Background When choosing spinal manipulative therapy (SMT) for low back pain (LBP), patient preferences are crucial. Discrete choice experiments (DCE) help establish how patients weigh expected outcomes against time, costs, and inconveniences. To conduct a DCE, clearly defined and relevant attributes are essential. Objective To identify and prioritize the attributes influencing Dutch LBP patients who choose SMT, informing the design of our future DCE. Methods Part 1: an update of a systematic review to construct a list of attributes; Part 2: 13 semi-structured interviews with SMT patients to identify which attributes they perceived relevant; Part 3: focus groups with 4 patients and 6 healthcare providers tested and prioritized these attributes. Finally, in part 4: the project group discussed the focus group results and considered broader aspects, such as clinical and policy relevance, to determine the final set of attributes . Results Part 1: 36 potentially relevant attributes were identified. Part 2: Excluded attributes not identified in the interviews or deemed unsuitable for inclusion in a DCE, narrowing this list to ten. Part 3: Focus groups identified three attributes as most influential: ‘effectiveness’, ‘treatment frequency’, and ‘duration of treatment plan’. The remaining attributes were considered important, but less influential. Part 4: Six attributes were retained based on both focus group results and broader considerations: ‘effectiveness’, ‘treatment frequency’, ‘duration of treatment plan’, ‘having to do self-management’, ‘side effects’, and ‘out-of-pocket costs’. Conclusions Six patient-informed attributes were identified that will form the foundation for our DCE.
Objective To assess the effects of radiofrequency (RF) denervation for chronic low back pain (LBP) from facet joint, sacroiliac joint, discogenic and non-specific pain.Design Systematic review and meta-analysis.Data sources We searched Medline, Embase, Cochrane Library, CINAHL, PsycINFO, ClinicalTrials.gov and WHO ICTRP up to 18 February 2025 for randomised controlled trials (RCTs).Study selection, data extraction and synthesis Pairs of reviewers independently selected studies, extracted data and assessed risk of bias (Cochrane RoB 2). Meta-analyses with clinically homogeneous studies were performed and certainty of evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation.Results 55 RCTs (n=4394) were included; many outcomes were at some risk of bias. Low to moderate certainty evidence suggested small improvements in pain and function with RF denervation versus sham for facet joint pain, sacroiliac, discogenic and non-specific chronic LBP. None exceeded predefined minimally clinically important between-group differences, suggesting limited clinical relevance.Conclusions RF denervation showed small improvements in pain and function compared with sham, steroid injection or standard care, but the effects did not reach clinically meaningful thresholds and the certainty of evidence was very low to moderate. Additional research is needed to clarify the effects of RF denervation and guide clinical decision-making.PROSPERO registration number CRD42023460743.
OBJECTIVES:Treatment mechanisms for exercise, cognitive behavioral therapy (CBT) and spinal manipulative therapy (SMT) are broadly theorized and examined in basic science studies; however, they are not typically incorporated in the design of randomized controlled trials (RCTs) for low back pain (LBP). The overall aim of this study is to answer the question, "what is the role of mechanisms and goal of treatment in RCTs for LBP?" Specifically, the objective is to answer: (1) how many RCTs of LBP consider an intervention-specific mechanism?, (2) are these mechanisms incorporated in their study design (ie, inclusion criteria)?; (3) Is an outcome measure aligned to the proposed mechanism measured at follow-up?; and, (4) do RCTs which describe a mechanism for the intervention, and include this in the design (ie, the inclusion criteria and outcome measures) of the study, demonstrate a different/stronger intervention effect compared to those that do not? The same line of questioning applies to goal of treatment. STUDY DESIGN AND SETTING:The basis for our analyses will be formed by the RCTs included in the Cochrane reviews investigating the effects of exercise, CBT, and SMT for chronic LBP. We will report the proportion of RCTs that: (1) describe a mechanism for the intervention; (2) incorporate the mechanism in the inclusion criteria; and (3) report an outcome measure aligned to the proposed mechanism. Similar proportions will be reported for goal of treatment. The data will be summarized for all trials, and stratified by intervention type. Also, we will examine the association between difference in pain or functional status at 3-month follow-up and the central determinant (mechanism (yes/no) for the intervention group (SMT, exercise, and CBT)) by performing metaregression analyses. The same analyses will be run for goal of treatment. CONCLUSION:This metaepidemiological analysis will provide insight into the proportion of RCTs that report a mechanism/goal of treatment for the intervention as well as outlining the differences in treatment outcomes for RCTs that do report an intervention specific mechanism or goal vs. those that do not. This may help improve RCT quality by highlighting the importance of including participants with criteria relevant to the treatment and/or mechanism under investigation. PLAIN LANGUAGE SUMMARY:This study looks at whether and how clinical trials explain how a treatment works (this is called a mechanism), if they test those treatments on the right group of people and if they are using the right tools to measure if the treatment actually works. At the moment, it is not clear whether explaining how a treatment works makes a difference in how well a treatment works compared to other treatments. Understanding both how a treatment works and who it works best for, helps with making a better treatment choice. For example, imagine a trial that tests exercises to strengthen the abdominal muscles for people with low back pain (LBP). If the trail includes people who already have strong abdominal muscles, the results may not show the true benefit of the exercises. It would make more sense to include people with weak abdominal muscles, as they are the ones most likely to benefit from the exercises. Also, you would need the right tool to assess whether a treatment actually works. Going back to the previous example, you have to use a tool that can accurately measure abdominal muscle strength to tell if the abdominal muscles become stronger. In our study, we will look at how many studies explain how a treatment works (in other words, explain the treatment mechanism), and whether they use that information to decide which people to include and to choose the right tool to the measure the results. In simple terms, are trials being done with the right group of people, and are the effects measured with the right tool? To answer this, we will evaluate trials that are included in the Cochrane reviews for three common treatments for chronic LBP; exercise, cognitive behavioral therapy (CBT), and spinal manipulative therapy (SMT).
In clinical research, statistically significant effects do not necessarily indicate that an intervention provides benefits that are meaningful to patients. This is particularly important for patient-reported outcomes, where thresholds used to interpret clinical relevance are often derived from within-person changes, such as the minimal clinically important difference, and then inappropriately applied to between-group effects in randomised trials and meta-analyses. This article clarifies the conceptual distinction between within-group change and between-group effects, and argues that the latter should be the focus when judging the comparative value of healthcare interventions. We introduce the smallest worthwhile effect (SWE) as a patient-centred, intervention-specific construct representing the smallest between-group effect of an intervention over a comparator that patients consider worthwhile when weighed against harms, costs and other inconveniences. We describe the main methods used to estimate the SWE, including benefit-harm trade-off studies and discrete choice experiments, and illustrate its application by reinterpreting a randomised trial of physiotherapy for low back pain and a meta-analysis of discectomy versus non-surgical care for sciatica. We also show how the SWE can inform judgements of imprecision within the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, offering a patient-derived threshold for distinguishing trivial from worthwhile effects. By focusing on patient-derived thresholds rather than arbitrary statistical or within-group approaches, the SWE construct can help researchers, clinicians and other stakeholders make more transparent and meaningful judgements about the worthwhileness of compared healthcare interventions from a patient perspective.
Systematic error undermines the internal validity of randomized controlled trials (RCTs). Elucidating how risk of bias (RoB) domains distort effect estimates strengthens evidence trustworthiness. Low back pain (LBP) research provides a representative field for this investigation, with spinal manipulative therapy (SMT) serving as a widely utilized intervention.Objective: To explore the association between risk of bias domains and effect estimates of SMT treatment in LBP trials.Methods: RCTs from the Cochrane systematic reviews which have examined the effect of SMT for acute and chronic LBP will be included. The Cochrane RoB 2 tool will be used. The influence of RoB domains on effect estimates for pain intensity and physical functioning will be explored through univariable and multivariable meta-regression models. Models will be adjusted for confounders identified through a directed acyclic graph, including sample size, trial registration, country income level, and comparator type, while exploring interactions.Significance: This study builds upon research in exercise therapy, investigating whether the association between RoB and effect estimates is consistent across other non-pharmacological LBP interventions. Findings may help refine the application of GRADE on SMT, and improve evidence synthesis and decision-making for researchers and policymakers.
Chronic low back pain (CLBP) is a leading cause of disability worldwide. Physiotherapy is a common treatment, but its effect on physical functioning is generally modest, particularly for patients with severe complaints (i.e., high levels of disability and pain). Virtual Reality (VR) may complement physiotherapy, yet evidence for its effectiveness remains limited. The aim of this study was to assess the effectiveness and feasibility of a VR intervention integrated within physiotherapy for people with severe CLBP. A cluster-RCT across Dutch physiotherapy practices was conducted. Patients in the control group received 12 weeks of usual care following physiotherapy guidelines. Patients in the intervention group received similar usual care, enhanced with integrated, home-based VR consisting of pain education, exercise therapy, and relaxation modules. The primary outcome was physical functioning at three months. Secondary outcomes included feasibility, pain intensity, and catastrophizing. Analyses were conducted using linear mixed-effect models accounting for clustering by physiotherapy practice. Twenty-five patients participated in the intervention group and seven in the VARIETY control group, instead of the planned sample size of 120 participants. Due to poor recruitment (n = 7), we supplemented the VARIETY control group with 18 historical controls from two comparable trials (total control n = 25), effectiveness analyses are therefore exploratory. Between-group differences were neither statistically significant nor clinically relevant for all outcome measures, compared to the VARIETY control group (e.g., ODI mean difference at three months: -4.80, 95
INTRODUCTION AND AIMS:The transmural allied healthcare pathway (TULIP) was developed to improve interprofessional collaboration and continuity of care during hospital-to-home transitions for patients with complex care needs. This process evaluation aimed to examine the implementation and integration of TULIP into routine care. METHODS:This study was a multi-methods process evaluation guided by the RE-AIM framework, assessing the reach, effectiveness, adoption, implementation, and maintenance of TULIP. Data were collected through interviews, focus groups, and surveys with professionals, patients, and managers across hospital, geriatric rehabilitation centers, and primary care settings. RESULTS:Reach included 84 healthcare professionals across hospital, geriatric rehabilitation, and primary care settings; patient enrollment was limited due to a small eligible population. Effectiveness showed a slight improvement in the consistency of care delivery among active users, with no significant changes in perceived collaboration or work performance, although limited intervention uptake may have constrained the assessment of potential effects. Adoption varied across professionals and settings and relied heavily on the implementation researcher, indicating limited organizational ownership. Implementation was hindered by intervention complexity, differing task perceptions among professionals, and challenges in cross-setting coordination and patient eligibility. Maintenance was considered unlikely without structural organizational support, integration into existing workflows, and a clearly perceived need among professionals. CONCLUSIONS:The sustainable implementation of TULIP requires stronger organizational commitment, clearer roles and responsibilities, and integration into routine workflows to support the continuity of care during hospital-to-home transitions.
BACKGROUND:Low back pain (LBP) is a disabling condition worldwide, and current evidence suggests low rates of referral to physical therapists and extensive use of low-value interventions such as pharmacological treatments and emergency visits. OBJECTIVE:To investigate the frequency of referrals and characterize people with LBP accessing primary care physical therapists, as well as characterize clinical and sociodemographic aspects and the use of health resources in Brazil. METHOD:Observational study using nationwide data on 1,459,710 adults with LBP, stratified according to G1: medical care only, G2: medical care and referral to physical therapist, G3: physical therapist as first contact. Data were analyzed descriptively. RESULTS:1,405,145 people with LBP were included in G1, followed by G2 (N:14,079), and G3 (N:40,486). The majority was female (56.3 %), and the average age was 49 (±17) years for females and 48 (±17) for males. Less than 1 % (G2) were referred to physical therapists. Of these, 8085 (57.4 %) had an average duration of 17.4 days (±65.6) between referral and their clinical appointment, and 5994 (42.6 %) had a longer duration (261.1 ± 146.9 days). A total of 130,570 (8.9 %) participants were referred for imaging, totaling 152,150 exams. G1 had 105.65 exams/1000 people and 128 referrals to specialists/1000 people. G2 had 196.32 exams and 384.76 referrals to specialists/1000 people, and G3 had 22.87 exams and 64.89 referrals to specialists/1000 people. CONCLUSION:We found a relatively low number of referrals of people with LBP to physical therapists in primary health care in Brazil, and a long period between the referral and the first contact with this professional. In addition, diagnostic imaging and referral to a specialist were frequently used.
With the rising adoption of virtual reality (VR) in health care, research publications on the topic are increasing rapidly. Guidance on reporting VR interventions is limited, which risks misinterpretation of findings, inappropriate data synthesis in reviews and meta-analyses, and reduced reproducibility. This could also result in possible misuse of VR interventions and might hinder further implementation in clinical practice. The aim of this study was to develop a reporting guideline for therapeutic, immersive VR interventions using head-mounted displays in scientific publications. To reach this aim, we intended to achieve expert consensus on key items and categories for reporting these interventions. We conducted a three-round, modified, online Delphi study with a validation meeting to develop a VR intervention reporting guideline. Participants were international experts in therapeutic VR research, working as academic or industrial researchers. Convenience, purposive, and snowball sampling were used to recruit participants. Consensus was defined a priori as ≥75% agreement on each reporting item and category. Of the 280 invited experts, 61 participants (22%) completed all three rounds of this Delphi study. Participants (32 females [52%]) had an average of 6 years' experience with VR research and diverse backgrounds in VR research settings and disciplines. The final consensus-based VR intervention reporting guideline consists of 16 reporting items divided into six categories (i.e., theory, content, deployment, development, safety, and context). The INVIRTUE intervention reporting guideline provides a framework for describing therapeutic VR interventions. Using this tool may enhance the uniformity and completeness of VR intervention reporting and support study replicability and scientific progress. The reporting guideline will also facilitate efficient empirical comparison across existing VR interventions and ultimately contribute to the appropriate use and effective implementation of therapeutic VR in clinical practice.
Introduction:Despite growing recognition of gender bias in healthcare, there is a lack of clarity on how gender bias is defined and understood in the literature. Existing definitions often did not consider modern gender constructs, limiting their applicability to current healthcare practices. In order to address these issues, we aim to perform a scoping review (ScR) to systematically explore what definitions and which characteristics of gender bias are found in the literature. Methods:This protocol follows the Joanna Briggs Institute methodology for ScR and reported according to PRISMA-ScR guidelines. A comprehensive search strategy will be performed in MEDLINE, EMBASE, Scopus and other relevant sources (date of last search: January, 15th 2025). We will include any studies that aim to provide structured definitions or conceptual frameworks to define and/or understand gender bias within healthcare clinical settings. Data will be charted using a standardized form to capture the characteristics of definitions, along with the healthcare population and contexts where gender bias has been described. Definitions will be described assessing their relevance from an analytical perspective and their potential for implementation. The findings will be summarized descriptively, with summary tables and figures to highlight key characteristics of the included studies.
Objective Therapeutic virtual reality (VR) is an emerging intervention in physiotherapy for patients with chronic low back pain (CLBP). However, broad adoption of VR by physiotherapists (PTs) is slow. This is possibly due to PT’s negative perceptions on and attitudes towards the added value of VR in physiotherapy for patients with CLBP. The aim of this study was to explore these perceptions and attitudes. Methods We performed a qualitative descriptive study using semi-structured interviews. The study sample included eleven primary care PTs with a median age of 35 years (range: 28-58). Participating PTs had at least one year of experience using VR for the treatment of patients with CLBP, after which they continued using VR or stopped using it. The interviews were transcribed verbatim and inductively analyzed using reflexive thematic analysis. Results Analysis of the interviews identified four overarching themes: (i) therapeutic VR is perceived as non-threatening to the PT’s role; (ii) VR has distinctive qualities that complement the PT’s toolbox; (iii) contrasting attitudes towards the added value of therapeutic VR for CLBP; and (iv) PTs need specific skills, positive attitudes and knowledge to administer therapeutic VR. Conclusion The study results showed that VR was perceived as a valuable and non-threatening innovation for physiotherapy in patients with CLBP, that fits the hands-off and coaching role of PTs. Therapeutic VR seems promising in physiotherapy for patients with CLBP, but further adoption depends on breaking practical and systemic barriers. Also, more education is needed to train PTs to effectively administer VR.
Objectives: To identify, critically appraise and evaluate the performance measures of the available prediction models for outcomes in people with low back pain (LBP) receiving conservative treatment. Study Design and Setting: In this systematic review, literature searches were conducted in Embase, Medline, and cumulative index of nursing and allied health literature from their inception until February 2024. Studies containing follow-up assessment (eg, prospective cohort studies, registry-based studies) investigating prediction models of outcomes (eg, pain intensity and disability) for people with LBP receiving conservative treatment were included. Two independent reviewers performed the study selection, the data extraction using the Checklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies, and risk of bias assessment using the Prediction model Risk of Bias Assessment. Findings of individual studies were reported narratively taking into account the discrimination and calibration measures of the prediction models. Results: Seventy-five studies developing or investigating the validity of 216 models were included in this review. Most prediction models investigated people receiving physiotherapy treatment and most models included sociodemographic variables, clinical features, and selfreported measures as predictors. The discriminatory capacity of the internal validity of the 27 prediction models for pain intensity varied greatly showing a c-statistic ranging from 0.48 to 0.94. Similarly, the discriminatory capacity for 31 models for disability had the same pattern showing a c-statistic ranging from 0.48 to 0.86. The calibration measures of the internal validity of the prediction models predicting pain intensity and disability showed to be adequate. Only one of 3 studies testing the external validity of models to predict pain intensity and disability and reported both discrimination and calibration measures, which showed to be inadequate. The prediction models predicting the secondary outcomes (eg, self-reported recovery, quality of life, return to work) showed varied performance measures for internal validity, and only 2 studies tested the external validity of models although they did not provide performance the performance measures. Conclusion: Several prediction models have been developed for people with LBP receiving conservative treatment; however, most show inadequate discriminatory validity. A few studies externally validated the prediction models and future studies should focus on testing this before implementing in clinical practice. (c) 2024 The Author(s). Published by Elsevier Inc. This is an open access article under the
Background: Multidisciplinary transitional care interventions aim to improve the coordination and continuity of healthcare during hospitalization and after discharge for patients with complex care needs related to physical, nutritional, or psychosocial status. Implementing such interventions is complex as they involve many stakeholders across multiple settings. Numerous studies have evaluated patients’, family members’, and healthcare professionals’ experiences with multidisciplinary transitional care interventions, which can provide insight into facilitators and barriers to their implementation. Objective: To provide an overview of facilitators and barriers to implementing multidisciplinary transitional care interventions, which could be considered before developing implementation strategies. Design: A qualitative systematic review using the Consolidated Framework for Implementation Research. Setting(s): Hospitals and primary care Participants: Adult patients admitted to a hospital, regardless of their diagnosis, as well as their family members and hospital and primary care healthcare professionals Methods: Embase, CINAHL, and Medline were searched for qualitative studies evaluating multidisciplinary transitional care interventions through patients', family members', and healthcare professionals' experiences and views from inception until June 2024. The methodological rigor was assessed with the Critical Appraisal Skills Program. We identified facilitators and barriers to the successful implementation of multidisciplinary transitional care interventions with the Consolidated Framework for Implementation Research. Facilitators and barriers were categorized into pre- or post-discharge or general factors. Results: Twelve studies were included and appraised. We identified 79 factors, mostly linked to three domains of the Consolidated Framework for Implementation Research: Innovation, Inner setting, and Individuals involved. Facilitators included ''comprehensive follow-up care needs assessment''(pre-discharge), ''immediate, tailored follow-up care''(post-discharge), and ''improved communication between stakeholders''(general). Barriers included ''shortage of hospital beds'' and ''lack of time''(pre-discharge), ''lack of available primary care professionals''(post-discharge), ''inconsistencies of stakeholders' schedules'' and ''intervention costs''(general). Conclusions: The factors identified could serve as a non-exhaustive inventory list to inspire readers who wish to implement a multidisciplinary transitional care intervention in their settings. Digital tools and alternative financing models might overcome cost and reimbursement issues, the increasing complexity of patient care, and shortcomings, such as the lack of available hospital beds or professionals. Further research should identify effective implementation strategies, considering the pre-, post-discharge, and general factors identified. Registration: The protocol was registered in PROSPERO (CRD42023421423). Tweetable abstract: Effective communication aids in implementing transitional care interventions, but patient care complexity and healthcare system pressures present challenges.
BACKGROUND CONTEXT: Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking. PURPOSE: To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (ie, usual care). STUDY DESIGN: Multicentre randomized controlled trial with economic evaluation and 1-year follow-up. PATIENT SAMPLE: Seventy-two adult patients on a waiting list for lumbar herniated disc surgery. OUTCOME MEASURES: Primary outcome was undergoing lumbar disc surgery during followup (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured. METHODS: Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38). RESULTS: Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95% CI, 0.02-0.35) and the adjusted risk ratio 0.29 (95% CI, 0.08-0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average 1,969, 1,754, and 2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (<= 0.66) across a range of willingness-to-pay values from 20,000/QALY to 80,000/ QALY, from a societal perspective. CONCLUSION: Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention. (c) 2025 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
OBJECTIVE: To assess the effectiveness of individual education for patients with chronic low back pain (CLBP), compared to no intervention, placebo, noneducational interventions, or other type of education. DESIGN: Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). LITERATURE SEARCH: PubMed, CINAHL, PEDro, Embase, and Scopus (up to January 14, 2024); citation tracking in Web of Science, grey literature and reference lists of previous systematic reviews. STUDY SELECTION CRITERIA: We included RCTs that evaluated individual patient education interventions for adults with CLBP. DATA SYNTHESIS: Random-effects meta-analysis for clinically homogeneous RCTs. We assessed risk of bias using the Cochrane Risk of Bias 2.0, and applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the certainty of evidence. RESULTS: We included 17 RCTs (n = 1893). There was moderate-certainty evidence that individual patient education had a clinically relevant effect compared to noneducational interventions on long-term disability (standardized mean difference, -0.23; 95% confidence interval [CI]: -1.13, 0.66). There was moderate-certainty evidence that individual patient education had no effect on short-term health-related quality of life compared to no intervention (mean difference, -0.003; 95% CI: -0.04, 0.04), and no effect on medium-term disability (SMD, 0.10; 95% CI: -0.37, 0.57) and long-term pain intensity (mean difference, -2.20; 95% CI: -14.43, 10.03) compared to noneducational interventions. CONCLUSION: Individual patient education provided a clinically relevant effect on long-term disability when compared to noneducational interventions. There were no other clinically relevant effects of individual patient education for CLBP. J Orthop Sports Phys Ther 2025;55(5):1-13. Epub 20 March 2025. doi:10.2519/jospt.2025.12794.
Objectives Chronic musculoskeletal pain (CMP) is a disabling condition, for which physiotherapy is a common treatment. Therapeutic virtual reality (VR) is an emerging treatment modality in physiotherapy care for patients with CMP. Treatment expectations of patients regarding therapeutic VR influence its effectiveness and could possibly be enhanced by the therapist by using positive language about therapeutic VR. The aim of the current studies was to explore the effect of physiotherapists explaining VR using positive versus neutral language, on treatment expectations of healthy participants (study 1) and patients with CMP (study 2). Methods Two web-based, double-blinded RCTs were conducted with two groups (healthy participants and patients with CMP), that were randomly allocated to a video explaining therapeutic VR using positive language or neutral language. The primary outcome measures were treatment credibility and expectancy, assessed at baseline and post-intervention. Between-group differences and within-group changes were respectively analyzed using simple linear regression analyses and repeated measures ANOVAs. All analyses were performed separately for healthy participants and patients with CMP. Results In total, 127 healthy participants (study 1) and 115 patients with CMP (study 2) were included and randomized. We found no between-group difference in treatment expectations between positive versus neutral language videos, neither in healthy participants nor patients with CMP. We found significant within-group changes for treatment expectations in both conditions (positive and neutral language) in healthy participants, and in the positive language condition only in the CMP group. Conclusions The studies show that any explanation of therapeutic VR (both using positive or neutral language) seems to improve treatment expectations. Unexpectedly, using positive language was not superior to using neutral language. Future research should examine strategies for healthcare providers to set optimal treatment expectations on therapeutic VR in patients with CMP. Practice implications A brief verbal explanation about therapeutic VR improves treatment expectations in both healthy participants and patients with CMP.
BACKGROUND:Multidisciplinary transitional care interventions promote care coordination after hospital discharge and address (older) patients' complex care needs related to their physical, nutritional, and/or psychosocial status. OBJECTIVE:This review aimed to identify, critically appraise, and synthesize evidence on the cost-effectiveness of multidisciplinary transitional care interventions compared to usual care. DESIGN:Systematic review and meta-analysis. SETTING(S):Hospitals and primary care. PARTICIPANTS:Adult patients admitted to a hospital, regardless of their condition, and discharged home. METHODS:Medline, Embase, CINAHL, and CENTRAL were searched for randomized controlled trials assessing multidisciplinary transitional care interventions' cost-effectiveness compared to usual care and reporting quality of life or quality-adjusted life years (QALY) from inception to July 2024. Findings were stratified by economic perspective and follow-up duration. Evidence certainty was assessed using Grading of Recommendations Assessment, Development, and Evaluation. The primary outcome was the incremental net monetary benefit (expressed as mean difference). Cost-effectiveness acceptability curves depicted probabilities of cost-effectiveness at various willingness-to-pay thresholds. RESULTS:Thirteen trials, containing 4114 patients, were included. From a healthcare perspective over 12 months, there was "low" certainty that multidisciplinary transitional care interventions reduced healthcare costs (MD, €-3452; 95 % CI, -8816 to 1912) while there was no difference in QALYs (MD, 0.00; 95 % CI, -0.03 to 0.04) compared to usual care. The probability of cost-effectiveness over 12 months was 90 % at a willingness-to-pay of €0/QALY, decreasing slightly to 84 % at higher willingness-to-pay thresholds ("moderate" certainty). Over six months, cost-effectiveness probabilities ranged from 43 % at €0/QALY to 87 % at €100,000/QALY, exceeding 80 % at a willingness to pay of €50,000/QALY ("low" to "moderate" certainty). From a societal perspective, the probabilities of cost-effectiveness were lower, primarily due to a limited number of studies with conflicting results. CONCLUSIONS:Multidisciplinary transitional care interventions demonstrate potential for cost-effectiveness. However, the "low" evidence certainty of most comparisons underscores the need for further research to explore the cost-effectiveness of different types of multidisciplinary transitional care interventions across patient populations and country income levels to identify the most cost-effective strategies. REGISTRATION:The review protocol was registered on PROSPERO, CRD42023421423.
BACKGROUND:Low back pain (LBP) is a disabling condition affecting all age groups globally. Exercise is safe and cost-effective for managing LBP. Pilates is an effective exercise modality recommended for LBP but is not reimbursed by the Brazilian Public Health System. This study aimed to estimate the budget impact of implementing Pilates for LBP patients within the Brazilian public health system compared to usual care. RESEARCH DESIGN AND METHODS:A budget impact analysis (BIA) was conducted over a five-year horizon, from healthcare and societal perspectives. Costs were extracted in local currency and converted to international dollars using purchasing power parities. Deterministic sensitivity analyses were performed. RESULTS:Over five years, healthcare costs in the usual care were Int$860.8 million, while Pilates reached Int$958 million, resulting in an incremental impact of Int$97.2 million. From the societal perspective, the usual care cost was Int$4.32 billion, and the Pilates scenario was Int$4.15 billion, indicating savings of Int$172.2 million. The incremental budget impact was negative, meaning that Pilates would provide savings of Int$172,203,216. CONCLUSION:Implementing a group-based Pilates program for LBP in the Brazilian public health system would increase healthcare costs by Int$97 million but generate societal savings of Int$172 million over five years.
Chronic non-specific low back pain (CNLBP) is a prevalent and costly condition that encourages research into self-management strategies. Mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. The aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with CNLBP. A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. Adults aged between 18 and 59 years and with self-reported LBP > 12 weeks will be included. Following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: (1) mhealth; (2) Conventional exercise delivered through a booklet. Outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. The primary clinical outcome is disability (Roland-Morris Disability Questionnaire), while secondary outcomes include pain (NRS), utility (Eq. 5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) to detect a 2-point between-groups difference on disability. A cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes. While mhealth applications show promise as interventions for people with LBP, there is still a gap regarding the type of delivery and personalisation strategies. This study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost-)effective. Trial registration: NCT06651099 (registration date 21/10/2024).
BACKGROUND AND OBJECTIVES:Multidisciplinary transitional care interventions (MTCIs) ensure care coordination and continuity after hospital discharge while addressing (older) patients' complex care needs related to their physical, nutritional, cognitive, and/or psychological status. This study aimed to identify, critically appraise, and synthesize the current body of evidence investigating the effectiveness of such interventions. RESEARCH DESIGN AND METHODS:Medline, Embase, CINAHL, and CENTRAL were searched for randomized controlled trials assessing MTCIs' impact on readmissions, mortality, and health-related outcomes from inception to July 2024. Risk of bias was evaluated with the Risk of Bias-2 tool. Subgroup analyses assessed whether different intervention types affected outcomes differently. The certainty of the evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation approach and the credibility of subgroup analyses with the Instrument to evaluate the Credibility of Effect Modification Analyses. RESULTS:Forty-nine trials involving 25,566 patients were included. There was low certainty that MTCIs reduced readmissions (relative risk [RR] = 0.88; 95% confidence intervals [95% CI] = 0.80 to 0.96) and high certainty for reduced mortality (RR = 0.92; 95% CI = 0.84 to 1.01). There was low to moderate certainty that MTCIs improved physical quality of life (standardized mean difference [SMD] = 0.54; 95% CI = -0.06 to 1.15), mental quality of life (SMD = 0.44; 95% CI = -0.08 to 0.96), patient satisfaction (SMD = 0.49; 95% CI = -0.14 to 1.12), and physical performance (SMD = 0.49; 95% CI = -0.11 to 1.10). Subgroup analysis revealed a larger and statistically significant effect on physical performance in more complex interventions (SMD = 0.83; 95% CI = 0.02 to 1.65). DISCUSSION AND IMPLICATIONS:These findings suggest that MTCIs can reduce readmissions and mortality while improving quality of life and physical performance. Further investigations should focus on tailoring MTCIs to specific contexts to maximize their impact.