J Biomed Inform - Usability standards meet scenario-based design: challenges and opportunities.

Tópicos

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{ record(1888) medic(1808) patient(1693) }
{ care(1570) inform(1187) nurs(1089) }
{ design(1359) user(1324) use(1319) }
{ cancer(2502) breast(956) screen(824) }
{ framework(1458) process(801) describ(734) }
{ research(1085) discuss(1038) issu(1018) }
{ ehr(2073) health(1662) electron(1139) }
{ patient(1821) servic(1111) care(1106) }
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{ cost(1906) reduc(1198) effect(832) }
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{ model(3404) distribut(989) bayesian(671) }
{ imag(1947) propos(1133) code(1026) }
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{ blood(1257) pressur(1144) flow(957) }
{ sampl(1606) size(1419) use(1276) }
{ use(1733) differ(960) four(931) }
{ detect(2391) sensit(1101) algorithm(908) }
{ system(1976) rule(880) can(841) }
{ method(1219) similar(1157) match(930) }
{ patient(2315) diseas(1263) diabet(1191) }
{ studi(2440) review(1878) systemat(933) }
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{ method(1557) propos(1049) approach(1037) }
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{ state(1844) use(1261) util(961) }
{ patient(2837) hospit(1953) medic(668) }
{ model(2656) set(1616) predict(1553) }
{ data(2317) use(1299) case(1017) }
{ medic(1828) order(1363) alert(1069) }
{ signal(2180) analysi(812) frequenc(800) }
{ gene(2352) biolog(1181) express(1162) }
{ first(2504) two(1366) second(1323) }
{ intervent(3218) particip(2042) group(1664) }
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{ method(1969) cluster(1462) data(1082) }
{ method(2212) result(1239) propos(1039) }

Resumo

The focus of this paper is on the challenges and opportunities presented by developing scenarios of use for interactive medical devices. Scenarios are integral to the international standard for usability engineering of medical devices (IEC 62366:2007), and are also applied to the development of health software (draft standard IEC 82304-1). The 62366 standard lays out a process for mitigating risk during normal use (i.e. use as per the instructions, or accepted medical practice). However, this begs the question of whether "real use" (that which occurs in practice) matches "normal use". In this paper, we present an overview of the product lifecycle and how it impacts on the type of scenario that can be practically applied. We report on the development and testing of a set of scenarios intended to inform the design of infusion pumps based on "real use". The scenarios were validated by researchers and practitioners experienced in clinical practice, and their utility was assessed by developers and practitioners representing different stages of the product lifecycle. These evaluations highlighted previously unreported challenges and opportunities for the use of scenarios in this context. Challenges include: integrating scenario-based design with usability engineering practice; covering the breadth of uses of infusion devices; and managing contradictory evidence. Opportunities included scenario use beyond design to guide marketing, to inform purchasing and as resources for training staff. This study exemplifies one empirically grounded approach to communicating and negotiating the realities of practice.

Resumo Limpo

focus paper challeng opportun present develop scenario use interact medic devic scenario integr intern standard usabl engin medic devic iec also appli develop health softwar draft standard iec standard lay process mitig risk normal use ie use per instruct accept medic practic howev beg question whether real use occur practic match normal use paper present overview product lifecycl impact type scenario can practic appli report develop test set scenario intend inform design infus pump base real use scenario valid research practition experienc clinic practic util assess develop practition repres differ stage product lifecycl evalu highlight previous unreport challeng opportun use scenario context challeng includ integr scenariobas design usabl engin practic cover breadth use infus devic manag contradictori evid opportun includ scenario use beyond design guid market inform purchas resourc train staff studi exemplifi one empir ground approach communic negoti realiti practic

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