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T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION
Abstract Background Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be random...
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Published in: | Schizophrenia bulletin 2018-04, Vol.44 (suppl_1), p.S132-S133 |
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creator | Schlögelhofer, Monika McGorry, Patrick D Nelson, Barnaby Markulev, Connie Yuen, Hok Pan Schäfer, Miriam Mossaheb, Nilufar Smesny, Stefan Hickie, Ian B Berger, Gregor Chen, Eric Y H de Haan, Lieuwe Nieman, Dorien H Nordentoft, Merete Riecher-Rössler, Anita Verma, Swapna Thompson, Andrew Yung, Alison Ruth Paul Amminger, G |
description | Abstract
Background
Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study.
Methods
Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (>25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention).
Results
Of 304 randomised participants, 57.9% (N = 176) were non-adherent (>25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication.
No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P < 0.001 and P = 0.020, respectively) compared to th |
doi_str_mv | 10.1093/schbul/sby016.325 |
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Background
Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study.
Methods
Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (>25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention).
Results
Of 304 randomised participants, 57.9% (N = 176) were non-adherent (>25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication.
No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P < 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P < 0.001).
Discussion
Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. Knowledge about factors associated with adherence could help to improve the delivery of interventions in young people at risk of psychosis.</description><identifier>ISSN: 0586-7614</identifier><identifier>EISSN: 1745-1701</identifier><identifier>DOI: 10.1093/schbul/sby016.325</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Abstracts</subject><ispartof>Schizophrenia bulletin, 2018-04, Vol.44 (suppl_1), p.S132-S133</ispartof><rights>Maryland Psychiatric Research Center 2018. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2255-32a824f3c64fcd9d6f158462f04b3a47e8c09d1520af51ffdab50623893012883</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5888024/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5888024/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids></links><search><creatorcontrib>Schlögelhofer, Monika</creatorcontrib><creatorcontrib>McGorry, Patrick D</creatorcontrib><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Markulev, Connie</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Schäfer, Miriam</creatorcontrib><creatorcontrib>Mossaheb, Nilufar</creatorcontrib><creatorcontrib>Smesny, Stefan</creatorcontrib><creatorcontrib>Hickie, Ian B</creatorcontrib><creatorcontrib>Berger, Gregor</creatorcontrib><creatorcontrib>Chen, Eric Y H</creatorcontrib><creatorcontrib>de Haan, Lieuwe</creatorcontrib><creatorcontrib>Nieman, Dorien H</creatorcontrib><creatorcontrib>Nordentoft, Merete</creatorcontrib><creatorcontrib>Riecher-Rössler, Anita</creatorcontrib><creatorcontrib>Verma, Swapna</creatorcontrib><creatorcontrib>Thompson, Andrew</creatorcontrib><creatorcontrib>Yung, Alison Ruth</creatorcontrib><creatorcontrib>Paul Amminger, G</creatorcontrib><title>T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</title><title>Schizophrenia bulletin</title><description>Abstract
Background
Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study.
Methods
Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (>25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention).
Results
Of 304 randomised participants, 57.9% (N = 176) were non-adherent (>25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication.
No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P < 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P < 0.001).
Discussion
Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. Knowledge about factors associated with adherence could help to improve the delivery of interventions in young people at risk of psychosis.</description><subject>Abstracts</subject><issn>0586-7614</issn><issn>1745-1701</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqNkM1OwkAUhSdGExF9AHd9AAv3zl-nLkwIjEKCYLAsXE2m045ggJKOmPD21pSYuHN1k3PPdxYfIbcIPYSU9YNb5YdNP-RHQNljVJyRDiZcxJgAnpMOCCXjRCK_JFchfAAgTyXtEJnxtBdlYx3N9HIxeFnMo9dsOXq7jwajsV7o2VBH2SmLnvVoMhxkk_nsmlx4uwnlzel2yfJRZ8NxPJ0_NZVp7CgVImbUKso9c5J7V6SF9CgUl9QDz5nlSakcpAUKCtYL9L6wuQBJmUoZIFWKdclDu7s_5NuycOXus7Ybs6_XW1sfTWXX5u9nt16Z9-rLCKUUUN4MYDvg6iqEuvS_LIL5MWdac6Y1ZxpzDXPXMtVh_4_6N9rqbgk</recordid><startdate>20180401</startdate><enddate>20180401</enddate><creator>Schlögelhofer, Monika</creator><creator>McGorry, Patrick D</creator><creator>Nelson, Barnaby</creator><creator>Markulev, Connie</creator><creator>Yuen, Hok Pan</creator><creator>Schäfer, Miriam</creator><creator>Mossaheb, Nilufar</creator><creator>Smesny, Stefan</creator><creator>Hickie, Ian B</creator><creator>Berger, Gregor</creator><creator>Chen, Eric Y H</creator><creator>de Haan, Lieuwe</creator><creator>Nieman, Dorien H</creator><creator>Nordentoft, Merete</creator><creator>Riecher-Rössler, Anita</creator><creator>Verma, Swapna</creator><creator>Thompson, Andrew</creator><creator>Yung, Alison Ruth</creator><creator>Paul Amminger, G</creator><general>Oxford University Press</general><scope>TOX</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20180401</creationdate><title>T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</title><author>Schlögelhofer, Monika ; McGorry, Patrick D ; Nelson, Barnaby ; Markulev, Connie ; Yuen, Hok Pan ; Schäfer, Miriam ; Mossaheb, Nilufar ; Smesny, Stefan ; Hickie, Ian B ; Berger, Gregor ; Chen, Eric Y H ; de Haan, Lieuwe ; Nieman, Dorien H ; Nordentoft, Merete ; Riecher-Rössler, Anita ; Verma, Swapna ; Thompson, Andrew ; Yung, Alison Ruth ; Paul Amminger, G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2255-32a824f3c64fcd9d6f158462f04b3a47e8c09d1520af51ffdab50623893012883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Abstracts</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schlögelhofer, Monika</creatorcontrib><creatorcontrib>McGorry, Patrick D</creatorcontrib><creatorcontrib>Nelson, Barnaby</creatorcontrib><creatorcontrib>Markulev, Connie</creatorcontrib><creatorcontrib>Yuen, Hok Pan</creatorcontrib><creatorcontrib>Schäfer, Miriam</creatorcontrib><creatorcontrib>Mossaheb, Nilufar</creatorcontrib><creatorcontrib>Smesny, Stefan</creatorcontrib><creatorcontrib>Hickie, Ian B</creatorcontrib><creatorcontrib>Berger, Gregor</creatorcontrib><creatorcontrib>Chen, Eric Y H</creatorcontrib><creatorcontrib>de Haan, Lieuwe</creatorcontrib><creatorcontrib>Nieman, Dorien H</creatorcontrib><creatorcontrib>Nordentoft, Merete</creatorcontrib><creatorcontrib>Riecher-Rössler, Anita</creatorcontrib><creatorcontrib>Verma, Swapna</creatorcontrib><creatorcontrib>Thompson, Andrew</creatorcontrib><creatorcontrib>Yung, Alison Ruth</creatorcontrib><creatorcontrib>Paul Amminger, G</creatorcontrib><collection>Oxford Open</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Schizophrenia bulletin</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schlögelhofer, Monika</au><au>McGorry, Patrick D</au><au>Nelson, Barnaby</au><au>Markulev, Connie</au><au>Yuen, Hok Pan</au><au>Schäfer, Miriam</au><au>Mossaheb, Nilufar</au><au>Smesny, Stefan</au><au>Hickie, Ian B</au><au>Berger, Gregor</au><au>Chen, Eric Y H</au><au>de Haan, Lieuwe</au><au>Nieman, Dorien H</au><au>Nordentoft, Merete</au><au>Riecher-Rössler, Anita</au><au>Verma, Swapna</au><au>Thompson, Andrew</au><au>Yung, Alison Ruth</au><au>Paul Amminger, G</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION</atitle><jtitle>Schizophrenia bulletin</jtitle><date>2018-04-01</date><risdate>2018</risdate><volume>44</volume><issue>suppl_1</issue><spage>S132</spage><epage>S133</epage><pages>S132-S133</pages><issn>0586-7614</issn><eissn>1745-1701</eissn><abstract>Abstract
Background
Adherence to a medication is generally defined as the extent to which patients take medications as prescribed by their health care providers. Poor adherence to study medication is not uncommon posing a major challenge to treatment trails. However, poor adherence may not be randomly distributed but rather be associated with demographic or illness factors. The aim of the present study was to identify factors associated with adherence to study medication in young people at ultrahigh risk of psychosis who participated in the NEURAPRO study.
Methods
Secondary analysis of data collected in a multi-centre, double-blind, placebo-controlled, randomized clinical trial to prevent or delay the onset of psychosis in participants at ultrahigh risk of psychosis testing omega-3 polyunsaturated fatty acids (omega-3 PUFAs) vs. placebo, in combination with cognitive behavioural case management (NEURAPRO) were included in this analysis. Measures included the Brief Psychiatric Rating Scale (BPRS), the Scale for the Assessment of Negative Symptoms (SANS), the Montgomery Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Social and Occupational Functioning Assessment Scale (SOFAS), and the Global Functioning: Social and Role scales. Adherence to the study medication was assessed monthly for each participant based on capsule count. The mean adherence rating over the 6-month intervention period was then computed and categorized as either adherent (≤25% of capsules returned) or non-adherent (>25% of capsules returned). Transition to psychosis was defined on the basis of operationalized criteria and assessed with the Comprehensive Assessment of the At-Risk Mental State. Levels of ω-3 PUFAs in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (amongst other fatty acids) were measured as percentage of total fatty acids in erythrocytes at baseline and at month 6 (end-of-intervention).
Results
Of 304 randomised participants, 57.9% (N = 176) were non-adherent (>25% of capsules returned) and 128 (42.1%) were adherent (≤25% capsules returned) to the study medication.
No sex differences were observed for adherence rates. At baseline the omega-3 index (EPA+DHA) was significantly lower in the non-adherent group (P = 0.018). The non-adherent group had significant lower scores on the SOFAS (P = 0.001) and the Global Functioning: Social and Role Scale at baseline assessment (P < 0.001 and P = 0.020, respectively) compared to the adherent group. No statistically significant differences were observed on symptom measures at baseline (BPRS, SANS, MADRS, YMRS). The cumulative transition to psychosis rate at month 12 was significantly higher in the non-adherent group compared to the adherent group (14.8% vs. 4.7%; Log rank test: P < 0.001).
Discussion
Adherence to study medication was relatively low in NEURAPRO. Poor functioning and lower levels of ω-3 PUFAs at baseline were associated with non-adherence. Young people who were non-adherent had a significantly higher risk of progressing to first episode psychosis. Knowledge about factors associated with adherence could help to improve the delivery of interventions in young people at risk of psychosis.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/schbul/sby016.325</doi><oa>free_for_read</oa></addata></record> |
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title | T49. THE NEURAPRO STUDY: ADHERENCE TO STUDY MEDICATION |
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