Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

PURPOSE: To describe the characteristics of patients and practice of clinicians during standard-of-care for weight management in a large, multiclinic health system before the implementation of PATHWEIGH, a pragmatic weight management intervention. METHODS: We analyzed baseline characteristics of patients, clinicians, and clinics during standard-of-care for weight management before the implementation of PATHWEIGH, which will be evaluated for effectiveness and implementation in primary care using an effectiveness-implementation hybrid type-1 cluster randomized stepped-wedge clinical trial design. A total of 57 primary care clinics were enrolled and randomized to 3 sequences. Patients included in the analysis met the eligibility requirements of age ≥18 years and body mass index (BMI) ≥25 kg/m2 and had a weight-prioritized visit (defined a priori) during the period March 17, 2020 to March 16, 2021. RESULTS: A total of 12% of patients aged ≥18 years and with a BMI ≥25 kg/m2 seen in the 57 practices during the baseline period (n = 20,383) had a weight-prioritized visit. The 3 randomization sequences of 20, 18, and 19 sites were similar, with an overall mean patient age of 52 (SD 16) years, 58% women, 76% non-Hispanic White patients, 64% with commercial insurance, and with a mean BMI of 37 (SD 7) kg/m2. Documented referral for anything weight related was low (<6%), and 334 prescriptions of an antiobesity drug were noted. CONCLUSIONS: Of patients aged ≥18 years and with a BMI ≥25 kg/m2 in a large health system, 12% had a weight-prioritized visit during the baseline period. Despite most patients being commercially insured, referral to any weight-related service or prescription of antiobesity drug was uncommon. These results fortify the rationale for trying to improve weight management in primary care.

Implementation and Qualitative Evaluation of a Primary Care Redesign Model with Expanded Scope of Work for Medical Assistants.

BACKGROUND: Implementation of primary care models involving expanded scope of work and redesigned workflows for medical assistants (MAs) as primary care team members can be challenging. Implementation strategies and participatory evaluation informed by implementation science frameworks may inform organizational decisions about model scale-up and sustainment. OBJECTIVE: This paper reports implementation strategies and qualitative evaluation of a primary care redesign (PCR) model implementation that included an expanded scope of work for MAs. DESIGN: Qualitative evaluation of implementation strategies and clinician and staff experience with implementation of PCR using semi-structured key informant interviews. The evaluation was guided by the RE-AIM framework and the Consolidated Framework for Implementation Research. PARTICIPANTS: Sixty-nine clinicians, staff, practice leaders, and administrators from 7 primary care practices (4 general internal medicine, 3 family medicine) implementing PCR. INTERVENTIONS: The PCR model included enhanced rooming and documentation support. The health system used multiple strategies to implement PCR, including rapid improvement events, changing clinic space configurations, developing electronic health record templates and performance dashboards, and practice coaching. APPROACH: The Consolidated Framework for Implementation Research and the RE-AIM evaluation and planning framework guided development of semi-structured interview guides. A deductive, structural coding approach was used for analysis. KEY RESULTS: PCR implementation was facilitated by clear communication about the intervention source, mechanisms for feedback about model goals, and physical environments and electronic health record (EHR) systems that supported the added staff and modified clinic workflow. Clinicians and staff benefited from the ability to see the model in action prior to go-live and opportunities for consistent provider-MA pairings. CONCLUSIONS: The PCR model can support achieving the Quadruple Aim when fully implemented with paired MAs and clinicians who are well prepared to follow redesigned workflows and function as a team. Implementation can be effectively supported by a participatory evaluation guided by implementation science frameworks.

The effect of distance on maternal institutional delivery choice: Evidence from Malawi.

In many low- and middle-income countries, geographical accessibility continues to be a barrier to health care utilization. In this paper, we aim to better understand the full relationship between distance to providers and utilization of maternal delivery services. We address three methodological challenges: non-linear effects between distance and utilization; unobserved heterogeneity through non-random distance "assignment"; and heterogeneous effects of distance. Linking Malawi Demographic Health Survey household data to Service Provision Assessment facility data, we consider distance as a continuous treatment variable, estimating a Dose-Response Function based on generalized propensity scores, allowing exploration of non-linearities in the effect of an increment in distance at different distance exposures. Using an instrumental variables approach, we examine the potential for unobserved differences between women residing at different distances to health facilities. Our results suggest distance significantly reduces the probability of having a facility delivery, with evidence of non-linearities in the effect. The negative relationship is shown to be particularly strong for women with poor health knowledge and lower socio-economic status, with important implications for equity. We also find evidence of potential unobserved confounding, suggesting that methods that ignore such confounding may underestimate the effect of distance on the utilization of health services.

Rural and urban differences in health system performance among older Chinese adults: cross-sectional analysis of a national sample.

BACKGROUND: Despite improvement in health outcomes over the past few decades, China still experiences striking rural-urban health inequalities. There is limited research on the rural-urban differences in health system performance in China. METHOD: We conducted a cross-sectional analysis to compare health system performance between rural and urban areas in five key domains of the health system: effectiveness, cost, access, patient-centredness and equity, using data from the WHO Study on Global AGEing and adult health (SAGE), China. Multiple logistic and linear regression models were used to assess the first four domains, adjusting for individual characteristics, and a relative index of inequality (RII) was used to measure the equity domain. FINDINGS: Compared to urban areas, rural areas had poorer performance in the management and control of hypertension and diabetes, with more than 50% lower odds of having breast (AOR = 0.44; 95% CI: 0.30, 0.64) and cervical cancer screening (AOR = 0.49; 95% CI: 0.29, 0.83). There was better performance in rural areas in the patient-centredness domain, with more than twice higher odds of getting prompt attention, respect, clarity of the communication with health provider and involvement in decision making of the treatment in inpatient care (AOR = 2.56, 2.15, 2.28, 2.28). Although rural residents incurred relatively less out-of-pocket expenditures (OOPE) for outpatient and inpatient services than urban residents, they were more likely to incur catastrophic expenditures on health (AOR = 1.30; 95% CI 1.16, 1.44). Wealth inequality was found in many indicators related to the effectiveness, costs and access domains in both rural and urban areas. Rural areas had greater inequalities in the management of hypertension and coverage of cervical cancer (RII = 7.45 vs 1.64). CONCLUSION: Our findings suggest that urban areas have achieved better prevention and management of non-communicable disease than rural areas, but access to healthcare was equivalent. A better understanding of the causes of the observed variations is needed to develop appropriate policy interventions which address these disparities.

Does global drug innovation correspond to burden of disease? The neglected diseases in developed and developing countries.

Although it is commonly argued that there is a mismatch between drug innovation and disease burden, there is little evidence on the magnitude and direction of such disparities. In this paper, we measure inequality in innovation, by comparing research and development activity with population health and gross domestic product data across 493 therapeutic indications to globally measure: (a) drug innovation, (b) disease burden, and (c) market size. We use concentration curves and indices to assess inequality at two levels: (a) broad disease groups and (b) disease subcategories for both 1990 and 2010. For some top burden disease subcategories (i.e., cardiovascular and circulatory diseases, neoplasms, and musculoskeletal disorders), innovation is disproportionately concentrated in diseases with high disease burden and large market size, whereas for others (i.e., mental and behavioral disorders, neonatal disorders, and neglected tropical diseases) innovation is disproportionately concentrated in low burden diseases. These inequalities persisted over time, suggesting inertia in pharmaceutical research and development in tackling the global health challenges. Our results confirm quantitatively assertions about the mismatch between disease burden and pharmaceutical innovation in both developed and developing countries and highlight the disease areas for which morbidity and mortality remain unaddressed.

Cost-Effectiveness of One-Time Hepatitis C Screening Strategies Among Adolescents and Young Adults in Primary Care Settings.

Background: High hepatitis C virus (HCV) rates have been reported in young people who inject drugs (PWID). We evaluated the clinical benefit and cost-effectiveness of testing among youth seen in communities with a high overall number of reported HCV cases. Methods: We developed a decision analytic model to project quality-adjusted life years (QALYs), costs (2016 US$), and incremental cost-effectiveness ratios (ICERs) of 9 strategies for 1-time testing among 15- to 30-year-olds seen at urban community health centers. Strategies differed in 3 ways: targeted vs routine testing, rapid finger stick vs standard venipuncture, and ordered by physician vs by counselor/tester using standing orders. We performed deterministic and probabilistic sensitivity analyses (PSA) to evaluate uncertainty. Results: Compared to targeted risk-based testing (current standard of care), routine testing increased the lifetime medical cost by $80 and discounted QALYs by 0.0013 per person. Across all strategies, rapid testing provided higher QALYs at a lower cost per QALY gained and was always preferred. Counselor-initiated routine rapid testing was associated with an ICER of $71000/QALY gained. Results were sensitive to offer and result receipt rates. Counselor-initiated routine rapid testing was cost-effective (ICER <$100000/QALY) unless the prevalence of PWID was <0.59%, HCV prevalence among PWID was <16%, reinfection rate was >26 cases per 100 person-years, or reflex confirmatory testing followed all reactive venipuncture diagnostics. In PSA, routine rapid testing was the optimal strategy in 90% of simulations. Conclusions: Routine rapid HCV testing among 15- to 30-year-olds may be cost-effective when the prevalence of PWID is >0.59%.

What is the impact of rerouting a cancer diagnosis from emergency presentation to GP referral on resource use and survival? Evidence from a population-based study.

BACKGROUND: Studies on alternative routes to diagnosis stimulated successful policy interventions reducing the number of emergency diagnoses and associated mortality risk. A dearth of evidence on the costs of such interventions might prevent new policies from achieving more ambitious targets. METHODS: We conducted a retrospective cohort study on the population of colorectal (88,051), breast (90,387), prostate (96,219), and lung (97,696) cancer patients diagnosed after a GP referral or an emergency presentation and reported in the Cancer Registry of England. Resource use and survival were compared 1 year before and 5 years after diagnosis (3 years for lung), including the costs of GP referrals not converted into a positive diagnosis. Risk-adjusted statistical models were used to calculate the effect of rerouting patient' diagnoses from emergency presentation to GP referral. RESULTS: Rerouting a cancer diagnosis results in a relatively small additional costs to the National Health System against additional years of life saved to the patient. The cost per year of life saved is £6456 in colorectal, £1057 in breast, -£662 in prostate (savings), and £819 in lung cancer. Reducing the overall prevalence of emergency presentations to the level achieved by the 20% of Clinical Commissioning Groups with the lowest prevalence would result in £11,481,948 against 1863 years of life saved for Colorectal, £847,750 against 889 years for breast, -£943,434 (cost savings) against 1195 years for prostate, and £609,938 against 1011 years for lung cancer. CONCLUSION: Redirecting diagnoses from emergency presentation to GP referral appears an achievable target that can produce large benefits to patients against modest additional costs to the National Health System.

Healthy Life-Years Lost and Excess Bed-Days Due to 6 Patient Safety Incidents: Empirical Evidence From English Hospitals.

BACKGROUND: There is little satisfactory evidence on the harm of safety incidents to patients, in terms of lost potential health and life-years. OBJECTIVE: To estimate the healthy life-years (HLYs) lost due to 6 incidents in English hospitals between the years 2005/2006 and 2009/2010, to compare burden across incidents, and estimate excess bed-days. RESEARCH DESIGN: The study used cross-sectional analysis of the medical records of all inpatients treated in 273 English hospitals. Patients with 6 types of preventable incidents were identified. Total attributable loss of HLYs was estimated through propensity score matching by considering the hypothetical remaining length and quality of life had the incident not occurred. RESULTS: The 6 incidents resulted in an annual loss of 68 HLYs and 934 excess bed-days per 100,000 population. Preventable pressure ulcers caused the loss of 26 HLYs and 555 excess bed-days annually. Deaths in low-mortality procedures resulted in 25 lost life-years and 42 bed-days. Deep-vein thrombosis/pulmonary embolisms cost 12 HLYs, and 240 bed-days. Postoperative sepsis, hip fractures, and central-line infections cost <6 HLYs and 100 bed-days each. DISCUSSION: The burden caused by the 6 incidents is roughly comparable with the UK burden of Multiple Sclerosis (80 DALYs per 100,000), HIV/AIDS and Tuberculosis (63 DALYs), and Cervical Cancer (58 DALYs). There were marked differences in the harm caused by the incidents, despite the public attention all of them receive. Decision makers can use the results to prioritize resources into further research and effective interventions.

Should Countries Set an Explicit Health Benefits Package? The Case of the English National Health Service.

BACKGROUND: A fundamental debate in the transition towards universal health coverage concerns whether to establish an explicit health benefits package to which all citizens are entitled, and the level of detail in which to specify that package. At one extreme, the treatments to be funded, and the circumstances in which patients qualify for the treatment, might be specified in great detail, and be entirely mandatory. This would make clinicians little more than automata, carrying out prescribed practice. At the other extreme, priorities may be expressed in very broad terms, with no compulsion or other incentives to encourage adherence. OBJECTIVES: The paper examines the arguments for and against setting an explicit benefits package, and discusses the circumstances in which increased detail in specification are most appropriate. METHODS: The English National Health Service is used as a case study, based on institutional history, official documents and research literature. RESULTS: Although the English NHS does not explicitly specify a health benefits package, it is in some respects establishing an 'intelligent' package, based on instruments such as an essential medicines list, clinical guidelines, provider payment and performance reporting, which acknowledges gaps in evidence and variations in local resource constraints. CONCLUSIONS: Further moves towards a more explicit specification are likely to yield substantial benefits in most health systems. Considerations in determining the 'hardness' of benefits package specification might include the quality of information about the costs and benefits of treatments, the heterogeneity of patient needs and preferences, the financing regime in place, and the nature of supply side constraints.

Cost of care for cancer patients in England: evidence from population-based patient-level data.

BACKGROUND: Health systems are facing the challenge of providing care to an increasing population of patients with cancer. However, evidence on costs is limited due to the lack of large longitudinal databases. METHODS: We matched cost of care data to population-based, patient-level data on cancer patients in England. We conducted a retrospective cohort study including all patients age 18 and over with a diagnosis of colorectal (275 985 patients), breast (359 771), prostate (286 426) and lung cancer (283 940) in England between 2001 and 2010. Incidence costs, prevalence costs, and phase of care costs were estimated separately for patients age 18-64 and ⩾65. Costs of care were compared by patients staging, before and after diagnosis, and with a comparison population without cancer. RESULTS: Incidence costs in the first year of diagnosis are noticeably higher in patients age 18-64 than age ⩾65 across all examined cancers. A lower stage diagnosis is associated with larger cost savings for colorectal and breast cancer in both age groups. The additional costs of care because of the main four cancers amounts to £1.5 billion in 2010, namely 3.0% of the total cost of hospital care. CONCLUSIONS: Population-based, patient-level data can be used to provide new evidence on the cost of cancer in England. Early diagnosis and cancer prevention have scope for achieving large cost savings for the health system.

Prior Influenza Infection Mitigates SARS-CoV-2 Disease in Syrian Hamsters.

Seasonal infection rates of individual viruses are influenced by synergistic or inhibitory interactions between coincident viruses. Endemic patterns of SARS-CoV-2 and influenza infection overlap seasonally in the Northern hemisphere and may be similarly influenced. We explored the immunopathologic basis of SARS-CoV-2 and influenza A (H1N1pdm09) interactions in Syrian hamsters. H1N1 given 48 h prior to SARS-CoV-2 profoundly mitigated weight loss and lung pathology compared to SARS-CoV-2 infection alone. This was accompanied by the normalization of granulocyte dynamics and accelerated antigen-presenting populations in bronchoalveolar lavage and blood. Using nasal transcriptomics, we identified a rapid upregulation of innate and antiviral pathways induced by H1N1 by the time of SARS-CoV-2 inoculation in 48 h dual-infected animals. The animals that were infected with both viruses also showed a notable and temporary downregulation of mitochondrial and viral replication pathways. Quantitative RT-PCR confirmed a decrease in the SARS-CoV-2 viral load and lower cytokine levels in the lungs of animals infected with both viruses throughout the course of the disease. Our data confirm that H1N1 infection induces rapid and transient gene expression that is associated with the mitigation of SARS-CoV-2 pulmonary disease. These protective responses are likely to begin in the upper respiratory tract shortly after infection. On a population level, interaction between these two viruses may influence their relative seasonal infection rates.

Does progress towards universal health coverage improve population health?

Many commentators, including WHO, have advocated progress towards universal health coverage on the grounds that it leads to improvements in population health. In this report we review the most robust cross-country empirical evidence on the links between expansions in coverage and population health outcomes, with a focus on the health effects of extended risk pooling and prepayment as key indicators of progress towards universal coverage across health systems. The evidence suggests that broader health coverage generally leads to better access to necessary care and improved population health, particularly for poor people. However, the available evidence base is limited by data and methodological constraints, and further research is needed to understand better the ways in which the effectiveness of extended health coverage can be maximised, including the effects of factors such as the quality of institutions and governance.

Incorporating financial protection into decision rules for publicly financed healthcare treatments.

Almost all health systems seek to offer some form of publicly financed healthcare insurance, and governments must therefore choose the size of the benefit package and the types of treatments to cover. Conventionally, the usual approach of economists has been to recommend choices on the basis of cost effectiveness of treatments, using metrics such as the 'cost per quality adjusted life year'. However, this approach is based on the assumption of health maximization subject to a budget constraint and ignores the potential impact of any additional concern with protecting individuals from the financial consequences of a health shock. Furthermore, it does not take account of the possible availability of complementary privately funded health care. This paper develops a model in which risk-averse individuals care about health but also place a value on protection from the financial consequences of rare but costly events. The paper shows how conventional cost-effectiveness analysis can readily be augmented to take account of financial protection objectives. The results depend on whether or not there exists a market in complementary privately funded health care. They have important implications for the methodology adopted by health technology assessment agencies and for the broader design of publicly funded health systems.

On the uses of routine patient-reported health outcome data.

It has long been standard practice to ask patients in clinical trials about their health status, but the practice is now being extended to patients receiving treatment on a routine basis. In this paper, we examine four types of analyses that these health data might inform: comparisons of alternative treatments for the same condition, of health care providers, of changes in performance over time and of treatments of different types of condition. Analytical challenges arise because counterfactuals cannot be observed and because health status cannot be measured continuously. The implications of these challenges and the ability to meet them vary according to the comparative exercise. We argue that, provided with a sufficient number of health status measures for each patient and proper risk adjustment, health status measurement has great potential to inform the first three types of comparison. However, we believe that it is not yet possible to use such data to make secure comparative judgements about the outcomes from treatment for different types of condition.

Building on value-based health care: Towards a health system perspective.

A variety of methodologies have been developed to help health systems increase the 'value' created from their available resources. The urgency of creating value is heightened by population ageing, growth in people with complex morbidities, technology advancements, and increased citizen expectations. This study develops a policy framework that seeks to reconcile the various approaches towards value-based policies in health systems. The distinctive contribution is that we focus on the value created by the health system as a whole, including health promotion, thus moving from value-based health care towards a value-based health system perspective. We define health system value to be the contribution of the health system to societal wellbeing. We adopt a framework of five dimensions of value, embracing health improvement, health care responsiveness, financial protection, efficiency and equity, which we map onto a society's aggregate wellbeing. Actors within the health system make different contributions to value, and we argue that their perspectives can be aligned with a unifying concept of health system value. We provide examples of policy levers and highlight key actors and how they can promote certain aspects of health system value. We discuss advantages of value-based approach based on the notion of wellbeing and some practical obstacles to its implementation.

A closer look at weight loss interventions in primary care: a systematic review and meta-analysis.

Purpose: The major aims were to quantify patient weight loss using various approaches adminstered by a primary care provider for at least 6 months and to unveil relevant contextual factors that could improve patient weight loss on a long-term basis. Methods: A systematic review and meta-analysis was conducted using Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Scopus, and Web of Science from inception to December 5, 2022. COVIDENCE systematic review software was used to identify and abstract data, as well as assess data quality and risk of bias. Results: Seven studies included 2,187 people with obesity testing (1) anti-obesity medication (AOM), (2) AOM, intensive lifestyle counseling + meal replacements, and (3) physician training to better counsel patients on intensive lifestyle modification. Substantial heterogeneity in the outcomes was observed, as well as bias toward lack of published studies showing no effect. The random effect model estimated a treatment effect for the aggregate efficacy of primary care interventions -3.54 kg (95% CI: -5.61 kg to -1.47 kg). Interventions that included a medication component (alone or as part of a multipronged intervention) achieved a greater weight reduction by -2.94 kg (p < 0.0001). In all interventions, efficacy declined with time (reduction in weight loss by 0.53 kg per 6 months, 95% CI: 0.04-1.0 kg). Conclusion: Weight loss interventions administered by a primary care provider can lead to modest weight loss. Weight loss is approximately doubled if anti-obesity medication is part of the treatment. Nevertheless, attenuated weight loss over time underscores the need for long-term treatment. Systematic review registration: [https://www.crd.york.ac.uk/prospero/ CRD4202121242344], identifier (CRD42021242344).

Effect of Cage Change Frequency on Perinatal Mortality in C57BL/6J Mice.

Perinatal mortality is a common problem in mouse breeding colonies. Few studies have examined the influence of environmental changes on mouse pup survival. In this study, monogamous breeding cages of C57BL/6J mice were set up and randomized into 3 cage change groups: 1) cage change at 8 d after parturition, 2) cage change at 3 d after parturition, or 3) cage change at 3 d after parturition with the addition of a polycarbonate hut in the cage. Pairs were bred to produce a minimum of 4 litters. Pup survival to weaning relative to experimental cage change date, and survival rates after cage change were evaluated. The results revealed no significant differences between experimental groups. The majority of pup loss occurred within the first 24 h after birth for those pups that were alive at birth. Overall, the postpartum day of cage change did not affect the perinatal survival of mouse pups.

The societal value of SARS-CoV-2 booster vaccination in Indonesia.

OBJECTIVES: To estimate the expected socio-economic value of booster vaccination in terms of averted deaths and averted closures of businesses and schools using simulation modelling. METHODS: The value of booster vaccination in Indonesia is estimated by comparing simulated societal costs under a twelve-month, 187-million-dose Moderna booster vaccination campaign to costs without boosters. The costs of an epidemic and its mitigation consist of lost lives, economic closures and lost education; cost-minimising non-pharmaceutical mitigation is chosen for each scenario. RESULTS: The cost-minimising non-pharmaceutical mitigation depends on the availability of vaccines: the differences between the two scenarios are 14 to 19 million years of in-person education and $153 to $204 billion in economic activity. The value of the booster campaign ranges from $2,500 ($1,400-$4,100) to $2,800 ($1,700-$4,600) per dose in the first year, depending on life-year valuations. CONCLUSIONS: The societal benefits of booster vaccination are substantial. Much of the value of vaccination resides in the reduced need for costly non-pharmaceutical mitigation. We propose cost minimisation as a tool for policy decision-making and valuation of vaccination, taking into account all socio-economic costs, and not averted deaths alone.

Effects of Housing Density on Reproductive Performance, Intracage Ammonia, and Welfare of Mice Continuously Housed as Breeders in Standard Mouse and Rat Caging.

Maintaining compliance with cage density recommendations in The Guide for the Care and Use of Laboratory Animals precludes continuous trio breeding in standard-sized mouse cages. This study evaluated and compared several parameters of reproductive performance, intracage ammonia concentration, and fecal corticosterone levels in 2 strains of mice, C57BL/6J (B6) and B6.129S(Cg)-Stat1tm1Dlv/J (STAT1-/-), housed as continuous breeding pairs or trios in standard-sized mouse cages, and continuous breeding trios in standard-sized rat cages. Reproductive performance data indicated that STAT1-/- trios raised in rat cages weaned significantly more pups per litter than did STAT1-/- trios raised in mouse cages, and B6 mice had higher pup survival rates at weaning than did STAT1-/- mice in mouse cages housing continuous breeding trios. In addition, the Production Index was significantly higher for B6 breeding trios in rat cages than for B6 trios in mouse cages. Intracage ammonia concentration increased with cage density, with significantly higher ammonia concentrations in mouse cages housing trios compared with rat cages housing trios. However, fecal corticosterone levels did not differ significantly regardless of genotype, breeding configuration, or cage size, and daily health checks revealed no clinical abnormalities under any of the conditions evaluated. These results suggest that, although continuous trio breeding in standard-sized mouse cages does not seem to compromise mouse welfare, it offers no advantage in reproductive performance compared with pair breeding, and in some cases, it might be disadvantageous in this regard. Further, high intracage ammonia in mouse cages containing breeding trios might necessitate more frequent cage changes.