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 |
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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. |
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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.</description><identifier>ISSN: 1049-8931</identifier><identifier>EISSN: 1557-0657</identifier><identifier>DOI: 10.1002/mpr.1480</identifier><identifier>PMID: 26184686</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>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</subject><ispartof>International journal of methods in psychiatric research, 2015-12, Vol.24 (4), p.257-265</ispartof><rights>Copyright © 2015 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5790-754a7b32098fd55c8320c80066bdb8897999627e3fc3a1eefcf2c2ac301e00493</citedby><cites>FETCH-LOGICAL-c5790-754a7b32098fd55c8320c80066bdb8897999627e3fc3a1eefcf2c2ac301e00493</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6878370/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6878370/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,724,777,781,882,1413,27906,27907,45556,45557,53773,53775</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26184686$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pesola, Francesca</creatorcontrib><creatorcontrib>Williams, Julie</creatorcontrib><creatorcontrib>Bird, Victoria</creatorcontrib><creatorcontrib>Freidl, Marion</creatorcontrib><creatorcontrib>Le Boutillier, Clair</creatorcontrib><creatorcontrib>Leamy, Mary</creatorcontrib><creatorcontrib>Macpherson, Rob</creatorcontrib><creatorcontrib>Slade, Mike</creatorcontrib><title>Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health</title><title>International journal of methods in psychiatric research</title><addtitle>Int. 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. 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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Humans</subject><subject>individualized outcome</subject><subject>Male</subject><subject>Mental Disorders - diagnosis</subject><subject>Mental Disorders - therapy</subject><subject>Mental Health</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Outcome Assessment, Health Care - methods</subject><subject>personalized measure</subject><subject>randomized controlled trial</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Surveys and Questionnaires</subject><subject>Time Factors</subject><subject>Young Adult</subject><issn>1049-8931</issn><issn>1557-0657</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkU9vEzEQxS0EoqUg8QmQJS7lsMVer__sBQkVCEENqaBAb5bjnSVuvetg76aUT49DQ0SRkDj5afzzmxk_hB5TckQJKZ93q3hEK0XuoH3KuSyI4PJu1qSqC1UzuocepHRBCFVlKe6jvVJQVQkl9tHVK1iDD6sO-gGbvsGwNn40gws9Dm2u4GnfuLVrRuPdD2jwfBxs6ADPwKQxAj6czmfPcBsijvl56H5BNvRDDN5nOURnfMKux5sWxuMlGD8sH6J7ba7Do-15gD69eX12_LY4mU-mxy9PCstlTQrJKyMXrCS1ahvOrcrSKkKEWDQLpWpZ17UoJbDWMkMBWtuWtjSWEQokb88O0Isb39W46KCxeYZovF5F15l4rYNx-vZN75b6a1hroaRikmSDw61BDN9GSIPuXLLgvekhjElTqQinkpf_gwqihKgYz-jTv9CLMMY-_0SmuOSK3uptY0gpQrubmxK9CV7n4PUm-Iw--XPPHfg76QwUN8CV83D9TyM9O_2wNdzyLg3wfcebeKmFZJLrL-8nWpy_m5x_PP2sz9hPUeDHbQ</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Pesola, Francesca</creator><creator>Williams, Julie</creator><creator>Bird, Victoria</creator><creator>Freidl, Marion</creator><creator>Le Boutillier, Clair</creator><creator>Leamy, Mary</creator><creator>Macpherson, Rob</creator><creator>Slade, Mike</creator><general>Blackwell Publishing Ltd</general><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TK</scope><scope>7XB</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201512</creationdate><title>Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health</title><author>Pesola, Francesca ; 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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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