03022nas a2200337   4500000000100000008004100001260001200042653003300054653002000087100001200107700001200119700001600131700001300147700001500160700001400175700001300189700001100202700001500213700002200228700001200250700001300262700001300275700001100288700001400299245012300313856009900436300001300535490000700548520211500555022001402670       2020                            d  c02/202010aCutaneous Leishmaniasis (CL)10aQuality of Life1 aErber A1 aArana B1 aBen Salah A1 aBennis I1 aBoukthir A1 aNoriega M1 aCissé M1 aCota G1 aHandjani F1 aLópez-Carvajal L1 aMarsh K1 aMedina D1 aPlugge E1 aLang T1 aOlliaro P00aPatients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.  uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0007996&type=printable  ae00079960 v143 a<p><b>BACKGROUND: </b>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. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials.</p><p><b>METHODOLOGY/PRINCIPAL FINDINGS: </b>We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae.</p><p><b>CONCLUSIONS/SIGNIFICANCE: </b>The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be addressed in clinical care.</p>  a1935-2735