Burden of metabolic syndrome on primary healthcare costs among older adults: A cross-sectional study.

BACKGROUND: The impact of metabolic syndrome (MetS) on healthcare costs remains unclear in the literature. OBJECTIVES: To determine the impact of MetS on primary healthcare costs of adults, as well as to identify the impact of physical activity and other covariates on this phenomenon. DESIGN AND SETTING: This cross-sectional study was conducted in the city of Presidente Prudente, State of São Paulo/Brazil, in 2016. METHODS: The sample comprised 159 older adults (> 50 years) of both sexes (110 women) who were identified from their medical records in the Brazilian National Health Service. Healthcare costs (US$) were assessed through medical records and divided into medical consultations, medications, laboratory tests, and total costs. MetS was assessed using medical records. RESULTS: The Brazilian National Health Service spent more on consultations (US$ 22.75 versus US$ 19.39; + 17.3%) and medication (US$ 19.65 versus US$ 8.32; + 136.1%) among adults with MetS than among those without MetS, but the costs for laboratory tests were similar (P = 0.343). Total costs were 53.9% higher in adults with MetS than in those without the diagnosis of the disease (P = 0.001). Regarding total costs, there was an increase of US$ 38.97 when five components of MetS were present (P = 0.015), representing an increase of approximately 700%, even after adjusting for sex, age, and physical activity. CONCLUSION: In conclusion, the presence of the MetS is responsible for increasing primary care costs among older adults, especially in those related to medicines.

Family out-of-pocket expenditure for type 2 diabetes mellitus care and percentage of family income.

BACKGROUND: Type 2 diabetes has economic implications involving family income and out-of-pocket spending. OBJECTIVE: Determine family out-of-pocket expenditure for type 2 diabetes mellitus care and percentage of family income. MATERIAL AND METHODS: Study of family out-of-pocket spending in families with patients with type 2 diabetes treated at primary care level. Out-of-pocket expenses included expenses for transportation, food-drinks, and external medications. Family income corresponded to the total economic income contributed by family members. The percentage of out-of-pocket spending in relation to family income was identified with the relationship between these two variables. Statistical analysis included averages and percentages. RESULTS: The annual family out-of-pocket expenditure on transportation was $2,621.24, the family out-of-pocket expenditure on food and beverages was $1,075.67, and the family out-of-pocket expenditure on external medications was $722.08. The total annual family out-of-pocket expense was $4,418.89 and corresponds to 4.73% of family income. CONCLUSION: The family out-of-pocket expense in the family with a patient with diabetes mellitus 2 was $4,418.89 and represents 4.73% of the family income.

ANTECEDENTES: La diabetes tipo 2 tiene implicaciones económicas en el ingreso familiar y el gasto de bolsillo. OBJETIVO: Determinar el gasto de bolsillo familiar en la atención de la diabetes mellitus tipo 2 y el porcentaje que representa en el ingreso familiar. MATERIAL Y MÉTODOS: Estudio de gasto de bolsillo de las familias con pacientes con diabetes tipo 2 atendidos en el primer nivel de atención. El gasto de bolsillo familiar incluyó gasto en traslado, alimentos-bebidas y medicamentos externos. El ingreso familiar correspondió al total de ingresos económicos aportados por los miembros de la familia. El porcentaje del gasto de bolsillo con relación al ingreso familiar se identificó con la relación entre estas dos variables. El análisis estadístico incluyó promedios y porcentajes. RESULTADOS: El gasto de bolsillo familiar anual en transporte fue de $2621.24, en alimentos y bebidas fue de $1075.67 y en medicamentos externos fue de $722.08. El gasto familiar de bolsillo total anual fue de $4418.89 y correspondió a 4.73 % del ingreso familiar. CONCLUSIÓN: El gasto de bolsillo en las familias con un paciente con diabetes mellitus tipo 2 fue de $4418.89 y representó 4.73 % del ingreso familiar.

Political factors and arrangements influencing primary health care financing and resource allocation: A scoping review protocol.

INTRODUCTION: Primary health care is a key element in the structuring and coordination of health systems, contributing to overall coverage and performance. PHC financing is therefore central in this context, with variations in sufficiency and regularity depending on the "political dimension" of health systems. Research that systematically examines the political factors and arrangements influencing PHC financing is justified from a global and multidisciplinary perspective. The scoping review proposed here aims to systematically map the evidence on this topic in the current literature, identifying groups, institutions, priorities and gaps in the research. METHODS AND ANALYSIS: A scoping review will be conducted following the method proposed by Arksey and O'Malley to answer the following question: What is known from the literature about political factors and arrangements and their influence on and repercussions for primary health care financing and resource allocation models? The review will include peer-reviewed papers in Portuguese, English or Spanish published between 1978 and 2023. Searches will be performed of the following databases: Medline (PubMed), Embase, BVS Salud, Web of Science, Scopus and Science Direct. The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Inclusion and exclusion criteria will be used for literature screening and mapping. Screening and data charting will be conducted by a team of four reviewers. REGISTRATION: This protocol is registered on the Open Science Framework (OSF) platform, available at https://doi.org/10.17605/OSF.IO/Q9W3P.

Continuity Matters: Financial Impact of the G2211 Code in Primary Care.

Family medicine is financially undervalued compared with other medical specialties, and reimbursement fails to recognize the valuable longitudinal care provided to patients. According to one estimate, a primary care physician earns approximately $80,000 less than a subspecialist peer in Medicare reimbursement over a one-year period.1 This gap persists despite primary care physicians addressing higher numbers of medical concerns during office visits. To address continuity, the Centers for Medicare and Medicaid Services created the G2211 code in 2019 to compensate for the "visit complexity inherent to evaluation and management associated with medical care services."2 The G2211 code was implemented in January 2024.

Willingness to pay for chronic disease management services provided by primary care nurses.

BACKGROUND: Due to the rapid increase in chronic diseases in South Korea, the Korean government has expanded chronic disease management to primary care. Thus, the role of primary care nurses is critical. However, the fee for chronic disease management services provided by primary care nurses has not been set, and few studies have evaluated the value of nursing services. This study aimed to estimate the willingness to pay (WTP) for chronic disease management services provided by primary care nurses and to identify the factors that affect WTP. METHODS: This study adopted a descriptive research design and conducted a cross-sectional online survey from January 16 to 18, 2023. The inclusion criteria were community residents aged ≥ 20 years living in South Korea and capable of participating in online surveys. A total of 520 people participated in this study. A contingent valuation method (CVM) was used with double-bound dichotomous choice questions along with open-ended questions. The mean WTP was calculated using a Tobit model. RESULTS: The mean WTP of the 520 study participants for one chronic disease management service provided by primary care nurses was 15,390.71 Korean won ($11.90). Factors affecting WTP were having a chronic disease, recognition of primary care nurses, and the first-bid price. Community residents with fewer chronic diseases, high awareness of primary care nurses, and a higher first-bid price showed higher WTP for chronic disease management services provided by primary care nurses. CONCLUSIONS: Primary care is important worldwide due to the increasing number of chronic diseases, and Korea is no exception. However, payment for services by primary care nurses is undervalued compared to their critical role and skills. This has led to problems such as a primary care nurse shortage and burnout. This study estimated individuals' WTP for chronic disease management services provided by primary care nurses. The results can be used as a basic resource for setting the fee for services provided by primary care nurses. It is also a good starting point to understand the benefits of primary care nurse services.

Is cost a barrier to general practice for Australians with mental illness?

What is known about the topic? Cost is thought to be a barrier to access to primary care for people with mental illness. What does this paper add? Nearly three-quarters of clients of one mental health services do not report cost to be a barrier to primary care. What are the implications for practitioners? Efforts to help people with mental illness engage in primary care may be best directed towards areas other than the cost of access.

[Financial aspects of healthcare development].

The topic of financial support for the development of healthcare is especially relevant today due to the fact that public health is the key to the successful functioning of the state system. The article examines the key areas of health care development and analyzes the expenditures of the budgets of the budgetary system of the Russian Federation on health care. The transformations in the healthcare system are aimed at optimizing the work of medical organizations providing primary health care, forming a system of continuous training of medical personnel and forming criteria for assessing the quality and accessibility of medical care.

Prevalence of Independence at Home-Qualifying Beneficiaries in Traditional Medicare, 2014-2021.

Importance: The Centers for Medicare & Medicaid Services Innovation Center Independence at Home (IAH) demonstration, a test of home-based primary care operating in a value-based shared-savings payment model, ended December 2023 after a decade of consistently showing savings to Medicare. It is important to assess whether high-need, IAH-qualified beneficiaries continue to pose a growing challenge to traditional Medicare (TM) or if Medicare Advantage (MA), with programmatic features favorable to caring for this subset of the general Medicare population, can disproportionately provide such care. Objective: To examine the size and share of IAH-qualified beneficiaries in TM and MA. Design, Setting, and Participants: This cohort study used all Medicare claims data and MA encounter data for 2014 and 2021. IAH qualifying criteria were applied to the TM populations enrolled in Parts A and B in 2014 and 2021, and to MA enrollees in 2021. Growth in the number of IAH-qualified TM beneficiaries from 2014 to 2021 was calculated, and the proportions and numbers of IAH-qualified enrollees in the total 2021 TM and MA populations were compared. Data were analyzed between April and June 2023. Main Outcomes and Measures: The number and share of beneficiaries meeting IAH criteria in TM and MA; the share of TM spending among IAH-qualified beneficiaries. Results: Among 64 million Medicare beneficiaries in 2021, there were 30.55 million beneficiaries in TM with Parts A and B coverage, down from 33.82 million in 2014. The number of IAH-qualified beneficiaries in TM grew 51%, from 2.16 million to 3.27 million, while their proportionate share in TM grew 67% from 6.4% to 10.7% of TM between 2014 and 2021. IAH-qualified beneficiaries represented $155 billion in 2021 Medicare Parts A and B spending, 44% of all TM spending, up from 29% of total spending in 2014. In 2021, 2.15 million IAH-qualified beneficiaries represented 8.0% of Medicare Advantage enrollees. Combining TM and MA, 5.42 million IAH-qualified beneficiaries represented 9.3% of all Medicare beneficiaries, with 3.27 million (60.3%) being insured by TM. Conclusions and Relevance: In this cohort study of IAH-qualified Medicare beneficiaries, the share of IAH-qualified beneficiaries in TM grew between 2014 and 2021, with 60% of Medicare high-need beneficiaries accounting for 44% of TM spending. The Centers for Medicare & Medicaid Services should continue to operate value-based programs like IAH that are specifically designed for these high-needs individuals.

Federal transfers to municipalities through parliamentary amendments: implications for SUS funding. / Transferências federais por emendas parlamentares aos municípios: implicações para o financiamento do SUS.

The present article analyzes the transfers from parliamentary amendments by the Ministry of Health to municipalities to finance public health actions and services from 2015 to 2021. A descriptive and exploratory study was carried out with secondary data, including all Brazilian cities. Resources from amendments showed an increase, particularly from 2018 onwards, indicating the expansion of their relevance for financing SUS. From 2016 to 2021, over 80% was allocated to municipalities, representing 9.5% of all federal transfers, with 91.2% for operational expenses. Transfers from amendments differ from regular transfers due to greater instability and per capita variation among the amounts collected by municipalities and due to the fact that they allocate most resources to the Northeast and primary care to the detriment of the Southeast and medium and high complexity care. These transfers represent a differentiated modality of resource allocation in SUS that produces new distortions and asymmetries, with implications for intergovernmental relations, as well as between the executive and legislative powers, increasing the risk of the discontinuity of actions and services and imposing challenges for the municipal management.

O artigo tem como objetivo analisar as transferências por emendas parlamentares do Ministério da Saúde aos municípios para o financiamento de ações e serviços públicos de saúde, de 2015 a 2021. Foi realizado estudo descritivo e exploratório com dados secundários, abrangendo a totalidade de municípios brasileiros. Os recursos provenientes de emendas apresentaram aumento, em especial a partir de 2018, indicando a expansão de sua relevância para o financiamento do SUS. No período de 2016 a 2021, mais de 80% foram alocados aos municípios, representando 9,5% dos repasses federais, com 91,2% de natureza de custeio. As transferências por emendas diferem dos repasses regulares por possuir maior instabilidade e variação per capita entre os montantes captados pelos municípios, e por destinar a maior parte dos recursos ao Nordeste e à atenção primária, em detrimento do Sudeste e da média e alta complexidade. Configura-se uma modalidade diferenciada de alocação de recursos no SUS que produz novas distorções e assimetrias, com implicações para as relações intergovernamentais e entre os poderes executivo e legislativo, ampliando o risco de descontinuidade de ações e serviços e impondo desafios para as gestões municipais.

Collaborative Care Cost-Sharing and Referral Rates in Colorado.

BACKGROUND: Collaborative care integrates mental health treatment into primary care and has been shown effective. Yet even in states where its use has been encouraged, take-up remains low and there are potential financial barriers to care. OBJECTIVE: Describe patient out-of-pocket costs and variations in referral patterns for collaborative care in Colorado. RESEARCH DESIGN: Retrospective observational study using administrative medical claims data to identify outpatient visits with collaborative care. For individuals with ≥1 visit, we measure spending and visits at the month level. Among physicians with billings for collaborative care, we measure prevalence of eligible patients with collaborative care utilization. SUBJECTS: Patients with Medicare, Medicare Advantage, or commercial health insurance in Colorado, 2018-2019. OUTCOMES: Out-of-pocket costs (enrollee payments to clinicians), total spending (insurer+enrollee payments to clinicians), percent of patients billed collaborative care. RESULTS: Median total spending (insurer+patient cost) was $48.32 (IQR: $41-$53). Median out-of-pocket cost per month in collaborative care was $8.35 per visit (IQR: $0-$10). Patients with commercial insurance paid the most per month (median: $15); patients with Medicare Advantage paid the least (median: $0). Among clinicians billing for collaborative care (n=193), a mean of 12 percent of eligible patients utilized collaborative care; family practice and advanced practice clinicians' patients utilized it most often. CONCLUSIONS: Collaborative care remains underused with fewer than 1 in 6 potentially eligible patients receiving care in this setting. Out-of-pocket costs varied, though were generally low; uncertainty about costs may contribute to low uptake.

Cost-effectiveness analysis of health tapestry, a complex primary care program for older adults: a post-hoc analysis.

BACKGROUND: We initially reported on the cost-effectiveness of a 6-month randomized controlled implementation trial which evaluated Health TAPESTRY, a primary care program for older adults, at the McMaster Family Health Team (FHT) site and 5 other FHT sites in Ontario, Canada. While there were no statistically significant between-group differences in outcomes at month 6 post randomization, positive outcomes were observed at the McMaster FHT site, which recruited 40% (204/512) of the participants. The objective of this post-hoc study was to determine the cost-effectiveness of Health TAPESTRY based on data from the McMaster FHT site. METHODS: Costs included the cost to implement Health TAPESTRY at McMaster as well as healthcare resource consumed, which were costed using publicly available sources. Health-related-quality-of-life was evaluated with the EQ-5L-5L at baseline and at month 6 post randomization. Quality-adjusted-life-years (QALYs) were calculated under an-area-under the curve approach. Unadjusted and adjusted regression analyses (two independent regression analyses on costs and QALYs, seemingly unrelated regression [SUR], net benefit regression) as well as difference-in-difference and propensity score matching (PSM) methods, were used to deal with the non-randomized nature of the trial. Sampling uncertainty inherent to the trial data was estimated using non-parametric bootstrapping. The return on investment (ROI) associated with Health TAPESTRY was calculated. All costs were reported in 2021 Canadian dollars. RESULTS: With an intervention cost of $293/patient, Health TAPESTRY was the preferred strategy in the unadjusted and adjusted analyses. The results of our bootstrap analyses indicated that Health TAPESTRY was cost-effective compared to usual care at commonly accepted WTP thresholds. For example, if decision makers were willing to pay $50,000 per QALY gained, the probability of Health TAPESTRY to be cost effective compared to usual care varied from 0.72 (unadjusted analysis) to 0.96 (SUR) when using a WTP of $50,000/QALY gained. The DID and ROI analyses indicated that Health Tapestry generated a positive ROI. CONCLUSION: Health TAPESTRY was the preferred strategy when implemented at the McMaster FHT. We caution care in interpreting the results because of the post-hoc nature of the analyses and limited sample size based on one site.

Economics of primary healthcare: cost estimation of clinical services at primary care facilities in the six countries of the Gulf Cooperation Council.

OBJECTIVE: While the Gulf Cooperation Council (GCC) countries have demonstrated a strong commitment to strengthening primary healthcare (PHC), the costs of delivering these services in this region remain relatively unexplored. Understanding the costs of PHC delivery is essential for effective resource allocation and health system efficiency. DESIGN: We used an ingredient-based method to estimate the cost of delivering a selection of services at PHC facilities in the six GCC countries in 2019. Services were categorised into eight programmes: immunisation; non-communicable diseases (NCDs); oral and dental care; child health; nutrition; mental health; reproductive, maternal, neonatal and child health and general practice. The cost estimation focused on two key ingredients: the costs of drugs and supplies and the healthcare workforce cost. The coverage rates of specific types of health services, including screening and mental health services, were also estimated. Data for the analysis were obtained from ministries of health, health statistics reports, online databases, national surveys and scientific literature. RESULTS: The estimated costs of delivering the selected services at public PHC facilities in the six GCC countries totalled US$5.7 billion in 2019, representing 0.34% of the combined 2019 GDP. The per capita costs varied from US$69 to US$272. General practice and NCD programmes constituted 79% of the total costs modelled while mental health ranged between 0.0% and 0.3%. Over 8 million individuals did not receive NCD screening services, and over 30 million did not receive needed mental health services in public PHC facilities across the region. CONCLUSIONS: To our knowledge, this is the first study to estimate the costs of services delivered at PHC facilities in the GCC countries. Identifying the main cost drivers and the services which individuals did not receive can be used to help strengthen PHC to improve efficiency and scale up needed services for better health outcomes.

Pediatric Primary Care Billing Trends After the 2021 Evaluation and Management Coding Changes.

This cross-sectional study examines the differences in billing trends for pediatric patient care compared with adult care after the 2021 evaluation and management (E/M) policy changes.

A cost-effectiveness analysis of the use of oral ibrexafungerp versus fluconazole for acute vulvovaginal candidiasis in the UK NHS primary care service.

BACKGROUND: Vulvovaginal Candidiasis (VVC) is a fungal infection causing inflammation of the vagina and/or the vulva. Symptoms include itching, irritation, and discharge. VVC presents commonly across primary care and, despite its mild symptoms, carries psychological burden and has a significant impact on women's quality of life. UK guidelines support treatment via oral or topical azole antifungal agents. Recent evidence attests to the superiority of novel non-azole antifungals. Thus, rigorous financial assessment of both antifungals is necessary for optimal VVC treatment allocation in UK primary care. AIM: To evaluate the cost-effectiveness of ibrexafungerp against the gold standard fluconazole as first-line treatment of VVC within the NHS. METHOD: A systematic review on the efficacy of ibrexafungerp and fluconazole in acute VVC was conducted. Cost-effectiveness analysis was initiated using health outcome data from the DOVE trial, a Phase 2 RCT. Costs in pound sterling were ascertained in monetary units, and effectiveness determined as reduced need for follow-up medication. RESULTS: An incremental cost-effectiveness ratio of £2185.74 was determined. This suggests oral ibrexafungerp being largely more costly yet slightly more effective than fluconazole, and thus has unfavourable net benefit. Two sensitivity analyses were conducted considering follow-up medication combination and market price, which provided confidence in the calculated cost-effectiveness ratio. CONCLUSION: This analysis highlights fluconazole's cost-effectiveness in current UK guidelines and favourability.

Improving access to primary health care through financial innovation in rural China: a quasi-experimental synthetic difference-in-differences approach.

BACKGROUND: Inadequate financing constrains primary healthcare (PHC) capacity in many low- and middle-income countries, particularly in rural areas. This study evaluates an innovative PHC financing reform in rural China that aimed to improve access to healthcare services through supply-side integration and the establishment of a designated PHC fund. METHODS: We employed a quasi-experimental synthetic difference-in-differences (SDID) approach to analyze county-level panel data from Chongqing Province, China, spanning from 2009 to 2018. The study compared the impact of the reform on PHC access and per capita health expenditures in Pengshui County with 37 other control counties (districts). We assessed the reform's impact on two key outcomes: the share of outpatient visits at PHC facilities and per capita total PHC expenditure. RESULTS: The reform led to a significant increase in the share of outpatient visits at PHC facilities (14.92% points; 95% CI: 6.59-23.24) and an increase in per capita total PHC expenditure (87.30 CNY; 95% CI: 3.71-170.88) in Pengshui County compared to the synthetic control. These effects were robust across alternative model specifications and increased in magnitude over time, highlighting the effectiveness of the integrated financing model in enhancing PHC capacity and access in rural China. CONCLUSIONS: This research presents compelling evidence demonstrating that horizontal integration in PHC financing significantly improved utilization and resource allocation in rural primary care settings in China. This reform serves as a pivotal model for resource-limited environments, demonstrating how supply-side financing integration can bolster PHC and facilitate progress toward universal health coverage. The findings underscore the importance of sustainable financing mechanisms and the need for policy commitment to achieve equitable healthcare access.

How personnel diversity and affective bonds affect performance-based financing: a moderator analysis of a difference-in-difference estimator.

To spur improvement in health-care service quality and quantity, performance-based financing (PBF) is an increasingly common policy tool, especially in low- and middle-income countries. This study examines how personnel diversity and affective bonds in primary care clinics affect their ability to improve care quality in PBF arrangements. Leveraging data from a large-scale matched PBF intervention in Tajikistan including 208 primary care clinics, we examined how measures of personnel diversity (position and tenure variety) and affective bonds (mutual support and group pride) were associated with changes in the level and variability of clinical knowledge (diagnostic accuracy of 878 clinical vignettes) and care processes (completion of checklist items in 2485 instances of direct observations). We interacted the explanatory variables with exposure to PBF in cluster-robust, linear regressions to assess how these explanatory variables moderated the PBF treatment's association with clinical knowledge and care process improvements. Providers and facilities with higher group pride exhibited higher care process improvement (greater checklist item completion and lower variability of items completed). Personnel diversity and mutual support showed little significant associations with the outcomes. Organizational features of clinics exposed to PBF may help explain variation in outcomes and warrant further research and intervention in practice to identify and test opportunities to leverage them. Group pride may strengthen clinics' ability to improve care quality in PBF arrangements. Improving health-care facilities' pride may be an affordable and effective way to enhance health-care organization adaptation.

An area-based analysis of general practice fees in Aotearoa New Zealand.

Introduction The pursuit of health care equity is a fundamental objective for Aotearoa New Zealand, and patient co-payments in primary care challenge this goal. Aim This study aimed to investigate the relationship between primary health care co-payments and the sociodemographic variables in areas where general practices provide health care. Methods Using census data, facilities information from the Ministry of Health, and socioeconomic deprivation indices, linear regression models were used to explore the relationship between weighted average fees charged by general practices and various sociodemographic variables in statistical area 2 regions. Results The study finds that areas with higher proportions of males and economically deprived individuals are associated with lower weighted average fees. Conversely, areas with higher proportions of retirement-aged and European individuals are linked with higher weighted average fees. The inclusion of the Very-Low-Cost-Access variable, indicating a subsidy scheme at the general practice level, made all the sociodemographic variables practically insignificant, suggesting Very-Low-Cost-Access practices are in the right geographical location to target high needs groups. Discussion The findings affirm the complexity of health care inequities in Aotearoa New Zealand, influenced not only by financial factors but also by demographic variables as they play out geographically. While subsidy schemes like the Very-Low-Cost-Access scheme appear to reach groups with greater need, a high level of unmet need due to cost suggests that the fees are still too high. Policymakers need to consider disparities in the on-going health care reforms and make further changes to subsidy schemes to reduce unmet need.

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Financial incentives to motivate treatment for hepatitis C with direct acting antivirals among Australian adults (The Methodical evaluation and Optimisation of Targeted IncentiVes for Accessing Treatment of Early-stage hepatitis C: MOTIVATE-C): protocol for a dose-response randomised controlled study.

BACKGROUND: Untreated hepatitis C virus (HCV) infection can result in cirrhosis and hepatocellular cancer. Direct-acting antiviral (DAA) therapies are highly effective and have few side effects compared to older interferon-based therapy. Despite the Australian government providing subsidised and unrestricted access to DAA therapy for chronic HCV infection, uptake has not been sufficient to meet the global target of eliminating HCV as a public health threat by 2030. This study will offer people with HCV financial incentives of varying values in order to evaluate its effect on initiation of DAA therapy in primary care. METHODS: Australian adults (18 years or older) who self-report as having current untreated HCV infection can register to participate via an automated SMS-based system. Following self-screening for eligibility, registrants are offered a financial incentive of randomised value (AUD 0 to 1000) to initiate DAA therapy. Study treatment navigators contact registrants who have consented to be contacted, to complete eligibility assessment, outline the study procedures (including the requirement for participants to consult a primary care provider), obtain consent, and finalise enrolment. Enrolled participants receive their offered incentive on provision of evidence of DAA therapy initiation within 12 weeks of registration (primary endpoint). Balanced randomisation is used across the incentive range until the first analysis, after which response-adaptive randomisation will be used to update the assignment probabilities. For the primary analysis, a Bayesian 4-parameter EMAX model will be used to estimate the dose-response curve and contrast treatment initiation at each incentive value against the control arm (AUD 0). Specified secondary statistical and economic analyses will evaluate the effect of incentives on adherence to DAA therapy, virological response, and cost-effectiveness. DISCUSSION: This project seeks to gain an understanding of the dose-response relationship between incentive value and DAA treatment initiation, while maximising the number of people treated for HCV within fixed budget and time constraints. In doing so, we hope to offer policy-relevant recommendation(s) for the use of financial incentives as a pragmatic, efficient, and cost-effective approach to achieving elimination of HCV from Australia. TRIAL REGISTRATION: ANZCTR (anzctr.org.au), Identifier ACTRN12623000024640, Registered 11 January 2023 ( https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384923&isReview=true ).