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advice meetings (n= 3), patient concept elicitation interviews (N= 60), b) concept selection and questionnaire construction activities, c) content evaluation (N= 20), and d) and psychometric evaluation (N= 200). Given the multiple contexts of use intended for the questionnaire, instrument developers created distinct, albeit corresponding questionnaires paying close attention to content, response options, recall period, focus of measurement (e.g., symptom at its worst vs. symptom on average), and number of items. Results: Developers simultaneously created and modified two questionnaires. The Self-Assessment of Psoriasis Symptoms for Clinical Trials (SAPS-CT) has nine items and asks respondents to rate their symptom “at its worst” in the 24 hours prior to assessment while the SAPS for Real World (SAPS-RW) has six items and asks respondents to rate their symptoms “on average” in the seven days prior to assessment. Results support both tools as content valid and capable of generating reliable and valid scores when administered among patients with chronic plaque psoriasis. Conclusions: Though not without challenges and limitations, the methods and results presented here may provide a model for outcomes researchers to more efficiently develop unique versions of a questionnaire suitable to the multiple contexts for which they are often asked to create PRO questionnaires.
called the “BODY-Q”. The present study aims to translate and linguistic validate the BODY-Q for use in Danish bariatric and body contouring patients. Methods: The Danish translation and linguistic validation of the BODY-Q has been performed in accordance with the ISPOR guidelines. All translators aimed to do a conceptually as opposed to literal translation, to use a simple and clear formulation and overall to undertake a translation understandable for all patients. Forward and backward translations were followed by an expert panel meeting and cognitive patient interviews. Results: A conceptually equivalent Danish version of the BODY-Q has been achieved and next step in our research program is Danish psychometric validation of the BODY-Q. Conclusions: The collection of PRO data regarding patient satisfaction and HR-QOL is essential. In clinical practice the BODY-Q can help to identify problems, facilitate communication, and direct appropriate treatment of underappreciated symptoms for the individual patient. Collection of PRO information can help inform the patients’ decision-making process and may also play an important role in creating realistic expectations toward outcomes. Furthermore, BODY-Q data can be used to facilitate comparative effectiveness research, inform discussions with the Danish board of health and support an evidence-based approach for Danish bariatric and body contouring patients.
PRM145 DEFINING AND CAPTURING PATIENT-CENTRED CARE IN LONG-TERM CONDITIONS: THE DEVELOPMENT OF A PATIENT-REPORTED EXPERIENCE MEASURE
PRM148 KNOWLEDGE, ATTITUDE, AND BELIEFS ON ANTIBIOTIC USE AND MISUSE IN ADULTS: A SURVEY IN THE COMMUNITY OF GUNTUR
Hadi M 1, Swinburn P 1, Gibbons E 2 1Mapi Group, London, UK, 2University of Oxford, Oxford, UK
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Objectives: The term patient-centred care (PCC) is commonly used in literature and health policy. However, it is ill defined and little is known about its applicability to the management of people with long-term conditions (LTCs). Our research aimed to identify key PCC experiences that matter to people with LTCs and consider the implications for their measurement. Methods: Four steps were conducted; a conceptual synthesis of existing PCC and patient experience frameworks to produce a new framework, secondary qualitative analysis of patient interviews to identify key experiences of PCC for people with LTCs, development of a PCC questionnaire for people with LTCs, further exploration through cognitive debriefing interviews with people with LTCs and health professionals. Results: The framework of PCC included; access, availability and choice, information, communication and education, relationship with health professionals, involvement in care, respect and dignity, responsiveness to individual needs and preferences, consistency, continuity and co-ordination, and effectiveness of treatment and care. Findings from secondary analysis suggested that the framework was applicable to people with LTCs, but that some aspects held additional value. The themes identified were used to generate items for a generic PCC experience questionnaire for people with LTCs. The final questionnaire consisted of 47 questions. Feedback from the debriefing interviews suggested that the questionnaire captured important aspects of care for people with LTCs and was relevant to a range of different LTCs. Conclusions: The framework of PCC demonstrated some conceptual problems in understanding and evaluating PCC for LTCs. Findings suggest that a questionnaire of experiences of PCC is feasible and acceptable to people with a range of different LTCs. However, future research needs to consider the potential use and contribution of data in enhancing value of care for people with LTCs alongside the associated cost-benefits of providing and capturing PCC services. PRM146 “STOOL” AND “BOWEL MOVEMENT”; THEY’RE THE SAME THING RIGHT?
Guntu M 1, Vasireddy K S 2, Yerram T 2 Institute of Pharmaceutical Sciences, GUNTUR, India, 2Chalapathi Institute Of Pharmaceutical Sciences, Guntur, India .
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Objectives: Through this study, we aim to analyse the knowledge, attitude and practices of antibiotics in an adult population of Guntur area, India. Also, correlate it with the gender, age, education level. Methods: A cross sectional study was conducted in a community of Guntur, India. A total of 200 subjects were interviewed using a questionnaire designed by the authors and the data collected was analyzed using Chi-square test. Results: A total of 200 subjects were included in the study. About 64.5% believed that antibiotics are useful for viral infections also, along with bacterial infections, around 39% of the age group between 20-30 believed antibiotic usage in viral infections wheareas age group between 31-40 and 41-50 believed antibiotics have role in viral infections about 71.4% and 75.6% respectively. Around 44% of the subjects stated that they would use the left over antibiotics for cold, sore throat and 64.3% of female subjects believed that antibiotics are also indicated for any kind of pain and inflammation. About 83% of the subjects buy antibiotics without a medical receipt and 71.5% of the subjects are not aware of antibiotic resistance mainly between age group 31-50. Conclusions: Overall, in this study it was found that misconceptions exist about the use and indications of antibiotics. Lack of knowledge regarding antibiotic resistance was prevalent. Effective strategies involving regulatory enforcement prohibiting sales of antibiotics without prescription should be implemented along with educational interventions for health professionals and the public. These findings will aid in the assessment of the adequacy of present public educational campaigns. Also, it will provide further insight in designing future multifaceted interventions to promote specific messages to rationalize antibiotic use, and compensate for knowledge and attitude gaps as an effort towards preventing development of antibiotic resistance. PRM149 A MULTILEVEL DISCRETE-TIME SURVIVAL LATENT VARIABLE MODEL McGinley J S 1, Shulman K J 2, Yedigarova L 2, Buse D C 3, Wirth R 1, Siffert J 2, Lipton R B 3 Psychometric Group, LLC, Chapel Hill, NC, USA, 2Avanir Pharmaceuticals, Inc, Aliso Viejo, NC, USA, 3Albert Einstein College of Medicine, Bronx, NY, USA .
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Towns L ICON Plc, Abingdon, UK
1Vector
Objectives: A popular topic for Clinical Outcomes Assessments (COAs) is questions concerning bowel conditions. In English, a varied and colourful vocabulary is used to describe and differentiate between forms of bowel excretions; however, during Linguistic Validation, difficulties can arise ensuring that linguists in different countries understand the source English consistently. Here we will look at two commonly used terms: stool and bowel movements. Methods: The terms ‘stool’ and ‘bowel movement’ and their meaning were investigated across 21 languages, including English. Results: In English ‘stool’ refers to a piece of faeces excreted from the anus, while ‘bowel movement’ is more ambiguous. For example, in a COA about children with Crohn’s Disease parents were asked if they had “observed their child having a bowel movement”. After clarification from the author, here they were interested only in defecation. Whilst in another COA for the same disease area the author stipulates within the questionnaire itself that any form of anal excretion should be counted as a ‘bowel movement’. 65% of languages examined agreed with the English explanation of ‘stool’; with 30% understanding it to mean any excretion from the anus; and 5% believing it to refer to the act of defecation. While of the 21 languages only 20% thought ‘bowel movement’ concerns the anal expulsion of any substance; 70% of languages understood this phrase to mean the act of defecation; with 5% thinking it referred to the faeces passed and the remaining 5% seeing it as both the faeces and the act of passing it. Conclusions: Due to the varying interpretations between different countries and individuals it is demonstrated that it is important to ensure the intention of the source is clearly specified so as to ensure conceptual equivalence across all languages, and global comprehension by subjects.
Objectives: In chronic disorders with episodic attacks (CEDAs), clinical trials often evaluate how quickly acute treatments reduce several correlated variables. For example, migraine endpoints could include time to meaningful pain relief (MR), time to pain freedom (PF) and time to disability freedom (DF). These observed events may be conceptualized as indicators of a latent migraine relief construct. Substantive theory suggests that relief should vary both between- and within-persons. Currently no analytic method is well-suited for handling these types of data and hypotheses. For this reason, we propose and demonstrate a flexible multilevel discrete-time survival latent variable model using data from a migraine trial as an example. Methods: COMPASS (NCT01667679) is a multiple attack, cross-over study comparing AVP-825 (novel Breath Powered™ Bi-Directional™ intranasal delivery of low-dose [22mg] sumatriptan powder) vs. 100 mg sumatriptan tablets. Participants were instructed to treat up to 5 attacks with each treatment in blinded, randomized, counterbalanced blocks. Observed outcomes included time to MR, PF and DF collected at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Results: Analyses included 259 subjects (84.6% female, 78.4% Caucasian, mean age 40.0) who treated an average of 6.7 attacks each. Results showed comparable between- and within-person variability in relief. For a typical individual and attack, MR preceded DF, which preceded PF. Results also demonstrated that, when an individual treated an attack with AVP-825, they had significantly greater migraine relief compared to sumatriptan tablets (p< .01). Additionally, the odds of PF, DF, and MPR were significantly larger when treating with AVP-825 compared to sumatriptan tablets (p< .01 for all). Conclusions: Findings demonstrated improved migraine relief using AVP-825 compared to oral sumatriptan, implying greater odds of MR, DF, and PF. This statistical model is well suited for studying migraine and other CDEAs. It joins quantitative methods with clinical theory to address important hypotheses about treatment effects.
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PRM147 TRANSLATION AND LINGUISTIC VALIDATION OF THE BODY-Q IN DENMARK: A NEW PATIENT-REPORTED OUTCOME MEASURE Poulsen L Odense University Hospital, Odense C, Denmark .
Objectives: Our research aim to enhance the understanding of patient-reported outcomes (PROs) in bariatric and body contouring surgery. In order to capture PROs appropriately, well-defined, reliable, valid and responsive instruments are needed. Following internationally accepted guidelines for the development of PRO instruments an international team has developed a comprehensive set of PRO scales,
PRM150 DETERMINING WHETHER THREE METHODS OF SCORING A PATIENT-REPORTED OUTCOME INSTRUMENT DIFFERENTIALLY IMPACTS ASSOCIATIONS WITH VARIOUS PREDICTORS Kudel I Kantar Health, New York, NY, USA .