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

TY - JOUR

T1 - Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health

AU - Pesola, Francesca

AU - Williams, Julie

AU - Bird, Victoria

AU - Freidl, Marion

AU - Le Boutillier, Clair

AU - Leamy, Mary

AU - Macpherson, Rob

AU - Slade, Mike

PY - 2015/12/2

Y1 - 2015/12/2

N2 - 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.

AB - 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.

KW - Individualized outcome

KW - Mental health

KW - Personalized measure

KW - Randomized controlled trial

UR - https://www.scopus.com/pages/publications/85027930993

U2 - 10.1002/mpr.1480

DO - 10.1002/mpr.1480

M3 - Article

SN - 1049-8931

VL - 24

SP - 257

EP - 265

JO - International Journal of Methods in Psychiatric Research

JF - International Journal of Methods in Psychiatric Research

IS - 4

ER -