Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: The PAGI-QOL©

Summarize the Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QOL©) development and provide results on its reliability and validity from the international psychometric validation in dyspepsia, GastroEsophageal Reflux Disease (GERD), and gastroparesis. Methods: Subjects completed the pilot PAGI-QOL at baseline and 8weeks; and a subsample also at 2weeks. Other assessments were: Patient Assessment of Upper GastroIntestinal Disorders-Symptom Severity Index, SF-36, number of disability days. Results: 1736 patients completed the PAGI-QOL at baseline. The questionnaire was reduced, producing a 30-item final version covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship (REL), and Psychological Well-Being and Distress. Internal consistency was excellent (Cronbachs range: 0.83–0.96). Test–retest reproducibility was good: intraclass correlations coefficients were over 0.70 except for the REL scale (0.61). Concurrent validity between the PAGI-QOL total score and all SF-36 subscale scores was good with moderate (0.52) to strong (0.72) correlations. PAGI-QOL scores showed excellent discriminant properties: patients who had spent some days in bed, had missed some days at work, and were kept from usual activities had much lower PAGI-QOL scores than those who did not (p<0.0001). Conclusion: The PAGI-QOL is a valid and reliable instrument assessing quality of life in patients with dyspepsia, GERD, or gastroparesis.     

Gastroparesis Cardinal Symptom Index (GCSI): Development and validation of a patient reported assessment of severity of gastroparesis symptoms

BACKGROUND: Patient-rated symptom assessments are needed for evaluating the effectiveness of medical treatments and for monitoring outcomes in gastroparesis. OBJECTIVE: This paper summarizes the development and psychometric evaluation of a new instrument, the Gastroparesis Cardinal Symptom Index (GCSI), for assessing severity of symptoms associated with gastroparesis. METHODS: The GCSI was based on reviews of the medical literature, patient focus groups, and interviews with clinicians. A sample of 169 patients with a documented diagnosis of gastroparesis participated in the psychometric evaluation study. Patients completed the GCSI, the SF-36 Health Survey, and disability days questions at baseline and after 8 weeks. A randomly selected sub-sample of 30 subjects returned at 2 weeks to assess test retest reliability. Clinicians rated severity of symptoms, and both clinicians and patients rated change in gastroparesis-related symptoms over the 8 week study. RESULTS: The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores. Construct validity was supported, given that we observed significant relationships between clinician assessed symptom severity and GCSI total score, significant differences between gastroparesis and dyspepsia patients (n = 760) on GCSI total (p < 0.0001) and subscale scores (p < 0.03 to p < 0.0001), moderate and significant relationships between GCSI total and SF-36 scores, and significant associations between GCSI total score and reports of restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported more symptom severity on GCSI total score. GSCI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (p < 0.0001) and patients (p = 0.0004). CONCLUSION: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring symptom severity in patients with gastroparesis.     

Reliability and validity of the gastrointestinal symptom rating scale in patients with gastroesophageal reflux disease

The objective of this study was to evaluate the reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) in US patients with gastroesophageal reflux disease (GERD). Five hundred and sixteen adults with predominant heartburn symptoms of GERD were recruited from gastroenterologist and family physician practices and treated with 6 weeks of 150mg ranitidine twice daily to identify poorly responsive symptomatic GERD. The GSRS, the Medical Outcomes Study Short Form-36 (SF-36) Health Survey and the Psychological General Well-being (PGWB) scale were administered at baseline and after 6 weeks of treatment. Reported ratings of GERD-related symptoms from physician and patient diaries were measured. The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. The internal consistency reliabilities for the GSRS scales ranged from 0.61 to 0.83 and the intraclass correlation coefficients ranged from 0.42 to 0.60. The GSRS scale scores were correlated with the SF-36 and PGWB scales and with the number and severity of heartburn symptoms. Patients with two or three clinician-rated GERD-related symptoms reported worse GSRS scale scores compared with patients with fewer symptoms (p < 0.0001). Statistically significant differences in the mean GSRS scale scores were observed between treatment responders and non-responders (p < 0.0001) and patients showing a response to treatment had larger mean changes in their GSRS scales than patients not showing a response to treatment (p < 0.0001). The standardized response means ranged from 0.42 to 1.43 for the GSRS scale scores. It was concluded that the GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The GSRS has good reliability and construct validity and the GSRS scales discriminate by GERD symptom severity and are responsive to treatment. The GSRS is a useful patient-rated symptom scale for evaluating the outcomes of treatment for GERD.     

Gender differences of symptom reporting and medical health care utilization in the German population

Aim: Gender differences in morbidity have been widely confirmed in representative health surveys in North America and Europe. Significantly more women than men suffer from somatic complaints. It is less clear whether differences in symptom reporting provide an impact on health care utilization and to which degree psychosocial factors exhibit confounding influence. Methods: We analyzed data from a representative health examination survey in Germany with 7466 participants in the age range of 25 to 69 years. Results: The analysis confirmed an overall excess in female symptom reporting, both in the total sample (n = 7460; p 0.001) and in the healthy subsample (n = 906, p 0.01). Also, female utilization of medical services was higher (p 0.0001). A simultaneous age related increase in the prevalence of symptom reporting in both groups peaked in the age group of 55–59 years followed by a subsequent slight decrease in higher age groups whereas utilization steadily increased over the adult life span in both sexes. As expected, more medical utilization was associated with higher symptom reporting levels. Nevertheless, females constantly exhibited more medical utilization than males in all symptom reporting groups. Age and marital status had no univariate influence on symptom reporting whereas low social class status (p = 0.001), poor perceived/self assessed health (p < 0.0001), and high levels of chronic distress (p < 0.0001) were associated with more symptom reporting. In multivariate analysis, the female gender lost its significance on heightened symptom reporting. Poor perceived/self assessed health had the most pronounced impact on symptom count (F-value 59.1; p < 0.001). Conclusions: The present study confirms a female excess of symptom reporting and utilization of medical services. Nevertheless, symptom reporting and utilization are not closely related. The gender gap in symptom reporting may be largely explained by low social class status, high levels of chronic distress and poor perceived/self assessed health.     

High prevalence of gastroesophageal reflux symptoms in type 2 diabetics with hypoadiponectinemia and metabolic syndrome

Background

The prevalence of gastroesophageal reflux disease (GERD) has been increasing worldwide. Abdominal obesity or visceral fat accumulation rather than simple obesity is associated with GERD. Previous reports demonstrated the association between GERD and type 2 diabetes mellitus (T2DM). Signification of visceral fat accumulation and adiponectin in T2DM patients with GERD remains unclear. The present study investigated the relationships between GERD symptoms, visceral fat accumulation and adiponectin in subjects with T2DM.

Findings

The study (ADMIT study) subjects were 66 Japanese T2DM outpatients, who answered the questionnaire regarding GERD symptoms in Frequency Scale for the Symptoms of GERD (FSSG), and were measured visceral fat area by bioelectrical impedance analysis. Patients with FSSG scores of more than 8 were considered as positive. The prevalence of FSSG score ?? 8 and average FSSG score in T2DM subjects with the metabolic syndrome (Mets) were significantly higher compared to those without Mets. The prevalence of FSSG score ?? 8 and average FSSG score in T2DM subjects with low levels of serum adiponectin were significantly higher compared to those with high levels of serum adiponectin. Moreover, the combination of Mets and hypoadiponectinemia had a multiplicative effect on GERD symptom score (p = 0.047).

Conclusions

Our study showed that the coexistence of MetS and low levels of serum adiponectin was associated with the higher prevalence of FSSG score ?? 8 and the higher scores of GERD symptom in subjects with T2DM.

Trial Registration

UMIN 000002271.     

Use of the SF-36 Health Status Survey with a Chronically Disabled Back Pain Population: Strengths and Limitations

The SF-36 is a widely used self-report health status survey. It has repeatedly demonstrated sound psychometric properties with regard to certain aspects of reliability and validity, and has proven effective as a means of tracking group outcomes. There were three major objectives of the present investigation: (1) to document group changes in a sample of chronically work disabled low back pain patients who underwent tertiary rehabilitation; (2) to evaluate the clinical utility of the SF-36 in measuring changes in patients as a result of treatment; and (3) to compare the SF-36 scores found for this sample to the United States norms for back pain/sciatica patients published elsewhere. All patients (n = 286) received an initial evaluation consisting of several assessment procedures, including the SF-36. First, the sample was broken down into a completer group (n = 188), a noncompleter group (n = 31), and a nonstarter group (n = 67). Next, the preprogram scores for the physical and mental component summary scales were compared to the norms for back pain/sciatica patients. Changes in the completer group's scores from preprogram to postprogram were then examined. To assess clinical utility, three additional self-report questionnaires were correlated to the eight scales and two summary scales of the SF-36. Results revealed no statistically significant differences with regard to demographics among the three groups. The preprogram scores for the physical and mental component summary scales were significantly lower when compared to the norms for back pain/sciatica patients. Further, patients who completed the program showed improvement on the SF-36 from preprogram to postprogram administration. When the correlations between SF-36 scales and other self-report questionnaires were examined, many of the highest correlations were found between the self-reported pain and disability measurements and the physical components of health on the SF-36. In terms of clinical usefulness, the SF-36 demonstrated limited clinical utility when attempts were made to use it on an individual patient basis. This is consistent with the psychometric limitations of the SF-36. Because of the brevity of each of the eight scales and the limited number of score levels, the reliability coefficients have been shown to be low in other studies (20), thereby increasing confidence intervals around an individual's scores on each of the scales.     

Self-perceived health in Swedish parents of children with Down's syndrome

In this comparative study, self-perceived health was investigated in 165 parents of 86 children with Down's syndrome (DS), using the Swedish version of the SF-36 questionnaire. Questionnaires were mailed to parents of children with DS in a defined Swedish population. The results were compared with those in a randomised control group of parents from the Swedish SF-36 norm population. Mothers and fathers replied separately. Student's t-test with the Bonferroni correction was used for multiple statistical comparisons. The mothers of children with DS (DS mothers) had significantly lower, less favourable scores than did the fathers of DS children (DS fathers) in the Vitality (p < 0.0005) domain. Further, DS mothers spent significantly more time in caring for their child with DS than did the DS fathers (p < 0.0001). DS mothers also had lower scores than the mothers of the control group in the Vitality (p < 0.001) and Mental Health (p < 0.001) domains. DS fathers and control fathers differed significantly in the Mental Health domain (p < 0.002), but not otherwise. In conclusion, DS mothers showed poorer health than their spouses and the control mothers. No differences similar to those found between the DS mothers and DS fathers were observed between control mothers and control fathers.     

Eating disorders and emotional and physical well-being: Associations between student self-reports of eating disorders and quality of life as measured by the SF-36

Objective: To assess health-related quality of life (HRQoL) in subjects with eating disorders in terms of eating disorder type and in relation to self-reports of longstanding illness, depression and self-harming behaviours. Method: Data on eating disorder history, SF-36 health status, longstanding illness, and self-reported frequencies of depression, self-harming behaviour, and suicidal thoughts or acts were collected during 1996 as part of a UK postal survey of students health. Completed questionnaires were returned by 1439 of 3750 students (response rate 42%). Results: Eighty-three respondents (5.8%; 8.9% of females) reported a probable eating disorder history: 54 (3.8%) bulimia nervosa, 22 (1.6%) binge eating disorder, and 7 (0.5%) anorexia nervosa. Eating disorder subjects reported more impairment in SF-36 emotional than physical well-being, with significantly lower mental (p<0.001) but not physical (p=0.21) component summary scores. This was most evident in bulimia nervosa and binge eating disorder subjects. Anorexia nervosa subjects reported fewer SF-36 emotional limitations although they were significantly more likely to report depression, self-harming behaviour, and suicidal ideation. Discussion: An eating disorder history is accompanied by HRQoL impairment primarily in emotional well-being. Anorexia nervosa subjects perceive fewer limitations than subjects with other eating disorders. While this is consistent with previous reports of better SF-36 emotional well-being in those with restrictive eating behaviours, it may also suggest that the SF-36 is insensitive to emotional distress in anorexia nervosa.     

Asymmetric responsiveness of disability and health-related quality of life to improvement versus decline in Parkinson’s disease

Purpose

Clinical trials in Parkinson’s disease commonly employ outcome measures of disability and quality of life. Responsiveness of these outcomes measures to symptomatic decline versus improvement has not been studied. We wanted to study the responsiveness of Schwab & England Activities of Daily Living Scale (SE) and Short Form-12 (SF-12) to symptomatic decline versus improvement in Parkinson’s disease over a 4-year period among a naturalistic cohort of patients.

Methods

Parkinson’s disease patients (N = 228, disease duration 6.1 years) were followed for 4 years with assessments of disease severity, Unified Parkinson’s Disease Rating Scale (UPDRS), health-related quality of life (SF-12 physical/mental health), and disability (SE). The sample was subdivided into those who declined (N = 118) or improved (N = 102) on total-UPDRS. Responsiveness was assessed with Cohen’s effect size and standardized response mean.

Results

At baseline, patients who improved over 4 years had greater disease severity and worse quality of life than decliners (p < .05). Decliners had a 13.5-point worsening on total-UPDRS, 26.3–39.8; p < .001) associated with concomitant decline on the SF-12 (physical health 42.9–39.2, mental health 50.0–46.6; both p < .001) and the SE (85–74 %; p < .001). Improvers had a 13.0-point improvement on total-UPDRS (39.8–26.8; p < .001) associated with minimal change on the SF-12 (physical health 40.8–39.5, mental health 47.1–46.3) and SE (79–79 %). Based on effect size, the rank order of responsiveness of measures for decliners from high to low was SE (?0.78), Short Form-12 mental health (?0.45), and SF-12 physical health (?0.34). Rank order of responsiveness for improvers was Short Form-12 physical health (?0.11), SF-12 mental health (?0.10), and SE (?0.03).

Conclusions

Among decliners, measures of disability and quality of life were moderate to highly responsive to change in disease severity. Among improvers, both disability and quality of life were poorly responsive despite UPDRS improvement of comparable magnitude.

     

Health-related quality of life of mothers of children with leukemia in Japan

Objective: The study compared the health-related quality of life (HRQOL) of Japanese mothers of children with leukemia to that of mothers of children without leukemia. Method: We used the Medical Outcomes Study 36-item Short-Form (SF-36) to measure the HRQOL of 97 mothers of children (average age 6.2, range 0–14) with leukemia diagnosed between 1999 and 2000, and compared their scores to those of 240 mothers of children without leukemia matched to the children with leukemia. Main results: Of the eight unadjusted domain scores of the SF-36, five were significantly low among mothers of children with leukemia compared to mothers of children without leukemia: role-physical functioning (RP), general health perception (GH), vitality (VT), social functioning (SF) and mental health (MH). Their SF-36 domain scores, when adjusted for demographic and clinical factors were also significantly low in RP, GH, VT, SF, RE and MH. The MH and SF scores in mothers of children with leukemia requiring hospital care were, respectively, approximately 20 points (1 standard deviation (SD), p < 0.0001) and 30 points (1.5 SD, p < 0.0001) lower than that of mothers of children without leukemia. Conclusion: Mothers of children with leukemia requiring hospital care have poor HRQOL, particularly with regard to mental health and social functioning, and are at a greater risk for depression. These results suggest that the current system for treating leukemic diseases of children in Japan should also include close monitoring of mothers mental health, and provision of appropriate treatment and psycho-social support.     

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities

Purpose

To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Methods

A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores.

Results

Mean patient age was 45.1 (SD 15.9) years, and 83 % of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: ?8 points on the PCS (p < 0.001) and ?6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores.

Conclusions

In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.     

Responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL)

Aims This study examined responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL), which was developed to assess health-related quality of life (HRQL) among adults with attention-deficit/hyperactivity disorder (ADHD). Methods Adults with ADHD completed the AAQoL, Conners’ Adult ADHD Rating Scale (CAARS), SF-36, and Endicott Work Productivity Scale (EWPS) at baseline and week 8 of a randomized, placebo-controlled trial of atomoxetine. Clinicians rated symptom severity and improvement (CGI-ADHD-S, CGI-ADHD-I). Responsiveness was examined through effect sizes and association with change in the measures listed previously (Spearman correlations, GLMs). Results Analyses included 328 patients (58.8% male; mean age = 36.9 years). All AAQoL scales reflected significant improvement from baseline to week 8 (P < 0.0001). AAQoL change scores were significantly correlated with change in the CGI-ADHD-S (r = −0.37 to −0.50), EWPS (r = −0.43 to −0.63), and CAARS (r = −0.35 to −0.62) (all P < 0.001). AAQoL change scores significantly discriminated among patients with various levels of symptom improvement. AAQoL effect sizes (−0.67 to −1.11) were larger than effect sizes for the SF-36 (0.15 to −0.39). Conclusions The AAQoL was responsive to change in symptoms of ADHD, and it appears to be a useful outcome measure for treatments of ADHD in adults.     

Rhinitis Symptom Utility Index (RSUI) in Chinese Subjects: A Multiattribute Patient-preference Approach

Background: The Rhinitis Symptom Utility Index (RSUI), originally developed in the United States, consists of a patient-preference weighting scheme and a 10-item questionnaire measuring the severity and frequency of rhinitis related symptoms over a 14-day period. This study aimed to determine whether the Chinese RSUI could adopt the US-based multi-attribute utility function (MAUF) in scoring rhinitis symptoms. Methods: In a Hong Kong study, 116 Chinese adults with allergic rhinitis completed the RSUI questionnaire and 36-item Short-Form Health Survey (SF-36) after they had been seen by two otorhinolaryngologists for disease-severity ratings. Respondents then completed computer-administered direct preference measures, i.e., visual analogue scale (VAS) and standard gamble (SG) assessments. The VAS and SG data were used to estimate a MAUF for the Chinese-based RSUI. Results: The derived MAUF was somewhat different than the one developed for the US RSUI. Test–retest reliability for the Chinese RSUI was satisfactory (ICC = 0.71, p<0.001). Scores differentiated among cases with mild, moderate, and severe symptoms (p<0.001); and between those who did and did not require medications to control symptoms (p = 0.031). Findings were significantly correlated with SF-36 domain scores (r = 0.19 to 0.37; p=0.041 to <0.001). When the US-based scoring function was applied to the Chinese subjects, the resulting mean RSUI score was significantly lower (p<0.001). Comparisons between directly measured VAS and SG scores between the US and Chinese samples, demonstrated significant differences (all p<0.05), with the US subjects consistently rating rhinitis symptoms as worse than Chinese subjects. Conclusions: The Chinese RSUI has good measurement properties that reflect patient preferences from the Chinese. Results suggest that there are differences in preference rating between US and Chinese subjects and that use of the US-based preference function for the RSUI would bias the measurement of rhinitis symptom outcomes in Chinese subjects.     

The SEIQoL-DW is a valid method for measuring individual quality of life in stroke survivors attending a secondary prevention clinic

Objectives: This paper examines the applicability and construct validity of the Schedule for the Evaluation of Individual Quality of Life-Direct Weight (SEIQoL-DW) for measuring quality of life in stroke survivors living at home that attend a secondary prevention clinic. Participants and methods: Forty-six individuals attending a secondary prevention clinic following a stroke or transient ischaemic attack participated in a semi-structured interview to complete a range of outcome measures. Assessments of cognitive impairment, disability, and handicap were conducted using the Mini mental State Examination (MMSE), Barthel Index (BI), and Rankin Scale (RS). Measures to assess quality of life included perceived health status (PHS), Visual Analogue Mood Scale (VAMS), the Hospital Anxiety and Depression Scale (HADS), and the SEIQoL-DW. The construct validity of the SEIQoL-DW was assessed by correlation with the other measures. Results: According to the cues elicited from the SEIQoL-DW, participants nominated relationships with family and friends as the most important life domain, followed by social and leisure activities, and health. Spearmans rho correlation coefficients demonstrated significant relationships between the SEIQoL-DW index scores, PHS (r=0.35, p=0.016), VAMS (r=0.419, p=0.004), and the HADS anxiety (r=–0.546, p < 0.0001) and depression (r=–0.701, p < 0.0001) subscale scores. Conclusions: The SEIQoL-DW demonstrated reasonable construct validity for use in assessing individual quality of life in a group of individuals following stroke or TIA that attend a secondary prevention clinic.     

Treatment and quality of life in patients with chronic obstructive pulmonary disease

Treatments administered to patients with chronic obstructive pulmonary disease (COPD), especially when used in multiple combinations, are not free of interactions and side effects that can potentially impair health-related quality of life (HRQL). We studied HRQL and its relationship with treatment in a group of 441 patients with stage II or III COPD (age: 66.6 (SD: 8.3) years; FEV1: 32.4% (SD: 8.1%)) using the St George's Respiratory Questionnaire (SGRQ) and the 12-item short form (SF-12) Health Survey. The most prescribed drugs were ipratropium bromide (87.5%), inhaled corticosteroids (69.4%) and short-acting -2 agonists (64.9%). Patients with stage III of the disease were receiving more drugs, particularly short-acting -2 agonists (p = 0.002) and inhaled corticosteroids (p = 0.031). The use of theophyllines was associated with a worse total SGRQ score ( = 4.49; p < 0.001), although this negative association decreased with advanced age. A trend towards worse SGRQ scores was observed with the use of high doses of long-acting -2 agonists ( = 3.22; p = 0.072). Patients receiving three drugs or more presented worse total SGRQ scores than patients receiving fewer drugs ( = 6.1, p < 0.001; and = 7.64, p < 0.001, respectively). These findings suggest that the use of multiple drugs in the treatment of patients with COPD is associated with worse total SGRQ scores. The effect of drugs, their dosages and associations with other drugs on HRQL merit further research.     

The equivalence of English and Chinese SF-36 versions in bilingual Singapore Chinese

Objective: To assess the equivalence of English and Chinese versions of the SF-36. Methods: Using a crossover design with block randomisation and stratification by age, identical English or Chinese questionnaires containing the English (UK) and Chinese (HK) SF-36 versions were administered 3–16 days apart to 168 free-living, bilingual, ethnic Chinese volunteers in Singapore. Item level equivalence of both versions was assessed by comparing item means and orderings within each scale. Scale level equivalence was assessed by comparing internal consistency (Cronbach's ), results of factor analysis and mean scale scores (using paired t-tests and intra-class correlations). Results: Item and scale level comparisons supported the equivalence of both versions. For both the versions, item means, item ordering and Cronbach's were similar, and factor analysis yielded two factors with similar factor loadings. There was no clinically important difference in mean scale scores for seven of eight scales, and intra-class correlations were excellent/good for five scales (0.69–0.77) and moderate for three scales (0.55–0.57). Conclusion: English (UK) and Chinese (HK) SF-36 versions are equivalent in bilingual Singapore Chinese. Our data suggest that SF-36 scores from English- and Chinese-speaking subjects may be combined in studies using the SF-36, increasing the power and representativeness of such studies.     

Management and Employee Agreement on Reports of Organizational Policies and Practices Important in Return to Work Following Carpal Tunnel Surgery

This studys purpose was to assess the agreement between management and employee ratings of organizational policies and practices (OPP) involved in the return to work process following carpal tunnel surgery. As a part of the prospective community-based Maine Carpal Tunnel II Study, 65 manager and employee pairs completed a questionnaire tapping four OPP dimensions: people oriented culture, safety climate, ergonomic practices, and disability management. It was hypothesized that managers and employees would agree on their assessment of the four OPPs and a composite organizational support index. Agreement was assessed using Lins concordance correlation coefficient. Employee and manager ratings were similar for the organizational support index (rho_c = 0.14, p = 0.08), and people oriented culture (rho_c = 0.25, p = 0.01) but not the other three OPPs. In larger companies (> 450 employees), ratings were also similar for safety climate (rho_c = 0.24, p = 0.09), disability management (rho_c = 0.22, p = 0.07) and ergonomic practices (rho_c = 0.35, p = 0.02). In unionized companies there was agreement for safety climate (rho = 0.44, p = 0.02), disability management (rho_c = 0.41, p = 0.01) and ergonomic practices (rho_c = 0.40, p = 0.06). These preliminary results suggest employees can report on certain OPPs and that an employee questionnaire can be used to assess organizational support. Given recent evidence that employee ratings of OPPs are predictive of injury/illness incidence, work disability and return-to-work outcomes, further research is needed to confirm these findings.     

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Validation of English version in Singapore

Objective: This study aimed to validate the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, English version 3.0) in Singaporean cancer patients. Methods: In a cross-sectional study, a heterogeneous sample of cancer patients (n = 57) self-administered a questionnaire containing the QLQ-C30, the Short Form 36 Health Survey (SF-36) and assessing health and sociodemographic status. Construct validity was assessed by testing a priori hypotheses that QLQ-C30 scales would be moderately or strongly correlated with SF-36 scales measuring similar dimensions of health-related quality of life (HRQoL) and that subjects reporting mild symptoms would have better HRQoL scores than those reporting severe symptoms. Internal consistency reliability was assessed using Cronbachs . Results: Strength of Spearmans correlations between the QLQ-C30 and SF-36 scales assessing similar dimensions of HRQoL ranged from 0.35 to 0.67. Subjects with mild symptoms had better scores than those with severe symptoms for all six QLQ-C30 HRQoL scales (p < 0.05 for five scales, Mann–Whitney U tests). Cronbachs ranged from 0.19 for the cognitive functioning scale to 0.91 for the global QoL scale. Conclusion: This study provides preliminary evidence for the validity and reliability of the EORTC QLQ-C30 in English-speaking Singaporean cancer patients.     

Do we believe what patients say about their neoplastic symptoms?

In order to analyze factors that influence an interviewer's judgement of the validity of responses given by patients on the duration of their neoplastic signs and symptoms, 183 consecutive symptomatic patients hospitalized for a digestive tract neoplasm were personally interviewed. The validity of the answers was judged by the interviewers to be high in 156 cases (85%), and low in 27 (15%). The subjective validity of the interview (SVI) was inversely related to the time elapsed from first medical symptom to interview (TFMSI), even after adjusting for the duration of the interview (p < 0.05). SVI was not influenced by whether patient and interviewer agreed on the first symptom. SVI was inversely related to educational level (p < 0.01) and to occupational class (p = 0.04).Patients whose Karnofsky's Index (KI) was 80 were over twice as likely to yield valid responses (TFMSI-adjusted odds ratio [OR] = 2.82, p = 0.037). Multivariate analyses selected education, TFMSI and KI as independent predictors of the interviewer assessment. The SVI of patients admitted to the hospital through the Emergency Department was lower than that of subjects whose admission was planned (OR = 6.49, p = 0.005). In this study SVI related in a logical manner to the characteristics of the interview, of the subjects and of their clinical course. It hence appeared to reasonably estimate the validity of data collected. Identifying factors that affect the reliability of patients' responses would help increase the validity of studies on the duration of cancer symptoms.Abbreviations FMS First medical symptom - FPS First symptom according to the patient - IAFMS Importance attributed by the patient to the first symptom - KI Karnofsky's Index - SVI Subjective validity of the interview - TFMSI Time from first medical symptom to interview     

The influence of demographic factors and health-related quality of life on treatment satisfaction in patients with gastroesophageal reflux disease treated with esomeprazole

Background

The correlation between treatment satisfaction and demographic characteristics, symptoms, or health-related quality of life (HRQL) in patients with gastroesophageal reflux disease (GERD) is unknown. The objective of this study was to assess correlates of treatment satisfaction in patients with GERD receiving a proton pump inhibitor, esomeprazole.

Methods

Adult GERD patients (n = 217) completed demography, symptom, HRQL, and treatment satisfaction questionnaires at baseline and/or after treatment with esomeprazole 40 mg once daily for 4 weeks. We used multiple linear regressions with treatment satisfaction as the dependent variable and demographic characteristics, baseline symptoms, baseline HRQL, and change scores in HRQL as independent variables.

Results

Among the demographic variables only Caucasian ethnicity was positively associated with treatment satisfaction. Greater vitality assessed by the Quality of Life in Reflux and Dyspepsia (QOLRAD) and worse heartburn assessed by a four-symptom scale at baseline, were associated with greater treatment satisfaction. The greater the improvement on the QOLRAD vitality (change score), the more likely the patient is to be satisfied with the treatment.

Conclusions

Ethnicity, baseline vitality, baseline heartburn severity, and change in QOLRAD vitality correlate with treatment satisfaction in patients with GERD.