[Standardized documentation of health-related quality of life in patients with psoriatic arthritis : Validation of the German version of the psoriatic arthritis quality of life (PsAQoL) questionnaire]. / Standardisierte Erfassung der gesundheitsbezogenen Lebensqualität bei Patienten mit Psoriasisarthritis : Validierung der deutschen Version des "Fragebogen zur Lebensqualität von Patienten mit Psoriasisarthritis (PsAQoL)".

BACKGROUND: The standardized assessment of health-related quality of life is becoming increasingly more important. The English questionnaire on psoriatic arthritis quality of life (PsAQoL) is a disease-specific instrument for measuring the quality of life of patients with psoriatic arthritis (PsA). The aim of the present study was to translate the PsAQoL into German and to validate the German version in a cohort of PsA patients recruited from routine care. METHOD: The translation and validation of the PsAQoL questionnaire was carried out in a stepwise procedure involving affected patients with PsA. After translation of the original English questionnaire the German version was evaluated in a field test. The psychometric features of the questionnaire were then examined in a PsA cohort from routine care. In addition to the construct and group validity, the reliability of the questionnaire was tested using test-retest reliability and internal consistency. The physical functioning was measured with the health assessment questionnaire (HAQ) and domains of the quality of life with the Nottingham health profile (NHP). RESULTS: In a field test with 10 patients the German version of the PsAQoL questionnaire proved to be relevant, easily understandable and feasible (processing time 4.7 ± 2.1 min). A total of 126 patients (37.3% male, age 55.6 ± 11.3 years) were included in the validation cohort. The PsAQoL showed moderate correlation with the HAQ (r = 0.65) and moderate to good correlation with the NHP (subdomains r = 0.58-0.75). The internal consistency was high (Cronbach's α 0.92) and reliability in patients with stable disease course was very good (Spearman correlation coefficient 0.94). The PsAQoL can differentiate between different patient groups. CONCLUSION: The German translation of the PsAQoL provides a valid disease-specific instrument for the standardized assessment of health-related quality of life in patients with PsA. The psychometric characteristics of this questionnaire are comparable with the original English version. The German PsAQoL can therefore be recommended for clinical and scientific application.

Translation and validation of the greek Psoriatic Arthritis Quality of Life Scale.

Psoriatic arthritis (PsA) is a chronic inflammatory disease that has a significant impact on patients' quality of life (QoL). The Psoriatic Arthritis Quality of Life (PsAQoL) Scale was developed in the UK to be specific to PsA patients and adopts the needs-based model of QoL. As a disease-specific measure, the PsAQoL is superior to generic measures of QoL in terms of relevance and sensitivity. The measure, which has been adapted into 50 languages, has not previously been available for use with Greek PsA patients. The aim of the study was to produce a Greek version of the PsAQoL that was suitable for native Greek speakers and that had comparable psychometric properties to the original UK version. The adaptation of the Greek PsAQoL consisted of three stages; translation, assessment of face and content validity and analysis of its psychometric properties. The translation stage adopted the dual panel methodology -a bilingual panel followed by a lay panel- to ensure conceptual equivalence of the scale to the original version. Cognitive debriefing interviews were conducted to determine the applicability and relevance of the adapted scale to patients. Finally, a postal validation survey was conducted to assess the psychometric properties of the draft measure, using the Nottingham Health Profile (NHP) as a comparator instrument. Non-parametric statistical analyses were performed to establish the reliability and construct validity of the PsAQoL. The translation panels produced a language version that sounded natural to native Greek speakers. Interviews revealed that patients found the measure comprehensible and appropriate. Only minor grammatical changes were made to the measure following these interviews. The Greek PsAQoL demonstrated good internal consistency (Cronbach's α=0.88) and excellent test-retest reliability (r=0.98). As expected, the measure correlated moderately highly with the Physical Mobility and Pain sections of the NHP and correlated moderately with other sections, indicating convergent validity. Known group validity was established by the ability of the measure to distinguish between patients who differed according to their perceived general health and disease severity. No significant differences in PsAQoL scores were observed between males and females or older and younger patients. The Greek PsAQoL was well-received by patients and demonstrated sound psychometric properties. It forms part of a growing body of disease-specific measures that are available in Greece. It is recommended for use in routine clinical practice, international clinical trials and research studies as a valid and reliable measure of QoL in PsA patients.

Applying Rasch analysis to evaluate measurement equivalence of different administration formats of the Activity Limitation scale of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).

BACKGROUND: Electronic formats of patient-reported outcome (PRO) measures are now routinely used in clinical research studies. When changing from a validated paper and pen to electronic administration it is necessary to establish their equivalence. This study reports on the value of Rasch analysis in this process. METHODS: Three groups of US pulmonary hypertension (PH) patients participated. The first completed an electronic version of the CAMPHOR Activity Limitation scale (e-sample) and this was compared with two pen and paper administrated samples (pp1 and pp2). The three databases were combined and analysed for fit to the Rasch model. Equivalence was evaluated by differential item functioning (DIF) analyses. RESULTS: The three datasets were matched randomly in terms of sample size (n = 147). Mean age (years) and percentage of male respondents were as follows: e-sample (51.7, 16.0 %); pp1 (50.0, 14.0 %); pp2 (55.5, 40.4 %). The combined dataset achieved fit to the Rasch model. Two items showed evidence of borderline DIF. Further analyses showed the inclusion of these items had little impact on Rasch estimates indicating the DIF identified was unimportant. CONCLUSIONS: Differences between the performance of the electronic and pen and paper administrations of the CAMPHOR Activity Limitation scale were minor. The results were successful in showing how the Rasch model can be used to determine the equivalence of alternative formats of PRO measures.

Co-calibrating quality-of-life scores from three pulmonary disorders: implications for comparative-effectiveness research.

Background Efficient use of health resources requires accurate outcome assessment. Disease-specific patient-reported outcome (PRO) measures are designed to be highly relevant to patients with a specific disease. They have advantages over generic PROs that lack relevance to patient groups and miss crucial impacts of illness. It is thought that disease-specific measurement cannot be used in comparative effectiveness research (CER). The present study provides further evidence of the value of disease-specific measures in making valid comparisons across diseases. Methods The Asthma Life Impact Scale (ALIS, 22 items), Living with Chronic Obstructive Pulmonary Disease (LCOPD, 22 items) scale, and Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR, 25 items) were completed by 140, 162, and 91 patients, respectively. The three samples were analyzed for fit to the Rasch model, then combined into a scale consisting of 58 unique items and re-analyzed. Raw scores on the three measures were co-calibrated and a transformation table produced. Results The scales fit the Rasch model individually (ALIS Chi(2) probability value (p-Chi(2)) = 0.05; LCOPD p-Chi(2 )=( )0.38; CAMPHOR p-Chi(2 )=( )0.92). The combined data also fit the Rasch model (p-Chi(2 )=( )0.22). There was no differential item functioning related to age, gender, or disease. The co-calibrated scales successfully distinguished between perceived severity groups (p < 0.001). Limitations The samples were drawn from different sources. For scales to be co-calibrated using a common item design, they must be based on the same theoretical construct, be unidimensional, and have overlapping items. Conclusions The results showed that it is possible to co-calibrate scores from disease-specific PRO measures. This will permit more accurate and sensitive outcome measurement to be incorporated into CER. The co-calibration of needs-based disease-specific measures allows the calculation of γ scores that can be used to compare directly the impact of any type of interventions on any diseases included in the co-calibration.

Greek adaptation and validation of the Ankylosing Spondylitis Quality of Life (ASQoL) measure.

BACKGROUND: Ankylosing Spondylitis (AS) is a chronic rheumatic disease that has a significant impact on patient's quality of life (QoL). The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific patient-reported outcome measure for assessing QoL in AS. While the ASQoL has been adapted for use in 46 countries worldwide, a Greek language version of the measure has not been available and was required for an international clinical trial. AIM: The aim was to develop and assess the psychometric properties of a Greek language version of the ASQoL. METHODS: The adaptation of the ASQoL into Greek involved three procedures: translation, assessment of face and content validity, and formal validation. The measure was translated into Greek using two translation panels. Cognitive debriefing interviews were employed to determine face and content validity. Finally, the translation's psychometric properties were examined by administering it on two occasions, with a 14-day interval. The Nottingham Health Profile (NHP) was used as a comparator measure. RESULTS: The ASQoL proved straightforward to translate into Greek and interviewees found it relevant, comprehensible and easy to complete.  The measure had good internal consistency (α =0.92) and test-retest reliability (r =0.98). Predicted correlations with the NHP provided evidence of the convergent validity of the two measures. Construct validity was confirmed by the measure's ability to distinguish groups of AS patients varying by perceived disease severity and general health. CONCLUSIONS: The Greek ASQoL has been shown to be well-accepted, reliable and valid and can be recommended for use in clinical studies and routine clinical practice in AS. Hippokratia 2015; 19 (2):119-124.

Comparing the impact of psoriasis and atopic dermatitis on quality of life: co-calibration of the PSORIQoL and QoLIAD.

BACKGROUND: Disease-specific patient-reported outcome (PRO) measures are designed to be highly relevant to one disease. It is widely believed that comparisons of outcomes between patients with different diseases are only possible using generic measures. The present study employs a novel method of using Rasch analysis to co-calibrate scores from different disease-specific PRO measures, allowing scores to be compared across diseases. METHODS: Psoriasis patients (n = 146, mean age = 44.4, males = 50 %) completed the Psoriasis Quality of Life scale (PSORIQoL) and atopic dermatitis patients (n = 146, mean age = 45.5, males = 50 %) the Quality of Life in Atopic Dermatitis scale (QoLIAD). Both measures employ the needs-based model of QoL, and they share five common items-providing a link between assessments. The groups were analysed separately, and then combined to test fit to the Rasch model. RESULTS: Both scales showed good fit to the Rasch model after minor adjustments (PSORIQoL: χ (2) p = 0.25; QoLIAD: χ (2) p = 0.51). For the combined dataset, one common item showing differential item functioning by disease was removed and fit to the Rasch model was achieved (χ (2) p = 0.08). The co-calibrated scale successfully distinguished between perceived severity groups (p < 0.001). CONCLUSIONS: It is possible to co-calibrate scores on the PSORIQoL and QoLIAD. This is one of the first studies in health research to demonstrate how Rasch analysis can be used to make comparisons across diseases using different disease-specific measures. Such an approach maintains the greater relevance and, consequently, accuracy associated with disease-specific measurement.

The impact of Dupuytren disease on patient activity and quality of life.

PURPOSE: To explore the impact of Dupuytren disease (DD) from the patients' perspective. METHODS: Audio-recorded interviews were conducted for patients with Dupuytren disease (DD) attending outpatient clinics. The interviews were transcribed and subjected to content analysis. This analysis highlighted key impact areas and common themes in individuals' personal experiences. These were then allocated to categories specified by the World Health Organization International Classification of Functioning, Disability, and Health (impairments and activity limitations) and the needs-based model of quality of life (QoL). RESULTS: Qualitative unstructured interviews were conducted with 34 patients (74% men; age, 41-80 y; mean [SD], 64 [13] y). The sample had a wide range of severity and duration of DD (range, 0.5-40; mean [SD], 13 [10] y). Nine hundred fifty-three statements relating to the impact of DD were identified from the interview transcripts. These statements fell into 2 major categories of impact: activity limitations (10 themes including problems with dressing, gripping, and personal care) and QoL (6 need categories: physiological, safety and security, social, affection, esteem, and cognitive needs). CONCLUSIONS: Findings from the interviews suggest that DD affects both performance of activities and QoL. To determine accurately the effectiveness of DD interventions from the patients' perspective, it is important to determine their impacts on both activity limitations and QoL. We intend to develop valid, reproducible, and responsive DD-specific scales for this purpose. CLINICAL RELEVANCE: The study identifies key issues specific to DD that influence patients' functioning and QoL. The information reported will form the basis of DD-specific patient-reported outcomes measures for use in clinical practice and evaluations of interventions.

Adapting the Asthma Life Impact Scale (ALIS) for use in Southern European (Italian) and Eastern European (Russian) cultures.

BACKGROUND: The Asthma Life Impact Scale (ALIS) is a disease-specific measure used to assess the quality-of-life of people with asthma. It was developed in the UK and US and has proven to be acceptable to patients, to have good psychometric properties, and to be unidimensional. OBJECTIVE: This paper reports on the adaptation and validation of the ALIS for use in representative Southern European (Italian) and Eastern European (Russian) languages. METHODS: The ALIS was translated for both cultures using the dual-panel process. The newly translated versions were then tested with asthma patients to ensure face and content validity. Psychometric properties of the new language versions were assessed via a test?re-test postal survey conducted in both countries. LIMITATIONS: It is possible that some cultural or language differences still exist between the different language versions. Further research should be undertaken to determine responsiveness. Further studies designed to determine the clinical validity of the Italian ALIS would be valuable. RESULTS: Linguistic nuances were easily resolved during the translation process for both language adaptations. Cognitive debriefing interviews (Russia n=9, male=11.1%, age mean (SD)=55.4 (13.2); Italy n=15, male=66.7%, age mean (SD)=63.5 (11.2)) indicated that the ALIS was easy to read and acceptable to patients. Psychometric testing was conducted on the data (Russia n=61, age mean (SD)=40.7 (15.4); Italy n=71, male=42.6%, age mean (SD)=49.5 (14.1)). The results showed that the new versions of the ALIS were consistent (Russian and Italian Cronbach's alpha=0.92) and reproducible (Russian test-re-test=0.86; Italian test-re-test=0.94). The Italian adaptation showed the expected correlations with the NHP and the Russian adaptation showed strong correlations with the CASIS and CAFS and weak-to-moderate correlations with %FEV1 and %PEF. In both adaptations the ALIS was able to distinguish between participants based on self-reported general health, self-reported severity, and whether or not they were hospitalized in the previous week.

Adaptation of the Psoriatic Arthritis Quality of Life (PsAQoL) instrument for Sweden.

OBJECTIVE: The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire is the first disease-specific patient-derived instrument for assessing QoL in patients with PsA and has been extensively validated in this population. The aim of the adaptation process reported here was to develop a Swedish version of the PsAQoL that was equivalent to, and met the same psychometric and acceptability standards as, the original instrument, which was developed in the UK. METHOD: Translation of the original questionnaire into Swedish was performed by a professional and a lay panel. Field testing for face and content validity was performed by interviewing 13 patients. Finally, 123 patients with PsA were included in a test-retest postal survey designed to test reproducibility and construct validity. The PsAQoL was administered on two occasions approximately 2 weeks apart. The Nottingham Health Profile (NHP) was used as a comparator instrument. RESULTS: The Swedish version of the PsAQoL questionnaire showed good reliability at both time points and, as expected, correlated with the NHP. The scale was able to distinguish between groups based on self-reported general health and flare-up. Patients with active symptoms of both arthritis and psoriasis had worse QoL. The results also indicated that duration of disease has a progressive impact on PsAQoL scores. CONCLUSIONS: This study provides evidence that the adapted PsAQoL can be used for clinical studies in Swedish patients. The instrument provides valuable information on the long-term effects of PsA on QoL.

The development and validation of the Unidimensional Fatigue Impact Scale (U-FIS).

BACKGROUND: The multidimensional assessment of fatigue is complicated by the interrelation of its multiple causes and effects. OBJECTIVE: The purpose of the research was to develop a unidimensional assessment of fatigue (U-FIS). METHODS: Data collected with the Fatigue Impact Scale (FIS) were subjected to Rasch analysis to identify potential problems with the scale. Additional items for the U-FIS were generated from interviews with UK MS patients. The U-FIS was tested for face and content validity in patient interviews and included in a validation survey to determine dimensionality (Rasch model), reliability and validity. RESULTS: The original FIS was not unidimensional when subscale items were combined. The modification of the FIS and addition of a number of items allowed the development of a 22-item unidimensional scale (U-FIS) that was reliable (Cronbach Alpha = 0.96; test-retest = 0.86,) and valid given correlations with the Nottingham Health Profile and ability to distinguish between MS severity groups. There was no significant difference in U-FIS scores according to MS type. CONCLUSION: It is valid to conceptualize the functional impact of fatigue as unidimensional. The U-FIS is a reliable and valid questionnaire that will allow the measurement of this construct in clinical studies.

The development of patient-reported outcome indices for multiple sclerosis (PRIMUS).

BACKGROUND: Complex diseases such as multiple sclerosis (MS) present dilemmas over the choice of patient-reported outcome measures as no single scale can inform on all types of MS impact from the patient's perspective. OBJECTIVE: To develop an outcome tool, the Patient-Reported Indices for Multiple Sclerosis (PRIMUS), to assess MS symptoms, activities, and quality of life. METHODS: PRIMUS content was derived from qualitative interviews with UK MS patients and checked by clinical experts. Semi-structured cognitive debriefing interviews assessed scale face and content validity. PRIMUS scaling properties, reliability, and construct validity were assessed by a test-retest postal survey. RESULTS: Cognitive debriefing interviews (n = 15) demonstrated scale clarity, relevance, and comprehensiveness. The postal survey was completed by 135 patients with MS. After removal of misfitting items and those exhibiting differential item functioning, all scales fitted the Rasch model, confirming unidimensionality. For all scales, test-retest reliability exceeded 0.80. Scale scores were related to perceived MS severity, general health, and symptoms of depression. Moderate correlations were observed between PRIMUS and Nottingham Health Profile scores. CONCLUSIONS: Clinicians and researchers can have confidence in scores obtained by respondents on the PRIMUS. The PRIMUS will aid the assessment of the impact of MS from the patient's perspective.

The development of the L-QoL: a quality-of-life instrument specific to systemic lupus erythematosus.

OBJECTIVES: Complex diseases, such as systemic lupus erythematosus (SLE), present dilemmas over choice of outcome measures. Using a battery of instruments to capture the impact of different impairments or activity limitations experienced does not provide assessment of the wider impact on quality of life (QoL). This paper describes the development and testing of a new instrument to measure QoL in systemic lupus erythematosus (L-QoL). METHODS: The development combines theoretical strengths of the needs-based QoL model with statistical and diagnostic powers of the Rasch model. Content was derived from in-depth interviews with relevant patients. Cognitive debriefing interviews assessed face and content validity. Rasch analysis was applied to data from an initial postal survey to remove misfitting items. A second postal survey assessed scaling properties, reliability, internal consistency and validity. RESULTS: A 55-item questionnaire was derived from interview transcripts. Cognitive debriefing confirmed acceptability. Rasch analysis of postal survey data (n = 95) removed misfitting items. A second postal survey (n = 93), produced a 25-item version with good item fit and stability, excellent test-retest reliability (0.92), internal consistency (0.92) and strict unidimensionality. CONCLUSIONS: It is concluded that the L-QoL should prove a valuable instrument for assessing patient-based outcome in clinical trials and practice.

The responsiveness and validity of the CAMPHOR Utility Index.

The aim of the present study was to validate and determine the minimal important difference (MID) and responsiveness of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Utility Index, a new tool enabling cost utility analyses. CAMPHOR, 6-min walking test (6MWT) and New York Heart Association (NYHA) data for 869 pulmonary hypertension patients (545 (63%) female; mean+/-SD age 56.6+/-15.4 yrs) from three centres were analysed. Utility was correlated with 6MWT data and calculated by NYHA class to assess validity. Effect sizes were calculated for those with two CAMPHOR assessments. Distribution and anchor-based MIDs were calculated. Analyses were carried out in patients receiving bosentan in order to determine whether or not those remaining in NYHA class III following treatment improved. The Utility Index distinguished between adjacent NYHA classes and correlated with 6MWT results. CAMPHOR subscales and utility were as responsive as the 6MWT (effect sizes ranged 0.31-0.69 for the CAMPHOR and 0.16-0.34 for the 6MWT). The within-group MID for the Utility Index was estimated to be approximately 0.09. Patients remaining in NYHA class III experienced, on average, a significant improvement (CAMPHOR Utility Index and functioning), which exceeded the MID. The CAMPHOR Utility Index is valid and responsive to change. Patients can experience significant and important improvements even if they do not improve on the basis of traditional outcomes, such as NYHA functional class.

The hidden cost of skin scars: quality of life after skin scarring.

BACKGROUND: Surprisingly little is known about how skin scars affect patients' lives, though specialist clinical impressions suggest their impact is related to both their physical and psychosocial effects. Facial scars have been shown to cause high levels of anxiety and self-consciousness, but further work has been neglected. We aimed to explore the influence of skin scars on patients' quality of life (QoL) and identify potential implications for clinical practice. METHODS: We adopted a needs-based approach to QoL and conducted semi-structured interviews with scar patients at a specialist clinic. Transcribed data underwent interpretative phenomenological analysis to identify common themes in individuals' personal experiences. RESULTS: Thirty-four scar patients (24 women; aged 14-70 years, mean=35.7 years, SD=17.9 years) with a wide range of scar type, severity and onset were recruited. Five hundred and seventy-three statements were identified from interview transcripts relating to need impairment by skin scars. These were subsequently classified into 44 themes covering five main areas: physical comfort and functioning; acceptability to self and others; social functioning; confidence in the nature and management of the condition; emotional well-being. The majority of respondents were unhappy with their scar's appearance due to their perceived stigma and psychological associations, and thus adopted different coping behaviours to hide or compensate for them. Often this made them unsociable and interfered with their communication skills, personal relationships, work life and leisure activities. Concerns about the diagnosis and persistent nature of scars were common, whilst unempathic management by general physicians and frustrations of current treatment compounded distress. CONCLUSIONS: There are five main areas of impact on the needs of scar patients that should be addressed in their management, which are greater and more complex than previously considered. Support services should be made available, along with clinician and public education to improve management and help reduce patient distress. A need for a carefully designed measure of scar-related QoL is also indicated, for use in clinical settings and trials.

Adaptation of the RAQoL for use in Australia.

Quality of life is an important patient-reported outcome of rheumatoid arthritis (RA) in addition to structural and functional outcomes. The RAQoL (Rheumatoid Arthritis Quality of Life questionnaire) was developed in the UK and the Netherlands as a disease-specific tool. It was adapted for use in the Australian social context and the reliability and validity was tested. A lay panel assessed the UK version and adapted the wording for use within Australia. Reliability and validity were assessed by a postal survey of the RAQoL and comparator questionnaires to 100 patients with RA. The RAQoL was easily adapted into Australian-English. Test-retest reliability was high with a Spearman rank correlation coefficient of 0.93. RAQoL scores correlated well with patient-perceived disease activity and severity--indicating good validity. The Australian version of the RAQoL is a valid and reliable tool for the assessment of quality of life. It is practical, easy to administer and has good potential for use in clinical settings and trials in Australia.

The Rheumatoid Arthritis Quality of Life (RAQoL) for Sweden: adaptation and validation.

OBJECTIVE: To produce and evaluate the official Swedish language version of the Rheumatoid Arthritis Quality of Life instrument (RAQoL). METHODS: The UK RAQoL was translated into Swedish by a bilingual translation panel. A separate lay panel was conducted to consider the appropriateness and comprehensibility of the items in Swedish. Interviews were conducted with 15 Swedish RA patients to assess face and content validity. Responses to a postal survey were used to calculate reproducibility and construct validity. RESULTS: Few difficulties arose in the translation process and the new language version was well received by the lay panel and field-test participants. One hundred and sixty-five RA patients participated in the postal survey (69% female; mean age 62.7 years, SD 11.3, RA duration range 1-62 years). Cronbach's alpha for the Swedish RAQoL was 0.91 and test-retest reliability was 0.95, indicating that the instrument has adequate inter-relatedness of items and very low inherent random measurement error. A high correlation with the Health Assessment Questionnaire (HAQ) was observed; this was expected because RA has significant physical manifestations that are in turn a significant determinant of QoL. The Swedish RAQoL was able to distinguish between patients who differed according to their self-perceived RA severity, general health, and rating of their RA today, in addition to whether or not the patient was experiencing a flare of RA. CONCLUSIONS: The official Swedish RAQoL was well received by RA patients. The psychometric quality of the adapted questionnaire means that it is suitable for inclusion in clinical trials involving patients with RA.

Treatment of paediatric atopic dermatitis with pimecrolimus (Elidel, SDZ ASM 981): impact on quality of life and health-related quality of life.

AIM: To report on quality of life (QoL) and health-related quality of life (HRQL) impacts of pimecrolimus (Elidel, Novartis A.G., Basel, Switzerland, SDZ ASM 981) 1% cream in the long-term treatment of paediatric atopic dermatitis. METHODS: QoL and HRQL data are presented from two 12-month international clinical trials evaluating the efficacy and safety of pimecrolimus 1% cream. Both trials were randomized and double blinded and compared two treatment strategies, one involving the use of emollients, pimecrolimus and topical corticosteroids, the other is 'usual care' (emollients plus topical corticosteroids) with a vehicle cream to maintain study blinding. The first trial (the infant trial) involved patients between ages 3 months and 2 years, whereas the children trial included patients aged 2-17 years. In both trials, QoL of the affected child's parent was evaluated with the parent's index of quality of life in atopic dermatitis (PIQoL-AD). HRQL was assessed in the children trial only with the children's dermatology life quality index (CDLQI). QoL and HRQL assessments were conducted at baseline, 6 weeks, 6 months and 12 months. RESULTS: Generalized linear modelling of PIQoL-AD scores at each post-baseline visit showed a greater impact on parent's QoL for pimecrolimus compared with control at all time-points in both trials. HRQL scores showed a greater improvement from baseline for children in the pimecrolimus group compared with those in the control group at all time-points. CONCLUSIONS: The results show a beneficial impact of pimecrolimus on parents' QoL in paediatric atopic dermatitis, confirming findings from earlier shorter term trials. There was also a clear benefit to the HRQL of the children treated.

The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): a measure of health-related quality of life and quality of life for patients with pulmonary hypertension.

OBJECTIVE: No outcome measures specific to pulmonary hypertension (PH) currently exist. The aim of the study was to develop health-related quality of life (symptoms and functioning) scales and a quality of life scale that would allow comprehensive, accurate and valid patient-reported outcome assessment in clinical studies. METHODS: The content of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) was derived from qualitative interviews conducted with 35 patients. Item reduction was based on the analysis of responses to a postal survey (n=75) and patient interviews (n=15) designed to determine face and content validity. A final postal validation study (n=91) was performed to determine reproducibility and construct validity. RESULTS: The questionnaire was well received by participants who found it to be relevant, comprehensible and quick and easy to complete. Rasch and factor analyses were conducted to ensure unidimensionality of the final CAMPHOR scales; Overall symptoms (made up of Energy, Breathlessness and Mood subscales), Functioning and Quality of life. The CAMPHOR scales had good internal consistency (alpha=0.90-0.92) and reproducibility (test-retest correlations=0.86-0.92). They also exhibited convergent, divergent and known groups validity. CONCLUSIONS: The CAMPHOR is a valuable new instrument for assessing patient-reported outcome in PH clinical trials and routine practice.