Adaptation and validation of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire for use in Bulgaria.

Rheumatoid arthritis (RA) is a chronic disease with an enormous impact on patients' quality of life. The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific measure of QoL for individuals with rheumatoid arthritis. Our aim was to adapt and validate the RAQoL for use in Bulgaria. The development of a new language version of the RAQoL consisted of three stages: translation, field testing and psychometric evaluation. The dual-panel methodology, requiring two independent panels of Bulgarian speakers, was applied to translate the UK English version of the RAQoL into Bulgarian. Face and content validity of the translated questionnaire were assessed through cognitive debriefing interviews. Lastly, the RAQoL was administered on two occasions to a random sample of RA patients to evaluate reliability and validity. At the first occasion, the SF-36 was also administered for use as a comparator scale. The RAQoL was successfully adapted into Bulgarian and considered easy to understand, acceptable and comprehensive by RA patients. A psychometric study demonstrated that the new language version has excellent internal consistency (Cronbach's alpha coefficients = 0.93 and 0.94) and test-retest reliability (a Spearman's rank correlation coefficient = 0.97). Convergent validity was established by correlating scores on the RAQoL with a comparator measure, the SF-36. A strong correlation between RAQoL scores and the physical functioning section of the SF-36 was observed. Known group validity was established by the ability of the measure to distinguish between subgroups of patients, who differed according to their perceived general health, disease severity (p < 0.001) and whether they were experiencing a flare-up (p < 0.01). The new language version is recommended for use in future research studies, clinical trials and routine practice with Bulgarian RA patients.

Translation, cross-cultural adaptation and validation of the Osteoarthritis Quality of Life (OAQoL) questionnaire for use in Portugal.

Osteoarthritis (OA) is the most prevalent rheumatic disease and is a leading cause of decreased quality of life (QoL). The OA Quality of Life questionnaire (OAQoL) is an OA-specific patient-reported outcome measures. The aim of this study was to translate and validate the original UK English version of the Osteoarthritis Quality of Life (OAQoL) questionnaire into European Portuguese. The translation of the questionnaire was carried out according to a dual panel methodology (bilingual panel followed by lay panel). This was followed by cognitive debriefing interviews (CDIs) with OA patients to assess comprehension and relevance of the translated questionnaire. Finally, a validation survey was conducted to assess its psychometric properties. The Portuguese OAQoL, a comparator scale (the Nottingham Health Profile-NHP) as well as questions relating to demographic and disease information were administered to OA patients. A sub-sample of patients also completed the Portuguese OAQoL two weeks later, to assess test-retest reliability. The internal consistency, construct validity and known group validity (according to perceived OA severity) of the scale was also assessed. Both the bilingual and lay panels consisted of five individuals and no major difficulties relating to the translation process were identified. A total of ten patients with OA participated in the CDIs. The mean time to complete the questionnaire was 5 min. These interviews revealed that the Portuguese version of the OAQoL was clear, relevant and easy to complete. Finally, 53 OA patients (44 females; mean age of 67.6 years) completed the validation survey. Cronbach's alpha coefficient was 0.87, demonstrating high internal consistency. Test-retest reliability, assessed by Spearman's rank correlation coefficient, was 0.86. Moderate correlations were found with the majority of the NHP sections, providing evidence of construct validity. Significant differences in OAQoL scores were found between patients who differed according to their perceived OA severity, providing evidence of known group validity. The Portuguese version of the OAQoL is a valid and reliable questionnaire that can be used to assess QoL in OA, both in clinical practice and for research purposes.

ADAPTATION AND VALIDATION OF THE CAMBRIDGE PULMONARY HYPERTENSION OUTCOME REVIEW (CAMPHOR) FOR CROATIA.

Pulmonary hypertension (PH) is a chronic disease which severely impairs quality of life (QoL). The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is the first disease-specific tool to assess patient-reported symptoms, functioning and QoL in PH patients. The aim of this study was to adapt and validate the CAMPHOR for use in Croatia. The adaptation process involved three stages: translation (bilingual and lay panel), cognitive debriefing interviews with patients and psychometric validation. For the latter stage, a postal survey was conducted with 50 patients to examine the reliability and validity of the adapted scale. All three scales of the Croatian CAMPHOR demonstrated excellent internal consistency (Symptoms = 0.93; Activity limitations = 0.94; QoL = 0.92) and test-retest reliability correlations (Symptoms = 0.90; Activity limitations = 0.95; QoL = 0.90). Predicted correlations with the SF-36 scales provided evidence for construct validity of the CAMPHOR scales. Evidence for known group validity was shown by the ability of the scales to distinguish between participants based on patient-perceived general health and disease severity. The Croatian version of the CAMPHOR is a valid and reliable tool for use in clinical routine and clinical research.

Measuring the Impact of Caring for a Spouse with Alzheimer's Disease: Validation of the Alzheimer's Patient Partners Life Impact Questionnaire (APPLIQue).

Alzheimer's disease (AD) is the most common form of dementia, characterized by cognitive, psychiatric and behavioral symptoms and increasing dependency. Family members typically assume increasing caregiving responsibilities, with considerable quality of life (QoL) impact. This article describes the testing of a needs-based QoL questionnaire for AD family caregivers. Initial analyses, according to Rasch measurement theory, suggested that items applied to spousal rather than non-spousal caregivers. Following removal of non-spousal responders, a 25-item questionnaire was identified that exhibited acceptable model fit, a mean (SD) person location of 0.194 (1.42) logits, residual correlations 0.173 and absence of DIF by age, gender or administration. Reliability was 0.85. This new measure, the Alzheimer's Patient Partners Life Impact Questionnaire (APPLIQue), may fill an important gap in assessing the impact of AD on spousal caregivers and outcomes of interventions aimed at caregivers as well as persons with AD.

Adaptation and validation of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire for use in Serbia.

Rheumatoid arthritis (RA) is one of the most prevalent inflammatory rheumatic diseases. As it is a chronic and a lifelong destructive disease, the aim of the treatment is to reduce disability and improve quality of life. The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a patient-reported outcome measure, specific to RA. To adapt and validate the RAQoL for use in Serbia, two translation panels were involved to produce the Serbian RAQoL. After successful translation, face and content validity was determined via cognitive debriefing interviews. The psychometric properties of the questionnaire were examined, including reliability and construct validity, by using the Nottingham Health Profile (NHP) as a comparator scale. The RAQoL was translated successfully and rated as applicable, relevant and comprehensive by respondents. The questionnaire had high internal consistency (alpha = 0.94 at both time points) and test-retest reliability (r = 0.92). Moderately high correlations were found between the RAQoL and physical mobility, pain and energy level sections of the NHP, providing evidence of convergent validity. The RAQoL was able to distinguish between patients grouped by perceived general health, incidence of flare-up and disease severity. The Serbian language version of the RAQoL showed strong evidence of reliability and validity and is recommended for use in clinical trials and routine general practice in RA.

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 of Chinese and English versions of the Ankylosing Spondylitis quality of life (ASQoL) scale for use in Singapore.

BACKGROUND: To cross-culturally adapt and validate the Singapore Chinese and Singapore English versions of the Ankylosing Spondylitis Quality of Life (ASQoL) scales. METHODS: Translation of the ASQoL into Singapore Chinese and English was performed by professional and lay translation panels. Field-testing for face and content validity was performed by interviewing ten Chinese speaking and ten English speaking axial spondyloarthritis (AxSpA) patients. AxSpA patients (either Chinese or English speaking) were invited to take part in validation surveys. The Health Assessment Questionnaire (HAQ), Short Form Health Survey (SF-36), Bath Indices, and other measures of disease activity were used as comparator scales for convergent validity. A separate sample of AxSpA patients were invited to participate in a test-retest postal study, with 2 weeks between administrations. RESULTS: The cross-sectional study included 183 patients (77% males, 82% English speaking), with a mean (SD) age of 39.4 (13.7) years. The ASQoL had excellent internal consistency (Cronbach's alpha = 0.88), and correlated moderately with all the comparator scales. The ASQoL was able to distinguish between patients grouped by disease activity and perceived general health. The ASQoL fulfilled the Rasch model analysis for fit, reliability and unidimensionality requirements. No significant differential item functioning was noted for gender, age below or above 50 years, and language of administration. Test-retest reliability was good (r = 0.81). CONCLUSIONS: The ASQoL was adapted into Singapore Chinese and English language versions, and shown to be culturally relevant, valid and reliable when used with combined samples of AxSpA patients who speak either Chinese or English.

Portuguese validation of the Cambridge pulmonary hypertension outcome review (CAMPHOR) questionnaire.

BACKGROUND: Patients with pulmonary arterial hypertension (PAH) and other forms of precapillary pulmonary hypertension (PH) have impaired quality of life (QoL). The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a PH-specific patient-reported outcome measure that assesses symptoms, activity limitations and QoL. It was originally developed in UK-English. The main objective of this study was to create an adaptation of the CAMPHOR suitable for a Portuguese-speaking population. METHODS: A multi-step approach was followed: bilingual and lay panel translation; cognitive debriefing interviews; and psychometric testing in repeated postal surveys (2 weeks apart) including assessment of internal consistency, reproducibility and validity. The Nottingham Health Profile (NHP) questionnaire was used as a comparator instrument to test convergent validity. RESULTS: The CAMPHOR was translated without difficulty by the two panels. Cognitive debriefing interviews showed the questionnaire was easily understood and considered relevant to patients' experience with their illness. Psychometric evaluation was performed with 50 PAH patients (47 ± 14 years, 37 women). Cronbach's alpha coefficients showed good internal consistency for the three CAMPHOR scales [Symptoms = 0.95; Activities = 0.93 and QoL = 0.94]. Test-retest coefficients showed that all scales had excellent reliability (Symptoms = 0.94; Activities = 0.89 and QoL = 0.93), indicating low levels of random measurement error. The CAMPHOR correlated as expected with the NHP. The magnitude of correlations followed a similar pattern to those in the original development study. The CAMPHOR also exhibited evidence of known group validity in its ability to distinguish between self-reported severity and general health groups. CONCLUSIONS: A valid and reliable version of the CAMPHOR questionnaire for the European Portuguese-speaking population was developed and is recommended for use.

Adaptation of Chinese and English versions of the Psoriatic Arthritis Quality of Life (PsAQoL) scale for use in Singapore.

BACKGROUND: To develop Singapore Chinese and English versions of the Psoriatic Arthritis Quality of Life (PsAQoL) scale that were equivalent to and met the same psychometric and acceptability standards as the original UK measure. METHODS: Translation of the original PsAQoL into contextualised English and Chinese versions for use in Singapore was performed by professional and lay translation panels. Ten Chinese speaking and ten English speaking local patients were interviewed to assess face and content validity. Psoriatic arthritis (PsA) patients (either Chinese or English speaking) fulfilling the Classification criteria of Psoriatic Arthritis were then invited to participate in a validation survey. Clinical variables, the Health Assessment Questionnaire (HAQ) and the Medical Outcome Short-form 36 (SF-36) were used as comparator instruments for convergent validity. A separate sample of PsA patients were invited to participate in a test-retest postal study, with two weeks between administrations. RESULTS: The validation sample included 98 patients (51 % men) with a mean (SD) age of 51.5 (13.8) years. The PsAQoL had excellent internal consistency (Cronbach's α = 0.92) and scores on the measure were moderately correlated with health status measures (pain, HAQ score, SF-36 scores) and patient and physician global assessments. The scale was able to distinguish between groups with active or inactive disease assessed by composite scores, HAQ and minimal disease activity. Test-retest reliability was excellent (r = 0.92). CONCLUSIONS: This study provides evidence that the adapted English and Chinese versions of the PsAQoL can be used in clinical studies with PsA patients in Singapore.

Assessing quality of life in Crohn's disease: development and validation of the Crohn's Life Impact Questionnaire (CLIQ).

PURPOSE: Despite the significant impact of Crohn's disease (CD) on patients' physical and emotional well-being, no CD-specific patient-reported outcome (PRO) measure is available for determining the efficacy of interventions. The objective of the study was to develop and validate the Crohn's Life Impact Scale (CLIQ), the first such measure. METHODS: Questionnaire content was derived from qualitative interviews with CD patients and face and content validity assessed by cognitive debriefing interviews (CDIs) with patients. A postal survey was conducted to identify the final scale, confirm its unidimensionality and determine reproducibility and construct validity. A subset of the respondents was sent a second questionnaire package 2 weeks after the first. The survey included the CLIQ, Nottingham Health Profile (NHP) and Unidimensional Fatigue Impact Scale (U-FIS). RESULTS: Content analysis was conducted on the 30 interview transcripts and a draft scale produced. The CDIs indicated that the draft scale was relevant, clear and easy to use. The questionnaire package was completed by 273 CD patients (65.6 % male; aged 16-79 (mean 43.9; SD 15.1) years). Of these, 104 also completed the second package. Rasch analysis confirmed a 27-item unidimensional QoL scale (p < 0.05). Both internal consistency and test-retest reliability were high (0.91). Scores on the CLIQ were related to both physical and emotional impairments (NHP) and to fatigue (U-FIS). CONCLUSION: The CLIQ, the first CD-specific PRO, is unidimensional and has excellent psychometric properties. It should prove to be a valuable tool for evaluating the impact of CD and its treatment from the patients' perspective.

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

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.

The PlexiQoL, a patient-reported outcome measure on quality of life in neurofibromatosis type 1-associated plexiform neurofibroma: translation, cultural adaptation and validation into the Dutch language for the Netherlands.

BACKGROUND: Half of the patients with Neurofibromatosis type 1 (NF1) develop one or more tumours called plexiform neurofibromas, which can have a significant impact on Quality of Life (QoL). The PlexiQoL questionnaire is a disease-specific QoL measure for adults with NF1-associated plexiform neurofibromas. The aim of this study was to adapt and validate a Dutch version of the PlexiQoL for the Netherlands. METHODS: The PlexiQoL was translated using the dual-panel methodology, followed by cognitive debriefing interviews to assess face and content validity. The psychometric properties were evaluated by administering the questionnaire on two separate occasions to a sample of adults with NF1 and plexiform neurofibromas. Feasibility was evaluated by the presence of floor/ceiling effects. Reliability was assessed by evaluating Cronbach's alpha coefficient and test-retest reliability, using Spearman's rank correlation coefficients. Mann-Whitney U tests were used to check for known group validity. The Nottingham Health Profile (NHP) questionnaire was used as comparator questionnaire to evaluate convergent validity. RESULTS: The translation and cognitive debriefing interviews resulted in a Dutch version of the PlexiQoL that reflected the original concept and underlying semantic meanings of the UK English version. Forty participants completed the validation survey. The Dutch PlexiQoL demonstrated excellent internal consistency (Cronbach's α 0.825) and test-retest reliability (Spearman correlation coefficient 0.928). The questionnaire detected differences in PlexiQoL scores between participants based on self-reported general health and disease severity. Convergent validity was confirmed for relevant NHP subsections. CONCLUSIONS: The Dutch PlexiQoL demonstrated excellent psychometric properties and can be reliably used to measure plexiform neurofibroma-related QoL in adults with NF1 in the Netherlands.

Adaptation and validation of the Bulgarian version of the Systemic Lupus Erythematosus Quality of Life Questionnaire (L-QoL).

OBJECTIVE: Systemic lupus erythematosus (SLE) is a heterogeneous disease with multiple clinical manifestations, which causes a significant deterioration in the quality of life (QoL). The Systemic Lupus Erythematosus Quality of Life Questionnaire (L-QoL) is a lupus-specific measure used to determine the burden of the disease and it applies the need-based model of QoL. Our aim was to produce the first successfully validated foreign language version of the questionnaire. METHODS: The development of the Bulgarian version involved three stages: translation, field testing and psychometric evaluation. Translation was conducted by an expert linguist working with a developer of the original L-QoL, followed by interviews with monolingual lay individuals. Face and content validity of the translation were assessed by cognitive debriefing interviews with Bulgarian SLE patients. Finally, the L-QoL was validated by administering the questionnaire to a random sample of SLE patients on two occasions, 2 weeks apart to evaluate its reliability and validity. RESULTS: In the validation survey, the new Bulgarian version demonstrated high internal consistency (the Cronbach's alpha coefficient was 0.92), and test-retest reliability (0.97). Additionally, scores on the L-QoL were correlated with those on the SF-36 sections to determine convergent validity and the strongest correlation was observed between L-QoL scores and the social functioning section of the SF-36. Known group validity was established by testing the ability of the Bulgarian L-QoL to distinguish between subgroups of patients from the study pool. CONCLUSIONS: The demonstrated excellent psychometric properties ensure that the Bulgarian L-QoL accurately captures the impact of SLE on the quality of life. Key points • The Bulgarian version of the L-QoL is a valid and reliable measure of QoL in lupus patients. • The Bulgarian version of the L-QoL can be used as an outcome measure in research, clinical trials and routine clinical practice.

The German adaptation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).

BACKGROUND: Individuals with precapillary pulmonary hypertension (PH) experience severely impaired quality of life. A disease-specific outcome measure for PH, the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was developed and validated in the UK and subsequently adapted for use in additional countries. The aim of this study was to translate and assess the reliability and validity of the CAMPHOR for German-speaking populations. METHODS: Three main adaptation stages involved; translation (employing bilingual and lay panels), cognitive debriefing interviews with patients and validation (assessment of the adaptation's psychometric properties). The psychometric evaluation included 107 patients with precapillary PH (60 females; age mean (standard deviation) 60 (15) years) from 3 centres in Austria, Germany and Switzerland. RESULTS: No major problems were found with the translation process with most items easily rendered into acceptable German. Participants in the cognitive debriefing interviews found the questionnaires relevant, comprehensive and easy to complete. Psychometric analyses showed that the adaptation was successful. The three CAMPHOR scales (symptoms, activity limitations and quality of life) had excellent test-retest reliability correlations (Symptoms = 0.91; Activity limitations = 0.91; QoL = 0.90) and internal consistency (Symptoms = 0.94; Activity limitations = 0.93; QoL = 0.94). Predicted correlations with the Nottingham Health Profile provided evidence of the construct validity of the CAMPHOR scales. The CAMPHOR adaptation also showed known group validity in its ability to distinguish between participants based on perceived general health, perceived disease severity, oxygen use and NYHA classification. CONCLUSIONS: The CAMPHOR has been shown to be valid and reliable in the German population and is recommend for use in clinical practice.

Adaptation and validation of the Cambridge pulmonary hypertension outcome review for Sweden.

BACKGROUND: The Cambridge pulmonary hypertension outcome review (CAMPHOR) is the first pulmonary hypertension-specific instrument for the assessment of the patient's perceived symptoms, activity limitations and quality of life (QoL). PURPOSE: To produce and validate a Swedish language version of the CAMPHOR. METHODS: Bilingual (n = 5) and lay panels (n = 5) were conducted to translate the CAMPHOR into Swedish. This new questionnaire was then field-tested with 14 patients and finally, it underwent psychometric evaluation by means of a postal validation study involving 38 patients with pulmonary hypertension (PH). RESULTS: Few problems were experienced in translating the CAMPHOR into Swedish. The field-test participants found the scales relevant, comprehensible and easy to complete. Psychometric analyses showed that the Swedish adaptation was successful. The Swedish CAMPHOR scales had good internal consistency. Cronbach's alpha coefficients were 0.92 for the symptoms scale, 0.92 for activity limitations and 0.95 for the quality of life. Predicted correlations with the Nottingham Health Profile provided evidence of the construct validity of the scales. The Swedish scales also indicated known groups validity. CONCLUSIONS: The Swedish version of the CAMPHOR is a reliable and valid measure of the impact of pulmonary hypertension on the lives of affected patients. It is recommended for use in clinical studies and routine practice in pulmonary hypertension patients.

Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science.

Interest in the patient's views of his or her illness and treatment has increased dramatically. However, our ability to appropriately measure such issues lags far behind the level of interest and need. Too often such measurement is considered to be a simple and trivial activity that merely requires the application of common sense. However, good quality measurement of patient-reported outcomes is a complex activity requiring considerable expertise and experience. This review considers the most important issues related to such measurement in the context of chronic disease and details how instruments should be developed, validated and adapted for use in additional languages. While there is often consensus on how best to undertake these activities, there is generally little evidence to support such accord. The present article questions these orthodox views and suggests alternative approaches that have been shown to be effective.

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

PURPOSE: The 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. METHODS: The study involved three stages in each language; translation, cognitive debriefing 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 NHP) and known group validity. RESULTS: The 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. CONCLUSIONS: The 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 language versions will prove valuable to multinational clinical trials and to clinical practice in the respective countries.

Development and validation of the living with chronic obstructive pulmonary disease questionnaire.

PURPOSE: Available patient-reported outcome (PRO) measures for chronic obstructive pulmonary disease (COPD) focus primarily on impairment (symptoms) and activities (functioning). The purpose of the study was to develop a patient-based PRO measure for COPD that captures the overall everyday impact of living with COPD from the patient's perspective. METHODS: LCOPD items (Living with COPD Questionnaire) were generated from qualitative interviews in the U.K. and focus groups in the U.S.A. The draft measure was tested for face and content validity in both countries. Item reduction and testing for reproducibility and construct validity was conducted via Rasch and traditional psychometric analyses. RESULTS: The draft LCOPD was found to be relevant and acceptable to patients in the U.K. (N = 19) and U.S. (N = 16). Application of Rasch analysis to data collected in validation studies (n = 162 in the U.K. and 145 in U.S.) identified a 22-item scale that measured a single construct in both countries. Psychometric analyses indicated that this version was internally consistent and reproducible. Scores on the measure were related as expected to clinician ratings of disease severity and patient ratings of COPD severity and general health. CONCLUSIONS: The LCOPD is a new measure examining the everyday impact of living with COPD. It demonstrates good scaling properties and may prove valuable in understanding treatment benefits.

Validation of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) for the Australian and New Zealand population.

BACKGROUND AND OBJECTIVE: Individuals with pulmonary arterial hypertension (PAH) experience severely impaired quality of life. A disease-specific patient reported outcome measure for PAH (the Cambridge Pulmonary Hypertension Outcome Review--CAMPHOR) has recently been developed and validated in the UK, USA and Canada. It has demonstrated reliability and validity in PAH populations in these countries. The aim of this study was to assess the reliability and validity of the CAMPHOR in an Australian and New Zealand (NZ) PAH population. METHODS: Semistructured interviews were conducted with a cohort of 15 PAH patients (aged 68.9±10.0 years; 11 women) to determine the relevance of the CAMPHOR and ensure the terminology and language used was understandable and appropriate for our PAH population. The test-retest reliability, internal consistency and construct validity of the CAMPHOR were then examined in an Australian and NZ PAH population (n=61, aged 56.9±14.5 years; 48 women). RESULTS: Data from the patient interviews confirmed that the CAMPHOR is appropriate for use in our PAH population. The three CAMPHOR scales (symptoms, activity limitations and quality of life) had excellent test-retest reliability (correlation coefficients (r(s))=0.86-0.94, P<0.01) and internal consistency (Cronbach's alpha coefficients=0.89-0.92). The CAMPHOR also demonstrated the ability to distinguish between individuals with PAH who differed according to World Health Organisation functional class. CONCLUSIONS: We have shown the CAMPHOR to be valid and reliable in an Australian and NZ PAH population and recommend its use in clinical practice.