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

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

Validation of the Italian version of the Cystic Fibrosis Quality of Life Questionnaire (CFQoL), a disease specific measure for adults and adolescents with cystic fibrosis.

BACKGROUND: Disease specific, health-related quality of life (HRQoL) measurement is important in cystic fibrosis (CF). This work aimed to translate the original English Cystic Fibrosis Quality of Life Questionnaire (CFQoL) into Italian, evaluate the linguistic translation and to psychometrically evaluate the Italian version of the CFQoL. METHODS: The linguistic translation followed the international guidelines of forward and backward translation. Psychometric evaluation of the Italian CFQoL involved the assessment of construct validity, internal reliability, concurrent validity, known groups validity and test-retest reliability. RESULTS: The instrument was acceptable to adolescents and adults with CF and demonstrated robust psychometric properties. Principle components analysis indicated that the factorial structure was essentially similar to the original, and the internal reliability of each domain was good (Cronbach alpha coefficients 0.73 to 0.91). Appropriate domains of the CFQoL and SF-36 correlated well indicating good concurrent validity (r=0.68-0.80). Consistent with theoretical expectations some domains were able to discriminate between disease severity groups. Test-retest reliability, assessed by intraclass correlation coefficients, was found to be excellent (ICC 0.83 to 0.98). CONCLUSIONS: The Italian CFQoL is a valid and reliable measure. Its use in individual patient monitoring and research should complement traditional clinical outcome measures.     

Reliability of a multidimensional questionnaire for adults with treated complete cleft lip and palate.

The purpose of this study was to evaluate the reliability of a multidimensional questionnaire for Swedish adults with treated complete unilateral or bilateral cleft lip and palate (CLP). The questionnaire was designed to be used in the evaluation of adults with treated CLP after treatment. Before any conclusions were drawn from the results of the study we assessed the test-retest reliability of the questionnaire. The questionnaire included 168 questions and assessed the following domains: aesthetics, functions associated with CLP, satisfaction with treatment and perceived need for treatment, quality of life, depression and non-specific physical symptoms, body image, and jaw function. The subjects answered the questionnaire twice at a 2-3-week interval. Sixty-one adults (38 men, 23 women) mean age 24 years (range 20-29) participated in the study. The response rate for the questionnaire was acceptable at 75%. The test-retest reliability varied among the different domains. The reliability of questions regarding aesthetics, functions associated with CLP, and treatment satisfaction was good to excellent (intraclass correlation coefficient (ICC) = 0.51 to 0.89). Good to excellent (ICC = 0.61 to 1.0) reliability was also found for the quality of life in various life domains and the wellbeing scales. The reliability of the body image scale was moderate (kappa = 0.43-0.60) for most items and lower than that of other scales used in this study. The reliability of the mean depression symptom score (ICC = 0.93) and the mean non-specific physical symptoms score (ICC = 0.85) were excellent. The reliability of the mandibular function impairment was good (ICC = 0.67). The conclusion of the study is that an overall reliability was good for the multidimensional questionnaire.     

Reliability of a multidimensional questionnaire for adults with treated complete cleft lip and palate

The purpose of this study was to evaluate the reliability of a multidimensional questionnaire for Swedish adults with treated complete unilateral or bilateral cleft lip and palate (CLP). The questionnaire was designed to be used in the evaluation of adults with treated CLP after treatment. Before any conclusions were drawn from the results of the study we assessed the test-retest reliability of the questionnaire. The questionnaire included 168 questions and assessed the following domains: aesthetics, functions associated with CLP, satisfaction with treatment and perceived need for treatment, quality of life, depression and non-specific physical symptoms, body image, and jaw function. The subjects answered the questionnaire twice at a 2-3-week interval. Sixty-one adults (38 men, 23 women) mean age 24 years (range 20-29) participated in the study. The response rate for the questionnaire was acceptable at 75%. The test-retest reliability varied among the different domains. The reliability of questions regarding aesthetics, functions associated with CLP, and treatment satisfaction was good to excellent (intraclass correlation coefficient (ICC) = 0.51 to 0.89). Good to excellent (ICC = 0.61 to 1.0) reliability was also found for the quality of life in various life domains and the wellbeing scales. The reliability of the body image scale was moderate (kappa = 0.43-0.60) for most items and lower than that of other scales used in this study. The reliability of the mean depression symptom score (ICC = 0.93) and the mean non-specific physical symptoms score (ICC = 0.85) were excellent. The reliability of the mandibular function impairment was good (ICC = 0.67). The conclusion of the study is that an overall reliability was good for the multidimensional questionnaire.     

Measuring perceived communicative ability after traumatic brain injury: reliability and validity of the La Trobe Communication Questionnaire

OBJECTIVE: Further psychometric evaluation of a measure designed to assess communication ability after traumatic brain injury (TBI). DESIGN: Internal consistency, test-retest reliability, and validity for self-report and close-other versions of the tool were evaluated. PARTICIPANTS: Eighty-eight adults with severe TBI (mean posttraumatic amnesia 53.12 days) and 71 close others (relatives or friends). MEASURE: The La Trobe Communication Questionnaire (LCQ), a 30-item questionnaire that measures cognitive-communication ability from multiple perspectives. RESULTS: Internal consistency coefficients were above 0.9 and test-retest reliability exceeded 0.80. The questionnaire was sensitive to the effect of severity of injury. CONCLUSION: The La Trobe Communication Questionnaire is a promising tool for measuring perceived communication ability in adults with severe TBI.     

Validation of the SF-36 for the assessment of quality of life in adolescents and adults with cystic fibrosis.

BACKGROUND: Generic health-related quality of life measures are often applied to disease groups without assessment of their psychometric properties. The current work assesses the properties of the Short Form 36-item (SF-36) questionnaire in a British sample of adolescents and adults with cystic fibrosis (CF). METHODS: Two hundred and twenty-three adolescents and adults with CF completed the SF-36 with a further 185 approached and not responding by non-completion of the questionnaire. The structure and internal reliability of the instrument was assessed by principal components analysis, Cronbach alpha coefficients and item to domain correlations. Differences between disease severity groups were assessed by analysis of variance. RESULTS: Factor analysis of the SF-36 scores broadly confirmed domain structures for the SF-36. Cronbach alpha coefficients were high (range 0.82-0.91) and item-to-same domain correlations were stronger than item-to-unrelated domain correlations. Examination of differences between mild, moderate and severe disease states revealed four significant main effects for: physical functioning, role limitation due to physical functioning, general health perceptions and energy and vitality. The analysis also revealed the presence of numerous ceiling effects across domains. CONCLUSIONS: The domain structure of the SF-36 was demonstrated to be robust. However, the discriminatory ability of the measure was disappointing. The presence of ceiling effects and the low frequency of differences between intermediate disease severity groups indicated that the SF-36 was not discriminatory with respect to mild disease states or progression of illness.     

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

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

Validation of the Spanish Version of the Revised Cystic Fibrosis Quality of Life Questionnaire in Adolescents and Adults (CFQR 14+ Spain)

BackgroundThe aim of this study was to assess the validity and reliability of the Spanish version of the revised disease-specific health related quality of life questionnaire for adolescents and adults with cystic fibrosis (CFQR 14+ Spain).Patients and methodsA total of 43 cystic fibrosis (CF) patients completed the CFQR 14+ Spain. Forced expiratory volume in 1 second, in percentage of predicted - FEV₁ (%) -, number of respiratory exacerbations, 6-minute walk test, Bhalla score (based on computerized tomography of the chest), fat-free mass index, body mass index (BMI), faecal fat and St George's Respiratory Questionnaire were included as measurements of health status.ResultsTen out of the twelve scales had alpha coefficients above 0.70. Test-retest correlations (Spearman) ranged from 0.49 to 0.95 and they were significant in all scales. Intraclass correlations ranged from 0.47 to 0.95 (ten out of the twelve scales were >0.70) forty out of the fifty items have correlations between items and scale above 0.70. All the CFQR 14+ scales, except the digestive symptoms scale, discriminated significantly between patients with mild, moderate and severe disease (according to FEV₁ [%]). Other respiratory parameters also discriminated significantly between patients with mild-moderate and severe disease. Only some scales discriminated significantly between nourished and malnourished patients. All of the scales met standards for floor effects (<15% of the responders with the lowest score) but not for ceiling effects (only five out of the twelve).ConclusionThe Spanish CFQR 14+ (Spain) is a reliable and valid instrument for measuring the health-related quality of life in Spanish adolescents and adults with CF, though with the exception of a few of its subscales.     

Cross-cultural adaptation and validation of simplified Chinese version of the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) 2.0 with its assessment in clinical setting

BACKGROUND CONTEXTThe treatment of spinal metastases (SM) has been significantly improved in recent years, which gives health-related quality of life (HRQOL) further significance in management of SM. The Spine Oncology Study Group Outcomes Questionnaire version 2.0 (SOSGOQ 2.0) was a specific targeted SM HRQOL criterion that was previously reported to pose good reliability and validity. However, there is no culturally adapted, reliable, and validated version of SOSGOQ 2.0 in mainland China.PURPOSEThe current study aimed to translate the SOSGOQ 2.0 in a cross-cultural fashion, before evaluating the reliability and validity of the adapted simplified Chinese version of (SC-SOSGOQ 2.0) for patients with spinal metastases (SM).STUDY DESIGN/SETTINGTranslation, cross-cultural adaptation, and validation were performed on the Chinese version of the SOSGOQ 2.0.PATIENT SAMPLEPatients who were diagnosed with metastatic spinal disease, posing at least 6-years experience of education and the ability to read and speak Chinese.OUTCOME MEASURESReliability and Validity of the SC-SOSGOQ 2.0 were measured to assess HRQOL in patients with SM.METHODSThe cross-cultural adaptation of the SOSGOQ 2.0 was conducted following international guidelines. The reliability and validity of the SC-SOSGOQ 2.0 was assessed in a multi-center, prospective observational study. The test-retest reliability was assessed by comparing the results of the first and final SC-SOSGOQ 2.0 scales, with 2 weeks apart. The discriminative, concurrent, and construct validity of the cross-culturally adapted questionnaire was individually evaluated. The relationship among the SC-SOSGOQ 2.0, SC-EQ-5D-5L and SC-SF-36 was assessed using the correlation coefficients.RESULTSOne hundred and twenty patients were included in this study. No floor or ceiling effects were observed for the SC-SOSGOQ 2.0. The Cronbach's α for domains of neurological function, pain, mental health, social function, and post-therapy were 0.825, 0.876, 0.896, 0.897, 0.943, and 0.835, respectively. The value of inter-class correlation coefficient ranged from 0.55 to 0.83, which reflected a satisfactory test-retest reliability. Concurrent assessment of criterion validity demonstrated a moderate-to-strong correlation in all domains of SC-SOSGOQ 2.0 with the SC-EQ-5D-5L (0.34–0.74) and SC-SF-36 (0.33–0.76). The best-correlated domain was physical function (0.741 in the EQ-5D-5L and 0.722 in the SF-36).CONCLUSIONSThe SC-SOSGOQ 2.0 demonstrated an excellent acceptability, score distribution, internal consistency, test-retest reliability and validity. It was therefore considered as a tool effective for evaluating HRQOL of Chinese patients with SM.     

Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients.

STUDY DESIGN: An outcome questionnaire was constructed to evaluate patient satisfaction and performance and to discriminate among patients with adolescent idiopathic scoliosis. OBJECTIVES: To determine reliability and validity in a new quality-of-life instrument for measuring progress among scoliosis patients. SUMMARY OF BACKGROUND DATA: Meta-analysis of the surgical treatment of adolescent idiopathic scoliosis determined that a uniform assessment of outcome did not exist. In addition, patient measures of well-being as opposed to process measures (e.g., radiographs) were not consistently reported. This established the need for a standardized questionnaire to assess patient measures in conjunction with process measures. METHODS: The instrument consists of 24 questions divided into seven equally weighted domains as determined by factor analysis: pain, general self-image, postoperative self-image, general function, overall level of activity, postoperative function, and satisfaction. The questionnaire takes approximately 5 minutes to complete and is taken at predetermined time intervals. A total of 244 of patients from three different sites responded to the questionnaire. RESULTS: The reliability based on internal consistency was confirmed with a Cronbach's alpha coefficient greater than 0.6 for each domain. In addition, acceptable correlation coefficient values greater than 0.68 were obtained for each domain by the test-retest method on normal controls. Similarly; to establish validity of the questionnaire, responses of normal high school students were compared with that of the patients. Consistent differences were noted in the domains between the two groups with P < 0.003. The largest differences were in pain (control, 29.96 +/- 0.20; patient, 13.23 +/- 5.55) and general level of activity (control, 14.96 +/- 0.20; patient, 12.16 +/- 3.23). Examination of the relationship between the domains and patient satisfaction showed that pain correlates with satisfaction to the greatest degree (Pearson's correlation co-efficient, r = -0.511; P < 0.001), followed by self-image (r = 0.412; P < 0.001). CONCLUSIONS: This questionnaire addresses patient measures for evaluation of outcome in adolescent idiopathic scoliosis surgery by examining several domains. It also allows for dynamic monitoring of scoliosis patients as they become adults. This is a validated instrument with good reliability measures.     

Validity and reliability of Swedish WOMAC osteoarthritis index: A self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NHP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Validity and reliability of Swedish WOMAC osteoarthritis index: A self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NHP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Validity and reliability of Swedish WOMAC osteoarthritis index: a self-administered disease-specific questionnaire (WOMAC) versus generic instruments (SF-36 and NHP)

We assessed whether a disease-specific, self-administered questionnaire could replace a generic instrument as an outcome tool after total hip replacement, and tested the validity and reliability of the Swedish WOMAC osteoarthritis index. 58 patients operated on with total hip arthroplasty 2-10 years ago were randomized to the study. All patients were asked to answer one disease-specific questionnaire (WOMAC osteoarthritis index) and two generic instruments (NUP and SF-36) in the same week. The procedure was repeated after 4 weeks. We tested content validity, construct validity, criterion validity, test-retest reliability and internal consistency reliability according to total score, domains and items. We found that both the generic instruments (NHP and SF-36) and the disease-specific test (WOMAC) had a high validity, i.e., measuring what they were supposed to measure (high validity). The questionnaires were also reproducible over time (high reliability). We suggest the Swedish WOMAC to be used after total hip arthroplasty in future studies.     

Test-retest reliability,minimal detectable change and minimal clinically important differences in modified shuttle walk test in children and adolescents with cystic fibrosis

BackgroundIn youths with cystic fibrosis (CF) the modified shuttle walk test (MSWT) has been shown to be useful for assessing exercise tolerance; however, no studies to date have evaluated the reliability of MSWT, the minimal detectable change (MDC) and the minimal clinically important differences (MCID) for the MSWT distance for children and adolescents with CF.MethodsTest-retest reliability: 35 CF patients and 34 healthy controls performed two MSWTs (separated by 2–4 days). MCID: 33 patients were invited to participate in a 6-week home-based exercise program consisting of 30–60-min sessions, 5 days a week.ResultsThe test-retest reliability of the MSWT distance for children and adolescents with CF was excellent, obtaining a MDC₉₀ and MDC₉₅ of 97.08 m and 115.32 m, respectively. The test-retest reliability also was excellent in healthy controls, founding a MDC₉₀ and MDC₉₅ of 69.12 m and 82.11 m, respectively. The ROC curve analysis established (with a sensitivity of 82% and specificity of 76%) that a change of 60 m represented MCID.ConclusionsThe MSWT is a reliable tool to measure of exercise tolerance in children/adolescents with CF and those without CF. We propose a change in the score of at least 97.08 m (MDC₉₀) as the most appropriate value for assessing the exercise response of children and adolescents with CF, given that this value exceeds the MCID based on the children's perception.     

中文版欧洲五维健康量表在慢性肾脏病患者中的信效度研究

目的:评价中文版欧洲五维量表(the euroqol group’s 5-domain 3 level questionnaire,EQ-5D-3L)应用于成年慢性肾脏病患者的信度和效度。方法:应用EQ-5D-3L量表对450例慢性肾脏病(chronic kidney disease,CKD)患者进行面对面访谈,2月后随机抽取45例患者进行重测。结果:信度检验显示健康描述系统内部一致性信度Cronbach’α系数为0.815,五维度及可视化评分(visual analogue scale,VAS)的重测信度在0.150～0.450之间;效度检验结果显示健康描述系统中的行动能力、自我照顾、日常活动三个维度分别解释总变异方差的20.846%、20.526%、20.367%,其累计贡献率为61.758%,且量表内部健康描述系统中五维度与VAS的相关系数r依次为:-0.475、-0.415、-0.517、-0.494和-0.444。结论:中文版EQ-5D-3L具有较好的信度和效度,可用于评价慢性肾脏病患者的生活质量。     

Validation of the Western Ontario and Mcmaster University osteoarthritis index in Asians with osteoarthritis in Singapore

OBJECTIVE: To assess the reliability and validity of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) as an outcome measure in Asian patients with knee or hip osteoarthritis (OA) in Singapore. DESIGN: The WOMAC was administered twice 7 days apart to 66 consecutive English-speaking Chinese, Malay or Indian inpatients and outpatients with knee or hip OA seen at a tertiary referral centre through a structured interview, which also assessed demographic and other characteristics. Internal consistency was assessed using Cronbach's alpha, reliability using Spearman's correlations, intraclass correlations and repeatability coefficients, and relationships between WOMAC domains and known determinants of function using Spearman's correlations and the Mann-Whitney U-test. RESULTS: The WOMAC showed good internal consistency (alpha=0.70 to 0.93) and good reliability, with intraclass correlations of 0.83 to 0.90 and mean test-retest score differences of 0.02 to 0.13 points (possible range 4 points). Results of Likert scoring assessment supported the validity of the WOMAC when interpreted in the context of the close association between pain and physical function. Eight of nine a priori hypotheses relating WOMAC Pain and Physical Function scores to known determinants of function were present, supporting construct validity of this scale. CONCLUSION: The WOMAC is a valid and reliable outcome measure in Asian patients with OA in Singapore.     

Validation of a Norwegian version of the Burn Specific Health Scale

BACKGROUND: The abbreviated Burn Specific Health Scale (BSHS-A) is an 80-item questionnaire that has proven useful in measuring physical, mental, social and general health in burn survivors. The aim of this study was to adapt the BSHS-A into Norwegian, including assessing reliability and validity. METHODS: Standard procedures for forward and backward translation including discussions with professionals and patients to ensure conceptual equivalence were used. A pilot study (11 burn patients) confirmed that the Norwegian version (BSHS-N) was clear, understandable and easy to self-administer. Subsequently, 95 adults admitted to the Burn Center, Haukeland University Hospital, between 1995 and 2000 entered a validation study by completing the BSHS-N and the general health measure SF-36. Sixty-nine of the 95 (72%) responders completed a retest. RESULTS: The overall internal consistency reliability (Cronbach's alpha=0.97) and the test-retest reliability (ICC=0.95) for the BSHS-N were satisfactory. Tests for criterion validity showed expected patterns for association between comparable domains in the BSHS-N and the SF-36, with correlations ranging from r=0.61 to 0.81. Tests for construct validity showed that patients with full thickness injury (P=0.003), patients hospitalised more than 10 days (P=0.003), patients undergoing more than two operations (P=0.001) and patients unemployed at the time of study (P<0.001), had significantly lower total scores than the rest of the patients. CONCLUSION: BSHS-N seems to be a reliable and valid instrument for use in the Norwegian population. The translation and cross-cultural adaptation of this instrument allows for comparative international studies.     

Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer

Objectives. Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL.Methods. Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach’s alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments.Results. Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r ≥0.80 and Cronbach’s alpha ≥0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r >0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap.Conclusions. EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management.     

Quality of life and mood in children with cystic fibrosis: Associations with sleep quality

Background

We aimed to investigate the relationship between sleep quality, mood and health-related quality of life (HRQOL) in children with CF and controls.

Translation, cultural adaptation, initial reliability, and validation of the Kidney Disease and Quality of Life-Short Form (KDQOL-SF 1.3) in Turkey

Health-related quality of life (HRQoL) is an important factor that can interfere with treatment outcomes. The aim of the present study was cultural adaptation, validation, and translation of the Kidney Disease Quality of Life-Short Form (KDQoL-SF 1.3) questionnaire into Turkish for the Turkish population. The KDQOL-SF was translated into Turkish and back-translated into English. Patient difficulties in understanding the questionnaire were evaluated and solved by a panel of experts. Measurement properties such as reliability and validity were determined by applying the questionnaire to 82 patients on dialysis, who were randomly selected from the dialysis units of 3 educational and research hospitals in Istanbul: 65% were females; mean patient age was 51 +/- 12 years. The most common primary causes of renal failure were glomerulonephritis (47%), hypertension (31%), and diabetes (7%). The median time on dialysis among the patients was 3 years. Test and retest methods were used for reliability. The total test-retest reliability Cronbach alpha coefficient of the Turkish KDQOL-SF questionnaire was 0.84 to 0.91. These coefficients were statistically significant (P < .05) for 19 dimensions of the KDQOL-SF that ranged from 0.75 to 0.91. The Cronbach alpha coefficient was higher than 0.80 for most components. To evaluate its construct validity, the KDQOL-SF was compared with the Turkish version of the 15D, an instrument for global assessment that contains 15 items divided into 5 dimensions. The scores range from 0 to 1 (0 = worse health status, 1 = better health status). Significant correlations were observed between the scores of the similar domains of the 15D and the KDQOL-SF. The best correlations were observed between physical functioning (KDQOL-SF) and mobility (15D; r = -.810) and between emotional well-being of (KDQOL-SF), and with the mental functions of 15D; (r = -.784), sexual function (KDQOL-SF) and sexual activity (15D; r = -.781), and patient satisfaction and distress (r = -.801). These findings support the construct validity of the new Turkish adapted KDQOL-SF. This study is reporting the complete process of translation and validation of the KDQOL-SF in the literature. These results demonstrate the high reliability and validity of this questionnaire for Turkish patients on dialysis.