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Family caregivers experience in the provision of palliative care for adult cancer patients in low-income and lower-middle-income countries: a qualitative systematic review protocol

Por: Karunarathna · K. · Uduwela · V. R. · Godage · G. · Isuruni · Y. · Seneviwickrama · M.
Introduction

In many low-income and lower-middle-income countries (LMICs), palliative care services are limited and much of the care for adults with advanced cancer is provided by family caregivers. This review aims to explore the family caregiver experience in providing palliative care to adult patients with cancer in LMICs.

Methods and analysis

This qualitative systematic review will be conducted using a comprehensive search strategy on PubMed (MEDLINE), Embase, CINAHL and PsycINFO without language or date restrictions. The COnnecting REpositories (CORE) database of the Open University will be searched for grey literature. Review questions will follow the PICo framework (Population, Phenomena of Interest and Context). Qualitative or mixed-method studies on the experience of family caregivers of adult patients with cancer (above 18 years) receiving palliative care in LMICs will be included. Study quality will be assessed using the Joanna Briggs Institute (JBI) critical appraisal tools. Findings will be synthesised using meta-aggregation or with a narrative synthesis if pooling is not feasible. The review process will follow the JBI methodology for systematic reviews of qualitative evidence and will be reported according to the ENhancing Transparency in REporting the synthesis of Qualitative research (ENTREQ) framework.

Ethics and dissemination

No ethical approval is required as the study involves secondary data analysis of published literature. Ethical principles of accurate reporting and transparency will be upheld. Findings will be published in peer-reviewed open-access journals and presented at academic conferences. Recommendations will be shared with policymakers and healthcare organisations responsible for the provision of palliative care for patients with cancer in LMICs.

PROSPERO registration number

CRD420251010556.

Designing and delivering youth mental health services for young people, with young people: what works? A protocol for a realist eDelphi study on effective co-production

Por: Jones · V. R. · Rathore · I. · Waring · J. · Wright · N. · Fenton · S.-J. H.
Introduction

Research and mental health services agree that more youth co-production in service design and delivery is needed, but there is little consensus on how to do it well. This study is trying to find agreement about the best ways to do this.

Methods and analysis

A realist eDelphi study will be conducted. People with experience of co-production and engagement in youth mental health services will be invited to participate. This will include young people with relevant lived experience, family members/carers of young people with mental ill health, youth mental health researchers and other professionals with experience of youth engagement work (eg, mental healthcare staff, mental health service managers and participation/engagement professionals in the sector). The target is to recruit 10–20 participants from each of these four groups (40–80 participants total).

The following steps will be taken: (1) an advisory group of young people will use results from a realist literature review completed prior to this study, to generate the first list of items for the survey; (2) using the online survey tool Qualtrics, participants will be invited to rate these items in an online survey. A prompt question formatted using a realist framework will allow participants to comment on their rating and how this survey item works (or does not work) in this context, for young people or other stakeholders. Participants will be able to add further suggestions at this stage; (3) using Qualtrics, a second survey round will be completed which will include the new suggestions from participants, and original items with their average participant ratings and comments displayed. Participants will be asked to rerate items in this round; (4) a list of items will be generated that comprises survey items believed to be ‘essential’ or ‘important’ by 80% or more of the participants; (5) this list will be discussed with the Youth Advisory Group to generate a final recommendations document and consider creative outputs and dissemination methods. Data analysis will include raw numbers, means and frequencies.

Ethics and dissemination

Ethical approval has been granted by the University of Birmingham Research Ethics Committee (Ref: ERN_1550-Apr2024). Both traditional and non-traditional outputs will be created (eg, conference presentations, publications, a plain English summary and social media infographics).

Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Mixed-methods integration during data analysis in clinical trials of complex healthcare interventions: how is it done, and what can it do? Protocol for a systematic methodological review

Por: Sugg · H. V. R. · Shaw · N. · Vesterlund · E. M. · Woodford · J.
Introduction

The importance of conducting qualitative research alongside clinical trials of complex healthcare interventions is well established. There are various ways in which these two methodologies can be combined in mixed-methods research, including integrating data and/or results from the qualitative and quantitative strands during analysis, using techniques such as joint displays. The potential benefits of integration during data analysis include understanding intervention mechanisms, reasons for variation in outcomes, ways of tailoring interventions to individuals and barriers and facilitators to implementation. However, integration during data analysis may rarely be undertaken in practice, and the extent to which integration can provide valuable insights appears to be underappreciated in the field.

In this review, we aim to summarise current methods of integrating qualitative and quantitative raw data and/or results during analysis in clinical trials of complex healthcare interventions, and the yield of these different methods. Our specific research questions focus on (1) which integration techniques are used; (2) whether the results meet the study authors’ aims and/or answer their research questions; (3) the insights obtained and/or meta-inferences generated from these techniques (classified as either global or specific, and as relational, predictive, causal, comparative or elaborative); (4) any relationship between these insights and/or meta-inferences and the integration technique used and (5) the quality of these studies.

Methods and analysis

We will systematically search MEDLINE, Embase, PsycINFO, CENTRAL, CINAHL, Scopus and Web of Science, and manually search reference lists. We will include studies if they integrate, during data analysis, raw data and/or results from a clinical (randomised, non-randomised or single-arm) trial and an embedded or subsequent associated qualitative study of a complex, non-pharmaceutical healthcare intervention (where the effects on a health outcome were measured). Two independent reviewers will screen titles, abstracts and full texts and perform data extraction. We will develop a descriptive account of the data, including mapping the key characteristics of included studies and narratively reporting our findings in relation to each of our research questions. We will explore how integration was undertaken, what insights were obtained and/or meta-inferences generated, and whether and how these relate to the type of integration technique used.

Ethics and dissemination

This study does not require ethical approval. We intend to publish our findings in a peer-reviewed open-access journal and to present our findings at national and/or international conferences.

Registration

This protocol was registered with Open Science Framework on 22 October 2025 (ref osf.io/yxtb9).

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.

Impact of telemedicine on reducing travel-related CO2 emissions in chronic disease care: a cross-sectional study in Northeast Brazil

Por: Gadenz · S. D. · Sperling · S. · Moraes · L. B. · Bezerra · V. R. · Motter · F. R.
Objective

This study aimed to estimate reductions in travel-related carbon dioxide (CO2) emissions, travel time and distance resulting from a telemedicine service for patients with chronic conditions, and to assess its potential to contribute to more equitable access to specialised care in Northeast Brazil.

Design

Cross-sectional study.

Setting

Primary healthcare units in the Northeast region of Brazil.

Participants

Patients between birth and 104 years of age with chronic conditions who received video-based teleconsultations between June 2022 and November 2023.

Primary and secondary outcome measures

The primary outcome was the reduction in travel-related carbon emissions due to avoided in-person referrals. Secondary outcomes included travel time and travel distance savings. Round-trip distances between primary healthcare units and referral centres were estimated using geolocation data. CO2 emissions were calculated using the Greenhouse Gas (GHG) Protocol adapted to Brazil (Brazilian GHG Protocol Programme), focusing on Scope 3 emissions from patient travel.

Results

A total of 4642 teleconsultations were conducted with 4106 patients. Of these, 4021 (86.6%) avoided in-person referrals, resulting in estimated savings of 226 900 miles in travel distance and 488 584 min in travel time. The estimated CO2 emissions avoided totalled 21 593 kg (21 930 kg CO2 equivalent), with a mean of 5.37 kg (SD±5.5) per teleconsultation (5.4 kg CO2 equivalent ; SD±5.5). Greater travel distance savings were observed among patients living in municipalities with lower Municipal Human Development Index (mean 92.3±104.2 miles vs 17.3±8.4 miles; p

Conclusions

Telemedicine use in Northeast Brazil significantly reduced patient travel, leading to substantial savings in CO2 emissions. These savings were more pronounced for patients in smaller, less developed municipalities. By reducing the need for travel, telemedicine can improve access to healthcare for remote or underserved populations, while also supporting environmental sustainability.

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