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ISCB2014_abstract_book

102 ISCB 2014 Vienna, Austria • Abstracts - Poster PresentationsTuesday, 26th August 2014 • 10:30-11:00 Monday25thAugustTuesday26thAugustThursday28thAugustAuthorIndexPostersWednesday27thAugustSunday24thAugust Tuesday, 26th August 2014 - 10.30-11.00 Poster session P2 P2.1 Longitudinal data analysis P2.1.54 Six- and 12-month follow-up of an interdisciplinary treatment of patients with fibromyalgia: results of a randomised trial J Martín1 , S García1,2 , F Torre3 , U Aguirre1,2 , A Callejo3 , A Arizaga3 , F Mendoza4 , JM Quintana1,2 1 Galdakao-Usansolo Hospital, Galdakao, Spain, 2 Health Services Research on Chronic Diseases Network-REDISSEC, Galdakao, Spain, 3 Pain Management Unit, Galdakao-Usansolo Hospital, Galdakao, Spain, 4 Department of Internal Medicine, Galdakao-Usansolo Hospital, Galdakao, Spain   Objective: To assess the efficacy of a 6-week interdisciplinary treatment that combines coordinated psychological, medical, educational, and phys- iotherapeutic components (PSYMEPHY) over time compared to standard pharmacologic care. Methods: Randomized controlled trial with follow-up at 6 months for the PSYMEPHY and control groups and 12 months for the PSYMEPHY group. Participants were 153 outpatients with FM recruited from a hos- pital pain management unit. Patients randomly allocated to the control group (CG) received standard pharmacologic therapy. The experimental group (EG) received an interdisciplinary treatment (12 sessions). The main outcome was changes in quality of life, and secondary outcomes were pain, physical function, anxiety, depression, use of pain coping strategies, and satisfaction with treatment as measured by the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Coping with Chronic Pain Questionnaire, and a question regarding satisfaction with the treatment. Results: Six months after the intervention, significant improvements in quality of life (p=0.04), physical function (p=0.01), and pain (p=0.03) were seen in the PSYMEPHY group (n=54) compared with controls (n=56). Patients receiving the intervention reported greater satisfaction with treat- ment. Twelve months after the intervention, patients in the PSYMEPHY group (n=58) maintained statistically significant improvements in quality of life, physical functioning, pain, and symptoms of anxiety and depres- sion, and were less likely to use maladaptive passive coping strategies compared to baseline. Conclusion: An interdisciplinary treatment for FM was associated with im- provements in quality of life, pain, physical function, anxiety and depres- sion, and pain coping strategies up to 12 months after the intervention.   P2.1.60 Assessment of the bias introduced by excluding patients from the analysis set due to missing post-randomization S Hantel1 1 Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany   The analysis set in randomized clinical trials is often restricted to patients for whom at least one measurement after start of randomized medication is observed. Several methods exist to handle situations that not all data after start of treatment are available like mixed model for repeated mea- surement (MMRM), pattern mixture models, multiple imputation (MI) or single imputation methods like last observation carried forward (LOCF), and the complete case analysis. Most of these methods are only valid un- der strong assumptions. Since the exclusion of patients based on post randomization findings like early drop-outs can introduce a bias, this poster investigates the per- formance of methods using the restricted set of patients with post ran- domization data (full analysis set, FAS) compared to methods using the all randomized patients set (itt set). In order to apply the MMRM to the itt set, post randomization data are imputed by baseline data carried forward (BOCF) or MI for patients without any post-randomization data. The as- sessment of the bias is based on simulation studies for normally distrib- uted longitudinal data. The simulation show that the use of the restricted analysis set can intro- duce a substantial bias. In this context, baseline carried forward and mul- tiple imputation using values more extreme than the observed values can play an important role in assessing the potential bias. P2.1.74 Progress of bilateral monitoring - case study K Hrach1 1 J.E.Purkyne University in Usti nad Labem, Usti nad Labem, Czech Republic   In our study, when observing neurological patients, oxygen, lactate/py- ruvate ratio, glycerol and glucose values are monitored bilaterally (from the healthy and the affected hemisphere of the brain), i.e. eight variables totally. Data collection is still ongoing.This contribution is dedicated to the exemplary editing data from one patient. It illustrates merging of variables (monitoring is not perfectly synchronized) and emphasizes the need for standardization (monitored variables have very different range). An important aspect is the selection of appropriate data summarization (averaging in time). In the case of analyzed patient, the eight resulting time series show similar patterns in the graph. The closest course has al- ways the same variable on healthy and the affected hemisphere, gener- ally. At least similar to all the remaining variables is lactate/pyruvate ratio (from both hemispheres). Confirmation of the visual analysis of this graph is an application of cluster analysis - dendrogram for gradual clustering of variables confirmed the aforementioned similarities (or dissimilarities) totally. The study is realized under the support of grant project n. NT13883- 4/2012 of the Czech Ministry of Health. P2.1.77 Assessing the‘General Health Questionnaire’and ‘Center of Epidemiological Studies Depression Scale’for depression screening: stroke and cancer patients SCE Ifeagwu1 , S Ayis1 1 King’s College London, London, United Kingdom   Background: The English Longitudinal Study of Ageing (ELSA) is a health survey that entails information in waves on British people aged 50 and over from 1998 to 2011 (waves 0-5). Depression was assessed by the General Health Questionnaire (GHQ-12) and Center of Epidemiological Studies Depression Scale (CES-D8). Aims: (1) To investigate the internal consistency, criterion validity and predictive power of the CES-D8 and GHQ-12 within waves 1 and 3 of the survey, where the two scales were used simultaneously for screening. (2) To assess the agreement of the two scales in case identification. Methods: 12,099 respondents were screened within wave 1 and 9,771 in wave 3. Cronbach’s alpha analysis was used to investigate the internal consistency between both instruments and the predictive power was cal- culated via STATA 12. ROC curve analyses were used to evaluate the opti- mal cut-off point of both scales and to assess the accuracy in identifying depression in patients with different comorbidities. Results: Excellent item consistency and good criterion validity were shown by the two scales. Optimal cut-off scores were ≥3 for CES-D8 and

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