Chronic cough: how do cough reflex sensitivity and subjective assessments correlate with objective cough counts during ambulatory monitoring?

BACKGROUND: Cough reflex sensitivity, subjective estimates of cough frequency and cough-related quality of life have been used to assess cough and monitor treatment responses. The relationships between these measures and objective cough monitoring remain unclear and the usefulness of subjective assessments remains questionable. SUBJECTS: 62 patients with chronic cough (39 women) were studied. Mean age of patients was 54.9 (SD 12.2) years, with a median duration of cough of 5.5 (range 1-30) years. METHODS: Cough reflex sensitivity testing (C5; citric acid) was performed in all patients before fully ambulatory day-time and night-time cough recordings. Patients scored the frequency and severity of their cough (Visual Analogue Scales (VAS) and 0-5 score) for each recording period and completed a cough-related quality-of-life questionnaire, Leicester Cough Questionnaire (LCQ). Ambulatory cough recordings were manually counted and reported in terms of cough seconds per hour (cs/h). Cough rates were log(10) transformed for analysis. RESULTS: The median time spent coughing was 11.36 (range 1.06-46) cs/h with median day rates of 15.59 (range 2-74.8) cs/h and median night rates of 2.94 (range 0-26.67) cs/h. An inverse relationship was seen between day cough rates and log(10) C5 (r = -0.452, p< or =0.001). Subjective cough scores and visual analogue scales were only moderately associated with objective time spent coughing, with night-time being scores more strongly associated than day-time scores. The strongest correlation with objective cough frequency was cough-related quality of life (LCQ), (r = -0.622, p< or =0.001), mediated through the psychological domain. CONCLUSIONS: Subjective measures of cough and cough reflex sensitivity are only moderately related to objective time spent coughing, and hence cannot be used as surrogate markers for objective cough-frequency measurements. Cough-related quality of life (LCQ) is most strongly related to objectively counted cough, and may be a useful adjunct to objective measures in the assessment of cough.     

Development of a disease specific health related quality of life measure for adults and adolescents with cystic fibrosis

BACKGROUND: Health related quality of life (HRQoL) measurement is important in determining the impact of disease on daily functioning and subsequently informing interventions. In cystic fibrosis (CF) generic HRQoL measures have been employed but these may not be sufficiently specific. The aim of the current work was to develop and validate a disease specific HRQoL measure for adults and adolescents with cystic fibrosis. METHODS: Areas of concern to adults and adolescents with CF were identified by unstructured interviews, self-administered questionnaires, consultation with multidisciplinary specialist staff, a review of the relevant literature, and examination of other HRQoL measures. Items for the questionnaire were generated on the basis of this process. Continued evaluation and development of the Cystic Fibrosis Quality of Life (CFQoL) questionnaire was undertaken by a process of statistical analysis and continued feedback from patients. The full testing and validation of the CFQoL questionnaire took place over four phases: (1) initial item generation and testing of a preliminary questionnaire, (2) testing and validation of the second version of the questionnaire, (3) test-retest reliability of a third and final version of the questionnaire, and (4) sensitivity testing of the final version of the questionnaire. RESULTS: Nine domains of functioning were identified using principal components analysis with varimax rotation. Internal reliability of the identified domains was demonstrated using Cronbach alpha coefficients (range 0.72-0.92) and item to total domain score correlations. Concurrent validity (range r = 0.64-0.74), discriminatory ability between different levels of disease severity, sensitivity across transient changes in health (effect size range, moderate d = 0.56 to large d = 1.95), and test-retest reliability (r = 0.74-0.96) were also found to be robust. CONCLUSIONS: The CFQoL questionnaire is a fully validated disease specific measure consisting of 52 items across nine domains of functioning which have been identified by, and are of importance to, adolescents and adults with cystic fibrosis. This measure will be useful in clinical trials and longitudinal studies.     

The National Institutes of Health chronic prostatitis symptom index: development and validation of a new outcome measure. Chronic Prostatitis Collaborative Research Network.

PURPOSE: Chronic abacterial prostatitis is a syndrome characterized by pelvic pain and voiding symptoms, which is poorly defined, poorly understood, poorly treated and bothersome. Research and clinical efforts to help men with this syndrome have been hampered by the absence of a widely accepted, reliable and valid instrument to measure symptoms and quality of life impact. We developed a psychometrically valid index of symptoms and quality of life impact for men with chronic prostatitis. MATERIALS AND METHODS: We conducted a structured literature review of previous work to provide a foundation for the new instrument. We then conducted a series of focus groups comprising chronic prostatitis patients at 4 centers in North America, in which we identified the most important symptoms and effects of the condition. The results were used to create an initial draft of 55 questions that were used for formal cognitive testing on chronic prostatitis patients at the same centers. After expert panel review formal validation testing of a revised 21-item draft was performed in a diverse group of chronic prostatitis patients and 2 control groups of benign prostatic hyperplasia patients and healthy men. Based on this validation study, the index was finalized. RESULTS: Analysis yielded an index of 9 items that address 3 different aspects of the chronic prostatitis experience. The primary component was pain, which we captured in 4 items focused on location, severity and frequency. Urinary function, another important component of symptoms, was captured in 2 items (1 irritative and 1 obstructive). Quality of life impact was captured with 3 items about the effect of symptoms on daily activities. The 9 items had high test-retest reliability (r = 0.83 to 0.93) and internal consistency (alpha = 0.86 to 0.91). All but the urinary items discriminated well between men with and without chronic prostatitis. CONCLUSIONS: The National Institutes of Health chronic prostatitis symptom index provides a valid outcome measure for men with chronic prostatitis. The index is psychometrically robust, easily self-administered and highly discriminative. It was formally developed and psychometrically validated, and may be useful in clinical practice as well as research protocols.     

The venous leg ulcer quality of life (VLU-QoL) questionnaire: development and psychometric validation

To develop and validate a disease-specific quality of life (QoL) measure, based on the conceptual model of the SKINDEX-29 for patients with a chronic venous leg ulcer (VLU), in-depth interviews, and focus groups of patients (n=36) with VLU were used to generate VLU-specific items. These items were added to selected SKINDEX-29 items that were adapted for use in VLU. Further samples of VLU patients were used for item reduction (n=124) and to assess the psychometric properties of the new tool (n=120). The final VLU-QoL contained 34 items: 17 items adapted from the SKINDEX-29 and 17 VLU-specific items. Factor analysis of the items confirmed the existence of three hypothesized domains: Activities (12 items), Psychological (12 items), and Symptom Distress (10 items). Reliability in terms of internal consistency and test-retest reliability was found to be good. The measure was also found to be valid and responsive to clinical change. The VLU-QoL has good psychometric properties. The instrument's sensitivity to differences in clinical outcome and responsiveness to change in clinical parameters makes it a useful tool to assess the outcomes of treatment from the patients' perspective.     

Development of the Facial Skin Care Index: A Health-Related Outcomes Index for Skin Cancer Patients

BACKGROUND: Existing health-related quality-of-life (HRQOL) tools do not appear to capture patients' specific skin cancer concerns. OBJECTIVE: To describe the conceptual foundation, item generation, reduction process, and reliability testing for the Facial Skin Cancer Index (FSCI), a HRQOL outcomes tool for skin cancer researchers and clinicians. METHODS: Participants in Phases I to III consisted of adult patients (N=134) diagnosed with biopsy-proven nonmelanoma cervicofacial skin cancer. Data were collected via self-report surveys and clinical records. RESULTS: Seventy-one distinct items were generated in Phase I and rated for their importance by an independent sample during Phase II; 36 items representing six theoretical HRQOL domains were retained. Test-retest I results indicated that four subscales showed adequate reliability coefficients (alpha=0.60 to 0.91). Twenty-six items remained for test-retest II. Results indicated excellent internal consistency for emotional, social, appearance, and modified financial/work subscales (range 0.79 to 0.95); test-retest correlation coefficients were consistent across time (range 0.81 to 0.97; lifestyle omitted). CONCLUSION: Pretesting afforded the opportunity to select items that optimally met our a priori conceptual and psychometric criteria for high data quality. Phase IV testing (validity and sensitivity before surgery and 4 months after Mohs micrographic surgery) for the 20-item FSCI is under way.     

Development of the Qualeffo–31, an osteoporosis-specific quality-of-life questionnaire

Introduction Vertebral deformities are a common consequence of osteoporosis and are known to decrease quality of life. The Qualeffo–41 is a quality-of-life questionnaire especially developed for measuring quality of life in patients with vertebral deformities. It consists of 41 questions arranged in five domains: pain, physical function, social function, general health perception, and mental function. The objectives of this study were: (1) to develop a shorter version of the Qualeffo–41 by removing redundant questions; and (2) to investigate the scale characteristics, reliability, and validity of this shorter version. Methods The study was performed using data from the Qualeffo validation study and the Multiple Outcomes of Raloxifene Evaluation (MORE) study. The analyses were performed in patients with vertebral deformities (n=579). Factor analysis on polychoric correlations and an item response theory (IRT) model, i.e., the generalized partial credit model (GPCM), were used to create a shorter version of Qualeffo–41. Using GPCM, scoring weights were computed for all items. Results Three items were removed from the data set because of too many missing values. Factor analysis identified three instead of five domains: (1) pain, (2) physical function, and (3) mental function. Five items had factor loadings <0.4 and were not included in the GPCM. After excluding several items, the domains pain (four items), physical function (18 items), and mental function (nine items) showed a good, reasonable, and excellent fit, respectively. This indicates that the mental function domain and the pain domain are more unidimensional than the physical function domain. All three domains showed a very high correlation (r ≥0.95) with the corresponding domains of the Qualeffo–41. Conclusions Qualeffo–31 was developed, consisting of three domains with a reasonable to excellent fit to the GPCM. Although the fit to the GPCM supports the construct validity of the Qualeffo–31, validation in a new study should be performed before using it in practice.     

Capsaicin cough sensitivity in bronchiectasis

BACKGROUND: Bronchiectasis is a suppurative airway disease characterised by persistent cough and sputum production associated with bronchial dilatation. A study was undertaken to determine whether cough sensitivity is increased in bronchiectatic patients. METHODS: Twenty two patients with bronchiectasis and 20 healthy non-smoking controls matched for age and sex were recruited into the study. Quality of life (Leicester Cough Questionnaire score), total cough symptom score, and extent of bronchiectasis on HRCT scans were recorded. Cough sensitivity was assessed using incremental inhalation of capsaicin concentrations; the concentration at which 5 or more coughs occurred (C5) was recorded. RESULTS: Patients with bronchiectasis had increased sensitivity to capsaicin compared with controls (mean (SE) log10 C5 1.22 (0.20) v 1.89 (0.21); p<0.03). Capsaicin sensitivity correlated positively with the Leicester Cough Questionnaire score (r = 0.64; p = 0.005) and inversely with the total cough symptom score (r = -0.58; p = 0.004), but not with the extent of the disease. It also correlated with forced expiratory volume in 1 second (FEV1) in litres (r = 0.58; p = 0.005) but not with FEV1 % predicted. Capsaicin sensitivity was not related to the presence of infected sputum or to corticosteroid or bronchodilator use. CONCLUSIONS: : Patients with bronchiectasis have a sensitive cough reflex which reflects the severity of cough symptoms. A measure of cough severity could be part of health assessment for patients with bronchiectasis.     

Development and validation of the Pectus Carinatum Body Image Quality of Life (PeCBI-QOL) questionnaire

IntroductionWhile body image disturbances and quality of life in persons with pectus excavatum (PE) have been well documented, very little has been done to systematically measure and document the same in patients with pectus carinatum (PC). Because of this, the current study aimed to develop and validate an instrument to assess body image related quality of life in patients with PC and their parents.MethodParticipants: Two waves of data collection took place. The development phase enrolled 78 PC patients and 76 matched parents. The validation phase enrolled 50 PC patients and 50 parents. Mean age at the initiation of treatment was 15.14 (SD = 2.54). Participants were mostly boys (85.9%) and White or Caucasian (89.7%).Instrument development, refinement, and validation: A group of 5 experts in chest wall deformities used existing measures of body image disturbances in PE, combined with the broader body image literature, to develop larger item pools for patients and their parents. Item analysis from this phase was used to remove poorly performing or statistically redundant items.In the validation phase, refined patient and parent instruments were examined using exploratory principal components factor analysis (EFA) with parallel analysis for factor retention, followed by Varimax rotation to identify a final factor solution.Results/discussionThis development and refinement process yielded a final questionnaire for patients (18 items) and parents (15 items). The patient questionnaire includes four subscales, each with good internal consistency: Body Image Disturbance; Treatment Motivation/Engagement; Physical Limitations; and Social Disadvantage. The parent questionnaire includes 3 subscales: Body Image Disturbance; Treatment Motivation/Engagement; Physical Limitations. Patient and parent scales showed moderate correlations. Among patients with measures pre- and posttreatment, there was a significant improvement in overall PeCBI-QOL score. We demonstrate, in this study, that body image and related quality of life can be reliably and validly assessed with the PeCBI-QOL, which has implications for more comprehensively documenting the negative psychological and functional consequences of pectus carinatum.Type of study/level of evidenceStudy of diagnostic test/III.     

Health-Related Quality of Life in Morbid Obesity

Background: In order to evaluate the impact of severe obesity and its treatment on quality of life (QoL), it would be important to first identify the areas of QoL most likely to be affected by the disease. Methods: We first constructed a list of 187 items potentially related to QoL of patients with morbid obesity. From this list, consecutive candidates for bariatric surgery were asked to identify what they felt were the most significant items and to grade their importance. The item impact was determined from the proportion of patients who identified it as important, and the mean importance score attributed to this item (impact score = frequency X importance). Results: 100 patients (68 female; mean body mass index 51.5 kg/m²; mean age 42) were interviewed. Overall, the impact of morbid obesity was more important in women than in men. The areas of impairment were very similar in both groups, with the important difference that women ranked their dissatisfaction with physical appearance higher than men. The items having the most important impact on QoL clustered into 7 domains: 1) activity/mobility; 2) symptoms; 3) personal hygiene/clothing; 4) emotions; 5) social interactions; 6) sexual life; and 7) eating behavior. Conclusion: The impact of morbid obesity on QoL is not limited to the activity/mobility domain. Morbid obesity contributes to the impairment of all domains of what is usually referred to as "health-related quality of life".     

Evaluating and improving health-related quality of life in patients with varicose veins.

PURPOSE: We set out to assess the new Aberdeen Varicose Veins Questionnaire (Aberdeen Questionnaire) for the properties necessary for a valid measure of health outcome, to determine quality of life of patients with varicose veins, and to determine the effect of surgery on quality of life. METHODS: A prospective consecutive cohort of 137 patients undergoing varicose vein surgery completed the self-administered SF-36 and Aberdeen Questionnaire and 25 questions relating to the symptoms and concerns of patients with varicose veins. Follow-up was done by repeated questionnaires 6 weeks after surgery. The Aberdeen Questionnaire was assessed for reliability, validity, responsiveness, and practicality. Quality of life of patients with varicose veins was compared with an age- and sex-matched sample of the general population. RESULTS: Reliability estimates for the 8 scales short-form health survey (SF-36) and the Aberdeen Questionnaire were all above 0.7 (Cronbach's alpha). The Aberdeen Questionnaire had a highly significant correlation (r = 0. 74, P <.0001) with the patients' symptoms and concerns questionnaire, which is evidence of its validity. Patients with varicose veins score lower than United Kingdom norms (P <.001) in the physical domains of the SF-36, indicating worse health. After surgery, the SF-36 scores improved in all 8 domains of health, reaching significance in "Mental Health" (P <.05) and approaching significance in "General Health" (P =.066). The Health Transition Item of the SF-36 and the Aberdeen Questionnaire both showed a highly significant improvement in health (P <.001). CONCLUSION: The Aberdeen Questionnaire is a valid measure of quality of life for patients with varicose veins. Persons with varicose veins have a reduced quality of life compared with the general population, and this discrepancy is significantly improved at 6 weeks by operating on them.     

Desarrollo y validación del primer cuestionario español de calidad de vida en pacientes con cáncer de próstata,basado en la percepción del paciente

BackgroundTo ensure health related quality of life (HRQOL) during the survival of patients with prostate cancer (PCa) is a priority. The development of specific HRQOL questionnaires aids to assess the disease impact, its treatment and the patient’s perception (concerns, expectations and interests) that might go unnoticed.ObjectivesTo develop and validate the first Spanish HRQL questionnaire specific for patients with PCa.Materials and methodsThe questionnaire CAVIPRES had 3 phases of development:1.-generation of items (literature research, expert meeting and 2 focus groups with patients), 2.- reduction of items (self-administered survey with a preliminary version and clinimetric and psychometric analyses), 3: validation of the questionnaire (observational study with 2 visits where patients completed the CAVIPRES, SF-36 and UCLA-PCI tests and analysis of psychometric properties in terms of validity, reliability and sensitivity to change).ResultsA preliminary list of 75 potential items was obtained in phase 1.412 patients were recruited and answered this preliminary version in phase 2. 35 items were deleted. 436 patients responded to the definitive-30-ítems obtained version (CAVIPRES- 30) in Phase 3. CAVIPRES-30 showed feasibility (items lost <4%, ceiling effect: 0% floor effect: 0% in the overall score), high reliability in terms of internal consistency (alpha = 0.77) and re-test reliability (ICC = 0.92). There was a good correlation between tests CAVIPRES and SGF-36 and UCLA-PCI for similar domainsConclusionThe questionnaire CAVIPRES-30 is a feasible, reliable and sensitive to change, useful in clinical research for prostate cancer.     

Reliability of an osteoporosis-targeted quality of life survey instrument for use in the community: OPTQoL

A brief Osteoporosis-Targeted Quality of Life (OPTQoL) questionnaire was previously developed as a cross-sectional survey instrument to assess the community impact of osteoporosis on quality of life in women. The initial development process involving item generation through focus groups, item reduction, and content and construct validation yielded a 36-item questionnaire with three domains (physical difficulty, adaptations and fears) and 10 health-related questions. In the present study, test-retest reliability and internal consistency of the questionnaire were assessed in a mail-based study with two clinical sites. Two hundred women (50 with severe osteoporosis, 50 with osteopenia, 50 with normal bone mineral density (BMD) and 50 with osteoarthritis and normal BMD), aged 43–84 years, completed the self-administered questionnaire initially and again about 2 weeks later. Using weighted kappas, agreement between questionnaire administrations ranged from 0.60 to 0.80 for most of the individual items. Intraclass correlation coefficients to assess reliability for the domain scores were 0.93 (physical difficulty), 0.82 (adaptations) and 0.88 (fears). Internal consistency of each of the domains was also high, with Cronbach’s alpha coefficients ranging from 0.89 to 0.91. Four items were dropped from the 36-item questionnaire due to high percentage of ‘not applicable’ responses. Results of the analyses support the validity and reliability of this instrument as a cross-sectional survey tool for assessing the impact of osteoporosis on quality of life in women living in the community. The questionnaire has been translated and culturally adapted into seven languages to allow cross-cultural studies of the community impact of osteoporosis.     

Development and Validation of a Quality-of Life Questionnaire for Patients With Chronic Respiratory Disease (CV-PERC): Preliminary Results

Introduction and ObjectivesThe instruments used to assess quality of life in patients with chronic respiratory difficulties have approached this construct in a limited and partial way. Due to this fact, the present paper aimed at describing the development and validation of the CV-PERC scale contemplating the dimensions of physical, psycho-emotional and social, cognitive, working, sexual functionalities and health perception and wellbeing.Patients and MethodsIt was built stemming from the Saint George Respiratory Questionnaire and the SF-36, generating new items after a theoretical revision and interviews to patients. The selected items were submitted to expert's judgments (Neumonologists and Health Psychologists) to assess validity, wording and appropriateness of language. The initial 60-item instrument was applied to a sample of 101 patients for item selection and analysis. Lastly, the final 50-item scale was administered to a sample of 255 patients from four hospitals in Caracas, Venezuela, to collect data for reliability and validity analyses.ResultsA 7-dimension factorial structure was found which explained 62.47% of the total variance (physical functionality, sexual functionality, working functionality, health perception and wellbeing, psychoemotional functionality, cognitive functionality and social functionality). Internal consistency of each dimension and of the total scale was over 0.67. Convergent validity and discriminant coefficients were above 0.64.ConclusionsThe results provide evidence that the CV-PERC scale is a valid and reliable measure to assess quality of life in asthma and EPOC patients.     

Psychosocial adjustment, coping, and quality of life in persons with venous ulcers and a history of intravenous drug use.

OBJECTIVE/PURPOSE: Psychosocial adjustment, coping, and quality of life for persons with a venous ulcer and a history of intravenous drug use were examined. DESIGN: A cross-sectional design was used. SETTING AND SUBJECTS: Data were collected in an urban outpatient clinic. All eligible persons were asked to participate. Thirty-two patients agreed to participate, providing an 89% response rate. The mean age of participants was 44.6 years (SD = 4.3); 91% were African American, and 72% were male. INSTRUMENTS: Subjects responded to questions about their health and substance abuse history and completed the Quality of Life With a Leg Ulcer Questionnaire, Psychosocial Adjustment to Illness Scale (PAIS), Ways of Coping Instrument, and Pain Questionnaire. Leg ulcer tracings were measured with the SigmaScan computer program. METHODS: Questionnaires were read to participants. Leg ulcers were traced at their borders onto plastic. RESULTS: Wound area correlated significantly with the domestic environment (r = .43) and the psychosocial distress (r = .38) scores of the PAIS. Wound area was negatively correlated to Quality of Life With a Leg Ulcer Questionnaire score (r = -.52). Pain interference was significantly related to the self-controlling coping score (r = .40), domestic environment score of the PAIS (r = .51), and Quality of Life With a Leg Ulcer Questionnaire score (r = -.65). Cox and Wermuth's multiple regression modeling approach was used to summarize the study's variables. CONCLUSIONS: A larger wound area was associated with greater illness-induced difficulties in the home environment, greater psychological distress, and poor quality of life. Pain Interference was associated with a greater effort to regulate one's feelings and actions, difficulties in the home, and poor quality of life.     

Behavioral disorders and low quality of life in children and adolescents with chronic kidney disease

Recent years has seen an increasing interest in the quality of life (QOL) of children with chronic kidney disease (CKD). The objective of this cross-sectional study was to investigate the prevalence of behavioral disorders and to assess the health-related QOL (HRQOL) in 136 patients with CKD. To estimate the prevalence of behavior disorders and analyze HRQOL, we used the Strengths and Difficulties Questionnaire (SDQ) and Pediatric Inventory of Quality of Life (PedsQL) Core Scales as assessment tools for both the patients and caregivers. When compared to healthy controls, the CKD group had significantly lower scores in almost all PedsQL domains. After adjustment, only absence of religion/other religions remained significantly associated with a lower global HRQOL score [odds ratio (OR) 6.2, P=0.009]. Among the parents, two factors remained significantly associated with a lower global HRQOL score: patients' age >10 years (OR 5.4, P=0.033) and absence of religion/other religions (OR 3.2, P=0.038). The CKD group demonstrated a higher proportion of behavioral and emotional disorders in all SDQ domains. There was a negative correlation between the presence of behavior and emotional disorders and HRQOL score (r=?-0.552, P<0.001). Our findings suggest the importance of evaluating behavioral and social repercussions of CKD in order to improve the life quality of this pediatric population.     

Visual analog scale questionnaire to assess quality of life specific to each symptom of the International Prostate Symptom Score

PURPOSE: We assessed patient quality of life specific to each of the 7 items on the International Prostate Symptom Score, as evaluated with a novel visual analog scale questionnaire. MATERIALS AND METHODS: A total of 246 male patients with a chief complaint of lower urinary tract symptom were asked to complete the International Prostate Symptom Score and visual analog scale questionnaires to assess bother or satisfaction regarding patient quality of life specific to each of the 7 items on the International Prostate Symptom Score. RESULTS: An item with the maximum visual analog scale measure matched the chief complaint in 169 patients (69%). In contrast, the chief complaint failed to match to an item with the most severe International Prostate Symptom Score in 104 patients (42%) (p = 0.012). Multiple regression analysis to define the best predictor of International Prostate Symptom Score quality of life score of the 14 items, including International Prostate Symptom Score and visual analog scale, revealed that the best predictor was the visual analog scale measure for nocturia (p = 0.0003), followed by visual analog scale measures for frequency (p = 0.0004) and incomplete emptying (p = 0.01). After alpha-blocker treatment improvement in the visual analog scale measure for the chief complaint correlated better with improvement in the International Prostate Symptom Score quality of life score than the change in International Prostate Symptom Score. The overall test-retest correlation for the visual analog scale questionnaire in 55 healthy elderly men and 44 patients with lower urinary tract symptoms was 0.772 and 0.742, respectively (p <0.00001). CONCLUSIONS: The novel visual analog scale measure of quality of life specific to each of the 7 items on the International Prostate Symptom Score has a significant impact on identifying the patient chief complaint as well as on patient specific quality of life. Our study supports the concomitant use of the International Prostate Symptom Score and visual analog scale questionnaires.     

Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction

Development and validation of a patient-reported measure of psychosocial variables in men with erectile dysfunction (ED) is described. Literature review, focus groups, and medical specialists identified 86 potential items. Redundant, ambiguous, or low item-to-total correlation items were removed. Data from 98 men reporting diagnosed ED and 94 controls assisted in final item selection and psychometric evaluation. Treatment responsiveness was evaluated in 93 men with ED in a 10-week open-label trial of sildenafil citrate (Viagra). The 14 chosen items resolved into two domains: Sexual Relationship (eight items) and Confidence (six items), the latter comprising Self-Esteem (four items) and Overall Relationship (two items) subscales. The resulting Self-Esteem And Relationship (SEAR) questionnaire demonstrated validity and reliability. The intervention study demonstrated responsiveness to beneficial treatment with significant improvement in scores (P=0.0001). The SEAR questionnaire possesses strong psychometric properties that support its validity and reliability for measuring sexual relationship, confidence, and particularly self-esteem.     

Development of a social morbidity score in patients with chronic ulcerative colitis as a potential guide to treatment

Aim Present quality of life instruments for inflammatory bowel disease do not evaluate many social aspects of patients’ lives that are potentially important in clinical decision making. We have developed a new Social Impact of Chronic Conditions – Inflammatory Bowel Disease (SICC‐IBD) questionnaire to assess these areas. Method A 34‐item questionnaire was piloted to determine quality of life relating to education, personal relationships, employment, independence and finance. It was compared with the Short Form 36‐Item version 2 (SF‐36v2) and the Inflammatory Bowel Disease Questionnaire (IBDQ) in 150 patients with chronic ulcerative colitis on an endoscopic surveillance register who had never had surgery. Results Reliability and validity testing enabled the questionnaire to be shortened to only eight items. There was a high level of reliability (Cronbach’s α = 0.72). The questionnaire correlated well with the social functioning domain of the SF‐36 (r_s = 0.56) and was able to distinguish clinical severity of disease. Conclusion The SICC‐IBD is a new tool for assessment of patients with ulcerative colitis, which has identified new aspects of social disability for further study and for potential use as an additional tool in therapy decisions.     

Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure

PURPOSE: We developed the ureteral stent symptom questionnaire (USSQ), a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. MATERIALS AND METHODS: A total of 309 patients were asked to participate during different phases of our study. In phase 1 a structured literature search, 9 patient interviews and studies of 90 patients using existing instruments formed the foundation for the initial draft of our new questionnaire. In phase 2 the USSQ was pilot tested, reviewed by experts and field tested in 40 patients to produce a final 38-item draft. In phase 3 formal validation studies were performed in 55 patients to assess validity, reliability and sensitivity to change. Discriminant validation was performed by administering the questionnaire to 3 groups of patients without stents. RESULTS: The final draft addressed various domains of health (6 sections and 38 items) affected by stents covering urinary symptoms, pain, general health, work performance, sexual matters and additional problems. The validation studies showed the questionnaire to be internally consistent (Cronbach's alpha > 0.7) with good test-retest reliability (Pearson's coefficient > 0.84). The questionnaire demonstrated good construct validity and sensitivity to change shown by significant changes in the score with and after removal of stents. The new USSQ discriminated patients with stents from healthy controls (p < 0.001) and patients with urinary calculi without stents and lower urinary tract symptoms. CONCLUSIONS: Indwelling ureteral stents have a significant impact on health related quality of life. The new USSQ is a valid and reliable instrument that is expected to become a standard outcome measure to evaluate the impact and compare different types of stents.     

Validation of ESCAP-CD as an instrument of measure for the evaluation of the quality of life in prostatic cancer. Part 2a

In order to make a measure of quality of life related to health (QLRH) useful in the investigation, it must fulfill the psychometric properties (validity, reliability and sensibility). The selection of an instrument is a job for the clinic that must choose the most effective for each proposed objective. We set out the objectives to validate the ESCAP-CDV in a multicentric study in Andalusia. We studied 88 patients who were submitted to the instrument presented to validation and two more tests recognized already: the QLQ-C30 from EORTC gold standard in Europe in the valuation of the neoplastic patients' quality of life and the KARNOFSKY the most clinic utility index in neoplastic patients, used to correlate the items. RESULTS: Questionnaire acceptance analysis: The difficulty of understanding was greater for QLQ C30 items (6.81%) than ESCAP items (1.98%). The lapse of time needed to carry out the test was shorter in the ESCAP test (9.84 min) than in the QLQ C30 (13.13), test. Structural analysis or internal validity analysis: The homogeneity index of the items is high (alfa of Cronbach = 0.93). The dimensionality proposed is not accepted, due to the existence of some modifications pund in the factorial analysis. Finally, the established dimensions: Physical and Emotional Capacity (PEC), 5 items; General Symptoms (GS), 4 items; Pain (P), 3 items; Ligh Functional Capcity (LFC), 4 items; Serious Functional Capacity (SFC), 2 items; Economic State (ES), 3 items; Social and Family State (SFE), 5 items; Capacity Sexual (CSX), 2 items; Isolated Variables (IV), 2 items; and Specific Questionnaire (P), 6 items. The ESCAP is a scale with a normal distribution. Approach or external validity analysis: The ESCAP test is well correlated with the other two scales. Reliability test retest: The interclass correlation coefficient is 0.94 in the ESCAP, not so in the KARNOFSKY that is 0.77. CONCLUSIONS: The ESCAP-CDV is a new instrument of valuation of the QLRH composed of a general questionnaire and other specific test of prostate cancer. It has turned out to be a very homogeneous scale due to its internal consistence (alfa of Cronbach of 0.93), showing that it has a normal distribution, that correlates correctly with the scales compared and it is a valid scale to measure the prostate cancer patients' quality of life. The ESCAP-CDV has shown to be a scale with a high reliability (0.94), setting up as an instrument not only useful for investigation, but to clinical use, as well.