This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines.
View Article and Find Full Text PDFBackground: Treatment guidance for children and older adult patients affected by cutaneous leishmaniasis (CL) is unclear due to limited representation of these groups in clinical trials.
Methods: We conducted a collaborative retrospective study to describe the effectiveness and safety of antileishmanial treatments in children ≤ 10 and adults ≥ 60 years of age, treated between 2014 and 2018 in ten CL referral centers in Latin America.
Results: 2,037 clinical records were assessed for eligibility.
Introduction: Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to report therapeutic responses with different available options for ML.
Methods: This study was based on a review of clinical records of 35 patients (24 men and 11 women) treated between 2009 and 2015.
Background: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas.
View Article and Find Full Text PDFBACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure.
View Article and Find Full Text PDFObjective: We propose the use of a formal approach to support content validation of a standard operating procedure (SOP) for a therapeutic intervention. Such an approach provides a useful tool to identify ambiguities, omissions and inconsistencies, and improves the applicability and efficacy of documents in the health settings.
Materials And Methods: We apply and evaluate a methodology originally proposed for the verification of software specification documents to a specific SOP.
Although intralesional meglumine antimoniate (MA) infiltration is considered an option for cutaneous leishmaniasis (CL) therapy and is widely used in the Old World, there have been few studies supporting this therapeutic approach in the Americas. This study aims to describe outcomes and adverse events associated with intralesional therapy for CL. This retrospective study reviewed the experience of a Brazilian leishmaniasis reference centre using intralesional MA to treat 31 patients over five years (2008 and 2013).
View Article and Find Full Text PDFBackground: Cutaneous leishmaniasis (CL) may manifest as single or multiple skin lesions, causing significant aesthetic impact and affecting the patient's quality of life (QoL). The objective of this study was to assess the impact of CL on the QoL.
Methods: The QoL of 20 patients with CL was assessed by the Dermatology Life Quality Index (DLQI).