Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health

Pre‐defined, researcher‐selected outcomes are routinely used as the clinical end‐point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Ind...

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Veröffentlicht in:International journal of methods in psychiatric research 2015-12, Vol.24 (4), p.257-265
Hauptverfasser: Pesola, Francesca, Williams, Julie, Bird, Victoria, Freidl, Marion, Le Boutillier, Clair, Leamy, Mary, Macpherson, Rob, Slade, Mike
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container_issue 4
container_start_page 257
container_title International journal of methods in psychiatric research
container_volume 24
creator Pesola, Francesca
Williams, Julie
Bird, Victoria
Freidl, Marion
Le Boutillier, Clair
Leamy, Mary
Macpherson, Rob
Slade, Mike
description Pre‐defined, researcher‐selected outcomes are routinely used as the clinical end‐point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient‐specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow‐up. For PPO, patients choose an outcome domain related to their goal from a pre‐defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow‐up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd.
doi_str_mv 10.1002/mpr.1480
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J. Methods Psychiatr. Res</addtitle><description>Pre‐defined, researcher‐selected outcomes are routinely used as the clinical end‐point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient‐specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow‐up. 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subjects Adolescent
Adult
Aged
Feasibility Studies
Female
Humans
individualized outcome
Male
Mental Disorders - diagnosis
Mental Disorders - therapy
Mental Health
Middle Aged
Original
Outcome Assessment, Health Care - methods
personalized measure
randomized controlled trial
Randomized Controlled Trials as Topic
Surveys and Questionnaires
Time Factors
Young Adult
title Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health
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