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Developing middle-range theories for the implementation of clinical practice guideline recommendations for pre-eclampsia prevention and management in eastern, central and southern Africa: a realist synthesis protocol

Por: Solnes Miltenburg · A. · Uwamahoro · N. S. · Mwanga · J. R. · Lindskog · B. V. · Misje · R. · Kihunrwa · A. · Pembe · A. B. · Gilmore · B. · Mukumbang · F. C.
Introduction

Hypertensive disorders of pregnancy, such as pre-eclampsia (PE), are one of the leading causes of maternal and perinatal deaths in low- and middle-income countries (LMICs). Although clinical practice guidelines (CPGs) for PE prevention and management are available, there is limited information on their implementation in LMIC contexts. This realist synthesis therefore aims to uncover the causal explanations underpinning the implementation of CPG recommendations for PE prevention and management in Eastern, Central and Southern African contexts. By developing and refining initial programme theories (IPTs), we will generate a pragmatic evidence base explaining how contextual factors trigger mechanisms that lead to intended and unintended outcomes and why implementation varies across the different settings.

Methods and analysis

We conceptualise the implementation of CPGs for PE prevention and management as complex social interventions operating within complex adaptive systems. The realist synthesis method will be employed to systematically review the literature for evidence synthesis. The review process will be conducted in five phases, each iteratively building on the previous phase to uncover generative causation and refine the IPTs. We will identify articles through iterative purposive searching in six electronic databases and search engines (Google Scholar, PubMed, Cochrane, MEDLINE, EMBASE Global Health) and through screening WHO sources. Advisory group consultations will be held to formulate, prioritise and refine IPTs. To conceptualise our realist theories through generative causation, we will analyse the data using a retroductive approach, an integration of inductive, deductive and abductive reasoning. We will inductively examine theoretical insights related to five established care moments and explore how CPGs operate during these moments, including where and how they fail to work as intended. The five care moments are: (1) Risk assessment/prevention, (2) Diagnosing disease, (3) Management of PE without severe features, (4) With severe features and (5) Decision making around birth. Deductive reasoning will support sense-making of evidence-based theories through the lens of theories that have been used to explain the adoption of guidelines in healthcare settings. Lastly, abductive reasoning, centring researcher hunches, will help to unearth mechanisms that have been insufficiently detailed in the literature. The intervention-context-actor-mechanism-outcome heuristic will be used to configure programme theories and articulate the theories using the if-then statements.

Ethics and dissemination

This project is part of the larger PREvention of Severe Hypertensive Adverse events (PRESHA) project, which aims to improve the detection, prevention and management of PE in Tanzania. PRESHA has ethical clearance from the Regional Ethics Board in Norway and the National Health Research Ethics Committee in Tanzania. Findings of the review will support the contextual development of CPGs for the prevention and management of PE, which will be implemented within the context of the PRESHA trial.

Developing a minimum dataset for a national patient registry on Long COVID in Canada: a Delphi consensus-based study

Por: Mazurik · K. · Amah · A. · Dumitrescu · D. I. · Ejalonibu · H. · Chavda · B. · Kemp · D. · Frederick · D. E. · Mclean · C. · Decary · S. · Gruneir · A. · Halas · G. · Hoens · A. · Kho · M. · Long COVID Web · Groot · G. · Bhereur · Cao · Cheung · Decary · Grant · Gruneir · Halas · Hoens · Kh
Objectives

To develop survey items for a national patient registry on Long COVID using a modified Delphi process.

Design

This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.

Setting

This study focused on healthcare systems in Canada and was conducted online.

Participants

A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.

Results

In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.

Conclusions

The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.

Syndromic management of sexually transmitted infections among female sex workers in Lomé (Togo), 2023

by Oumarou I. Wone Adama, Iman Frédéric Youa, Alexandra Bitty-Anderson, Arnold Junior Sadio, Rogatien Comlan Atoun, Yao Rodion Konu, Hezouwe Tchade, Martin Kouame Tchankoni, Kokou Herbert Gounon, Kparakate Bouboune Kota-Mamah, Abissouwessim Egbare Tchade, Godonou Amivi Mawussi, Fiali Ayawa Lack, Fifonsi Adjidossi Gbeasor-Komlavi, Anoumou Claver Dagnra, Didier Koumavi Ekouevi

Introduction

In Togo, the syndromic approach is used for the diagnosis and management of sexually transmitted infections (STIs). The aim of this study was to evaluate the syndromic approach for diagnosis of STIs among female sex workers (FSW) in Lomé, Togo.

Methods

A cross-sectional study was carried out from September to October 2023 among FSW in Lomé (Togo). FSW aged 18 years and above were included. A gynecological examination was performed for syndromic diagnosis, and the Xpert® CT/NG were used to screen vaginal swabs for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The performance (predictive values) of the syndromic approach to STI diagnosis was evaluated using the Xpert® CT/NG test as the gold standard.

Results

A total of 357 FSW were recruited. The median age of FSW was 32 years (IQR: [26–40 years]) and 8.2% had attained a higher level of education. The prevalence of syndromic STI among FSW was 33.3%. Vaginal swabs were positive for CT (8.4%) and NG (8.7%), with a prevalence of bacterial STIs (CT and/or NG) of 14.3%. The syndromic approach to STI diagnosis demonstrated a positive predictive value of 24.3%.

Conclusion

The prevalence of STIs is relatively high among FSW in Lomé. According to this study, the diagnosis of STIs using the syndromic approach has limited relevance. National STI screening and management policies urgently need to be rethought, incorporating recent technological advances.

Autologous peripheral blood mononuclear cell-loaded injectable cell scaffold (ICS-001) for revolutionising angiogenic therapy: a study protocol for an exploratory clinical trial

Por: Yamahara · K. · Akahori · H. · Kawai · K. · Suna · S. · Yoshihara · S. · Ishihara · M. · Kakibuchi · M. · Furukawa · M. · Kogai · Y. · Sato · H. · Fukumoto · S. · Furuzono · T. · Tani-Yokoyama · A. · Okamoto · R. · Fujita · Y. · Kawamoto · A.
Introduction

This research paper presents a study protocol for an exploratory clinical trial evaluating the safety and potential efficacy of autologous peripheral blood mononuclear cell (PBMNC)-loaded injectable cell scaffold (ICS-001) for angiogenic therapy in chronic limb-threatening ischaemia (CLTI). CLTI, the advanced stage of peripheral artery disease, presents significant therapeutic challenges.

Methods and analysis

Angiogenic therapy using ICS-001 with PBMNCs—a novel approach designed to enhance local cell retention and promote neovascularisation—will be explored. The study will address the pathophysiology of CLTI, the limitations of current treatments and the rationale for cell-based therapies, alongside the clinical trial design for evaluating the safety and efficacy of ICS-001. We hypothesise that ICS-001 will improve ulcer healing and reduce ischaemic rest pain in patients with CLTI. This paper outlines the methodology, including patient selection, CD34+ cell mobilisation, scaffold preparation, injection protocols, clinical assessments, data collection and safety monitoring. The anticipated results, discussion and conclusion will offer insight into the clinical significance and potential impact of ICS-001 as a pioneering angiogenic therapy for CLTI.

Ethics and dissemination

The institutional review boards of all participating hospitals approved this study protocol (latest version V.6.0, 5 June 2025). Final data will be made publicly available. A report detailing the study results will be submitted for publication in an appropriate peer-reviewed journal.

Data availability statement

Data are available on reasonable request. Technical appendix, statistical code is available by contacting the corresponding author. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build on this work non-commercially, and licence their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Trial registration number

jRCT2052230115, Japan Registry of Clinical Trials.

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