Development and Psychometric Evaluation of the Hypoglycemia Perspectives Questionnaire in Patients with Type 2 Diabetes Mellitus.

AIMS: The aim of this study was to evaluate the factor structure and psychometric characteristics of the Hypoglycemia Perspectives Questionnaire (HPQ) assessing experience and perceptions of hypoglycemia in patients with type 2 diabetes mellitus (T2DM). METHODS: HPQ was administered to adults with T2DM in a clinical sample from Cyprus (HYPO-Cyprus, n = 500) and a community sample in the United States (US, n = 1257) from the 2011 US National Health and Wellness Survey. Demographic and clinical data were collected. Analysis of HPQ data from two convenience samples examined item performance, factor structure, and HPQ measurement properties (reliability, convergent validity, known-groups validity). RESULTS: Analyses supported three HPQ domains: symptom concern (six items), compensatory behavior (five items), and worry (five items). Internal consistency was high for all three domains (all ≥0.75), supporting reliability. Convergent validity was supported by moderate Spearman correlations between HPQ domain scores and the Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) total score. Patients with recent hypoglycemia events had significantly higher HPQ scores, supporting known-group validity. CONCLUSIONS: HPQ may be a valid and reliable measure capturing the experience and impact of hypoglycemia and useful in clinical trials and community-based settings.

The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease.

No current patient-centred instrument captures all dimensions of physical activity in chronic obstructive pulmonary disease (COPD). Our objective was item reduction and initial validation of two instruments to measure physical activity in COPD.Physical activity was assessed in a 6-week, randomised, two-way cross-over, multicentre study using PROactive draft questionnaires (daily and clinical visit versions) and two activity monitors. Item reduction followed an iterative process including classical and Rasch model analyses, and input from patients and clinical experts.236 COPD patients from five European centres were included. Results indicated the concept of physical activity in COPD had two domains, labelled "amount" and "difficulty". After item reduction, the daily PROactive instrument comprised nine items and the clinical visit contained 14. Both demonstrated good model fit (person separation index >0.7). Confirmatory factor analysis supported the bidimensional structure. Both instruments had good internal consistency (Cronbach's α>0.8), test-retest reliability (intraclass correlation coefficient ≥0.9) and exhibited moderate-to-high correlations (r>0.6) with related constructs and very low correlations (r<0.3) with unrelated constructs, providing evidence for construct validity.Daily and clinical visit "PROactive physical activity in COPD" instruments are hybrid tools combining a short patient-reported outcome questionnaire and two activity monitor variables which provide simple, valid and reliable measures of physical activity in COPD patients.

Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study.

BACKGROUND: Symptoms, particularly dyspnea, and activity limitation, have an impact on the health status and the ability to function normally in patients with chronic obstructive pulmonary disease (COPD). METHODS: To develop an electronic patient diary (eDiary), qualitative patient interviews were conducted from 2009 to 2010 to identify relevant symptoms and degree of bother due to symptoms. The eDiary was completed by a subset of 209 patients with moderate-to-severe COPD in the 26-week QVA149 SHINE study. Two morning assessments (since awakening and since the last assessment) and one evening assessment were made each day. Assessments covered five symptoms ("shortness of breath," "phlegm/mucus," "chest tightness," "wheezing," and "coughing") and two impact items ("bothered by COPD" and "difficulty with activities") and were scored on a 10-point numeric scale. RESULTS: Patient compliance with the eDiary was 90.4% at baseline and 81.3% at week 26. Correlations between shortness of breath and impact items were >0.95. Regression analysis showed that shortness of breath was a highly significant (P<0.0001) predictor of impact items. Exploratory factor analysis gave a single factor comprising all eDiary items, including both symptoms and impact items. Shortness of breath, the total score (including five symptoms and two impact items), and the five-item symptom score from the eDiary performed well, with good consistency and reliability. The eDiary showed good sensitivity to change, with a 0.6 points reduction in the symptoms scores (on a 0-10 point scale) representing a meaningful change. CONCLUSION: The eDiary was found to be valid, reliable, and responsive. The high correlations obtained between "shortness of breath" and the ratings of "bother" and "difficulty with activities" confirmed the relevance of this symptom in patients with COPD. Future studies will be required to explore further psychometric properties and their ability to differentiate between COPD treatments.

The PROactive innovative conceptual framework on physical activity.

Although physical activity is considered an important therapeutic target in chronic obstructive pulmonary disease (COPD), what "physical activity" means to COPD patients and how their perspective is best measured is poorly understood. We designed a conceptual framework, guiding the development and content validation of two patient reported outcome (PRO) instruments on physical activity (PROactive PRO instruments). 116 patients from four European countries with diverse demographics and COPD phenotypes participated in three consecutive qualitative studies (63% male, age mean±sd 66±9 years, 35% Global Initiative for Chronic Obstructive Lung Disease stage III-IV). 23 interviews and eight focus groups (n = 54) identified the main themes and candidate items of the framework. 39 cognitive debriefings allowed the clarity of the items and instructions to be optimised. Three themes emerged, i.e. impact of COPD on amount of physical activity, symptoms experienced during physical activity, and adaptations made to facilitate physical activity. The themes were similar irrespective of country, demographic or disease characteristics. Iterative rounds of appraisal and refinement of candidate items resulted in 30 items with a daily recall period and 34 items with a 7-day recall period. For the first time, our approach provides comprehensive insight on physical activity from the COPD patients' perspective. The PROactive PRO instruments' content validity represents the pivotal basis for empirically based item reduction and validation.

Development and validation of the AFSymp™: an atrial fibrillation-specific measure of patient-reported symptoms.

BACKGROUND: Patients with atrial fibrillation (AF) can be severely incapacitated by symptoms, but validated symptom measures are lacking. The aim of this study was to develop an AF-specific symptom questionnaire (AFSymp™). METHODS: Following a literature review, qualitative interviews with 91 patients (United States [US], n = 30; United Kingdom [UK], n = 16; France, n = 15; Germany, n = 15; Japan, n = 15) with paroxysmal, persistent, and permanent AF were conducted to identify emergent concepts and to develop the items and response options for the AFSymp™. Clinical experts (n = 21) in the US, the UK, France, Germany, and Japan provided feedback on the most clinically relevant symptoms via an email survey. Cognitive interviews with 30 patients were conducted to evaluate content validity. A prospective, observational, psychometric evaluation study (n = 313) consisting of two study visits was performed at 32 sites across the US. RESULTS: After item reduction, the AFSymp™ consisted of 11 items with a 1-week recall period. Exploratory and confirmatory factor analysis resulted in three subscales (heart symptoms, tiredness, chest discomfort) and two items: dizziness and shortness of breath. Internal consistency was strong across subscales (Cronbach's α 0.82-0.91). The test-retest reliability of items and subscales was acceptable (intra-class correlation [ICC] 0.58-0.78). The reproducibility of the single global score was strong (ICC 0.78). The construct and known-groups validity was acceptable. CONCLUSION: The AFSymp™ demonstrates evidence of reliability and validity as a comprehensive measure of AF symptoms that can be used to assess patient outcomes in clinical and research settings. More research is needed to evaluate the instrument's responsiveness.

Determinants and outcomes of physical activity in patients with COPD: a systematic review.

BACKGROUND: The relationship between physical activity, disease severity, health status and prognosis in patients with COPD has not been systematically assessed. Our aim was to identify and summarise studies assessing associations between physical activity and its determinants and/or outcomes in patients with COPD and to develop a conceptual model for physical activity in COPD. METHODS: We conducted a systematic search of four databases (Medline, Embase, CINAHL and Psychinfo) prior to November 2012. Teams of two reviewers independently selected articles, extracted data and used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) to assess quality of evidence. RESULTS: 86 studies were included: 59 were focused on determinants, 23 on outcomes and 4 on both. Hyperinflation, exercise capacity, dyspnoea, previous exacerbations, gas exchange, systemic inflammation, quality of life and self-efficacy were consistently related to physical activity, but often based on cross-sectional studies and low-quality evidence. Results from studies of pharmacological and non-pharmacological treatments were inconsistent and the quality of evidence was low to very low. As outcomes, COPD exacerbations and mortality were consistently associated with low levels of physical activity based on moderate quality evidence. Physical activity was associated with other outcomes such as dyspnoea, health-related quality of life, exercise capacity and FEV1 but based on cross-sectional studies and low to very low quality evidence. CONCLUSIONS: Physical activity level in COPD is consistently associated with mortality and exacerbations, but there is poor evidence about determinants of physical activity, including the impact of treatment.

Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study.

We evaluated the effect of QVA149, a dual bronchodilator combining indacaterol and glycopyrronium, on direct patient-reported dyspnoea in patients with moderate-to-severe chronic obstructive pulmonary disease. In this multicentre, blinded, double-dummy, three-period crossover study, 247 patients were randomised to once-daily QVA149 110/50 µg, placebo or tiotropium 18 µg. Superiority of QVA149 versus placebo (primary objective) and tiotropium (secondary objective) was assessed for improvement in dyspnoea via the self-administered computerised (SAC) version of the Baseline and Transition Dyspnoea Index after 6 weeks. Secondary end-points included lung function, rescue medication use and safety. After 6 weeks, the SAC Transition Dyspnoea Index total score was significantly higher with QVA149 versus placebo (least squares mean (LSM) treatment difference 1.37, p<0.001) and tiotropium (LSM treatment difference 0.49, p=0.021). QVA149 provided significant improvements in lung function, with higher forced expiratory volume in 1 s area under the curve from 0-4 h post-dose versus placebo and tiotropium at day 1 and week 6 (all p<0.001). Rescue medication use was significantly lower with QVA149 versus placebo (p<0.001) and tiotropium (p=0.002). All treatments were well tolerated. Once-daily QVA149 provided superior improvements in patient-reported dyspnoea and lung function versus placebo and tiotropium. These benefits were associated with improvements in other symptoms and reduced use of rescue medication.

Improving physical activity in COPD: towards a new paradigm.

Chronic obstructive pulmonary disease (COPD) is a debilitating disease affecting patients in daily life, both physically and emotionally. Symptoms such as dyspnea and muscle fatigue, lead to exercise intolerance, which, together with behavioral issues, trigger physical inactivity, a key feature of COPD. Physical inactivity is associated with adverse clinical outcomes, including hospitalization and all-cause mortality. Increasing activity levels is crucial for effective management strategies and could lead to improved long-term outcomes. In this review we summarize objective and subjective instruments for evaluating physical activity and focus on interventions such as pulmonary rehabilitation or bronchodilators aimed at increasing activity levels. To date, only limited evidence exists to support the effectiveness of these interventions. We suggest that a multimodal approach comprising pulmonary rehabilitation, pharmacotherapy, and counselling programs aimed at addressing emotional and behavioural aspects of COPD may be an effective way to increase physical activity and improve health status in the long term.

The Caregiver Burden Questionnaire for Heart Failure (CBQ-HF): face and content validity.

BACKGROUND: A new caregiver burden questionnaire for heart failure (CBQ-HF v1.0) was developed based on previously conducted qualitative interviews with HF caregivers and with input from HF clinical experts. Version 1.0 of the CBQ-HF included 41 items measuring the burden associated with caregiving in the following domains: physical, emotional/psychological, social, and impact on caregiver's life. Following initial development, the next stage was to evaluate caregivers' understanding of the questionnaire items and their conceptual relevance. METHODS: To evaluate the face and content validity of the new questionnaire, cognitive interviews were conducted with caregivers of heart failure patients. The cognitive interviews included a "think aloud" exercise as the patient completed the CBQ-HF, followed by more specific probing questions to better understand caregivers' understanding, interpretation and the relevance of the instructions, items, response scales and recall period. RESULTS: Eighteen caregivers of heart failure patients were recruited. The mean age of the caregivers was 50 years (SD = 10.2). Eighty-three percent of caregivers were female and most commonly the patient was either a spouse (44%) or a parent (28%). Among the patients 55% were NYHA Class 2 and 45% were NYHA Class 3 or 4. The caregiver cognitive interviews demonstrated that the CBQ-HF was well understood, relevant and consistently interpreted. From the initial 41 item questionnaire, fifteen items were deleted due to conceptual overlap and/or item redundancy. The final 26-item CBQ-HF (v3.0) uses a 5-point Likert severity scale, assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens using a 4-week recall period. CONCLUSIONS: The CBQ-HF (v3.0) is a comprehensive and relevant measure of subjective caregiver burden with strong content validity. This study has established that the CBQ-HF (v3.0) has strong face and content validity and should be valuable as an outcomes measure to help understand and monitor the relationship between patient heart failure severity and caregiver burden. A Translatability AssessmentSM of the measure has since been performed confirming the cultural appropriateness of the measure and psychometric validation is planned for the future to further explore the reliability, and validity of the new questionnaire in a larger caregiver sample.

Beyond FEV1 in COPD: a review of patient-reported outcomes and their measurement.

Patients with chronic obstructive pulmonary disease (COPD) present with a variety of symptoms and pathological consequences. Although primarily viewed as a respiratory disease, COPD has both pulmonary and extrapulmonary effects, which have an impact on many aspects of physical, emotional, and mental well-being. Traditional assessment of COPD relies heavily on measuring lung function, specifically forced expiratory volume in 1 second (FEV(1)). However, the evidence suggests that FEV(1) is a relatively poor correlate of symptoms such as breathlessness and the impact of COPD on daily life. Furthermore, many consequences of the disease, including anxiety and depression and the ability to perform daily activities, can only be described and reported reliably by the patient. Thus, in order to provide a comprehensive view of the effects of interventions in clinical trials, it is essential that spirometry is accompanied by assessments using patient-reported outcome (PRO) instruments. We provide an overview of patient-reported outcome concepts in COPD, such as breathlessness, physical functioning, and health status, and evaluate the tools used for measuring these concepts. Particular attention is given to the newly developed instruments emerging in response to recent regulatory guidelines for the development and use of PROs in clinical trials. We conclude that although data from the development and validation of these new PRO instruments are emerging, to build the body of evidence that supports the use of a new instrument takes many years. Furthermore, new instruments do not necessarily have better discriminative or evaluative properties than older instruments. The development of new PRO tools, however, is crucial, not only to ensure that key COPD concepts are being reliably measured but also that the relevant treatment effects are being captured in clinical trials. In turn, this will help us to understand better the patient's experience of the disease.

Validation of the Treatment Satisfaction Questionnaire for Medication in patients with cystic fibrosis.

BACKGROUND: Our objective was to confirm the measurement properties of the Treatment Satisfaction Questionnaire with Medication (TQSM) in patients with cystic fibrosis (CF) receiving inhaled antibiotics. METHODS: The TSQM was included in the EAGER study, a clinical trial comparing a nebulized and a dry powder device for inhaled tobramycin in a CF population with chronic Pseudomonas aeruginosa (Pa) lung infection, aged 6 years and above (N=553). Reliability and validity of the questionnaire were investigated using Cronbach's α and multitrait-multimethod approach. RESULTS: The TSQM demonstrated very good reliability and construct validity: all Cronbach's α were above 0.86 and all items met the convergent and discriminant validity criteria. In multivariate regressions, higher patient satisfaction and lower perceived impact of side-effects were associated with better treatment compliance. CONCLUSIONS: The TSQM showed very good measurement properties that strongly support its use to assess satisfaction of patients with CF taking inhaled antibiotics.

A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence.

PURPOSE: To explore the published evidence on the link between treatment satisfaction and patients' compliance, adherence, and/or persistence. METHODS: Articles published from January 2005 to November 2010 assessing compliance, adherence, or persistence and treatment satisfaction were identified through literature searches in Medline, Embase, and PsycInfo. Abstracts were reviewed by two independent researchers who selected articles for inclusion. The main attributes of each study examining the link between satisfaction and adherence, compliance, or persistence were summarized. RESULTS: The database searches yielded 1278 references. Of the 281 abstracts that met the inclusion criteria, 20 articles were retained. In the articles, adherence and compliance were often used interchangeably and various methods were used to measure these concepts. All showed a positive association between treatment satisfaction and adherence, compliance, or persistence. Sixteen studies demonstrated a statistically significant link between satisfaction and compliance or persistence. Of these, ten demonstrated a significant link between satisfaction and compliance, two showed a significant link between satisfaction and persistence, and eight demonstrated a link between either a related aspect or a component of satisfaction (eg, treatment convenience) or adherence (eg, intention to persist). An equal number of studies aimed at explaining compliance or persistence according to treatment satisfaction (n = 8) and treatment satisfaction explained by compliance or persistence (n = 8). Four studies only reported correlation coefficients, with no hypothesis about the direction of the link. The methods used to evaluate the link were varied: two studies reported the link using descriptive statistics, such as percentages, and 18 used statistical tests, such as Spearman's correlation or logistic regressions. CONCLUSION: This review identified few studies that evaluate the statistical association between satisfaction and adherence, compliance, or persistence. The available data suggested that greater treatment satisfaction was associated with better compliance and improved persistence, and with lower regimen complexity or treatment burden.

Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation.

BACKGROUND: Symptoms related to atrial fibrillation and their impact on health-related quality of life (HRQoL) are often evaluated in clinical trials. However, there remains a need for a properly validated instrument. We aimed to develop and validate a short symptoms scale for patients with AF. METHODS: One hundred and eleven patients with a variety of symptoms related to AF were scheduled for DC cardioversion. The mean age was 67.1 +/- 12.1 years, and 80% were men. The patients completed the new symptoms scale, the Toronto Symptoms Check List (SCL) and the generic Short Form 36 (SF-36) the day before the planned DC cardioversion. Compliance was excellent, with only 1 of 666 answers missing. RESULTS: One item, 'limitations in working capability', was deleted because of a low numerical response rate, as many of the patients were retired. The internal consistency reliability of the remaining six items was 0.81 (Cronbach's alpha). Patients scored highest in the items of 'dyspnoea on exertion', 'limitations in daily life due to AF' and 'fatigue due to AF', with scores of 4.5, 3.3 and 4.5, respectively. There was a good correlation to all relevant SF-36 domains and to the relevant questions of the SCL. The Rasch analyses showed that the items are unidimensional and that they are clearly separated and cover an adequate range. Test-retest reliability was performed in patients who failed DC and was adequate for three of six items, > 0.70. CONCLUSION: The psychometric characteristics of the new short symptoms scale were found to have satisfactory reliability and validity.

An international comparison of the burden of illness in patients with dyspepsia.

BACKGROUND/AIMS: This study investigates the symptoms and the impact of symptoms on health-related quality of life (HRQL) in patients consulting with dyspepsia. METHODS: Consecutive patients with a diagnosis of dyspepsia were recruited from primary and secondary care in Germany, Hungary, Italy, Poland, South Africa and Spain. Investigators assessed symptom frequency and severity, and subjects completed the following questionnaires: the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire, the Hospital Anxiety and Depression (HAD) scale and the Short Form 36 (SF-36). RESULTS: 853 dyspepsia patients were included. Mean GSRS scores showed that patients were most troubled by abdominal pain and indigestion. QOLRAD scores indicated that symptoms caused emotional distress, food/drink problems and reduced vitality, with a lesser effect on sleep and physical functioning. Mean SF-36 scores were lower than mean normative values for all domains, indicating that patients had a worse HRQL than the normal population, particularly for Bodily Pain, Role Physical and Role Emotional. Of patients in each country, 18-43% were anxious and 11-21% were depressed. CONCLUSIONS: Patients with dyspepsia have reduced HRQL because their symptoms - particularly abdominal pain and indigestion - cause emotional distress, problems with food and drink, and impaired vitality.

Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study.

BACKGROUND: Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia. METHODS: 853 patients with symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale. RESULTS: The internal consistency reliability of the GSRS was 0.43-0.87 and of the QOLRAD 0.79-0.95. Test-retest reliability of the GSRS was 0.36-0.75 and of the QOLRAD 0.41-0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to symptom frequency and severity. CONCLUSION: The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic symptoms and their impact on patients' daily lives in multinational clinical trials.

[Psychometric validation of the Polish translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) Questionnaire in patients with reflux disease]. / Psychometryczna walidacja polskiego tlumaczenia Skali Ilosciowej Oceny Objawów Zolkdkowo-Jelitowych (GSRS, Gastrointestinal Symptom Rating Scale) oraz Kwestionariusza Oceny Jakosci Zycia w Chorobie Refluksowej i Dyspepsji (QOLRAD, Quality of Life in Reflux and Dyspepsia Questionnaire) u pacjentów z choroba refluksowa.

UNLABELLED: Symptoms of heartburn and their impact on health-related quality of life (HRQL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim of the study is to document the psychometric characteristics of the Polish translation of the Gastrointestinal Symptom Rating Scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) questionnaire. One hundred and thirty-five patients with symptoms of heartburn (mean age: 44, SD = 14.6; females % = 60.7) completed the Polish translation of GSRS, the heartburn version of QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Seventy patients were scheduled for a second visit a week later to complete the GSRS and QOLRAD again. The internal consistency reliability of GSRS ranged from 0.58 to 0.88 and of QOLRAD from 0.84 to 0.95, and the test-retest reliability of GSRS ranged from 0.34 to 0.63 and of QOLRAD from 0.51 to 0.74. The relevant domains of the GSRS, "reflux", "abdominal pain" and "indigestion", and all QOLRAD domain scores significantly correlated. GSRS domains "abdominal pain" and "indigestion" were related to all SF-36 domains. All QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSIONS: the psychometric characteristics of the Polish translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The test-retest reliability of the GSRS "reflux" domain was however not optimal.

[Burden of illness in Polish patients with reflux disease]. / Obciazenie polskich pacjentów zwiazane z choroba refluksowa przelyku.

The clinical and socioeconomic burden of gastro-esophageal reflux disease (GERD) is considerable. The primary symptom of GERD is heartburn, but it may also be associated with extraesophageal manifestations, such as asthma, chest pain and otolaryngologic disorders. The objective of the study was to describe the impact of heartburn on patients' Health-Related Quality of Life (HRQL) in Poland, using validated generic and disease-specific instruments to measure patient-reported outcomes. Patients with symptoms of heartburn completed the Polish versions of the Gastrointestinal Symptom Rating Scale (GSRS), the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD), the Short Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Frequency and severity of heartburn during the previous 7 days were also recorded. 135 patients completed the assessments (mean age of 44 years, SD = 15; 61% female). 55% of patients had moderate symptoms and nearly two thirds (64%) had symptoms on 5 or more days in the previous week. Patients were most bothered by symptoms of reflux (mean GSRS score of 4.1, on a scale of 1 [not bothered] to 7 [very bothered]), indigestion (3.5) and abdominal pain (3.2). As a result of their symptoms, patients experienced impaired vitality (mean QOLRAD score of 3.8, on a scale of 1 to 7, where 1 represents the most severe impact on daily functioning), problems with food and drink (3.9), emotional distress (4.1) and sleep disturbance (4.7). Using HAD, 32% of heartburn patients were anxious and 10% were depressed. In conclusion it should be stated that there is consistent evidence that GERD substantially impairs all aspects of health-related quality of life.

Impact of irritable bowel syndrome on patients' lives: development and psychometric documentation of a disease-specific measure for use in clinical trials.

OBJECTIVE: To develop a disease-specific questionnaire to capture the impact of irritable bowel syndrome (IBS) and its treatment on patients' lives, the Irritable Bowel Syndrome Impact Scale (IBS-IS). PATIENTS AND METHODS: One hundred and fifty-five IBS patients participated (126 (81%) female; age (mean+/-SD) 45.5+/-12.4 years). We developed the initial 39 items from the literature, available IBS-specific instruments and input from physicians, nurses and patients. We deleted IBS-IS items with a high ceiling effect, items that measured a different construct and items showing a high correlation (r>0.90) with another item and with Rasch analysis, leaving 26 items. We then applied exploratory factor analysis to examine domain groupings. Subjects completed the IBS-IS instrument, the Gastrointestinal Symptom Rating Scale for IBS (GSRS-IBS), Short Form-36 (SF-36), Visceral Sensitivity Index (VSI), and Hospital Anxiety and Depression (HAD) scale. Internal consistency, construct validity and discriminate validity were assessed. RESULTS: The 26 items represented five domains: fatigue, impact on daily activities, sleep disturbance, emotional distress and eating habits. The internal consistency reliability for the domains was 0.87 to 0.96. Most associations between similar constructs in the IBS-IS, GSRS-IBS, SF-36, VSI, and HAD were >0.40. Each IBS-IS domain score decreased with increasing IBS symptom severity (P<0.05), and the patients scored >5 score units lower than a US general population scored on all eight SF-36 dimensions. CONCLUSION: The IBS-IS is a short, user-friendly instrument with excellent psychometric properties that has potential usefulness for clinical trials.

An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire.

BACKGROUND: Few studies have evaluated patient-reported outcomes in connection with a primary event of deep venous thrombosis, partly due to a lack of disease-specific measures. The aim here was to develop a disease-specific health-related quality of life (HRQL) measure, the deep venous thrombosis quality of life questionnaire (DVTQOL), for patients with recent exposition and treatment of proximal deep venous thrombosis. METHODS: A total of 121 consecutive outpatients (50 % males; mean age 61.2 +/- 14 years) treated with warfarin (Waran) for symptomatic proximal deep venous thrombosis were included in the study. Patients completed the SF-36, EQ-5D and the pilot version of the DVTQOL. RESULTS: Items having: high ceiling and floor effect, items with lower factor loadings than 0.50 and items loading in several factors were removed from the pilot version of DVTQOL. In addition, overlapping and redundant items identified by the Rasch analysis were excluded. The final DVTQOL questionnaire consists of 29 items composing six dimensions depicting problems with: emotional distress; symptoms (e.g. pain, swollen ankles, cramp, bruising); limitation in physical activity; hassle with coagulation monitoring; sleep disturbance; and dietary problems. The internal consistency reliability was high (alpha value ranged from 0.79 to 0.93). The relevant domains of the SF-36 and EQ-5D significantly correlated with DVTQOL, thereby confirming its construct validity. CONCLUSIONS: The DVTQOL is a short and user-friendly instrument with good reliability and validity. Its test-retest reliability and responsiveness to change in clinical trials, however, must be explored.

Psychometric validation of the italian translation of the gastrointestinal symptom-rating scale and quality of life in reflux and dyspepsia questionnaire in patients with gastro-oesophageal reflux disease.

BACKGROUND: Symptoms of heartburn and their impact on health-related quality of life (HR-QOL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. OBJECTIVE: To document the psychometric characteristics of the Italian translation of the Gastrointestinal Symptom-Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. PATIENTS AND METHODS: 152 consecutive patients with symptoms of heartburn (mean +/- SD age 46.5 +/- 16.2 years; 40.1% males) completed the Italian translation of GSRS, the heartburn version of QOLRAD, the 36-item Short-Form health survey (SF-36), and the Hospital Anxiety and Depression (HAD) scale. RESULTS: The internal consistency reliability of GSRS ranged from 0.62 to 0.76 and of QOLRAD from 0.77 to 0.89. The relevant domains of the GSRS ('Reflux', 'Abdominal Pain' and 'Indigestion') and QOLRAD domain scores significantly correlated. GSRS domains 'Reflux' and 'Abdominal Pain' strongly correlated (negatively) with most of the domains of the SF-36. Similarly, all QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSION: The psychometric characteristics of the Italian translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity.