Validation assessment of the Chinese version of the Snore Outcomes Survey

The aim of this study was to use a parallel model to translate the Snore Outcomes Survey (SOS) into Mandarin Chinese language by comparing performing characteristics and statistical properties of the original and Chinese versions SOS. The Chinese version SOS (CSOS) was validated in a prospective, non-randomized manner. A total of 359 patients with sleep-disordered breathing (SDB) aged 18 years and older diagnosed as having SDB participated in the study at entry. Reliability, validity, and longitudinal sensitivity data for CSOS were obtained. CSOS demonstrated good test–retest reliability (Intra-class correlation coefficient = 0.751). The Cronbach's coefficient was 0.86. The item–total correlation coefficients varied from 0.30 to 0.99. The CSOS correlated well with polysomnogram (PSG) parameters including respiratory distress index (RDI), lowest arterial O₂ saturation (LAST). CSOS also yielded significant correlations with vitality subscale of Chinese Taiwan version SF-36 (r = 0.4, p = 0.0011). The standard response mean (SRM) for CSOS was 1.33. The validation demonstrated only minor effects of language; the statistical properties of the CSOS were equivalent to the English version. The CSOS is a valid tool to evaluate adults with SDB among Chinese-speaking population.     

Outcomes research: Implications for occupational health

Concerns about quality, cost, and unnecessary medical care have led to substantial interest and growth in outcomes research with studies to determine the full range of effects of disease and comparative effectiveness of treatments. Investigators have developed new conceptual models of health-related quality of life and associated questionnaires, study designs that maximize use of administrative databases and the generalizability of results, and methods to control for severity and co-morbidity. As similar concerns about occupational health care have emerged, these approaches are being adapted for use in the occupational setting, and studies are beginning to address the concerns of working populations. These investigations will require development of new models of outcome, interdisciplinary research teams, adaptation of data collection methods to address the unique concerns of workers and the unique aspects of the workplace, use of new information databases, and methods of analysis. The implications of these concepts for a hypothetical study of carpal tunnel syndrome and a proposed agenda for future studies in occupational health outcomes research are presented. © 1996 Wiley-Liss, Inc.     

A Brief Mental Health Outcomes Measure: Translation and Validation of the Czech Version of the Schwartz Outcomes Scale-10

The Schwartz Outcomes Scale-10 (SOS-10) is a 10-item scale developed to measure the effectiveness of psychiatric treatments. Using standard methodology, we translated the scale into Czech and examined the psychometric properties of the Czech version. 207 in-patients admitted to Prague Psychiatric Center were included in the study. All patients completed the SOS at admission and discharge. The SOS-10 scale was also administered to 170 persons from the general population. Reliability, validity and sensitivity to treatment change of the Czech SOS-10 were analyzed. The Cronbach’s α coefficient was 0.92. The item-total correlation coefficients varied from 0.56 to 0.82. The SOS-10 correlated well with condition-specific measures including depression (BDI) and anxiety (BAI) and a global self-rated symptom severity scale (CGI). The SOS-10 also had significant correlations with the Health, Basic needs, Relationship, and Leisure time domains of the Czech version of the Subjective Quality of Life Analysis (SQUALA-CZ). The scale discriminated well between patients and controls, with patients scoring significantly lower on all SOS items. The patient sample’s admission and discharge scores were significantly different, indicating that the scale is sensitive to treatment changes. We concluded that the Czech SOS-10 is valid with reliability and factor structure similar to the American language version.     

The Korean Version of the Multicultural Quality of Life Index (MQLI-Kr): Development and Validation

Our research team of multilingual and multicultural members designed comprehensive, yet efficient, culture-informed, and self-rated Multicultural Quality of Life Indexes for both English-speaking individuals and for growing immigrant groups in the United States. A Korean version of the Multicultural Quality of Life Index (MQLI-Kr) was developed as part of this multilingual project. The team tested the MQLI-Kr on 130 Koreans (100 psychiatric patients and 30 professionals). MQLI-Kr was quite efficient and easy to use. The internal consistency attained a Cronbach’s α of 0.97 for the combined sample. A factor analysis yielded one single factor, which accounted for 81.5% of the items’ variance. The test–retest reliability correlation coefficient of the MQLI-Kr was 0.85. Significant differences in the mean MQLI-Kr scores were observed between the patients’ group and the professionals’ group (p < 0.001). Thus the results of this study showed high feasibility, internal consistency, reliability, and discriminant validity for the MQLI-Kr.     

Validation of the HIV Treatment Satisfaction Questionnaire (HIVTSQ)

Human immunodeficiency virus (HIV) therapies need to be both effective and acceptable. The 10-item HIV Treatment Satisfaction Questionnaire (HIVTSQ) was validated amongst 150 HIV-1 sero-positive individuals, receiving one of two protease inhibitors as part of combined therapy in an open-label randomised trial. Scale and subscale scoring was determined psychometrically. It was hypothesised that satisfaction with control would be greater amongst those with lower viral loads, satisfaction with side-effects would be inversely related to severity of adverse events and satisfaction with the new treatment would be greater than with the control treatment. Principal components analyses suggested that patient ratings of nine items can be summed to compute the total satisfaction scale (Cronbach's α 0.82), and/or divided into subscales: general satisfaction/clinical (α 0.80) and lifestyle/ease (α 0.74). One item (asking how demanding the treatment was) needs modification before inclusion. The HIVTSQ showed construct validity: viral load correlated negatively (Spearman's r − 0.33 p < 0.01) with satisfaction with HIV control; those with <400 copies HIV-1 RNA/ml were more satisfied with HIV control than those with higher viral loads (Mann–Whitney p < 0.01); adverse event grade correlated r − 0.18 (p < 0.05) with satisfaction with side-effects. The HIVTSQ was sensitive to differences between groups: compared with patients in the control group, those receiving the new treatment had significantly higher perceived flexibility and lifestyle/ease scores at week 8 (Mann–Whitney p < 0.01). Patient perceptions did not simply mirror clinical measures, highlighting the importance of measuring patient views. This revised version was published online in June 2006 with corrections to the Cover Date.     

Vaccination of Sexually Active Homosexual Men Against Hepatitis A: Analysis of Costs and Benefits

Objective: To estimate costs and benefits of vaccinating young homosexual men against hepatitis A. Design and setting: A decision-analytic model was used to assess vaccination from the societal perspective. Effects of vaccination at age 20 were modeled through each person's lifetime, with costs discounted at 3% annually. Intervention: Two doses of formalin-inactivated vaccine (Havrix, Smithkline Beecham Pharmaceuticals) administered by intramuscular injection 6–12 months apart. Results: Vaccination of 10,000 men would cost $959,000. Over the lifetimes of cohort members, hepatitis A-related hospitalizations would decline from 366 to 76, and treatment costs would decline from $2,577,000 to $363,000. Treatment cost reduction would fully offset vaccination costs within 10 years. Productivity losses associated with hepatitis A morbidity, primarily work absenteeism, would decline by $5,231,000. Vaccination would prevent an estimated 8.6 premature deaths, saving 213 life-years and $2,836,000 in mortality-related productivity losses. Results are only modestly affected when model assumptions are varied within plausible ranges. Conclusions: Hepatitis A vaccine provides improved patient outcomes and cost reduction. From a societal perspective, vaccination provides $10.72 in economic benefits for every $1 spent on vaccination. Physicians should counsel homosexual men to be vaccinated against hepatitis A. Health insurers would find it in their own financial interest to cover vaccination.     

Validation of the Adult Attention-Deficit/Hyperactivity Disorder Quality-of-Life Scale (AAQoL): A Disease-Specific Quality-of-Life Measure

Introduction: A growing body of evidence suggests that symptoms of attention-deficit/hyperactivity disorder (ADHD) persist into adulthood and are associated with ongoing impairment and co-morbidity. The absence of a conceptually sound and well-validated ADHD-specific quality-of-life measure has been an obstacle to understanding this impact. To address this gap, the Adult ADHD Quality-of-Life Scale (AAQoL) was developed based on well accepted methods for designing patient reported outcomes. The purpose of this study was to validate the AAQoL. Methods: Nine Hundred and Eighty Nine adults in a retrospective cohort study were administered the AAQoL and psychometric validation was conducted according to an a priori statistical analysis plan. Results: A 29-item AAQoL was found to have robust scale structure with four domains: Life Productivity, Psychological Health, Relationships and Life outlook. Internal consistency was adequate (0.93 for overall, 0.75–0.93 for subscales), and construct and known-groups validity were supported. Conclusion: The AAQoL appears to be a valid measure of quality of life for adults with ADHD and can be considered for incorporation into future studies. The ability to quantify the quality-of-life consequences of adult ADHD should facilitate future research, assist clinicians in identifying appropriate treatment targets and contribute to the ultimate goal of improving the well-being and functioning of adults with ADHD.     

Validation of a French health-related quality of life instrument for adolescents: The VSP-A

The French Health Ministry, stating the limits of traditional indicators to take into account the different aspects of adolescent health, declared adolescent health status assessment as a priority. Thus a French health-related quality of life (HRQL) generic self-administered indicator was developed on the adolescent's viewpoint for healthy and ill adolescents of 11–17: the VSP-A, Vécu et Santé Perçue de l'Adolescent, intended to be used as a discriminative, predictive and evaluative instrument. This paper reports the validation study of the 40-item VSP-A including 2941 adolescents. Six dimension scores were computed: psychological well-being, energy, friends, parents, leisure, school, as well as an index. Content and construct validity were confirmed. Factorial validity was shown. As expected, scale scores were significantly associated with a one-item global well-being visual analogue scale (r = 0.53; p < 0.001) and with a self-esteem score (r = 0.62; p < 0.001). On the VSP-A index, girls and older adolescents were found to have the lowest scores. The VSP-A is reliable in terms of internal consistency (Cronbach's = 0.83) and test–retest results (r = 0.69; p < 0.001). The ability of VSP-A, filled in less than 15 min, was shown to discriminate between ill and healthy adolescents, and to predict an impairment of their health status. The next phase of the research involves testing in various populations and more specifically in populations with diverse acute and chronical health conditions, so as to refine the content of the instrument and to add much to what is known about the sensitivity to changes of the VSP-A scores in patients who are under treatment.     

Validation of the Japanese version of EORTC QLQ-CR38

Purpose The objective of this study was to test the reliability and validity of the Japanese version of the European Organization for Research and Treatment of Cancer (EORTC) Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38). Methods The questionnaire was tested among 109 colorectal cancer patients on several occasions. The timing was prior to treatment with radiotherapy or chemotherapy, during treatment and 3 months following the second assessment. For purpose of test–retest reliability, a subgroup of patients completed the QLQ-CR38 1 week following the third assessment. Results Multitrait scaling analysis confirmed the hypothesised scale structure of both the function scales and the symptom scales except female sexual problem scale. Cronbach’s alpha coefficients for seven of the nine scales exceeded the 0.7 criterion at one or both assessments. The test–retest reliability for all scales except three symptom scales was 0.67 or higher. On the basis of known-groups comparisons, four of 46 comparisons distinguished between patients differing in disease stage, initial and on-treatment performance status and presence or absence of a stoma. Additionally, these scales detected change over time as a function of change in performance status and treatment-induced change. Conclusion These preliminary results suggest that the Japanese EORTC QLQ-CR38 may be a reliable and valid supplementary measure of quality of life in colorectal cancer patients.     

Cord Blood Manganese Concentrations in Relation to Birth Outcomes and Childhood Physical Growth: A Prospective Birth Cohort Study

Gestational exposure to manganese (Mn), an essential trace element, is associated with fetal and childhood physical growth. However, it is unclear which period of growth is more significantly affected by prenatal Mn exposure. The current study was conducted to assess the associations of umbilical cord-blood Mn levels with birth outcomes and childhood continuous physical development. The umbilical cord-blood Mn concentrations of 1179 mother–infant pairs in the Sheyang mini birth cohort were measured by graphite furnace atomic absorption spectrometry (GFAAS). The association of cord-blood Mn concentrations with birth outcomes, and the BMI z-score at 1, 2, 3, 6, 7 and 8 years old, were estimated separately using generalized linear models. The relationship between prenatal Mn exposure and BMI z-score trajectory was assessed with generalized estimating equation models. The median of cord-blood Mn concentration was 29.25 μg/L. Significantly positive associations were observed between Mn exposure and ponderal index (β, regression coefficient = 0.065, 95% CI, confidence interval: 0.021, 0.109; p = 0.004). Mn exposure was negatively associated with the BMI z-score of children aged 1, 2, and 3 years (β = −0.383 to −0.249, p < 0.05), while no significant relationships were found between Mn exposure and the BMI z-score of children at the age of 6, 7, and 8 years. Prenatal Mn exposure was related to the childhood BMI z-score trajectory (β = −0.218, 95% CI: −0.416, −0.021; p = 0.030). These results indicated that prenatal Mn exposure was positively related to the ponderal index (PI), and negatively related to physical growth in childhood, which seemed most significant at an early stage.     

实验设计在医疗器械生产过程确认中的应用

为研究如何应用实验设计技术在医疗器械过程确认中,来实现产品质量的改进、成本的节约以及满足监管的需求,笔者根据实际工作中的案例,选取医疗器械无菌包装的热封的生产工艺作为研究对象。以实验设计技术为指导,利用析因实验设计进行拟合模型、方差分析以及残差分析,采用了响应曲面的中心复合序贯设计法进行分析,并通过Minitab软件进行参数的优化和选择,给出了优化后的参数水平,最后通过实际测试过程能力验证了设计的有效性。     

Measuring health literacy in Asia: Validation of the HLS-EU-Q47 survey tool in six Asian countries

Background

Health literacy has been increasingly recognized as one of the most important social determinants for health. However, an appropriate and comprehensive assessment tool is not available in many Asian countries. This study validates a comprehensive health literacy survey tool European health literacy questionnaire (HLS-EU-Q47) for the general public in several Asian countries.

确认程序在采供血工作中的应用

分析了采供血工作中确认程序存在的问题,从策划和建立确认程序,过程、方法、设备、计算机软件、检验试剂、质控品和一次性关键物料的确认过程,以及不同项目确认的相互关联和整合3个方面,就如何进行采供血工作确认过程进行了探讨,旨在为同行提供借鉴。     

Validation of stroke diagnosis in the National Hospital Discharge Register and the Register of Causes of Death in Finland

The validity of stroke diagnosis in the National Hospital Discharge Register and the Register of Causes of Death was examined among 546 middle-aged men in Finland. The subjects were cases of cerebrovascular diseases of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study and identified by record linkage to the registers. In all, 375 events with cerebrovascular disease as hospital discharge diagnosis and 218 events with cerebrovascular disease as the underlying cause of death were reviewed using specific criteria modified from the classifications of the National Survey of Stroke and the WHO MONICA Study. For hospital stroke diagnoses, there was agreement on diagnosis for all strokes in 90%, for subarachnoid hemorrhage in 79%, intracerebral hemorrhage in 82%, and cerebral infarction in 90%. The respective agreement rates for stroke as the underlying cause of death were 97%, 95%, 91%, and 92%. The data were insufficient for review in 1% and 3% of the stroke events, respectively. Age, observation year and trial supplementation with alpha-tocopherol or beta-carotene had no effect on validity. In conclusion, the validity of stroke diagnosis was good in registers of hospital diagnoses and causes of death justifying their use for endpoint assessment in epidemiological studies.     

某石化企业和化纤企业女工不良妊娠结局的危险因素分析

目的 分析职业女工不良妊娠结局的危险因素。方法 按标准要求和方法,在调查员统一培训后,同时调查了某大型石化企业和化纤企业1992－1997年登记结婚的女工1241人和1208人,通过单因素和多因素非条件Logistic回归分析,探讨了影响女工不良妊娠结局的危险因素。结果和结论 导致女工发生不良妊娠结局的因素主要有人工流产、倒班、苯系混合物（苯、甲苯、二甲苯）接触和饮酒,其中苯系混合物接触可作为一项独立的危险因素。     

The Isocaloric Substitution of Plant-Based and Animal-Based Protein in Relation to Aging-Related Health Outcomes: A Systematic Review

Plant-based and animal-based protein intake have differential effects on various aging-related health outcomes, but less is known about the health effect of isocaloric substitution of plant-based and animal-based protein. This systematic review summarized current evidence of the isocaloric substitutional effect of plant-based and animal-based protein on aging-related health outcomes. PubMed and Embase databases were searched for epidemiologic observational studies published in English up to 15 March 2021. Studies that included adults ≥18 years old; use of a nutritional substitution model to define isocaloric substitution of plant protein and animal protein; health outcomes covering mortality, aging-related diseases or indices; and reported association estimates with corresponding 95% confidence intervals were included. Nine cohort studies and 3 cross-sectional studies were identified, with a total of 1,450,178 subjects included in this review. Consistent and significant inverse association of substituting plant protein for various animal proteins on all-cause mortality was observed among 4 out of 5 studies with relative risks (RRs) from 0.54 to 0.95 and on cardiovascular disease (CVD) mortality among all 4 studies with RRs from 0.58 to 0.91. Among specific animal proteins, the strongest inverse association on all-cause and CVD mortality was identified when substituting plant protein for red and/or processed meat protein, with the effect mainly limited to bread, cereal, and pasta protein when replacing red meat protein. Isocaloric substitution of plant-based protein for animal-based protein might prevent all-cause and CVD-specific mortality. More studies are needed on this topic, particularly for cancer incidence and other specific aging-related diseases.