First-line treatment for femoroacetabular impingement syndrome and hip-related quality of life: study protocol for a multicentre randomised controlled trial comparing a 6-month supervised strength exercise intervention to usual care (the Better Hip Trial).

INTRODUCTION: Femoroacetabular impingement syndrome (FAIS) is a motion-related and position-related clinical condition of the hip associated with pain, reduced physical function and hip-related quality of life (QoL). Interestingly, higher maximal muscle strength is associated with less pain, better physical function and improved QoL in people with FAIS. Furthermore, preliminary evidence suggests that a proportion of patients with FAIS respond positively to strength exercise as first-line treatment. Nonetheless, there is little evidence supporting a specific exercise intervention offered as a first-line treatment. We will conduct a randomised controlled trial investigating the clinical effectiveness and cost-effectiveness of a 6-month strength exercise intervention compared with usual care as first-line treatment in patients with FAIS. METHODS AND ANALYSIS: This is a multicentre randomised controlled trial that will be conducted at hospitals and physiotherapy clinics across Denmark and Australia. A total of 120 patients with FAIS will be randomised (1:1) to 6 months of supervised strength exercise or usual care. The primary outcome is the change in hip-related QoL measured using the International Hip and Outcome Tool 33 (iHOT-33) from baseline to the end of intervention. A health economic evaluation will be conducted from a societal and healthcare perspective based on the data collection over a 12-month period starting at baseline. The analysis will calculate incremental cost-effectiveness ratios using quality-adjusted life-years and iHOT-33 scores while estimating costs using microcosting and cost questionnaires. Secondary outcomes include objectively measured physical function at baseline and after 6 months and patient-reported outcomes measured at baseline, 3-month, 6-month and 12-month follow-up. ETHICS AND DISSEMINATION: The trial has been approved by the Committee on Health Research Ethics in the Central Denmark Region (journal no 1-10-72-45-23) and La Trobe University Human Ethics Committee (HEC24042) and is registered at the Central Denmark Region List of Research Projects (journal no 1-16-02-115-23). Informed consent will be obtained from each participant before randomisation. Results will be published in international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05927935.

Cost of out-of-hospital cardiac arrest survivors compared with matched control groups.

INTRODUCTION: Societal costs of out-of-hospital cardiac arrest (OHCA) survivors may be extensive due to high health care utilization and sick leave. Knowledge of the costs of OHCA survivors may guide decision-makers to prioritize health resources. AIM: The aims of the study were to evaluate the costs of OHCA survivors from a societal perspective, and to compare these costs to the costs of individuals with non-cardiac arrest myocardial infarction (MI) and individuals with no cardiac disease (non-CD). METHODS: From the Danish OHCA Registers, survivors, with a cardiac arrest between 2005-2018 were identified. Each case was assigned one MI control and one non-CD control, matched on gender and age. Based on register data, costs of healthcare utilization, sick leave, vocational rehabilitation, disability pension and other social benefits one year before event and five years after, were estimated. RESULTS: In total 5,646 OHCA survivors were identified with associated control groups. The mean costs for OHCA survivors during the 6-year period were €119,106 (95%CI: 116,297-121,916), with €83,472 (95%CI: 81,392-85,552) being healthcare costs. Mean costs of OHCA survivors were €49,132 higher than the MI-control group and €100,583 higher than the non-CD control group. CONCLUSIONS: Total costs of OHCA survivors were considerably higher than costs of MI- and non-CD controls. Hospital costs were highest during the first year after event, and work inability during the second to fifth year with sick leave and later disability pension as main burdens.

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.

Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation.

OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders. METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months. RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90). CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).

Prognostic factors for high societal costs: a register-based study on 561,665 patients with shoulder disorders.

ABSTRACT: Shoulder disorders are common and associated with high societal costs, especially for a small group of patients. Prognostic factors can help identify high-cost patients, which is crucial to optimize early identification and develop tailored interventions. We aimed to identify prognostic factors for high societal costs, to examine whether the prognostic factors were similar for high healthcare costs and high costs of sick leave, and to investigate the model's robustness across 4 diagnostic categories. Using national Danish registers, potential prognostic factors (age, sex, educational level, long-term sick leave, admission, visits to general practitioner and physiotherapist, comorbidity, diabetes, low back pain, and neck pain) were included in a logistic regression model with high societal costs, defined by the top 10th percentile, as the main outcome. The model's prognostic accuracy was assessed using the Nagelkerke R2 and its discriminative ability using area under the receiver operating curve (AUC). Data on 80% of the patients (n = 449,302) were used to develop the model and 20% (n = 112,363) to validate the model. By far the strongest prognostic factor for high societal costs and high costs of sick leave was sick leave at the time of diagnosis (OR: 20.2, 95% CI: 19.5-20.9). Prognostic factors for high healthcare costs were high age, comorbidity, and hospital admission the year before diagnosis. The model was robust across diagnostic categories and sensitivity analyses. In the validation sample, the primary model's discriminative ability was good (AUC = 0.80) and the model explained 28% of the variation in the outcome (Nagelkerke R2 ).

Cost-effectiveness of occupational therapy return-to-work interventions for people with mental health disorders: A systematic review.

BACKGROUND: Return-to-work (RTW) resources for persons with mental health disorders are limited and costs are typically shared by several stakeholders in society. Occupational therapists (OT) provide RTW interventions for this target group, however, increased knowledge of health, and employment effects, as well as costs are needed to better inform decision makers in their prioritisations. AIMS/OBJECTIVES: To identify and summarise evidence of cost-effectiveness of RTW interventions for persons with mental health disorders which OTs provide. MATERIALS AND METHODS: A systematic search was applied and resulted in 358 articles. After screening, nine articles met inclusion criteria and were reviewed. Quality assessment was conducted using the economic evaluation tool by Joanna Briggs Institute. RESULTS: Supported employment, Individual Placement and Support was cost-effective in several contexts while three studies showed larger effects and higher costs. An OT intervention added to treatment for major depression was indicated to be cost-beneficial and an advanced supported employment was cost-saving. The methodological quality varied considerably between studies. CONCLUSIONS AND SIGNIFICANCE: The results of the included studies are promising, however, to further strengthen the economic perspective in OT RTW interventions, the need for conducting more and methodologically robust economic evaluations is crucial in future studies.

Cost-effectiveness of specialised manual therapy versus orthopaedic care for musculoskeletal disorders: long-term follow-up and health economic model.

Background: Physiotherapy is usually the first line of treatment for musculoskeletal disorders. If pain persists, an appointment with an orthopaedic surgeon is indicated, but many disorders for which patients are placed on orthopaedic waiting lists cannot be treated in an orthopaedic clinic. Specialised manual therapy, although not mainstream, can be an effective alternative to orthopaedic care, although its cost-effectiveness beyond 12 months is unknown. Objectives: To perform an 8-year follow-up of the quality of life and costs of specialised manual therapy versus standard orthopaedic care for working-age patients with common nonsurgical musculoskeletal disorders referred to orthopaedic surgeons and to develop a health economic model. Design: Cost-effectiveness study using Markov modelling. Methods: The index group of a previously published pragmatic randomised controlled trial received a maximum of five treatment sessions of specialised manual therapy, while the control group received orthopaedic 'care as usual'. At 3, 6, 12 and 96 months, Health-Related Quality of Life and costs were measured with Short Form Health Survey 36, Short Form Health Survey 6D and Diagnostic Related Groups. An incremental cost-effectiveness ratio was calculated, a Markov model was developed and a sensitivity analysis was performed. Results: Overall, 95% (n = 75) of the participants completed the 8-year follow-up. Recovery rates during the first 3 months ('per protocol') in the index and control group were 69% and 58%, respectively. The index group had 0.159 more gains in quality-adjusted life years and cost 40,270 SEK (€4027) less per patient over 8 years. The sensitivity analysis results were consistent with the main results. Conclusion: Specialised manual therapy dominated standard care after 8 years. The results of this small but very first study are promising; therefore, further exploration within other health care professions, clinics and/or countries is required. Our study raises questions about the triaging of orthopaedic outpatients, cost-effectiveness and resource allocation. Registration: Not applicable per the information provided by ClinicalTrials.gov. Plain Language Summary: Specialised manual therapy is more cost-effective than 'care as usual' for working-age patients referred to an orthopaedist. This study provides an 8-year follow-up of the cost effects and quality of life of a previously published trial. Why was this study conducted? The standard care for musculoskeletal pain consists of exercises with a physiotherapist in primary care. If the pain persists, a referral to an orthopaedic clinic is often made. Many of these referrals are inappropriate because they concern pain from muscles and joints that do not benefit from surgery or the resources available in an orthopaedic clinic. There is a gap in competence and treatment between primary and specialised care that is costly, time- and resource-consuming and causes prolonged patient suffering. Although specialised manual therapy (MT) is effective, its use is not mainstream. Costs and effects after more than 12 months of treatment that may shorten waiting lists have never been evaluated. What did the researchers do? Quality of life and costs were compared in 75 patients with nonsurgical disorders referred to orthopaedic surgeons at 8 years after treatment with specialised MT or standard orthopaedic care. A health economics model for the probability of recovery was also developed and tested. What did the researchers find? Compared with the control group, the study participants treated with specialised MT had a better quality of life, required fewer health care interventions, underwent less surgery, incurred significantly lower costs and demonstrated an increased probability of recovery. What do these findings mean? It seems probable that using specialised MT for an old, well-known structural problem may yield better treatment effects at a significantly lower cost. Our study findings suggest that policy recommendations should focus on costs and effects rather than resource utilisation alone. The study is small and requires expansion using its economic health model.

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.

Reliability and responsiveness of the Danish version of The Chelsea Critical Care Physical Assessment tool (CPAx).

INTRODUCTION: Measurement instruments are important in clinical practice and research for assessing physical function in critically ill patients in the intensive care unit (ICU). OBJECTIVE: To investigate inter-rater reliability and responsiveness of the Danish version of the CPAx (CPAx-D). METHOD: Critically ill patients from three Danish ICUs were included. Patients were assessed with CPAx-D by two blinded testers during a regular physiotherapy session. Follow-up tests were performed in patients who stayed in the ICU for more than 24 hours, were not transferred to another hospital or received palliative care. Floor and ceiling effects were examined in all assessments.Results For the reliability analysis 66 patients were included.Results Showed no significant difference between raters. For the total score, intra class correlation coefficient (ICC) was 0.996 (95% CI: 0.993; 0.997), standard error of measurement was 0.72 point and minimal detectable change 2.0 points. Bland-Altman plot revealed no heteroscedacity. The responsiveness results of 24 patients showed that the effect size was 1.2 and the standardized response mean 1.1, which was in accordance with the hypothesis. No ceiling or floor effect was revealed. CONCLUSION: The CPAx-D showed excellent inter-rater reliability and responsiveness.

A scoping review of statistical methods for trial-based economic evaluations: The current state of play.

The statistical quality of trial-based economic evaluations is often suboptimal, while a comprehensive overview of available statistical methods is lacking. Therefore, this review summarized and critically appraised available statistical methods for trial-based economic evaluations. A literature search was performed to identify studies on statistical methods for dealing with baseline imbalances, skewed costs and/or effects, correlated costs and effects, clustered data, longitudinal data, missing data and censoring in trial-based economic evaluations. Data was extracted on the statistical methods described, their advantages, disadvantages, relative performance and recommendations of the study. Sixty-eight studies were included. Of them, 27 (40%) assessed methods for baseline imbalances, 39 (57%) assessed methods for skewed costs and/or effects, 27 (40%) assessed methods for correlated costs and effects, 18 (26%) assessed methods for clustered data, 7 (10%) assessed methods for longitudinal data, 26 (38%) assessed methods for missing data and 10 (15%) assessed methods for censoring. All identified methods were narratively described. This review provides a comprehensive overview of available statistical methods for dealing with the most common statistical complexities in trial-based economic evaluations. Herewith, it can provide valuable input for researchers when deciding which statistical methods to use in a trial-based economic evaluation.

Cost-effectiveness and return-on-investment of C-reactive protein point-of-care testing in comparison with usual care to reduce antibiotic prescribing for lower respiratory tract infections in nursing homes: a cluster randomised trial.

OBJECTIVES: C-reactive protein point-of-care testing (CRP POCT) is a promising diagnostic tool to guide antibiotic prescribing for lower respiratory tract infections (LRTI) in nursing home residents. This study aimed to evaluate cost-effectiveness and return-on-investment (ROI) of CRP POCT compared with usual care for nursing home residents with suspected LRTI from a healthcare perspective. DESIGN: Economic evaluation alongside a cluster randomised, controlled trial. SETTING: 11 Dutch nursing homes. PARTICIPANTS: 241 nursing home residents with a newly suspected LRTI. INTERVENTION: Nursing home access to CRP POCT (POCT-guided care) was compared with usual care without CRP POCT (usual care). MAIN OUTCOME MEASURES: The primary outcome measure for the cost-effectiveness analysis was antibiotic prescribing at initial consultation, and the secondary outcome was full recovery at 3 weeks. ROI analyses included intervention costs, and benefits related to antibiotic prescribing. Three ROI metrics were calculated: Net Benefits, Benefit-Cost-Ratio and Return-On-Investment. RESULTS: In POCT-guided care, total costs were on average €32 higher per patient, the proportion of avoided antibiotic prescribing was higher (0.47 vs 0.18; 0.30, 95% CI 0.17 to 0.42) and the proportion of fully recovered patients statistically non-significantly lower (0.86 vs 0.91; -0.05, 95% CI -0.14 to 0.05) compared with usual care. On average, an avoided antibiotic prescription was associated with an investment of €137 in POCT-guided care compared with usual care. Sensitivity analyses showed that results were relatively robust. Taking the ROI metrics together, the probability of financial return was 0.65. CONCLUSION: POCT-guided care effectively reduces antibiotic prescribing compared with usual care without significant effects on recovery rates, but requires an investment. Future studies should take into account potential beneficial effects of POCT-guided care on costs and health outcomes related to antibiotic resistance. TRIAL REGISTRATION NUMBER: NL5054.

Costs of shoulder disorders in Denmark: a nationwide cost-of-illness study investigating 617,334 patients and matched controls.

ABSTRACT: Shoulder disorders are very common musculoskeletal conditions. Few studies have focused on the costs associated with shoulder disorders, and the economic burden has never been established in a nationwide cost-of-illness study. We aimed to evaluate the healthcare costs and costs of productivity loss (sick leave) and to evaluate if costs were higher for specific subgroups. Using national Danish registers, we identified individuals with shoulder disorders (subacromial pain, stiffness, fracture, or dislocation) diagnosed between 2005 and 2017 and controls matched on age and gender without shoulder disorders. Health care usage, sick leave, and related costs were estimated. During the 13-year inclusion period, 617,334 unique individuals were identified and the incidence rate was 1215 per 100,000 person-years in 2017. The expected additional societal costs were €1.21 billion annually. The mean additional total costs for the 6-year period were €11,334 (11,014-11,654) for individuals aged ≥65 years and €25,771 (25,531-26,012) for individuals aged <65 years. For individuals in the working age, the costs of sick leave accounted for approximately 70% of the total costs. Individuals aged ≥65 years had healthcare costs that were twice as high as individuals aged <65 years. Additionally, the 20% of cases accruing the highest costs accounted for 66% of the total costs. In conclusion, incidence rates of shoulder disorders were high and costs of sick leave accounted for a large proportion of total costs associated with illness in working age people. Furthermore, a minority of patients accounted for a substantial share of the total costs.

Electrical stimulation to prevent recurring pressure ulcers in individuals with a spinal cord injury compared to usual care: the Spinal Cord Injury PREssure VOLTage (SCI PREVOLT) study protocol.

BACKGROUND: Pressure ulcers (PUs) on the buttocks are among the most common secondary complications in individuals with chronic spinal cord injury (SCI). PUs can result from sitting for extended periods, disuse atrophy, increased sitting pressure and reduced circulation. Compared with usual care, activation of paralysed muscles using electrical stimulation (ES) has been shown to markedly increase paralysed muscle mass, improve circulation of skin and muscle and improve sitting pressure distribution. ES might therefore be a useful method to reduce PU incidence. METHODS: A multicentre randomized controlled trial (SCI PREVOLT) will be conducted with an economic and process evaluation alongside. One hundred participants with a SCI in the chronic phase and a minimal incidence of 1 PU in the last 5 years will be recruited from rehabilitation centres across the Netherlands. Participants will be stratified by centre and age and randomized to the intervention or control group. The intervention group will use ES at least 1 h/day during at least 4 times a week for 1 year next to usual care. The control group will only receive usual care. The primary outcome is the incidence of PUs, measured by a blinded person assessing the presence or absence of a PU on the buttocks on a photo made by the participant or his/her caregiver. The incidence of a PU will be evaluated every 2 weeks. Secondary outcomes include interface pressure distribution, blood flow in the profunda femoris artery, muscle thickness of the hamstrings and gluteal muscles and questionnaires about different dimensions of life, e.g. participation and quality of life. Secondary outcomes will be measured at baseline and 3, 6, 9 and 12 months after randomization. DISCUSSION: This study will assess if electrical stimulation is a (cost-)effective method to prevent PUs and reduce the risk factors of getting PUs. If ES is effective and cost-effective compared with usual care, ES could be implemented in daily treatment of individuals with a SCI. TRIAL REGISTRATION: Netherlands Trials Register NTR NL9469 . Registered on 26 May 2021.

Cost-effectiveness of full endoscopic versus open discectomy for sciatica.

OBJECTIVE: To assess the costs and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) compared with open microdiscectomy among patients with sciatica. METHODS: This economic evaluation was conducted alongside a 12-month multicentre randomised controlled trial with a non-inferiority design, in which patients were randomised to PTED or open microdiscectomy. Patients were aged from 18 to 70 years and had at least 6 weeks of radiating leg pain caused by lumbar disc herniation. Effect measures included leg pain and quality-adjusted life years (QALYs), as derived using the EQ-5D-5L. Costs were measured from a societal perspective. Missing data were multiply imputed, bootstrapping was used to estimate statistical uncertainty, and various sensitivity analyses were conducted to determine the robustness. RESULTS: Of the 613 patients enrolled, 304 were randomised to PTED and 309 to open microdiscectomy. Statistically significant differences in leg pain and QALYs were found in favour of PTED at 12 months follow-up (leg pain: 6.9; 95% CI 1.3 to 12.6; QALYs: 0.040; 95% CI 0.007 to 0.074). Surgery costs were higher for PTED than for open microdiscectomy (ie, €4500/patient vs €4095/patient). All other disaggregate costs as well as total societal costs were lower for PTED than for open microdiscectomy. Cost-effectiveness acceptability curves indicated that the probability of PTED being less costly and more effective (ie, dominant) compared with open microdiscectomy was 99.4% for leg pain and 99.2% for QALYs. CONCLUSIONS: Our results suggest that PTED is more cost-effective from the societal perspective compared with open microdiscectomy for patients with sciatica. TRIAL REGISTRATION NUMBER: NCT02602093.

Can EQ-5D-3L utility values of low back pain patients be validly predicted by the Oswestry Disability Index for use in cost-effectiveness analyses?

PURPOSE: To assess whether regression modeling can be used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in low back pain (LBP) patients for use in cost-effectiveness analysis. METHODS: EQ-5D-3L utility values of LBP patients were estimated using their ODI scores as independent variables using regression analyses, while adjusting for case-mix variables. Six different models were estimated: (1) Ordinary Least Squares (OLS) regression, with total ODI score, (2) OLS, with ODI item scores as continuous variables, (3) OLS, with ODI item scores as ordinal variables, (4) Tobit model, with total ODI score, (5) Tobit model, with ODI item scores as continuous variables, and (6) Tobit model, with ODI item scores as ordinal variables. The models' performance was assessed using explained variance (R2) and root mean squared error (RMSE). The potential impact of using predicted instead of observed EQ-5D-3L utility values on cost-effectiveness outcomes was evaluated in two empirical cost-effectiveness analysis. RESULTS: Complete individual patient data of 18,692 low back pain patients were analyzed. All models had a more or less similar R2 (range 45-52%) and RMSE (range 0.21-0.22). The two best performing models produced similar probabilities of cost-effectiveness for a range of willingness-to-pay (WTP) values compared to those based on the observed EQ-5D-3L values. For example, the difference in probabilities ranged from 2 to 5% at a WTP of 50,000 €/QALY gained. CONCLUSION: Results suggest that the ODI can be validly used to predict low back pain patients' EQ-5D-3L utility values and QALYs for use in cost-effectiveness analyses.

Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial.

BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely. METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed. DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.

Interpretation of trial-based economic evaluations of musculoskeletal physical therapy interventions.

BACKGROUND: As resources for healthcare are scarce, decision-makers increasingly rely on economic evaluations when making reimbursement decisions about new health technologies, such as drugs, procedures, devices, and equipment. Economic evaluations compare the costs and effects of two or more interventions. Musculoskeletal disorders have a high prevalence and result in high levels of disability and high costs worldwide. Because physical therapy interventions are usually the first line of treatment for musculoskeletal disorders, economic evaluations of such interventions are becoming increasingly important for stakeholders in the field of physical therapy, including physical therapists, decision-makers, and reseachers. However, economic evaluations are relatively difficult to interpret for the majority of stakeholders. OBJECTIVE: To support physical therapists, decision-makers, and researchers in the field of physical therapy interpreting trial-based economic evaluations and translating the results of such studies to clinical practice. METHODS: The design, analysis, and interpretation of economic evaluations performed alongside randomized controlled trials are discussed. To further illustrate and explain these concepts, we use a case study assessing the cost-effectiveness of exercise therapy compared to standard advice in patients with musculoskeletal disorders. CONCLUSIONS: Economic evaluations are increasingly being used in healthcare decision-making. Therefore, it is of utmost importance that their design, conduct, and analysis are state-of-the-art and that their interpretation is adequate. This masterclass will help physical therapists, decision-makers, and researchers in the field of physical therapy to critically appraise the quality and results of trial-based economic evaluations and to apply the results of such studies to their own clinical practice and setting.

The statistical approach in trial-based economic evaluations matters: get your statistics together!

BACKGROUND: Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. METHODS: Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. RESULTS: In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to - 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively. CONCLUSIONS: Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.

Measurement Properties of Isokinetic Dynamometry for Assessment of Shoulder Muscle Strength: A Systematic Review.

OBJECTIVE: To investigate the evidence of measurement properties of isokinetic dynamometry (ID) for assessment of shoulder muscle strength in healthy individuals and patients with nonneurologic shoulder pathology. DATA SOURCES: Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and Physiotherapy Evidence Database were searched up to February 2020 without restrictions. Reference lists and citations were hand-searched. STUDY SELECTION: Two review authors independently included studies that met the following criteria: (1) evaluated measurement properties of ID when used on the glenohumeral joint and (2) included individuals 18 years and older. Studies including patients with neurologic, neuromuscular, or systemic diseases or critical illness were excluded. DATA EXTRACTION: The quality assessment and data synthesis were performed according to the COnsensus-based Standards for the selection of health Measurement INstruments methodology. DATA SYNTHESIS: Twenty-one studies with a total of 597 participants were included. The results were combined separately for isometric, concentric, and eccentric test mode; for the velocities 30°/s-60°/s, 90°/s, 120°/s, and 240°/s; for the seated, supine, and standing position; and for internal rotation (IR), external rotation (ER), and the ER/IR ratio. The reliability of ID was overall sufficient with the majority of intraclass correlation coefficients ≥0.70. The quality of evidence was moderate or low for 20 of 30 strata examined. The measurement error results were rated as insufficient for all strata. The SEM ranged from 4%-28%. The quality of evidence varied depending of strata examined. CONCLUSIONS: The reliability of ID for measurement of shoulder strength was overall sufficient for all positions, velocities, and modes of strength. The measurement error was not sufficient. Because most studies used the seated position, the velocities 30°/s-60°/s or 120°/s, and the concentric test mode, the quality of evidence was highest for these conditions.

Assessing the Impact of EQ-5D Country-specific Value Sets on Cost-utility Outcomes.

PURPOSE: To assess the impact of EQ-5D country-specific value sets on cost-utility outcomes. METHODS: Data from 2 randomized controlled trials on low back pain (LBP) and depression were used. 3L value sets were identified from the EuroQol Web site. A nonparametric crosswalk was employed for each tariff to obtain the likely 5L values. Differences in quality-adjusted life years (QALYs) between countries were tested using paired t tests, with United Kingdom as reference. Cost-utility outcomes were estimated for both studies and both EQ-5D versions, including differences in QALYs and cost-effectiveness acceptability curves. RESULTS: For the 3L, QALYs ranged between 0.650 (Taiwan) and 0.892 (United States) in the LBP study and between 0.619 (Taiwan) and 0.879 (United States) in the depression study. In both studies, most country-specific QALY estimates differed statistically significantly from that of the United Kingdom. Incremental cost-effectiveness ratios ranged between &OV0556;2044/QALY (Taiwan) and &OV0556;5897/QALY (Zimbabwe) in the LBP study and between &OV0556;38,287/QALY (Singapore) and &OV0556;96,550/QALY (Japan) in the depression study. At the NICE threshold of &OV0556;23,300/QALY (≈£20,000/QALY), the intervention's probability of being cost-effective versus control ranged between 0.751 (Zimbabwe) and 0.952 (Taiwan) and between 0.230 (Canada) and 0.396 (Singapore) in the LBP study and depression study, respectively. Similar results were found for the 5L, with extensive differences in ICERs and moderate differences in the probability of cost-effectiveness. CONCLUSIONS: This study indicates that the use of different EQ-5D country-specific value sets impacts on cost-utility outcomes. Therefore, to account for the fact that health state preferences are affected by sociocultural differences, relevant country-specific value sets should be used.