included if they investigated the effects of attrition, missing data, compliance and related biases on treatment estimates. The seven studies meeting inclusion criteria were coded for type of biases and summarized using a narrative and/or quantitative approach when appropriate. Evidence synthesis Findings demonstrated that trials reporting higher levels of attrition (differences in ES: 0.18 [95%CI: 0.15, 0.22 ]), exclusion of participants from analyses (differences in ES: 0.13 [95% CI: -0.03, 0.29]), lack of good control of incomplete outcome data (differences in ES: 0.14 [95%CI: -0.02, 0.30]) and analysis by "as treated"(differences in ES:-0.39 [95%CI: -0.99, 0.2]) or "per protocol" (differences in ES:-0.46 [95%CI: -0.92, 0]) analyses were more likely to have higher effects than those that did not. Conclusions These findings suggest that attrition, missing data, compliance, and related biases have an influence in treatment effect estimates in rehabilitation trials. Therefore, these results should be taken into consideration when designing, conducting and reporting trials in the rehabilitation field.

Background The craniocervical flexion test (CCFT) is recommended when examining patients with neck pain related conditions and as a deep cervical retraining exercise option. During the execution of the CCFT the examiner should visually assess that the amount of craniocervical flexion range of motion (ROM) progressively increases. However, this task is very subjective. The use of inertial wearable sensors may be a user-friendly option to measure and objectively monitor the ROM. The objectives of our study were (1) to measure craniocervical flexion range of motion (ROM) associated with each stage of the CCFT using a wearable inertial sensor and to determine the reliability of the measurements and (2) to determine craniocervical flexion ROM targets associated with each stage of the CCFT to standardize their use for assessment and training of the deep cervical flexor (DCF) muscles. Methods Adults from a university community able to successfully perform the CCFT participated in this study. Two independent examiners evaluated the CCFT in two separate sessions. During the CCFT, a small wireless inertial sensor was adhered to the centre of the forehead to provide real-time monitoring and to record craniocervical flexion ROM. The intra- and inter-rater reliability of the assessment of craniocervical ROM was calculated. This study was approved by the Research Ethics Committee of CEU San Pablo University (236/17/08). Results Fifty-six participants (18 males, 23 females; mean [SD] age, 21.8 [3.45] years) were included in the study and successfully completed the study protocol. All interclass correlation coefficient (ICC) values indicated good or excellent reliability of the assessment of craniocervical ROM using a wearable inertial sensor. There was high variability between subjects on the amount of craniocervical ROM necessary to achieve each stage of the CCFT. Conclusions The use of inertial sensors is a reliable method to measure the craniocervical flexion ROM associated with the CCFT. The great variability in the ROM limits the possibility to standardize a set of targets of craniocervical flexion ROM equivalent to each of the pressure targets of the pressure biofeedback unit.

Background In this meta-epidemiological study, we aimed to examine associations between treatment effect size estimates and sponsorship bias in oral health randomized clinical trials. Methods We selected oral health related meta-analyses that included a minimum of five randomized controlled trials. We extracted data, in duplicate, related to influence of sponsorship bias. We quantified the extent of bias associated with influence of sponsorship on the magnitude of effect size estimates of continuous variables using a two-level meta-meta-analytic approach with random-effects models to allow for intra- and inter-meta-analysis heterogeneity. Results We initially identified 540 randomized trials included in 64 meta-analyses. Risk of sponsorship bias was judged as being “unclear” in 72.8% (n = 393) of the trials, while it was assessed as “low” in 16.7% (n = 90) and as “high” in 10.6% (n = 57) of the trials. Using a meta-epidemiological analysis (37 meta-analyses, including 328 trials that analyzed 85,934 patients), we identified statistically significant larger treatment effect size estimates in trials that had ”high or unclear” risk of sponsorship bias (difference in treatment effect size estimates=0.10; 95% confidence intervals: 0.02 to 0.19) than in trials that had “low” risk of sponsorship bias. Conclusions We identified significant differences in treatment effect size estimates between dental trials based on sponsorship bias. Treatment effect size estimates were 0.10 larger in trials with “high or unclear” risk of sponsorship bias. Practical Implications Clinicians should have an adequate knowledge of sponsorship bias in a clinical trial and be able to estimate the degree to which the conclusions of a systematic review are synthesized and interpreted, based on trials with low risk of sponsorship bias.

Background: Studies exploring interventions targeting the cervical spine to improve symptoms in patients with temporomandibular disorders (TMD) are limited. Objectives: To determine whether mobilisation of the upper cervical region and craniocervical flexor training decreased orofacial pain, increased mandibular function and pressure pain thresholds (PPTs) of the masticatory muscles and decreased headache impact in women with TMD when compared to no intervention. Methods: In a single‐blind randomised controlled trial, 61 women with TMD were randomised into an intervention group (IG) and a control group (CG). The IG received upper cervical mobilisations and neck motor control and stabilisation exercises for 5 weeks. The CG received no treatment. Outcomes were collected by a blind rater at baseline and 5‐week follow‐up. Orofacial pain intensity was collected once a week. A mixed ANOVA and Cohen's d were used to determine differences within/between groups and effect sizes. Results: Pain intensity showed significant time‐by‐group interaction (P < 0.05), with significant between‐group differences at four and five weeks (P < 0.05), with large effect sizes (d > 0.8). The decrease in orofacial pain over time was clinically relevant only in the IG. Change in headache impact was significantly different between groups, and the IG showed a clinically relevant decrease after the treatment. No effects were found for PPT or mandibular function. Conclusion: Women with TMD reported a significant decrease in orofacial pain and headache impact after 5 weeks of treatment aimed at the upper cervical spine compared to a CG.