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1.  Health Related Quality of Life in Iranian Patients With Irritable Bowel Syndrome: Reliability and Validity of the Persian Version of the IBS-QOL 
Background
Irritable bowel syndrome (IBS) is a gastrointestinal disease that is accompanied by pain, diarrhea, constipation and abdominal bloating. Hence, IBS has a major effect on patients’ quality of life.
Objectives
The present study aimed to examine validity and reliability of the Persian version of the IBS-QOL questionnaire in Iran.
Patients and Methods
The original 34 items of the IBS-QOL were translated from English into Persian through a structured procedure for the translation and cultural adaptation of the original English IBS-QOL into Persian. Ninety one patients who had GI symptoms but did not have any organic diseases (including 70 IBS patients diagnosed by Rome II criteria) were recruited from teaching hospitals Shiraz University in Iran and completed a Persian version of the IBS-QOL along with a Persian version of Room ΙΙ and IBS severity index (IBSSI).
Results
Our findings showed that the IBS-QOL has excellent convergent and acceptable discriminant validity. All domains had Cronbach's alpha greater than 0.7 except health worry. Seventy patients who were diagnosed as IBS by the Room ΙΙ had significantly lower scores in the IBS-QOL than those who were not (FBD) (43.7 ± 20.1 vs. 73.4 ± 14.9, P < 0.01). Age, sex, education or marital status did not affect scores in measuring the quality of life.
Conclusions
In conclusion, the Persian version of the IBS-QOL provided a well-defined measure of QOL in IBS patients with high validity and reliability that is an appropriate measure to use in further IBS clinical studies in Iran.
doi:10.5812/ircmj.4605
PMCID: PMC3918199  PMID: 24578842
Quality of Life; Irritable Bowel Syndrome; Questionnaires
2.  Validity, reliability, and factor analysis of Persian version of quality of life questionnaire for irritable bowel syndrome (IBS-QOL-34) 
Background:
Quality of life (QOL) improvement is the main objective of treating patients with irritable bowel syndrome (IBS). This study aimed to assess the validity, reliability, and factor analysis of IBS-QOL-34 questionnaire as a common transcultural instrument for Iranian IBS patients.
Materials and Methods:
Two hundred and forty patients with IBS (based on gastroenterologists’ diagnosis according to ROM III criteria) were referred to Digestive Health Clinic in Psychosomatic Research Center have been selected in this study. Aside with IBS-QOL-34, MOS 36-item short-form health survey (SF-36) and IBS severity index (IBSSI) questionnaires were completed by the cases for determination of correlation coefficients; the data were analyzed using descriptive statistics, factor analysis, Cronbach's alpha, Pearson correlation coefficient by Statistical Package for Social Sciences (SPSS) software, version 18.
Results:
Total reliability of the questionnaire was reported by using Cronbach's alpha as 0.95, ranging from 0.65 to 0.90. Correlation coefficients of concurrent implementation of IBS-QOL with SF-36 and IBSSI resulted in −0.61 and 0.64, respectively. Exploratory factor analysis using varimax rotation identified eight principle components, which will determine QOL at 67% variance.
Conclusion:
According to the results, IBS-QOL-34 questionnaire has good psychometric properties in the research community and can be safely used as a valid tool to assess QOL of patients with IBS for healthcare and therapeutic purposes.
PMCID: PMC3818619  PMID: 24250698
Factor analysis; irritable bowel syndrome; quality of life questionnaire; reliability; validity
3.  Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients 
Background
Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d.
Methods
Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change.
Results
This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA’s Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors.
Conclusions
We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that the IBS-QOL items demonstrate very good construct validity and ability to detect changes due to treatment effects. Furthermore, our analyses suggest that the IBS-QOL items measure a univariate construct and we believe further modeling of the IBS-QOL from an item response theory (IRT) approach under both non-treatment and treatment conditions would greatly further our understanding as item-based methods could be used to develop a short form.
doi:10.1186/1477-7525-11-208
PMCID: PMC3895767  PMID: 24330412
IBS-QOL; Patient-reported Outcomes; Psychometrics; HRQOL; Irritable Bowel Syndrome; Diarrhea; Eluxadoline
4.  Translation and validation of the Chinese version of the quality of life radiation therapy instrument and the head & neck module (QOL-RTI/H&N) 
Background
To translate and validate the Chinese version of the Quality Of Life Radiation Therapy Instrument and the Head & Neck Module (QOL-RTI/H&N), a disease-specific scale to measure quality of life (QOL) for patients with head and neck cancer (HNC) who received radiotherapy.
Methods
The QOL-RTI/H&N was translated and validated according to the standard process: a translation and back-translation procedure, pilot testing and a validation study. HNC patients were enrolled from the Cancer Center of Sun Yat-sen University and assessed using the QOL-RTI/H&N, QLQ-C30 and QLQ-H&N35. Reliability (internal consistency reliability, split-half reliability and test-retest reliability), validity (content validity, construct validity, criterion validity and discriminant validity), and responsiveness analysis were performed to evaluate the psychometric characteristics of the QOL-RTI/H&N.
Results
A total of 238 patients (99.2%) completed the questionnaire. Item RTI23 had 16.0% missing data. Other items had low percentages of missing data (0.4% or 0.8%) or no missing data. The average time to finish the scale was 9.8 minutes. Cronbach's alpha of the domains ranged from 0.41 to 0.77. The split-half reliability coefficients ranged from 0.43 to 0.77. All of the intra-class correlation coefficients were equal to or greater than 0.8. All of the item-own domain correlation coefficients were greater than those of the item-other domain. Confirmatory factor analysis showed that Comparative Fit Index, Normed Fit Index and Non-Normed Fit Index were equal to 1.00. Root Mean Square Error of Approximation was 0.01, with 90% CI (0.00, 0.10). The domain scores of the QOL-RTI/H&N were significantly correlated with those of the QLQ-C30 or QLQ-H&N3. All domain scores of patients in different radiotherapy stages were statistically significant (P < 0.05), apart from the speech domain.
Conclusions
The Chinese version of the QOL-RTI/H&N is a valid, reliable and responsive scale to measure QOL in HNC patients and can be used to assess the effects of radiotherapy treatment on these patients.
doi:10.1186/1477-7525-12-51
PMCID: PMC4022371  PMID: 24731442
Head and neck cancer; Quality of Life; QOL-RTI/H&N; Translation; Validation
5.  The NFTI-QOL: A Disease-Specific Quality of Life Questionnaire for Neurofibromatosis 2 
The objective of this study was to develop a reliable, validated disease-specific score measuring quality of life (QOL) in clinical practice and treatment trials in Neurofibromatosis 2 (NF2) individuals. In NF2 patients, qualitative interviews (n = 15) and a focus group session (n = 30) generated items for a pilot questionnaire. This was tested and refined (n = 20). The final version (NFTI-QOL) was validated (n = 50) with two generic QOL questionnaires (SF-36 and EuroQOL). The NFTI-QOL was also administered to patients with solitary vestibular schwannoma (SVS) (n = 30) and normal controls (n = 30). The participants were NF2 patients, SVS patients, and normal controls. NFTI-QOL score, SF-36 score, and EuroQOL score were the main outcome measures. Mean NFTI-QOL score was 9.4 (range: 0 to 20, maximum possible score = 24). The NFTI-QOL score correlated strongly with EuroQOL (r = 0.71, p < 0.001) and SF-36 (r = 0.81, p < 0.001). NF2 individuals were significantly worse than the SVS patients, who in turn were worse than the controls on the NIFTI-QOL. The NFTI-QOL showed good internal reliability (Cronbach's α = 0.87). We developed an eight-item disease-specific QOL score for NF2 patients, validated against SF-36 and EuroQOL. It correlated strongly with clinician-rated disease severity in NF2, with better correlation than the SF-36 in this regard.
doi:10.1055/s-0032-1301396
PMCID: PMC3424623  PMID: 23543835
NFTI-QOL; quality of life; neurofibromatosis 2; vestibular schwannoma; SF-36; EuroQOL
6.  Development and validation of the Chinese Quality of Life Instrument 
Background
This paper describes the development of the Chinese Quality of Life Instrument (ChQOL) which is a self-report health status instrument. Chinese Medicine relies very much on asking subjective feelings of patients in the process of diagnosis and monitoring of treatment. For thousands of years, Chinese Medicine practitioners have accumulated a good wealth of experiences in asking questions about health of their patients based on the concept of health in Chinese Medicine. These experiences were then transformed into questions for the ChQOL. It is believed that ChQOL can contribute to the existing Patient Report Outcome measures. This paper outlines the concept of health and disease in Traditional Chinese Medicine, the building of the conceptual framework of the ChQOL, the steps of drafting, selecting and validating the items, and the psychometric properties of the ChQOL.
Methods
The development of the ChQOL was based on the concept of health in Traditional Chinese Medicine with a theory driven approach. Based on the results of literature review, the research team developed an initial model of health which encompassed the concept of health in TCM. An expert panel was then invited to comment and give suggestions for improvement of the initial model. According to their suggestions, the model was refined and a set of initial items for the ChQOL was drafted. The refined model, together with the key domains, facets and initial items of the ChQOL were then mailed to a sample of about 100 Chinese medicine practitioners throughout Mainland China for their comments and advice. A revised set of items were developed for linguistic testing by a convenience sample consisting of both healthy people and people who attended Chinese Medicine treatment. After that, an item pool was developed for field-testing. Field test was conducted on a convenience sample of healthy and patient subjects to determine the construct validity and psychometric properties of the ChQOL.
Results
Construct validity was established by various methods, i.e. the internal consistency in all facets and domains were good; the correlation between facets to domain, and domains to overall ChQOL correlation were high; confirmatory factor analysis showed that the structure fitness of all facets, domain and overall structure were good with CFI > 0.9. Test-retest reliability was also good, especially in the domain scores with ICC value ranging from 0.83 to 0.90. No ceiling or floor effect was noted which indicated that ChQOL can be applied to subjects with a wide range of health status. Most facet scores, domain scores and the overall CHQOL scores were able to discriminate groups of subjects with known differences in health status. The ChQOL had mild positive convergence with the other generic health related QOL measures, i.e. the WHOQOL-100 and the SF-36, with moderate correlations.
Conclusion
In conclusion, the study indicated that the ChQOL is conceptually valid with satisfactory psychometric properties. It can provide additional information on health and QOL on top of the existing generic health related QOL measures. Furthermore, it forms basis for further testing and applications in clinical trials.
doi:10.1186/1477-7525-3-26
PMCID: PMC1090607  PMID: 15833138
Quality of life; self-reported health status; theory driven approach; Ying-yang, structure fitness, validation, psychometric properties; the Chinese Quality of Life instrument
7.  Evaluation of health related quality of life in irritable bowel syndrome patients 
Background
Quality of life (QOL) is an important measure in the management of Irritable Bowel Syndrome (IBS). Controversy exists in the findings of studies evaluating QOL in IBS subtypes, and little is known about this issue in Iranian patients. Determination of the factors affecting QOL in IBS patients may influence treatment outcomes. The aims of this study are to: 1) compare QOL between subtypes in a sample of Iranian IBS patients, 2) determine the factors associated with QOL in IBS.
Methods
This cross sectional study included two hundred and fifty IBS patients with the mean age (± standard deviation) of 31.62 (± 11.93) years that were referred to outpatient gastroenterology clinic. IBS patients were diagnosed based on Rome-3 criteria by a gastroenterologist, and then they were categorized into three subtypes according to the predominant type of bowel habit. The "QOL specific for IBS", "Stait-trait anxiety inventory", and "Beck depression inventory-2" questioners were used to evaluate QOL, anxiety, and depression symptoms, respectively.
Results
The mean QOL scores in IBS mixed subtype (71.7 ± 25.57), constipation predominant subtype (80.28 ± 25.57), and diarrhea predominant subtype (76.43 ± 19.13) were not different. (P value: 0.05) In multivariate linear regression analysis, anxiety symptom scores were inversely correlated with QOL scores. [Standardized beta: -0.43, (95% confidence interval: -0.70, -0.39), P value: < 0.01]
Conclusion
It seems reasonable to manage anxiety symptoms properly in IBS patients since this might increase their QOL.
doi:10.1186/1477-7525-10-12
PMCID: PMC3298501  PMID: 22284446
Quality of life; Irritable bowel syndrome; Gender; Anxiety; Depression
8.  Age-related symptom and life quality changes in women with irritable bowel syndrome 
AIM: To explore age-related changes in symptoms and quality of life (QoL) of women with irritable bowel syndrome (IBS).
METHODS: Two-hundred and fifty-four female adult outpatients with IBS attending the Department of Gastroenterology at the First Affiliated Hospital of Nanjing Medical University between January, 2008 and October, 2008 were approached. Patients with a history of abdominal surgery, mental illness or those who had recently taken psychotropic drugs were excluded. A physician obtained demographic and abdominal symptom data. All patients were asked to complete the Zung Self-Rated Anxiety and Depression Scale (SDS/SAS) and the IBS-specific QoL questionnaire. The patients were divided into six groups according to age, in 10-year increments: 18-27 years, 28-37 years, 38-47 years, 48-57 years, 58-67 years and 68-75 years (maximum 75 years). Age-related differences of abdominal pain or discomfort were analyzed using rank-sum tests. Differences in SDS/SAS and IBS-QoL scores between age groups were analyzed using one-way analysis of variance. Pearson’s correlations evaluated potential associations between IBS symptoms, psychological factors and QoL in each age group.
RESULTS: There were no differences in the distribution of IBS subtypes between age groups (χ2 = 20.516, P = 0.153). Differences in the severity of abdominal pain/discomfort with age were statistically significant (χ2 = 25.638, P < 0.001); patients aged 48-57 years, 58-67 years or 68-75 years had milder abdominal pain/discomfort than those in the younger age groups. The severity of anxiety or depressive symptoms did not differ between age groups (SDS, χ2 = 390.845, P = 0.110; SAS, χ2 = 360.071, P = 0.220). Differences of IBS-QoL scores were statistically significant between age groups (χ2 = 1098.458, P = 0.011). The scores of patients in the 48-57-year group were lower than those in the 18-27-year and 28-37-year groups (48-57-year group vs 18-27-year group, 74.88 ± 8.76 vs 79.76 ± 8.63, P = 0.021; 48-57-year group vs 28-37-year group, 74.88 ± 8.76 vs 79.04 ± 8.32, P = 0.014). The scores in the 68-75-year group were lower than those in the 18-27-year, 28-37-year and 38-47-year groups (68-75-year group vs 18-27-year group, 71.98 ± 9.83 vs 79.76 ± 8.63, P = 0.003; 68-75-year group vs 28-37-year group, 71.98 ± 9.83 vs 79.04 ± 8.32, P = 0.002; 68-75-year group vs 38-47-year group,71.98 ± 9.83 vs 76.44 ± 8.15, P = 0.039). Anxiety and depression were negatively correlated with QoL in all age groups (SDS and QoL: 18-27-year group, r = -0.562, P = 0.005; 28-37-year group, r = -0.540, P < 0.001; 38-47-year group, r = -0.775, P < 0.001; 48-57-year group, r = -0.445, P = 0.001; 58-67-year group, r = -0.692, P < 0.001; 68-75-year group, r = -0.732, P < 0.001. SAS and QoL: 18-27-year group, r = -0.600, P = 0.002; 28-37-year group, r = -0.511, P < 0.001; 38-47-year group, r = -0.675, P < 0.001; 48-57-year group, r = -0.558, 58-67-year group, P = 0.001; r = -0.588, P < 0.001; 68-75-year group, r = -0.811, P < 0.001). A negative correlation between abdominal pain severity and QoL was found in patients aged more than 58 years (58-67-year group, r = -0.366, P = 0.017; 68-75-year group, r = -0.448, P = 0.048 ), but not in younger patients (18-27-year group, r = 0.080, P = 0.716; 28-37-year group, r = -0.063, P = 0.679; 38-47-year group, r = -0.029, P = 0.812; 48-57-year group, r = -0.022, P = 0.876).
CONCLUSION: Factors affecting QoL should always be treated in IBS, especially emotional problems in young adults. Even mild abdominal pain should be controlled in elderly patients.
doi:10.3748/wjg.v18.i48.7175
PMCID: PMC3544019  PMID: 23326122
Irritable bowel syndrome; Female; Age; Symptom; Quality of life
9.  Developing Valid and Reliable Health Utilities in Irritable Bowel Syndrome: Results From the IBS PROOF Cohort 
The American journal of gastroenterology  2009;104(8):10.1038/ajg.2009.232.
OBJECTIVES
A “utility” is a measure of health-related quality of life (HRQOL) that ranges between 0 (death) and 1 (perfect health). Disease-targeted utilities are mandatory to conduct cost–utility analyses. Given the economic and healthcare burden of irritable bowel syndrome (IBS), cost–utility analyses will play an important role in guiding health economic decision-making. To inform future cost–utility analyses in IBS, we measured and validated the IBS utilities.
METHODS
We analyzed data from Rome III IBS patients in the Patient Reported Observed Outcomes and Function (PROOF) Cohort—a longitudinal multi-center IBS registry. At entry, the patients completed a multi-attribute utility instrument (EuroQOL), bowel symptom items, IBS severity measurements (IBS Severity Scale (IBSSS), Functional Bowel Disease Severity Index (FBDSI)), HRQOL indexes (IBS quality-of-life instrument (IBS-QOL), Center for disease control-4 (CDC-4)), and the Worker Productivity Activity Index for IBS (WPAI). We repeated assessments at 3 months.
RESULTS
There were 257 patients (79% women; age = 43±15 years) at baseline and 85 at 3 months. The mean utilities in patients with severe vs. non-severe IBS were 0.70 and 0.80, respectively (P < 0.001). There were no differences in utilities among IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed IBS (IBS-M) subgroups. EuroQOL utilities correlated with FBDSI (r = 0.31; P < 0.01), IBSSS (r = 0.36; P < 0.01), IBS-QOL (r = 0.36; P < 0.01), CDC-4 (r = 0.44; P < 0.01), WPAI presenteeism (r = 0.16; P < 0.01), abdominal pain (r = 0.43; P < 0.01), and distension (r = 0.18; P = 0.01). The utilities in patients reporting “considerable relief” of symptoms at 3 months vs. those without considerable relief were 0.78 and 0.73, respectively (P = 0.02).
CONCLUSIONS
EuroQOL utilities are valid and reliable in IBS. The utility of severe IBS (0.7) is similar to Class III congestive heart failure and rheumatoid arthritis. These validated utilities can be employed in future IBS cost–utility analyses.
doi:10.1038/ajg.2009.232
PMCID: PMC3839573  PMID: 19491835
10.  Demographic factors affecting quality of life of hemodialysis patients – Lahore, Pakistan 
Pakistan Journal of Medical Sciences  2014;30(5):1123-1127.
Objective: The objective of the study was to determine the demographic factors affecting Quality Of Life (QOL) of hemodialysis (HD) patients.
Methods: This observational study was conducted at Shalamar Hospital, Lahore. Patients of End Stage Renal Disease (ESRD) and on maintenance HD for more than three months were included during the period March to June 2012. Patient of ESRD not on dialysis and Acute Renal Failure were excluded. One hundred and twenty five patients who fulfilled the criteria were included. Demographic data containing age, sex, residence, socio economic status, education, mode of traveling for dialysis, total time consumed in dialysis were collected by the investigators. QOL index was measured using 26 items, WHO QOL BREF.
Results: There were 89(71.2%) male and 36(28.8%) female patients. Environmental domain score was highest (p=0.000) than all other domains in HD Patients. In overall analysis age, marital status and total time consumed in getting HD effect QOL significantly (p=<0.05). In domain wise analysis, male has better QOL in social relationship domain than female. Age has negative relationship with physical health and psychological health domain. QOL of unmarried and literate patients is significantly better (p=<0.05) in physical health domain. Employed patients have better QOL in physical, psychological and social relationship domain (p=<0.05) than unemployed patients. Patients of residence of rural areas have better QOL in physical and environment domain. Financial status of HD patients affect QOL in social domain. Distance covered to reach hospital effect QOL in psychological domain (p=<0.05). Patients traveling in private transport have better QOL in environmental domain (p=<0.05). Total time consumed in getting HD effect social relation in QOL (p=<0.05). According to linear regression model, marital status is positive predictor and unemployment is negative predictor of QOL in physical health domain. Age is negative predictor of QOL in psychological domain, monthly income is positive predictor of QOL in domain. Unemployment is positive predictor of QOL in social relation domain. Monthly income and place of residence is positive predictor of QOL in environment domain.
Conclusion: Gender, age, marital status, unemployment, residence of rural area, economical status, distance covered to reach hospital, mode of transport, total time consumed in getting HD, effect QOL in HD patient. Education level is a positive factor for improving QOL of HD patients.
doi:10.12669/pjms.305.5239
PMCID: PMC4163245  PMID: 25225539
ESRD; Hemodialyis; QOL; Demographic factors; WHO QOL BREF
11.  Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study 
BMJ Open  2013;3(8):e002984.
Objectives
To investigate whether additional catheter-directed thrombolysis (CDT) improves long-term quality of life (QOL) compared with standard treatment with anticoagulation and compression stockings alone in patients with proximal deep vein thrombosis (DVT).
Design
Open-label randomised controlled trial.
Setting
19 Hospitals in the Norwegian southeastern health region.
Participants
Patients (18–75 years) with a high proximal DVT, symptoms <21 days and no increased risk of bleeding were eligible. 189 of 209 recruited patients completed 24 months of follow-up.
Interventions
Participants were randomised to additional CDT with alteplase for 1–4 days or to standard treatment only with 6 months of anticoagulation and 24 months of compression stockings.
Primary and secondary outcome measures
Planned secondary outcome measures included QOL as assessed with the generic instrument EQ-5D and the disease-specific instrument VEINES-QOL/Sym. Primary outcome measure was post-thrombotic syndrome (PTS) after 24 months.
Results
After 24 months there were no differences in QOL between the additional CDT and standard treatment arms; mean difference for the EQ-5D index was 0.04 (95% CI −0.10 to 0.17), for the VEINES-QOL score 0.2 (95% CI −2.8 to 3.0) and for the VEINES-Sym score 0.5 (95% CI −2.4 to 3.4; p values>0.37). Independent of treatment arms, patients with PTS had poorer outcomes than patient without PTS; mean difference for EQ-5D was 0.09 (95% CI 0.03 to 0.15), for VEINES-QOL score 8.6 (95% CI 5.9 to 11.2) and for VEINES-Sym score 9.8 (95% CI 7.3 to 12.3; p values<0.001).
Conclusions
QOL did not differ between patients treated with additional CDT compared with standard treatment alone. Patients who developed PTS reported poorer QOL and more symptoms than patients without PTS. QOL should be included as an outcome measure in clinical studies on patients at risk of PTS.
Trial registration
NCT00251771
doi:10.1136/bmjopen-2013-002984
PMCID: PMC3758969  PMID: 23988361
12.  Family caregiver quality of life in multiple sclerosis among Kuwaitis: a controlled study 
Background
Research interest in the quality of life (QOL) of persons with multiple sclerosis (MS) has been spurred by the need to broaden outcome measures. Far less of this interest has been directed at the family caregivers, who bear most of the burden of care. The objectives of the study were: First, to compare the subjective QOL of family caregivers of persons with relapsing remitting and progressive MS, with those of a matched general population sample and caregivers of diabetes and psychiatric patients. Second, to assess the relationship of QOL with caregiver attitudes to MS and patient's variables.
Methods
Consecutive MS clinic attendees were assessed with the 26 – item WHOQOL Instrument, and for depression and disability. Similarly, caregivers independently rated their own QOL as well as their impression of patients' QOL and attitudes to patients' illness.
Results
The 170 caregivers, mean age 35.7 years, had no significant diagnostic differences in QOL domain scores and attitudes to MS. Caregivers had significantly lower QOL than the general population control group for five out of six domains and the general facet (P < 0.01), but higher QOL than the patients. When the scores were corrected for patients' depression and disability, caregivers had similar QOL with the general population group for four domains. Using corrected scores, MS caregivers had lower scores than diabetic and psychiatric caregivers in the physical, psychological and social relations domains. Majority expressed negative attitudes to MS. Caregiver QOL was more affected by their fear of having MS than their feelings about the illness and caregiving role. Caregiver attitudes had mostly no significant impact on their proxy ratings of patients' QOL. The significant predictor of caregivers' overall QOL was their impression of patients' QOL.
Conclusion
Caregivers need specific attention if they are less educated, unemployed, afraid of having MS and caring for patients with longer duration of illness and less education. In particular, attention to patients' depression and disability could improve caregivers' QOL. Caregivers need specific programs to address fear of having MS, negative attitudes to illness and their unmet needs.
doi:10.1186/1472-6963-8-206
PMCID: PMC2576463  PMID: 18840287
13.  Quality of life among patients receiving palliative care in South Africa and Uganda: a multi-centred study 
Background
Quality of life (QOL) is a core outcome of palliative care, yet in African settings there is a lack of evidence on patients' levels of QOL. We aimed to describe QOL among patients with incurable, progressive disease receiving palliative care in South Africa and Uganda, to compare QOL in cancer and HIV, to determine how domains of QOL correlate with overall QOL, and compare levels of QOL in this population with those in other studies using the same tool.
Methods
A cross-sectional survey was conducted using the Missoula Vitas Quality of Life Index (MVQOLI), a 26-item QOL questionnaire with five subscales (Function, Symptom, Interpersonal, Well being, Transcendent) covering physical, social, psychological and spiritual domains and one global QOL item. One item in each subscale assesses the subjective importance of the domain on a score from 1 (least important) to 5 (most important), used to weight the contribution of the subscale towards the Total QOL score. The tool was translated into 6 languages and administered to consecutively recruited patients at four facilities in South Africa and one in Uganda.
Results
285 patients were recruited, with a mean age of 40.1; 197 (69.1%) were female. Patients' primary diagnoses were HIV (80.7%), cancer (17.9%) and other conditions (1.4%). The mean global QOL score was 2.81 (possible range 0 (worst) to 5 (best)); mean Total score 17.32 (possible range 0 to 30). Patients scored most poorly on Function (mean 0.21), followed by Well being (2.59), Symptoms (5.38), Transcendent (5.50), Interpersonal (9.53) (possible range for subscale scores -30 to 30). Most important to patients were: close relationships (mean 4.13), feeling at peace (4.12), sense of meaning in life (4.10), being active (3.84), physical comfort (2.58). Cancer patients were predominantly recruited at three of the sites; hence comparison with HIV-infected patients was restricted to these sites. HIV+ patients (n = 115) scored significantly worse than cancer patients (n = 50) on Well being (Z = -2.778, p = 0.005), Transcendence (Z = -2.693, p = 0.007) and Total QOL (Z = -2.564, p = 0.01). Global QOL score was most weakly correlated with Total QOL (r = 0.37) and the Transcendent subscale was most highly correlated (r = 0.77) (both p < 0.001). Patients receiving palliative care in South Africa and Uganda exhibited significantly poorer QOL compared to similar populations in the USA.
Conclusions
Feeling at peace and having a sense of meaning in life were more important to patients than being active or physical comfort, and spiritual wellbeing correlated most highly with overall QOL. It is therefore vital to identify and meet the psychological and spiritual care needs of patients, as well as to assess and treat pain and other symptoms. Our finding that patients scored most poorly on the Function domain warrants further research.
doi:10.1186/1477-7525-9-21
PMCID: PMC3094195  PMID: 21477274
14.  Quality of life in patients with skin diseases in central Saudi Arabia 
Background
Previous national and international studies of quality of life (QoL) in patients with skin diseases have revealed different levels of QoL impairment. The aims of this study were to assess QoL in patients with skin diseases in central Saudi Arabia using the newly validated Skindex-16 instrument and to determine the association between QoL in patients with skin disease, sociodemographic data, and disease characteristics.
Methods
A cross-sectional study was conducted in 283 adult patients who visited the outpatient dermatology clinics of King Abdulaziz Medical City, Riyadh, Saudi Arabia, over 3 months. The patients were interviewed using a pretested Arabic version of the Skindex-16 to measure the effect of skin disorders on their QoL during the previous 7 days. Patient characteristics, medical history, and clinical findings were collected. Multiple linear regression analyses were used to relate the demographic and clinical characteristics to the percentage mean QoL score, and P ≤ 0.05 was considered to be statistically significant.
Results
QoL was good in 69% of the respondents, with a total percent mean score of 31.80 ± 20.16. The emotional domain was the most affected (mean percentage score 44.27 ± 27.06), followed by symptoms (31.45 ± 28.40) and functioning (14.61 ± 22.75). After adjustment for potential confounders, poorer QoL was significantly associated with female gender (P = 0.03), older age (P = 0.003), rural origin (P = 0.03), positive family history of the same lesion(s) (P = 0.01), shorter duration of ≤6 months (P = 0.02), generalized spread (P ≤ 0.02), and lack of isotretinoin treatment (P = 0.02).
Conclusion
. The QoL results in this study were generally more optimistic than those of many previous studies. This discrepancy may be due to biases in questionnaire responses or to cultural differences in experience of skin disease and perception of disability. Significant predictors of QoL were not the same for the three domains of the Skindex scale. Further studies of specific diseases and educational programs targeting patients at higher risk for QoL impairments are recommended.
doi:10.2147/IJGM.S33276
PMCID: PMC3410718  PMID: 22866015
quality of life; skin disease; Saudi Arabia
15.  Cross-cultural adaptation and validation of Behçet's disease quality of life questionnaire 
Background
Currently, there is one Behçet's disease (BD) specific self reporting questionnaire developed and published in the literature, The Leeds BD-quality of life (QoL). We conducted a cross-cultural adaptation and validation of the Arabic version of the Leeds BD-QoL
Methods
A cross-sectional study was conducted among 41 consecutive patients attending rheumatology clinics at the American University of Beirut Medical Center between June and December 2007. The BD-QoL questionnaire, the Katz Index of Activities of Daily Living (ADL) and the Lawton Instrumental Activities of Daily Living (IADL) questionnaires were co-administered during the same visit, and severity scores were calculated. Cross-cultural adaptation of BD-QoL was performed using forward and backward translations of the original questionnaire. Internal consistency and test-retest reliability of the final version were determined. Exploratory Factor Analysis (EFA) was used to assess the dimensionality of the scale items. External construct validity was examined by correlating Arabic BD-QoL with the severity score, ADL and IADL.
Results
The 30 items of the adapted Arabic BD-QoL showed a high internal consistency (KR-20 coefficient 0.89) and test-retest reliability (Spearman's test 0.91). The convergence of all 30 items suggests that the 30-item adapted Arabic BD-QoL scale is unidimensional. BD-QoL did not correlate with any of the patients' demographics. Still, it was positively correlated with patient severity score (r 0.4, p 0.02), and IADL (but not ADL).
Conclusions
This cross-cultural adaptation has produced an Arabic BD-QoL questionnaire that is now available for use in clinical settings and in research studies, among Arabic speaking patients.
doi:10.1186/1471-2288-11-52
PMCID: PMC3111402  PMID: 21507231
Behçet's disease; Quality of life; Arabic version of BD-QoL; Cross-cultural adaptation; Validity and reliability
16.  Relationship of depression, disability, and family caregiver attitudes to the quality of life of Kuwaiti persons with multiple sclerosis: a controlled study 
BMC Neurology  2007;7:31.
Background
Assessment of subjective quality of life (QOL) of persons with multiple sclerosis (MS) could facilitate the detection of psychosocial aspects of disease that may otherwise go unrecognized. The objectives of the study were to (i) compare the QOL ratings of relapsing remitting (RRMS) and progressive (PMS) types of MS with those of a general population group and the impression of their family caregivers; and (ii) assess the association of demographic, clinical, treatment, depression, and caregiver variables with patients' QOL.
Methods
Consecutive clinic attendees at the national neurology hospital were assessed with the 26 -item WHOQOL Instrument, Beck's Depression Inventory and Expanded Disability Scale. Caregivers rated their impression of patients' QOL and attitudes to patients' illness.
Results
The 170 patients (60 m, 109 f) consisted of 145(85.3%) with RRMS and 25 with PMS, aged 32.4(SD 8.8), age at onset 27.1(7.7), EDSS score 2.9 (1.8), and 76% were employed. The patients were predominantly dissatisfied with their life circumstances. The RRMS group had higher QOL domain scores (P < 0.001), and lower depression(P > 0.05) and disability (P < 0.0001) scores than the PMS group. Patients had significantly lower QOL scores than the control group (P < 0.001). Caregiver impression was significantly correlated with patients' ratings. Depression was the commonest significant covariate of QOL domains. When we controlled for depression and disability scores, differences between the two MS groups became significant for only one (out of 6) QOL domains. Patients who were younger, better educated, employed, felt less sick and with lesser side effects, had higher QOL. The predictors of patients' overall QOL were disability score, caregiver impression of patients' QOL, and caregiver fear of having MS.
Conclusion
Our data indicate that MS patients in stable condition and with social support can hope to have better QOL, if clinicians pay attention to depression, disability, the impact of side effects of treatment and family caregiver anxieties about the illness. The findings call for a regular program of psychosocial intervention in the clinical setting, to address these issues and provide caregiver education and supports, in order to enhance the quality of care.
doi:10.1186/1471-2377-7-31
PMCID: PMC2041952  PMID: 17877820
17.  Quality of Life in Patients with Irritable Bowel Syndrome (IBS), Assessed Using the IBS–Quality of Life (IBS-QOL) Measure After 4 and 8 Weeks of Treatment with Mebeverine Hydrochloride or Pinaverium Bromide: Results of an International Prospective Observational Cohort Study in Poland, Egypt, Mexico and China 
Clinical Drug Investigation  2014;34(11):783-793.
Background and Objective
Irritable Bowel Syndrome (IBS) has a substantial impact on health-related quality of life (HR-QoL) but high-quality data pre- and post-treatment using the IBS–Quality of Life (IBS-QOL) measure are limited. The objective of this study was to evaluate the changes from baseline of the IBS-QOL scores, symptom scores and health economic data in IBS patients, after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide.
Methods
This was a prospective observational cohort study in patients with IBS, diagnosed using the Rome III criteria in four countries (Poland, Egypt, Mexico and China).
Results
A total of 607 patients were enrolled. At baseline, the IBS-QOL total scores were 52.0 in Poland, 48.9 in Egypt, 51.9 in Mexico, 76.4 in China and 56.4 overall. Increases in IBS-QOL total score were statistically significant at Weeks 4 and 8 overall and in each country (overall: 11.8 at Week 4, 24.3 at Week 8; p < 0.001). Improvements were shown in all IBS-QOL subscales and scores. Symptoms and health economic outcomes were improved. Furthermore, the favourable safety profile of these treatments was confirmed in this study.
Conclusions
This study demonstrated that IBS patients have a substantially reduced HR-QoL and that treatment with mebeverine hydrochloride or pinaverium bromide improved HR-QoL.
doi:10.1007/s40261-014-0233-y
PMCID: PMC4210642  PMID: 25258162
18.  German-Translated Norfolk Quality of Life (QOL-DN) Identifies the Same Factors as the English Version of the Tool and Discriminates Different Levels of Neuropathy Severity 
Background
The development and validation of Norfolk QOL-DN, a fiber-specific, quality-of-life tool for diabetic neuropathy, was published previously (Part 1). This study (Part 2) defines the psychometric properties of the German-translated Norfolk QOL-DN in a large multicenter (96 sites) population with neuropathy ranging from minimal to severe, comparing them with those in the original English/American version in a 30-center European/North American population with mild neuropathy; determines the power of the German-translated version in a five-staged diabetic peripheral neuropathy (DPN) German population to discriminate different levels of neuropathy severity; and establishes factors having the greatest impact on QOL.
Methods
One hundred eighty-six German patients were assessed: asymptomatic of DPN (n = 40), symptomatic (n = 46), DN with foot-ulcer history (n = 32), DN with amputations (n = 22), and DN amputation history (n = 46). German-translated Norfolk QOL-DN was administered to 177 patients with staged DN complications. German-translated Norfolk QOL-DN data were compared with QOL-DN data from the European/American study of 379 mild neuropathy patients. Exploratory factor analysis assessed factor structure consistency in the translated instrument. Ordinal regression analysis (polytomous universal model) was used to evaluate the association between factor scores and complication stages.
Results
The German translation identified the same five factors in more advanced neuropathy as in the English mild neuropathy population. Total QOL scores differed among each of the five neuropathy severity groups [analysis of variance p < 0.001, Tukey–Kramer post hoc, α = 0.05]. Two factors emerged as predictors of impaired QOL and disease severity: physical function/large fiber (Wald χ2 = 6.188, p = 0.013) and activities of daily living (ADL)(Wald χ2 = 9.098, p = 0.003).
Conclusions
Norfolk QOL-DN discriminates levels of neuropathy within and between populations. Physical functioning and ADL are the most important determinants of QOL. Early occurrence of orthostasis suggests a redefinition of autonomic neuropathy to be more symptom inclusive.
PMCID: PMC2769831  PMID: 19885296
ADLs; autonomic; large fiber; nerve fiber specific; QOL
19.  The Skin Cancer Index: Clinical Responsiveness and Predictors of Quality of Life 
The Laryngoscope  2007;117(3):399-405.
Objective
To establish the clinical responsiveness of the Skin Cancer Index (SCI), a new disease-specific quality of life (QOL) instrument, and to assess demographic and clinical factors which impact QOL in patients with nonmelanoma skin cancer (NMSC).
Study Design
Prospective study of 183 patients with NMSC of the face and neck referred to a tertiary care Mohs surgery clinic.
Methods
The SCI is a 15 item, validated, disease-specific QOL instrument with 3 distinct subscales, Emotion, Social, and Appearance. Higher scores reflect better QOL. The SCI and the Dermatology Life Quality Index (DLQI), a general dermatology instrument, was administered at initial consultation and 4 months after surgical treatment. Multivariate analysis was conducted to assess demographic and clinical factors predictive of QOL for both instruments.
Results
The SCI total score and all three subscale scores increased with treatment, demonstrating strong evidence of responsiveness over time (P < .001) in contrast with the DLQI (P = .46). Predictors of poorer QOL for the SCI included female sex and cancers located on the lip. Patients who demonstrated greatest improvement in QOL with treatment included those who were younger (< 50 yr) and had lower reported household income. Also, first time NMSC patients and those patients who underwent less extensive reconstructions demonstrated greater improvements in QOL.
Conclusion
The SCI is a sensitive and responsive QOL instrument for patients with NMSC. Distinct demographic and clinical variables that impact QOL have been demonstrated using this multidimensional, disease-specific instrument.
doi:10.1097/MLG.0b013e31802e2d88
PMCID: PMC1847346  PMID: 17334300
Skin cancer; quality of life; basal cell cancer; squamous cell cancer
20.  The Effect of Tegaserod on Symptoms and Quality of Life in Korean Women with Irritable Bowel Syndrome with Constipation 
Introduction
Tegaserod has been used for treatment of irritable bowel syndrome (IBS) but there is no data regarding its effect on Korean patients. The aim of this study was to evaluate the effect of tegaserod on symptoms and quality of life (QOL) in Korean female IBS patients with constipation and to evaluate the usefulness of the IBS-QOL in clinical study.
Methods
A prospective, open labeled, multicenter study was performed. Female patients fulfilling Rome II criteria for IBS received 6 mg of tegaserod twice a day for 4 weeks. The efficacy on IBS symptoms and QOL was assessed using 7-point scaled symptom questionnaire and IBS-QOL questionnaire, respectively.
Results
A total of 81 female patients (range 18-73 years of age) were enrolled in this study. Tegaserod therapy significantly reduced the overall symptom scores after 4 weeks (p <0.01). The improved symptoms included abdominal discomfort or pain, hard or lumpy stool, straining during a bowel movement, feeling of incomplete bowel movement, and abdominal fullness or bloating. The IBS-QOL of responders to tegaserod treatment was also significantly improved after 4 weeks (p <0.01). Furthermore, improvement of symptom scores significantly correlated with improvement of the IBS-QOL scores (r = -0.60, p <0.001).
Conclusions
Tegaserod 6 mg given twice daily improved the QOL as well as the bowel symptoms in Korean female IBS patients with constipation. The IBS-QOL can be used as a reliable end-point in clinical study.
doi:10.5056/jnm.2010.16.1.61
PMCID: PMC2879829  PMID: 20535328
Tegaserod; Irritable bowel syndrome; Quality of life
21.  Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study 
Background
Glatiramer acetate (GA) and interferon-beta (INFb) are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS). Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL) in the first 12 months. It is not known whether HR-QoL increases during treatment with GA.
Methods
197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32), fatigue (Fatigue Impact Scale [FIS]) and depressed mood (Beck Depression Inventory-Short Form [BDI-SF]) at baseline and 6 and 12 months after start of GA treatment.
Results
At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p < 0.001), not in the pre-treated group. At month 12 43% of treatment-naïve patients had improved HR-QoL (increase LMS-QoL score 3 or more points) (p < 0.001). Likewise, mean FIS scores were decreased at months 6 and 12 in the treatment-naïve group (p < 0.01), not in the pre-treated group. In both groups mean BDI-SF scores did not change. No demographic or clinical baseline factor was predictive of HR-QoL increase. HR-QoL changes were zero to negative for patients who had discontinued GA before month 12 (28.4% of patients).
Conclusions
In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.
doi:10.1186/1477-7525-8-133
PMCID: PMC2999586  PMID: 21078142
22.  Ethnic differential item functioning in the assessment of quality of life in cancer patients 
Background
Past research has shown that Filipino cancer patients report lower levels of quality of life (QoL) than other ethnic groups. One possible explanation for this is that Filipinos do not define QoL in the same manner as others, resulting in bias in their assessments. Hence, Filipinos would not necessarily have lower QoL.
Methods
Item response theory methods were used to assess differential item functioning (DIF) in the quality of life (measured by the EORTC QLQ-C30) of cancer patients across four ethnic groups (Caucasian, Filipino, Hawaiian, and Japanese). The sample consisted of 359 cancer patients.
Results
Results showed the presence of DIF on several items, indicating ethnic differences in the assessment of quality of life. Relative to the Caucasian and Japanese groups, items related to physical functioning, cognitive functioning, social functioning, nausea and vomiting, and financial difficulties exhibited DIF for Filipinos. On these items Filipinos exhibited either higher or lower QoL scores, even though their overall QoL was the same.
Conclusion
This evidence may explain why Filipinos have previously been found to have lower overall QoL. Although Filipinos score lower on QoL than other groups, this may not reflect lower QoL, but rather differences in how QoL is defined. The presence of DIF did not appear, however, to alter the psychometric properties of the QLQ-C30.
doi:10.1186/1477-7525-3-60
PMCID: PMC1277838  PMID: 16209720
differential item functioning; ethnicity; item response theory; quality of life
23.  A Psychometric Analysis of Quality of Life Tools in Lung Cancer Patients Who Smoke 
Lung cancer is the leading cause of cancer death for both men and women in the United States. Patient quality of life (QOL) prior to cancer treatment is known to be a strong predictor of survival and toleration of treatment toxicities. A lung cancer patient’s self-assessment of QOL is highly valued among clinicians as it guides treatment-related decisions and impacts clinical outcomes. Smokers are known to report a lower QOL. Limited research has been conducted on QOL outcomes in lung cancer patients who continue to smoke.
To assess QOL, a reliable and valid QOL measure specific to lung cancer is required. The Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L) and Lung Cancer Symptom Scale (LCSS) are instruments that specifically examine QOL among lung cancer patients. The LCSS is a focused QOL instrument that includes physical and functional domains of QOL and disease symptomatology. The FACT-L is a broader QOL instrument that includes physical, functional, social and emotional domains and disease symptomatology. Both are psychometrically valid and are widely used in the literature, but have not been exclusively evaluated in smokers. Furthermore, there is no ‘gold standard’ instrument since there has never been a correlation study to compare estimates of reliability and validity between these instruments. The purpose of this study is to report the internal consistency and convergence validity of the FACT-L and the LCSS among newly diagnosed lung cancer patients who smoke.
This data were collected and analyzed from a larger study examining smoking behavior among newly diagnosed lung cancer patients (n=51). Descriptive statistics were calculated on the FACT-L and LCSS scores, internal consistency was assessed by estimating Cronbach’s alpha coefficients, and Pearson correlation coefficients were estimated between the two scales. Internal consistency coefficients demonstrated good reliability for both scales, and the two instruments demonstrated a strong correlation, suggesting good convergence validity. Either of these instruments are appropriate measures for QOL in lung cancer patients who smoke. Given the conceptual difference between the two instruments, it is important to carefully consider the research aims when selecting the appropriate QOL measurement instrument.
doi:10.1016/j.lungcan.2008.12.018
PMCID: PMC2785015  PMID: 19181418
Quality of life; smoking; tobacco use; lung cancer; questionnaire; psychometric analysis
24.  Quality of life and physicians' perception in myelodysplastic syndromes 
To detect factors associated with quality of life (QOL) of patients with myelodysplastic syndrome (MDS) and to compare the MDS patients’ self-assessed QOL with that perceived by their physicians. In an observational, non-interventional, prospective, multicentre study, QOL was evaluated in 148 patients with newly diagnosed low- and intermediate-risk IPSS MDS. QOL measures (QOL-E v.2, LASA and EQ-5D) and patient-related candidate determinants of QOL were assessed for up to 18 months. Patients' QOL scores were compared with those obtained by appointed hematologists’ assessment and with ECOG performance status (PS). Fatigue was not prevalent at diagnosis, though physical QOL and energy levels were low. Transfusion-dependent patients had worse QOL scores. In multivariate analysis, Hb levels and comorbidities were a major determinant of QOL. Physicians’ perception of patients’ well-being correlated with patients’ QOL. Physicians underestimated the impact of disturbances on patients’ QOL, mainly in the MDS-specific components. ECOG PS did not discriminate patients according to QOL status. In conclusion, the association of anemia with QOL is confirmed, while co-morbidities emerge as an independent predictor of QOL in MDS. Fatigue is not a major concern. ECOG PS is not a valuable surrogate of patient’s QOL, thus highlighting that physician’s judgment of patient’s well-being must not substitute patient-reported outcomes. Appropriate questionnaires should be used to assess MDS patients’ QOL in order to improve communication and therapeutic choice.
PMCID: PMC3384400  PMID: 22762033
Myelodysplastic syndromes; quality of life; comorbidities; anemia; transfusion-dependence; patient-reported outcomes
25.  Quality of life assessment and reporting in randomized controlled trials: a study of literature published from Japan 
Background
Standardization of quality of life (QOL) assessment and reporting in clinical trials is an imperative issue. While English-speaking countries have led this movement in standardization, there persists to be a limited amount of information from non-English-speaking including Japan. In this study, we bibliographically analyze the reporting of randomized controlled trials (RCT) conducted in Japan that used a QOL instrument.
Methods
A PubMed search of reports published between 1970–2003 followed by an examination of QOL reporting and its frequency of use in RCTs published from Japan.
Results
Percentages of QOL reporting in RCTs have increased between 1970–2003 both worldwide (0% for 1970–1974 to 4.4% for 2000–2003) and in Japan (0% to 1.8% for the identical periods). We found and evaluated 46 RCT reports published from Japan (32 in English, 14 in Japanese). The most commonly studied clinical condition was cancer (26, 56.5%) and the most common intervention was drug therapy (29, 63.0%). QOL was used as the primary endpoint in 10 studies (21.7%). Authors used established QOL instruments in 12 studies (26.1%), developed original instruments in 8 studies (17.5%) and assessed the symptoms or performance status in 10 studies (21.7%). Authors conceptually defined QOL in only 6 studies (13.0%). Neither response rate nor number of respondents for questionnaire surveys was specified in 16 studies (34.8%); furthermore, 11 studies (23.9%) did not describe respondents' attributes.
Conclusions
Findings on relative frequency suggested that Japanese authors of RCT reports have less interest in QOL instruments than other international researchers in Western Europe and North America. Examination of RCT reports published from Japan revealed that there were several points to be improved in reporting QOL instruments. This study highlights the need to define QOL measures specific to clinical specialty and to examine methodology for assessing and reporting QOL.
doi:10.1186/1477-7525-2-31
PMCID: PMC449732  PMID: 15217517

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