ABSTRACT
BACKGROUND: Buruli ulcer (BU) is a neglected tropical disease caused by Mycobacterium ulcerans that affects skin, soft tissues, and bones, causing long-term morbidity, stigma, and disability. The recommended treatment for BU requires 8 weeks of daily rifampicin and clarithromycin together with wound care, physiotherapy, and sometimes tissue grafting and surgery. Recovery can take up to 1 year, and it may pose an unbearable financial burden to the household. Recent in vitro studies demonstrated that beta-lactams combined with rifampicin and clarithromycin are synergistic against M. ulcerans. Consequently, inclusion of amoxicillin/clavulanate in a triple oral therapy may potentially improve and shorten the healing process. The BLMs4BU trial aims to assess whether co-administration of amoxicillin/clavulanate with rifampicin and clarithromycin could reduce BU treatment from 8 to 4 weeks. METHODS: We propose a randomized, controlled, open-label, parallel-group, non-inferiority phase II, multi-centre trial in Benin with participants stratified according to BU category lesions and randomized to two oral regimens: (i) Standard: rifampicin plus clarithromycin therapy for 8 weeks; and (ii) Investigational: standard plus amoxicillin/clavulanate for 4 weeks. The primary efficacy outcome will be lesion healing without recurrence and without excision surgery 12 months after start of treatment (i.e. cure rate). Seventy clinically diagnosed BU patients will be recruited per arm. Patients will be followed up over 12 months and managed according to standard clinical care procedures. Decision for excision surgery will be delayed to 14 weeks after start of treatment. Two sub-studies will also be performed: a pharmacokinetic and a microbiology study. DISCUSSION: If successful, this study will create a new paradigm for BU treatment, which could inform World Health Organization policy and practice. A shortened, highly effective, all-oral regimen will improve care of BU patients and will lead to a decrease in hospitalization-related expenses and indirect and social costs and improve treatment adherence. This trial may also provide information on treatment shortening strategies for other mycobacterial infections (tuberculosis, leprosy, or non-tuberculous mycobacteria infections). TRIAL REGISTRATION: ClinicalTrials.gov NCT05169554 . Registered on 27 December 2021.
Subject(s)
Anti-Bacterial Agents , Buruli Ulcer , Amoxicillin-Potassium Clavulanate Combination/therapeutic use , Anti-Bacterial Agents/therapeutic use , Benin , Buruli Ulcer/drug therapy , Clarithromycin/therapeutic use , Clinical Trials, Phase II as Topic , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Rifampin/therapeutic use , Treatment OutcomeABSTRACT
Objetivo: Analizar la composición por sexo de los comités de personas expertas creados para la gestión y la toma de decisiones políticas durante la pandemia de COVID-19 en España. Método: Se realizó una revisión por pares para identificar los comités destinados a la gestión de la COVID-19 en las comunidades autónomas y de ámbito estatal. Se recopilaron el nombre, el número de integrantes, el sexo y las fuentes de información, y se calculó el porcentaje de mujeres. Resultados: En las comunidades autónomas se identificó la composición de 11 comités específicos, con una media de representación de las mujeres del 39,2%, siendo del 42,9% en todo el Estado. El 75% del conjunto de los comités representó a las mujeres por debajo del umbral de paridad. Conclusiones: Existe una significativa infrarrepresentación de las mujeres en los comités para la gestión de la COVID-19, lo que puede limitar la necesaria mirada feminista para la recuperación de la crisis. (AU)
Objective: To analyse the gender composition of the advisory boards created for the management and policy decision-making during the COVID-19 pandemic in Spain. Method: A peer review was carried out to identify the advisory boards involved in the management of COVID-19 in the autonomous regions and in Spain. Name, number of members, sex and sources of information were collected, and the percentage of women was calculated. Results: At the regional level, the composition of eleven advisory boards was identified, with a mean representation of women of 39.2%; 42.9% at the national level. 75% of all boards represented women below the parity threshold. Conclusions: There is a significant under-representation of women in the advisory boards for the COVID-19 management, which may limit a necessary feminist perspective for the crisis recovery. (AU)
Subject(s)
Humans , History, 21st Century , Pandemics , Coronavirus Infections/epidemiology , Gender Perspective , Advisory Committees , Spain , Health PolicyABSTRACT
La subjetividad de multitud de dimensiones que inciden en la salud requiere abordajes sistémicos, diseños de estudios que integren datos de salud poblacionales y las narrativas de la población, así como abordajes metodológicos específicos que permitan capturar la evidencia procedente de procesos sociales y comunitarios. El uso de metodologías participativas en los diagnósticos de salud urbana es clave para capturar las diferentes perspectivas y conocimientos del contexto local, contribuyendo a un análisis más completo de la realidad. Esta nota metodológica expone el desarrollo del proceso participativo realizado como parte del diagnóstico de salud de Bilbao: la identificación de agentes participantes y criterios de selección, la invitación a participar y las dinámicas desarrolladas. Compartir experiencias que hayan incorporado procesos participativos es necesario para favorecer su desarrollo metodológico, y así, impulsar su práctica. (AU)
The subjectivity of a multitude of dimensions that affect health requires systemic approaches, study designs that integrate population health data and the narratives of the population, as well as specific methodological approaches that allow the capture of evidence from social and community processes. The use of participatory methodologies in urban health diagnoses is key to capturing the different perspectives and knowledge of the local context, contributing to a more complete analysis of reality. This methodological note presents the development of the participatory process carried out as part of the Bilbao health diagnosis; the identification of participating agents and selection criteria, the invitation to participate and the dynamics developed. Sharing experiences that have incorporated participatory processes is necessary to foster its methodological development, and thus, to promote it practice. (AU)
Subject(s)
Diagnosis of Health Situation , Urban Health , Education , Community Participation , Surveys and Questionnaires , Social ParticipationABSTRACT
OBJECTIVE: To analyse the gender composition of the advisory boards created for the management and policy decision-making during the COVID-19 pandemic in Spain. METHOD: A peer review was carried out to identify the advisory boards involved in the management of COVID-19 in the autonomous regions and in Spain. Name, number of members, sex and sources of information were collected, and the percentage of women was calculated. RESULTS: At the regional level, the composition of eleven advisory boards was identified, with a mean representation of women of 39.2%; 42.9% at the national level. 75% of all boards represented women below the parity threshold. CONCLUSIONS: There is a significant under-representation of women in the advisory boards for the COVID-19 management, which may limit a necessary feminist perspective for the crisis recovery.
Subject(s)
COVID-19 , Pandemics , COVID-19/epidemiology , Decision Making , Female , Humans , Policy , Policy MakingABSTRACT
The subjectivity of a multitude of dimensions that affect health requires systemic approaches, study designs that integrate population health data and the narratives of the population, as well as specific methodological approaches that allow the capture of evidence from social and community processes. The use of participatory methodologies in urban health diagnoses is key to capturing the different perspectives and knowledge of the local context, contributing to a more complete analysis of reality. This methodological note presents the development of the participatory process carried out as part of the Bilbao health diagnosis; the identification of participating agents and selection criteria, the invitation to participate and the dynamics developed. Sharing experiences that have incorporated participatory processes is necessary to foster its methodological development, and thus, to promote it practice.
Subject(s)
Urban Health , HumansABSTRACT
BACKGROUND: The optimal form of exercise for individuals with cancer has yet to be identified, but there is evidence that exercise improves their quality of life. The aim of this study is to assess the efficacy and efficiency of an innovative physical exercise programme, for individuals undergoing chemotherapy for breast, gastrointestinal or non-small cell lung tumours, for improving quality of life, reducing level of fatigue, and enhancing functional capacity over time. DESIGN/METHODS: We will conduct a clinical trial in 66 patients with stage IV breast, gastrointestinal or non-small cell lung cancer, recruited by the Department of Oncology of the referral hospital from 4 primary care health centres of the Basque Health Service (Osakidetza). These patients will be randomised to one of two groups. The treatment common to both groups will be the usual care for cancer: optimized usual drug therapies and strengthening of self-care; in addition, patients in the intervention group will participate in a 2-month exercise programme, including both aerobic and strength exercises, supervised by nurses in their health centre. The principal outcome variable is health-related quality of life, measured blindly with the 30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire and Short Form-36 four times: at baseline, and 2, 6 and 12 months later. The secondary outcome variables are fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire), functional capacity (6-Minute Walk Test and cardiorespiratory test), muscle strength (hand-held dynamometry and sit-to-stand test), radiological response to treatment (Response Evaluation Criteria In Solid Tumors) and progression-free and overall survival. Age, sex, diagnosis, chemotherapy regimen, Eastern Cooperative Oncology Group performance status and smoking status will be considered as predictive variables. Data will be analysed on an intention-to-treat basis, comparing changes at each time point between groups, adjusting for baseline values by analysis of covariance. DISCUSSION: As well as achieving the objectives set, this study will provide us with information on patient perception of the care received and an opportunity to develop a project based on collaborative action between the primary care and oncology professionals. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01786122 Registration date: 02/05/2013.
