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Study protocol for a multi-site case study evaluation of a Canadian quality improvement collaborative to improve Baby-Friendly practices in community health services

Por: Turner · S. E. · Enns · J. E. · Seager · E. · LeDrew · M. · Benoit · B. · Semenic · S. · Snelgrove-Clarke · E. · Shittu · B. · Gordon Pappas · D. · CBFI-C Implementation and Evaluation Team · Nickel · N. C. · Campbell-Yeo · Frittenburg · Haiek · McClure · Rashid · Swan · Abbass-Di
Introduction

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

Methods and analysis

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics and dissemination

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Incorporating behavioural and psychological factors into cardiovascular disease risk prediction models: protocol for a systematic review

Por: Tang · C. · Ng · N. C.-S. · Ming · L. C. · Wong · R. S.-Y.
Objectives

This systematic review aims to: (1) evaluate how behavioural and psychological factors have been incorporated into cardiovascular disease (CVD) risk prediction models; (2) assess their impact on model performance metrics such as area under the curve (AUC) and net reclassification index (NRI); and (3) identify which specific variables are most consistently associated with predictive improvements. This protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) 2015, and the systematic review will follow the Cochrane Handbook and report findings based on PRISMA 2020.

Design

A systematic review protocol developed in accordance with the (PRISMA-P) 2015 guidelines.

Data sources

Systematic searches will be carried out in PubMed, Scopus, Web of Science and Google Scholar, limited to studies published from 2019 to 2024.

Eligibility criteria

Peer-reviewed original studies involving adult populations (≥18 years) at risk of CVD, incorporating at least one behavioural or psychological variable into a CVD risk prediction model. Studies must report model performance metrics such as AUC or NRI. Studies focusing solely on biochemical or demographic factors, paediatric populations, or non-CVD outcomes will be excluded.

Data extraction and synthesis

Two independent reviewers will screen eligible studies, extract data and assess study quality using the Newcastle-Ottawa Scale and Quality in Prognostic Studies tool. A narrative synthesis will be performed, with meta-analysis conducted if feasible.

Ethics and dissemination

Ethical approval is not required for this study. Findings will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD420251014218.

Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol

Por: Karampatakis · G. D. · Wood · H. E. · Griffiths · C. J. · Taylor · S. J. · Toffolutti · V. · Bird · V. J. · Lea · N. C. · Ashcroft · R. · Coulson · N. S. · Panzarasa · P. · Li · X. · Sheikh · A. · Relton · C. · Sastry · N. · Watson · J. S. · Mant · J. · Marsh · V. · Day · B. · Mihaylova · B
Introduction

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

Methods and analysis

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

Ethics and dissemination

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

Trial registration number

NCT06849245.

Influenza and respiratory syncytial virus dynamics in Lao PDR during the COVID-19 pandemic: a hospital-based surveillance study

Por: Phommasone · K. · Chommanam · D. · Christy · N. C. · Yiaye · T. · Phoutthavong · S. · Keomoukda · P. · Thammavong · S. · Bounphiengsy · T. · Lathsachack · T. · Boutthasavong · L. · Vidhamaly · V. · Sibounheuang · B. · Phonemixay · O. · Panapruksachat · S. · Praphasiri · V. · Keomany
Objectives

Globally, the circulation of influenza and other seasonal respiratory viruses changed dramatically during the COVID-19 pandemic. This study aims to determine the trends of acute respiratory infections (ARIs) caused by SARS-CoV-2, influenza A, influenza B and respiratory syncytial viruses (RSVs) in patients presenting to hospitals in the Lao People’s Democratic Republic (PDR) (Laos).

Design

Prospective surveillance study.

Setting

Four provincial hospitals across Laos between March 2021 and July 2023.

Participants

Participants of all ages who met our case definition for an ARI (axillary temperature ≥37.5°C or history of fever AND cough or other respiratory symptoms/signs OR loss of smell and/or taste) presenting to the hospital less than 10 days after symptom onset were eligible to be enrolled in the study. Combined nasopharyngeal and throat swabs were tested for SARS-CoV-2, influenza A, influenza B and human RSV (hRSV) using probe-based real-time RT (Reverse transcription)-PCR assays.

Primary outcome measure

The proportion of patients in whom SARS-CoV-2, influenza A, influenza B and hRSV was detected.

Results

There were 4203 patients recruited, of whom 898 (21%) were children aged under 5 years. SARS-CoV-2 was detected in 16.9% of patients, followed by influenza A, influenza B and hRSV (8.4%, 7.2% and 4.7%, respectively). 98 patients (2.3%) were diagnosed with probable co-infection, with at least two viruses detected. After May 2022, the number of cases of influenza A, influenza B and hRSV increased rapidly. Six per cent of patients (263) had a quick Sequential Organ Failure Assessment score of ≥2, and 34 (0.8%) patients died, of whom 11 tested positive for a respiratory virus.

Conclusions

During the COVID-19 pandemic in Laos, few respiratory viruses were detected by passive surveillance until the relaxation of non-pharmaceutical interventions implemented for infection control. After restrictions were lifted, influenza A, influenza B and hRSV emerged rapidly, showing the importance of continuous surveillance.

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