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Patterns in meperidine distribution and associations with income and obesity in the USA and Puerto Rico between 2019 and 2023: a retrospective study

Por: Gonzalez · B. · Healy · L. G. · Harrison · L. R. · Piper · B. J.
Objectives

Meperidine, once viewed as relatively safe, is now discouraged in clinical settings due to its associated risks. Previous studies have identified a significant decrease in meperidine distribution across the USA from 2000 to 2021. Regional disparities accompanied this decline. The goal of this study was to investigate if the decrease in meperidine distribution has continued in recent years, 2019–2023, and if regional variations persist. This investigation also aimed to identify correlates of meperidine distribution, including adult obesity prevalence and annual income, to provide insight into the regional variation.

Design

Retrospective observational study using data from the Automation of Reports and Consolidated Orders System Drug Retail Summary Reports by the Drug Enforcement Administration (DEA), the Centers for Disease Control and Prevention (CDC) and the US Census Bureau.

Setting

USA, including Puerto Rico.

Participants

US population.

Primary and secondary outcome measures

The primary outcome was the meperidine distribution across the US between 2019 and 2023. Secondary outcomes included associations between meperidine distribution and adult obesity prevalence and median household income.

Results

Total meperidine distribution across the USA dropped by 57.8% from 2019 to 2023. A substantial geographic variation was found with southern states accounting for the second, third and fourth highest in meperidine use per capita in 2023, only behind Puerto Rico. In contrast, northeastern states accounted for four of the five lowest states. A significant relationship was found between annual income and meperidine distribution in 2022 (r(49) = –0.38, p

Conclusion

Our study revealed a continued decrease in meperidine distribution and sustained presence of geographical variation from 2019 to 2023. Furthermore, novel relationships were identified between meperidine distribution, annual income and adult obesity prevalence.

Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial: a protocol for a pragmatic randomised study of diverticulitis treatment in the USA

Por: Hantouli · M. N. · Schmicker · R. H. · Tufte · J. E. · Ali · F. G. · Bennett · R. D. · Cohan · J. N. · Comstock · B. A. · Curran · T. · Davidson · G. H. · Eisenstein · S. · Fischkoff · K. N. · Fleming · F. J. · Gribovskaja-Rupp · I. · Jafari · M. D. · Kessler · L. G. · Krane · M. K.
Introduction

Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.

The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.

Methods and analysis

COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.

Ethics and dissemination

This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

NCT04095663.

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.

What are the barriers and facilitators to the acceptance of information and communication technology-based interventions for improving resilience and mental health of healthcare workers: a scoping review protocol

Por: Alves · E. · Rodrigues · R. · Fonseca · C. · Lopes · M. · Faria · I. · Dalkner · N. · Barach · P. · Folkvord · F. · Carlson · J. I. · Reininghaus · E. · Wessa · M. · Prinzellner · Y. · Leung · V. · Turk · E. · de Pinho · L. G. · on behalf of the XR2ESILIENCE team members
Introduction

Healthcare workers (HCWs) report overwhelming demands and experience crisis levels of burnout and unique challenges that further impair their mental health. Promotion of mental health among HCWs using information and communication technology (ICT) has received little empirical research attention and interventions for improving mental health resilience in HCWs are not well established.

Design

Scoping review to map existing evidence and identify gaps for future research regarding the main barriers and facilitators of the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in all healthcare settings.

Methods and analysis

This protocol was developed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive bibliographic search will be conducted between October 2024 and October 2025 in Pubmed, Web of Science, PsycINFO, Scopus, Cochrane Library and CINAHL Ultimate (MedicLatina, Psychology and Behavioural Sciences Collection), with the assistance of a qualified research librarian, to retrieve studies describing data on the main barriers and facilitators to the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in healthcare settings. There will be no restrictions based on date of publication or language. Inclusion and exclusion criteria will be defined for each element of the PICO(D) framework, and both quantitative and qualitative data will be extracted. Quality will be assessed using the mixed methods assessment tool. Two independent investigators will perform the eligibility assessment and data extraction, and any disagreements will be resolved by a third reviewer. The main results will be narratively synthesised and analysed.

Ethics and dissemination

Since secondary data will be analysed, no ethical approval is required. The results will be disseminated through publications subject to peer review.

Registration

https://doi.org/10.17605/OSF.IO/5R36Q.

Association between hospitalisations for ambulatory care-sensitive conditions and primary healthcare physician specialisation: a longitudinal ecological study in Belo Horizonte, Brazil

Por: Rodrigues · G. V. · Afonso · M. P. D. · de Mendonca · L. G. · Pedro · S. · da Silva · H. P. · Macieira · C. · de Oliveira · V. B.
Objectives

Ambulatory care sensitive conditions (ACSCs) are conditions for which the provision of timely and skilled primary care can reduce risks of hospitalisation when preventing, treating or controlling a disease. For this reason, hospitalisations for ACSC have been commonly employed by health systems as an indicator of effectiveness for the primary level of care. This study aims to evaluate whether the provision of primary care services by physicians with residency training in family medicine is associated with rates of general hospitalisations for ACSCs in the Brazilian Unified Health System network in the city of Belo Horizonte, Brazil.

Design

Longitudinal ecological study using a Generalised Linear Model for Gamma-distributed variables.

Setting

Primary healthcare centres in Belo Horizonte, Brazil, from January 2017 to December 2021, aggregated at the primary healthcare centres level.

Participants

Data aggregated at the primary healthcare centre level, encompassing socioeconomic, professional and health-related variables.

Primary outcome measures

Incidence rates of hospitalisations for ACSCs, adjusted for age and sex.

Results

After adjusting for age, sex and socioeconomic variables using the Health Vulnerability Index, a higher concentration of family physicians was significantly associated with a lower incidence of hospitalisations for ACSCs. If all physicians in the primary care network were family physicians, compared with a scenario in which none were, an estimated 11.89% reduction in hospitalisations would be expected (95% CI 7.3% to 16.3%, p

Conclusions

The findings suggest that specialisation in family medicine positively impacts health outcomes by reducing hospitalisations for ACSCs. These results can inform the development of evidence-based public policies to enhance primary care effectiveness.

Characteristics, reporting, risk of bias and pragmatism in prehospital emergency care randomised trials from 2010 to 2024: a protocol for a meta-epidemiological study

Por: Tarkanyi · G. · Czina · L. · Ferenci · T. · Hirt · J. · Hemkens · L. G. · Lohner · S.
Introduction

Prehospital emergency care (PEC) requires rapid evidence-based decisions to maximise the effectiveness of care and to improve clinical outcomes. There are multiple challenges related to clinical research performed in the PEC setting. The aim of our study is to systematically review and assess the characteristics, quality of reporting, risk of bias and pragmatism in recent PEC trials, thereby identifying potential gaps and strengths that can guide the design of future prehospital studies.

Methods and analysis

We will systematically search databases MEDLINE, Embase and Cochrane CENTRAL to identify all randomised controlled trials conducted in the field of PEC and published in English language between 2010 and 2024. No restrictions will be made to the participants, interventions and outcomes. Risk of bias will be evaluated using the Cochrane Risk of Bias 2 tool. The level of pragmatism will be assessed using the Pragmatic-Explanatory Continuum Indicator Summary-2 score. Exploratory data analysis will be used to investigate and summarise main patterns. Differences in characteristics between PEC fields, study designs, publication year and associations between pragmatism levels, risk of bias and quality of reporting will be the primary focus.

Ethics and dissemination

There are no ethical concerns directly relevant to this review. This study has been previously registered with the Open Science Framework (osf.io/rzn9j). The manuscript will be submitted for publication to a relevant, peer-reviewed journal.

Mixed-methods process evaluation of ctDNA use to guide decision-making in patients with advanced solid cancers: study protocol for a substudy of the LIQPLAT trial

Por: Schwenke · J. M. · Schmitt · A. M. · McLennan · S. · Janiaud · P. · Läubli · H. · Binder · M. · Alborelli · I. · Matter · M. S. · Hinke · J. · Widmer · C. C. · Hemkens · L. G. · Kasenda · B. · Briel · M.
Introduction

There is an urgent need to better understand how information from circulating tumour DNA (ctDNA) can be integrated into routine care for patients with advanced solid cancer.

Methods and analysis

The implementation of liquid biopsies in routine care of patients with advanced solid cancer trial (LIQPLAT) is a single-centre, single-arm trial investigating the implementation of ctDNA in the routine care of patients with advanced solid cancer. We present a mixed-methods process evaluation embedded in the LIQPLAT trial, following Medical Research Council guidance and the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. We show a logic model, which details the causal chain and related assumptions from recruiting patients into the trial to the goal of improving quality of life and survival. Data collection is longitudinal and includes: semistructured interviews with healthcare professionals (pathologists, biologists, oncologists; planned n=20) and patients (planned n=15) to identify implementation barriers and facilitators; recordings of molecular tumour board meetings to analyse clinical decision-making; the 23-item Normalisation MeAsure Development survey for healthcare professionals (planned n=20) at four time points. Quantitative data from hospital records will be used to assess implementation outcomes like patient acceptance rates and ctDNA workflow success. Qualitative data will undergo thematic and content analysis, and quantitative data will be analysed using a Bayesian framework.

Ethics and dissemination

The LIQPLAT trial was approved by the regional ethics committee of Northwestern and Central Switzerland (BASEC 2024-00358). The qualitative aspects of the process evaluation were exempted from ethics review according to the Swiss Human Research Act. We follow guidelines for data security, confidentiality and information governance. Results will be submitted for publication in peer-reviewed journals and discussed at conferences.

Trial registration number

NCT06367751, SNCTP000005844.

Digital cognitive behavioural therapy for cardiac anxiety following acute coronary syndrome: protocol for a randomised controlled trial comparing CBT to a digital lifestyle intervention

Por: Johnsson · A. · Ljotsson · B. · Braunschweig · F. · Mellbin · L. G. · Särnholm · J.
Introduction

Cardiac anxiety is common following acute coronary syndrome (ACS) and is characterised by fear of recurrence, heightened attention to cardiac sensations and avoidance of cardiac-related activities in daily life. It is associated with depression, reduced quality of life (QoL) and an adverse cardiac prognosis. We have developed a digital cognitive–behavioural therapy protocol for cardiac anxiety (CA-CBT) post ACS, previously evaluated in clinical trials including one randomised controlled trial (RCT), in which the intervention was compared to usual care. This protocol article describes a follow-up RCT, designed to further evaluate the efficacy of CA-CBT compared with an active control receiving a digital cardiac lifestyle intervention (CLI).

Method and analysis

Participants with ACS (ST-elevation myocardial infarction (STEMI)/non-STEMI/unstable angina ≥6 months prior) and elevated cardiac anxiety (Cardiac Anxiety Questionnaire; CAQ ≥18 and as per clinical interviews) (n=176) are randomised 1:1 to 8 weeks of CA-CBT or CLI. Primary outcome is change in cardiac anxiety, measured by the CAQ, from pre-intervention to post-intervention. Analyses will be conducted according to the ‘intention-to-treat’ principle, using hierarchical linear mixed-effects model, with random intercepts and including 10 weekly assessments collected during the treatment period. Secondary outcomes include disease-specific Quality of Life (Heart QoL), depression (Patient Health Questionnaire-9), insomnia (Insomnia Severity Index), in addition to both self-rated and accelerometer-measured physical activity. Secondary outcomes will be analysed using similar statistical methods.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority (Dnr 2023-07605-01), and the first patient enrolled on 7 March 2024. Recruitment is ongoing, and the completion date is expected to fall in the latter half of 2026. All participants receive information about the study and provide informed consent in accordance with ethical guidelines before inclusion. The results will be analysed at group level, and trial outcomes will be published in a peer-reviewed scientific journal, regardless of results.

Trial registration number

NCT06298864.

Adaptation of the serious illness conversation guide to a multicultural context in Singapore: a qualitative study

Por: Ramakrishnan · C. · Lee · A. S. Y. · Malhotra · C. · Phua · G. L. G. · Yee · A. · Neo · S. H.-S.
Objective

To adapt the Serious Illness Conversation Guide (SICG), Ariadne Labs, Massachusetts USA, to a local Singapore version and evaluate its acceptability.

Design

Qualitative study using semistructured interviews.

Participants

49 participants (30 patients with serious illnesses, five family caregivers and 14 healthcare providers (HCP)) recruited from three public hospitals in Singapore.

Setting

Face-to-face or virtual indepth interviews.

Methods

Guided by the Heuristic Framework and Cultural Sensitivity model, we employed a multi-stage iterative design. Starting with the original SICG, we iterated the guide following three rounds of cognitive interviews among patients followed by expert consultation (n=4) to derive a local version, subsequently reviewed by caregivers and HCP. We assessed acceptability of the SICG using traffic light colour codes—red (unacceptable), orange (needs change) and green (no change) and gathered suggestions to rephrase them. Using content analysis, we compared acceptability of questions as proportion of red, orange and green responses at each interview round and inductively derived themes reflecting views towards the guide.

Results

The original SICG showed low acceptability, and most questions received high proportions of red responses. Negative words and phrases dampening hope, lack of comprehension due to complex framing and cultural insensitivity to prognostic discussions were key themes reflecting low acceptability. Surface and deep structural revisions that centred around positive framing with hopeful language, focusing on current values and individualising conversations (‘use if appropriate’ prompts) significantly improved the guide’s acceptability.

Conclusion

We derived a local Singapore SICG that aligns with the core elements of the original guide and fosters cultural sensitivity. The adapted version could be further tested in other Asian countries.

Assessing the impact of the COVID-19 pandemic among internally displaced persons in Burkina Faso, Mali and Niger: a cross-sectional study using respondent-driven sampling

Por: Pham · P. N. · Keegan · K. · Johnston · L. G. · Diallo · D. Y. · OMealia · T. · Goh · M. · Vinck · P.
Objectives

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

Design

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Setting

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

Participants

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

Primary and secondary outcome measures

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Results

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

Conclusions

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Patient-reported outcome measures for fatigue in patients with chronic kidney disease: a systematic review

Por: Hughes · A. · Ju · A. · Cazzolli · R. · Howell · M. · Guha · C. · Levin · A. · Manera · K. · Teixeira-Pinto · A. · Torrisi · L. G. · Wheeler · D. C. · Wong · G. · Wu · R. · Jaure · A.
Objective

Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).

Design

Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.

Data sources

We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.

Eligibility criteria for selecting studies

All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.

Results

We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.

Conclusion

PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.

Evaluating an intervention to promote access to mental healthcare for low language proficient migrants and refugees across Europe (MentalHealth4All): study protocol for a pretest-post-test cross-national survey study

Por: van Lent · L. G. G. · Hodakova · S. · Hanft-Robert · S. · Mösko · M. · Rao · C. · Kerremans · K. · Cox · A. · Lazaro Gutierrez · R. · Temizöz · O. · Mankauskiene · D. · Biel · Łucja · Di Maria · E. · Schouten · B. · MentalHealth4All consortium · Weert · Looper · Hernandez · Chen
Background

Migrants and refugees with low language proficiency (LLP) in the dominant language of their host country have a higher risk of suffering from certain mental health disorders compared with non-migrant populations. They are also more likely to experience a lack of access to mental healthcare due to language-related and culture-related barriers. As part of the MentalHealth4All project, a digital multilingual communication and information platform was developed to promote access to mental healthcare for LLP migrants and refugees across Europe. This paper describes the study protocol for evaluating the platform in practice, among both health and/or social care providers (HSCPs) and LLP migrants and refugees.

Methods and analysis

We will conduct a pretest–post-test cross-national survey study to evaluate the platform’s effect evaluation (primary objective) and process evaluation (secondary objective). The primary outcomes (measured at T0, T2 and T3) are four dimensions of access to mental healthcare services: availability, approachability, acceptability and appropriateness of mental healthcare. Secondary outcomes (measured at T2) are: actual usage of the platform (ie, tracking data), perceived ease of use, usefulness of content, comprehensibility of information, attractiveness of content and emotional support. Participants will be recruited from nine European countries: Belgium, Germany, Italy, Lithuania, the Netherlands, Poland, Slovakia, Spain and the UK. Using convenience sampling through professional networks/organisations and key figures, we aim to include at least 52 HSCPs (ie, 6–10 per country) and 260 LLP migrants (ie, 30–35 per country). After completing a pretest questionnaire (T0), participants will be requested to use the platform, and HSCPs will participate in an additional personalised training (T1). Next, participants will fill out a post-test questionnaire (T2) and will be requested to participate in a second post-test questionnaire (T3, about 6–8 weeks after T2) to answer additional questions on their experiences through a brief phone interview (T3 is optional for migrants/refugees).

Ethics and dissemination

For all nine countries, the ethical review board of the participating university (hospital) has assessed and approved the protocol. If successful, the MentalHealth4All platform will be made publicly available to help improve access to mental healthcare services, as well as HSCPs’ cultural competencies in delivering such services, for any LLP migrants and refugees across Europe (and beyond). Findings will also be disseminated through peer-reviewed journals and conferences.

Registration details

The ‘MHealth4All project’ was prospectively registered on Open Science Framework, DOI: 10.17605/OSF.IO/U4XSM.

Developing an evidence brief for policy on implementing deprescribing practices across different levels of healthcare: a protocol

Por: Moura · M. D. G. · Lopes · L. P. N. · de Oliveira · J. C. · Neiva · L. · Fulone · I. · Mazzei · L. G. · Santos · D. M. d. S. S. d. · Lopes · L. C.
Objectives

To identify and contextualise evidence-based strategies for implementing deprescribing practices at different levels of healthcare in Brazil, through the development of an evidence brief for policy that includes stakeholder deliberation and considers barriers, facilitators and equity aspects.

Methods and analysis

This protocol outlines the development of an evidence brief for policy using a mixed-methods design. It involves synthesising evidence for health policies by integrating global research and local evidence through three stages: stakeholder exchange, evidence brief development and external endorsement. The Supporting Policy-Relevant Reviews and Trials tools for evidence-informed health policies will guide both the synthesis of strategies and the facilitation of deliberative dialogues. The synthesis will encompass evidence from systematic reviews and meta-analysis on deprescribing strategies across healthcare levels, focusing on effectiveness, harms, costs, perceptions, barriers, facilitators and equity. Studies proposing strategies not yet implemented will be excluded. Study selection and data extraction will be conducted independently and in duplicate. The methodological quality of included studies will be assessed using the A Measurement Tool for Assessing the Methodological Quality of Systematic Reviews-2 criteria. Synthesised evidence will be used to develop evidence-based strategies, which will then be presented in deliberative dialogues for endorsement by stakeholders and adaptation to the Brazilian context. Endorsement rates will be classified as high, moderate or low based on predefined criteria.

Ethics and dissemination

This study was approved by the University of Sorocaba Research Ethics Committee (certificate 82098324.7.0000.5500). Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42024548845.

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