Keratoconus and the Impact of Treatment on Patients' Quality of Life: A Qualitative Study.

INTRODUCTION: Keratoconus has a significant impact on patients' quality of life (QoL), from diagnosis to the advanced stages of the disease. The aim of this research was to identify domains of QoL affected by this disease and its treatment. METHODS: Phone interviews were conducted using a semi-structured interview guide, with patients with keratoconus stratified according to their current treatment. A board of keratoconus experts helped identify the guide's main themes. RESULTS: Thirty-five patients (rigid contact lenses, n = 9; cross-linking, n = 9; corneal ring implants, n = 8; and corneal transplantation, n = 9) were interviewed by qualitative researchers. Phone interviews revealed several QoL domains affected by the disease and its treatments: "psychological", "social life", "professional life", "financial costs" and "student life". All domains were impacted, independently of the treatment history. Few differences were found between treatment regimens and keratoconus stages. Qualitative analysis enabled the development of a conceptual framework based on Wilson and Cleary's model for patient outcomes common to all patients. This conceptual model describes the relationship between patients' characteristics, their symptoms, their environment, their functional visual impairment and the impact on their QoL. CONCLUSIONS: These qualitative findings supported the generation of a questionnaire to evaluate the impact of keratoconus and its treatment on patients' QoL. Cognitive debriefings confirmed its content validity. The questionnaire is applicable for all stages of keratoconus and treatments and may help tracking change over time in regular clinical settings. Psychometric validation is yet to be performed before its use in research and clinical practices.

Real-world utilities and health-related quality-of-life data in hemophilia patients in France and the United Kingdom.

Purpose: Congenital hemophilia A and B are bleeding disorders characterized by deficiency of factors VIII and IX, respectively. This study aimed to collect health-related quality-of-life (HRQoL) and health-utility data from hemophilia patients with differing disease severity. Methods: Individuals with hemophilia aged ≥12 years living in France or the UK completed a series of questionnaires, including the EQ-5D-3L and -5L and SF-36 version 2. Association with demographic and clinical variables was explored using linear regression, and health-utility comparison was completed using Pearson and intraclass correlation coefficients. Results: A total of 122 patients in France and 62 in the UK completed the survey. The combined sample primarily consisted of hemophilia A patients, mean age of 41 years, 70% had severe hemophilia, and 56% were on long-term prophylaxis. Similar HRQoL and utility scores were observed across the French and UK samples. The presence of more than two target joints, occurrence of joint surgery, and increased joint-pain frequency were independent predictors of lower SF-36 - physical health summary scores and lower health-utility scores. No statistically significant reductions in SF-36 - mental health summary scores were observed, except for participants with target joints. Strong correlations were observed between health- utility values derived from the three instruments (r=0.69-0.79). Conclusion: Results of this study reinforce the importance of appropriate treatment to limit the physical burden and long-term joint damage associated with hemophilia. Further, utility values collected here reflect real-world data, and can serve as health-state weights in future cost-utility analyses.

Utility valuation of health states for haemophilia and related complications in Europe and in the United States.

INTRODUCTION: There is currently a paucity of health utility data describing the consequences of haemophilia and related complications. AIM: To quantify the impact of distinct stages of severity of haemophilia and disease-related complications on health-related quality of life, expressed as health utilities in Europe and the United States. METHODS: Nine health state descriptions were developed based on literature review and interviews with haematologists and haemophilia patients. Three descriptions characterized the impact of mild, moderate and severe haemophilia without inhibitors. Six descriptions characterized disease-related complications added to the moderate haemophilia description (arthroscopic synovectomy, prosthetic joint replacement, chronic pain, spontaneous bleed, traumatic bleed and end-stage joint disease). Time trade-off (TTO) interviews were conducted with 100 adults from the general public in the UK, France, Germany, Italy, Sweden and the United States. Mean TTO-derived utility values were expressed on a scale from 0 (death) to 1 (full health). RESULTS: Utility values obtained for the health states corresponding to mild (0.73-0.86), moderate (0.68-0.76) and severe (0.64-0.71) haemophilia followed the increase in severity. The addition of a complication to the "moderate" state leads to a decrease in the associated utility value. The most severe disutility (0.23-0.36) across all countries was associated with the burden of end-stage joint disease. CONCLUSIONS: This study underlines the value that the French, Italian, German, Swedish, United States and UK populations ascribe to the avoidance of disease progression in haemophilia without inhibitors. Improved treatment options hold a potential for important benefits to haemophilia patients.

Assessing narcolepsy with cataplexy in children and adolescents: development of a cataplexy diary and the ESS-CHAD.

OBJECTIVE: The aim of this study was to qualitatively evaluate concepts for incorporation into a daily diary to capture cataplexy frequency and to assess the content validity of the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) in pediatric patients with narcolepsy. PATIENTS AND METHODS: Face-to-face concept elicitation and cognitive interviews were conducted with children (7-9 years; n=13) and adolescents (10-17 years; n=16) who have narcolepsy with cataplexy, and their parents/caregivers. RESULTS: Similarities and differences were noted between narcolepsy concepts described by children and their parents/caregivers, suggesting some different but complementary perspectives; parents may not recognize cataplexy symptoms/triggers as well as children, but parents have greater recognition of the circumstances of falling asleep. Cataplexy diary modifications included changes in definitions and examples of cataplexy, using child-friendly terminology, adding a quantitative question to determine daily frequency, and standardizing the questionnaire for evening administration with self-completion by the child. Modifications were made to ESS-CHAD for child-friendly wording and to ensure that items reflect activities (eating, watching TV/video) and environments (school, bus/car transport) in which children are likely to participate. Two ESS-CHAD versions were proposed: one with a 1-month recall period, for general use, and the other with a recall period of "since your last study visit," for research, which could be shorter or longer than 1 month (as short as 1 week). CONCLUSION: The cataplexy diary and ESS-CHAD were modified for the assessment of children and adolescents. Further psychometric validation is recommended. These measures are being used in a Phase III, placebo-controlled clinical trial of sodium oxybate in children and adolescents with narcolepsy.

Assessing sleepiness and cataplexy in children and adolescents with narcolepsy: a review of current patient-reported measures.

OBJECTIVE: The objective of this study was to review patient-reported outcome measures assessing excessive daytime sleepiness (EDS) or cataplexy in children or adolescents to determine their usefulness and limitations in pediatric narcolepsy assessment. METHODS: Searches were performed in Embase and Medline for pediatric measures of EDS and cataplexy that are either patient- or proxy-reported, and searches of http://www.clinicaltrials.gov/ were conducted for studies in narcolepsy that included at least one patient-reported measure. Further review was performed if sleepiness questionnaires (child or proxy-reported), sleep questionnaires that may contain sleepiness questions, proxy-reported child behavior questionnaires, or information on cataplexy measures were mentioned. RESULTS: All self-reported cataplexy questionnaires from among 27 citations were study-specific diaries and were not identifiable as a recognized validated questionnaire. For EDS, 118 of 401 abstracts were further reviewed and the names of 21 questionnaires identified, of which eight questionnaires did not return additional citations of their validation. The Epworth Sleepiness Scale (ESS) or a modified version was the most frequently used measure of EDS. Although all measures were associated with limitations for use in the pediatric population, the ESS has been successfully used in adolescents and was deemed readily amenable to further modification for children. CONCLUSIONS: There remains a dearth of validated measures for assessing EDS and cataplexy in children and adolescents with narcolepsy. The need for these measures may be filled by modification or adaptation of existing adult measures; a daily cataplexy diary and the ESS may be readily modified to make them child-friendly with regard to wording and settings, but should still undergo psychometric validation.

Scoring and psychometric validation of the 'Determinants of Intentions to Vaccinate' (DIVA©) questionnaire.

BACKGROUND: Primary care physicians (PCPs) play a key role regarding vaccination in France. The aims of the present study were to define the scoring rules and to assess the measurement properties of the 'Determinants of Intentions to Vaccinate' (DIVA©) questionnaire that aims to assess PCPs' attitudes and beliefs toward vaccination. METHODS: The DIVA questionnaire was derived from a literature review and PCPs focus groups. Scoring and early validation of the DIVA questionnaire were determined during a cross-sectional study conducted in France. During the study, PCPs had to complete the DIVA questionnaire for any of the six vaccine-preventable diseases (VPDs) to which they were randomly assigned (measles, pertussis, pneumococcus infection, seasonal influenza, human papillomavirus -HPV- infection and tetanus). Descriptive analyses of items and the analysis of the grouping of items into domains were conducted. Internal consistency reliability and construct validity was assessed according to each VPD. RESULTS: The DIVA questionnaire was completed by 1,069 PCPs and was well accepted. The 'Commitment of the PCP to the vaccination approach' score showed very good internal consistency reliability (Cronbach's alpha >0.70 overall and for each VPD). The construct validity of the DIVA questionnaire was confirmed. CONCLUSIONS: The DIVA questionnaire is a valid and reliable measure of PCPs' attitudes and beliefs toward vaccination.

[The commitment of French general practitioners to vaccination: the DIVA study (Determinants of Vaccination Intentions)]. / L’engagement des médecins généralistes français dans la vaccination : l’étude DIVA (Déterminants des Intentions de Vaccination).

OBJECTIVES: Vaccination is an effective way to reduce morbidity and mortality related to infectious diseases. In France, primary care physicians are the main administrators of vaccines. Our objective was to conduct an exploratory qualitative study with primary care physicians to identify determinants of their commitment to vaccination. METHODS: A qualitative research study was conducted with 36 primary care physicians from different geographical regions in France. Six focus group discussions, following a semi-structured interview guide, were held. Qualitative analysis based on coding of the transcribed discussions was performed to identify the factors influencing primary care physicians' attitudes toward vaccination. These factors were then organized into themes. Saturation was also evaluated. RESULTS: Diphtheria, tetanus, poliomyelitis, measles, mumps, rubella, hepatitis B, tuberculosis, pneumococcal infections, meningococcus, human papillomavirus, rotavirus, pertussis, varicella and flu vaccinations were all discussed in each focus group. Saturation was reached from the fourth focus group. Forty identified determinants were divided into six themes: vaccine characteristics, disease characteristics, primary care physicians' past experience, practical aspects, expected benefits and primary care physician-patient relationship. CONCLUSIONS: This study identified the behavioural and organizational determinants influencing primary care physicians' attitudes toward vaccination. These attitudes and determinants varied according to diseases and vaccines. The identified determinants and themes were used as a basis for the development of a questionnaire evaluating the Determinant of Vaccination Intentions (DIVA) of primary care physicians.

Assessment of the impact of phenylketonuria and its treatment on quality of life of patients and parents from seven European countries.

BACKGROUND: The strict and demanding dietary treatment and mild cognitive abnormalities seen in PKU treated from a young age can be expected to affect the health-related quality of life (HRQoL) of patients and their families. Our aim was to describe the HRQoL of patients with PKU from a large international study, using generic HRQoL measures and an innovative PKU-specific HRQoL questionnaire (PKU-QOL). Analyses were exploratory, performed post-hoc on data collected primarily to validate the PKU-QOL. METHODS: A multicentre, prospective, non-interventional, observational study conducted in France, Germany, Italy, The Netherlands, Spain, Turkey and the UK. Patients diagnosed with PKU aged ≥9 years old and treated with a Phe-restricted diet and/or Phe-free amino acid protein supplements and/or pharmacological therapy were included in the study; parents of at least one patient with PKU aged <18 years were also included. HRQoL was assessed by generic measures (Pediatric Quality-of-Life Inventory; Medical Outcome Survey 36 item Short Form; Child Health Questionnaire 28 item Parent Form) and the newly developed PKU-QOL. Mean generic domain scores were interpreted using published reference values from the general population. PKU-QOL domain scores were described overall and in different subgroups of patients defined according to severity of PKU, overall assessment of patient's health status by the investigator and treatment with tetrahydrobiopterin (BH4). RESULTS: Data from 559 subjects were analysed: 306 patients (92 children, 110 adolescents, 104 adults) and 253 parents. Mean domain scores of generic measures in the study were comparable to the general population. The highest PKU-QOL impact scores (indicating greater impact) were for emotional impact of PKU, anxiety about blood Phe levels, guilt regarding poor adherence to dietary restrictions or Phe-free amino acid supplement intake and anxiety regarding blood Phe levels during pregnancy. Patients with mild/moderate PKU and those receiving BH4 reported lower practical and emotional impacts of the diet and Phe-free amino acid supplement intake. CONCLUSION: Patients with PKU showed good HRQoL in the study, both with the generic and PKU-specific measures. Negative impacts of PKU on a patient's life, including the emotional impact of PKU and its management, was delineated by the PKU-QOLs across all age groups.

Development and psychometric validation of measures to assess the impact of phenylketonuria and its dietary treatment on patients' and parents' quality of life: the phenylketonuria - quality of life (PKU-QOL) questionnaires.

BACKGROUND: The aim of our study was to develop and validate the first set of PKU-specific Health-related Quality of Life (HRQoL) questionnaires that: 1) were developed for patients with PKU and their parents, 2) cover the physical, emotional, and social impacts of PKU and its treatment on patients' lives, 3) are age specific (Child PKU-QOL, Adolescent PKU-QOL, Adult PKU-QOL), 4) enable the evaluation of the HRQoL of children by their parents (Parent PKU-QOL), and 5) have been cross-culturally adapted for use in seven countries (i.e. France, Germany, Italy, The Netherlands, Spain, Turkey and the UK). METHODS: The PKU-QOL questionnaires were developed according to reference methods including patients', parents' and healthcare professionals' interviews; testing in a pilot study (qualitative step in six countries), and linguistic validation of the finalised pilot versions in Turkish. For finalisation and psychometric validation, the pilot versions were included in a multicentre, prospective, non-interventional, observational study conducted in 34 sites in France, Germany, Italy, The Netherlands, Spain, Turkey and the UK. Iterative multi-trait analyses were conducted. Psychometric properties were assessed (concurrent and clinical validity, internal consistency reliability and test-retest reliability). RESULTS: Data from 559 subjects (306 patients, 253 parents) were analysed. After finalisation, the PKU-QOL questionnaires included 40 items (Child PKU-QOL), 58 items (Adolescent PKU-QOL), 65 items (Adult PKU-QOL) and 54 items (Parent PKU-QOL), distributed in four modules: PKU symptoms, PKU in general, administration of Phe-free protein supplements and dietary protein restriction. The measurement properties of the Adolescent, Adult and Parent PKU-QOL questionnaires were overall fairly satisfactory, but weaker for the Child questionnaire. CONCLUSIONS: The four PKU-QOL questionnaires developed for different ages (Child PKU-QOL, Adolescent PKU-QOL, Adult PKU-QOL), and for parents of children with PKU (Parent PKU-QOL) are valid and reliable instruments for assessing the multifaceted impact of PKU on patients of different age groups (children, adolescents and adults) and their parents, and are available for use in seven countries. They are very promising tools to explore how patients' perceptions evolve with age, to increase knowledge of the impact of PKU on patients and parents in different countries, and to help monitor the effect of therapeutic strategies.

Development of a questionnaire to assess the impact on parents of their infant's bronchiolitis hospitalization.

BACKGROUND: Bronchiolitis is a distressing respiratory condition and the most common cause of hospitalization during the first year of life. The hospitalization of an infant is a stressful event for parents and deserves careful consideration. The objective of this work was to develop and validate a self-administered instrument that comprehensively assesses the impact on parents of the hospitalization of their infant for bronchiolitis. METHODS: The Impact of Bronchiolitis Hospitalization Questionnaire (IBHQ©) was developed using a literature review and pre-study interviews with both parents and clinicians. For finalization and psychometric validation, it was included in a multicenter, longitudinal, observational study conducted in France. Parents of infants under the age of 1 year and hospitalized for bronchiolitis were asked to complete the questionnaire at hospital discharge, and 3 months after. RESULTS: Seven hundred and seven questionnaires were completed by the parents of the 463 eligible infants. After finalization, based on principal component analyses, the IBHQ included 30 core items allowing the calculation of 7 dimension core scores (Worries and distress; Fear for future; Guilt; Impact on daily organization; Physical impact; Impact on behavior with hospitalized infant; Financial impact), as well as 16 optional items, allowing the calculation of 5 optional dimension scores (Disturbed breastfeeding; Physical reaction of hospitalized infant; Impact on feeding; Impact on behavior with other infants; Siblings' reaction). Internal consistency reliability and construct validity of the IBHQ were satisfactory. The highest impact was observed for "Worries and distress", "Fear for future" and "Impact on daily organization" scores. CONCLUSIONS: The IBHQ is a reliable and valid instrument for assessing the multifaceted impact on parents of the hospitalization of their infant for bronchiolitis.

Development of a new subjective questionnaire: the Freedom from Glasses Value Scale (FGVS).

PURPOSE: To develop a patient self-administered questionnaire assessing the added value of complete independence from spectacles (hereafter referred to as glasses) after multifocal intraocular lens (IOL) surgery. METHODS: Exploratory interviews with five cataract patients and six presbyopic patients with AcrySof ReSTOR IOLs (Alcon Laboratories Inc) implanted in both eyes for at least 6 months were conducted. The questionnaire's conceptual framework was developed after interview analysis. Based on the identified concepts, items were generated simultaneously in French and Spanish using patients' own words, and comprehension tested with six French patients; the Spanish questionnaire underwent clinician review and was further tested with four Spanish patients. French and Spanish versions were accordingly refined. The questionnaire was linguistically validated in UK English and Danish. RESULTS: Interview analysis resulted in the identification of 9 global concepts: global vision, practical constraints related to wearing glasses, impact of eye surgery on the patient's life, improvement of practical issues without glasses, improvement of psychological constraints without glasses, physical appearance/aesthetic aspect, self-image and in the eyes of others, eyesight problems left behind after surgery, and recommendation of surgery to others. The initial version of the test questionnaire contained 23 items; 2 items were deleted and changes were made after clinician review and patient testing. The final questionnaire named Freedom from Glasses Value Scale (FGVS) contained 21 items and four general additional questions. CONCLUSIONS: Beyond functional aspects, this qualitative study identified additional benefits in cataract and presbyopic patients living free of glasses after receiving multifocal IOLs. The FGVS now needs to be psychometrically validated (eg, construct validity and reliability).

Comprehensive evaluation of bladder and urethral dysfunction symptoms: development and psychometric validation of the Urinary Symptom Profile (USP) questionnaire.

OBJECTIVES: To develop and validate a standardized tool assessing urinary symptoms among men and women with stress, urge, frequency, or urinary obstructive symptoms for use in clinical practice to complement clinical measures and diagnosis. METHODS: After development by an advisory committee and comprehension testing with patients, the Urinary Symptoms Profile (USP) item content and validity were evaluated by clinicians. Patients with urinary symptoms (n = 253) and without symptoms (n = 75) completed the final questionnaire at day 0 and day 7. Psychometric properties were assessed, including construct and clinical validity, reliability, and predictive ability for detection of and differentiation between urinary disorders. RESULTS: Principal Component Analysis with Varimax Rotation confirmed the final USP structure of 13 items in 3 dimensions: stress urinary incontinence (SUI), overactive bladder (OAB), and low stream (LS). Internal consistency reliability (Cronbach's alpha ranging from 0.69 to 0.94) and concurrent validity (Spearman correlation coefficients between International Consultation on Incontinence Questionnaire and SUI and OAB dimensions of 0.73 and 0.62, respectively) were good. Test-retest reproducibility over 7 days was excellent in stable patients (Intraclass Correlation Coefficients from 0.84 to 0.91). USP clinical validity was demonstrated by comparing micturition diary with USP scores. USP dimension scores were excellent predictors of urinary disorder presence and identification. CONCLUSIONS: USP is the first valid and reliable questionnaire providing comprehensive evaluation of all urinary disorders and their severity in both men and women with SUI, OAB, and LS. It allows the screening and contributes to the differential diagnosis of these symptoms. The USP is a valuable tool for use in clinical practice.

Measurement of health-related quality of life with glaucoma: validation of the Glau-QoL 36-item questionnaire.

PURPOSE: To validate a glaucoma-specific health-related quality of life (HRQoL) questionnaire: the Glau-QoL. METHODS: Patients with ocular hypertension (OHT) or glaucoma took part in a cross-sectional psychometric validation study (n = 573) and a separate reproducibility study (n = 244). Patients answered the 36-item Glau-QoL, designed from in-depth patient interviews. RESULTS: The clinical validity of the Glau-QoL was excellent and clearly demonstrated that as disease severity and visual field impairment increased, HRQoL scores for the Psychological Wellbeing, Self-image, Daily Life, Driving, Anxiety and Burden of Treatment domains were negatively affected. Increased age and lower visual acuity were also associated with lower HRQoL scores, although to a lesser extent than the previously mentioned criteria. Worsening of HRQoL domains correlated with the clinical stage of glaucoma: Anxiety and Burden of Treatment scores dropped noticeably when patients were first diagnosed and started treatment, followed by a decrease in scores for Driving, Daily Life, Psychological Wellbeing, and Self-image as clinical conditions worsened. Psychometric validation showed acceptable convergent and discriminant validity of the Glau-QoL, and good reproducibility, with intraclass correlation coefficients (ICC) and concordance correlation coefficients (CCC) > or = 0.69. Internal consistency reliability was high (Cronbach's alpha coefficients > 0.70) for the Daily Life, Psychological Wellbeing, Burden of Treatment and Driving domains; acceptable (coefficients of 0.65 and 0.68, respectively) for the Self-image and Anxiety domains; and weak (coefficient = 0.58) for the Confidence in Health Care domain. CONCLUSIONS: The Glau-QoL questionnaire is a valid and specific HRQoL instrument that demonstrates excellent correlations with disease progression in patients with glaucoma and/or OHT.

Studying the Hurdles of Insulin Prescription (SHIP): development, scoring and initial validation of a new self-administered questionnaire.

BACKGROUND: Although insulin therapy is well-accepted by symptomatic diabetic patients, it is still often delayed in less severe patients, in whom injectable insulin remains under-used. A better understanding of patients' perception of insulin would eventually help physicians to adopt the most appropriate dialogue when having to motivate patients to initiate or to intensify insulin injection. METHODS: The 'Studying the Hurdles of Insulin Prescription' (SHIP) questionnaire was developed based on a list of concepts derived from three diabetic patients' focus groups, and was included into two cross-sectional studies with similar design: SHIP Oral study and SHIP Premix study. Diabetic patients treated with oral hypoglycaemic agents (OHA; n = 1,494) and patients already treated with insulin (n = 1,150) completed the questionnaire at baseline, 6- and 12 months. Psychometric properties were assessed: 1) structure analysis by Principal Component Analysis (PCA) with Varimax rotation, 2) internal consistency reliability (Cronbach's alpha), and 3) concurrent validity (Spearman correlation coefficients with the Fear of Self-Injecting (FSI) score of the Diabetes Fear of Injecting and Self-testing Questionnaire. Reluctance/motivation towards insulin was assessed. Scores' ability to predict patients' insulin injection reluctance/motivation and initiation/intensification was evaluated with the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC). RESULTS: PCA analysis confirmed the structure of the 14 items grouped into 3 dimensions: 'acceptance and motivation', 'fear and constraints', and 'restraints and barriers' towards insulin injection. Internal consistency reliability was excellent (Cronbach's alpha > 0.70); concurrent validity was good. The three scores were significantly predictive of patients' reluctance/motivation towards insulin injection initiation, as they were of patients' actual switch, except for the 'restraints and barriers' dimension. 'Acceptance and motivation' and 'fears and constraints' dimensions were also significantly predictive of patients' reluctance/motivation towards insulin intensification. By the end of the 12-month study, 179 of the initially OHA-treated patients had started insulin injections; 186 of the patients already treated with insulin had increased their injections. CONCLUSION: The SHIP questionnaire provides reliable and valid assessment of diabetic patients' attitude towards insulin and injections. The predictive power of scores for patients' reluctance/motivation and actual treatment decisions demonstrates encouraging potential for further application in clinical practice.

Validation of the short-form REFLUX-QUAL (RQS), a gastro-esophageal reflux disease (GERD) specific quality of life questionnaire.

INTRODUCTION: Being an easy-to-use (eight items) quality of life questionnaire specific to GERD, the Reflux-Qual Short form (RQS) was developed for use in everyday practice. The purpose of this study was to assess the psychometric properties of the RQS. METHODS AND MATERIALS: The reliability of the RQS was measured by the Cronbach's alpha coefficient and its clinical validity by comparing the RQS score for increasing clinical severity groups. The RQS discriminative power was compared with that of the SF12. Sensitivity to change over time was measured by calculating effect-sizes. RESULTS: The reliability and validity of the questionnaire were assessed on a sample of 1195 patients. Its psychometric properties were very satisfactory: Cronbach alpha = 0.84; RQS score significantly reduced for the worst-affected patients; the discriminative power was up to 5 times higher when compared with the SF-12. Sensitivity to change over time, evaluated with 362 patients, showed highly significant differences between groups with different levels of clinical progression (P = 0.0001). CONCLUSION: The RQS is a quality of life measurement instrument specific to GERD which is short, reliable, valid, and sensitive to within and between-subject differences.