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.

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).

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.

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.