Estimating deaths averted and cost per life saved by scaling up mRNA COVID-19 vaccination in low-income and lower-middle-income countries in the COVID-19 Omicron variant era: a modelling study

Objectives
While almost 60% of the world has received at least one dose of COVID-19 vaccine, the global distribution of vaccination has not been equitable. Only 4% of the population of low-income countries (LICs) has received a full primary vaccine series, compared with over 70% of the population of high-income nations.

Design
We used economic and epidemiological models, parameterised with public data on global vaccination and COVID-19 deaths, to estimate the potential benefits of scaling up vaccination programmes in LICs and lower-middle-income countries (LMICs) in 2022 in the context of global spread of the Omicron variant of SARS-CoV2.

Setting
Low-income and lower-middle-income nations.

Main outcome measures
Outcomes were expressed as number of avertable deaths through vaccination, costs of scale-up and cost per death averted. We conducted sensitivity analyses over a wide range of parameter estimates to account for uncertainty around key inputs.

Findings
Globally, universal vaccination in LIC/LMIC with three doses of an mRNA vaccine would result in an estimated 1.5 million COVID-19 deaths averted with a total estimated cost of US$61 billion and an estimated cost-per-COVID-19 death averted of US$40 800 (sensitivity analysis range: US$7400–US$81 500). Lower estimated infection fatality ratios, higher cost-per-dose and lower vaccine effectiveness or uptake lead to higher cost-per-death averted estimates in the analysis.

Conclusions
Scaling up COVID-19 global vaccination would avert millions of COVID-19 deaths and represents a reasonable investment in the context of the value of a statistical life. Given the magnitude of expected mortality facing LIC/LMIC without vaccination, this effort should be an urgent priority.

Leggi
Settembre 2022

Scoping review of the literature to ascertain how follow-up care is provided to major trauma patients post discharge from acute care

Objectives
Survival following traumatic injury has increased, requiring ongoing patient follow-up. While longitudinal outcomes of trauma patients are reported, little is known about optimal delivery of follow-up service for this group. The aim of this scoping review was to identify and describe the structure, process and outcomes of postdischarge follow-up services for patients who sustained major trauma.

Evidence review
This scoping review was conducted by searching CINAHL, MEDLINE and EMBASE databases. Articles were screened by three independent reviewers. The data of selected articles were organised in the categories of the Donabedian quality framework: structure, processes and outcomes.

Results
Twenty-six articles were included after screening by title/abstract then full text against the inclusion/exclusion criteria; 92% (n=24) were from the USA.
Follow-up services were provided by designated trauma centres and delivered by a mixture of health disciplines. Delivery of follow-up was multimodal (in person/telehealth). Protocols and guidelines helped to deliver follow-up care for non-physician led services.
Ongoing health issues including missed injuries, pain and infection were identified. No standardised criteria were established to determine recipients, the timing or frequency of follow-up was identified. Patients who engaged with follow-up services were more likely to participate in other health services. Patients reported satisfaction with follow-up care.

Conclusion
There are wide variations in how follow-up services for major trauma patients are provided. Further evaluation should focus on patient, family and organisational outcomes. Identifying who is most likely to benefit, when and how follow-up care is delivered are important next steps in improving outcomes.

Leggi
Settembre 2022

Cost-effectiveness of follow-up invasive coronary angiography after percutaneous coronary stenting: a real-world observational cohort study in Japan

Objectives
Follow-up invasive coronary angiography (FUICA) after percutaneous coronary intervention (PCI) has been shown to increase the rate of early coronary revascularisation without reducing the incidence of subsequent myocardial infarction or death. However, no studies have evaluated the cost-effectiveness of FUICA in patients after coronary stenting. Therefore, this study aimed to evaluate the cost-effectiveness of FUICA after PCI.

Design
Retrospective observational cohort study.

Setting
497 hospitals.

Participants and interventions
Overall, 558 patients who underwent coronary artery stenting between April 2014 and March 2015 were matched and included in the invasive angiographic follow-up (AF) group (n=279), in which patients underwent FUICA 6–12 months after PCI, or in the clinical follow-up alone group (CF; n=279) using propensity scores.

Primary and secondary outcome measures
The primary endpoint was the composite outcome of death, myocardial infarction, urgent coronary revascularisation, stroke or hospitalisation for the heart failure. The secondary endpoints included all-cause death, non-fatal myocardial infarction, urgent revascularisation, coronary artery bypass grafting, stroke, hospitalisation for the heart failure and any coronary revascularisation after a minimum of 6 months of follow-up.

Results
Costs were calculated as direct medical expenses based on medical fee billing information. The cumulative 3-year incidence of the primary endpoint was 5.3% in the AF group and 4.7% in the CF group (HR 1.02; 95% CI 0.47 to 2.20; p=0.98). The total incremental cost at the 3-year endpoint in the AF group was US$1874 higher than that in the CF group (US$8947±US$5684 vs US$7073±US$6360; p≤0.001).

Conclusions
FUICA increased the costs but did not improve clinical benefits. Thus, FUICA is not economically more attractive than CF alone.

Trial registration number
UMIN000039768.

Leggi
Agosto 2022

Factors influencing the translation of shared cancer follow-up care into clinical practice: a systematic review

Background
The increasing incidence of cancer, coupled with improved survivorship, has increased demand for cancer follow-up care and the need to find alternative models of care. Shared cancer follow-up care in general practice is a safe option in terms of quality of life and cancer recurrence; however, there are barriers to translating this into practice. This review aimed to identify factors that influence the translation of shared cancer follow-up care into clinical practice.

Methods
Systematic review. Seven electronic databases: MEDLINE, Science Citation Index, Academic Search Complete, CINAHL, APA Psychinfo, Health Source: Nursing/Academic Edition and Psychology and Behavioural Sciences Collection, were searched for published papers between January 1999 and December 2021. The narrative review included papers if they were available in full-text, English, peer-reviewed and focused on shared cancer follow-up care.

Results
Thirty-eight papers were included in the final review. Five main themes emerged: (1) reciprocal clinical information sharing is needed between oncologists and general practitioners, and needs to be timely and relevant; (2) responsibility of care should be shared with the oncologist overseeing care; (3) general practitioners skills and knowledge to provide cancer follow-up care; (4) need for clinical management guidelines and rapid referral to support general practitioners to provide shared follow-up care and (5) continuity of care and satisfaction of care is vital for shared care.

Conclusion
The acceptability of shared cancer follow-up care is increasing. Several barriers still exist to translating this into practice. Work is required to develop a shared-care model that can support general practitioners, while the oncologist can oversee the care and implement two-way communication between general and oncologists’ clinics. The move towards integrating electronic healthcare records and web-based platforms for information exchange provides a promise to the timely exchange of information.

PROSPERO registration number
CRD42020191538.

Leggi
Agosto 2022

Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study

Objetives
To analyse the effects of COVID-19 lockdown on mental well-being variables of older women, and to determine the influence of lifestyle and age on such effects. The hypothesis of the study was that all parameters related to mental well-being would worsen in older women during the COVID-19 lockdown.

Design
Observational follow-up study. Pre lockdown measurements were taken before the lockdown. Post lockdown measurements were taken as soon as began the de-escalation.

Setting
Senior centres in the Region of Murcia (Spain).

Participants
The sample was composed of 40 older women volunteers, over 54 years of age (mean age=62.35±8.15 years).

Primary and secondary outcome measures
Pre lockdown and post lockdown evaluations were carried out face to face. The following questionnaires were completed: Satisfaction with Life Scale, The Center for Epidemiologic Studies Depression Scale, The Short Form 36 Health Survey, The Pittsburgh Sleep Quality Index, the Global Physical Activity Questionnaire and Prevention with Mediterranean Diet.

Results
Post lockdown, a worsening was found in the variables of life satisfaction (p=0.001); depression (p

Leggi
Agosto 2022

Pessary or progesterone to prevent preterm birth in women with short cervical length: protocol of the 4-6 year follow-up of a randomised controlled trial (Quadruple-P)

Introduction
Vaginal progesterone and a cervical pessary are both interventions that are investigated for the prevention of preterm birth (PTB). Thus far, beneficial or harmful effects of these interventions on long-term child health and development are described, but evidence is not robust enough to draw firm conclusions. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of PTB considering the child’s health at 4–6 years of corrected age.

Methods and analysis
This study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of PTB. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4–6 years of corrected age. Children will be assessed using parental questionnaires. Main outcomes are child (neuro)development and behaviour. Other outcomes include child mortality, growth and general health. A composite of adverse child outcomes will be compared between the progesterone and pessary groups reporting OR and the corresponding 95% CI. Analyses will be performed separately for singletons and multiples and using the intention-to-treat approach.

Ethics and dissemination
The Medical Research Ethics Committee from Amsterdam UMC confirmed that de Medical Research Involving Human Subjects Act (WMO) did not apply to our study (W20_481 #20.531). Results will be published in a peer-reviewed journal and shared with stakeholders and participants. This protocol is published before analysis of the results.

Trial registration number
Dutch Trial Register (NL9646).

Leggi
Agosto 2022

Which factors play a role in the decision of mothers to participate in child follow-up examinations after participation in an RCT?: a semi-quantitative study

Objectives
To determine which factors contribute to the decision of mothers to participate with their child in follow-up (FU) examinations after participation in a randomised controlled trial (RCT) prior to conception.

Design
A cross-sectional survey, including Likert-scale items. Comparisons will be made between respondents who participated in all FU rounds of data collection and those who did not participate in any FU round with their child.

Participants
Women who participated in an RCT investigating the effect of a preconception lifestyle intervention (LIFEstyle study: Netherlands Trial Register: NTR1530) were invited to participate with their child in three FU data collections when the child had a mean age of 4.2 years, 4.6 years and 6.5 years, respectively. FU rounds included a health questionnaire, physical examination and cardiac assessment, successively.

Results
Sixty-seven respondents were included, of whom 7 (10%) did not participate in any FU round and 24 (36%) participated in all FU rounds. Women who participated with their child in all 3 FU data collection rounds felt more involved in the FU research (95.8%) and agreed more often that the FU was introduced well (91.7%) as compared with women that did not participate in any FU data collection round with their child (14.3% and 28.6%, respectively). Participants of FU rounds more often agreed that participation felt like a health check for their child as compared with non-participants. In addition, participants of the physical examination and cardiac assessment more often let their decision to participate depend fully on their child, as compared with non-participants (39.4% vs 17.7% and 52.5% vs 24%, respectively).

Conclusions
To increase participation rates in future FU studies of children after maternal participation in an RCT, we suggest to involve women in the design of the FU study, to emphasise possible perceived benefits of participation and to encourage women to actively involve their child in the decision of participation.

Leggi
Agosto 2022

A 5-Year Follow-Up of a Submucosal Tumor in the Stomach

Question: An asymptomatic 51-year-old man underwent esophagogastroduodenoscopy (EGD) at a health examination in August 2015, which revealed a gastric submucosal tumor at the lesser curvature of the lower gastric body (Figures A and B). The biopsy of the lesion showed chronic inflammation of the mucosa, with no evidence of gastric carcinoma; the patient was Helicobacter pylori–negative (Figure C). No significant abnormality was found during the physical examination or using laboratory tests such as blood biochemistry index and tumor makers.

Leggi
Agosto 2022

Long-term outcomes following antenatal exposure to low-dose aspirin: study protocol for the 4-year follow-up of the APRIL randomised controlled trial

Introduction
The use of low-dose aspirin by pregnant women to prevent preterm pre-eclampsia is gradually increasing. The administration of aspirin during pregnancy improves perinatal outcome, which could translate into improved child outcome in the long term. However, antenatal exposure to aspirin could have adverse effects on child development that may manifest later in life. The aim of this follow-up study is to assess the long-term effects of antenatal exposure to low-dose aspirin compared with placebo on survival, (neuro)development, behaviour and general health at 4 years corrected age.

Methods and analysis
This is a follow-up study of the Dutch double-blind randomised controlled APRIL trial which assessed the effectiveness of treatment with aspirin (80 mg daily) compared with placebo for the prevention of preterm birth in women with a previous spontaneous preterm birth. Treatment was initiated before 16 weeks of gestation and continued until 36 weeks or birth. We aim to follow-up all 379 children born to women who participated in the APRIL trial and survived the neonatal period, at the corrected age of 4 years. The main outcomes are (neuro)development as assessed by the Ages and Stages Questionnaire, and behaviour as assessed by the Strength and Difficulties Questionnaire. Additional outcomes include mortality, growth and general health from birth up to 4 years, and a composite outcome including mortality, abnormal (neuro)development and problem behaviour. Analyses will be performed by intention-to-treat using a superiority design.

Ethics and dissemination
Institutional Review Board approval was obtained from the Medical Research Ethics Committee from Amsterdam Medical Center (no. W20 289#20.325). The results will be published in a peer-reviewed journal and presented at conferences.

Trial registration number
The APRIL trial (NTR5675, NL5553; EudraCT number 2015-003220-31) and the APRIL follow-up study (NL8950) are registered in the Dutch trial register. The study is funded by the Amsterdam Reproduction & Development research institute.

Leggi
Agosto 2022

Three-month follow-up of durability of response to the third dose of the SARS-CoV-2 BNT162b2 vaccine in adults aged 60 years and older: a prospective cohort study

Objective
To evaluate the durability of response 3 months after the third BNT162b2 vaccine in adults aged 60 years and older.

Design
Prospective cohort study.

Setting
Single tertiary centre.

Participants
Healthcare workers/family members aged ≥60 years old who received the third BNT162b2 dose.

Interventions
Blood samples were drawn immediately before (T0), 10–19 days (T1) and 74–103 days (T2) after the third dose.

Primary and secondary outcome measures
Anti-spike IgG titres were determined using a commercial assay and seropositivity was defined as ≥50 arbitrary units (AU)/mL. Neutralising antibody titres were determined at T2. Adverse events, COVID-19 infections and Clinical Frailty Scale (CFS) levels were documented.

Results
The analysis included 97 participants (median age, 70 years (IQR, 66–74), 58% CFS level 2). IgG titres, which increased significantly from T0 to T1 (median, 440 AU/mL (IQR, 294–923) and median, 25 429 AU/mL (IQR, 14 203–36 114), respectively; p

Leggi
Agosto 2022

Short-term Health Insurance Plans Come Up Short for Patients With Cancer

Health care, particularly cancer care, is expensive. The current American health care system relies heavily on health insurance coverage to protect patients from catastrophic costs. Under the Affordable Care Act (ACA), standard insurance plans improved health care access for those with cancer by requiring insurance to cover a comprehensive set of medical issues, prohibiting plans from excluding coverage based on preexisting conditions, and restricting companies from charging higher premiums based on health status or sociodemographic factors. Unsurprisingly, comprehensive coverage under the ACA has led to overall higher premiums; however, total spending (premium plus out-of-pocket costs) decreased for individuals with low income and remained stable for individuals with high income from 2012 through 2015. The ACA market disruptions starting in 2017—attributed to changes in the political climate leading to escalating policy changes seeking to undermine and erode key ACA provisions—led to a steep 30% increase in premiums from 2017 through 2018 and a decrease in insurance coverage for cancer survivors. While premiums have since stabilized, costs of these plans have led some to consider cheaper alternatives, including short-term, limited-duration insurance (STLDI) plans. The STLDI plans were initially intended to fill short gaps between more comprehensive coverage and were limited under ACA rules to 90 days. They are exempt from covering the ACA’s 10 essential health benefits and typically provide bare-bones coverage of only limited medical services and do not provide protections for individuals with preexisting conditions (Table). An executive order in October 2017 expanded access to these plans, and regulatory changes by the US Department of Health and Human Services ultimately resulted in lengthening their duration (currently ≤364 days) and allowing for renewal for up to 36 months. Enrollment in STLDI plans subsequently increased 27% from 2018 to 2019.

Leggi
Agosto 2022

Enigma of the cholesterol paradox in acute myocardial infarction: lessons from an 8-year follow-up of all-cause mortality in an age-matched and sex-matched case-control study with controls from the patients recruitment area

Objective
To assess the impact of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) on long-term all-cause mortality (ACM) in patients with acute myocardial infarction (AMI) and controls.

Design
Matched case–control study with 8-year follow-up.

Setting
Vastmanland County Hospital, Vasteras, Sweden.

Participants
Consecutive patients with AMI admitted to the coronary care unit from March 2005 to May 2010 and age-matched and sex-matched controls from the general population.

Outcome measures
ACM.

Results
Person-year at risk among patients with AMI and controls was 11 667 (cases: 5780 and controls: 5887). During follow-up, 199 patients and 84 controls died, implying 3.4 deaths among patients and 1.4 among controls per 100 person-years at risk. Unadjusted Cox analyses showed significantly increasing mortality by decreasing TC and LDL-C levels in both patients (HR=0.70, 95% CI 0.62 to 0.79, p

Leggi
Luglio 2022

Missed opportunities for vaccination (MOV) in children up to 5 years old in 19 Medecins Sans Frontieres-supported health facilities: a cross-sectional survey in six low-resource countries

Objective
To describe missed opportunities for vaccination (MOV) among children visiting Médecins Sans Frontières (MSF)-supported facilities, their related factors, and to identify reasons for non-vaccination.

Design
Cross-sectional surveys conducted between 2011 and 2015.

Setting and participants
Children up to 59 months of age visiting 19 MSF-supported facilities (15 primary healthcare centres and four hospitals) in Afghanistan, Democratic Republic of the Congo, Mauritania, Niger, Pakistan and South Sudan. Only children whose caregivers presented their vaccination card were included.

Outcome measures
We describe MOV prevalence and reasons for no vaccination. We also assess the association of MOV with age, type of facility and reason for visit.

Results
Among 5055 children’s caregivers interviewed, 2738 presented a vaccination card of whom 62.8% were eligible for vaccination, and of those, 64.6% had an MOV. Presence of MOV was more likely in children visiting a hospital or a health facility for a reason other than vaccination. MOV occurrence was significantly higher among children aged 12–23 months (84.4%) and 24–59 months (88.3%) compared with children below 12 months (56.2%, p≤0.001). Main reasons reported by caregivers for MOV were lack of vaccines (40.3%), reason unknown (31.2%) and not being informed (17.6%).

Conclusions
Avoiding MOV should remain a priority in low-resource settings, in line with the new ‘Immunization Agenda 2030’. Children beyond their second year of life are particularly vulnerable for MOV. We strongly recommend assessment of eligibility for vaccination as routine healthcare practice regardless of the reason for the visit by screening vaccination card. Strengthening implementation of ‘Second year of life’ visits and catch-up activities are proposed strategies to reduce MOV.

Leggi
Luglio 2022

Parametric and non-parametric estimation of reference intervals for routine laboratory tests: an analysis of health check-up data for 260 889 young men in the South Korean military

Objectives
Determination of reference intervals (RIs) using big data faces several obstacles due to heterogeneity in analysers, period and ethnicity. The present study aimed to establish the RIs for routine common blood count (CBC) and biochemistry laboratory tests in homogeneous, healthy, male Korean soldiers in their 20s using a large health check-up data set, comparing parametric and non-parametric estimation.

Design
A multicentre, cross-sectional study.

Setting
Seven armed forces hospitals in South Korea.

Participants
A total of 609 649 men underwent health examination when promoted to corporal between January 2015 and September 2021. 260 889 eligible individuals aged 20–25 were included in the analysis.

Main outcomes and measures
The RIs were established by parametric and non-parametric methods. In the parametric approach, maximum likelihood estimation was applied to measure the Box-Cox transformation parameter and the values at the 2.5th and 97.5th percentiles were recalculated. The non-parametric approach adopted the Tukey’s exclusion test and the values at the 2.5th and 97.5th percentiles were obtained. Classification by body mass index was also performed.

Results
The obtained RIs for haematology parameters were comparable between devices. If the values followed a Gaussian distribution, parametric and non-parametric methods were well matched for haematology and biochemical markers. When the values were right-skewed, the upper limits were higher with parametric than with non-parametric methods. Participants with obesity showed higher RIs for CBC, some liver function tests and some lipid profiles than participants without obesity.

Conclusions
Using data from healthy, male Korean soldiers in their 20s, we proposed the RIs for CBC and biochemical parameters, comparing parametric and non-parametric estimation. As such approaches based on large data sets become more prevalent, further studies are needed to discriminate eligible individuals and determine RIs in an extrapolated sample.

Leggi
Luglio 2022

Overall quit in triple users of conventional cigarette, e-cigarette and heated tobacco product among healthy adults: a Korea Medical Institute health check-up study

Objective
While multiuse patterns of e-cigarettes (EC) or heated tobacco products (HTP) with conventional cigarettes (CC) have been reported, smoking cessation of multiusers is not well known. We aimed to analyse overall quit in triple users of CC, EC and HTP among healthy adults.

Methods
A questionnaire was conducted on 89 360 adults who visited the Korea Medical Institute health check-ups in Seoul, Korea, from May 2018 to September 2019. Among 38 812 ever smokers, 9252 were ever triple users of CC, EC and HTP. Frequency and related factors of overall quit were analysed in the cross-sectional study.

Results
The average age was 38.8±9.0 years, and 8458 (91.4%) were men. There were 5329 (57.6%) current triple users, 3547 (38.3%) single or dual product quitters and 376 (4.1%) overall quitters. Among the former triple users, the most common tobacco product use pattern was ‘dual quit of EC and HTP (eg, current CC use)’ both in men (21.3%) and women (26.3%). Age 60s or older (OR 8.5, 95% CI 5.2 to 13.8), women (OR 1.7, 95% CI 1.1 to 2.5), no hyperlipidaemia and married status were significantly related to overall quit.

Conclusion
The most common pathway for ‘ever triple users’ of the three tobacco products was ‘current triple users’, and the second was ‘CC users’. Single or dual product quitters could continue to smoke by EC or HTP instead of quit. Further research on overall quit will be needed to develop effective regulations.

Leggi
Luglio 2022

Different Approaches to requesting Consent for Routine data linkage in Neonatal follow-up (ACORN): protocol for a 2×2 factorial randomised trial

Introduction
Routinely collected data can be linked to research data to create a rich dataset and inform practice. However, consent is normally required to link identifiable data. Reported rates of consent to data linkage for children ranged from 21% to 96%, but no studies have investigated different approaches to seeking consent for data linkage for school-age children.

Methods and analysis
The Approaches to Consent for Routine Data Linkage in Neonatal Follow-up (ACORN) trial is a 2×2 factorial randomised trial to assess whether, for children who participated in neonatal randomised trials (pre-hypoglycaemia Prevention with Oral Dextrose Gel (hPOD), hPOD and The Impact of Protein Intravenous Nutrition on Development in Extremely Low Birth Weight Babies (ProVIDe)) and are approached to participate in an in-person assessment at 6–7 years of age, parental consent to data linkage is higher if consent is sought (1) after the in-person assessment (delayed) or concurrently and (2) for health and education data combined or separately. The primary outcomes will be rates of consent to linkage of (1) either health or education data and (2) both health and education data. A pilot study indicates the potentially available cohort size of 2110 (80% follow-up of the neonatal trial cohorts) would be adequate to detect an absolute difference of 6%–5%–4% from a baseline consent rate of 70%–85%–90%, respectively (2-tailed alpha 0.05, 90% power). With at least 1136 participants, the ACORN trial would have 90% power to detect an absolute difference of 5% in the primary outcome for each factor, assuming a consent rate of 90% in the control groups and alpha 0.05. Data are categorical and will be presented as number and per cent. The effects of factors will be tested using generalised linear models and presented as ORs and 95% CIs.

Ethics and dissemination
Ethics approval by the New Zealand Health and Disability Ethics Committee (19/STH/202). Dissemination will be via peer-reviewed publications, scientific meetings, educational sessions and public fora.

Trial registration number
ACTRN12621000571875 (Australian New Zealand Clinical Trials Registry).

Leggi
Luglio 2022