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Ayer — Mayo 14th 2024BMJ Open

Exploring community participation in vectorborne disease control in Southeast Asia: a scoping review protocol

Por: Naserrudin · N. A. · Adhikari · B. · Culleton · R. · Hod · R. · Saffree Jeffree · M. · Ahmed · K. · Hassan · M. R.
Introduction

Vector borne diseases (VBDs) present significant public health challenges in Southeast Asia (SEA), and the increasing number of cases threatens vulnerable communities. Inadequate vector control and management have been linked to the spread of VBDs. To address these issues, community participation has been proposed as a promising approach to enhance health programmes and control of VBDs. This article outlines a protocol for a scoping review of the published literature on community-participation approaches to control VBDs in the SEA region. The primary research question is ‘How does community participation complement the control of VBDs in SEA?’ This review aims to provide an overview of various approaches and identify barriers and facilitators to effective implementation.

Methods and analysis

The research questions will guide the scoping review. In stage 1, peer-reviewed publications from PubMed, Web of Science and Scopus will be searched using predefined search terms related to community-based approaches and VBDs in the SEA region, English, Indonesian and Malay published between 2012 and 2022. In stage 2, the references from relevant articles will be screened for eligibility. In stage 3, eligible articles will be charted in Microsoft Excel to facilitate the review process, and studies will be characterised based on the investigated diseases; this review will also highlight the methodological context of these studies. In stage 4, a thematic analysis will be conducted to derive meaningful findings from the dataset relevant to the research inquiry, followed by writing the results in stage 5. This scoping review aims to be the first to explore community participation in VBD control in the SEA population, providing valuable insights for future research and stakeholders involved in disease control.

Ethics and dissemination

This scoping review does not require ethical approval because the methodology synthesises information from available articles. This review is planned for dissemination in academic journals, conference presentations and shared with stakeholders as part of knowledge sharing among those involved in VBD control.

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L.
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

Cost-effectiveness of a complex continuum of care intervention targeting women and children: protocol for an economic evaluation of the Bukhali trial in South Africa

Por: Palmer · T. · Leiva Granados · R. · Draper · C. · Norris · S. A. · Batura · N.
Introduction

As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial).

Methods and analysis

The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child’s lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status.

Ethics and dissemination

The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Trial registration number

Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

Interdisciplinary research approach based on a mixed-methods design to explore patient altruism at the end of life: a study protocol

Por: Bernard · M. · Gamondi · C. · Sterie · A.-C. · Larkin · P. J. · Jox · R. · Borasio · G. D.
Introduction

In the end of life context, patients are often seen as somewhat passive recipients of care provided by health professionals and relatives, with little opportunity to be perceived as autonomous and active agents. Since studies show a very high prevalence of altruistic dispositions in palliative care patients, we strive to investigate the concept of patient altruism in a set of six interdisciplinary studies by considering three settings: (1) in the general palliative context—by studying to what extent patient altruism is associated with essential psychological outcomes of palliative care (subproject 1a), how altruism is understood by patients (subproject 1b) and how altruism expressed by patients is experienced by palliative care nurses (subproject 1c); (2) in two concrete decision-making contexts—advance care planning (subproject 2a) and assisted suicide (subproject 2b); and (3) through verbal and non-verbal patient communication in palliative care settings (subproject 3).

Methods and analysis

Subproject 1a: a cross-sectional study using validated and standardised questionnaires. Subprojects 1b and 1c: a constructivist grounded theory method aiming at developing a novel theory from semistructured interviews in both patients and nurses. Subproject 2a: a thematic analysis based on (1) audio-recordings of advance care planning encounters and (2) follow-up semidirective interviews with patients and their relatives. Subproject 2b: a qualitative study based on thematic analysis of interviews with patients actively pursuing assisted suicide and one of their relatives.Subproject 3: a conversation analysis based on audio and video-recorded interactions in two settings: (1) palliative inpatient unit and (2) advance care planning discussions.

Ethics and dissemination

The study project was approved by the Ethics Committees of the Canton of Vaud, Bern and Ticino (no: 2023-00088). In addition to participation in national and international conferences, each project will be the subject of two scientific publications in peer-reviewed journals. Additional publications will be realised according to result triangulation between projects. A symposium opened to professionals, patients and the public will be organised in Switzerland at the end of the project.

Tobacco policies and changes in the tendency of smoking cessation in cigarette users in Chile: a longitudinal cross-sectional study

Objective

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Design

Longitudinal cross-sectional study.

Setting

National level.

Participants

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary and secondary outcomes measures

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Results

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Conclusions

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

Por: van Gils · L. · de Boer · M. A. · Bosmans · J. · Duijnhoven · R. · Schoenmakers · S. · Derks · J. B. · Prins · J. R. · Al-Nasiry · S. · Lutke Holzik · M. · Lopriore · E. · van Drongelen · J. · Knol · M. H. · van Laar · J. O. E. H. · Jacquemyn · Y. · van Holsbeke · C. · Dehaene · I. · L
Introduction

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

Methods and analysis

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

Ethics and dissemination

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

Trial registration number

ClinicalTrials.gov, NCT05968794.

Autologous concentrated bone marrow injection for precollapse osteonecrosis of the femoral head concurrent with contralateral total hip arthroplasty: protocol for a clinical trial

Por: Homma · Y. · Yamasaki · T. · Tashiro · K. · Okada · Y. · Shirogane · Y. · Watari · T. · Hayashi · K. · Baba · T. · Nagata · K. · Yanagisawa · N. · Ohtsu · H. · Fujiwara · N. · Ando · J. · Yamaji · K. · Tamura · N. · Ishijima · M.
Introduction

The femoral head contralateral to the collapsed femoral head requiring total hip arthroplasty (THA) often manifests in the precollapse stage of osteonecrosis of the femoral head (ONFH). It is not yet demonstrated how autologous concentrated bone marrow injection may prevent collapse of the femoral head concurrent with contralateral THA. The primary objective is to evaluate the efficacy of autologous concentrated bone marrow injection for the contralateral, non-collapsed, femoral head in patients with bilateral ONFH, with the ipsilateral collapsed femoral head undergoing THA.

Methods and analysis

This is a multicentre, prospective, non-randomised, historical-data controlled study. We will recruit patients with ONFH who are scheduled for THA and possess a non-collapsed contralateral femoral head. Autologous bone marrow will be collected using a point-of-care device. After concentration, the bone marrow will be injected into the non-collapsed femoral head following the completion of THA in the contralateral hip. The primary outcome is the percentage of femoral head collapse evaluated by an independent data monitoring committee using plain X-rays in two directions 2 years after autologous concentrated bone marrow injection. Postinjection safety, adverse events, pain and hip function will also be assessed. The patients will be evaluated preoperatively, and at 6 months, 1 year and 2 years postoperatively.

Ethics and dissemination

This protocol has been approved by the Certified Committee for Regenerative Medicine of Tokyo Medical and Dental University and Japan’s Ministry of Healthy, Labour and Welfare and will be performed as a class III regenerative medicine protocol, in accordance with Japan’s Act on the Safety of Regenerative Medicine. The results of this study will be submitted to a peer-review journal for publication. The results of this study are expected to provide evidence to support the inclusion of autologous concentrated bone marrow injections in the non-collapsed femoral head in Japan’s national insurance coverage.

Trial registration number

jRCTc032200229.

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

Por: Marshall · H. · Ward · J. · Wang · B. · Andraweera · P. · McMillan · M. · Flood · L. · Bell · C. · Sisnowski · J. · Krause · V. · Webby · R. · Childs · E. · Gunathilake · M. · Egoroff · N. · Leong · L. · Lawrence · A. · Baird · R. · Freeman · K. · Menouhos · D. · Whiley · D. M. · Karnon · J.
Introduction

The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections.

Methods and analyses

This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4–7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison.

Ethics and dissemination

The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Sex and gender-based analysis and diversity metric reporting in acute care trials published in high-impact journals: a systematic review

Por: Granton · D. · Rodrigues · M. · Raparelli · V. · Honarmand · K. · Agarwal · A. · Friedrich · J. O. · Perna · B. · Spaggiari · R. · Fortunato · V. · Risdonne · G. · Kho · M. · VanderKaay · S. · Chaudhuri · D. · Gomez-Builes · C. · D'Aragon · F. · Wiseman · D. · Lau · V. I. · Lin · C. · Reid
Objective

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Design

Systematic review.

Data sources

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Study selection

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

Data abstraction and synthesis

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

Results

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Conclusions

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

PROSPERO registration number

CRD42022282565.

Implementation of the WHO Safe Childbirth Checklist: a scoping review protocol

Introduction

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

Methods and analysis

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

Ethics and dissemination

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

Trial registration number

https://doi.org/10.17605/OSF.IO/RWY27.

Experiences of living with overweight/obesity and early type 2 diabetes in Singapore--a qualitative interview study

Por: Lee · M. · Khoo · H. S. · Krishnasamy · C. · Loo · M. E. · Wong · S. K. W. · Cheng · S. C. · Bei · E. · Tan · S. Y. · Xie · P. · Lee · E. S. · Tang · W. E.
Objectives

To understand the lived experience of adults with overweight/obesity and early type 2 diabetes in a modern urban environment, and the interrelations among the various aspects of these experiences and participants’ attitudes to weight management.

Design

Qualitative inductive approach to analysing data thematically from semistructured interviews and interpreted from a socioecological perspective.

Setting

Primary care clinics located in northern and central Singapore.

Participants

21 patients between 29 and 59 years old who are living with overweight/obese (Body Mass Index of 25.3–44.0kg/m2) and type 2 diabetes for 6 years or less.

Results

The main themes everyday life, people around me and within me pointed to a combination of barriers to weight and health management for participants. These included environmental factors such as easy physical and digital access to unhealthy food, and high-stress work environments; social factors such as ambiguous family support and dietary practices of peers; and individual factors such as challenges with self-regulation, prioritising work, dealing with co-existing medical conditions and the emotional significance of food. While lack of motivation and cultural dietary practices are hard to change, a problem-solving attitude, and presence of role models, may enable behaviour change.

Conclusion

An exploration of the lifeworld of patients with overweight/obese and early type 2 diabetes revealed that work demands, dietary practices in the workplace and at home, and the easy availability of calorie-dense foods afforded by a technology-infused environment hindered the individual’s efforts at maintaining a healthy weight and lifestyle. Policy and initiatives promoting work-life balance as well as individualised interventions can support participants’ stress management, and problem-solving capability for behaviour change. These barriers stemmed from the various domains of the environmental, interpersonal and intrapersonal but were interrelated. They underscored the need for an integrated approach to weight and diabetes management.

Contextually appropriate nurse staffing models: a realist review protocol

Introduction

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Methods and analysis

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethics and dissemination

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

Por: Gomber · A. · Valeta · F. · Coates · M. M. · Trujillo · C. · Ferrari · G. · Boti · M. · Kumwenda · K. · Mailosi · B. · Nakotwa · D. · Drown · L. · Wroe · E. B. · Thapa · A. · Mithi · V. · Matanje · B. · Msekandiana · A. · Park · P. H. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler
Objectives

To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.

Design

A 2:1 open randomised controlled feasibility trial.

Setting

Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi.

Participants

45 people living with type 1 diabetes (PLWT1D).

Interventions

Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education.

Outcomes

Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life.

Results

Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention.

Conclusions

This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge.

Trial registration number

PACTR202102832069874.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study

Por: Thapa · A. · Chibvunde · S. · Schwartz · L. · Trujillo · C. · Ferrari · G. · Drown · L. · Gomber · A. · Park · P. H. · Matanje · B. · Msekandiana · A. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler · A. J.
Objectives

The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi.

Design

We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach.

Setting

First-level hospitals in Neno district, Malawi.

Participants

Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers.

Results

Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management.

Conclusions

Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings.

Trial registration number

PACTR202102832069874; Post-results.

Factors influencing optimal diabetes care and clinical outcomes in Thai patients with type 2 diabetes mellitus: a multilevel modelling analysis

Por: Surawit · A. · Pongkunakorn · T. · Manosan · T. · Mongkolsucharitkul · P. · Chamnan · P. · Suvarnabhumi · K. · Puangpet · T. · Suta · S. · Pumeiam · S. · Pinsawas · B. · Ophakas · S. · Pisitpornsuk · S. · Utchin · C. · Mayurasakorn · K.
Background

Increasing levels of poor glycaemic control among Thai patients with type 2 diabetes mellitus (T2DM) motivated us to compare T2DM care between urban and suburban primary care units (PCUs), to identify gaps in care, and to identify significant factors that may influence strategies to enhance the quality of care and clinical outcomes in this population.

Methods

We conducted a cross-sectional study involving 2160 patients with T2DM treated at four Thai PCUs from 2019 to 2021, comprising one urban and three suburban facilities. Using mixed effects logistic regression, we compared care factors between urban and suburban PCUs.

Results

Patients attending suburban PCUs were significantly more likely to undergo eye (adjusted OR (AOR): 1.83, 95% CI 1.35 to 1.72), foot (AOR: 1.61, 95% CI 0.65 to 4.59) and HbA1c (AOR: 1.66, 95% CI 1.09 to 2.30) exams and achieved all ABC (HbA1c, blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)) goals (AOR: 2.23, 95% CI 1.30 to 3.83). Conversely, those at an urban PCU were more likely to undergo albuminuria exams. Variables significantly associated with good glycaemic control included age (AOR: 1.51, 95% CI 1.31 to 1.79), T2DM duration (AOR: 0.59, 95% CI 0.41 to 0.88), FAACE (foot, HbA1c, albuminuria, LDL-C and eye) goals (AOR: 1.23, 95% CI 1.12 to 1.36) and All8Q (AOR: 1.20, 95% CI 1.05 to 1.41). Chronic kidney disease (CKD) was significantly linked with high triglyceride and HbA1c levels (AOR: 5.23, 95% CI 1.21 to 7.61). Elevated HbA1c levels, longer T2DM duration, insulin use, high systolic BP and high lipid profile levels correlated strongly with diabetic retinopathy (DR) and CKD progression.

Conclusion

This highlights the necessity for targeted interventions to bridge urban–suburban care gaps, optimise drug prescriptions and implement comprehensive care strategies for improved glycaemic control, DR prevention and CKD progression mitigation among in Thai patients with T2DM. The value of the clinical target aggregate (ABC) and the process of care aggregate (FAACE) was also conclusively demonstrated.

Acute watery diarrhoea cases during cholera outbreak in Syria: a cohort study

Por: Arnaout · A. Y. · Nerabani · Y. · Sawas · M. N. · Alhejazi · T. J. · Farho · M. A. · Arnaout · K. · Alshaker · H. · Shebli · B. · Helou · M. · Mobaied · B. B. · Mouti · M. B. · Kady · F. · Aljarad · Z. · Aleppo University Hospital Team · shalabi · Dasouki · Breij · Shheibar · Alabdull
Objectives

The aim of this study is a descriptive presentation of cases of acute watery diarrhoea (AWD) that were presented to Aleppo University Hospital (AUH) during the recent cholera outbreak in Syria.

Design

Prospective, observational, cohort study.

Setting and participants

A total of 1061 patients with AWD were admitted to AUH during the timeframe of 20 September 2022 to 20 October 2022. The data collection was done through a structured questionnaire. This includes comprehensive clinical observation, laboratory analyses, therapeutic interventions and holistic case evaluations.

Results

The analysis has revealed notable insights: a predominant proportion of patients (58.6%) were residents from urban areas and 40.3% were residents from rural areas. Intriguingly, a diverse range of potential infection sources emerged from patient data within our hospital, including uncontrolled well water, vegetables and faecal-oral transmission through contaminated street/fast food. At discharge, most patients were in good health (79.7%), followed by moderate health (17.6%) and poor health (2.3%), with a minimal percentage dying before discharge (0.4%). The most common complications reported at admission and during hospitalisation included electrolyte imbalance (28.2%), followed by severe dehydration (16.3%). In the follow-up period, the majority of patients exhibited good health (81.0%). Older patients (>60 years) had poorer outcomes, with 8.4% having poor health and 4.2% death rate.

Conclusions

The study found results consistent with previous AWD outbreaks in developing countries like Yemen, Nigeria and Lebanon. Preventative measures like improving water sanitation and hygiene practices are essential to prevent future outbreaks and ease the strain on healthcare systems. Therefore, future studies must investigate the risk factors that increase the spread and the severity of the disease and investigate the best management method.

Burden of COVID-19 pandemic on tuberculosis hospitalisation patterns at a tertiary care hospital in Rajasthan, India: a retrospective analysis

Por: Rajotiya · S. · Mishra · S. · Singh · A. K. · Debnath · S. · Raj · P. · Singh · P. · Bareth · H. · Nakash · P. · Sharma · A. · Singh · M. · Nathiya · D. · Joshi · N. · Tomar · B. S.
Objective

This study aimed to investigate the burden of the COVID-19 pandemic on tuberculosis (TB) trends, patient demographics, disease types and hospitalisation duration within the Respiratory Medicine Department over three distinct phases: pre-COVID-19, COVID-19 and post-COVID-19.

Design

Retrospective analysis using electronic medical records of patients with TB admitted between June 2018 and June 2023 was done to explore the impact of COVID-19 on patients with TB. The study employed a meticulous segmentation into pre-COVID-19, COVID-19 and post-COVID-19 eras.

Setting

National Institute of Medical Science Hospital in Jaipur, Rajasthan, India.

Primary and secondary outcome measures

Primary outcome includes patients admitted to the Respiratory Medicine Department of the hospital and secondary outcome involves the duration of hospital stay.

Results

The study encompassed 1845 subjects across the three eras, revealing a reduction in TB incidence during the post-COVID-19 era compared with the pre-COVID-19 period (p

Conclusion

The study underscores the influence of the COVID-19 pandemic on the TB landscape and hospitalisation dynamics. Notably, patient burden of TB declined during the COVID-19 era, with a decline in the post-COVID-19 era compared with the pre-COVID-19 era. Prolonged hospitalisation in the post-COVID-19 period indicates the need for adaptive healthcare strategies and the formulation of public health policies in a post-pandemic context. These findings contribute to a comprehensive understanding of the evolving TB scenario, emphasising the necessity for tailored healthcare approaches in the aftermath of a global health crisis.

System-wide governance challenges of the Ebonyi State Malaria Elimination Programme and recommendations for malaria health system strengthening: a qualitative study among stakeholders in Ebonyi state, Nigeria

Por: Omale · U. I. · Ogbonnaya · L. U. · Iyare · O. · Nnachi · O. O.
Objectives

The burden of malaria has persistently been high in Ebonyi state and Nigeria despite long-standing collaborations with international partners with huge and increased amounts of financial investments. We explored the system-wide governance challenges of the Ebonyi State Malaria Elimination Programme (SMEP) and the factors responsible in order to make recommendations for malaria health system strengthening.

Design

We did a qualitative study informed by the health system governance framework by Mikkelsen-Lopez et al and Savedoff’s concept of governance.

Setting and participants

Between 18 October 2022 and 8 November 2022, 25 semistructured face-to-face in-depth interviews were conducted in English with purposively selected key stakeholders in the Ebonyi SMEP aged 18 years or older with at least 2 years of involvement in the SMEP and who gave consent.

Analysis

Data were analysed deductively and the analytical strategy was informed by the framework method for the analysis of qualitative data by Gale et al.

Results

Many system-wide governance challenges of the SMEP were identified including the absence of state’s strategic vision and plans for malaria elimination; very weak primary and secondary healthcare systems; inadequate financial allocation and untimely release of budgeted funds by the state government; lack of human resources for health and very poor mosquito net distribution system. Other challenges were inadequate stakeholders’ participation; poor accountability culture; impaired transparency and corruption and impaired ability to address corruption. The fundamental responsible factors were the lack of state government’s concern for people’s welfare and lack of interest and commitment to the malaria elimination effort, chronic non-employment of staff and lack of human resources in the entire health sector including SMEP, and nepotism and godfatherism.

Conclusions

The system-wide governance challenges and the responsible factors call for changing the ‘business as usual’ and refocusing on strengthening malaria health system governance in addressing the persisting malaria health problems in Ebonyi state (and Nigeria).

Prevalence and health effects of post-COVID-19 condition in Africa: a scoping review protocol

Por: Ansah · E. W. · Salu · P. K. · Daanko · M. S. · Banaaleh · D. N. · Amoadu · M.
Introduction

SARS-CoV-2 pandemic has caused global devastations in the social, economic and health systems of every nation, but disproportionately the nations in Africa. Apart from its grave effects on the global systems, is the persistence of post-COVID-19 condition in individuals infected with the virus. Therefore, the aim of this scoping review is to collate and summarise the existing research evidence about the prevalence and health effects of post-COVID-19 infection conditions in Africa.

Methods and analysis

Five main databases will be thoroughly searched from 1 September 2023 to 30 April 2024, for eligible articles based on the inclusion and exclusion criteria. These databases include PubMed, Central, Scopus, Dimensions AI and JSTOR. Meanwhile, Arksey and O’Malley guidelines will guide this scoping review using article published between 1 January 2020 and 30 April 2024. This review will provide a useful insight into the prevalence of the post-COVID-19 symptoms and their health effects within the population in Africa. The results and findings of the review will be valuable for health system interventions, including restructuring and reorientation of health systems in the continent.

Ethics and dissemination

This scoping review will involve analysis of secondary data, therefore, no ethical approval is needed. Dissemination of the results will be done through international journals and available research conferences.

Retrospective study investigating naloxone prescribing and cost in US Medicaid and Medicare patients

Por: Manko · C. D. · Ahmed · M. S. · Harrison · L. R. · Kodavatiganti · S. A. · Lugo · N. · Konadu · J. O. · Khan · F. · Massari · C. A. · Sealey · T. K. · Addison · M. E. · Mbah · C. N. · McCall · K. L. · Fraiman · J. B. · Piper · B. J.
Background

Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses.

Objective

This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019.

Design

Observational pharmacoepidemiologic study

Setting

US Medicare and Medicaid naloxone claims

Intervention

The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019.

Outcome measures

States with naloxone prescription rates that were outliers of quartile analysis were noted.

Results

The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees.

Conclusions

This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted.

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