Evaluation of Transparency and Openness Guidelines in Physical Therapist Journals.

OBJECTIVE: The goals of this study were to evaluate the extent that physical therapist journals support open science research practices by adhering to the Transparency and Openness Promotion (TOP) guidelines and to assess the relationship between journal scores and their respective journal impact factor (JIF). METHODS: Scimago, mapping studies, the National Library of Medicine, and journal author guidelines were searched to identify physical therapist journals for inclusion. Journals were graded on 10 standards (29 available total points) related to transparency with data, code, research materials, study design and analysis, preregistration of studies and statistical analyses, replication, and open science badges. The relationship between journal transparency and openness scores and their JIF was determined. RESULTS: Thirty-five journals' author guidelines were assigned transparency and openness factor scores. The median score (interquartile range) across journals was 3.00 out of 29 (3.00) points (for all journals the scores ranged from 0 to 8). The 2 standards with the highest degree of implementation were design and analysis transparency (reporting guidelines) and study preregistration. No journals reported on code transparency, materials transparency, replication, and open science badges. TOP factor scores were a significant predictor of JIF scores. CONCLUSION: There is low implementation of the TOP standards by physical therapist journals. TOP factor scores demonstrated predictive abilities for JIF scores. Policies from journals must improve to make open science practices the standard in research. Journals are in an influential position to guide practices that can improve the rigor of publication which, ultimately, enhances the evidence-based information used by physical therapists. IMPACT: Transparent, open, and reproducible research will move the profession forward by improving the quality of research and increasing the confidence in results for implementation in clinical care.

The influence of exercise therapy dosing on pain and functional outcomes in patients with subacromial pain syndrome: A systematic review.

Background: The objective was to identify exercise therapy dosing parameters for subacromial pain syndrome (SAPS) associated with improved pain and function outcomes (via effect sizes) and determine the extent of exercise intervention reproducibility. Methods: An electronic search of PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Cochrane Database of Systematic Reviews, and SportDiscus identified studies that used exercise therapy exclusively to treat SAPS. Exercise therapy dosing parameters were extracted and within-group effect sizes were calculated for all pain and functional outcomes. Template for Intervention Description and Replication and Consensus on Exercise Reporting were used to record intervention reporting. The risk of bias and Grading of Recommendations, Assessment, Development, and Evaluation were assessed by two reviewers. Results: Twenty-one trials with 674 subjects were included. Effect sizes for pain and function were large in 18 studies, medium in six studies, and small or no effect in four studies, despite the type of supervision. With moderate certainty, effect sizes of pain and function were not influenced by exercise therapy dosing parameters. Intervention reporting was generally poor. Discussion: Exercise therapy for SAPS was associated with large effect sizes for improvement in pain and function but optimal exercise therapy dosing parameters could not be identified. Strong recommendations conditionally suggest treating SAPS with a variety of exercise therapy dosing parameters.

Treatment fidelity in clinical trials.

In the context of clinical trials, treatment fidelity (TF) has traditionally referred to the extent to which an intervention or treatment is implemented by the clinicians as intended by the researchers who designed the trial. Updated definitions of TF have included an appropriate design of the intervention that was performed in a way that is known to be therapeutically beneficial. This requires careful attention to three key components: (1) protocol and dosage adherence, (2) quality of delivery, and (3) participant adherence. In this viewpoint, we describe several cases in which TF was lacking in clinical trials and give opportunities to improve the deficits encountered in those trials. We feel that along with quality, risk of bias, and certainty of evidence, TF should be considered an essential element of the veracity of clinical trial.

How Reproducible Are Manual Therapy Interventions in Trials for Low Back Pain? A Scoping Review.

OBJECTIVES: To assess the reproducibility of manual therapy interventions used in clinical trials for low back pain (LBP), and summarize knowledge gaps in assessing the reproducibility of manual therapy interventions for LBP. DESIGN: Scoping review. LITERATURE SEARCH: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), and Embase were searched for trials from inception through April 2023. STUDY SELECTION CRITERIA: Randomized controlled trials were included if they described the use of manual therapy to treat LBP in adults 18 to 65 years old and were accessible in English. DATA SYNTHESIS: The Consensus on Exercise Reporting Template (CERT) checklist, used for exercise reporting, was previously modified for manual therapy reporting. This 11-item modified CERT was used to extract details of manual therapy reporting in the included trials. Frequency counts were calculated to identify items most and least commonly reported. RESULTS: Of 128 trials, none reported all 11 items of the modified CERT. The most commonly reported items were the description of how the application of manual therapy was decided (n = 113, 88.3%) and a description of adjunct interventions provided (n = 82, 64.1%). The least reported items were the description of an associated home program (n = 27, 21.1%) and a detailed description of the application of manual therapy (n = 22, 17.2%). CONCLUSION: Reporting of manual therapy interventions in trials investigating LBP was poor overall, limiting the reproducibility of these treatments. Using a checklist designed explicitly for manual therapy intervention reporting may improve reproducibility of these interventions and help align clinical outcomes with experimental findings. J Orthop Sports Phys Ther 2024;54(4):1-10. Epub 29 January 2024. doi:10.2519/jospt.2024.12201.

Self-acknowledged limitations in exercise therapy trials for low back pain.

RATIONALE: Despite the widespread recommendation to engage in therapeutic exercise for the treatment of low back pain (LBP), there is conflicting evidence regarding clinical outcomes and effectiveness. Poor methodological quality may be to blame for reducing the overall strength of evidence for this intervention, yet little is known about the difficulties researchers encounter when designing and implementing their study methods. AIMS AND OBJECTIVES: The aim of this study was to characterize the extent and type of self-acknowledged limitations (SALs) in exercise therapy trials for LBP to gain a better understanding of challenges encountered when conducting this research. METHODS: This is a methodological review of clinical trials in which SALs were extracted, categorized by theme and subcategorized within each theme. Counts and prevalence rates were tabulated for the number of SALs in each category and subcategory. RESULTS: There were 914 SALs among the 312 included trials, with a mean of 2.93 (95% confidence interval [CI], 2.77-3.09) per trial. Analysis of the data resulted in the development of 13 distinct categories of limitations, among which were 37 subcategories. The top three categories pertained to statistical power (14.3% of total SALs), study length and/or follow-up (14.3%) and inclusion criteria (14.2%). The top three subcategories were lack of long-term follow-up (13.8% of total SALs), inadequate sample size (13.3%) and inclusion of specific populations (12.3%). CONCLUSION: Statistical power, study length and/or follow-up, and inclusion criteria were the three most commonly reported categories of SALs in exercise trials for LBP. Lack of long-term follow-up, inadequate sample size and inclusion of specific populations were the most common subcategories. Research protocols recognizing and avoiding these limitations will enhance the overall quality of evidence of exercise therapy trials for LBP.

The relationships between pain-associated psychological distress, pain intensity, patient expectations, and physical function in individuals with musculoskeletal pain: A retrospective cohort study.

INTRODUCTION: The presence of pain-associated psychological distress (PAPD) in musculoskeletal disorders, including negative mood, fear-avoidance, and lack of positive affect/coping, is associated with prolonged disability. The importance of considering psychological influence on pain is well known, but practical ways of addressing it are not as straightforward. Identifying relationships between PAPD and pain intensity, patient expectations, and physical function may guide the development of future studies that assess causality and inform clinical practice. OBJECTIVE: To assess the relationship between PAPD measured by the Optimal Screening for Prediction of Referral and Outcome-Yellow Flag tool, and baseline pain intensity, expectations of treatment effectiveness, and self-reported physical function at discharge. DESIGN: Retrospective cohort study. SETTING: Hospital-based outpatient physical therapy. PARTICIPANTS: Patients 18 to 90 years old with spinal pain or lower extremity osteoarthritis. MAIN OUTCOME MEASURES: Pain intensity and patient expectations of treatment effectiveness at intake, and self-reported physical function at discharge. RESULTS: A total of 534 patients, 56.2% female, median (interquartile range [IQR]) age 61 (21) years with an episode of care between November 2019 and January 2021 were included. A multiple linear regression showed a significant association between PAPD and pain intensity with 6.4% (p < .001) of the variance explained. PAPD explained 3.3% (p < .001) of the variance in patient expectations. One additional yellow flag present resulted in a 0.17-point increase in pain intensity and 1.3% decrease in patient expectations. PAPD was also associated with physical function with 3.2% (p < .001) of the variance explained. PAPD explained 9.1% (p < .001) of the variance in physical function at discharge in the low back pain cohort only when assessed independently by body region. CONCLUSION: These findings support the theory that the pain experience is complex and multiple factors should be considered when evaluating a patient with musculoskeletal pain. Clinicians who have identified PAPD may consider these relationships when planning or modifying interventions and pursuing multidisciplinary collaboration.