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.

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Settembre 2022

Low back pain in the Bangladeshi adult population: a cross-sectional national survey

Objective
Low back pain (LBP) is a common musculoskeletal disorder. This study aims to determine the residence-specific and sex-specific prevalence and the factors associated with LBP in Bangladesh.

Methods
The study subjects (aged ≥18 years) were identified from 20 primary sampling units of the national census following a cross-sectional multistage stratified sampling design. We considered the mechanical type of LBP for this study. A Bangla version of the modified Community Oriented Programme for Control of Rheumatic Disorders questionnaire was used. A team of trained field workers, rheumatology residents and rheumatologists collected the data. Analysis was done using weighted data.

Results
Two thousand subjects were approached, but 1843 could be screened. Among them, 561 had musculoskeletal disorders, and 343 were diagnosed with LBP. The weighted prevalence of LBP was 18.5% (95% CI: 11.8% to 25.2%) and age-standardised prevalence of LBP was 19.4% (95% CI: 14.0% to 24.8%), which was higher in women (27.2%, 19.3% to 35.1%) than men (14.0%, 8.7% to 19.3%). The prevalence persistently increased from age group 18–34 years (10.5%, 5.7 to 15.4) to ≥55 years (27.8%, 16.1% to 39.5%). People with no education had the highest prevalence (31.3%, 22.3% to 40.4%). The prevalence did not differ between urban and rural residential locations. Four factors were significantly associated with LBP: age (adjusted odds ratio: 2.4, 95% CI: 1.7 to 3.4), female sex (2.2, 1.5 to 3.3), absence of formal education (2.3, 1.6 to 3.3) and hypertension (1.7, 1.1 to 2.6).

Conclusion
LBP is a common problem in Bangladeshi adults. The factors identified are age, female sex, no formal education and hypertension. These should be addressed adequately to prevent and treat LBP.

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Settembre 2022

Global, regional and national trends in statin utilisation in high-income and low/middle-income countries, 2015-2020

Objective
Prior studies have reported inequitable global access to essential medicines for cardiovascular disease (CVD) prevention, especially statins. Here we examine recent trends and disparities in statin utilisation at the income group, regional and country levels.

Design
Ecological study. Pharmaceutical sales data were used to examine statin utilisation in high-income counties (HICs) and low/middle-income countries (LMICs) from 2015 to 2020. Population estimates were obtained from the Global Burden of Disease. Fixed-effects panel regression analysis was used to examine associations between statin utilisation and country-level factors.

Setting
Global, including 41 HICs and 50 LMICs.

Participants
Population older than 40 years of age.

Primary and secondary outcome measures
Statin utilisation was measured using defined daily doses (DDDs) per 1000 population ≥40 years per day (TPD).

Results
Globally, statin utilisation increased 24.7% from 54.7 DDDs/TPD in 2015 to 68.3 DDDs/TPD in 2020. However, regional and income group disparities persisted during this period. In 2020, statin utilisation was more than six times higher in HICs than LMICs (192.4 vs 28.4 DDDs/TPD, p

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Settembre 2022

Prevalence and changes of low-value care at acute care hospitals: a multicentre observational study in Japan

Objectives
We aimed to examine the use and factors associated with the provision of low-value care in Japan.

Design
A multicentre observational study.

Setting
Routinely collected claims data that include all inpatient and outpatient visits in 242 large acute care hospitals (accounting for approximately 11% of all acute hospitalisations in Japan).

Participants
345 564 patients (median age (IQR): 62 (40–75) years; 182 938 (52.9%) women) seeking care at least once in the hospitals in the fiscal year 2019.

Primary and secondary outcome measures
We identified 33 low-value services, as defined by clinical evidence, and developed two versions of claims-based measures of low-value services with different sensitivity and specificity (broader and narrower definitions). We examined the number of low-value services, the proportion of patients receiving these services and the proportion of total healthcare spending incurred by these services in 2019. We also evaluated the 2015–2019 trends in the number of low-value services.

Results
Services identified by broader low-value care definition occurred in 7.5% of patients and accounted for 0.5% of overall annual healthcare spending. Services identified by narrower low-value care definition occurred in 4.9% of patients and constituted 0.2% of overall annual healthcare spending. Overall, there was no clear trend in the prevalence of low-value services between 2015 and 2019. When focusing on each of the 17 services accounting for more than 99% of all low-value services identified (narrower definition), 6 showed decreasing trends from 2015 to 2019, while 4 showed increasing trends. Hospital size and patients’ age, sex and comorbidities were associated with the probability of receiving low-value service.

Conclusions
A substantial number of patients received low-value care in Japan. Several low-value services with high frequency, especially with increasing trends, require further investigation and policy interventions for better resource allocation.

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Settembre 2022

Systematic review of suicide prevention studies with data on youth and young adults living in low-income and middle-income countries

Objectives
This review aimed to provide a summary of peer-reviewed, published literature on suicide preventive interventions with data on youth and young adults in low-income and middle-income countries (LMIC).

Design
A systematic review was conducted using electronic databases of PubMed/MEDLINE, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Education Resources Information Center and The Campbell Collaboration databases for English-language articles published between 1 January 1990 and 15 February 2022.

Eligibility criteria
Interventions of interest could include behavioural, community, clinical/medical or policy studies, or any combination of these, so long as the studies had at least one outcome of interest and at least one control group or control period. Outcomes included suicide ideation, suicide attempt and suicide. Interventions must have been conducted in an LMIC. Studies with individuals ages 0–25 in the sample were included. Articles describing data on individuals over age 25 could be included if individuals ages 0–25 were part of the sample.

Results
A total of 44 eligible studies were identified, representing a broad range of universal, selective and indicated interventions. Most studies assessed interventions designed to address lethal means or mental health. Most studies were conducted in lower-middle-income or upper-middle-income countries, with the largest proportion in Asia. Assessment of outcomes across studies was heterogeneous and there were few large-scale investigations tailored specifically for youth.

Conclusions
Most of the published, peer-reviewed suicide intervention research from LMIC is concentrated in a few countries. While geographical coverage to date has been limited, strategies and samples in included studies were diverse, representing populations in clinical, educational and community settings. While current findings hold promise, this review identified a need for large-scale studies designed specifically for youth.

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Settembre 2022

Prefabricated contoured foot orthoses to reduce pain and increase physical activity in people with hip osteoarthritis: protocol for a randomised feasibility trial

Introduction
The aim of this randomised feasibility trial is to determine the feasibility of conducting an adequately powered randomised controlled trial (RCT) investigating the efficacy of prefabricated contoured foot orthoses in people with hip osteoarthritis (OA). The secondary aims of the trial are to compare the effect of prefabricated contoured foot orthoses to a flat shoe insert comparator on outcomes of hip-related pain, physical activity and quality of life. We hypothesise that the demand, implementation, acceptability and practicality of foot orthoses as a treatment option for people with hip OA will be deemed feasible, informing the development of an adequately powered RCT to evaluate the efficacy and long term outcomes.

Methods and analysis
We will recruit 28 people with hip OA who will be randomised to receive either prefabricated contoured foot orthoses or flat shoe inserts to use for a 6-week period. Both groups will receive standardised education on hip OA and physical activity. The study’s primary outcome is the feasibility domains of demand, implementation, acceptability and practicality. The secondary outcomes include the change in Hip Osteoarthritis Outcome Score-12, Patient Health Questionnaire-9, Brief Fear of Movement Scale for OA, Physical activity accelerometry and the Physical Activity Questionnaire-short form. Descriptive statistics will be used to describe feasibility outcomes with limited efficacy analysis used for the secondary outcomes. Linear mixed models will be used to analyse between-group differences at 6 weeks, with baseline values used as covariates, treatment allocation as a fixed factor and participant as a random factor.

Ethics and dissemination
This trial has been approved by the La Trobe University Human Research Ethics Committee (HEC20427), St. Vincent’s Hospital Melbourne, Human Research Ethics Committee (HREC 266/20) and Northern Health Research Governance (NH-2021-292862). The results will be disseminated via a peer-reviewed journal and presented at international conferences.

Trial registration number
NCT05138380.

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Settembre 2022

Patients self-reported medical care for low back pain: a nationwide population-based study

Objectives
To estimate the prevalence of medical care-seeking among adults with low back pain (LBP) and to characterise and compare use of diagnostic procedures and medical management between primary and secondary care.

Design
Cross-sectional study.

Setting
Data from the EpiReumaPt, a nationwide population-based study conducted in Portugal including a representative sample of non-institutionalised adults (n=10 661) stratified by administrative territorial units was analysed.

Participants
Individuals who self-reported history of LBP within the previous 12 months (n=6434) and sought medical care for this problem in the same period (n=2618).

Outcome measures
Patients’ self-reported diagnostic workup and management procedures performed by medical care for LBP collected through a structured questionnaire. Medical care procedures were stratified by level of care.

Results
The prevalence of medical care-seeking for LBP was 38.0% (95% CI 35.9% to 40.1%). Primary care in isolation (45.3%) was the most sought level of care. Emergency departments (25.9%) and orthopaedics (19.4%) were the most sought secondary medical specialties. Several pathoanatomical diagnoses were used, supported by laboratory or imaging tests (91.1%). Disc herniation (20.4%) and osteoarthritis (19.7%) were the most frequent diagnoses, and X-ray (63.7%) was the most frequent diagnostic procedure self-reported by individuals. Most (75.1%) reported being treated for LBP: 80.4% with oral medication and 49.9% with injectables. The mean duration of pharmacological treatment was 104.24 (SD, 266.80) days. The use of pathoanatomical diagnoses, laboratory or imaging tests, and pharmacological treatments were generally more frequent for secondary care (p

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Settembre 2022

Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial

Introduction
Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty.

Methods and analysis
RECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed at nine Danish hospitals. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Eligible participants undergoing total hip arthroplasty are randomised to:group A: oral paracetamol 1000 mg x 4+oral ibuprofen 400 mg x 4+intravenous placebo; group B: oral paracetamol 1000 mg x 4+intravenous dexamethasone 24 mg+oral placebo; group C: oral ibuprofen 400 mg x 4+intravenous dexamethasone 24 mg+oral placebo; group D: oral paracetamol 1000 mg x 4+oral ibuprofen 400 mg x 4+intravenous dexamethasone 24 mg.
Primary outcome is cumulative opioid consumption at 0–24 hours. Secondary outcomes are pain at rest, during mobilisation and during a 5 m walk and adverse events. Follow-up includes serious adverse events and patient reported outcome measures at 90 days and 1 year. A total of 1060 participants are needed to demonstrate a difference of 8 mg in 24-hour morphine consumption assuming an SD of 24.5 mg, a risk of type I errors of 0.0083 and a risk of type 2 errors of 0.2. Primary analysis will be a modified intention-to-treat analysis.
With this trial we aim to verify recommendations for pain treatment after total hip arthroplasty, and investigate the role of dexamethasone as an analgesic adjuvant to paracetamol and ibuprofen.

Ethics and dissemination
This trial is approved by the Region Zealand Committee on Health Research Ethics (SJ-799). Plans for dissemination include publication in peer-reviewed journals and presentation at scientific meetings.

Trial registration number
NCT04123873.

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Settembre 2022

Acupuncture versus massage for pain in patients living with advanced cancer: a protocol for the IMPACT randomised clinical trial

Introduction
Pain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.

Methods and analysis
We describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.

Ethics and dissemination
The Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.

Trial registration number
NCT04095234.

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Settembre 2022

Process evaluation of complex interventions in non-communicable and neglected tropical diseases in low- and middle-income countries: a scoping review

Objectives
The aim of this review is to map out the use of process evaluation (PE) in complex interventions that address non-communicable diseases (NCDs) and neglected tropical diseases (NTDs) to identify gaps in the design and conduct, as well as strengths, limitations and implications, of this type of research in low- and middle-income countries (LMICs).

Design
Scoping review of PE studies of complex interventions implemented in LMICs. Six databases were searched focused on studies published since 2008.

Data sources
Embase, PubMed, EbscoHost, Web of Science (WOS), Virtual Health Library (VHL) Regional Portal and Global Index Medicus: Regional Indexes AIM (AFRO), LILACS (AMRO/PAHO), IMEMR (EMRO), IMSEAR (SEARO), WPRIM (WPRO) Global Index Regional Indexes, MEDLINE, SciELO.

Eligibility criteria
Studies conducted in LMICs on PEs of randomised controlled trials (RCTs) and non-RCTs published between January 2008 and January 2020. Other criteria were studies of interventions for people at risk or having physical and mental NCDs, and/or NTDs, and/or their healthcare providers and/or others related to achieve better health for these two disease groups. Studies were excluded if they were not reported in English or Spanish or Portuguese or French, not peer-reviewed articles, not empirical research and not human research.

Data extraction and synthesis
Data extracted to be evaluated were: available evidence in the utilisation of PE in the areas of NCDs and NTDs, including frameworks and theories used; methods applied to conduct PEs; and in a subsample, the barriers and facilitators to implement complex interventions identified through the PE. Variables were extracted and categorised. The information was synthesised through quantitative analysis by reporting frequencies and percentages. Qualitative analysis was also performed to understand facilitators and barriers presented in these studies. The implications for PEs, and how the information from the PE was used by researchers or other stakeholders were also assessed in this approach.

Results
303 studies were identified, 79% were for NCDs, 12% used the label ‘PE’, 27% described a theory or framework for the PE, and 42% used mixed methods to analyse their findings. Acceptability, barriers and facilitators to implement the interventions, experiences and perceptions, and feasibility were the outcomes most frequently evaluated as part of the PEs. Barriers and facilitators themes identified were contextual factors, health system factors, human resources, attitudes and policy factors.

Conclusions
PEs in NCDs and NTDs are used in LMICs with a wide variety of methods. This review identified many PEs that were not labelled by the authors as such, as well as a limited application of PE-related theories and frameworks, and heterogeneous reporting of this type of study.

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Settembre 2022