Objectives: The National Vaccination Plan against SARS-CoV-2/COVID-19 was launched by the Ministry of Health and Social Protection on 14 February 2021. The main objective of this study was to evaluate the effectiveness of the CoronaVac in preventing the three clinical outcomes of infection, hospitalisation, or death, in a real-world scenario.
Design: This was a population-based retrospective dynamic cohort study using a multivariate Cox model to calculate hazard ratios to estimate vaccine effectiveness from 17 February 2021 to 30 June 2022.
Introduction: The control of the COVID-19 epidemic has been focused on the development of vaccines against SARS-CoV-2. All developed vaccines have reported safety and efficacy results in preventing infection and its consequences, although the quality of evidence varies depending on the vaccine considered. Different methodological designs have been used for their evaluation, which can influence our understanding of the effects of these interventions.
View Article and Find Full Text PDFBackground: Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going.
View Article and Find Full Text PDFIntroduction: Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments.
View Article and Find Full Text PDFObjective: To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews.
Methods: Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement.
Results: We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments.
Background: Cutaneous leishmaniasis causes a high disease burden in Colombia, and available treatments present systemic toxicity, low patient compliance, contraindications, and high costs. The purpose of this study was to estimate the cost-effectiveness of thermotherapy versus Glucantime in patients with cutaneous leishmaniasis in Colombia.
Methods: Cost-effectiveness study from an institutional perspective in 8133 incident cases.
Introduction: Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).
Materials And Methods: Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.
Objective: The treatment of cutaneous leishmaniasis is toxic, has contraindications, and a high cost. The objective of this study was to estimate the cost-effectiveness of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis.
Methods: Effectiveness was the proportion of healing and safety with the adverse effects; these parameters were estimated from a controlled clinical trial and a meta-analysis.
Background: Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials.
Methods: A meta-analysis based on a search of nine databases with eight strategies was conducted.
Introduction: The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power.
Objective: To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis.
Methods: A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality.