Trials and tribulations of transparency related to inconsistencies between plan and conduct in peer-reviewed physiotherapy publications: A methodology review.

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.

Association between changes in function among patients with lumbar impairments classified according to the STarT Back Screening Tool and managed by McKenzie credentialed physiotherapists.

PURPOSE: To examine the association between functional status (FS) scores using a Patient Reported Outcome Measure (PROM) for patients with non-specific low back pain classified according to psychosocial risk using the STarT Back Screening Tool and managed by physiotherapists credentialed in McKenzie methods. METHODS: Participants (n = 705) completed FS and STarT surveys at intake and discharge. Prevalence of STarT risk classifications and change in STarT risk was calculated. Regression models were developed to examine associations between baseline and change in STarT risk categories, and FS outcomes at discharge from rehabilitation services. RESULTS: FS outcomes at discharge was not significantly different (p-values > 0.10) across baseline STarT risk subgroups after controlling for model covariates. Seventy-eight and 91.5% of medium and high-risk patients respectively decreased STarT risk. When compared with subjects whose STarT risk decreased, there was no significant difference in subjects whose STarT risk remained low. For subjects whose risk remained medium/high, or whose risk worsened, FS outcome scores were statistically significant (p < 0.001) and clinically relevant (-15.76 and -23.42 points respectively) compared to patients whose STarT risk decreased. CONCLUSIONS: Baseline STarT psychosocial risk stratifications should be interpreted cautiously to estimate the likelihood of good or poor FS outcomes at discharge from physiotherapy practice in the US when patients are managed by clinicians credentialed in McKenzie methods. Decreased STarT risk was associated with clinically important improvements in FS outcomes scores at discharge from McKenzie directed physiotherapy care.

Cognitive behavioural interventions, and function and pain outcomes among patients with chronic neck pain managed with the McKenzie approach.

OBJECTIVES: Graded activity and graded exposure in vivo are recommended cognitive behavioural approaches to improve function and pain outcomes for patients receiving physiotherapy for chronic nonspecific neck pain. The McKenzie method is a common treatment approach for patients with neck pain. The study objectives were to examine associations between interventions with graded activity and/or graded exposure, as determined by the treating physiotherapist, and function and pain outcomes for patients with chronic nonspecific neck pain managed by clinicians with credentials in the McKenzie approach. METHOD: A cohort study was carried out, in which subjects (n = 366) with chronic nonspecific neck pain completed intake surveys (i.e., the Neck Functional Status Computerized Adaptive Test and the Numeric Pain Rating Scale), and questions related to their demographic, lifestyle and health status. Treatment with graded activity/graded exposure during the episode of care was recorded. Function and pain measures were repeated at discharge. Multivariable models examining associations between patients receiving versus not receiving graded activity/graded exposure, and pain and function outcomes were constructed, controlling for potential confounding effects. RESULTS: Despite statistical significance, there were no clinically relevant differences between treatment versus no treatment with graded activity/graded exposure, and function or pain outcomes. CONCLUSION: There is insufficient evidence to suggest that patients being managed with McKenzie methods will attain clinically relevant improvements in function or pain outcomes when augmenting treatment with graded activity and/or graded exposure when the choice to intervene with these cognitive behavioural approaches is determined by the treating physiotherapist.

Directional preference, cognitive behavioural interventions, and outcomes among patients with chronic low back pain.

OBJECTIVES: Graded activity and graded exposure are recommended cognitive behavioural approaches to improve function and pain outcomes for patients receiving physiotherapy for chronic nonspecific low back pain. Directional preference identified following the McKenzie method is also associated with favourable patient outcomes. Study objectives were to examine associations between graded activity and/or graded exposure, and directional preference or no directional preference combined with or without graded activity/graded exposure subgroups, and function and pain outcomes among patients with chronic nonspecific low back pain managed by clinicians credentialed in the McKenzie approach. METHOD: Cohort study: Subjects (n = 801) with chronic nonspecific low back pain completed intake surveys, that is, the Lumbar Computer Adaptive Test measuring function and the Numeric Pain Rating Scale measuring pain, and questions addressing their demographic, lifestyle, and health status. Directional preference was determined at intake. Treatment with graded activity/graded exposure during the episode of care was recorded. Function and pain measures were repeated at discharge. Two models were developed controlling for potential confounding effects. The first model examined associations between patients receiving versus not receiving graded activity/graded exposure. The second model examined interaction effects between four combinations of directional preference and graded activity/graded exposure. Outcome measures were changes in function and pain during rehabilitation. RESULTS: Regarding the first objective, there were no clinically relevant differences between treatment versus no treatment with graded activity/graded exposure, and functional outcomes. Regarding the second objective, patients in the no-directional preference group were more likely to see benefits from the addition of graded activity/graded exposure to their treatment groups than those with a directional preference. CONCLUSION: Clinicians using McKenzie methods might attain improved patient functional outcomes when augmenting treatment with graded activity and/or graded exposure among patients who do not demonstrate directional preference.

Directional preference and functional outcomes among subjects classified at high psychosocial risk using STarT.

BACKGROUND AND PURPOSE: Physiotherapy has an important role in managing patients with non-specific low back pain who experience elevated psychosocial distress or risk for chronic disability. In terms of evidence-based physiotherapy practice, cognitive-behavioural approaches for patients at high psychosocial risk are the recommended management to improve patient treatment outcomes. Evidence also suggests that directional preference (DP) is an important treatment effect modifier for prescribing specific exercises for patients to improve outcomes. Little is known about the influence of treatment techniques based on DP on outcomes for patients classified as high psychosocial risk using the Subgroups for Targeted Treatment (STarT) Back Screening Tool. This study aimed to examine the association between functional status (FS) at rehabilitation discharge for patients experiencing low back pain classified at high STarT psychosocial risk and whose symptoms showed a DP versus No-DP. METHODS: High STarT risk patients (n = 138) completed intake surveys, that is, the lumbar FS of Focus On Therapeutic Outcomes, Inc., and STarT, and were evaluated for DP by physiotherapists credentialed in McKenzie methods. The FS measure of Focus On Therapeutic Outcomes, Inc., was repeated at discharge. DP and No-DP prevalence rates were calculated. Associations between first-visit DP and No-DP and change in FS were assessed using univariate and multivariate regression models controlling for 11 risk-adjusted variables. RESULTS: One hundred nine patients classified as high STarT risk had complete intake and discharge FS and DP data. Prevalence rate for DP was 65.1%. A significant and clinically important difference (7.98 FS points; p = .03) in change in function at discharge between DP and No-DP was observed after controlling for all confounding variables in the final model. CONCLUSION: Findings suggest that interventions matched to DP are effective for managing high psychological risk patients and may provide physiotherapists with an alternative treatment pathway compared to managing similar patients with cognitive-behavioural approaches. Stricter research designs are required to validate study conclusions.

Effect of Adding McKenzie Syndrome, Centralization, Directional Preference, and Psychosocial Classification Variables to a Risk-Adjusted Model Predicting Functional Status Outcomes for Patients With Lumbar Impairments.

Study Design Retrospective cohort. Background Patient-classification subgroupings may be important prognostic factors explaining outcomes. Objectives To determine effects of adding classification variables (McKenzie syndrome and pain patterns, including centralization and directional preference; Symptom Checklist Back Pain Prediction Model [SCL BPPM]; and the Fear-Avoidance Beliefs Questionnaire subscales of work and physical activity) to a baseline risk-adjusted model predicting functional status (FS) outcomes. Methods Consecutive patients completed a battery of questionnaires that gathered information on 11 risk-adjustment variables. Physical therapists trained in Mechanical Diagnosis and Therapy methods classified each patient by McKenzie syndromes and pain pattern. Functional status was assessed at discharge by patient-reported outcomes. Only patients with complete data were included. Risk of selection bias was assessed. Prediction of discharge FS was assessed using linear stepwise regression models, allowing 13 variables to enter the model. Significant variables were retained in subsequent models. Model power (R(2)) and beta coefficients for model variables were estimated. Results Two thousand sixty-six patients with lumbar impairments were evaluated. Of those, 994 (48%), 10 (<1%), and 601 (29%) were excluded due to incomplete psychosocial data, McKenzie classification data, and missing FS at discharge, respectively. The final sample for analyses was 723 (35%). Overall R(2) for the baseline prediction FS model was 0.40. Adding classification variables to the baseline model did not result in significant increases in R(2). McKenzie syndrome or pain pattern explained 2.8% and 3.0% of the variance, respectively. When pain pattern and SCL BPPM were added simultaneously, overall model R(2) increased to 0.44. Although none of these increases in R(2) were significant, some classification variables were stronger predictors compared with some other variables included in the baseline model. Conclusion The small added prognostic capabilities identified when combining McKenzie or pain-pattern classifications with the SCL BPPM classification did not significantly improve prediction of FS outcomes in this study. Additional research is warranted to investigate the importance of classification variables compared with those used in the baseline model to maximize predictive power. Level of Evidence Prognosis, level 4. J Orthop Sports Phys Ther 2016;46(9):726-741. Epub 31 Jul 2016. doi:10.2519/jospt.2016.6266.