A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial.

Timely detection and treatment of postpartum hemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide objective, accurate and early diagnosis of PPH, and a treatment bundle can address delays or inconsistencies in the use of effective interventions. Here we conducted an economic evaluation alongside the E-MOTIVE trial, an international, parallel cluster-randomized trial with a baseline control phase involving 210,132 women undergoing vaginal delivery across 78 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania. We aimed to assess the cost-effectiveness of the E-MOTIVE intervention, which included a calibrated blood-collection drape for early detection of PPH and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation), compared with usual care. We used multilevel modeling to estimate incremental cost-effectiveness ratios from the perspective of the public healthcare system for outcomes of cost per severe PPH (blood loss ≥1,000 ml) avoided and cost per disability-adjusted life-year averted. Our findings suggest that the use of a calibrated blood-collection drape for early detection of PPH and bundled first-response treatment is cost-effective and should be perceived by decision-makers as a worthwhile use of healthcare budgets. ClinicalTrials.gov identifier: NCT04341662 .

Erratum to "Exploring the cost-effectiveness of high versus low perioperative fraction of inspired oxygen in the prevention of surgical site infections among abdominal surgery patients in three low- and middle-income countries" [BJA Open 7 (2023) 100207].

[This corrects the article DOI: 10.1016/j.bjao.2023.100207.].

Erratum to 'Exploring the cost-effectiveness of high versus low perioperative fraction of inspired oxygen in the prevention of surgical site infections among abdominal surgery patients in three low- and middle-income countries' [BJA Open 7 (2023) 100207].

[This corrects the article DOI: 10.1016/j.bjao.2023.100207.].

The cost-effectiveness of adding an ultrasound corticosteroid and local anaesthetic injection to advice and education for hip osteoarthritis.

OBJECTIVES: Evidence for the comparative cost-effectiveness of intra-articular corticosteroid injection in people with hip osteoarthritis (OA) remains unclear. This study investigated the cost-effectiveness of best current treatment (BCT) comprising advice and education plus a single ultrasound-guided intra-articular hip injection (USGI) of 40 mg triamcinolone acetonide and 4 ml 1% lidocaine hydrochloride (BCT+US-T) versus BCT alone. METHODS: A trial-based cost-utility analysis of BCT+US-T compared with BCT was undertaken over 6 months. Patient-level cost data were obtained, and effectiveness was measured in terms of quality-adjusted life years (QALYs), allowing the calculation of cost per QALY gained from a United Kingdom (UK) National Health Service (NHS) perspective. RESULTS: BCT+US-T was associated with lower mean NHS costs (BCT+US-T minus BCT: £-161.6, 95% CI: £-583.95 to £54.18) and small but significantly higher mean QALYs than BCT alone over 6 months (BCT+US-T minus BCT: 0.0487, 95% CI: 0.0091, 0.0886). In the base case, BCT+US-T was the most cost-effective and dominated BCT alone. Differences in total costs were driven by number of visits to NHS consultants, private physiotherapists, and chiropractors, and hip surgery, which were more common with BCT alone than BCT+US-T. CONCLUSION: Intra-articular corticosteroid injection plus BCT (BCT+US-T) for patients with hip OA results in lower costs and better outcomes, and is highly cost-effective, compared with BCT alone. TRIAL REGISTRATION: EudraCT: 2014-003412-37 (August 8, 2015) and registered with Current Controlled Trials: ISRCTN 50550256 (July 28, 2015). TRIAL PROTOCOL: Full details of the trial protocol can be found in the Supplementary Appendix, available with the full text of this article at https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2153-0#citeas. DOI: doi.org/10.1186/s12891-018-2153-0.

Economic burden of dengue in urban Bangladesh: A societal perspective.

BACKGROUND: Dengue, a vector-borne disease, is a major public health problem in many tropical and subtropical countries including Bangladesh. The objective of this study is to estimate the societal cost of illness of dengue infections among the urban population in Dhaka, Bangladesh. METHODS: A cost-of-illness study was conducted using a prevalence-based approach from a societal perspective. Costs attributable to dengue were estimated from a bottom-up strategy using the guideline proposed by the World Health Organization for estimating the economic burden of infectious diseases. RESULTS: A total of 302 hospitalized confirmed dengue patients were enrolled in this study. The average cost to society for a person with a dengue episode was US$ 479.02. This amount was ranged between US$ 341.67 and US$ 567.12 for those patients who were treated at public and private hospitals, respectively. The households out-of-pocket cost contributed to a larger portion of the total costs of illness (66%) while the cost burden was significantly higher for the poorest households than the richest quintile. CONCLUSIONS: Dengue disease imposes a substantial financial burden on households and society. Therefore, decision-makers should consider the treatment cost of dengue infections, particularly among the poor in the population while balancing the benefits of introducing potentially effective dengue preventive programs in Bangladesh.

A Prospective, Observational Cost Comparison of Laparoscopic and Open Appendicectomy in Three Tertiary Hospitals in Nigeria.

BACKGROUND: The clinical benefits of laparoscopic appendicectomy are well recognized over open appendicectomy. However, laparoscopic procedures are not frequently conducted in many low-and middle-income countries (LMICs) for several reasons, including perceived higher costs. The aim of this study was to assess the feasibility and cost of laparoscopic appendicectomy compared to open appendicectomy in Nigeria. METHODS: A multicenter, prospective, cohort study among patients undergoing appendicectomy was conducted at three tertiary hospitals in Nigeria. Data were collected from October 2020 to February 2022 and analyses compared the average healthcare costs at 30 days after surgery. Quantile regression was conducted to identify variables that had an impact on the costs, reported in Nigerian Naira (Naira) and US dollars ($), with standard deviations (SD). FINDINGS: This study included 105 patients, of which 39 had laparoscopic appendicectomy and 66 had open appendicectomy. The average healthcare cost of laparoscopic appendicectomy (147,562 Naira (SD: 97,130) or $355 (SD: 234)) was higher than open appendicectomy (113,556 Naira (SD: 88,559) or $273 (SD: 213)). The average time for return to work was shorter with laparoscopic than open appendicectomy (mean: 8 days vs. 14 days). At the average daily income of $5.06, laparoscopic appendicectomy was associated with 9778 Naira or $24 cost savings in return to work. Further, 5.1% of laparoscopic appendicectomy patients had surgical site infections compared to 22.7% for open appendicectomy. Regression analysis results showed that laparoscopic appendicectomy was associated with $14 higher costs than open appendicectomy, albeit non-significant (p = 0.53). INTERPRETATION: Despite selection bias in this real-world study, laparoscopic appendicectomy was associated with a slightly higher overall cost, a lower societal cost, a lower infection rate, and a faster return to work, compared to open appendicectomy. It is technically and financially feasible, and its provision in Nigeria should be expanded.

The Growth Hormone Deficiency (GHD) Reversal Trial: effect on final height of discontinuation versus continuation of growth hormone treatment in pubertal children with isolated GHD-a non-inferiority Randomised Controlled Trial (RCT).

BACKGROUND: Growth hormone deficiency (GHD) is the commonest endocrine cause of short stature and may occur in isolation (I-GHD) or combined with other pituitary hormone deficiencies. Around 500 children are diagnosed with GHD every year in the UK, of whom 75% have I-GHD. Growth hormone (GH) therapy improves growth in children with GHD, with the goal of achieving a normal final height (FH). GH therapy is given as daily injections until adult FH is reached. However, in many children with I-GHD their condition reverses, with a normal peak GH detected in 64-82% when re-tested at FH. Therefore, at some point between diagnosis and FH, I-GHD must have reversed, possibly due to increase in sex hormones during puberty. Despite increasing evidence for frequent I-GHD reversal, daily GH injections are traditionally continued until FH is achieved. METHODS/DESIGN: Evidence suggests that I-GHD children who re-test normal in early puberty reach a FH comparable to that of children without GHD. The GHD Reversal study will include 138 children from routine endocrine clinics in twelve UK and five Austrian centres with I-GHD (original peak GH < 6.7 mcg/L) whose deficiency has reversed on early re-testing. Children will be randomised to either continue or discontinue GH therapy. This phase III, international, multicentre, open-label, randomised controlled, non-inferiority trial (including an internal pilot study) will assess whether children with early I-GHD reversal who stop GH therapy achieve non-inferior near FH SDS (primary outcome; inferiority margin 0.55 SD), target height (TH) minus near FH, HRQoL, bone health index and lipid profiles (secondary outcomes) than those continuing GH. In addition, the study will assess cost-effectiveness of GH discontinuation in the early retesting scenario. DISCUSSION: If this study shows that a significant proportion of children with presumed I-GHD reversal generate enough GH naturally in puberty to achieve a near FH within the target range, then this new care pathway would rapidly improve national/international practice. An assumed 50% reversal rate would provide potential UK health service cost savings of £1.8-4.6 million (€2.05-5.24 million)/year in drug costs alone. This new care pathway would also prevent children from having unnecessary daily GH injections and consequent exposure to potential adverse effects. TRIAL REGISTRATION: EudraCT number: 2020-001006-39.

Experiences of patients and their relatives of postoperative radiological surveillance and surveillance intensity following primary resection of a soft tissue sarcoma and its impact on their quality of life: a systematic review protocol.

INTRODUCTION: Postoperative radiological surveillance following primary resection of a soft tissue sarcoma (sarcoma of the retroperitoneum, abdomen, pelvis, trunk or extremities) is standard of care in all international high-volume sarcoma centres in the world. The intensity of postoperative surveillance imaging is highly varied and knowledge of the impact of surveillance and surveillance intensity on patients' quality of life is limited. The aim of this systematic review is to summarise the experiences of patients and their relatives/caregivers of postoperative radiological surveillance following resection of a primary soft tissue sarcoma and its impact on their quality of life. METHODS AND ANALYSIS: We will systematically search MEDLINE, EMBASE, PsycINFO, CINAHL Plus and Epistemonikos. Hand searching of reference lists of included studies will be conducted. Further searches will be performed via Google Scholar, to reveal further studies within unpublished 'grey' literature. Two reviewers will independently screen the titles and abstracts following the eligibility criteria. After retrieval of the full text of the selected studies, the methodological quality will be appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research and the Center for Evidence-Based Management checklist for Critical Appraisal of a Cross-Sectional Study. Data on the study population, relevant themes and conclusions will be extracted from the selected papers, and a narrative synthesis will be conducted. ETHICS AND DISSEMINATION: The systematic review does not require ethics approval. The findings of the proposed work will be published in a peer-reviewed journal and disseminated widely to patients, clinicians and allied health professionals through the Sarcoma UK website, the Sarcoma Patient Advocacy Global Network and the Trans-Atlantic Australasian Retroperitoneal Sarcoma Working Group. In addition, the outcomes of this research will be presented at national and international conferences. PROSPERO REGISTRATION NUMBER: CRD42022375118.

The effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome: 24-month follow-up of a randomized trial.

OBJECTIVES: This follow-up study of the INSTinCTS (INjection vs SplinTing in Carpal Tunnel Syndrome) trial compared the effects of corticosteroid injection (CSI) and night splinting (NS) for the initial management of mild-to-moderate CTS on symptoms, resource use and carpal tunnel surgery, over 24 months. METHODS: Adults with mild-to-moderate CTS were randomized 1:1 to a local corticosteroid injection or a night splint worn for 6 weeks. Outcomes at 12 and 24 months included the Boston Carpal Tunnel Questionnaire (BCTQ), hand/wrist pain intensity numeric rating scale (NRS), the number of patients referred for and undergoing CTS surgery, and healthcare utilization. A cost-utility analysis was conducted. RESULTS: One hundred and sixteen participants received a CSI and 118 a NS. The response rate at 24 months was 73% in the CSI arm and 71% in the NS arm. By 24 months, a greater proportion of the CSI group had been referred for (28% vs 20%) and undergone (22% vs 16%) CTS surgery compared with the NS group. There were no statistically significant between-group differences in BCTQ score or pain NRS at 12 or 24 months. CSI was more costly [mean difference £68.59 (95% CI: -120.84, 291.24)] with fewer quality-adjusted life-years than NS over 24 months [mean difference -0.022 (95% CI: -0.093, 0.045)]. CONCLUSION: Over 24 months, surgical intervention rates were low in both groups, but less frequent in the NS group. While there were no differences in the clinical effectiveness of CSI and NS, initial treatment with CSI may not be cost-effective in the long-term compared with NS.

Exploring the roles of players in strategic purchasing for healthcare in Africa-a scoping review.

Following the World Health Organization (WHO) guidance on strategic purchasing in 2000, low- and middle-income countries (LMICs) are trying to shift from passive purchasing (using fixed budgets) to strategic purchasing of healthcare which ties reimbursement to outcomes. However, there is limited evidence on strategic purchasing in Africa. We conducted a scoping literature review aimed at summarizing the roles played by governments, purchasers and providers in relation to citizens/population in strategic purchasing in Africa. The review searched for scientific journal articles that contained data on strategic purchasing collected from Africa. The literature search identified 957 articles of which 80 matched the inclusion criteria and were included in the review. The study revealed that in some countries strategic purchasing has been used as a tool for healthcare reforms or for strengthening systems that were not functional under fixed budgets. However, there was some evidence of a lack of government commitment in taking leading roles and funding strategic purchasing. Further, in some countries the laws need to be revised to accommodate new arrangements that were not part of fixed budgets. The review also established that there were some obstacles within the public health systems that deterred purchasers from promoting efficiency among providers and that prevented providers from having full autonomy in decision making. As African countries strive to shift from passive to strategic purchasing of healthcare, there is need for full government commitment on strategic purchasing. There is need to further revise appropriate legal frameworks to support strategic purchasing, conduct assessments of the healthcare systems before designing strategic purchasing schemes and to sensitize the providers and citizens on their roles and entitlements respectively.

Comparison of health-care utilization, costs and health-related quality of life across the subgroups defined by the Keele STarT MSK Tool.

OBJECTIVES: The aim of this study was to describe and compare health economic outcomes [health-care utilization and costs, work outcomes, and health-related quality of life (EQ-5D-5L)] in patients classified into different levels-of-risk subgroups by the Keele STarT MSK Tool. METHODS: Data on health-care utilization, costs and EQ-5D-5L were collected from a health-care perspective within a primary care prospective observational cohort study. Patients presenting with one (or more) of the five most common musculoskeletal pain presentations were included: back, neck, shoulder, knee or multi-site pain. Participants at low, medium and high risk of persistent disabling pain were compared in relation to mean health-care utilization and costs, health-related quality of life, and employment status. Regression analysis was used to estimate costs. RESULTS: Over 6 months, the mean (s.d.) total health-care (National Health Service and private) costs associated with the low, medium, and high-risk subgroups were £132.92 (167.88), £279.32 (462.98) and £476.07 (716.44), respectively. Mean health-related quality of life over the 6-month period was lower and more people changed their employment status in the high-risk subgroup compared with the medium- and low-risk subgroups. CONCLUSIONS: This study demonstrates that subgroups of people with different levels of risk for poor musculoskeletal pain outcomes also have different levels of health-care utilization, health-care costs, health-related quality of life, and work outcomes. The findings show that the STarT MSK Tool not only identifies those at risk of a poorer outcome, but also those who will have more health-care visits and incur higher costs.

Economic Evaluation of Type 2 Diabetes Mellitus Interventions in Low- and Middle-Income Countries: A Systematic Review of the Literature.

The primary aim of this study is to assess the evidence on the cost-effectiveness of type 2 diabetes mellitus (T2DM) interventions with a focus on diabetes education, lifestyle modifications, surgical intervention, and pharmacological therapy in low- and middle-income countries (LMICs). A systematic review was conducted to identify economic evaluations of T2DM interventions published in LMICs for the period 2009-2019. A total of 25 studies were identified, with more than half of the studies being decision analytic models. Critical appraisal of the identified studies showed they were of good quality. Overall, the reported interventions in this review were very heterogeneous, which made them difficult to compare. However, there was strong evidence suggesting that diabetes education was a very cost-effective strategy in LMICs. Further evidence on affordability and budget impact of bariatric surgery is required before adopting the intervention. Metformin-based therapy showed promising evidence on cost-effectiveness and thus should be offered to T2DM patients in LMICs. On the contrary, the cost-effectiveness of lifestyle modifications remains understudied in LMICs. The findings in this review can inform policy guidance toward the inclusion of T2DM interventions in the benefit packages for Universal Health Coverage in LMICs.

Planning human resources and facilities to achieve Sustainable Development Goals: a decision-analytical modelling approach to predict cancer control requirements in Indonesia.

OBJECTIVES: Indonesia aims to achieve universal health coverage (UHC) and Sustainable Development Goals (SDGs), including SDG 3 target 4, which focuses on cancer control, by 2030. This study aimed to forecast the human resources for health (HRH) and facilities required for cancer control in Indonesia over an 11-year period to support these goals. DESIGN: A two-stage Markov model was developed to forecast the demand side of facilities and HRH requirements for cancer control in Indonesia over an 11-year period. SETTING: Data sources used include the Indonesia Health Profile Report (2019), the Indonesian Radiation Oncology Society Database and National Cancer Control Committee documents (2019). METHODS: The study involved modelling the current availability of HRH and healthcare facilities in Indonesia and predicting future requirements. The gap between the current and the required HRH and facilities related to oncology, and the costs associated with meeting these requirements, were analysed. RESULTS: Results indicate the need to increase the number of healthcare facilities and HRH to achieve SDG targets. However, UHC for cancer care still may not be achieved, as eastern Indonesia is predicted to have no tertiary hospital until 2030. The forecast shows that Indonesia had a median of only 39% of the HRH requirements in 2019. Closing the HRH gap requires around a 47.6% increase in salary expenditure. CONCLUSION: This study demonstrates the application of decision-analytical modelling approach to planning HRH and facilities in the context of a low-to-middle-income country. Scaling up oncology services in Indonesia to attain the SDG targets will require expansion of the number and capability of healthcare facilities and HRH. This work allows an in-depth understanding of the resources needed to achieve UHC and SDGs and could be utilised in other disease areas and contexts.

Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial.

OBJECTIVE: To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis. DESIGN: Pragmatic, three arm, parallel group, single blind, randomised controlled trial. SETTING: Two community musculoskeletal services in England. PARTICIPANTS: 199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine. INTERVENTIONS: BCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received. MAIN OUTCOME MEASURES: The primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months. RESULTS: Mean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference -1.43 (95% confidence interval -2.15 to -0.72), P<0.001; standardised mean difference -0.55 (-0.82 to -0.27). No difference in hip pain intensity over six months was reported between BCT plus ultrasound-triamcinolone-lidocaine compared with BCT plus ultrasound-lidocaine (-0.52 (-1.21 to 0.18)). The presence of ultrasound confirmed synovitis or effusion was associated with a significant interaction effect favouring BCT plus ultrasound-triamcinolone-lidocaine (-1.70 (-3.10 to -0.30)). One participant in the BCT plus ultrasound-triamcinolone-lidocaine group with a bioprosthetic aortic valve died from subacute bacterial endocarditis four months after the intervention, deemed possibly related to the trial treatment. CONCLUSIONS: Ultrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis. TRIAL REGISTRATION: EudraCT 2014-003412-37; ISRCTN50550256.

Convergent and Discriminant Validity of the Barthel Index and the EQ-5D-3L When Used on Older People in a Rehabilitation Setting.

This study compares the empirical performance of a commonly used functional-status measure, the Barthel Index (BI), to that of a widely used generic preference-based instrument, the EuroQoL-5-Dimensions 3 Level (EQ-5D-3L), in older people. Data from older people receiving rehabilitation services were used to test the validity of the BI and EQ-5D-3L. Convergent validity was investigated using Spearman's correlation, exploratory factor analysis (EFA), scatter plots, Krippendorff's alpha and modified Bland-Altman plots. Discriminant validity was examined using Kruskal Wallis tests, ceiling effects and EFA. A total of 1690 participants were included in the analysis. The BI total and EQ-5D-3L utility scores showed moderate correlation (r = 0.51; Krippendorff's alpha = 0.52). Kendall's Tau-B correlations between BI items and EQ-5D-3L dimensions measuring the same construct were weak to moderate (0.05 ≤ absolute r ≤ 0.54). In the EFA, some BI items cross-loaded onto the same factors as EQ-5D-3L dimensions, suggesting that the instruments were interrelated. The BI, however, focuses more on physical functioning, while the EQ-5D-3L measures broader wellbeing concepts. Both instruments showed good discriminant validity and would therefore be equally valuable for measuring subgroup differences. Researchers should consider using the BI in rehabilitation to capture more physical functioning-specific constructs not measured by the EQ-5D-3L.

Preliminary model assessing the cost-effectiveness of preoperative chlorhexidine mouthwash at reducing postoperative pneumonia among abdominal surgery patients in South Africa.

BACKGROUND: Pneumonia is a common and severe complication of abdominal surgery, it is associated with increased length of hospital stay, healthcare costs, and mortality. Further, pulmonary complication rates have risen during the SARS-CoV-2 pandemic. This study explored the potential cost-effectiveness of administering preoperative chlorhexidine mouthwash versus no-mouthwash at reducing postoperative pneumonia among abdominal surgery patients. METHODS: A decision analytic model taking the South African healthcare provider perspective was constructed to compare costs and benefits of mouthwash versus no-mouthwash-surgery at 30 days after abdominal surgery. We assumed two scenarios: (i) the absence of COVID-19; (ii) the presence of COVID-19. Input parameters were collected from published literature including prospective cohort studies and expert opinion. Effectiveness was measured as proportion of pneumonia patients. Deterministic and probabilistic sensitivity analyses were performed to assess the impact of parameter uncertainties. The results of the probabilistic sensitivity analysis were presented using cost-effectiveness planes and cost-effectiveness acceptability curves. RESULTS: In the absence of COVID-19, mouthwash had lower average costs compared to no-mouthwash-surgery, $3,675 (R 63,770) versus $3,958 (R 68,683), and lower proportion of pneumonia patients, 0.029 versus 0.042 (dominance of mouthwash intervention). In the presence of COVID-19, the increase in pneumonia rate due to COVID-19, made mouthwash more dominant as it was more beneficial to reduce pneumonia patients through administering mouthwash. The cost-effectiveness acceptability curves shown that mouthwash surgery is likely to be cost-effective between $0 (R0) and $15,000 (R 260,220) willingness to pay thresholds. CONCLUSIONS: Both the absence and presence of SARS-CoV-2, mouthwash is likely to be cost saving intervention for reducing pneumonia after abdominal surgery. However, the available evidence for the effectiveness of mouthwash was extrapolated from cardiac surgery; there is now an urgent need for a robust clinical trial on the intervention on non-cardiac surgery.

Refinement and validation of a tool for stratifying patients with musculoskeletal pain.

BACKGROUND: Patients with musculoskeletal pain in different body sites share common prognostic factors. Using prognosis to stratify and treatment match can be clinically and cost-effective. We aimed to refine and validate the Keele STarT MSK Tool for prognostic stratification of musculoskeletal pain patients. METHODS: Tool refinement and validity was tested in a prospective cohort study, and external validity examined in a pilot cluster randomized controlled trial (RCT). Study population comprised 2,414 adults visiting U.K. primary care with back, neck, knee, shoulder or multisite pain returning postal questionnaires (cohort: 1,890 [40% response]; trial: 524). Cohort baseline questionnaires included a draft tool plus refinement items. Trial baseline questionnaires included the Keele STarT MSK Tool. Physical health (SF-36 Physical Component Score [PCS]) and pain intensity were assessed at 2- and 6-month cohort follow-up; pain intensity was measured at 6-month trial follow-up. RESULTS: The tool was refined by replacing (3), adding (3) and removing (2) items, resulting in a 10-item tool. Model fit (R2 ) was 0.422 and 0.430 and discrimination (c statistic) 0.839 and 0.822 for predicting 6-month cohort PCS and pain (respectively). The tool classified 24.9% of cohort participants at low, 41.7% medium and 33.4% high risk, clearly discriminating between subgroups. The tool demonstrated model fit of 0.224 and discrimination 0.73 in trial participants. Multiple imputation confirmed robustness of findings. CONCLUSIONS: The Keele STarT MSK Tool demonstrates good validity and acceptable predictive performance and clearly identifies groups of musculoskeletal pain patients with different characteristics and prognosis. Using prognostic information for stratification and treatment matching may be clinically/cost-effective. SIGNIFICANCE: The paper presents the first musculoskeletal pain prognostic stratification tool specifically for use among all primary care patients with the five most common musculoskeletal pain presentations (back, neck, knee, shoulder or multisite pain). The Keele STarT MSK Tool identifies groups of musculoskeletal pain patients with clearly different characteristics and prognosis. Using this tool for stratification and treatment matching may be clinically and cost-effective.

Multivariate Generalized Linear Mixed-Effects Models for the Analysis of Clinical Trial-Based Cost-Effectiveness Data.

Economic evaluations conducted alongside randomized controlled trials are a popular vehicle for generating high-quality evidence on the incremental cost-effectiveness of competing health care interventions. Typically, in these studies, resource use (and by extension, economic costs) and clinical (or preference-based health) outcomes data are collected prospectively for trial participants to estimate the joint distribution of incremental costs and incremental benefits associated with the intervention. In this article, we extend the generalized linear mixed-model framework to enable simultaneous modeling of multiple outcomes of mixed data types, such as those typically encountered in trial-based economic evaluations, taking into account correlation of outcomes due to repeated measurements on the same individual and other clustering effects. We provide new wrapper functions to estimate the models in Stata and R by maximum and restricted maximum quasi-likelihood and compare the performance of the new routines with alternative implementations across a range of statistical programming packages. Empirical applications using observed and simulated data from clinical trials suggest that the new methods produce broadly similar results as compared with Stata's merlin and gsem commands and a Bayesian implementation in WinBUGS. We highlight that, although these empirical applications primarily focus on trial-based economic evaluations, the new methods presented can be generalized to other health economic investigations characterized by multivariate hierarchical data structures.

The cost-effectiveness of different approaches to exercise and corticosteroid injection for subacromial pain (impingement) syndrome.

OBJECTIVES: To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. METHODS: An incremental cost-utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. RESULTS: The cost-utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI -0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI -59.36, 109.86) and 0.024 (95% CI -0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. CONCLUSION: Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. CLINICAL TRIAL REGISTRATION: ISRCTN, http://www.isrctn.com, ISRCTN42399123.

The STarT Back stratified care model for nonspecific low back pain: a model-based evaluation of long-term cost-effectiveness.

ABSTRACT: The STarT Back approach comprises subgrouping patients with low back pain (LBP) according to the risk of persistent LBP-related disability, with appropriate matched treatments. In a 12-month clinical trial and implementation study, this stratified care approach was clinically and cost-effective compared with usual, nonstratified care. Despite the chronic nature of LBP and associated economic burden, model-based economic evaluations in LBP are rare and have shortcomings. This study therefore produces a de novo decision model of this stratified care approach for LBP management to estimate the long-term cost-effectiveness and address methodological concerns in LBP modelling. A cost-utility analysis from the National Health Service perspective compared stratified care with usual care in patients consulting in primary care with nonspecific LBP. A Markov state-transition model was constructed where patient prognosis over 10 years was dependent on physical function achieved at 12 months. Data from the clinical trial and implementation study provided short-term model parameters, with extrapolation using 2 cohort studies of usual care in LBP. Base-case results indicate this model of stratified care is cost-effective, delivering 0.14 additional quality-adjusted life years at a cost saving of £135.19 per patient over a time horizon of 10 years. Sensitivity analyses indicate the approach is likely to be cost-effective in all scenarios and cost saving in most. It is likely this stratified care model will help reduce unnecessary healthcare usage while improving the patient's quality of life. Although decision-analytic modelling is used in many conditions, its use has been underexplored in LBP, and this study also addresses associated methodological challenges.