ABSTRACT
BACKGROUND: 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. Of them, the main reason for non-inclusion was lack of data on treatment follow-up and therapeutic response (182/242, 75% of children and 179/468, 38% of adults). Data on 1,325 eligible CL patients (736 children and 589 older adults) were analyzed. In both age groups, disease presentation was mild, with a median number of lesions of one (IQR: 1-2) and median lesion diameter of less than 3 cm. Less than 50% of the patients had data for two or more follow-up visits post-treatment (being only 28% in pediatric patients). Systemic antimonials were the most common monotherapy regimen in both age groups (590/736, 80.2% of children and 308/589, 52.3% of older adults) with overall cure rates of 54.6% (95% CI: 50.5-58.6%) and 68.2% (95% CI: 62.6-73.4%), respectively. Other treatments used include miltefosine, amphotericin B, intralesional antimonials, and pentamidine. Adverse reactions related to the main treatment were experienced in 11.9% (86/722) of children versus 38.4% (206/537) of older adults. Most adverse reactions were of mild intensity. CONCLUSION: Our findings support the need for greater availability and use of alternatives to systemic antimonials, particularly local therapies, and development of strategies to improve patient follow-up across the region, with special attention to pediatric populations.
Subject(s)
Antiprotozoal Agents , Leishmaniasis, Cutaneous , Humans , Child , Aged , Retrospective Studies , Leishmaniasis, Cutaneous/drug therapy , Pentamidine , Treatment OutcomeABSTRACT
OBJECTIVE: 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. The verification methodology uses the graph formalism to model the document. Semi-automatic analysis identifies possible problems in the model and in the original document. The verification is an iterative process that identifies possible faults in the original text that should be revised by its authors and/or specialists. RESULTS: The proposed method was able to identify 23 possible issues in the original document (ambiguities, omissions, redundant information, and inaccuracies, among others). The formal verification process aided the specialists to consider a wider range of usage scenarios and to identify which instructions form the kernel of the proposed SOP and which ones represent additional or required knowledge that are mandatory for the correct application of the medical document. CONCLUSION: By using the proposed verification process, a simpler and yet more complete SOP could be produced. As consequence, during the validation process the experts received a more mature document and could focus on the technical aspects of the procedure itself.
Subject(s)
Decision Support Techniques , Documentation/standards , Leishmaniasis, Cutaneous/therapy , Medical Records/standards , Practice Guidelines as Topic/standards , Software , Validation Studies as Topic , Humans , Quality Assurance, Health CareABSTRACT
BACKGROUND: 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). RESULTS: For 70% of patients CL had a moderate/large impact on their QoL, with 'Work and School' being the most affected domain. This is the first study to use the DLQI to assess the impact of CL. CONCLUSION: CL has a moderate to large negative effect on QoL.
