Evaluating clinical efficacy of hospital-based surveillance with mammography and ultrasonography for breast cancer.

Periodic mammography and/or sonography examinations are conducted across numerous hospitals nationalwidely, especially for antedees with a positive mammography screening. Despite the regular practice, clinical efficacy of hospital-based breast cancer surveillance remains unclear. Specifically, the impact of surveillance interval upon survival and prognostic surrogates stratified by menopausal status, as well as malignant transition rate should be deciphered. We retrieved cancer registry to ascertain 841 breast cancers with surveillance history through administration data. Healthy controls underwent breast surveillance and were concurrently free of cancer. More benign diseases rather than cancers were identified from premenopausal women (age ≤50 years) with sonography alone within one year, as well as older women (age >50) with both mammography and sonography one to two years before a cancer or benign diagnosis. Among breast cancers, mammography alone during the antecedent one to two years had a protective effect for diagnosing carcinoma in situ rather than invasive cancer (age-adjusted odds ratio: 0.048, P = 0.016). Three-state time homogeneous Markov model showed that hospital-based breast surveillance within 2 years of disease onset reduced the malignant transition rate by 65.16% (59.79-76.74%). The clinical efficacy of breast cancer surveillance was evidenced.

Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale.

PURPOSE: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. METHODS: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. RESULTS: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from - 3 to - 14. CONCLUSIONS: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

Psychometric properties of the updated EORTC module for assessing quality of life in patients with lung cancer (QLQ-LC29): an international, observational field study.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer. METHODS: This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691. FINDINGS: Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ2=370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status). INTERPRETATION: Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies. FUNDING: EORTC Quality of Life Group.

A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts.

OBJECTIVE: Paclitaxel-coated balloons are used to reduce neointimal hyperplasia in native arteriovenous (AV) fistulas. However, no study specifically evaluated their effect on venous anastomotic stenosis of dialysis grafts. We aimed to compare the efficacy of angioplasty with drug-coated balloons (DCBs) and angioplasty with conventional balloons (CBs) for venous anastomotic stenosis in dysfunctional AV grafts. METHODS: In this investigator-initiated, single-center, single-blinded, prospective randomized controlled trial, we randomly assigned 44 patients who had venous anastomotic stenosis to undergo angioplasty with DCBs (n = 22) or CBs (n = 22) from July 2015 to August 2018. Access function was observed per the hemodialysis center's protocols; ancillary angiographic follow-up was performed every 2 months for 1 year after the interventions. The primary end point was target lesion primary patency at 6 months. Secondary outcomes included anatomic and clinical success after angioplasty, circuit primary patency at 6 months and 1 year, and target lesion primary patency at 1 year. RESULTS: At 6 months, target lesion primary patency in the DCB group was significantly greater than that in the CB group (41% vs 9%; hazard ratio [HR], 0.393; 95% confidence interval [CI], 0.194-0.795; P = .006), as was the primary patency of the entire access circuit (36% vs 9%; HR, 0.436; 95% CI, 0.218-0.870; P = .013). At 1 year, the target lesion primary patency in the DCB group remained greater than that in the CB group (23% vs 9%; HR, 0.477; 95% CI, 0.243-0.933; P = .019) but not the primary patency of the access circuit (14% vs 9%; HR, 0.552; 95% CI, 0.288-1.059; P = .056). No difference in anatomic or clinical success was observed; no major complications were noted. CONCLUSIONS: Angioplasty with DCBs showed a modest improvement in primary patency of venous anastomotic stenosis and all dialysis AV grafts at 6 months. The short-term benefit was not durable to 1 year, and reinterventions were eventually needed.

Sensitivity to change of the EORTC quality of life module measuring cancer-related fatigue (EORTC QlQ-Fa12): Results from the international psychometric validation.

OBJECTIVE: The European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) has developed a multidimensional instrument measuring cancer-related fatigue, the EORTC QLQ-FA12. The analysis of sensitivity to change is an essential part of psychometric validation. With this study, we investigated the EORTC QLQ-FA12's sensitivity to change. METHODS: The methodology follows the EORTC guidelines of EORTC QLG for phase IV validation of modules. We included cancer patients undergoing curative and palliative treatment at t1 and followed them up prospectively over the course of their treatment (t2) and 4 weeks after completion of treatment (t3). Data were collected prospectively at 17 sites in 11 countries. Sensitivity to change was investigated using analysis of variance. RESULTS: A total sample of 533 patients was enrolled with various tumour types, different stages of cancer, and receiving either curative treatment (n=311) or palliative treatment (n=222). Over time all fatigue scores were significantly higher in the palliative treatment group compared with the curative group (p < .001). Physical fatigue increased with medium effect size over the course of treatment in the curative group (standardized response mean [SRM] (t1,t2) = 0.44]. After treatment physical [SRM (t2,t3) = 0.39], emotional [SRM (t2,t3)= 0.28] and cognitive fatigue (SRM [t2,t3] = 0.22) declined significantly in the curative group. In the palliative group, emotional (SRM [t2,t3] = 0.18) as well as cognitive [SRM [t2,t3] = 0.26) fatigue increases significantly. CONCLUSIONS: The EORTC-QLQ-FA12 proved to identify clinically significant changes in fatigue in the course of curative and palliative cancer treatment.

Validation of the Taiwan Chinese version of the EORTC QLQ-CR29 to assess quality of life in colorectal cancer patients.

BACKGROUND: The increasing incidence of colorectal cancer in Taiwan has generated a need for a disease-specific quality-of-life measuring instrument. We aimed to validate the Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29. METHODS: A total of 108 patients were interviewed. Convergent and discriminant validity, Cronbach's alpha coefficient, test-retest reliability, and known-groups comparisons were used to examine the reliability and validity. RESULTS: We found good internal consistency reliability for multi-item scales of the QLQ-C30 and QLQ-CR29, except for the cognitive function and pain scale of the QLQ-C30. Patients in the active treatment group reported compromised functional scale scores (global health status/quality of life, QLQ-C30) and worse symptoms (blood and mucus in stool, QLQ-CR29) than those in the follow-up group. Similar results were found in comparisons based on Eastern Cooperative Oncology Group (ECOG) Performance Status and Bristol Stool Scale: higher physical function/sexual interest, less fatigue/urine frequency symptoms for patients with the lowest ECOG Performance Status (Grade 0), and borderline worse stool frequency scores from Types 5 and 6 patients on the Bristol Stool Scale. CONCLUSION: The study validated the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-CR29. The clinical applicability warrants further studies with greater number of participants.

Quantitative maternal hepatitis B surface antigen predicts maternally transmitted hepatitis B virus infection.

Despite immunoprophylaxis, hepatitis B virus (HBV) transmission in highly viremic mothers remains a global health issue. Using quantitative maternal surface antigen (HBsAg) to predict HBV infection in infants has not been investigated. We enrolled 526 mother-infant pairs with positive maternal HBsAg under current immunoprophylaxis. Maternal viral load and quantitative HBsAg were measured in the peripartum period. Infant HBsAg seropositivity for more than 6 months was defined as chronic infection. Rates of chronic infection in infants at various maternal HBsAg levels were estimated using a multivariate logistic regression model. Results showed that maternal HBsAg was positively correlated with maternal viral load (r = 0.69; P < 0.001) and accurately predicted maternal viral load above 6, 7, and 8 log10 IU/mL with an area under the receiver operating characteristic curve (AUC) of 0.97, 0.98, and 0.95. Nineteen infants were chronically infected. After adjustment for the other risk factor, maternal HBsAg level was significantly associated with risk of infection (adjusted odds ratio for each log10 IU/mL increase, 15.02; 95% confidence interval [CI], 3.89-57.94; P < 0.001). The AUC for predicting infection by quantitative maternal HBsAg was comparable to that by maternal viral load (0.89 vs. 0.87; P = 0.459). Estimated rates of infection at maternal HBsAg levels of 4, 4.5, and 5 log10 IU/mL were 2.4% (95% CI, 0.1-4.6; P = 0.04), 8.6% (95% CI, 4.5-12.7; P < 0.001), and 26.4% (95% CI, 12.6-40.2; P < 0.001). CONCLUSION: Quantitative maternal HBsAg predicts infection in infants as well as maternal viral load does. Antiviral therapy may be considered in pregnant women with an HBsAg level above 4-4.5 log10 IU/mL to interrupt mother-to-infant transmission. (Hepatology 2016;64:1451-1461).

EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries.

PURPOSE: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. METHODS: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. RESULTS: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. CONCLUSIONS: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Predicting the risk of osteopenia for women aged 40-55 years.

BACKGROUND/PURPOSE: Osteoporosis has been linked to an increased fracture risk and subsequent mortality in the later life. Previous prediction models have focused on osteoporosis in postmenopausal women; however, a prediction tool for osteopenia is needed. Our objective was to establish a prediction model for osteopenia risk in women aged 40-55 years. METHODS: This was a cross-sectional study. A total of 1350 Taiwanese women aged 40-55 years were recruited from a health checkup center from 2009 to 2010. The main outcome measure was osteopenia (-1≥bone mineral density T-score > -2.5). RESULTS: The Osteoporosis Preclinical Assessment Tool (OPAT) developed in this study was based on variables with biological importance to osteopenia and variables that remained significant (p<0.05) in the multivariable analysis, which include age, menopausal status, weight, and alkaline phosphatase level. The OPAT has a total score that ranges from 0 to 7, and categorizes women into high-, moderate-, and low-risk groups. The predictive ability of the OPAT (area under the receiver operating characteristic curve=0.77) was significantly better than that of the Osteoporosis Self-assessment Tool for Asians (area under the receiver operating characteristic curve=0.69). The inclusion of serum total alkaline phosphatase level in the model, which is easy to obtain from routine health checkups, significantly enhanced the sensitivity (McNemar test, p=0.004) for detecting osteopenia in women aged 40-55 years. CONCLUSION: Our findings provide an important tool for identifying women at risk of osteoporosis at the preclinical phase.

Development of an item bank for computerized adaptive test (CAT) measurement of pain.

PURPOSE: Patient-reported outcomes should ideally be adapted to the individual patient while maintaining comparability of scores across patients. This is achievable using computerized adaptive testing (CAT). The aim here was to develop an item bank for CAT measurement of the pain domain as measured by the EORTC QLQ-C30 questionnaire. METHODS: The development process consisted of four steps: (1) literature search, (2) formulation of new items and expert evaluations, (3) pretesting and (4) field-testing and psychometric analyses for the final selection of items. RESULTS: In step 1, we identified 337 pain items from the literature. Twenty-nine new items fitting the QLQ-C30 item style were formulated in step 2 that were reduced to 26 items by expert evaluations. Based on interviews with 31 patients from Denmark, France and the UK, the list was further reduced to 21 items in step 3. In phase 4, responses were obtained from 1103 cancer patients from five countries. Psychometric evaluations showed that 16 items could be retained in a unidimensional item bank. Evaluations indicated that use of the CAT measure may reduce sample size requirements with 15-25% compared to using the QLQ-C30 pain scale. CONCLUSIONS: We have established an item bank of 16 items suitable for CAT measurement of pain. While being backward compatible with the QLQ-C30, the new item bank will significantly improve measurement precision of pain. We recommend initiating CAT measurement by screening for pain using the two original QLQ-C30 pain items. The EORTC pain CAT is currently available for "experimental" purposes.

Change of government's subsidization policy improves smoking cessation services: a cross-sectional study from the perspectives of physicians.

BACKGROUND: The Taiwanese government increased financial subsidies for smoking cessation services in 2012. We aimed to evaluate the effects of this new policy on smoking cessation services from the physician's perspective. METHODS: This was a cross-sectional nationwide survey. Physicians who provided smoking cessation services for more than ten patient encounters in the preceding year of the new policy (February 2011 to March 2012) were recruited. The questionnaire was developed by two experts and was validated by a committee consisting of 11 delegates. RESULTS: We sent a total of 1,319 questionnaires. The response rate was 45.9 %. The majority of respondents were male (88.4 %), middle-aged (65.3 %), and worked as family physicians (56.1 %). Most physicians agreed that the new policy had increased the number of patients seeking smoking cessation, increased patients' willingness to adopt pharmacotherapy, helped physicians to prescribe medications, improved patients' adherence to medications, and improved quality of care. These changes were most prominent in medical centers. Changes in the practice of the 5As (ask, advise, assess, assist, arrange) were moderate. Among different medical settings, the most significant change was an increase in the expenditure on smoking cessation medications. CONCLUSIONS: The new subsidization policy in Taiwan has improved smoking cessation services. Overall, physicians reported positive effects of the new policy. Further study is warranted to evaluate the long-term influence of the policy.

Use of the lung cancer-specific Quality of Life Questionnaire EORTC QLQ-LC13 in clinical trials: A systematic review of the literature 20 years after its development.

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) covers 13 typical symptoms of lung cancer patients and was the first module developed in conjunction with the EORTC core quality-of-life (QL) questionnaire. This review investigates how the module has been used and reported in cancer clinical trials in the 20 years since its publication. Thirty-six databases were searched with a prespecified algorithm. This search plus an additional hand search generated 770 hits, 240 of which were clinical studies. Two raters extracted data using a coding scheme. Analyses focused on the randomized controlled trials (RCTs). Of the 240 clinical studies that were identified using the LC13, 109 (45%) were RCTs. More than half of the RCTs were phase 3 trials (n = 58). Twenty RCTs considered QL as the primary endpoint, and 68 considered it as a secondary endpoint. QL results were addressed in the results section of the article (n = 89) or in the abstract (n = 92); and, in half of the articles, QL results were presented in the form of tables (n = 53) or figures (n = 43). Furthermore, QL results had an impact on the evaluation of the therapy that could be clearly demonstrated in the 47 RCTs that yielded QL differences between treatment and control groups. The EORTC QLQ-LC13 fulfilled its mission to be used as a standard instrument in lung cancer clinical trials. An update of the LC13 is underway to keep up with new therapeutic trends and to ensure optimized and relevant QL assessment in future trials.

Development of a lack of appetite item bank for computer-adaptive testing (CAT).

PURPOSE: A significant proportion of oncological patients experiences lack of appetite. Precise measurement is relevant to improve the management of lack of appetite. The so-called computer-adaptive test (CAT) allows for adaptation of the questionnaire to the individual patient, thereby optimizing measurement precision. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30 questionnaire. Here, we report on the development of the lack of appetite CAT. METHODS: The EORTC approach to CAT development comprises four phases: literature search, operationalization, pre-testing, and field testing. Phases 1-3 are described in this paper. First, a list of items was retrieved from the literature. This was refined, deleting redundant and irrelevant items. Next, new items fitting the "QLQ-C30 item style" were created. These were evaluated by international samples of experts and cancer patients. RESULTS: The literature search generated a list of 146 items. After a comprehensive item selection procedure, the list was reduced to 24 items. These formed the basis for 21 new items fitting the QLQ-C30 item style. Expert evaluations (n = 10) and patient interviews (n = 49) reduced the list to 12 lack of appetite items. CONCLUSIONS: Phases 1-3 resulted in 12 lack of appetite candidate items. Based on a field testing (phase 4), the psychometric characteristics of the items will be assessed and the final item bank will be generated. This CAT item bank is expected to provide precise and efficient measurement of lack of appetite while still being backward compatible to the original QLQ-C30 scale.

Conceptual structure of the Taiwan Chinese version of the EORTC QLQ-C30.

OBJECTIVE: This study aimed to evaluate the conceptual structure of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) by analyzing data collected from patients with major cancers in Taiwan. The conceptual structure underlying QLQ-C30, including higher-order factors, was explored by structural equation modeling (SEM). METHODS: The Taiwan Chinese version of the EORTC QLQ-C30 was used as the measuring instrument. Higher-order models, including mental health/physical health, mental function/physical burden, symptom burden/function, single latent health-related quality of life, formative symptom burden/function, and formative health-related quality of life, were tested. RESULTS: Study subjects included 283 patients with breast, lung, and nasopharyngeal cancers. The original QLQ-C30 multi-factorial structure demonstrated poor composite reliability of the cognitive function subscale. The formative symptom/burden model was favored by model fit indices, further supporting causal-indicator duality, but was compromised by unexpected associations between symptomatic subscales and latent factors. The formative health-related quality of life was proposed with a single second-order latent factor where symptomatic subscales remained formative. Two additional symptom measures from the formal cognitive function subscale with the formative health-related quality-of-life model were proposed as the alterative conceptual structure for the Taiwan Chinese QLQ-C30. CONCLUSIONS: Results of the current study represent the complete SEM approach for the EORTC QLQ-C30. The formative health-related quality-of-life model with elimination of cognitive function enhances the conceptual structure of the Taiwan Chinese version with parsimonious fit and interpretability.

Quality of life changes in patients undergoing treatment for hepatocellular carcinoma.

PURPOSE: Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death worldwide. One of the primary treatment goals for incurable advanced cases is to prolong quality of life (QoL). Thus, to determine which HCC therapies may be linked to a more favorable QoL, we assessed the association between QoL changes and different treatments in HCC patients. METHODS: We analyzed a non-randomized multicenter longitudinal study, which included 171 patients treated with surgery (n = 53), ablation (n = 53) or embolization (n = 65) from seven centers: four Asian and three European sites. All participants completed the EORTC QLQ-C30 and QLQ-HCC18 questionnaires before and after treatment. Propensity scores were calculated and used in addition to race for adjustment in the logistic regression model to account for the confounding effects of patient characteristics including age, gender, race, employment, living with family, at least one comorbid condition, years since diagnosis, prior treatment history, BCLC stage, Child-Pugh grade, cirrhosis, bilirubin levels and QoL score before treatment. RESULTS: After adjustment for confounders, patients tended to have higher odds of QoL deterioration when treated with ablation versus embolization (dyspnea: p = 0.019; appetite loss: p = 0.018; body image: p = 0.035) or ablation versus surgery (dyspnea: p = 0.099; appetite loss: p = 0.100; body image: p = 0.038). CONCLUSIONS: There were significant differences in QoL deterioration across different treatment groups. This information may assist patients and providers when selecting patient-centered treatment approaches for HCC.

Association of quality of life with laboratory measurements and lifestyle factors in community dwelling older people in Taiwan.

OBJECTIVES: Little is known about the influence of routine laboratory measurements and lifestyle factors on generic quality of life (QOL) at older ages. We aimed to study the relationship between generic QOL and laboratory measurements and lifestyle factors in community dwelling older Chinese people. METHODS: We conducted a cross-sectional analysis. Six hundred and ninety nine elders were randomly selected from the examinees of the annual health examination in Taipei City, Taiwan. Blood, urine and stool of the participants were examined and lifestyle data were collected. Participants completed the CASP-19 (control, autonomy, self-realization, pleasure) questionnaire, a 19-item QOL scale. The relationship between QOL and laboratory results and lifestyle factors was explored, using multiple linear regression and profile analysis. RESULTS: The mean age of the participants was 75.5 years (SD = 6.5), and 49.5% were female. Male gender standardized ß coefficients (ß = 0.122) and exercise habit (ß = 0.170) were associated with a better QOL, whereas advanced age (ß = -0.242), blurred vision (ß = -0.143), depression (ß = -0.125), central obesity (ß = -0.093), anemia (ß = -0.095), rheumatoid arthritis (ß = -0.073), Parkinsonism (ß = -0.079), malignancy (ß = -0.086) and motorcycle riding (ß = -0.086) were associated with a lower QOL. Profile analysis revealed that young-old males, social drinkers, regular exercisers and car drivers had the best QOL (all p < 0.001). CONCLUSION: Of the many laboratory measurements, only anemia was associated with the lower QOL. By contrast, several lifestyle factors, such as social drinking, exercise habit and car driving, were associated with better QOL, whereas abdominal obesity and motorcycle riding were associated with lower QOL.

Method-specific performance of vancomycin MIC susceptibility tests in predicting mortality of patients with methicillin-resistant Staphylococcus aureus bacteraemia.

OBJECTIVES: Emerging evidence shows that methicillin-resistant Staphylococcus aureus (MRSA) infections caused by isolates with higher vancomycin MICs within the susceptibility range are associated with adverse outcomes. No study, however, has examined different susceptibility tests in predicting treatment outcomes of MRSA infections. METHODS: This retrospective cohort study included 393 patients with MRSA bacteraemia. Vancomycin MICs for all MRSA isolates were determined simultaneously by agar dilution and the Etest, and using the MicroScan, VITEK-2 and Phoenix automated systems, and categorized into low- and high-MIC isolates at a breakpoint of ≥ 2 mg/L. The essential and categorical agreement between testing methods was compared. The method-specific ability to predict in-hospital mortality was examined by multivariate logistic regression analysis controlling for other potential confounders using clinical data from 310 vancomycin-treated MRSA bacteraemia patients. RESULTS: The agar dilution, Etest, MicroScan, VITEK-2 and Phoenix methods assessed 14.2% (56/393), 9.7% (38/393), 28.8% (113/393), 22.6% (89/393) and 3.1% (12/393) of MRSA isolates as having high (≥ 2 mg/L) vancomycin MICs. The essential and categorical agreement between testing methods ranged from 98.5% to 100% and from 73.8% to 91.9%, respectively. High vancomycin MICs for isolates determined using agar dilution and the Etest independently predicted mortality when controlling for confounding factors [adjusted OR, 2.321; 95% CI, 1.160-4.641; and adjusted OR, 3.121; 95% CI, 1.293-7.536, respectively]. High vancomycin MICs determined using all three automated systems failed to predict mortality. CONCLUSIONS: Vancomycin MICs generated by the agar dilution and Etest methods, but not the automated systems, independently predicted mortality among vancomycin-treated MRSA bacteraemia patients. Clinicians should incorporate this information with clinical assessment for decisions on appropriate anti-MRSA treatment.

International cross-cultural field validation of an European Organization for Research and Treatment of Cancer questionnaire module for patients with primary liver cancer, the European Organization for Research and Treatment of Cancer quality-of-life questionnaire HCC18.

UNLABELLED: This international field validation study examined the psychometric properties and clinical validity of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma (HCC), the EORTC quality-of-life questionnaire (QLQ)-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30, to 272 patients from seven centers in 6 countries. Patient acceptability of the module was examined with a debriefing questionnaire, and psychometric and clinical properties were assessed. Multitrait scaling analyses confirmed the hypothesized scale structure without any scaling error, and the fatigue scale demonstrated satisfactory internal consistency. The test-retest reliability scores were high for all scales, except abdominal swelling and sexual interest. The correlations between all scales of the QLQ-HCC18 and the QLQ-C30 were low or moderate, and many scales could distinguish patients with different clinical conditions. The module demonstrated responsiveness to clinical change in pain before and after surgery and some borderline change in patients undergoing systemic treatment. CONCLUSION: The EORTC QLQ-HCC18 can be used as a supplementary module for the EORTC QLQ-C30 in clinical trials for patients with HCC.

Cross-cultural differences in information disclosure evaluated through the EORTC questionnaires.

OBJECTIVE: Informational needs among cancer patients are similar, but the degree of information disclosure in different cultural areas varies. In this paper, we present the results of a cross-cultural study on information received. METHODS: The EORTC information questionnaire, EORTC QLQ-INFO25, was administered during the treatment process. This questionnaire evaluates the information that patients report they have received. Cross-cultural differences in information have been evaluated using statistical tests such as Kruskall-Wallis and multivariate models with covariates to account for differences in clinical and demographic characteristics across areas. RESULTS: Four hundred and fifty-one patients from three cultural areas, North-Middle Europe, South Europe, and Taiwan, were included in the study. Significant differences among the three cultural areas appeared in eight QLQ-INFO25 dimensions: information about the disease; medical tests; places of care; written information; information on CD/tape/video; satisfaction; wish for more information; and information helpfulness. North-Middle Europe patients received more written information (mean = 67.2 (North) and 33.8 (South)) and South Europe patients received more information on different places of care (mean = 24.7 (North) and 35.0 (South)). Patients from North-Middle Europe and South Europe received more information than patients from Taiwan about the disease (mean = 57.9, 60.6, and 47.1, respectively) and medical tests (70.9, 70.4, and 54.5), showed more satisfaction (64.8, 70.2, and 35.0), and considered the information more helpful (71.9, 73.9, and 50.4). These results were confirmed when adjusting for age, education, and disease stage. CONCLUSION: There are cross-cultural differences in information received. Some of these differences are based on the characteristics of each culture.

Risk factors for single and recurrent falls: a prospective study of falls in community dwelling seniors without cognitive impairment.

OBJECTIVE: The purpose of this study is to contribute evidence towards heterogeneity in risk factors for single and recurrent falls. METHOD: This is a prospective study conducted in Taiwan. Participants were randomly selected from the examinees of the annual health examination in 2010. Participants were interviewed with a detailed questionnaire and followed up one year later. Predictor variables included socio-demographic characteristics, medical conditions, laboratory data, and risk factors for osteoporosis. The outcome was falls in the ensuing 12 months. RESULTS: The mean age of the 653 completers was 75.6 ± 6.4. Half (48.7%) were women. Fallers and recurrent fallers comprised 14.5% and 6.0% of the participants, respectively. Blurred vision (adjusted odds ratio (aOR): 1.93, 95% confidence interval (CI): 1.02-3.67), minimal outdoor activities (aOR: 2.28, 95% CI: 1.06-4.88), and overactive thyroid/parathyroid (aOR: 3.49, 95% CI: 1.29-9.50) were associated with single falls. Frailty (aOR: 2.81, 95% CI: 1.11-7.09), decreased body height (aOR: 3.15, 95% CI: 1.52-6.54) and taking sedatives/hypnotics (aOR: 4.23, 95% CI: 2.06-8.67) were associated with recurrent falls. Previous falls (aOR: 2.64, 95% CI: 1.44-4.84 for single falls; aOR: 5.26, 95% CI: 2.61-10.60 for recurrent falls) were associated with all falls. CONCLUSION: Different intervention strategies should be developed for single and recurrent fallers.