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AnteayerBMJ Open

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Por: Sonneville · R. · Couffignal · C. · Sigaud · F. · Godard · V. · Audibert · J. · Contou · D. · Celier · A. · Djibre · M. · Schmidt · J. · Jaquet · P. · Mekontso Dessap · A. · Bourel · C. · Bellot · R. · Roy · C. · Lamara · F. · Essardy · F. · Timsit · J.-F. · Cornic · R. · Bouadma · L. · On b
Introduction

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number

NCT04273360.

Efficacy of a physiotherapy, yoga and patient education programme for patients with breast cancer and hormone therapy-induced pain: a multicentre randomised study protocol (SKYPE 2)

Por: Faravel · K. · Jarlier · M. · Meignant · L. · Thomaso · M. · Del Rio · M. · Jacot · W. · Stoebner · A.
Introduction

Osteoarticular pain is experienced by approximately 50% of patients with breast cancer under hormone therapy and can increase the risk of therapy discontinuation. Among complementary therapies, yoga has shown efficacy regarding reduction of fatigue, anxiety, pain due to hormone therapy and inflammation. Personalised patient education programmes increase engagement and motivation, and induce effective behavioural changes. The SKYPE programme, an integrated intervention combining physiotherapy, yoga and patient education, showed promising efficacy on hormone therapy-induced pain in a previous pilot study. In this study, we hypothesised that using theory-based patient education favour learning and practising 15 min of at-home yoga every day to decrease hormone therapy-induced pain.

Methods and analysis

This multicentre randomised study will assess the efficacy of the SKYPE programme on pain reduction compared with standard care in patients with breast cancer reporting osteoarticular pain due to hormone therapy. Main secondary objectives will describe pain evolution and characteristics, patient adhesion to yoga sessions and home practice, forward flexibility, quality of life, fatigue, anxiety and compliance to hormone therapy. Patients in the intervention group will participate in 1 weekly educational yoga session of 90 min for 6 weeks, supervised by physiotherapists (period 1). They will also perform daily at-home 15 min yoga sessions for 12 weeks, the total duration of the intervention (periods 1 and 2). Pain will be evaluated during physiotherapy check-ups at baseline (T0), at 6 weeks (T1) and at 12 weeks (T2).

Ethics and dissemination

This study was approved by the ethics committee (CPP Ile de France 8 on 22 June 2020). The results will be disseminated to patients and healthcare professionals, and published in a peer-reviewed journal.

Trial registration number

NCT04457895.

Methods and measures to evaluate the impact of participatory model building on public policymakers: a scoping review protocol

Por: Henson · R. M. · Purtle · J. · Headen · I. · Stankov · I. · Langellier · B. A.
Introduction

Public policymakers are increasingly engaged in participatory model building processes, such as group model building. Understanding the impacts of policymaker participation in these processes on policymakers is important given that their decisions often have significant influence on the dynamics of complex systems that affect health. Little is known about the extent to which the impacts of participatory model building on public policymakers have been evaluated or the methods and measures used to evaluate these impacts.

Methods and analysis

A scoping review protocol was developed with the objectives of: (1) scoping studies that have evaluated the impacts of facilitated participatory model building processes on public policymakers who participated in these processes; and (2) describing methods and measures used to evaluate impacts and the main findings of these evaluations. The Joanna Briggs Institute’s Population, Concept, Context framework was used to formulate the article identification process. Seven electronic databases—MEDLINE (Ovid), ProQuest Health and Medical, Scopus, Web of Science, Embase (Ovid), CINAHL Complete and PsycInfo—will be searched. Identified articles will be screened according to inclusion and exclusion criteria and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist for scoping reviews will be used and reported. A data extraction tool will collect information across three domains: study characteristics, methods and measures, and findings. The review will be conducted using Covidence, a systematic review data management platform.

Ethics and dissemination

The scoping review produced will generate an overview of how public policymaker engagement in participatory model building processes has been evaluated. Findings will be disseminated through peer-reviewed publications and to communities of practice that convene policymakers in participatory model building processes. This review will not require ethics approval because it is not human subject research.

Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol

Por: Amraoui · J. · Bordenave · L. · Leclerc · G. · Salvignol · G. · Jarlier · M. · Fiess · C. · Philibert · L. · Fuzier · R. · Touraine · C.
Introduction

Preoperative anxiety is a frequent problem that can lead to complications both during anaesthesia and in the postoperative period, especially in oncology. Studies have shown that it can be managed using non-pharmacological approaches, but few works have evaluated psychoeducational programmes. The aim of the COHErence Cardiaque (COHEC) II Study is to evaluate the combination of medical hypnosis (MH) and cardiac coherence (CC) training to manage preoperative anxiety in patients with cancer.

Methods and analysis

COHEC II is an ongoing multicentre randomised clinical trial carried out in three French comprehensive cancer centres. In total, 296 patients who will undergo surgery for cancer will be recruited during 18 months and will be randomised in the control arm or the intervention arm. Patients in the intervention arm will follow a daily programme that combines MH and CC, starting 7 days before surgery. The control arm will receive the standard treatment to manage preoperative anxiety. The primary endpoint is the anxiety level on surgery day, measured using a Visual Analogue Scale. Secondary endpoints are patient adherence to the programme, satisfaction and postsurgery recovery quality.

Ethics and dissemination

The study protocol was approved by the French Ethics Committee (Comité de Protection des Personnes EST-II) on 24 November 2021 and will be carried out following the good practice guidelines and the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences.

Trial registration number

NCT05197972.

Blood cell differential count discretisation modelling to predict survival in adults reporting to the emergency room: a retrospective cohort study

Por: Fumagalli · R. M. · Chiarelli · M. · Cazzaniga · M. · Bonato · C. · D'Angelo · L. · Cavalieri D'Oro · L. · Cerino · M. · Terragni · S. · Lainu · E. · Lorini · C. · Scarazzati · C. · Tazzari · S. E. · Porro · F. · Alde · S. · Burati · M. · Brambilla · W. · Nattino · S. · Locatelli · M. · Va
Objectives

To assess the survival predictivity of baseline blood cell differential count (BCDC), discretised according to two different methods, in adults visiting an emergency room (ER) for illness or trauma over 1 year.

Design

Retrospective cohort study of hospital records.

Setting

Tertiary care public hospital in northern Italy.

Participants

11 052 patients aged >18 years, consecutively admitted to the ER in 1 year, and for whom BCDC collection was indicated by ER medical staff at first presentation.

Primary outcome

Survival was the referral outcome for explorative model development. Automated BCDC analysis at baseline assessed haemoglobin, mean cell volume (MCV), red cell distribution width (RDW), platelet distribution width (PDW), platelet haematocrit (PCT), absolute red blood cells, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets. Discretisation cut-offs were defined by benchmark and tailored methods. Benchmark cut-offs were stated based on laboratory reference values (Clinical and Laboratory Standards Institute). Tailored cut-offs for linear, sigmoid-shaped and U-shaped distributed variables were discretised by maximally selected rank statistics and by optimal-equal HR, respectively. Explanatory variables (age, gender, ER admission during SARS-CoV2 surges and in-hospital admission) were analysed using Cox multivariable regression. Receiver operating curves were drawn by summing the Cox-significant variables for each method.

Results

Of 11 052 patients (median age 67 years, IQR 51–81, 48% female), 59% (n=6489) were discharged and 41% (n=4563) were admitted to the hospital. After a 306-day median follow-up (IQR 208–417 days), 9455 (86%) patients were alive and 1597 (14%) deceased. Increased HRs were associated with age >73 years (HR=4.6, 95% CI=4.0 to 5.2), in-hospital admission (HR=2.2, 95% CI=1.9 to 2.4), ER admission during SARS-CoV2 surges (Wave I: HR=1.7, 95% CI=1.5 to 1.9; Wave II: HR=1.2, 95% CI=1.0 to 1.3). Gender, haemoglobin, MCV, RDW, PDW, neutrophils, lymphocytes and eosinophil counts were significant overall. Benchmark-BCDC model included basophils and platelet count (area under the ROC (AUROC) 0.74). Tailored-BCDC model included monocyte counts and PCT (AUROC 0.79).

Conclusions

Baseline discretised BCDC provides meaningful insight regarding ER patients’ survival.

Measuring under-5 mortality and fertility through mobile phone surveys: an assessment of selection bias in 34 low-income and middle-income countries

Por: Sanchez-Paez · D. A. · Masquelier · B. · Menashe-Oren · A. · Baruwa · O. J. · Reniers · G.
Objectives

This study aims to assess sample selection bias in mobile phone survey estimates of fertility and under-5 mortality.

Design

With data from the Demographic and Health Surveys, we use logistic regressions to identify sociodemographic correlates of mobile phone ownership and access, and Poisson regressions to estimate the association between mobile phone ownership (or access) and fertility and under-5 mortality estimates. We evaluate the potential reasons why estimates by mobile phone ownership differ using a set of behavioural characteristics.

Setting

34 low-income and middle-income countries, mostly in sub-Saharan Africa.

Participants

534 536 women between the ages of 15 and 49.

Outcome measures

Under-5 mortality rate (U5MR) and total fertility rate (TFR).

Results

Mobile phone ownership ranges from 23.6% in Burundi to 96.7% in Armenia. The median TFR ratio and U5MR ratio between the non-owners and the owners of a mobile phone are 1.48 and 1.29, respectively. Fertility and mortality rates would be biased downwards if estimates are only based on women who own or have access to mobile phones. Estimates of U5MR can be adjusted through poststratification using age, educational level, area of residence, wealth and marital status as weights. However, estimates of TFR remain biased even after adjusting for these covariates. This difference is associated with behavioural factors (eg, contraceptive use) that are not captured by the poststratification variables, but for which there are also differences between mobile phone owners and non-owners.

Conclusions

Mobile phone surveys need to collect data on sociodemographic background characteristics to be able to weight and adjust mortality estimates ex post facto. Fertility estimates from mobile phone surveys will be biased unless further research uncovers the mechanisms driving the bias.

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