The quality of life (QOL) is an important indicator for disease-severity classification and outcome measurement in obtaining treatment sinonasal diseases. The sinonasal outcome test 22 (SNOT 22) questionnaire has been introduced as the best specific sinonasal instrument for QOL measurement.
To prepare a valid and reliable Persian language version of SNOT 22 questionnaire.
Patients and Methods
After forward and backward translation of the original version of SNOT 22 questionnaire from English to Persian, a group of patients with nasal septal deviation who need septal surgery and another group of healthy volunteers answered the Persian version of the questionnaire. The responsiveness rate, validity (Pearson correlations and differential validity) and reliability (internal consistency and test-retest reliability) of the 22 items of the questionnaire was calculated. P value < 0.05 was considered significant.
Thirty adults with nasal septal deviation need surgical correction and 30 healthy volunteers were included (mean age 30.4 ± 7.1 vs. 33 ± 6.7, P value = 0.148). The questionnaire was introduced to subjects two times with a two-week-period gap. Total responsiveness rate for 22 items was more than 97%. The total Cronbach's Alfa coefficient was 0.898 (ranging 0.890-0.903). The Pearson correlations were 0.85 and 0.96 for patients and healthy volunteers, respectively. The mean total score were 25.6 ± 13.3 (range 6-52) and 7.6 ± 9.1 (range 0-45) in patients and healthy volunteers, respectively (P < 0.0001). The subscales scores were also significantly different between two groups.
The Persian version of SNOT 22 questionnaire is a valid and reliable instrument for accessing sinonasal diseases in Persian-speaking people.
Quality of Life; Nasal Septal; Questionnaires
Background and aims
Despite occasional positive reports on the efficacy of acupuncture (AC) on functions of the gastrointestinal tract, there is no conclusive evidence that AC is effective in the treatment of irritable bowel syndrome (IBS).
Patients and methods
Forty three patients with IBS according to the Rome II criteria were randomly assigned to receive either AC (n = 22) or sham acupuncture (SAC) (n = 21) using the so‐called “Streitberger needle”. Treatment duration was 10 sessions with an average of two AC sessions per week. The primary end point was improvement in quality of life (QOL) using the functional digestive diseases quality of life questionnaire (FDDQL) and a general quality of life questionnaire (SF‐36), compared with baseline assessments. QOL measurements were repeated three months after treatment.
Both the AC and SAC groups improved significantly in global QOL, as assessed by the FDDQL, at the end of treatment (p = 0.022), with no differences between the groups. SF‐36 was insensitive to these changes (except for pain). This effect was partially reversed three months later. Post hoc comparison of responders and non‐responders in both groups combined revealed a significant prediction of the placebo response by two subscales of the FDDQL (sleep, coping) (F = 6.746, p = 0.003) in a stepwise regression model.
Acupuncture in IBS is primarily a placebo response. Based on the small differences found between the AC and SAC groups, a study including 566 patients would be necessary to prove the efficacy of AC over SAC. The placebo response may be predicted by high coping capacity and low sleep quality in individual patients.
irritable bowel syndrome; acupuncture; sham acupuncture; quality of life; placebo response
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.
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.
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]
It seems reasonable to manage anxiety symptoms properly in IBS patients since this might increase their QOL.
Quality of life; Irritable bowel syndrome; Gender; Anxiety; Depression
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.
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.
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.
Factor analysis; irritable bowel syndrome; quality of life questionnaire; reliability; validity
There is no widely accepted objective evaluation for lumbar spine disorders. New outcome measures should be patient-oriented and should measure symptoms and self-reported functional status in multiple dimensions. The aim of this study was to identify items to be included in the disease-specific quality of life (QOL) questionnaire for the assessments of patients with lumbar spine disorders.
The draft of the QOL questionnaire that consisted of a total of 60 items, including 24 items derived from the Japanese version of the Roland Morris Disability Questionnaire (RDQ) and 36 items derived from the Japanese version of Short Form 36 (SF-36), were administered to patients and controls. After obtaining written informed consent, the following data were collected from the patient group (n = 328) and the control group (n = 213): (1) background characteristics, including age, diagnosis, Japanese Orthopaedic Association (JOA) score, and finger to floor distance; (2) responses to the questionnaire; (3) the identification rate by discrimination analysis to select the candidates for adoption and by adopting explanatory variables. The items to be excluded were determined by examining the explanatory variables, which were selected after the discrimination analysis, by setting the candidate to-be-excluded items as an objective variable.
Based on the distribution of the responses, two items, RDQ-15 and RDQ-19, were excluded. From the results of the correlation coefficient calculation for each question in the patient group, 33 items were excluded and 27 candidate items were adopted. Based on the adoption explanatory variable used in the discrimination analysis, 25 of the 27 candidate items for adoption were accepted.
This study identified the 25 specific questionnaire items that should be included in the questionnaire to evaluate QOL of patients with various lumbar spine disorders.
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.
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.
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.
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.
IBS-QOL; Patient-reported Outcomes; Psychometrics; HRQOL; Irritable Bowel Syndrome; Diarrhea; Eluxadoline
The Japanese Orthopaedic Association Hip Score is widely used in Japan, but this tool is designed to reflect the viewpoint of health-care providers rather than that of patients. In gauging the effect of medical therapies in addition to clinical results, it is necessary to assess quality of life (QOL) from the viewpoint of patients. However, there is no tool evaluating QOL for Japanese patients with hip-joint disease.
With the aim of more accurately classifying QOL for Japanese patients with hip-joint disease, we prepared a questionnaire with 58 items for the survey derived from 464 opinions obtained from approximately 100 Japanese patients with hip-joint disease and previously devised evaluation criteria. In the survey, we collected information on 501 cases, and 402 were subjected to factor analysis. From this, we formulated three categories—movement, mental, and pain—each comprising 7 items, for a total of 21 items to be used as evaluation criteria for hip-joint function.
The Cronbach’s α coefficients for the three categories were 0.93, 0.93, and 0.95, respectively, indicating the high reliability of the evaluation criteria. The 21 items included some related to the Asian lifestyle, such as use of a Japanese-style toilet and rising from the floor, which are not included in other evaluation tools.
This self-administered questionnaire may become a useful tool in the evaluation of not only Japanese patients, but also of members of other ethnic groups who engage in deep flexion of the hip joint during daily activities.
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.
NFTI-QOL; quality of life; neurofibromatosis 2; vestibular schwannoma; SF-36; EuroQOL
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.
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.
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).
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.
Disease-specific quality of life (QoL) measures have enhanced the capacity of outcome measures to evaluate subtle changes and differences between groups. However, when the specific disease is rare, the cohort of patients is small and international collaboration is often necessary to accomplish meaningful research. As many of the QoL measures have been developed in North American English, they require translation to ensure their usefulness in a multi-cultural and/or international society. Published guidelines provide formal methods to achieve cross-culturally comparable versions of a QoL tool. However, these guidelines describe a rigorous process that is not always feasible, particularly in rare disease groups. The objective of this manuscript is to describe the process that was developed to achieve accurate cross-cultural translations of a disease-specific QoL measure, to overcome the challenges of a small sample size, i.e. children with a rare disorder.
A measurement study was conducted in the United Kingdom (UK), France, Germany and Uruguay, during which the validated measure was translated into the languages of the respective countries.
This is a report of a modified, child-centric, cross-cultural translation and adaptation process in which culturally appropriate and methodologically valid translations of a disease-specific QoL measure, the Kids' ITP Tools (KIT), were performed in children with immune thrombocytopenic purpura (ITP). The KIT was translated from North American English into UK English, French, German, and Spanish.
This study was a successful international collaboration. The modified process through which culturally appropriate and methodologically valid translations of QoL measures may be achieved in a pediatric population with a relatively rare disorder is reported.
This study examined the measurement properties of the Japanese version of the European Organisation for Research and Treatment of Cancer (EORTC) Hepatocellular Carcinoma-Specific Quality of Life Questionnaire (QLQ-HCC18).
EORTC quality of life (QOL) translation guidelines were followed to create a Japanese version of the EORTC QLQ-HCC18. This was then administered to 192 patients with hepatocellular carcinoma along with the EORTC QLQ-C30 and FACT-Hep questionnaires. Tests for reliability and validity were conducted including comparison of scores between the EORTC and FACT questionnaire and detailed assessment of the new scales and items in clinically distinct groups of patients.
Multi-trait scaling analysis confirmed three putative scales in the QLQ-HCC18, fatigue, fever and nutrition. Cronbach’s alpha for these scales were between 0.68 and 0.78. The QLQ-HCC18 scales correlated with scales measuring similar items in the FACT-Hep and the questionnaire was stable over time with an intra-class correlation score of 0.70 for almost all scales. The questionnaire had the ability to distinguish between patients with different Karnofsky Performance Status, and Child-Pugh liver function class.
The Japanese version of EORTC QLQ-HCC18 is a reliable supplementary measure to use with EORTC QLQ-C30 to measure QOL in Japanese patients with hepatocellular carcinoma.
EORTC QLQ-HCC18; FACT-Hep; Hepatocellular carcinoma; Quality of life; Questionnaire
To improve quality of life (QOL) in patients with multiple sclerosis (MS), it is important to decrease disability and prevent relapse. The aim of this study was to examine the causal and mutual relationships contributing to QOL in Japanese patients with MS, develop path diagrams, and explore interventions with the potential to improve patient QOL.
Data of 163 Japanese MS patients were obtained using the Functional Assessment of MS (FAMS) and Nottingham Adjustment Scale-Japanese version (NAS-J) tests, as well as four additional factors that affect QOL (employment status, change of income, availability of disease information, and communication with medical staff). Data were then used in structural equation modeling to develop path diagrams for factors contributing to QOL.
The Expanded Disability Status Scale (EDSS) score had a significant effect on the total FAMS score. Although EDSS negatively affected the FAMS symptom score, NAS-J subscale scores of anxiety/depression and acceptance were positively related to the FAMS symptom score. Changes in employment status after MS onset negatively affected all NAS-J scores. Knowledge of disease information improved the total NAS-J score, which in turn improved many FAMS subscale scores. Communication with doctors and nurses directly and positively affected some FAMS subscale scores.
Disability and change in employment status decrease patient QOL. However, the present findings suggest that other factors, such as acquiring information on MS and communicating with medical staff, can compensate for the worsening of QOL.
Multiple sclerosis; Quality of life; Structural equation modeling; Severity; Treatment; and Intervention
Although the quality of life (QoL) of prostate cancer (PCa) patients is a major issue, there is no unified and useful methodology for assessing QoL. The Expanded Prostate Cancer Index Composite (EPIC) is a globally used tool to measure QoL after PCa treatment that comprises urinary, bowel, sexual, and hormonal domains. Acknowledging the need for such a tool applicable to Korean PCa patients, we translated EPIC into Korean and validated the new version.
Materials and Methods
The Korean version of EPIC was devised by translation, back-translation, and reconciliation. Subsequently, we randomly selected 153 patients with localized PCa treated with radical perineal prostatectomy (67, 43.8%), radical retropubic prostatectomy (19, 12.4%), laparoscopic radical prostatectomy (12, 7.8%), robot-assisted laparoscopic radical prostatectomy (36, 23.5%), and high-intensity focused ultrasound ablation of the prostate (19, 12.4%) and asked them to complete EPIC. Reliability was assessed by test-retest correlation and Cronbach's alpha. Validity was assessed by factor analysis, interscale correlation, and correlation with Functional Assessment of Cancer Therapy-Prostate (FACT-P).
Test-retest correlation and Cronbach's alpha were high in each of the domains (0.92, 0.91, 0.76, 0.84 and 0.86, 0.84, 0.92, 0.83, p<0.0001). Interscale correlation among the domains was low (r<0.37), which indicated that EPIC is composed of proper domains. Interscale correlation between the function and bother subscales was high (0.94, 0.81, 0.84 and 0.80, p<0.0001). EPIC domains had low correlation with FACT-P, permitting complementary use.
The Korean version of EPIC was developed by a proper process, as evident by its high reliability and validity. Therefore, it is a reliable, comprehensive, systematic method that evaluates QoL in Korean patients after PCa treatment. Furthermore, it can be adapted as an objective methodology for research globally.
Prostatic neoplasms; Quality of life; Reproducibility of results
Hypertension is one of the most prevalent chronic conditions in Saudi Arabia. It is the leading risk factor for cardiovascular diseases and a major reason for visits to clinic and prescription of medications. Inspite of this, the degree of its control is not to the optimum. This could be due to its impact on patients’ quality of life (QOL). Impaired physical and psychological well-being may lead to non-compliance or even the withdrawal of treatment . The aim of this study was to assess QOL of hypertensive patients registered in Al-Khobar.
The QOL of hypertensive patients was compared with QOL of a control group. A total of 404 subjects (202 cases and 202 controls) were interviewed. The cases and controls were matched for age and sex. Patients’ self-assessment of QOL was measured with an Arabic version of SF-36, a 36-item Short Form Health Survey Questionnaire encompassing two main dimensions, physical and mental.
The QOL of hypertensive patients was substantially impaired in comparison to the control group. The mean scores for the physical component summary scale (PCS) were 39.3 and 50.8 for cases and controls respectively. The mean scores for the mental component summary scale (MCS) were 43.7 and 50.8 for cases and controls respectively. The burden of hypertension was concentrated in the physical dimension of health. Older age, female gender, unmarried patients, patients with hypertension complications, comorbid DM, use of Aldomet and shorter duration of hypertension were independently related to poorer QOL. The variability of the two summary measures explained by selected demographic and clinical characteristics was 24.3% and 10% for the PCS and MCS respectively.
Conclusions and recommendations:
The QOL of hypertensive patients was substantially impaired in comparison to the control group. Notably, the total explained variation of QOL by the selected characteristics was small, suggesting that the determinants of QOL are multi-factorial. Further research to explore the determinants and indices of QOL in hypertensive patients is warranted. From a clinical perspective, QOL should be considered in the monitoring of hypertensive patients to estimate the burden of hypertension and monitor their outcome.
Quality of life; hypertension; primary health care; SF-36 questionnaire
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
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.
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).
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.
Behçet's disease; Quality of life; Arabic version of BD-QoL; Cross-cultural adaptation; Validity and reliability
The Quality of Life Scale (QOLS), created originally by American psychologist John Flanagan in the 1970's, has been adapted for use in chronic illness groups. This paper reviews the development and psychometric testing of the QOLS. A descriptive review of the published literature was undertaken and findings summarized in the frequently asked questions format. Reliability, content and construct validity testing has been performed on the QOLS and a number of translations have been made. The QOLS has low to moderate correlations with physical health status and disease measures. However, content validity analysis indicates that the instrument measures domains that diverse patient groups with chronic illness define as quality of life. The QOLS is a valid instrument for measuring quality of life across patient groups and cultures and is conceptually distinct from health status or other causal indicators of quality of life.
Quality of Life Scale; QOLS; chronic illness outcomes; quality of life evaluation
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.
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.
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).
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.
Tegaserod; Irritable bowel syndrome; Quality of life
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.
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.
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.
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.
Quality of life; self-reported health status; theory driven approach; Ying-yang, structure fitness, validation, psychometric properties; the Chinese Quality of Life instrument
Quality of life (QoL) is considered to be an indispensable outcome measure of curative and palliative treatment. However, QoL research often yields findings that raise questions about what QoL measurement instruments actually assess and how the scores should be interpreted.
To investigate how patients interpret and respond to questions on the EORTC-QLQ-C30 over time and to find explanations to account for counterintuitive findings in QoL measurement.
Qualitative investigation was made of the response behaviour of small-cell lung cancer patients (n = 23) in the measurement of QoL with the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Focus was on physical functioning (PF, items 1 to 5), role functioning (RF, items 6 and 7), global health and QoL rating (GH/QOL, items 29 and 30). Interviews were held at four points: at the start of the chemotherapy, 4 weeks later, at the end, and 6 weeks after the end of chemotherapy. Patients were asked to ‘think aloud’ when filling in the questionnaire.
Patients used various response strategies when answering questions about problems and limitations in functioning, which impacted the accuracy of the scale. Patients had scores suggesting they were less limited than they actually were by taking the wording of questions literally, by guessing their functioning in activities that they did not perform, and by ignoring or excluding certain activities that they could not perform.
Terminally ill patients evaluate their functioning in terms of what they perceive to be normal under the circumstances. Their answers can be interpreted in terms of change in the appraisal process (Rapkin and Schwartz 2004; Health and Quality of Life Outcomes, 2, 14). More care should be taken in assessing the quality of a set of questions about physical and role functioning.
Quality of life (QoL) dwells in a person's overall well-being. Recently, QoL measures have become critical and relevant in stroke survivors. Instruments measuring QoL of individuals with aphasia are apparently rare in the Indian context. The present study aimed to develop a Kannada instrument to measure the QoL of people with aphasia. Study objectives were to validate Stroke and aphasia quality of life-39 (SAQOL-39) into Kannada, to measure test–retest reliability and internal consistency.
Materials and Methods:
The original English instrument was modified considering socio-cultural differences among native English and Kannada speakers. Cross-linguistic adaptation of SAQOL-39 into Kannada was carried out through forward–backward translation scheme. The scale was administered on 32 people from Karnataka (a state in India) having aphasia. For a direct understanding of the subject's QoL, scores were categorized into QoL severity levels. Item reliability of the Kannada version was examined by measuring Cronbach's alpha. Test–retest reliability was examined by calculating the intraclass correlation coefficient (ICC).
Kannada SAQOL-39 showed good acceptability with minimum missing data and excellent test–retest reliability (ICC = 0.8). Value of Cronbach's α observed for four items modified in the original version was 0.9 each and the mean α of all Kannada items was 0.9, demonstrating high internal consistency.
The present study offers a valid, reliable tool to measure QoL in Kannada-speaking individuals with aphasia. This tool is useful in a cross-center, cross-national comparison of QoL data from people with aphasia. This instrument also permits direct translation into other Indian languages as the items are culturally validated to the Indian population. This study promotes future research using the Kannada SAQOL-39.
Aphasia; Kannada; quality of life; stroke and aphasia quality of life-39; stroke
Irritable Bowel Syndrome (IBS) is a chronic/common condition that causes a significant effect on the individual (reduced quality of life), society (time lost off work) and health services. Comparison of studies evaluating the management of IBS has been hindered by the lack of a widely adopted validated symptom score. The aim of this study was to develop and validate a disease specific score to measure the symptoms of patients with IBS.
A self-administered 14-item symptom questionnaire (based on Rome II criteria) was mailed to 533 persons included in a prevalence study of IBS. The reliability of each underlying dimension identified was measured by Cronbach's α. Validity was assessed by comparing symptom scores with concurrent IBS specific quality of life (QoL) scores. Reproducibility was measured by the test-retest method and responsiveness measured by effect size.
379 (71%) questionnaires were returned. The underlying dimensions identified were pain, diarrhoea and constipation. Cronbach's α was 0.74 for pain, 0.90 for diarrhoea and 0.79 for constipation. Pain and diarrhoea dimensions had good external validity (r = -0.3 to -0.6), constipation dimension had moderate external validity (r = -0.2 to -0.3). All dimensions were reproducible (ICCs 0.75 to 0.81). Effect sizes of 0.27 to 0.53 were calculated for those with a reported improvement in symptoms.
The Birmingham IBS Symptom Questionnaire has been developed and tested. It has been shown to be suitable for self-completion and acceptable to patients. The questionnaire has 3 internal dimensions which have good reliability, external validity and are responsive to a change in health status.
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.
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.
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).
. 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.
quality of life; skin disease; Saudi Arabia
Quality of life (QoL) is increasingly recognized as an important outcome measure in clinical trials. The Canadian Hemophilia Outcomes-Kids Life Assessment Tool (CHO-KLAT) shows promise for use in China.
To adapt the CHO-KLAT version 2.0 for use in clinical trials in China.
Forward and back translations of the CHO-KLAT2.0 were completed in 2008. Between October 2009 and June 2010, a series of 3 focus groups were held with 20 boys and 31 parents in rural and urban China to elicit additional concepts, important to their QoL, for the Chinese CHO-KLAT2.0. All of the items identified by boys and parents were reviewed by a group of experts, resulting in a Chinese version of the CHO-KLAT2.0. This version underwent a detailed cognitive debriefing process between October 2010 and June 2011. Thirteen patient-parent pairs participated in this cognitive debriefing process until a stable and clearly understood Chinese version of the CHO-KLAT2.0 was obtained.
The initial back translation of the Chinese CHO-KLAT2.0 was slightly discrepant from the original English version on 12 items. These were all successfully adjudicated. The focus groups identified 9 new items that formed an add-on Socio-Economic Context (SEC) module for China. Linguistic improvements were made after the 2nd, 5th, 7th and 13th cognitive debriefings pairs and affected a total of 18 items. The result was a 35 item CHO-KLAT2.0 and a SEC module in Simplified Chinese, both of which have good content validity.
This detailed process proved to be extremely valuable in ensuring the items were accurately interpreted by Chinese boys with hemophilia ages ≤18 years. The need for the additional SEC module highlighted the different context that currently exists in China with regard to hemophilia care as compared to many Western countries, and will be important in tracking progress within both rural and urban China over time. Changes based on the cognitive debriefings suggest that expert verbatim translation alone is not sufficient. The Chinese version of the CHO-KLAT2.0 is well understood by boys with hemophilia in China. Next steps will be to test its construct validity and reliability in boys with hemophilia in China.
Quality of life; Hemophilia; China; Children; Cross-cultural studies
Although impaired health-related quality of life (HRQOL) has been reported in patients with sarcoidosis, there is currently no sarcoidosis-specific questionnaire in Japan. The 29-item Sarcoidosis Health Questionnaire (SHQ), originally developed in the United States, is the only sarcoidosis-specific HRQOL questionnaire currently available. The primary aim of this study was to develop and validate a Japanese version of the SHQ.
The SHQ was translated into Japanese following the forward-backward procedure. The reliability and validity of the Japanese version of the SHQ were examined. One hundred twenty-two Japanese patients with biopsy-proven sarcoidosis were evaluated by the SHQ, the Medical Outcomes Study 36-item short form (SF-36), the St. George's Respiratory Questionnaire (SGRQ), chest radiography, an electrocardiogram, laboratory blood tests, pulmonary function tests, an echocardiogram, and assessments of dyspnea and depressive symptoms. The SHQ was found to have acceptable levels of internal consistency (Cronbach's coefficient α values = 0.68 to 0.91). SHQ scores correlated significantly with scores on the SF-36 and SGRQ. The domain or total scores on the SHQ also significantly correlated with serum levels of the soluble interleukin-2 receptor, the percentage of the predicted forced vital capacity, pulmonary arterial systolic pressure, dyspnea, and depressive symptoms. Also, the SHQ scores of patients who had one or two organ systems affected by sarcoidosis were significantly different from those of patients who had three or more organ systems involvement.
The Japanese version of the SHQ can be used to assess the HRQOL of patients with sarcoidosis.
While the physical disability aspect of multiple sclerosis (MS) is of great importance, quality of life (QoL) measurements are being considered increasingly important with regard to evaluating disease progression, treatment, and the management of care provided to MS patients. Despite the acknowledged need to consider QoL issues, QoL assessment remains underutilized in clinical practice. These issues should be explored and understood to promote the use of measuring QoL in MS clinical practice. We explore the difficulties for clinicians: choosing and determining the most appropriate QoL measure and how to best integrate QoL measurements into clinical practice. This paper discusses several avenues to provide to clinicians arguments of the clinical relevance and accuracy of QoL instruments and ultimately to enhance the use of QoL measures in clinical practice for MS patients.