(Cost-)effectiveness of personalised multimodal physiotherapy compared to surgery in patients with cervical radiculopathy: A systematic review.

RATIONALE: Cervical radiculopathy is initially typically managed conservatively. Surgery is indicated when conservative management fails or with severe/progressive neurological signs. Personalised multimodal physiotherapy could be a promising conservative strategy. However, aggregated evidence on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with/without post-operative physiotherapy is lacking. AIM/OBJECTIVES: To systematically summarise the literature on the (cost-)effectiveness of personalised multimodal physiotherapy compared to surgery with or without post-operative physiotherapy in patients with cervical radiculopathy. METHODS: PubMed, Embase, CINAHL, PsycINFO and Web of Science were searched from inception to 1st of March 2023. Primary outcomes were effectiveness regarding costs, arm pain intensity and disability. Neck pain intensity, perceived recovery, quality of life, neurological symptoms, range-of-motion, return-to-work, medication use, (re)surgeries and adverse events were considered secondary outcomes. Randomised clinical trials comparing personalised multimodal physiotherapy versus surgical approaches with/without post-operative physiotherapy were included. Two independent reviewers performed study selection, data-extraction, and risk of bias assessment using the Cochrane RoB 2 and Consolidated Health Economic Evaluation Reporting Standards statement. Certainty of the evidence was determined using Grading of Recommendations, Assessment, Development and Evaluations. RESULTS: From 2109 records, eight papers from two original trials, with 117 participants in total were included. Low certainty evidence showed there were no significant differences on arm pain intensity and disability, except for the subscale 'heavy work' related disability (12 months) and disability at 5-8 years. Cost-effectiveness was not assessed. There was low certainty evidence that physiotherapy improved significantly less on neck pain intensity, sensory loss and perceived recovery compared to surgery with/without physiotherapy. Low certainty evidence showed there were no significant differences on numbness, range of motion, medication use, and quality of life. No adverse events were reported. CONCLUSION: Considering the clinical importance of accurate management recommendations and the current low level of certainty, high-quality cost-effectiveness studies are needed.

Cost-effectiveness of Transforaminal epidural steroid injections for patients with ACUTE sciatica: a randomized controlled trial.

BACKGROUND: Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial. METHODS: Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty. RESULTS: None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures. CONCLUSION: These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting. TRIAL REGISTRATION: Dutch National trial register: NTR4457 (March, 6th, 2014).

Clinical Patient-Relevant Outcome Domains for Persistent Spinal Pain Syndrome-A Scoping Review and Expert Panels.

Large variation exists in the monitoring of clinical outcome domains in patients with persistent spinal pain syndrome (PSPS). Furthermore, it is unclear which outcome domains are important from the PSPS patient's perspective. The study objectives were to identify patient-relevant outcome domains for PSPS and to establish a PSPS outcomes framework. PubMed, CINAHL, Cochrane, and EMBASE were searched to identify studies reporting views or preferences of PSPS patients on outcome domains. The Arksey and O'Malley framework was followed to identify outcome domains. An expert panel rated the domains based on the importance for PSPS patients they have treated. A framework of relevant outcome domains was established using the selected outcome domains by the expert panel. No studies were found for PSPS type 1. Five studies with 77 PSPS type 2 patients were included for further analysis. Fourteen outcome domains were identified. An expert panel, including 27 clinical experts, reached consensus on the domains pain, daily activities, perspective of life, social participation, mobility, mood, self-reliance, and sleep. Eleven domains were included in the PSPS type 2 outcomes framework. This framework is illustrative of a more holistic perspective and should be used to improve the evaluation of care for PSPS type 2 patients. Further research is needed on the prioritization of relevant outcome domains.

Translation, validity and reliability of the pain attitudes and beliefs scale for physiotherapists in French.

BACKGROUND: The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) questionnaire evaluates manual therapists' biomedical and biopsychosocial beliefs regarding the management of chronic low back pain. Its usage in clinical settings is an important step in the implementation of national guidelines and policies to improve patient management. OBJECTIVES: The objective of this study was to translate the PABS-PT questionnaire into French, to adapt it culturally, and to conduct a psychometric analysis. DESIGN: Qualitative and cross-sectional study. METHOD: The translation process followed published guidelines with cross-cultural validation by an expert committee. We followed a forward and backward translation procedure and an expert committee, including the original author of the questionnaire and a linguistics expert ensuring good cultural adaptation, issued a finalised version. Psychometric analysis of the French version of the questionnaire was conducted among 390 French manual therapists in two phases. The first phase evaluated structural validity as well as external validity compared with the TSK and BBQ questionnaires. Then, reliability and scalability were analysed. The second phase evaluated test-retest reproducibility by sending the same questionnaire 3 months later. RESULTS: The validity study revealed three subscales: the classic biomedical subscale and two subscales for biopsychosocial beliefs (aetiology of pain and physical activity). With 21 items in total for the PABS-PT-FR, the structural validity scores were good (BM: alpha = 0.82, H = 0.38; Physical Activity: alpha = 0.62, H = 0.32; Aetiology of Pain: alpha = 0.55, H = 0.29). CONCLUSIONS: This study provides a validated tool to assess French physiotherapists' and, more generally, healthcare providers' beliefs about chronic low back pain, with a new insight into the BPS subscale internal construct.

Barriers and facilitators associated with the upscaling of the Transmural Trauma Care Model: a qualitative study.

BACKGROUND: To assess the barriers and facilitators associated with upscaling the Transmural Trauma Care Model (TTCM), a multidisciplinary and patient-centred transmural rehabilitation care model. METHODS: Semi-structured interviews were conducted with eight trauma surgeons, eight hospital-based physiotherapists, eight trauma patients, and eight primary care physiotherapists who were part of a trauma rehabilitation network. Audio recordings of the interviews were made and transcribed verbatim. Data were analysed using a framework method based on the "constellation approach". Identified barriers and facilitators were grouped into categories related to structure, culture, and practice. RESULTS: Various barriers and facilitators to upscaling were identified. Under structure, barriers and facilitators belonged to one of five themes: "financial structure", "communication structure", "physical structures and resources", "rules and regulations", and "organisation of the network". Under culture, the five themes were "commitment", "job satisfaction", "acting as a team", "quality and efficiency of care", and "patients' experience". Under practice, the two themes were "practical issues at the outpatient clinic" and "knowledge gained". CONCLUSION: The success of upscaling the TTCM differed across hospitals and settings. The most important prerequisites for successfully upscaling the TTCM were adequate financial support and presence of "key actors" within an organisation who felt a sense of urgency for change and/or expected the intervention to increase their job satisfaction. TRIAL REGISTRATION: NL8163 The Netherlands National Trial Register, date of registration 16-11-2019.

Systemic Inflammation, Sleep, and Psychological Factors Determine Recovery Trajectories for People With Neck Pain: An Exploratory Study.

We conducted an explorative prospective cohort study with 6 months follow-up to 1) identify different pain and disability trajectories following an episode of acute neck pain, and 2) assess whether neuroimmune/endocrine, psychological, behavioral, nociceptive processing, clinical outcome, demographic and management-related factors differ between these trajectories. Fifty people with acute neck pain (ie, within 2 weeks of onset) were included. At baseline, and at 2, 4, 6, 12, and 26 weeks follow-up, various neuroimmune/endocrine (eg, inflammatory cytokines and endocrine factors), psychological (eg, stress symptoms), behavioral (eg, sleep disturbances), nociceptive processing (eg, condition pain modulation), clinical outcome (eg, trauma), demographic factors (eg, age), and management-related factors (eg, treatment received) were assessed. Latent class models were performed to identify outcome trajectories for neck pain and disability. Linear mixed models or the Pearson chi-square test were used to evaluate differences in these factors between the trajectories at baseline and at each follow-up assessment and over the entire 6 months period. For pain, 3 trajectories were identified. The majority of patients were assigned to the "Moderate pain - Favourable recovery" trajectory (n = 25; 50%) with smaller proportions assigned to the "Severe pain - Favourable recovery" (n = 16; 32%) and the "Severe pain - Unfavourable recovery" (n = 9; 18%) trajectories. For disability, 2 trajectories were identified: "Mild disability - Favourable recovery" (n = 43; 82%) and "Severe disability - Unfavourable recovery" (n = 7; 18%). Ongoing systemic inflammation (increased high-sensitive C-reactive protein), sleep disturbances, and elevated psychological factors (such as depression, stress and anxiety symptoms) were mainly present in the unfavorable outcome trajectories compared to the favorable outcome trajectories. PERSPECTIVE: Using exploratory analyses, different recovery trajectories for acute neck pain were identified based on disability and pain intensity. These trajectories were influenced by systemic inflammation, sleep disturbances, and psychological factors.

Management of low back pain and lumbosacral radicular syndrome: the Guideline of the Royal Dutch Society for Physical Therapy (KNGF).

BACKGROUND: Significant progress and new insights have been gained since the Dutch Physical Therapy guideline on low back pain (LBP) in 2013 and the Cesar en Mensendieck guideline in 2009, necessitating an update of these guidelines. AIM: To update and develop an evidence-based guideline for the comprehensive management of LBP and lumbosacral radicular syndrome (LRS) without serious specific conditions (red flags) for Dutch physical therapists and Cesar and Mensendieck Therapists. DESIGN: Clinical practice guideline. SETTING: Inpatient and outpatient. POPULATION: Adults with LBP and/or LRS. METHODS: Clinically relevant questions were identified based on perceived barriers in current practice of physical therapy. All clinical questions were answered using published guidelines, systematic reviews, narrative reviews or systematic reviews performed by the project group. Recommendations were formulated based on evidence and additional considerations, as described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence-to-Decision framework. Patients participated in every phase. RESULTS: The guideline describes a comprehensive assessment based on the International Classification of Functioning, Disability and Health (ICF) Core Set for LBP and LRS, including the identification of alarm symptoms and red flags. Patients are assigned to three treatment profiles (low, moderate and high risk of persistent symptoms) based on prognostic factors for persistent LBP. The guideline recommends offering simple and less intensive support to people who are likely to recover quickly (low-risk profile) and more complex and intensive support to people with a moderate or high risk of persistent complaints. Criteria for initiating and discontinuing physical therapy, and referral to a general practitioner are specified. Recommendations are formulated for information and advice, measurement instruments, active and passive interventions and behavior-oriented treatment. CONCLUSIONS: An evidence based physical therapy guideline for the management of patients with LBP and LRS without red flags for physical therapists and Cesar and Mensendieck therapists was developed. Cornerstones of physical therapy assessment and treatment are risk stratification, shared decision-making, information and advice, and exercises. CLINICAL REHABILITATION IMPACT: This guideline provides guidance for clinicians and patients to optimize treatment outcomes in patients with LBP and LRS and offers transparency for other healthcare providers and stakeholders.

Predicting direct healthcare costs of general practitioner-guided care in patients with musculoskeletal complaints.

ABSTRACT: Information on healthcare utilization and costs of general practitioner (GP)-guided care in patients with musculoskeletal complaints is important for keeping healthcare affordable and accessible. A registry-based study was performed to describe healthcare utilization and costs of GP-guided care in patients with musculoskeletal complaints and to predict having higher direct healthcare costs. Healthcare costs of GP-guided care included all healthcare resources used by patients due to a musculoskeletal condition in 2018. Data were extracted from the database with a 1-year follow-up and descriptively analyzed. A general linear model was developed to predict having higher direct healthcare costs. In total, 403,719 patients were included, of whom 92% only received a single consultation. The number of referrals varied across the different types of complaints. Total annual direct healthcare costs amounted to €39,180,531, of which a key cost driver was referrals. Primary care consultations accounted for the largest part of referral-related costs. For all musculoskeletal conditions combined, the mean annual direct healthcare cost per patient was €97 (SEM = €0.18). Older age, being a woman, low socioeconomic status, spine complaints, high number of musculoskeletal diagnoses, and a high comorbidity score were predictive of having higher direct healthcare costs and explained 0.7% of the variance. This study showed that mean annual direct healthcare costs of GP-guided care in patients with musculoskeletal conditions were relatively low and did not differ considerably across conditions. The predictive model explained a negligible part of the variance in costs. Thus, it is unclear which factors do predict high direct healthcare costs in this population.

The impact of being overweight or obese on 12 month clinical recovery in patients following lumbar microdiscectomy for radiculopathy.

BACKGROUND CONTEXT: The proportion of patients who undergo lumbar microdiscectomy due to lumbar radiculopathy who are also overweight or obese is high. However, whether high body mass index (BMI) affects clinical outcomes is not well-studied. PURPOSE: To investigate the difference in the clinical course between normal weight, overweight, and obese patients with radiculopathy who underwent lumbar microdiscectomy followed by physical therapy and to evaluate whether high BMI is associated with poor recovery. STUDY DESIGN/SETTING: A prospective cohort study with a 12-month follow-up was conducted in a multidisciplinary clinic. PATIENT SAMPLE: We included 583 patients (median [IQR] age: 45 [35-52] years; 41% female) with clinical signs and symptoms of lumbar radiculopathy, consistent with magnetic resonance imaging findings, who underwent microdiscectomy followed by postoperative physical therapy. OUTCOME MEASURES: Outcomes were leg pain and back pain intensity measured with a visual analogue scale, disability measured with the Roland Morris Disability Questionnaire at 3 and 12-month follow-ups, and complications. METHODS: Patients were classified as being normal weight (46.9%), overweight (38.4%), or obese (14.7%). A linear mixed-effects model was used to assess the difference in the clinical course of pain and disability between the three BMI categories. The association between BMI and outcomes was evaluated using univariable and multivariable logistic regression analyses. RESULTS: All three patient groups experienced a significant improvement in leg pain, back pain, and disability over 3 and 12-month follow-up. Patients who were overweight, obese, or normal weight experienced comparable leg pain (p=.14) and disability (p=.06) over the clinical course (p=.14); however, obese patients experienced higher back pain (MD=-6.81 [95%CI: -13.50 to -0.14]; p=.03). The difference in back pain scores was not clinically relevant. CONCLUSIONS: In the first year following lumbar microdiscectomy, patients demonstrated clinical improvements and complications that were unrelated to their preoperative BMI.

Bias in the measurement of the outcome is associated with effect sizes in randomized clinical trials on exercise therapy for chronic low back pain: a meta-epidemiological study.

OBJECTIVES: To explore the relationships between the risk of bias and treatment effect estimates for exercise therapy interventions on pain intensity and physical functioning outcomes in randomized controlled trials (RCTs) involving patients with chronic low back pain. STUDY DESIGN AND SETTING: A cross-sectional meta-epidemiological study of the 230 RCTs (31,674 participants) in the 2021 'Exercise therapy for chronic low back pain' Cochrane Review were included. Study design characteristics, sample size, prospective trial registration, flowchart information, interventions, and comparisons were extracted. Independent pairs of reviewers assessed the risk of bias using the Cochrane Risk of Bias 2 tool. RESULTS: The metaregression included 220 (pain intensity) and 203 (physical functioning) effect sizes. Unadjusted and adjusted metaregression models showed no significant associations between the bias domains and pain intensity effect sizes. Only domain 'bias in the measurement of the outcome' was significantly associated with physical functioning (standardized mean difference: -0.40, 95% confidence interval: -0.77 to -0.02) when adjusted for flowchart reported (yes/no), prospective trial registration, sample size, and comparator type. CONCLUSION: The risk of bias in the measurement of the outcome could lead to slight overestimates of the effect size for physical functioning. Clinicians should consider this when they read and assess RCT results in this field. We encourage metaresearchers to replicate our findings using a consistent approach for evaluating the risk of bias (i.e., the RoB 2 tool) in other musculoskeletal conditions and interventions to investigate their generalizability.

Development and feasibility of stratified primary care physiotherapy integrated with eHealth in patients with neck and/or shoulder complaints: results of a mixed methods study.

BACKGROUND: Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. METHODS: This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. RESULTS: In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient's risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient's suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paper-based workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered 'OK' by physiotherapists. Patients considered the e-Exercise app to be of 'best imaginable' usability. The paper-based workbook was not used. CONCLUSION: Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial.

Effectiveness of a Primary Care Multidisciplinary Treatment for Patients with Chronic Pain Compared with Treatment as Usual.

To manage chronic pain, multidisciplinary interventions have been increasingly deployed, mostly in secondary or tertiary care settings. Evidence on the effectiveness of multidisciplinary intervention within primary care is scarce. This study examined the effectiveness of a primary care multidisciplinary treatment for chronic pain compared with treatment as usual (TAU). The intervention consisted of pain neuroscience education and treatment by a GP, psychologist, and physiotherapist. Both groups filled out patient-reported outcome measures at baseline, 6 months, and 12 months. The results indicated there were no statistically significant differences for the primary outcomes of pain intensity, number of pain sites, and health-related quality of life (HR-QoL). There was a statistically significant difference in the secondary outcome perceived health change in favor of the intervention group. None of the other differences were statistically significant. A post-hoc analysis showed that there were statistically significant effects on patients' illness perceptions in favor of the intervention group. Based on the results, the findings do not support effectiveness of a low intensity outpatient multidisciplinary primary care treatment to treat chronic pain compared with TAU. However, as a result of several study limitations, it is considered unwarranted to conclude that multidisciplinary treatment in primary care is not valuable at all.

Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?

OBJECTIVES: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models. METHODS: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R2), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations. RESULTS: The Non-p performed the best (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR). CONCLUSIONS: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations.

No evidence for stratified exercise therapy being cost-effective compared to usual exercise therapy in patients with knee osteoarthritis: Economic evaluation alongside cluster randomized controlled trial.

BACKGROUND: A stratified approach to exercise therapy may yield superior clinical and economic outcomes, given the large heterogeneity of individuals with knee osteoarthritis (OA). OBJECTIVE: To evaluate the cost-effectiveness during a 12-month follow-up of a model of stratified exercise therapy compared to usual exercise therapy in patients with knee OA, from a societal and healthcare perspective. METHODS: An economic evaluation was conducted alongside a cluster-randomized controlled trial in patients with knee OA (n = 335), comparing subgroup-specific exercise therapy for a 'high muscle strength subgroup', 'low muscle strength subgroup', and 'obesity subgroup' supplemented by a dietary intervention for the 'obesity subgroup' (experimental group), with usual ('non-stratified') exercise therapy (control group). Clinical outcomes included quality-adjusted life years - QALYs (EuroQol-5D-5 L), knee pain (Numerical Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score in daily living). Costs were measured by self-reported questionnaires at 3, 6, 9 and 12-month follow-up. Missing data were imputed using multiple imputation. Data were analyzed through linear regression. Bootstrapping techniques were applied to estimate statistical uncertainty. RESULTS: During 12-month follow-up, there were no significant between-group differences in clinical outcomes. The total societal costs of the experimental group were on average lower compared to the control group (mean [95% confidence interval]: € 405 [-1728, 918]), albeit with a high level of uncertainty. We found a negligible difference in QALYs between groups (mean [95% confidence interval]: 0.006 [-0.011, 0.023]). The probability of stratified exercise therapy being cost-effective compared to usual exercise therapy from the societal perspective was around 73%, regardless of the willingness-to-pay threshold. However, this probability decreased substantially to 50% (willingness-to-pay threshold of €20.000/QALY) when using the healthcare perspective. Similar results were found for knee pain and physical functioning. CONCLUSIONS: We found no clear evidence that stratified exercise therapy is likely to be cost-effective compared to usual exercise therapy in patients with knee OA. However, results should be interpreted with caution as the study power was lower than intended, due to the Coronavirus disease (COVID-19) pandemic.

Responsiveness and Minimal Important Change of the PROMIS Pain Interference Item Bank in Patients Presented in Musculoskeletal Practice.

We evaluated the responsiveness of the Patient Reported Outcome Information System Pain Interference item bank in patients with musculoskeletal pain by testing predefined hypotheses about the relationship between the change scores on the item bank, change scores on legacy instruments and Global Ratings of Change (GRoC), and we estimated Minimal Important Change (MIC). Patients answered the full Dutch-Flemish V1.1 item bank. From the responses we derived scores for the standard 8-item short form (SF8a) and a CAT-score was simulated. Correlations between the change scores on the item bank, GRoC and legacy instruments were calculated, together with Effect Sizes, Standardized Response Means, and Area Under the Curve. GRoC were used as an anchor for estimating the MIC with (adjusted) predictive modeling. Of 1,677 patients answering baseline questionnaires 960 completed follow-up questionnaires at 3 months. The item bank correlated moderately high with the GRoC (Spearman's rho 0.63) and with the legacy instruments (Pearson's R ranging from .45 to .68). It showed a high ES (.97) and Standardized Response Means (.71), and could distinguish well between improved and not improved patients based on the GRoC (Area Under the Curve .77). Comparable results were found for the derived SF8a and CAT-scores. The MIC was estimated to be 3.2 (CI 2.6-3.7) T-score points. PERSPECTIVE: Our study supports the responsiveness of the PROMIS-PI item bank in patients with musculoskeletal complaints. Almost all predefined hypotheses were met (94%). The PROMIS-PI item bank correlated well with several legacy instruments which supports generic use of the item bank. MIC for PROMIS-PI was estimated to be 3.2 T-score points.

The Hip Disability and Osteoarthritis Outcome Score-Physical Function Shortform Does Not Adequately Represent Physical Functioning in Patients Undergoing Total Hip Arthroplasty.

OBJECTIVES: A frequently used patient-reported outcome measure for assessing physical functioning in patients with hip problems is the 5-item Hip Disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS). Nevertheless, its content validity (whether this instrument adequately reflects the construct of physical functioning) is unknown. This study aimed to assess the content validity of the HOOS-PS. METHODS: A quantitative and qualitative research approach was used. Physical functioning was defined as the ability to perform activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills, often within a social context. Patients (n = 51) and experts (n = 25) completed questionnaires regarding the relevance, comprehensiveness, and comprehensibility of the HOOS-PS. Semistructured interviews (n = 5) explored issues identified in the quantitative data in more depth. Thematic content analysis was conducted using a coding frame. RESULTS: One of the 5 items was considered relevant to measure physical functioning. Comprehensiveness was considered insufficient by both patients and experts. Furthermore, comprehensibility was considered inadequate. Several items were found ambiguous or double barreled. Regarding interpretability, floor or ceiling effects were not found. CONCLUSIONS: This study showed concerns about the content validity of the HOOS-PS: most items are considered not relevant, the HOOS-PS is considered not comprehensive, and several items are considered not comprehensible. These findings challenge the applicability of the HOOS-PS in clinical practice, research, value-based healthcare, and benchmarking.

Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain?

OBJECTIVE: To examine the validity, reliability, and responsiveness of 3 commonly used questionnaires for assessing physical function (ie, Oswestry Disability Index [ODI], Quebec Back Pain Disability Scale [QBPDS], and Roland-Morris Disability Questionnaire [RMDQ]) in older patients undergoing chiropractic care for low back pain (LBP). DESIGN: Head-to-head clinimetric comparison. METHODS: Patients completed the ODI, QBPDS, and RMDQ at baseline and after 2 weeks of treatment. Reliability was evaluated for internal consistency (Cronbach α), test-retest reliability (interclass correlation coefficient [ICC]), and measurement error (standard error of measurement and smallest detectable change [SDC]). Structural validity was evaluated through unidimensional confirmatory factor analysis, and construct validity was investigated by a priori hypotheses with other measures. Responsiveness was evaluated by testing a priori hypotheses using data at baseline and at 2-week follow-up. RESULTS: Two hundred fourteen patients (53% males and 47% females) with a mean age of 66.2 years (standard deviation = 7.8 years) were included, of which 193 patients completed the 2-week follow-up for our responsiveness analysis. The RMDQ, ODI, and QBPDS showed sufficient internal consistency (Cronbach α of .89, .86, and .94, respectively) and test-retest reliability (ICC[2,1] of 0.85, 0.89, and 0.84, respectively). The SDC for the RMDQ was 6.9, for the ODI was 19.1, and for the QBPDS was 23.6, which are values larger than the minimal important change. None of the measures met all criteria for sufficient structural validity, but the RMDQ and ODI exhibited a partial unidimensional fit. The questionnaires had sufficient construct validity and responsiveness. CONCLUSION: The ODI, QBPDS, and RMDQ have similar measurement properties in older adults with LBP. J Orthop Sports Phys Ther 2022;52(7):457-469. Epub: 18 May 2022. doi:10.2519/jospt.2022.10802.