Substantial discrepancies exist between registered protocol and published manuscript in trials on exercise interventions for chronic low back pain: a metaresearch study.

OBJECTIVES: Reporting bias, prevalent in biomedical fields, can undermine evidence credibility. Our objective was to evaluate the proportion of discrepancies between registered protocols and published manuscripts in randomized controlled trials (RCTs) on exercise interventions for patients with chronic low back pain (CLBP). STUDY DESIGN AND SETTING: We conducted a cross-sectional meta-research study, starting from the 2021 "Exercise therapy for CLBP" Cochrane Review. We selected all RCTs reporting a protocol registration on a primary register of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov. We extracted data from both registered protocol and published manuscript of RCTs, collecting recruitment and administrative information (eg, record dates) and details of trial characteristics (eg, outcomes, arms, statistical analysis plan details [SAPs]). Independent pairs of reviewers assessed discrepancies between registered protocol and published manuscript for the reporting of primary and secondary outcomes domains, measurement instruments, time-points, number of arms and SAPs(if attached). Outcome discrepancies were characterized as addition, omission, upgrade or downgrade. RESULTS: We included 116 RCTs reporting an available protocol registration. Overall, 100 RCTs (86.2%) distinguished between primary and secondary outcomes. Of these, 39 RCTs (39.0%) reported one or more discrepancies in primary outcomes, and 78 RCTs (78.0%) reported one or more discrepancies in secondary outcomes. Focusing on discrepancies for the primary outcome, 64.5% of added, upgraded or downgraded outcomes favored statistically significant effects. Few RCTs (n = 6) reported discrepancies in the number of arms. SAPs were poorly reported in the registered protocols (n = 3) for being compared to the publications. CONCLUSION: We found substantial outcome discrepancies comparing registered protocols and published manuscripts in RCTs assessing exercise interventions for patients with CLBP, with some impacting the statistical significance of the effects. Readers are encouraged to approach RCTs results in this field with caution.

Improvements Are Needed in the Adherence to the TRIPOD Statement for Clinical Prediction Models for Patients With Spinal Pain or Osteoarthritis: A Metaresearch Study.

This metaresearch study aimed to evaluate the completeness of reporting of prediction model studies in patients with spinal pain or osteoarthritis (OA) in terms of adherence to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) statement. We searched for prognostic and diagnostic prediction models in patients with spinal pain or OA in MEDLINE, Embase, Web of Science, and CINAHL. Using a standardized assessment form, we assessed the adherence to the TRIPOD of the included studies. Two independent reviewers performed the study selection and data extraction phases. We included 66 studies. Approximately 35% of the studies declared to have used the TRIPOD. The median adherence to the TRIPOD was 59% overall (interquartile range (IQR): 21.8), with the items of the methods and results sections having the worst reporting. Studies on neck pain had better adherence to the TRIPOD than studies on back pain and OA (medians of 76.5%, 59%, and 53%, respectively). External validation studies had the highest total adherence (median: 79.5%, IQR: 12.8) of all the study types. The median overall adherence was 4 points higher in studies that declared TRIPOD use than those that did not. Finally, we did not observe any improvement in adherence over the years. The adherence to the TRIPOD of prediction models in the spinal and OA fields is low, with the methods and results sections being the most poorly reported. Future studies on prediction models in spinal pain and OA should follow the TRIPOD to improve their reporting completeness. PERSPECTIVE: This article provides data about adherence to the TRIPOD statement in 66 prediction model studies for spinal pain or OA. The adherence to the TRIPOD statement was found to be low (median adherence of 59%). This inadequate reporting may negatively impact the effective use of the models in clinical practice.

(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.

Predictors of outcome following an epidural steroid injection for disc-related sciatica: a Delphi consensus study.

PURPOSE: Trial data shows modest reductions in leg pain, disability and surgery avoidance following epidural steroid injections (ESI) for severe sciatica. Despite their common use, there is no clear evidence about which patients are more likely to benefit from ESI. The aim of this study was to generate consensus on potential predictors of outcome following ESI for disc-related sciatica. METHODS: A list of potential predictors of outcome was generated during a consensus meeting of seven experts. The items were subsequently presented in a two round on-line Delphi study to generate consensus among experts on which items are potential predictors of outcome. Consensus was defined as 70% agreement among participants. RESULTS: Sixty-one items were generated during the consensus meeting. Of ninety experts invited to participate in the on-line Delphi study, 44 (48%) and 33 (73%) took part in rounds one and two respectively. Twenty-eight additional items suggested by participants in round one were included in round two. Overall, 14 items reached consensus reflecting domains of health, medication use, pain intensity, psychosocial factors, imaging findings and type of injection. CONCLUSION: Based on expert consensus, items that can be routinely collected in clinical practice were identified as potential predictors of outcomes following ESI.

The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study.

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise.

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.

Development of a Multimodal, Personalized Intervention of Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low-Back Pain.

Background: Chronic low-back pain (CLBP) is the leading cause of years lived with disability. Physiotherapy is the most common treatment option for CLBP, but effects are often unsatisfactory. Virtual reality (VR) offers possibilities to enhance the effectiveness of physiotherapy treatment. Primary aim was to develop and test a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP. Methods: This study describes an intervention development process using mixed methods design that followed the Medical Research Council (MRC) framework. This involved a cocreation process with patients, physiotherapists, and researchers. A draft intervention was constructed based on a literature review and focus groups, and subsequently tested in a feasibility study and evaluated in focus groups. Focus group data were analyzed using thematic analysis. This intervention development process resulted in a final intervention. Results: Focus group data showed that VR and physiotherapy can strengthen each other when they are well integrated, and that VR needs to be administered under the right conditions including flawless technology, physiotherapists with sufficient affinity and training, and the right expectations from patients. The draft intervention was considered feasible after evaluation by four patients and three physiotherapists and was further complemented by expanding the training for physiotherapists and improving the protocols for physiotherapists and patients. The final intervention consisted of a 12-week physiotherapy treatment with three integrated VR modules: pain education, physical exercise, and relaxation. Conclusion: Using the MRC framework in cocreation with the end users, a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP was developed. This intervention was found to be feasible and will subsequently be evaluated for (cost-)effectiveness in a cluster randomized controlled trial.

Engaging patients in designing a transmural allied health pathway: A qualitative exploration of hospital-to-home transitions.

INTRODUCTION: The transition from hospital to home is often suboptimal, resulting in patients not receiving the necessary allied healthcare after discharge. This may, in turn, lead to delayed recovery, a higher number of readmissions, more emergency department visits and an increase in mortality and healthcare costs. This study aimed to gain insight into patients' experiences, perceptions, and needs regarding hospital-to-home transition, focusing on allied healthcare as a first step towards the development of a transitional integrated allied healthcare pathway for patients with complex care needs after hospital discharge. METHODS: We conducted semistructured interviews with patients. Participants were recruited from universities and general hospitals in the Amsterdam region between May and July 2023. They were eligible if they (1) were discharged from the hospital minimally 3 and maximally 12 months after admission to an oncologic surgery department, internal medicine department, intensive care unit, or trauma centre, (2) received hospital-based care from at least one allied healthcare provider, who visited the patient at least twice during hospital admission, (3) spoke Dutch or English and (4) were 18 years or older. Interviews were audio-recorded and transcribed verbatim. We performed a thematic analysis of the interview data. RESULTS: Nineteen patients were interviewed. Three themes emerged from the analysis. 'Allied healthcare support during transition' depicts patients' positive experiences when they felt supported by allied health professionals during the hospital-to-home transition. 'Patient and family involvement' illustrates how much patients value the involvement of their family members during discharge planning. 'Information recall and processing' portrays the challenges of understanding and remembering overwhelming amounts of information, sometimes unclear and provided at the wrong moment. Overall, patients' experiences of transitional care were positive when they were involved in the discharge process. Negative experiences occurred when their preferences for postdischarge communication were ignored. CONCLUSIONS: This study suggests that allied health professionals need to continuously collaborate and communicate with each other to provide patients and their families with the personalized support they need. To provide high-quality and person-centred care, it is essential to consider how, when, and what information to provide to patients and their families to allow them to contribute to their recovery actively. PATIENT OR PUBLIC CONTRIBUTION: The interview guide for this manuscript was developed with the assistance of patients, who reviewed it and provided us with feedback. Furthermore, patients provided us with their valuable lived experiences by participating in the interviews conducted for this study.

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.

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.

Limited use of virtual reality in primary care physiotherapy for patients with chronic pain.

BACKGROUND: Chronic pain is a disabling condition which is prevalent in about 20% of the adult population. Physiotherapy is the most common non-pharmacological treatment option for chronic pain, but often demonstrates unsatisfactory outcomes. Virtual Reality (VR) may offer the opportunity to complement physiotherapy treatment. As VR has only recently been introduced in physiotherapy care, it is unknown to what extent VR is used and how it is valued by physiotherapists. The aim of this study was to analyse physiotherapists' current usage of, experiences with and physiotherapist characteristics associated with applying therapeutic VR for chronic pain rehabilitation in Dutch primary care physiotherapy. METHODS: This online survey applied two rounds of recruitment: a random sampling round (873 physiotherapists invited, of which 245 (28%) were included) and a purposive sampling round (20 physiotherapists using VR included). Survey results were reported descriptively and physiotherapist characteristics associated with VR use were examined using multivariable logistic regression analysis. RESULTS: In total, 265 physiotherapists participated in this survey study. Approximately 7% of physiotherapists reported using therapeutic VR for patients with chronic pain. On average, physiotherapists rated their overall experience with therapeutic VR at 7.0 and "whether they would recommend it" at 7.2, both on a 0-10 scale. Most physiotherapists (71%) who use therapeutic VR started using it less than two years ago and use it for a small proportion of their patients with chronic pain. Physiotherapists use therapeutic VR for a variety of conditions, including generalized (55%), neck (45%) and lumbar (37%) chronic pain. Physiotherapists use therapeutic VR mostly to reduce pain (68%), improve coordination (50%) and increase physical mobility (45%). Use of therapeutic VR was associated with a larger physiotherapy practice (OR = 2.38, 95% CI [1.14-4.98]). Unfamiliarity with VR seemed to be the primary reason for not using VR. DISCUSSION: Therapeutic VR for patients with chronic pain is in its infancy in Dutch primary care physiotherapy practice as only a small minority uses VR. Physiotherapists that use therapeutic VR are modestly positive about the technology, with large heterogeneity between treatment goals, methods of administering VR, proposed working mechanisms and chronic pain conditions to treat.

Nociceptive, neuropathic, or nociplastic low back pain? The low back pain phenotyping (BACPAP) consortium's international and multidisciplinary consensus recommendations.

The potential to classify low back pain as being characterised by dominant nociceptive, neuropathic, or nociplastic mechanisms is a clinically relevant issue. Preliminary evidence suggests that these low back pain phenotypes might respond differently to treatments; however, more research must be done before making specific recommendations. Accordingly, the low back pain phenotyping (BACPAP) consortium was established as a group of 36 clinicians and researchers from 13 countries (five continents) and 29 institutions, to apply a modified Nominal Group Technique methodology to develop international and multidisciplinary consensus recommendations to provide guidance for identifying the dominant pain phenotype in patients with low back pain, and potentially adapt pain management strategies. The BACPAP consortium's recommendations are also intended to provide direction for future clinical research by building on the established clinical criteria for neuropathic and nociplastic pain. The BACPAP consortium's consensus recommendations are a necessary early step in the process to determine if personalised pain medicine based on pain phenotypes is feasible for low back pain management. Therefore, these recommendations are not ready to be implemented in clinical practice until additional evidence is generated that is specific to these low back pain phenotypes.

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.

Virtual Reality Breathing Interventions for Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Breathing exercises have been shown to reduce mental health problems among clinical and non-clinical populations. Although virtual reality (VR) breathing interventions are assumed to have potential benefits, it remains unclear whether VR breathing interventions are more effective at improving mental health than non-VR breathing interventions. We conducted a systematic literature search in six electronic databases (Web of Science, PsycINFO, Embase, Cochrane Central Register of Controlled Trials, Scopus, and PubMed) from inception to 30th September, 2022. We included randomized controlled trials in adults evaluating effects of VR compared to non-VR breathing interventions on primary outcomes of mental health (stress, anxiety and mood), and secondary outcomes of physiological stress measures (e.g., heart rate (HR), heart rate variability (HRV)). Within these selected studies, we explored differences in likeability and future use between VR and non-VR breathing interventions. 2.848 records were identified of which 65 full-text articles were assessed. Six RCTs were included, of which five were suitable for meta-analyses. Comparing VR to non-VR breathing interventions, there were no significant differences in overall mental health, stress, anxiety or mood, nor in HR or HRV. There was no evidence that participants liked VR breathing interventions more than non-VR, nor would use them more in the future. These results suggest that there is no evidence that VR breathing interventions are more effective than non-VR in improving mental health outcomes, HR, HRV. Further research is required to determine whether there may be advantages to longer-term VR-implementation and practice, and explore possible mechanisms.

Is the use of diagnostic imaging and the self-reported clinical management of low back pain patients influenced by the attitudes and beliefs of chiropractors? A survey of chiropractors in the Netherlands and Belgium.

BACKGROUND: No previous studies have examined the association between attitudes and beliefs of chiropractors and their adherence to low back pain (LBP) guidelines. The aim of this study is: (1) to assess the attitudes and beliefs towards the management of LBP of Dutch and Belgian chiropractors; and (2) to investigate the association of these attitudes and beliefs on the use of diagnostic imaging and on the adherence to diagnostic guidelines and guidelines in the management of patients with LBP. METHODS: STUDY DESIGN: Cross-sectional study using a web-based questionnaire in chiropractic private practices in the Netherlands and Belgium. The survey included sociodemographic characteristics, use of diagnostic imaging, the Pain Attitude and Beliefs Scale-Physiotherapists (PABS.PT) and 6 vignettes (3 acute and 3 chronic LBP patients). We used Latent Profile Analysis (LPA) to categorise the chiropractors into clusters depending on their PABS.PT outcome, whereby the classes differed primarily on the biomedical score. We used linear, logistic, and mixed models to examine the associations between these clusters, and adherence to the recommendations of guidelines on: (1) diagnostic imaging use, and (2) management of LBP (i.e. advice on activity, treatment, return-to-work, and bedrest). RESULTS: The response rate of the Dutch and Belgian chiropractors was 61% (n = 149/245) and 57% (n = 54/95), respectively. The majority of chiropractors scored midrange of the biomedical scale of the PABS.PT. Three clusters were identified using LPA: (1) high biomedical class (n = 18), (2) mid biomedical class (n = 117) and (3) low biomedical class (n = 23). Results from the vignettes suggest that chiropractors in the high biomedical class better adhere to diagnostic imaging guidelines and to LBP guidelines when it concerns advice on return-to-work and activity compared to the other two classes. However, no differences were identified between the classes for treatment of LBP. All chiropractors adhered to the guidelines' recommendation on bedrest. CONCLUSION: The high biomedical class demonstrated better overall adherence to the practice guidelines for the management of LBP and diagnostic imaging than the other classes. Due to the small numbers for the high and low biomedical classes, these results should be interpreted with caution.

Minimal important change and difference in health outcome: An overview of approaches, concepts, and methods.

OBJECTIVE: To provide an overview of approaches, concepts, and methods used to define and assess minimal important change and difference in health outcome. METHOD: A narrative review of the literature, guided by a conceptual framework. RESULTS: We distinguish between (i) interpretation of health outcome in individuals versus groups, (ii) change within individuals or groups versus difference between change within individuals or groups; and (iii) the responder approach (based on the proportion of patients that obtain a defined response) versus the group average approach (based on the average amount of change in a group). We review approaches, concepts, and methods. CONCLUSION: By bringing together and juxtaposing various approaches, concepts, and methods, we set a precursory step in the direction of consensus building in the field concerned with defining and assessing minimal important change and difference in health outcome. We emphasize the need for conceptual clarification and terminological standardization. We argue that assessing minimal importance of change and difference in health outcome is essentially a value judgment involving a range of considerations and perspectives.