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Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

ABSTRACT: The 'Perception of Anti-Coagulant Treatment Questionnaire' (PACT-Q) was developed to assess patients' expectations of, and satisfaction with their anticoagulant treatment. This questionnaire needs to be finalised and psychometrically validated.The PACT-Q was included in the United States, The Netherlands and France into three phase III multinational clinical trials conducted to evaluate efficacy and safety of a new long-acting anticoagulant drug (idraparinux) compared to vitamin K antagonist (VKA). PACT-Q was administered to patients with deep venous thrombosis (DVT), atrial fibrillation (AF) or pulmonary embolism (PE) at Day 1, to assess patients' expectations, and at 3 and 6 months to assess patients' satisfaction and treatment convenience and burden. The final structure of the PACT-Q (Principal Component Analysis--PCA--with Varimax Rotation) was first determined and its psychometric properties were then measured with validity of the structure (Multitrait analysis), internal consistency reliability (Cronbach's alpha coefficients) and known-group validity.PCA and multitrait analyses showed the multidimensionality of the "Treatment Expectations" dimension, comprising 7 items that had to be scored independently. The "Convenience" and "Burden of Disease and Treatment" dimensions of the hypothesised original structure of the questionnaire were combined, thus resulting in 13 items grouped into the single dimension "Convenience". The "Anticoagulant Treatment Satisfaction" dimension remained unchanged and included 7 items. All items of the "Convenience" and "Anticoagulant Treatment Satisfaction" dimensions displayed good convergent and discriminant validity. The internal consistency reliability was good, with a Cronbach's alpha of 0.84 for the "Convenience" dimension, and 0.76 for the "Anticoagulant Treatment Satisfaction" dimension. Known-group validity was good, especially with regard to occurrence of thromboembolic events within 3 months from randomisation.The PACT-Q is a valid and reliable instrument that allows the assessment of patients' expectations and satisfaction regarding anticoagulant treatment, as well as their opinion about treatment convenience of use. Its two-part structure--assessment of expectations at baseline in the first part, and of convenience, burden and treatment satisfaction in the second--was validated and displays good and stable psychometric properties. These results are not sufficient to recommend the use of satisfaction as primary endpoint in clinical trials; further validation work is needed to support the interpretation of PACT-Q dimension scores. However, this first validation makes the PACT-Q an appropriate measure for use in clinical and pharmacoepidemiological research, as well as in real-life studies.(ClinicalTrials.gov numbers, NCT00067093, NCT00062803 and NCT00070655).

SUBMITTER: Prins MH

PROVIDER: S-EPMC2686675 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

Prins M H MH Guillemin I I Gilet H H Gabriel S S Essers B B Raskob G G Kahn S R SR

Health and quality of life outcomes 20090407

<h4>Background</h4>The 'Perception of Anti-Coagulant Treatment Questionnaire' (PACT-Q) was developed to assess patients' expectations of, and satisfaction with their anticoagulant treatment. This questionnaire needs to be finalised and psychometrically validated.<h4>Methods</h4>The PACT-Q was included in the United States, The Netherlands and France into three phase III multinational clinical trials conducted to evaluate efficacy and safety of a new long-acting anticoagulant drug (idraparinux) c ...[more]

PMID: 19348685

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Project description:Lifestyle is intimately related to health. A questionnaire that specifically scores the healthiness of lifestyle of Catalan adolescents is needed. The objective of this study was to develop and validate a scoring questionnaire called VISA-TEEN to assess the healthy lifestyle of young Catalans that can be answered quickly and user-friendly.A lifestyle questionnaire was developed based on the analysis of contributions from two focus groups, one with adolescents and the other with people who work with them (teachers and doctors). A panel of experts validated the content of items that were ultimately selected for the VISA-TEEN questionnaire. Three hundred ninety-six adolescents (215 boys and 181 girls, age = 13-19 years) completed the VISA-TEEN. Internal consistency was assessed using Cronbach's alpha (?) reliability coefficient. Test-retest reliability, using an intraclass correlation coefficient (ICC), was calculated based on scores attained two weeks apart. Construct validity was assessed by the extraction of components with an exploratory factor analysis. The relationship between the scores was measured using the health-related quality of life (HRQoL) KIDSCREEN-10 Index (the relationship was assessed by calculating Pearson's r correlation coefficient). The association of scores in the VISA-TEEN for self-rated health (SRH) was also examined by executing an analysis of variance (ANOVA) between the different categories of this variable. We also calculated the index of fit for factor scales (IFFS) for each component, as well as the discriminatory power of the instrument using Ferguson's ? (delta) coefficient.The VISA-TEEN questionnaire showed acceptable reliability (? = 0.66, ?est = 0.77) and a very good test-retest agreement (ICC = 0.860). It could be broken down into the following five components, all with an acceptable or very good IFFS (0.7-0.96): diet, substance abuse, physical activity, Rational Use of Technological Leisure (RUTL), and hygiene. Scores on the VISA-TEEN showed significant correlation with the KIDSCREEN index (r = 0.21, p < 0.001) and were associated with SRH (p < 0.001). The discriminatory power was found to be ? = 0.97.The VISA-TEEN questionnaire developed to study the lifestyle of Catalan adolescents is a valid instrument to apply in this population as it is shown in the present psychometric tests to understand the role of lifestyle in the health of teenagers or to test the efficacy of health campaigns intended to improve teenagers' lifestyle.

Project description:INTRODUCTION: The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia (FM) patients. Over the last 18 years, since the publication of the original FIQ, several deficiencies have become apparent and the cumbersome scoring algorithm has been a barrier to widespread clinical use. The aim of this paper is to describe and validate a revised version of the FIQ: the FIQR. METHODS: The FIQR was developed in response to known deficiencies of the FIQ with the help of a patient focus group. The FIQR has the same 3 domains as the FIQ (that is, function, overall impact and symptoms). It differs from the FIQ in having modified function questions and the inclusion of questions on memory, tenderness, balance and environmental sensitivity. All questions are graded on a 0-10 numeric scale. The FIQR was administered online and the results were compared to the same patient's online responses to the 36-Item Short Form Health Survey (SF-36) and the original FIQ. RESULTS: The FIQR was completed online by 202 FM patients, 51 rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) patients (31 RA and 20 SLE), 11 patients with major depressive disorder (MDD) and 213 healthy controls (HC). The mean total FIQR score was 56.6 +/- 19.9 compared to a total FIQ score of 60.6 +/- 17.8 (P < 0.03). The total scores of the FIQR and FIQ were closely correlated (r = 0.88, P < 0.001). Each of the 3 domains of the FIQR correlated well with the 3 related FIQ domains (r = 0.69 to 0.88, P < 0.01). The FIQR showed good correlation with comparable domains in the SF-36, with a multiple regression analysis showing that the three FIQR domain scores predicted the 8 SF-36 subscale scores. The FIQR had good discriminant ability between FM and the 3 other groups; total FIQR scores were HC (12.1 +/- 11.6), RA/SLE (28.6 +/- 21.2) and MDD (17.3 +/- 11.8). The patient completion time was 1.3 minutes; scoring took about 1 minute. CONCLUSIONS: The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score. It has scoring characteristics comparable to the original FIQ, making it possible to compare past FIQ results with future FIQR results.

Dataset Information

Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

Publications

Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q).

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