F110. SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING
Abstract Background Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective natu...
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| creator | Garcia-Portilla, M P Llorca, P M Maina, G Bozikas, V P Devrimci-Ozguven, H Kim, S W Bergmans, P Usankova, I Cherubin, P Najarian, Dean Pungor, K |
| description | Abstract
Background
Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective nature of randomized clinical trials, populations studied may not be entirely representative of schizophrenia patients in real life.
Methods
A prospective, single-arm, open-label, 52-week study (REMISSIO) was conducted in a naturalistic setting to assess the impact of conversion from paliperidone palmitate 1-month formulation (PP1M) to PP3M in patients with clinically stable schizophrenia. Patients aged 18–50 years with schizophrenia (DSM-5) were eligible to participate if they had been adequately treated with PP1M for ≥4 months (the last 2 doses of PP1M being the same) and had a baseline Positive and Negative Syndrome Scale (PANSS) total score 6 months v |
| doi_str_mv | 10.1093/schbul/sbz018.522 |
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Background
Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective nature of randomized clinical trials, populations studied may not be entirely representative of schizophrenia patients in real life.
Methods
A prospective, single-arm, open-label, 52-week study (REMISSIO) was conducted in a naturalistic setting to assess the impact of conversion from paliperidone palmitate 1-month formulation (PP1M) to PP3M in patients with clinically stable schizophrenia. Patients aged 18–50 years with schizophrenia (DSM-5) were eligible to participate if they had been adequately treated with PP1M for ≥4 months (the last 2 doses of PP1M being the same) and had a baseline Positive and Negative Syndrome Scale (PANSS) total score <70. The initial dose of PP3M and subsequent dose changes (possible at clinicians’ discretion) were made according to the product label [5]. The primary outcome was the number of patients who achieved SR (score ≤3 on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9, maintained for ≥6 months) at the last observation carried forward (LOCF) endpoint [1]. Other outcomes included PANSS total and subscores, Clinical Global Impression of Change (CGI-C), and adverse events (AEs). The intent-to-treat (ITT) population comprised 305 patients from Europe, Middle East and Asia, who had received ≥1 dose of PP3M. Treatment response analyses were performed on the efficacy ITT population (n=303). Endpoint analysis using LOCF was performed, in addition to observed case analysis.
Results
Patients had a mean (standard deviation; SD) age of 36.5 (8.0) years, 66% were male, and mean (SD) time since schizophrenia diagnosis was 9.2 (7.3) years. A total of 291 patients completed the 52-week study period. Mean (SD) first dose of PP3M was 363.6 (115.4) mg and mean (SD) mode dose during the study period was 362.2 (118.3) mg; all except 1 patient had the correct conversion from PP1M to PP3M. 4.9% and 3.6% of patients experienced PP3M dose decreases and increases, respectively.
58.0% of patients met the PANSS severity criterion at PP3M start, SR was achieved by 172 patients (56.8%) at LOCF endpoint, and Kaplan-Meier estimated median time to SR was 247 (95% confidence interval [CI], 189, 275) days. SR was achieved by 58.3% of patients on PP1M for >6 months vs. 50.9% of patients on PP1M for 4–6 months, and by 55.8% and 57.0% of patients switching from antipsychotic polytherapy or monotherapy, respectively. Mean PANSS total score for all patients improved from baseline (52.4 [SD 10.6]) to LOCF endpoint (–3.1 [95% CI, –4.1, –2.0]), and 67.8% of patients had achieved at least minimal improvement in their health status (according to CGI-C) at LOCF endpoint. A total of 29.4% of patients experienced ≥1 treatment-emergent AE considered related to study medication; 5.6% of patients reported bodyweight increase as an AE, and 4.6% of patients experienced possibly hyperprolactinemia-related AEs.
Discussion
In conclusion, for the majority of schizophrenia patients, converting from PP1M in a naturalistic setting, PP3M achieved SR and maintained symptom stability.
References:
[1] Andreasen NC et al. 2005. Am J Psychiatry 162,441–449.
[2] Berwaerts J et al. 2015. JAMA Psychiatry 72, 830–839.
[3] Savitz AJ et al. 2016. Int J Neuropsychopharmacol 19, 1–14.
[4] Savitz AJ et al. 2017. Int Clin Psychopharmacol 32, 329–336.
[5] TREVICTA prolonged release suspension for injection. Summary of Product Characteristics.</description><identifier>ISSN: 0586-7614</identifier><identifier>EISSN: 1745-1701</identifier><identifier>DOI: 10.1093/schbul/sbz018.522</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Poster Session II</subject><ispartof>Schizophrenia bulletin, 2019-04, Vol.45 (Supplement_2), p.S295-S296</ispartof><rights>The Author(s) 2019. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6455476/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6455476/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,1583,27922,27923,53789,53791</link.rule.ids></links><search><creatorcontrib>Garcia-Portilla, M P</creatorcontrib><creatorcontrib>Llorca, P M</creatorcontrib><creatorcontrib>Maina, G</creatorcontrib><creatorcontrib>Bozikas, V P</creatorcontrib><creatorcontrib>Devrimci-Ozguven, H</creatorcontrib><creatorcontrib>Kim, S W</creatorcontrib><creatorcontrib>Bergmans, P</creatorcontrib><creatorcontrib>Usankova, I</creatorcontrib><creatorcontrib>Cherubin, P</creatorcontrib><creatorcontrib>Najarian, Dean</creatorcontrib><creatorcontrib>Pungor, K</creatorcontrib><title>F110. SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING</title><title>Schizophrenia bulletin</title><description>Abstract
Background
Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective nature of randomized clinical trials, populations studied may not be entirely representative of schizophrenia patients in real life.
Methods
A prospective, single-arm, open-label, 52-week study (REMISSIO) was conducted in a naturalistic setting to assess the impact of conversion from paliperidone palmitate 1-month formulation (PP1M) to PP3M in patients with clinically stable schizophrenia. Patients aged 18–50 years with schizophrenia (DSM-5) were eligible to participate if they had been adequately treated with PP1M for ≥4 months (the last 2 doses of PP1M being the same) and had a baseline Positive and Negative Syndrome Scale (PANSS) total score <70. The initial dose of PP3M and subsequent dose changes (possible at clinicians’ discretion) were made according to the product label [5]. The primary outcome was the number of patients who achieved SR (score ≤3 on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9, maintained for ≥6 months) at the last observation carried forward (LOCF) endpoint [1]. Other outcomes included PANSS total and subscores, Clinical Global Impression of Change (CGI-C), and adverse events (AEs). The intent-to-treat (ITT) population comprised 305 patients from Europe, Middle East and Asia, who had received ≥1 dose of PP3M. Treatment response analyses were performed on the efficacy ITT population (n=303). Endpoint analysis using LOCF was performed, in addition to observed case analysis.
Results
Patients had a mean (standard deviation; SD) age of 36.5 (8.0) years, 66% were male, and mean (SD) time since schizophrenia diagnosis was 9.2 (7.3) years. A total of 291 patients completed the 52-week study period. Mean (SD) first dose of PP3M was 363.6 (115.4) mg and mean (SD) mode dose during the study period was 362.2 (118.3) mg; all except 1 patient had the correct conversion from PP1M to PP3M. 4.9% and 3.6% of patients experienced PP3M dose decreases and increases, respectively.
58.0% of patients met the PANSS severity criterion at PP3M start, SR was achieved by 172 patients (56.8%) at LOCF endpoint, and Kaplan-Meier estimated median time to SR was 247 (95% confidence interval [CI], 189, 275) days. SR was achieved by 58.3% of patients on PP1M for >6 months vs. 50.9% of patients on PP1M for 4–6 months, and by 55.8% and 57.0% of patients switching from antipsychotic polytherapy or monotherapy, respectively. Mean PANSS total score for all patients improved from baseline (52.4 [SD 10.6]) to LOCF endpoint (–3.1 [95% CI, –4.1, –2.0]), and 67.8% of patients had achieved at least minimal improvement in their health status (according to CGI-C) at LOCF endpoint. A total of 29.4% of patients experienced ≥1 treatment-emergent AE considered related to study medication; 5.6% of patients reported bodyweight increase as an AE, and 4.6% of patients experienced possibly hyperprolactinemia-related AEs.
Discussion
In conclusion, for the majority of schizophrenia patients, converting from PP1M in a naturalistic setting, PP3M achieved SR and maintained symptom stability.
References:
[1] Andreasen NC et al. 2005. Am J Psychiatry 162,441–449.
[2] Berwaerts J et al. 2015. JAMA Psychiatry 72, 830–839.
[3] Savitz AJ et al. 2016. Int J Neuropsychopharmacol 19, 1–14.
[4] Savitz AJ et al. 2017. Int Clin Psychopharmacol 32, 329–336.
[5] TREVICTA prolonged release suspension for injection. Summary of Product Characteristics.</description><subject>Poster Session II</subject><issn>0586-7614</issn><issn>1745-1701</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNqNkdtKxDAQhoMouB4ewLs8gNVOD0l7I5SatYGeaCOy3oSmTd2V1V1aV9AH8LnNUhG882IYhpnvm4sfoQuwr8AO3euxXard-npUnzYEV77jHKAZUM-3gNpwiGa2HxCLEvCO0ck4Pts2eCFxZuhrDkaB60VWiiKLBI9xxTJe17zI8QMXCS6jlJes4rdFzvZDxkUkGHatrMhFki7wvKiy-9SghuA5ruOEPxZlUrGcRwYQnOWi3m8iHKc853GU4rKKYvOL4ZoJwfO7M3TUN-tRn__0U3Q_ZyJOrLS42wNWC5Q6Vt8QCINOac_1gg5Up5Si4IDW0GgnII0KPe10HXH7lviB4wN1KaggbFtTPbin6GbybnfqRXetfn0bmrXcDquXZviQm2Yl_25eV0v5tHmXxPN9jxIjgEnQDptxHHT_y4It90nIKQk5JSFNEoa5nJjNbvuP82-pkoWL</recordid><startdate>20190409</startdate><enddate>20190409</enddate><creator>Garcia-Portilla, M P</creator><creator>Llorca, P M</creator><creator>Maina, G</creator><creator>Bozikas, V P</creator><creator>Devrimci-Ozguven, H</creator><creator>Kim, S W</creator><creator>Bergmans, P</creator><creator>Usankova, I</creator><creator>Cherubin, P</creator><creator>Najarian, Dean</creator><creator>Pungor, K</creator><general>Oxford University Press</general><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20190409</creationdate><title>F110. SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING</title><author>Garcia-Portilla, M P ; Llorca, P M ; Maina, G ; Bozikas, V P ; Devrimci-Ozguven, H ; Kim, S W ; Bergmans, P ; Usankova, I ; Cherubin, P ; Najarian, Dean ; Pungor, K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1772-fa6198dbe4348d1bdbbb7121ee1ae286ab94e2dd63fc6582517371b89cc89cf13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Poster Session II</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garcia-Portilla, M P</creatorcontrib><creatorcontrib>Llorca, P M</creatorcontrib><creatorcontrib>Maina, G</creatorcontrib><creatorcontrib>Bozikas, V P</creatorcontrib><creatorcontrib>Devrimci-Ozguven, H</creatorcontrib><creatorcontrib>Kim, S W</creatorcontrib><creatorcontrib>Bergmans, P</creatorcontrib><creatorcontrib>Usankova, I</creatorcontrib><creatorcontrib>Cherubin, P</creatorcontrib><creatorcontrib>Najarian, Dean</creatorcontrib><creatorcontrib>Pungor, K</creatorcontrib><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>Garcia-Portilla, M P</au><au>Llorca, P M</au><au>Maina, G</au><au>Bozikas, V P</au><au>Devrimci-Ozguven, H</au><au>Kim, S W</au><au>Bergmans, P</au><au>Usankova, I</au><au>Cherubin, P</au><au>Najarian, Dean</au><au>Pungor, K</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>F110. SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING</atitle><jtitle>Schizophrenia bulletin</jtitle><date>2019-04-09</date><risdate>2019</risdate><volume>45</volume><issue>Supplement_2</issue><spage>S295</spage><epage>S296</epage><pages>S295-S296</pages><issn>0586-7614</issn><eissn>1745-1701</eissn><abstract>Abstract
Background
Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective nature of randomized clinical trials, populations studied may not be entirely representative of schizophrenia patients in real life.
Methods
A prospective, single-arm, open-label, 52-week study (REMISSIO) was conducted in a naturalistic setting to assess the impact of conversion from paliperidone palmitate 1-month formulation (PP1M) to PP3M in patients with clinically stable schizophrenia. Patients aged 18–50 years with schizophrenia (DSM-5) were eligible to participate if they had been adequately treated with PP1M for ≥4 months (the last 2 doses of PP1M being the same) and had a baseline Positive and Negative Syndrome Scale (PANSS) total score <70. The initial dose of PP3M and subsequent dose changes (possible at clinicians’ discretion) were made according to the product label [5]. The primary outcome was the number of patients who achieved SR (score ≤3 on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9, maintained for ≥6 months) at the last observation carried forward (LOCF) endpoint [1]. Other outcomes included PANSS total and subscores, Clinical Global Impression of Change (CGI-C), and adverse events (AEs). The intent-to-treat (ITT) population comprised 305 patients from Europe, Middle East and Asia, who had received ≥1 dose of PP3M. Treatment response analyses were performed on the efficacy ITT population (n=303). Endpoint analysis using LOCF was performed, in addition to observed case analysis.
Results
Patients had a mean (standard deviation; SD) age of 36.5 (8.0) years, 66% were male, and mean (SD) time since schizophrenia diagnosis was 9.2 (7.3) years. A total of 291 patients completed the 52-week study period. Mean (SD) first dose of PP3M was 363.6 (115.4) mg and mean (SD) mode dose during the study period was 362.2 (118.3) mg; all except 1 patient had the correct conversion from PP1M to PP3M. 4.9% and 3.6% of patients experienced PP3M dose decreases and increases, respectively.
58.0% of patients met the PANSS severity criterion at PP3M start, SR was achieved by 172 patients (56.8%) at LOCF endpoint, and Kaplan-Meier estimated median time to SR was 247 (95% confidence interval [CI], 189, 275) days. SR was achieved by 58.3% of patients on PP1M for >6 months vs. 50.9% of patients on PP1M for 4–6 months, and by 55.8% and 57.0% of patients switching from antipsychotic polytherapy or monotherapy, respectively. Mean PANSS total score for all patients improved from baseline (52.4 [SD 10.6]) to LOCF endpoint (–3.1 [95% CI, –4.1, –2.0]), and 67.8% of patients had achieved at least minimal improvement in their health status (according to CGI-C) at LOCF endpoint. A total of 29.4% of patients experienced ≥1 treatment-emergent AE considered related to study medication; 5.6% of patients reported bodyweight increase as an AE, and 4.6% of patients experienced possibly hyperprolactinemia-related AEs.
Discussion
In conclusion, for the majority of schizophrenia patients, converting from PP1M in a naturalistic setting, PP3M achieved SR and maintained symptom stability.
References:
[1] Andreasen NC et al. 2005. Am J Psychiatry 162,441–449.
[2] Berwaerts J et al. 2015. JAMA Psychiatry 72, 830–839.
[3] Savitz AJ et al. 2016. Int J Neuropsychopharmacol 19, 1–14.
[4] Savitz AJ et al. 2017. Int Clin Psychopharmacol 32, 329–336.
[5] TREVICTA prolonged release suspension for injection. Summary of Product Characteristics.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/schbul/sbz018.522</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Poster Session II |
| title | F110. SYMPTOMATIC REMISSION WITH PALIPERIDONE PALMITATE 3-MONTHLY FORMULATION IN SCHIZOPHRENIA PATIENTS IN A CLINICAL PRACTICE SETTING |
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