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Poster #182 COMPULSORY PSYCHIATRIC TREATMENT IN CANADA: 100 CASES
S156
Abstracts of the 3rd Biennial Schizophrenia International Research Conference / Schizophrenia Research 136, Supplement 1 (2012) S1–S375
dioimmunoassay. Vitamin D insufficiency was defined as having 25 OHD levels between 25-50nmol/L and vitamin D deficiency defined as levels below 25nmol/L. Results: Vitamin D levels (mean ± SD) were significantly lower in cases (36.7±22.9 nmol/L) than in controls (53.7±33.0 nmol/L; p=0.000). Vitamin D deficiency was present in 34.8% of cases and 14.5% of controls, while prevalence of vitamin D insufficiency was similar in both groups, with 43.5% of the first episode group and 40.5% of controls having insufficient vitamin D levels. Discussion: Our findings support previous associations between schizophrenia and vitamin D deficiency and indicate that even at first onset of psychosis mean vitamin D levels are significantly lower than in controls. In this sample, one third of first episode patients met criteria for Vitamin D deficiency.
Poster #181 ONGOING DATA QUALITY MONITORING OF VIDEOTAPED PATIENT INTERVIEWS IN GLOBAL SCHIZOPHRENIA CLINICAL TRIALS: INITIAL FINDINGS David Daniel 1 , Alan Kott 2 United BioSource Corporation, McLean, Virginia, USA; 2 United BioSource Corporation, Prague, Czech Republic 1
Background: There is increased concern with signal detection capability in global schizophrenia clinical trial settings. (1) External review of site ratings and diagnostic proceedings with rapid feedback to the site and sponsor has been proposed as a means of supporting quality and reliability of clinical trials assessments. Methods: Prior to study initiation raters were trained at investigators meetings by highly interactive procedures including slide presentations, rating of videotaped patient interviews, and in some cases interview and rating of live actors trained to portray schizophrenia symptoms. During the study at the site a video/audio recording system is used to assess the accuracy and quality of site diagnostic and rating procedures. Multiple schizophrenia clinical trials involving North America, Europe, South America and Asia are underway utilizing this technique. Sites upload videotaped diagnostic and ratings assessments for review by calibrated external reviewers of the same language and culture. External reviewers provide feedback on an ongoing basis to the site and sponsor on diagnostic and scoring accuracy and interview quality. Interview quality is evaluated by the Research Interview Assessment Scale (RISA) (2). The below results are based on initial analyses of early data available from these ongoing studies. Additional data will be reported. Results: Of 201 patients considered eligible at screening by sites 92% were considered eligible by external reviewers based on review of videotaped interviews. 155 videotaped PANSS administrations at sites were graded for interview quality by external reviewers using the RISA. 74.7% were regarded as excellent (RISA Score 28-30), 20.7% as acceptable (RISA score 24-27) and 4.6% as poor or unacceptable. Exact matches were obtained between the site and external rater on 60% or more of ratings for all 30 PANSS items. Mismatches between the site and external raters of 2 anchor points or greater in scoring any PANSS item were relatively uncommon and only exceeded 10% of ratings on items P2 (Conceptual Disorganization) and N7 (Stereotyped Thinking). Discussion: External review of videotaped diagnostic and ratings interviews with timely feedback to sites and sponsors is feasible in schizophrenia clinical trials settings. The initially available data may indicate that interview quality at the sites and agreement between site and external PANSS ratings is relatively high. The results presented above are early findings from multiple ongoing studies. New patterns may emerge and the results may differ as the size and cultural diversity of the sample increases. Future analyses will assess cultural differences in measures of ratings quality. In addition, the relationship between performance on tests of interview and scoring competency at the investigators meeting and quality of ratings of patients at the site will be assessed in future analyses.
Poster #182 COMPULSORY PSYCHIATRIC TREATMENT IN CANADA: 100 CASES Luc Nicole, Marie Boivin, Kathe Villeneuve, Benedicte Nicole, Christian Desmarais Hôpital Louis-H. Lafontaine, Montreal, QC, Canada Background: The Civil code of Québec (S.Q. 1991, c.64) and the Code of civil procedure (RSQ, c C-25) established that in the case of a person incapable of giving or refusing his consent to care, that person can be submitted against his consent, to psychiatric treatment. Some clinicians, family members and health administrators argue the this measure is either underused or with too much delay, preventing the patient to receive treatment and ultimately, getting access to a full recovery. On the opposite, others argue that this legal measure leads to neglect of patients rights, and that in recent years, there is a dangerous tendancy to an increase of its use. Louis-H.Lafontaine Hospital (Institut en santé mentale de l’Université de Montréal) has a catchment area of 380,000 inhabitants. A specialised lawyer (M.B) is employed by the hospital for all legal procedures, including compulsory treatment court order. The present study aimed at defining quantitative and qualitative aspects of the 108 patients for wich such measures were authorized between 2005 and 2010. Methods: A focus group (including the head of the hospital, the hospital’s chief psychiatrist, the hospital’s specialized lawyer and the authors) determined the relevant questions (cf. results) the study should address.The study had two parts: Quantitative: A data base was available from the Hospital’s Office of Legal affairs for the time period 2005-2010. A total of 108 cases were reviewed. The psychiatric report for each of these cases provided socio-demographic and clinical information on each case. Reasons motivating the request for compulsory treatment were documented. This data base was enriched by service use (hospital stays-number and duration, and emergency consultations-number) for each case. It was also possible to document delays between the first consultation in the hospital and the compulsory treatment court order. SPSS was used to conduct analysis. Qualitative: Interviews were conducted in order to basically determine for 5 cases 1) if the measure was useful or not, 2) if it should have been used earlier, 3) what suggestions could be formulated in order to improve the process. For each one of those cases, 3 persons were interviewed: the patient, a family member and the mental health professional responsible for that particular case. Results: Descriptive statistics showing the sociodemographic, diagnostic (including comorbidity), living conditions, occupations, other legal conditions and the different reasons cited by the psychiatrists (ex; dangerosity, social decline, symptomatic state, functional state among others) for asking the court order will be presented. Comparative analysis will be made for: 1) annual number of compulsory psychiatric treatment court order for each year during the last five years,2) the evolution of delays in the request of the court order for each year during the last five years, 3) service utilisation for the period before and after the compulsoty psychiatric treatment A synthesis of the qualitative data cumulated with the 15 interviews conducted, will be presented. Discussion: The use of a legal measure to submit a person to psychiatric treatment against his will has many implications: ethical, legal, clinical and economic. The results presented will put some of these in perspective and will, hopefully, help the clinician, patient, family member and administrators to consider the compulsory psychiatric treatment as an important tool in the intervention.
Poster #183 METABOLIC SYNDROME IN PATIENTS WITH SCHIZOPHRENIA AND ACTIONS FROM MENTAL HEALTH SERVICES Jose M. Pelayo-Teran 1 , Yolanda Zapico-Merayo 2, Ana R. Alonso-Fernandez 2 , Pedro Trabajo-Vega 1 , Eva Povedano 1 , Nicolas Martin-Navarro 2, Jovita Martinez-Diaz 1 , Mario M. Martinez-Perez 2 , Consolacion Rodriguez-Fonseca 1 , Camino Fernandez-Borregan 2 , Alfonso Hurtado-Casanova 2, Raul Arenas-Fernandez 1 1 Mental Health Service of Arriondas (VIth Health Area) Arriondas, Principate of Asturias, Spain; 2 Hospital El Bierzo Pomferrada, Castilla y Leon, Spain Background: Premature death in patients with schizophrenia is particularly associated to cardiovascular risk. However, Mental Health Services
Abstracts of the 3rd Biennial Schizophrenia International Research Conference / Schizophrenia Research 136, Supplement 1 (2012) S1–S375
dioimmunoassay. Vitamin D insufficiency was defined as having 25 OHD levels between 25-50nmol/L and vitamin D deficiency defined as levels below 25nmol/L. Results: Vitamin D levels (mean ± SD) were significantly lower in cases (36.7±22.9 nmol/L) than in controls (53.7±33.0 nmol/L; p=0.000). Vitamin D deficiency was present in 34.8% of cases and 14.5% of controls, while prevalence of vitamin D insufficiency was similar in both groups, with 43.5% of the first episode group and 40.5% of controls having insufficient vitamin D levels. Discussion: Our findings support previous associations between schizophrenia and vitamin D deficiency and indicate that even at first onset of psychosis mean vitamin D levels are significantly lower than in controls. In this sample, one third of first episode patients met criteria for Vitamin D deficiency.
Poster #181 ONGOING DATA QUALITY MONITORING OF VIDEOTAPED PATIENT INTERVIEWS IN GLOBAL SCHIZOPHRENIA CLINICAL TRIALS: INITIAL FINDINGS David Daniel 1 , Alan Kott 2 United BioSource Corporation, McLean, Virginia, USA; 2 United BioSource Corporation, Prague, Czech Republic 1
Background: There is increased concern with signal detection capability in global schizophrenia clinical trial settings. (1) External review of site ratings and diagnostic proceedings with rapid feedback to the site and sponsor has been proposed as a means of supporting quality and reliability of clinical trials assessments. Methods: Prior to study initiation raters were trained at investigators meetings by highly interactive procedures including slide presentations, rating of videotaped patient interviews, and in some cases interview and rating of live actors trained to portray schizophrenia symptoms. During the study at the site a video/audio recording system is used to assess the accuracy and quality of site diagnostic and rating procedures. Multiple schizophrenia clinical trials involving North America, Europe, South America and Asia are underway utilizing this technique. Sites upload videotaped diagnostic and ratings assessments for review by calibrated external reviewers of the same language and culture. External reviewers provide feedback on an ongoing basis to the site and sponsor on diagnostic and scoring accuracy and interview quality. Interview quality is evaluated by the Research Interview Assessment Scale (RISA) (2). The below results are based on initial analyses of early data available from these ongoing studies. Additional data will be reported. Results: Of 201 patients considered eligible at screening by sites 92% were considered eligible by external reviewers based on review of videotaped interviews. 155 videotaped PANSS administrations at sites were graded for interview quality by external reviewers using the RISA. 74.7% were regarded as excellent (RISA Score 28-30), 20.7% as acceptable (RISA score 24-27) and 4.6% as poor or unacceptable. Exact matches were obtained between the site and external rater on 60% or more of ratings for all 30 PANSS items. Mismatches between the site and external raters of 2 anchor points or greater in scoring any PANSS item were relatively uncommon and only exceeded 10% of ratings on items P2 (Conceptual Disorganization) and N7 (Stereotyped Thinking). Discussion: External review of videotaped diagnostic and ratings interviews with timely feedback to sites and sponsors is feasible in schizophrenia clinical trials settings. The initially available data may indicate that interview quality at the sites and agreement between site and external PANSS ratings is relatively high. The results presented above are early findings from multiple ongoing studies. New patterns may emerge and the results may differ as the size and cultural diversity of the sample increases. Future analyses will assess cultural differences in measures of ratings quality. In addition, the relationship between performance on tests of interview and scoring competency at the investigators meeting and quality of ratings of patients at the site will be assessed in future analyses.
Poster #182 COMPULSORY PSYCHIATRIC TREATMENT IN CANADA: 100 CASES Luc Nicole, Marie Boivin, Kathe Villeneuve, Benedicte Nicole, Christian Desmarais Hôpital Louis-H. Lafontaine, Montreal, QC, Canada Background: The Civil code of Québec (S.Q. 1991, c.64) and the Code of civil procedure (RSQ, c C-25) established that in the case of a person incapable of giving or refusing his consent to care, that person can be submitted against his consent, to psychiatric treatment. Some clinicians, family members and health administrators argue the this measure is either underused or with too much delay, preventing the patient to receive treatment and ultimately, getting access to a full recovery. On the opposite, others argue that this legal measure leads to neglect of patients rights, and that in recent years, there is a dangerous tendancy to an increase of its use. Louis-H.Lafontaine Hospital (Institut en santé mentale de l’Université de Montréal) has a catchment area of 380,000 inhabitants. A specialised lawyer (M.B) is employed by the hospital for all legal procedures, including compulsory treatment court order. The present study aimed at defining quantitative and qualitative aspects of the 108 patients for wich such measures were authorized between 2005 and 2010. Methods: A focus group (including the head of the hospital, the hospital’s chief psychiatrist, the hospital’s specialized lawyer and the authors) determined the relevant questions (cf. results) the study should address.The study had two parts: Quantitative: A data base was available from the Hospital’s Office of Legal affairs for the time period 2005-2010. A total of 108 cases were reviewed. The psychiatric report for each of these cases provided socio-demographic and clinical information on each case. Reasons motivating the request for compulsory treatment were documented. This data base was enriched by service use (hospital stays-number and duration, and emergency consultations-number) for each case. It was also possible to document delays between the first consultation in the hospital and the compulsory treatment court order. SPSS was used to conduct analysis. Qualitative: Interviews were conducted in order to basically determine for 5 cases 1) if the measure was useful or not, 2) if it should have been used earlier, 3) what suggestions could be formulated in order to improve the process. For each one of those cases, 3 persons were interviewed: the patient, a family member and the mental health professional responsible for that particular case. Results: Descriptive statistics showing the sociodemographic, diagnostic (including comorbidity), living conditions, occupations, other legal conditions and the different reasons cited by the psychiatrists (ex; dangerosity, social decline, symptomatic state, functional state among others) for asking the court order will be presented. Comparative analysis will be made for: 1) annual number of compulsory psychiatric treatment court order for each year during the last five years,2) the evolution of delays in the request of the court order for each year during the last five years, 3) service utilisation for the period before and after the compulsoty psychiatric treatment A synthesis of the qualitative data cumulated with the 15 interviews conducted, will be presented. Discussion: The use of a legal measure to submit a person to psychiatric treatment against his will has many implications: ethical, legal, clinical and economic. The results presented will put some of these in perspective and will, hopefully, help the clinician, patient, family member and administrators to consider the compulsory psychiatric treatment as an important tool in the intervention.
Poster #183 METABOLIC SYNDROME IN PATIENTS WITH SCHIZOPHRENIA AND ACTIONS FROM MENTAL HEALTH SERVICES Jose M. Pelayo-Teran 1 , Yolanda Zapico-Merayo 2, Ana R. Alonso-Fernandez 2 , Pedro Trabajo-Vega 1 , Eva Povedano 1 , Nicolas Martin-Navarro 2, Jovita Martinez-Diaz 1 , Mario M. Martinez-Perez 2 , Consolacion Rodriguez-Fonseca 1 , Camino Fernandez-Borregan 2 , Alfonso Hurtado-Casanova 2, Raul Arenas-Fernandez 1 1 Mental Health Service of Arriondas (VIth Health Area) Arriondas, Principate of Asturias, Spain; 2 Hospital El Bierzo Pomferrada, Castilla y Leon, Spain Background: Premature death in patients with schizophrenia is particularly associated to cardiovascular risk. However, Mental Health Services