SAFER framework for moving forward on the medical device right to repair

Across various industries, the right to repair (RTR) movement has gained momentum as more than 20 states have proposed RTR laws to expand access to repair of consumer products. Medical device equipment shortages during the COVID-19 pandemic demonstrated that stronger repair mechanisms are necessary for the US health system to become more efficient, affordable and sustainable. We propose a 5-point SAFER framework including safety and security, adaptability, fiscal, environmental and regulatory factors for consideration in implementing medical device RTR. The healthcare community can help advance RTR legislation in a manner that serves our patients and healthcare system best.Copyright © 2023 BMJ Publishing Group. All rights reserved.

Essays on labor markets and health: Employment conditions and drug, suicide, and alcohol-related mortality among working-age adults in the United States

Americans in the twenty-first century are dying earlier in life and at higher rates from preventable causes than in nearly any other developed economy. Understanding of the root determinants of the recent reversal in life expectancy and identifying policy approaches to combat the rise in midlife mortality is a national public health and economic imperative. This dissertation focuses on the well-documented increase in fatal drug overdose, suicide, and alcohol-related mortality-a collection of causes of death often referred to as the "deaths of despair"-and examines the potential economic determinants of the acceleration in these causes of death over the past several decades. Building upon extensive literature examining macroeconomic and labor market conditions as upstream factors shaping population health, the following chapters consist of two empirical analyses intended to estimate the causal effect of short- to medium-term changes in local employment rates on these causes of death among working-age adults during the 2003-2017 period. These studies are of increasing importance as the United States continues to experience widespread employment uncertainty and prolonged economic distress in the wake of the COVID-19 pandemic.The first study presented in this dissertation focuses on the effects of county-level employment conditions on "deaths of despair" using a Bartik-style shift-share instrument to isolate demand-driven variation in county-level employment rates. In line with most existing studies that document countercyclical variation in suicide, I estimate that a one percentage point increase in the current-year employment-to-population ratio decreases non-drug suicide rates by one to two percent. On the other hand, my causal models suggest that rates of fatal drug overdose increase by a similar magnitude as the economy improves, and I find no evidence of changes in alcohol-related mortality in response to short-term employment shocks. I conduct a simulation exercise based on these point estimates to show that in general, and especially for accidental drug overdose, these estimated effects are small relative to the increases in cause-specific mortality over the 2003-2017 period.Motivated by the procyclical variation in accidental drug overdose uncovered in the first study, the second analysis examines the extent to which county employment rates affect the demand for prescription opioid medication among a population of commercially insured adults. This study draws on de-identified, individual-level pharmacy and medical claims from 2003-2017 aggregated to the county level to test the hypothesis that county-level employment fluctuations differentially affect the demand for prescription opioids that place individuals at higher (versus lower) risk for abuse and dependence. Unlike existing studies, I find no evidence of an effect of employment conditions on the demand for prescription opioids overall or differential effects between high- and low-risk prescriptions.The relatively small magnitude of the estimated effects, suggestive evidence of heterogeneity across demographic groups, and mixed findings on the cyclicality of these causes of death over various time horizons all point to a more complex set of factors underlying the rising rates of "deaths of despair" that is not explained by local employment rates alone. Developing a more nuanced understanding of these trends-particularly along key dimensions such as race/ethnicity and socioeconomic status-will be critically important in designing equitable policies to help the country recover from the COVID-19 pandemic and to reverse the disconcerting trends of increasing midlife mortality in the years to come. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Physician behavior and low-value care

Inappropriate prescribing and overprescribing are examples of low- or no-value care that result in high costs with little to no clinical benefit and patient harms. Suboptimal prescribing is the result of suboptimal physician decision-making. Physician behavior is influenced by intrinsic and extrinsic factors, such as reimbursement models, patient demand, diagnostic uncertainty, and poor numeracy. When faced with numerous diagnostic and treatment decisions per day, physicians rely on mental shortcut, or "heuristics", that unconsciously alter their perception of the risks and benefits of a treatment. While overtreatment or inappropriate prescribing occurs in many conditions, this dissertation concentrates on opioids, COVID-19 treatments, and benzodiazepines. The three aims of this dissertation include: (1) the downstream harms of opioid overprescribing during COVID-19;(2) the impact of setting on physician behavior in treating COVID-19 outpatients and associated outcomes;and (3) the effectiveness of a behavioral economic intervention on inappropriate benzodiazepine prescribing. We primarily address these aims using LA County Department of the Medical Examiner-Coroner autopsy reports, California Controlled Substance Utilization Review and Evaluation System data, and claims data (Optum's de-identified Clinformatics Data Mart Database (2007-2020)). We identify community- and decedent-level characteristics associated with opioid-related deaths following the implementation of stay-at-home orders in Los Angeles County. We estimate if the likelihood of initial provider interventions for COVID-19, including inappropriate prescribing, differs by appointment setting (i.e., urgent care center versus dedicated telehealth company) and if inappropriate prescribing for COVID-19 is associated with adverse outcomes (i.e., hospitalizations and mortality). Lastly, we measure the effect of a behavioral economic intervention in reducing benzodiazepine prescribing in a secondary analysis of a randomized controlled trial. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Pandemic justice: fairness, social inequality and COVID-19 healthcare priority-setting.

A comprehensive understanding of the ethics of the COVID-19 pandemic priorities must be sensitive to the influence of social inequality. We distinguish between ex-ante and ex-post relevance of social inequality for COVID-19 disadvantage. Ex-ante relevance refers to the distribution of risks of exposure. Ex-post relevance refers to the effect of inequality on how patients respond to infection. In the case of COVID-19, both ex-ante and ex-post effects suggest a distribution which is sensitive to the prevalence social inequality. On this basis, we provide a generic fairness argument for the claim that welfare states ought to favour a healthcare priority scheme that gives particular weight to protecting the socially disadvantaged.

Differences in Perception of Healthcare Management between Patients and Professionals.

Patient perception and the organizational and safety culture of health professionals are an indirect indicator of the quality of care. Both patient and health professional perceptions were evaluated, and their degree of coincidence was measured in the context of a mutual insurance company (MC Mutual). This study was based on the secondary analysis of routine data available in databases of patients' perceptions and professionals' evaluations of the quality of care provided by MC Mutual during the period 2017-2019, prior to the COVID-19 pandemic. Eight dimensions were considered: the results of care, coordination of professionals, trust-based care, clinical and administrative information, facilities and technical means, confidence in diagnosis, and confidence in treatment. The patients and professionals agreed on the dimension of confidence in treatment (good), and the dimensions of coordination and confidence in diagnosis (poor). They diverged on confidence in treatment, which was rated worse by patients than by professionals, and on results, information and infrastructure, which were rated worse by professionals only. This implies that care managers have to reinforce the training and supervision activities of the positive coincident aspects (therapy) for their maintenance, as well as the negative coincident ones (coordination and diagnostic) for the improvement of both perceptions. Reviewing patient and professional surveys is very useful for the supervision of health quality in the context of an occupational mutual insurance company.

Developing a telepharmacy programme with home medication dispensing and informed delivery in a tertiary hospital: description of the model and analysis of the results.

OBJECTIVES: This study aimed to describe the actions taken to implement a telepharmacy programme with home medication dispensing and informed delivery in an outpatient pharmaceutical care unit of a tertiary hospital, where approximately 5000 patients are treated per year. It also aimed to substantiate the applicability and benefits of the programme through analysing the findings and measuring patient satisfaction. METHODS: We identified the operational, logistical, technological and legal needs, as well as the need for training, information and coordination with the care team and patient associations. A standard operating procedure was developed which described the home dispensing model and the profile of patients eligible for telepharmacy. Care activity was evaluated, between the months of July 2020 and January 2021; and a survey was conducted to measure patient satisfaction based on the Enopex project, a cross-sectional observational study of patients who used telepharmacy services during the COVID-19 lockdown period in Spain. RESULTS: A total of 2536 medication deliveries were made over 144 working days, with a mean of 18 (standard deviation (SD): 6) deliveries per day, and a total of 2854 dispensings (1.1 drugs per delivery). In total, 197 different types of pharmaceutical formulations were delivered, corresponding to 123 active ingredients. The distance and time avoided during the study period totalled 1 05 624 km and 1 09 452 min (76 days), whereby the median distance and time saved per patient were 66 (interquartile range (IQR):122 km and 90 (IQR:90) minutes, which represents an approximate carbon footprint reduction of 25 kg of CO2 per patient and 16.5 tonnes in total. The satisfaction survey conducted, completed by 134 patients, revealed high satisfaction with the pharmacy service of 9.88 points out of 10. CONCLUSIONS: The SARS-CoV-2 pandemic (COVID-19) has provided the pharmacy service with an opportunity to develop and implement a telepharmacy programme that benefits patients, which has enabled better organisation of the unit and greater accessibility for patients attending in person. It is a replicable method that is applicable in other pharmacy services with similar characteristics and requirements.

'VaxTax': a follow-up proposal for a global vaccine pandemic response fund.

Equal access to vaccines has been one of the key ethical challenges during the COVID-19 pandemic. Most scholars consider the massive purchase and hoarding of vaccines by high-income countries, especially at the beginning of the pandemic, to be unjust towards the vulnerable living in low-income countries. A recent proposal by Andreas Albertsen of a vaccine tax has been put forward to remedy this problem. Under such a scheme, high-income countries would pay a contribution, conceptualised as a vaccine tax, dedicated to buying vaccines and distributing them to low and middle-income countries. Proceeding from this proposal, we critically assess the feasibility of a vaccine tax and suggest how to conceptualise and implement a vaccine tax in practice. We present our 'VaxTax model' and explore its comparative advantages and disadvantages while considering other possible measures to address the global vaccine access problem, also in view of future pandemics and disease outbreaks.

Fair compensation and the affective costs for indigenous doulas in Canada: A qualitative study.

BACKGROUND: In Canada, Indigenous doulas, or birth workers, who provide continuous, culturally appropriate perinatal support to Indigenous families, build on a long history of Indigenous birth work to provide accessible care to their underserviced communities, but there is little research on how these doulas organize and administer their services. METHODS: Semi-structured interviews were conducted in 2020 with five participants who each represented an Indigenous doula collective in Canada. One interview was conducted in person while the remaining four were conducted over Zoom due to COVID-19. Participants were selected through Internet searches and purposive sampling. Interview transcripts were approved by participants and subsequently coded by the entire research team to identify key themes. RESULTS: One of the five emergent themes in these responses is the issue of fair compensation, which includes two sub-themes: the need for fair payment models and the high cost of affective labour in the context of cultural responsibility and racial discrimination. DISCUSSION: Specifically, participants discuss the challenges and limitations of providing high quality care to families with complex needs and who cannot afford to pay for their services while ensuring that they are fairly compensated for their labour. An additional tension arises from these doulas' sense of cultural responsibility to support their kinship networks during one of the most sacred and vulnerable times in their lives within a colonial context of racism and a Western capitalist economy that financializes and medicalizes birth. CONCLUSION: These Indigenous birth workers regularly expend more affective labour than mainstream non-racialized counterparts yet are often paid less than a living wage. Though there are community-based doula models across the United States, the United Kingdom, and Sweden that serve underrepresented communities, further research needs to be conducted in the Canadian context to determine an equitable, sustainable pay model for community-based Indigenous doulas that is accessible for all Indigenous families.

Earlier cancer diagnosis in primary care: a feasibility economic analysis of ThinkCancer!

BACKGROUND: UK cancer survival rates are much lower compared with other high-income countries. In primary care, there are opportunities for GPs and other healthcare professionals to act more quickly in response to presented symptoms that might represent cancer. ThinkCancer! is a complex behaviour change intervention aimed at primary care practice teams to improve the timely diagnosis of cancer. AIM: To explore the costs of delivering the ThinkCancer! intervention to expedite cancer diagnosis in primary care. DESIGN & SETTING: Feasibility economic analysis using a micro-costing approach, which was undertaken in 19 general practices in Wales, UK. METHOD: From an NHS perspective, micro-costing methodology was used to determine whether it was feasible to gather sufficient economic data to cost the ThinkCancer! INTERVENTION: Owing to the COVID-19 pandemic, ThinkCancer! was mainly delivered remotely online in a digital format. Budget impact analysis (BIA) and sensitivity analysis were conducted to explore the costs of face-to-face delivery of the ThinkCancer! intervention as intended pre-COVID-19. RESULTS: The total costs of delivering the ThinkCancer! intervention across 19 general practices in Wales was £25 030, with an average cost per practice of £1317 (standard deviation [SD]: 578.2). Findings from the BIA indicated a total cost of £34 630 for face-to-face delivery. CONCLUSION: Data collection methods were successful in gathering sufficient health economics data to cost the ThinkCancer! INTERVENTION: Results of this feasibility study will be used to inform a future definitive economic evaluation alongside a pragmatic randomised controlled trial (RCT).

Cost analysis of severe burn victims in Southwest China: A 7-year retrospective study.

Background: Severe burn injury can be a life-threatening experience and can also lead to financial issues for suffers. The purpose of the current study was to analyze the direct hospitalization costs of severe burn inpatients in Southwest China. Methods: Data related to all inpatients admitted with severe burns [total body surface area (TBSA) ≥30%] pooled from 2015 to 2021 were reviewed retrospectively at the Institute of Burn Research of Army Medical University. Demographic parameters, medical economics, and clinical data were obtained from medical records. Results: A total of 668 cases were identified. The average age was 37.49 ± 21.00 years, and 72.3% were men. The average TBSA was 51.35 ± 19.49%. The median length of stay of inpatients in the burn intensive care unit was 14 [interquartile range (IQR): 5.0-34.8] days, and the median length of stay (LOS) was 41 (IQR: 22.0-73.8) days. The mortality rate was 1.6%. The median total cost was 212,755.45 CNY (IQR: 83,908.80-551,621.57 CNY) per patient varying from 3,521.30 to 4,822,357.19 CNY. The direct cost of scald burns was dramatically lower compared with that of other types of burns, with 11,213.43 to 2,819,019.14 CNY. Medical consumables presented the largest portion of total costs, with a median cost of 65,942.64 CNY (IQR: 18,771.86-171,197.97 CNY). The crucial risk factors for medical cost in our study were TBSA, surgical frequency, LOS, depth of burn, and outcome. Conclusion: We conclude that an effective burn prevention program, shorter hospital stays, and facilitating the healing of wounds should be focused on with tailored precautionary protocols to reduce the medical costs of inpatients with severe burns.

SAFER framework for moving forward on the medical device right to repair

Across various industries, the right to repair (RTR) movement has gained momentum as more than 20 states have proposed RTR laws to expand access to repair of consumer products. Medical device equipment shortages during the COVID-19 pandemic demonstrated that stronger repair mechanisms are necessary for the US health system to become more efficient, affordable and sustainable. We propose a 5-point SAFER framework including safety and security, adaptability, fiscal, environmental and regulatory factors for consideration in implementing medical device RTR. The healthcare community can help advance RTR legislation in a manner that serves our patients and healthcare system best.

Costs of Persons with Dementia Living in Nursing Homes in The Netherlands.

BACKGROUND: Disease modifying treatments (DMTs) currently under development for Alzheimer's disease, have the potential to prevent or postpone institutionalization and more expensive care and might delay institutionalization of persons with dementia. OBJECTIVE: The current study estimates costs of living in a nursing home for persons with dementia in the Netherlands to help inform economic evaluations of future DMTs. METHODS: Data were collected during semi-structured interviews with healthcare professionals and from the financial administration of a healthcare organization with several nursing homes. Personnel costs were calculated using a bottom-up approach by valuing the time estimates. Non-personnel costs were calculated using information from the financial administration of the healthcare organization. RESULTS: Total costs of a person with dementia per 24 hours, including both care staff and other healthcare providers, were € 151 for small-scale living wards and € 147 for independent living wards. Non-personnel costs were € 37 per day. CONCLUSION: This study provides Dutch estimates for total healthcare costs per day for institutionalized persons with dementia. These cost estimates can be used in cost-effectiveness analyses for future DMTs in dementia.

Depression and anxiety symptoms in workers during the COVID-19 pandemic

The COVID-19 pandemic caused a health, economic and social crisis, with important repercussions on working conditions, jobs, domestic life, and people's mental health. This study aimed to identify symptoms of depression and anxiety experienced during the COVID-19 pandemic in a sample of workers. For data collection, an online protocol was used, consisting of a sociodemographic and occupational questionnaire, the DASS-21 screening scale (Depression, Anxiety and Stress Scale-Short Form) and the Mental and Occupational Health Battery (BSMO). The study was carried out with 503 professionals, 78.5% female, with a mean age of 41.38 years (SD 11.89). Most of the sample (92%) had attended higher education and resided in the southern region of Brazil. It was found that single females who reported contact with people infected with COVID-19 and who indicated that they were more concerned about the disease had higher scores in anxiety/or depression. It is concluded that the BSMO scale discriminates anxiety from depression well and presents good correlation indicators with the DASS-21 scale. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Portuguese) Este estudo teve por objetivo identificar sintomas de depressao e ansiedade vivenciados durante a pandemia de COVID-19 em uma amostra de trabalhadores. Para a coleta de dados utilizou-se um protocolo on-line, composto por um questionario sociodemografico e ocupacional, pela escala de rastreio DASS-21 (Depression, Anxiety and Stress Scale-Short Form) e a Bateria de Saude Mental e Ocupacional (BSMO). O estudo foi realizado com 503 profissionais de diferentes ocupacoes, 78,5% do sexo feminino, com idade media de 41,38 anos (DP 11,89). A maioria (92%) cursou o ensino superior e reside na regiao Sul do Brasil. Foi verificado que pessoas do sexo feminino, solteiras, que referiram contato com pessoas contaminadas pela COVID-19 e que se mostraram mais preocupadas com a doenca tiveram escores mais altos em ansiedade e/ou depressao. Conclui-se que a escala BSMO discrimina bem a ansiedade da depressao e apresenta bons indicadores de correlacao com a escala DASS-21. (PsycInfo Database Record (c) 2022 APA, all rights reserved) (Spanish) Este estudio tuvo como objetivo identificar los sintomas de depresion y ansiedad experimentados durante la pandemia de COVID-19 en una muestra de trabajadores. Para la recoleccion de datos se utilizo un protocolo online, compuesto por un cuestionario sociodemografico y ocupacional, la escala de cribado DASS-21 (Depression, Anxiety and Stress Scale-Short Form) y la Bateria de Salud Mental y Ocupacional (BSMO). El estudio se realizo con 503 profesionales de diferentes ocupaciones, 78,5% mujeres, con una edad media de 41,38 anos (DP 11,89). La mayoria de la muestra (92%) asistio a la educacion superior y reside en la region sur de Brasil. Se encontro que las mujeres solteras que informaron haber estado en contacto con personas infectadas con COVID-19 y que indicaron que estaban mas preocupadas por la enfermedad tenian puntuaciones mas altas en ansiedad y/o depresion. Se puede concluir que la escala BSMO discrimina bien la ansiedad de la depresion y presenta buenos indicadores de correlacion con la escala DASS-21. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

Costs of seasonal influenza vaccination in South Africa.

BACKGROUND: Influenza accounts for a substantial number of deaths and hospitalisations annually in South Africa. To address this disease burden, the South African National Department of Health introduced a trivalent inactivated influenza vaccination programme in 2010. METHODS: We adapted and populated the WHO Seasonal Influenza Immunization Costing Tool (WHO SIICT) with country-specific data to estimate the cost of the influenza vaccination programme in South Africa. Data were obtained through key-informant interviews at different levels of the health system and through a review of existing secondary data sources. Costs were estimated from a public provider perspective and expressed in 2018 prices. We conducted scenario analyses to assess the impact of different levels of programme expansion and the use of quadrivalent vaccines on total programme costs. RESULTS: Total financial and economic costs were estimated at approximately USD 2.93 million and USD 7.91 million, respectively, while financial and economic cost per person immunised was estimated at USD 3.29 and USD 8.88, respectively. Expanding the programme by 5% and 10% increased economic cost per person immunised to USD 9.36 and USD 9.52 in the two scenarios, respectively. Finally, replacing trivalent inactivated influenza vaccine (TIV) with quadrivalent vaccine increased financial and economic costs to USD 4.89 and USD 10.48 per person immunised, respectively. CONCLUSION: We adapted the WHO SIICT and provide estimates of the total costs of the seasonal influenza vaccination programme in South Africa. These estimates provide a basis for planning future programme expansion and may serve as inputs for cost-effectiveness analyses of seasonal influenza vaccination programmes.

Multispecialty multidisciplinary input into comorbidities along with treatment optimisation in heart failure reduces hospitalisation and clinic attendance.

AIMS: Heart failure (HF) is associated with comorbidities which independently influence treatment response and outcomes. This retrospective observational study (January 2020-June 2021) analysed the impact of monthly HF multispecialty multidisciplinary team (MDT) meetings to address management of HF comorbidities and thereby on provision, cost of care and HF outcomes. METHODS: Patients acted as their own controls, with outcomes compared for equal periods (for each patient) pre (HF MDT) versus post-MDT (multispecialty) meeting. The multispecialty MDT comprised HF cardiologists (primary, secondary, tertiary care), HF nurses, nephrologist, endocrinologist, palliative care, chest physician, pharmacist, clinical pharmacologist and geriatrician. Outcome measures were (1) all-cause hospitalisations, (2) outpatient clinic attendances and (3) cost. RESULTS: 334 patients (mean age 72.5±11 years) were discussed virtually through MDT meetings and follow-up duration was 13.9±4 months. Mean age-adjusted Charlson Comorbidity Index was 7.6±2.1 and Rockwood Frailty Score 5.5±1.6. Multispecialty interventions included optimising diabetes therapy (haemoglobin A1c-HbA1c pre-MDT 68±11 mmol/mol vs post-MDT 61±9 mmol/mol; p<0.001), deprescribing to reduce anticholinergic burden (pre-MDT 1.85±0.4 vs 1.5±0.3 post-MDT; p<0.001), initiation of renin-angiotensin aldosterone system inhibitors in HF with reduced ejection fraction (HFrEF) with advanced chronic kidney disease (9% pre vs 71% post-MDT; p<0.001). Other interventions included potassium binders, treatment of anaemia, falls assessment, management of chest conditions, day-case ascitic, pleural drains and palliative support. Total cost of funding monthly multispecialty meetings was £32 400 and resultant 64 clinic appointments cost £9600. The post-MDT study period was associated with reduction in 481 clinic appointments (cost saving £72150) and reduced all-cause hospitalisations (pre-MDT 1.1±0.4 vs 0.6±0.1 post-MDT; p<0.001), reduction of 1586 hospital bed-days and cost savings of £634 400. Total cost saving to the healthcare system was £664 550. CONCLUSION: HF multispecialty virtual MDT model provides integrated, holistic care across all healthcare tiers for management of HF and associated comorbidities. This approach is associated with reduced clinic attendances and all-cause hospitalisations, leading to significant cost savings.

Preoperative virtual video visits only: a convenient option that should be offered to caregivers beyond the pandemic.

Objective: During the COVID-19 pandemic, our group implemented preoperative video visits (VVs) to limit physical contact. The aim of this study was to determine caregivers' and providers' perceptions of this practice and to determine feasibility for continuation. Methods: All patients who had only a preoperative VV prior to an elective surgery were identified from March-October 2020. Caregivers, surgeons, and clinic staff were surveyed about their experiences. Results: Thirty-four preoperative VVs were followed by an elective surgery without a preceding in-person visit. Of the 31 caregiver surveys completed, the majority strongly agreed that the VV was more convenient (87%, n=27). Eighty-one percent (n=25) strongly agreed or agreed that the VV saved them money. Ninety-four percent (n=29) strongly agreed or agreed that they would choose the VV option again. Caregivers saved an average travel distance of 60.3 miles one way (range 6.1-480). Of the 13/17 providers who responded, 77% (n=10) expressed that the practice should continue. Conclusions: Virtual health became a necessity during the pandemic, and caregivers were overwhelmingly satisfied. Continuing VVs as an option beyond the pandemic may be a reasonable and effective way to help eliminate some of the hurdles that impede healthcare-seeking behavior and should be offered.