Jeanette Wilburn

Further international adaptation and validation of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire.

Abstract The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire was developed directly from rheumatoid arthritis (RA) patients in the United Kingdom and the Netherlands to measure quality of life (QoL). Since then, it has become widely used in clinical studies and trials and has been adapted for use in 24 languages. The objective was to develop and validate 11 additional language versions of the RAQoL in US English, Mexican Spanish, Argentinean Spanish, Belgian French, Belgian Flemish, French, Romanian, Czech, Slovakian, Polish and Russian. The language adaptation and validation required three stages: translation, cognitive debriefing interviews and validation survey. The translation process involved a dual-panel methodology (bilingual panel followed by a lay panel). The validation survey tested the psychometric properties of the new scales and included either the Nottingham Health Profile (NHP) or the Health Assessment Questionnaire (HAQ) as comparators. Internal consistency of the new language versions ranged from 0.90 to 0.97 and test–retest reliability from 0.85 to 0.99. RAQoL scores correlated as expected with the HAQ. Correlations with NHP sections were as expected: highest with energy level, pain and physical mobility and lowest with emotional reactions, sleep disturbance, and social isolation. The adaptations exhibited construct validity in their ability to distinguish subgroups of RA patients varying by perceived disease severity and general health. The new language versions of the RAQoL meet the high psychometric standards of the original UK English version. The new adaptations represent valid and reliable tools for measuring QoL in international clinical trials involving RA patients.

A qualitative study of the impact of Crohn's disease from a patient's perspective

Objective To understand how the lives of people with Crohns disease (CD) are affected. Most research in CD has focused on symptoms and functioning rather than on how these outcomes influence quality of life (QoL). Design As part of a study to develop a CD-specific patient-reported outcome measure, qualitative interviews were conducted with patients from Manchester Royal Infirmary to determine how CD affects QoL. The needs-based model was adopted for the study. The interviews, which took the form of focused conversations covering all aspects of the impact of CD and its treatment, were audio-recorded. Theoretical thematic analysis of the transcripts identified needs affected by CD. Results Thirty patients (60% female) aged 25–68 years were interviewed. Participants had experienced CD for between 2 and 40 years. Nearly 1300 statements relating to the impact of CD were identified. Thirteen main need themes were identified: nutrition, hygiene, continence, freedom from infection, security, self-esteem, role, attractiveness, relationships, intimacy, clear-mindedness, pleasure and autonomy. Conclusions The findings from the interviews indicate that CD has a major impact on need-fulfilment. Such issues should be addressed in CD audit, clinical trials and when evaluating clinical practice.

Development and validation of the Bowel Cleansing Impact Review (BOCLIR)

Objective Acceptability and tolerability of bowel cleansers influence whether patients are able to complete the prescribed dose and, consequently, the quality of the cleansing achieved. No standardised means of assessing patients’ experience of using bowel cleansing is currently available. The aim of the study was to develop the Bowel Cleansing Impact Review (BOCLIR) to assess patient response to bowel cleansing products. Design Content was derived from qualitative interviews. Face and content validity were assessed via cognitive-debriefing interviews. Finally, patients completed the BOCLIR and a demographic questionnaire. Item response theory (Rasch analysis) was employed for item reduction and assessment of unidimensionality. Internal consistency and construct validity were also assessed. Results Analysis of 40 interviews resulted in the production of three scales; patient satisfaction, symptomatic impact and activity limitations. Scales were designed to be used alone or together. 19 debriefing interviews demonstrated BOCLIR acceptability, relevance and ease of completion. The validation survey involved 166 patients (52% male, mean (SD) age 54.3 (15.2) years). After misfitting and redundant items were removed all scales fit the Rasch model confirming their unidimensionality. Cronbachs α-coefficients were high (0.77–0.94) indicating good internal consistency. Scores on the BOCLIR were related to patients’ willingness to use the product in future and ease of drinking the full preparation (p<0.01 for each scale). Conclusions The BOCLIR is a new measure consisting of three unidimensional scales (satisfaction, symptoms and activity limitations) with good psychometric and scaling properties. The BOCLIR will allow accurate assessment of patients’ response to bowel cleansing preparations.

Patient value: its nature, measurement, and role in real world evidence studies and outcomes-based reimbursement

Abstract The assessment of “patient value” is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value—they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.

Adaptation of the osteoarthritis-specific quality of life scale (the OAQoL) for use in Germany, Hungary, Italy, Spain and Turkey

The Osteoarthritis Quality of Life scale (OAQoL) is specific to individuals with osteoarthritis. The present study describes the adaptation of the OAQoL for use in the following five European languages: German, Hungarian, Italian, Spanish and Turkish. The study involved three stages in each language; translation, cognitive debriefing (face and content validity) and validation. The validation stage assessed internal consistency (Cronbach’s alpha), reproducibility (test–retest reliability using Spearman’s rank correlations), convergent and divergent validity (correlations with the Health Assessment Questionnaire, The Western Ontario and McMaster Universities Index of osteoarthritis and Nottingham Health Profile) and known group validity. The OAQoL was successfully translated into the target languages with minimal problems. Cognitive debriefing interviewees found the measures easy to complete and identified few problems with content. Internal consistency ranged from 0.94 to 0.97 and test–retest reliability (reproducibility) from 0.87 to 0.98. These values indicate that the new language versions produce very low levels of measurement error. Median OAQoL scores were higher for patients reporting a current flare of osteoarthritis in all countries. Scores were also related, as expected, to perceived severity of osteoarthritis. The OAQoL was successfully adapted for use in Germany, Hungary, Italy, Spain and Turkey. The addition of these new language versions will prove valuable to multinational clinical trials and to clinical practice in the respective countries.

Adaptation and Validation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for Use in Spain

INTRODUCTION AND OBJECTIVES The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a patient-reported outcome measure of health-related quality of life and quality of life specific to individuals with pulmonary hypertension (PH). This questionnaire has demonstrated superiority over other instruments assessing similar domains. The objective of the present study was to adapt and validate the Spanish version of the questionnaire. METHODS The adaptation consisted of 3 stages: translation from English to Spanish using bilingual and lay panels, cognitive debriefing interviews with patients, and assessment of psychometric properties by means of a postal validation survey. RESULTS The translation panels produced a version of the CAMPHOR that was considered suitable for use by Spanish PH patients. The relevance, comprehensiveness, and acceptability of this version were confirmed in interviews with PH patients. Finally, the validation survey (n = 70) revealed that the 3 CAMPHOR scales (Symptoms, Activities, and Quality of life) showed strong psychometric properties. The internal consistency (Cronbach α) coefficients of the scales were above 0.89, and the test-retest reliability was above 0.87. The convergent and known group validity of the CAMPHOR scales was also demonstrated. CONCLUSIONS The Spanish version of the CAMPHOR is a valid and reliable instrument for the assessment of health-related quality of life and quality of life in Spanish PH patients. Therefore, it is recommended for use in future research and clinical practice in the Spanish population of PH patients.

AB0741 Psoriatic arthritis quality of life questionnaire: translation, cultural adaptation and validation into portuguese language

Background Psoriatic Arthritis (PsA) has a strong negative impact in the quality of life of patients, through pain, stiffness, functional disability, deformity and a variety of other dimensions. The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire is a disease-specific instrument developed to measure quality of life in patients with PsA. Objectives The aims of this study were to culturally adapt the questionnaire for Portugal, and evaluate its reliability and validity in patients with PsA. Methods The original UK English version of PsAQoL was translated into Portuguese by a bilingual translation panel. An independent lay panel reviewed the instruments item phrasing to ensure appropriateness in colloquial European Portuguese. Structured cognitive debriefing interviews were conducted with ten PsA patients to assess the acceptability, the understanding and the redundancy or ambiguity of the questionnaire. The Portuguese PsAQoL was subsequently applied to PsA patients followed at the Rheumatology Department of Centro Hospitalar do Baixo Vouga, E.P.E. To assess reproducibility, thirty patients with PsA completed the Portuguese PsAQoL on two occasions, two weeks apart. A larger sample was recruited to determine internal consistency and construct validity. Descriptive statistical analysis was used to characterize the data. The Nottingham Health Profile (NHP) was used as a comparator instrument. Results Translation and adaptation were successful. The validation sample included 104 patients, 67% of whom were men. Their median age was 50.2 (SD=12.1) years and most were married. Cronbachs alpha for the Portuguese version of the PsAQoL was 0.91 and the test-retest reliability was 0.92, indicating that the measure has good internal consistency and produces low random measurement error. The PsAQoL could distinguish between groups of patients defined by self-reported general health status, self-reported severity of PsA and flare of arthritis. Duration of arthritis did not influence PsAQoL scores. There was a positive correlation between the total score of APsQoL and each of the dimensions of the NHP. Conclusions The Portuguese version on the PsAQoL was found to be relevant, understandable and easy to complete, reliable and valid. It should be considered for use in clinical practice and research settings to asses PsA-specific QoL. References McKenna S, Doward LC, Whalley D, et al. Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis. Ann Rheum Dis 2014; 63(2): 162–169. Wink F, Arends S, McKenna S, et al. Validity and reliability of the Dutch adaptation of the Psoriatic Arthritis Quality of Life (PsAQoL) Questionnaire. PloS One 2013; 8(2): e55912. Billing E, McKenna S, Staun M & Lindqvist U. Adaptation of the Psoriatic Arthritis Quality of Life (PsAQoL) instrument for Sweden. Scand J Rheumatol 2010; 39: 223–228. Disclosure of Interest None declared

Adaptation of the QoL-AGHDA scale for adults with growth hormone deficiency in four Slavic languages.

PurposeThe Quality of Life in Adult Growth Hormone Deficiency Assessment (QoL-AGHDA) is a disease-specific quality of life measure specific to individuals who are growth hormone deficient. The present study describes the adaptation of the QoL-AGHDA for use in the following four Slavic languages; Czech, Polish, Serbian and Slovakian.MethodsThe study involved three stages in each language; translation, cognitive debriefing and validation. The validation stage assessed internal consistency (Cronbachs alpha), reproducibility (test-retest reliability using Spearmans rank correlations), convergent and divergent validity (Correlations with the NHP) and known group validity.ResultsThe QoL-AGHDA was successfully translated into the target languages with minimal problems. Cognitive debriefing interviewees (n = 15-18) found the measures easy to complete and identified few problems with the content. Internal consistency (Czech Republic = 0.91, Poland = 0.91, Serbia = 0.91 and Slovakia = 0.89) and reproducibility (Czech Republic = 0.91, Poland = 0.91, Serbia = 0.88 and Slovakia = 0.93) were good in all adaptations. Convergent and divergent validity and known group validity data were not available for Slovakia. The QoL-AGHDA correlated as expected with the NHP scales most relevant to GHD. The QoL-AGHDA was able to distinguish between participants based on a range of variables.ConclusionsThe QoL-AGHDA was successfully adapted for use in the Czech Republic, Poland, Serbia and Slovakia. Further validation of the Slovakian version would be beneficial. The addition of these new lanaguage versions will prove valuable to multinational clinical trials and to clinical practice in the respective countries.