Lynette Lim

OBJECTIVE: As conflicting studies have recently been published, we aimed to determine if Helicobacter pylori (H. pylori) infection is associated with gastric adenocarcinoma. METHODS: This was a meta-analysis of observational epidemiological studies. RESULTS: A total of 42 studies met the selection criteria and were categorized by the type of study design: eight cohort and 34 case-control studies. The pooled odds ratio for H. pylori in relation to gastric carcinoma was 2.04 (95% CI: 1.69-2.45). Both patient age (OR 0.77, 95% CI: 0.68-0.89) and intestinal type cancers (OR 1.14, 95% CI: 1.05-1.25) were independent effect modifiers. Analysis of other effect modifiers showed no relationship with female gender (OR 0.76, 95% CI: 0.64-0.89), stage of cancer (advanced %) (OR 1.12, 95% CI: 0.88-1.43), anatomical location (cardia %) (OR 1.54, 95% CI: 0.32-7.39) or cohort (nested case-control) studies (OR 1.72, 95% CI: 0.32-9.17). There was significant heterogeneity among the studies (tau2 = 149; p < 0.001). The quality of the studies varied considerably, with the majority of excellent studies producing positive results and the very poor to moderate studies producing mixed results. CONCLUSIONS: H. pylori infection is associated with a 2-fold increased risk of developing gastric adenocarcinoma.

Many extensions of survival models based on the Cox proportional hazards approach have been proposed to handle clustered or multiple event data. Of particular note are five Cox-based models for recurrent event data: Andersen and Gill (AG); Wei, Lin and Weissfeld (WLW); Prentice, Williams and Peterson, total time (PWP-CP) and gap time (PWP-GT); and Lee, Wei and Amato (LWA). Some authors have compared these models by observing differences that arise from fitting the models to real and simulated data. However, no attempt has been made to systematically identify the components of the models that are appropriate for recurrent event data. We propose a systematic way of characterizing such Cox-based models using four key components: risk intervals; baseline hazard; risk set, and correlation adjustment. From the definitions of risk interval and risk set there are conceptually seven such Cox-based models that are permissible, five of which are those previously identified. The two new variant models are termed the 'total time - restricted' (TT-R) and 'gap time - unrestricted' (GT-UR) models. The aim of the paper is to determine which models are appropriate for recurrent event data using the key components. The models are fitted to simulated data sets and to a data set of childhood recurrent infectious diseases. The LWA model is not appropriate for recurrent event data because it allows a subject to be at risk several times for the same event. The WLW model overestimates treatment effect and is not recommended. We conclude that PWP-GT and TT-R are useful models for analysing recurrent event data, providing answers to slightly different research questions. Further, applying a robust variance to any of these models does not adequately account for within-subject correlation.

BACKGROUND: The measurement of health, the effects of disease, and the impact of health care include not only an indication of changes in disease frequency and severity but also an estimate of patients' perception of health status before and after treatment. One of the more important developments in health care in the past decade may be the recognition that the patient's perspective is as legitimate and valid as the clinician's in monitoring health care outcomes. This has lead to the development of instruments to quantify the patients' perception of their health status before and after treatment. METHODS: We review evidence supporting the measurement properties of the MacNew Heart Disease Health-related Quality of Life [MacNew] Questionnaire which was designed to evaluate how daily activities and physical, emotional, and social functioning are affected by coronary heart disease and its treatment. RESULTS: Reliability was demonstrated by using internal consistency and the intraclass correlation coefficients for the three domains in the Dutch, English, Farsi, German, and Spanish versions of the MacNew. With internal consistency and intraclass correlation coefficients =>0.73, reliability is high. Validity of the MacNew was examined with factor analysis and three core underlying factors, physical, emotional, and social, were identified, explaining 63.0 - 66.5% of the observed variance and replicated in the translations with psychometric data. Construct validity of the MacNew was further demonstrated by extensive substantiation of the logical relationships, defined a priori, between items and other comparison tools. The MacNew is responsive and sensitive to changes in HRQL following various interventions for patients with heart disease with 11 of 13 effect size statistics >0.80. Taking an average of 10 minutes or less to complete, the respondent-burden for the MacNew is low and its acceptability is demonstrated by response rates of over 90%. Normative data are available for patients with myocardial infarction, angina, and heart failure in the English version. CONCLUSION: The MacNew may be a valuable tool for assessing and evaluating health related quality of life in patients with heart disease.

BACKGROUND AND PURPOSE: The influence of body temperature on stroke outcome remains uncertain. The aim of this study was to investigate the prognostic role of admission body temperature on short-term and long-term mortality in a retrospective cohort study of patients with acute stroke. METHODS: A retrospective cohort of 509 patients with acute stroke, admitted to a tertiary hospital between July 1, 1995, and June 30, 1997, was studied. The relationship between admission body temperature and mortality both in-hospital and at 1-year mortality was evaluated. Body temperature on admission was classified as hypothermia (</=36.5 degrees C), normothermia (>36.5 degrees C and </=37.5 degrees C), and hyperthermia (>37.5 degrees C). Logistic regression and proportional hazards function analysis were performed after adjustment for clinical predictors of stroke outcome. RESULTS: In ischemic stoke, mortality was lower among patients with hypothermia and higher among patients with hyperthermia. The odds ratio for in-hospital mortality in hypothermic versus normothermic patients was 0.1 (95% CI, 0.02 to 0.5). The relative risk for 1-year mortality of hyperthermic versus normothermic patients was 3.4 (95% CI, 1.6 to 7.3). A similar but nonsignificant trend for in-hospital mortality was seen among patients with hemorrhagic stroke. CONCLUSIONS: An association between admission body temperature and stroke mortality was noted independent of clinical variables of stroke severity. Hyperthermia was associated with an increase in 1-year mortality. Hypothermia was associated with a reduction in in-hospital mortality.

OBJECTIVES: To investigate the distribution of month of birth in people with multiple sclerosis in Australia. To use the large regional and seasonal variation in ambient ultraviolet radiation in Australia to explore the association between exposure to ultraviolet radiation during pregnancy and subsequent risk of multiple sclerosis in offspring. DESIGN: Data were gathered on birth month and year (1920-1950), sex, and state of birth for all patients surveyed in 1981 in Queensland, Western Australia, New South Wales (including Australian Capital Territory), South Australia, and Hobart (Tasmania). Population denominators were derived from the 1981 census and supplementary birth registration data. A variable for exposure to ambient ultraviolet radiation "at birth" was generated from monthly averages of daily total ambient ultraviolet radiation for each region. Negative binomial regression models were used to investigate exposure to ambient ultraviolet radiation at birth and at various intervals before birth. SETTING: Patient data from multiple sclerosis prevalence surveys carried out in 1981; 1981 Australian census (giving the total number of people born in Australia and still alive and living in Australia in 1981 by year of birth 1920-50); supplementary Australian birth registration data covering the same birth years by month and state. PARTICIPANTS: 1524 patients with multiple sclerosis born in Australia 1920-50 from total population of 2 468 779. MAIN OUTCOME MEASURE: Cumulative incidence rate of multiple sclerosis. RESULTS: There was a pattern of risk of multiple sclerosis with month of birth (adjusted incidence rate ratio 1.32, 95% confidence interval 1.10 to 1.58, P<0.01, for those born in November-December compared with those born in May-June). This pattern mirrored that previously reported in the northern hemisphere. Region of birth was related to risk. After adjustment for region of birth and other factors, there was an inverse association between ambient ultraviolet radiation in the first trimester and risk of multiple sclerosis (with ≥25 erythemal (skin reddening) dose units as reference (that is, adjusted incidence rate ratio=1.00), the rates were 1.54 (1.10 to 2.16) for 20-<25 units; 1.58 (1.12 to 2.22) for 15-<20 units; 1.65 (1.17 to 2.33) for 10-<15 units; 1.65 (1.18 to 2.29) for 5-<10 units; and 1.67 (1.18 to 2.37) for <5 units). After adjustment for this exposure during early pregnancy, there was no residual association between month of birth and multiple sclerosis. CONCLUSION: Region of birth and low maternal exposure to ultraviolet radiation in the first trimester are independently associated with subsequent risk of multiple sclerosis in offspring in Australia.