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STUDY DESIGN: Cost-effectiveness of two trial interventions for low back pain. OBJECTIVE: To investigate the incremental cost-effectiveness between risk-stratified and usual care for low back pain. SUMMARY OF BACKGROUND DATA: A recent trial compared risk-stratified care to usual care for patients with low back pain (LBP) in the US Military Health System. While the outcomes were no different between groups, risk-stratified care is purported to use fewer resources and therefore could be a more cost-effective intervention. Risk-stratified care matches treatment based on low, medium, or high risk for poor prognosis. METHODS: The cost-effectiveness of usual care versus risk-stratified care for low back pain was assessed, using the healthcare perspective. Patients were recruited from primary care. The main outcome was indicating incremental cost-effectiveness between two alternative treatments. Acceptability curves of bootstrapped incremental cost effectiveness ratios (ICER) were used to identify the proportion of ICERs under the specific willingness-to-pay (WTP) level ($50,000 to $100,000). Health system costs (total and back-related) and health-related quality-of-life (HRQoL) based on quality-adjusted-life-years (QALYs) were obtained. RESULTS: 271 participants (33.6% female), mean age 34.3 +/-8.7 were randomized 1:1 and followed for 1 year. Mean back-related medical costs were not significantly different (mean difference $5; 95CI -$398, $407; P=0.982), nor were total medical costs (mean difference $827, 95CI -$1748, $3403; P=0.529). The mean difference in QALYs was not significantly different between groups (0.009; 95CI -0.014, 0.032; P=0.459). The incremental net monetary benefit (NMB) at the willingness to pay (WTP) threshold of $100,000 was $792 for back-related costs, with the lower bound confidence interval negative at all WTP levels. CONCLUSION: Risk-stratified care was not cost-effective for medium- and low-risk individuals compared to usual care. Further research is needed to assess whether there is value for high-risk individuals or for other risk-stratification approaches.

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OBJECTIVE: Study of the association between smoking and pain intensity has produced conflicting results; with less focus on pain interference. Different pain constructs could have varying associations with smoking behaviors. This study sought to investigate the association between smoking history and not only pain intensity, but also pain interference, symptom distribution and physical function. METHODS: Smoking history (current, past, or none), pain interference (Pain, Enjoyment of Life, and General Activity scale), symptom distribution and physical function scores were extracted from medical records of patients seen in physical therapy for common sites of musculoskeletal pain (lumbar and cervical spine, knee, or hip). Generalized linear models assessed the relationship between smoking history and pain/function. RESULTS: 833 patients from an integrated healthcare system were included (mean: 57.6 years, SD=16.3; 43 % male). After controlling for several variables, current smokers had significantly higher baseline pain interference scores compared to never and former smokers (beta [B]: 0.65, 95 %CI: 0.13 to 1.18, P=.02). Smoking was not a significant predictor of symptom distribution at baseline [B: 0.17, 95 %CI -0.06 to 0.42, P=.16] or physical function scores at discharge [B: -0.03, 95 %CI: -0.08 to 0.02, P=.25]. CONCLUSION: Smokers experienced a greater impact of pain at baseline. However, symptom distribution at intake and function upon discharge were similar between all smoking groups. These findings suggest smoking cessation and abstinence may be important recommendations to help curb pain interference.

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OBJECTIVE: To determine if maladaptive imaging beliefs correlated with, and predicted pain interference and physical function outcomes in people with musculoskeletal pain disorders. DESIGN: A prospective cohort study of patients with musculoskeletal disorders receiving outpatient physical therapy from April 2022 to August 2023. METHODS: Four questions about imaging were asked to assess maladaptive beliefs, the need to rule out serious conditions, guide treatment, determine diagnosis, and validate symptoms. Correlations with beliefs and outcomes were assessed using Kendall's tau rank and Spearman's rho correlation coefficients. Generalized linear models determined if these beliefs predicted outcomes at baseline and 6 weeks. RESULTS: The cohort included 152 participants (mean [standard deviation] age: 56.13 [15.13]; 32.2% male). Maladaptive imaging beliefs correlated positively with pain interference and negatively with physical function. The need to rule out serious conditions and validate symptoms correlated with pain interference (range: τb = 0.17, 0.20; P = .003, .0121) and physical function (range: ρ = -0.22, -0.22; P = .006, .008). All but 1 belief correlated with pain interference (range: τb = 0.19, 0.24; P<.001, .004) and physical function (range: ρ = -0.26, -0.21; P = .001, .009) at 6 weeks. Each additional belief slightly increased pain interference at 6 weeks (ß = 0.01; 95% CI: 0.001, 0.03; P = .04) and lowered physical function at both baseline (ß = -0.97; 95% CI: -1.66, -0.28; P = .01) and 6 weeks (ß = -0.76; 95% CI: -1.37, -0.15; P = .02). CONCLUSION: Maladaptive imaging beliefs were significantly (albeit weakly) correlated with pain and physical function. Each additional maladaptive imaging belief increased pain interference at 6 weeks and lowered physical function at baseline and 6 weeks. Beliefs about the necessity of imaging to properly manage musculoskeletal disorders may influence outcomes. J Orthop Sports Phys Ther 2024;54(9):1-10. Epub 5 July 2024. doi:10.2519/jospt.2024.12625.

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RATIONALE: Low back pain (LBP) is a common condition with a significant societal burden. Manual therapy is an effective treatment for LBP and recommended in clinical practice guidelines. While the quantity of literature supporting the use of manual therapy is large, the methodological quality and transparency of this collective work are unclear. AIMS AND OBJECTIVES: Explore the transparency in reporting of clinical trials assessing manual therapy interventions in patients with LBP by comparing planned components in the trial registration with what was reported in the published manuscript. METHODS: Three databases were searched to identify trials assessing the treatment effect of manual therapy for LBP from January 2005 to May 2023. Studies were included if the manual therapy consisted of thrust manipulations, mobilizations or muscle energy techniques. RESULTS: From 4462 studies initially identified, 167 studies remained in the final review after title, abstract and full-text review. Only 87 (52.1%) of the 167 studies were registered (n = 57 prospectively and n = 30 retrospectively). Primary outcomes in the publications were identical to the registration in 54 (62.1%) of the registered trials. Secondary outcomes in the publication were identical to the registration in 27 (31.0%) of the registered trials. The CONSORT reporting guideline was referenced in only 19 (21.8%) trials. Multiple discrepancies between registration and publication were noted for primary and secondary outcomes. All trials had eligibility criteria in the registration that matched their corresponding manuscript, while only four (4.6%) trial registrations addressed any type of statistical analysis plan. CONCLUSION: Approximately half of the trials were not registered. Of those registered, only half were registered prospectively. Substantial discrepancies existed between registered and published outcomes that were never addressed by the authors, raising questions about potential bias. Transparency can be improved through more stringent requirements during manuscript submission to journals, and better reporting of the rationale for discrepancies between registration and publication.

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STUDY DESIGN: Prospective cohort using routinely-collected health data. OBJECTIVE: To compare opioid use based on surgery intensity (low or high). SUMMARY OF BACKGROUND DATA: Many factors influence an individual's experience of pain. The extent to which post-surgical opioid use is influenced by the severity of spine surgery is unknown. METHODS: The participants were individuals undergoing spine surgery in a large military hospital. Procedures were categorized as low-intensity (e.g., microdiscectomy and laminectomy) and high-intensity (e.g., fusion and arthroplasty). The Surgical Scheduling System and Military Health System Data Repository were queried for healthcare utilization the 1 year before and after surgery. We compared opioid use after surgery between groups, adjusting for prior opioid use and surgical complications. RESULTS: 342 individuals met the inclusion criteria, mean age 45.4 years (SD 10.9), 33.0% female. Of these, 221(64.6%) underwent a low-intensity procedure and 121(35.4%) underwent a high-intensity procedure. Mean postoperative opioid prescription fills were greater in the high- versus low-intensity group (9.0 vs. 5.7;P<0.001), as were the mean total days' supply (158.9 vs. 81.8;P<0.001). Median morphine milligram equivalents were not significantly different (MME; 40.2 vs. 42.7;P=0.287). 26.3% of the cohort were chronic opioid users after surgery. Adjusted rates of long-term opioid use were not different between groups when only accounting for prior opioid use, but significantly higher for the high-intensity group when adjusting for surgical complications (OR=2.08;95CI 1.09,3.97). 52.5% of the entire cohort was still filling opioid prescriptions after six months. CONCLUSION: Higher-intensity procedures were associated with greater postoperative opioid use than lower-intensity procedures. Chronic opioid use was not significantly different between surgical intensity groups when considering only prior opioid use. Chronic opioid use was significantly higher among higher intensity procedures when accounting for surgical complications. The prresence of surgical complications is a stronger predictor of post-surgical long-term opioid use in high intensity surgeries than history of opioid use alone.

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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.

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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.

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BACKGROUND: Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice. OBJECTIVE: The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum. METHODS: A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool. RESULTS: A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias. CONCLUSION: Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.

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Objective: This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention for extremity conditions using the Consolidated Standards of Reporting Trials (CONSORT)-Harms extension as the benchmark. The secondary aim was to determine whether the quality of AE reporting improved after the availability of the CONSORT reporting checklist. Design: Systematic review. Methods: A literature search was conducted using multiple databases to identify trials where MT was used to treat extremity conditions. Studies that reported AEs were identified and evaluated using the CONSORT-Harms extension. The frequency of trials reporting study AEs before and after the publication of the updated 2010 CONSORT statement was calculated, along with the categorization of how study AEs were reported. Results: Of the 55,539 studies initially identified, 220 trials met all inclusion criteria. Eighty trials (36.4%) reported AE occurrence. None of the studies that reported AEs adhered to all 10 criteria proposed by the 2010 CONSORT-Harms extension. The most commonly reported criterion was number four, which clarified how AE-related information was collected (30% of trials). The least reported criterion was number six, which describes the participant withdrawals for each arm due to AEs and the experience with the allocated treatment (1.3% of trials). The nomenclature used to describe AEs varied substantially. Fifty-nine of 76 trials (33.3%) were published after the updated CONSORT Harms-checklist was available, compared to 21 of 44 trials (46.7%) published before it was available. Conclusion: Reporting of AEs in trials investigating MT for extremity conditions is poor. Every included trial lacked adherence to all 10 criteria proposed by the CONSORT-Harms Extension. The quality and comprehensiveness of AE reporting did not improve after the most recent CONSORT update recommending AE reporting. Clinicians must obtain informed consent before performing any intervention, including MT, which requires disclosing potential risks, which could be better known with improved tracking, analyzing, and reporting of AEs. The authors recommend improved adherence to best practices for adequately tracking and reporting AEs in future MT trials.

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Introduction: Manual therapy is an often-utilized intervention for the management of knee osteoarthritis (OA). The interpretation of results presented by these trials can be affected by how well the study designs align applicability to real-world clinical settings. Aim: To examine the existing body of clinical trials investigating manual therapy for knee OA to determine where they fall on the efficacy-effectiveness spectrum. Methods: This systematic review has been guided and informed by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Randomized controlled trials that investigated manual therapy treatments for adults with knee OA were retrieved via searches of multiple databases to identify trials published prior to April 2023. The Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool was used to objectively rate the efficacy-effectiveness nature of each trial design. The Cochrane Risk of Bias 2.0 assessment tool (RoB-2) was used to assess the risk of bias across five domains. Results: Of the 36 trials, a higher percentage of trials had a greater emphasis on efficacy within all four domains: participant characteristics (75.0%), trial setting (77.8%), flexibility of intervention (58.3%), and clinical relevance of experimental and comparison intervention (47.2%). In addition, 13.9% of the trials had low risk of bias, 41.7% had high risk of bias, and 44.4% had some concerns regarding bias. Conclusions: While many trials support manual therapy as effective for the management of knee OA, a greater focus on study designs with an emphasis on effectiveness would improve the applicability and generalizability of future trials.

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PURPOSE: To assess and identify patients' perceptions about the overall value of physical therapy services for musculoskeletal conditions and how these values were associated with their outcomes. METHODS: The association between the perceived value of physical therapy (as a score) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and physical function at 6-weeks was assessed in a prospective cohort. Generalised linear models were used to identify relationships between the value of physical therapy score and PROMIS outcomes. Kendall's tau was used to identify correlations between responses and outcomes. RESULTS: A total of 133 participants met the final inclusion criteria. The majority of participants were female (63.9%) with a mean age of 55.53 (SD 15.36) years. A majority of participants (63.9%) reported a previous positive personal experience with physical therapy. There was no significant relationship between perceived value of physical therapy and pain interference (ß -0.32, p = 0.07, 95% CI-0.67, 0.03) or physical function (ß 0.19, p = 0.29, 95% CI-0.16, 0.54). Stronger beliefs in agreement with the value of non-invasive treatment were significant, but weakly correlated with lower pain interference (r = -0.18, p = 0.048) and higher physical function scores (r = 0.22, p = 0.03). CONCLUSIONS: Participants had an overall positive perception of the value of physical therapy prior to initiating physical therapy, but this perception was not associated with 6-week pain and function outcomes. A better understanding of the driving factors encouraging patients to seek physical therapy services is needed to provide value-based care.

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OBJECTIVE: The primary objective was to describe rates of general and pain-related psychological distress for individuals with low back pain (LBP) in the Military Health System (MHS). We identified common phenotypes defined by rates of general and pain-related psychological distress and compared phenotypes on their level of pain interference, physical function, anxiety, and depression. METHODS: We created a cohort from two completed trials assessing nonpharmacological treatment for LBP in the MHS (n = 510 total). The Optimal Screening for Prediction of Referral and Outcome Yellow Flag assessment tool identified the presence of 11 different yellow flags. Latent class analysis (LCA) used yellow flag indicators to identify common psychological phenotypes. We then compared Patient-Reported Outcomes Measurement Information Systems measures of pain interference, physical function, sleep disturbance, depression, and anxiety across phenotypes. RESULTS: LCA identified five phenotypes (percentage of the sample): low distress (32%), high distress (27%), poor pain coping and low self-efficacy (18%), low self-efficacy and acceptance (14%), and poor pain coping (10%). Highly distressed phenotypes reported higher levels of pain interference, sleep disturbance, depression, and anxiety than those with other phenotypes, whereas the low distress phenotype had significantly lower pain interference and higher physical function scores than those characterized by all other phenotypes. CONCLUSION: These phenotypes provide opportunities for clinicians and researchers to develop novel LBP treatment pathways tailored to patients with different profiles of psychological distress. Future work is needed to validate their predictive capabilities for clinical outcomes.

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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.

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OBJECTIVE: To determine the reproducibility of exercise therapy interventions in randomized controlled trials for rotator cuff-related shoulder pain (RCRSP). DATA SOURCES: Data sources included Medline, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and SPORTDiscus from studies published from database inception to April 23, 2022. STUDY SELECTION: Randomized controlled trials studying the use of exercise therapy for RCRSP. DATA EXTRACTION: Two reviewers extracted exercise reporting details from all studies using the Template for Intervention Description and Replication (TIDieR) and the modified Consensus on Exercise Reporting Template (CERT). The same 2 reviewers assessed risk of bias of all studies using Cochrane Risk of Bias Tool version 2.0. DATA SYNTHESIS: For 104 studies meeting inclusion criteria, the average number of items reported on the TIDieR was 5.27 (SD 2.50, range 1-12 out of 12) and 5.09 (SD 4.01, range 0-16 out of 16) on the CERT. Improved reporting over time was seen on both the TIDieR and CERT dating back to 1993 and through April 23, 2022. When comparing groups of studies published before and after the TIDieR (2014) and CERT (2016) were established, a statistically significant increase in median scores was noted on the TIDieR (P=.02) but not the CERT (P=.31). Quality of exercise therapy reporting was highest in studies with "low risk" of bias, and lowest in studies with "high risk" of bias on the RoB-2. CONCLUSION: Overall exercise reporting in trials for RCRSP is incomplete despite the development of the TIDieR and CERT checklists. This has implications for translating evidence into practice.

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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.

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PURPOSE: To identify how pre-surgical conservative care is characterized and reported in randomized controlled trials of adults undergoing elective lumbar fusion, including duration and type of treatment. METHODS: The study design is a scoping review. Data sources include PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ovid Medline, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL). All randomized controlled trials published in English between January 1, 2005, and February 15, 2022, assessing lumbar fusion as the intervention were included in this review. RESULTS: Of 166 studies, 62.0% reported a failure in conservative care prior to lumbar fusion, but only 15.1% detailed the type of specific conservative care received. None of the trials provided sufficient details to understand the nature of the pre-surgical conservative treatment, such as frequency, recency/timing, or dosage of conservative interventions. CONCLUSION: Although roughly two-thirds of trials reported that patients failed conservative care prior to receiving a lumbar fusion, few studies named the conservative intervention provided and no studies provided any details regarding dosing or recency of care. This lack of information creates ambiguity in the surgical decision-making process, setting the assumption that all patients received adequate conservative care prior to surgery. Details about pre-surgical conservative care should be disclosed to allow for appropriate clinical application, decision-making, and interpretation of treatment effects.

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OBJECTIVE: To systematically review the orientation of trials analyzing exercise for low back pain (LBP) on the efficacy-effectiveness spectrum. DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Ovid MEDLINE were searched for trials published between January 1, 2010, and August 13, 2022. STUDY SELECTION: Randomized controlled trials investigating exercise for adults with LBP. DATA EXTRACTION: Two reviewers independently used the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool to determine the efficacy-effectiveness orientation. The same 2 reviewers assessed the risk of bias for all studies using the Cochrane Collaboration risk of bias 2.0 tool. DATA SYNTHESIS: The search identified 2975 records. Full-text review was conducted on 674 studies, and 159 studies were included. The proportion of trials with a strong or rather strong efficacy orientation (RITES rating=1 or 2), balanced emphasis (RITES rating=3), or strong or rather strong effectiveness (RITES rating=4 or 5) orientation on the efficacy-effectiveness spectrum within each RITES domain were reported. A greater proportion of trials had an efficacy orientation when compared with effectiveness or a balanced emphasis within 4 domains: participant characteristics: efficacy 43.9%, 41.9% effectiveness, balanced 14.5%; trial setting: 69.0% efficacy, effectiveness 15.8% balanced 15.2%; flexibility of interventions: 74.2% efficacy, effectiveness 8.8%, balanced 17.0%; clinical relevance of experimental and comparison interventions: 50.3% efficacy, 33.3% effectiveness 33.3%, balanced 16.4%. A high risk of bias was found in 42.1% (n=67) of trials. CONCLUSION: Trials investigating the effect of exercise for LBP have a greater orientation toward efficacy across multiple trial design domains. Researchers should consider pragmatic designs in future trials to improve generalizability. Clinicians should consider the efficacy-effectiveness orientation when translating evidence into clinical practice.

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RATIONALE: The physiotherapy profession strives to be a leader in providing quality care and strongly recognizes the value of research to guide clinical practice. Adherence to guidelines for research reporting and conduct is a significant step towards high-quality, transparent and reproducible research. AIM/OBJECTIVE: Assess integrity between planned and conducted methodology in randomized controlled trials (RCTs) and systematic reviews (SRs) published in physiotherapy journals. METHODS: Eighteen journals were manually searched for RCTs and SRs published from 1 July 2021 through 31 December 2021. Studies were included if the journal or specific study was indexed in PubMed and published/translated in English. Descriptive statistics determined congruence between preregistration data and publication. RESULTS: Forty RCTs and 68 SRs were assessed. Forty-three SRs included meta-analysis (MA). Of the 34 registered RCTs, 7 (20.6%) had no discrepancy between the registration and publication. Two trials (5.9%) addressed all discrepancies, 4 (11.8%) addressed some and 21 (61.8%) did not address any discrepancies. Of the 36 registered MAs, 33 (91.7%) had discrepancies between the registration and publication. Two (5.6%) addressed all discrepancies and three (8.3%) had no discrepancies. Eight SRs without MA published information not matching their registration, and none provided justification for the discrepancies. CONCLUSION: Most RCTs/SRs were registered; the majority had discrepancies between preregistration and publication, potentially influencing the outcomes and interpretations of findings. Journals should require preregistration and compare the submission with the registration information when assessing publication suitability. Readers should be aware of these inconsistencies and their implications when interpreting and translating results into practice.

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BACKGROUND: Psychologic variables have been shown to have a strong relationship with recovery from injury and return to work or sports. The extent to which psychologic variables predict successful return to work in military settings is unknown. QUESTIONS/PURPOSES: In a population of active duty soldiers, (1) can a psychologic profile determine the risk of injury after return to full duty? (2) Do psychologic profiles differ between soldiers sustaining injuries in the spine (thoracic or lumbar) and those with injuries to the lower extremities? METHODS: Psychologic variables were assessed in soldiers returning to full, unrestricted duty after a recent musculoskeletal injury. Most of these were noncombat injuries from work-related physical activity. Between February 2016 and September 2017, 480 service members who were cleared to return to duty after musculoskeletal injuries (excluding those with high-velocity collisions, pregnancy, or amputation) were enrolled in a study that tracked subsequent injuries over the following year. Of those, we considered individuals with complete 12-month follow-up data as potentially eligible for analysis. Based on that, approximately 2% (8 of 480) were excluded because they did not complete baseline surveys, approximately 2% (11 of 480) were separated from the military during the follow-up period and had incomplete injury data, 1% (3 of 480) were excluded for not serving in the Army branch of the military, and approximately 2% (8 of 480) were excluded because they were not cleared to return to full duty. This resulted in 450 soldiers analyzed. Individuals were 86% (385 of 450) men; 74% (331 of 450) had lower extremity injuries and 26% (119 of 450) had spinal injuries, including soft tissue aches and pains (for example, strains and sprains), fractures, and disc herniations. Time-loss injury within 1 year was the primary outcome. While creating and validating a new prediction model using only psychological variables, 19 variables were assessed for nonlinearity, further factor selection was performed through elastic net, and models were internally validated through 2000 bootstrap iterations. Performance was deciphered through calibration, discrimination (area under the curve [AUC]), R 2 , and calibration in the large. Calibration assesses predicted versus actual risk by plotting the x and y intersection of these values; the more similar predicted risk values are to actual ones, the closer the slope of the line formed by the intersection points of all subjects is to equaling "1" (optimal calibration). Likewise, perfect discrimination (predicted injured versus actual injured) presents as an AUC of 1. Perfect calibration in the large would equal 0 because it represents the average predicted risk versus the actual outcome rate. Sensitivity analyses stratified groups by prior injury region (thoracic or lumbar spine and lower extremity) as well as the severity of injury by days of limited duty (moderate [7-27 days] and severe [28 + days]). RESULTS: A model comprising primarily psychologic variables including depression, anxiety, kinesiophobia, fear avoidance beliefs, and mood did not adequately determine the risk of subsequent injury. The derived logistic prediction model had 18 variables: R 2 = 0.03, calibration = 0.63 (95% confidence interval [CI] 0.30 to 0.97), AUC = 0.62 (95% CI 0.52 to 0.72), and calibration in the large = -0.17. Baseline psychologic profiles between body regions differed only for depression severity (mean difference 1 [95% CI 0 to 1]; p = 0.04), with greater mean scores for spine injuries than for lower extremity injuries. Performance was poor for those with prior spine injuries compared with those with lower extremity injuries (AUC 0.50 [95% CI 0.42 to 0.58] and 0.63 [95% CI 0.57 to 0.69], respectively) and moderate versus severe injury during the 1-year follow-up (AUC 0.61 [95% CI 0.51 to 0.71] versus 0.64 [95% CI 0.64 to 0.74], respectively). CONCLUSION: The psychologically based model poorly predicted subsequent injury. This study does not minimize the value of assessing the psychologic profiles of injured athletes, but rather suggests that models looking to identify injury risk should consider a multifactorial approach that also includes other nonpsychologic factors such as injury history. Future studies should refine the most important psychologic constructs that can add the most value and precision to multifactorial models aimed at identifying the risk of injury. LEVEL OF EVIDENCE: Level III, prognostic study.

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