Abstract:
OBJECTIVES:Complex longitudinal sampling and the observational structure of patient registers in health services research are associated with methodological challenges regarding data management and statistical evaluation. We exemplify common pitfalls and want to stimulate discussions on the design, development, and deployment of future longitudinal patient registers and register-based studies. STUDY DESIGN AND SETTING:For illustrative purposes, we use data from the prospective, observational, German DIabetes Versorgungs-Evaluation register. One aim was to explore predictors for the initiation of a basal insulin supported therapy in patients with type 2 diabetes initially prescribed to glucose-lowering drugs alone. RESULTS:Major challenges are missing mortality information, time-dependent outcomes, delayed study entries, different follow-up times, and competing events. We show that time-to-event methodology is a valuable tool for improved statistical evaluation of register data and should be preferred to simple case-control approaches. CONCLUSION:Patient registers provide rich data sources for health services research. Analyses are accompanied with the trade-off between data availability, clinical plausibility, and statistical feasibility. Cox' proportional hazards model allows for the evaluation of the outcome-specific hazards, but prediction of outcome probabilities is compromised by missing mortality information.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Bluhmki T,Bramlage P,Volk M,Kaltheuner M,Danne T,Rathmann W,Beyersmann Jdoi
10.1016/j.jclinepi.2016.11.001subject
Has Abstractpub_date
2017-02-01 00:00:00pages
103-111eissn
0895-4356issn
1878-5921pii
S0895-4356(16)30645-Xjournal_volume
82pub_type
杂志文章,多中心研究abstract::Previous work has suggested that recall bias in case-control studies may be more serious when the overall study quality is lower. This paper summarizes a systematic literature search to examine the question. All relevant studies published between 1966 and 1990 were included if they met the following criteria: (1) they...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)00132-a
更新日期:1995-02-01 00:00:00
abstract::This review critically appraises 22 recent articles of trials of physical activity, as a means of reducing blood pressure. The quality of the literature remains poor and of the 13 controlled trials of habitual activity only one did not have a major design fault. Overall, blood pressure was reduced by physical activity...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/0895-4356(92)90093-3
更新日期:1992-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the coronavirus disease 2019 (COVID-19) pandemic. The number of registered trials related to COVID-19 is increasing by the day. The objective of this study was to describe ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.06.005
更新日期:2020-09-01 00:00:00
abstract::Whether or not to treat patients with non-rheumatic atrial fibrillation with anticoagulants to prevent embolic stroke is a dilemma for physicians. If randomized trials, currently underway, demonstrate a beneficial effect, the dilemma will not be solved because not all of the relevant factors can be addressed by trials...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90219-y
更新日期:1991-01-01 00:00:00
abstract:OBJECTIVES:The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. STUDY ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2017.07.010
更新日期:2017-11-01 00:00:00
abstract:OBJECTIVE:To address methodologic issues in searching for observational studies by presenting database search methods and results. STUDY DESIGN AND SETTING:Results of two literature searches for publications reporting on observational studies of alcohol consumption and the risk of breast cancer and large bowel cancer ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.03.004
更新日期:2005-09-01 00:00:00
abstract:OBJECTIVE:This study estimated the inter- and intraobserver reliability of a set of noninstrumented physical examination measures for knee pain in older adults. STUDY DESIGN AND SETTING:Forty-five patients from primary care, and 13 patients from secondary care, were each examined by two out of a team of three physical...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.11.004
更新日期:2006-05-01 00:00:00
abstract:OBJECTIVE:Exposure to ultraviolet radiation has consistently been linked to an increased risk of melanoma. Epidemiologic studies are susceptible to measurement error, which can distort the magnitude of observed effects. Although the reliability of self-report of many sun exposure factors has been previously described i...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.09.004
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVES:In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. STUDY DESIGN AND SETTINGS:We focus on challenges with rating the confidence in effect estima...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2012.04.012
更新日期:2013-02-01 00:00:00
abstract::Health screening is defined as the use of a test or a series of tests to detect unrecognized health risks or preclinical disease in apparently healthy populations to permit prevention and timely intervention. A health screening strategy consists of the sequence of a screening test, confirmatory test(s), and finally, t...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2010.09.009
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:To demonstrate the value of item response theory (IRT) and differential item functioning (DIF) methods in examining a health-related quality-of-life measure in children and adolescents. STUDY DESIGN AND SETTING:This illustration uses data from 5,429 children using the four subscales of the PedsQL 4.0 Generic...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2007.05.002
更新日期:2008-03-01 00:00:00
abstract:OBJECTIVE:Asymptomatic peripheral arterial occlusive disease (PAOD) is a common atherosclerotic disorder among the elderly population. Scarce data are available on the risk of nonfatal and fatal cardiovascular diseases in these subjects. We investigated cardiovascular morbidity and mortality of asymptomatic PAOD subjec...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2003.09.003
更新日期:2004-03-01 00:00:00
abstract::The traditional approach in epidemiology of relating exposure to an environmental agent such as a drug or infective agent has been to measure an overall risk (i.e., average and then "adjust risk for demographic variables and other confounders"). An attempt is sometimes made to define a "susceptible" subgroup. The anal...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(97)00052-8
更新日期:1997-06-01 00:00:00
abstract:OBJECTIVES:To assess differences between three different decision-making approaches in the method of panel diagnosis as reference standard in diagnostic research. STUDY DESIGN AND SETTING:Within a diagnostic study, the prevalence of heart failure (HF) and chronic obstructive pulmonary disease (COPD) was compared using...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2014.09.020
更新日期:2015-04-01 00:00:00
abstract:OBJECTIVE:To develop a questionnaire with which to measure quality of life (QoL) in patients with knee and hip osteoarthritis (OA). STUDY DESIGN AND SETTING:Thirty-two caregivers and 96 OA patients were interviewed individually (using cognitive and face-to-face techniques) and in focus groups. A group of experts worki...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2004.04.011
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVES:The receiver operating characteristic curves (ROC curves) are often used to compare continuous diagnostic tests or determine the optimal threshold of a test; however, they do not consider the costs of misclassifications or the disease prevalence. The ROC graph was extended to allow for these aspects. STUDY ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.01.003
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVES:To determine which factors predict favorable results and positive conclusions in systematic reviews (SRs) and to assess the level of agreement between SR results and conclusions. STUDY DESIGN AND SETTING:A sample of 296 English SRs indexed in MEDLINE (November, 2004) was obtained. Two investigators independ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.08.008
更新日期:2009-04-01 00:00:00
abstract:OBJECTIVES:To assess the role of quality of work-life (QWL) research in a clinical research environment. STUDY DESIGN AND SETTING:A phenomenological qualitative research study was conducted. This research was conducted in a large Canadian ambulatory cancer treatment center that serves over 2.3 million people in Ontari...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.03.003
更新日期:2008-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The prospective investigation of repetitive nonfatal suicidal behavior is associated with two methodological problems. Due to the commonly used definitions of nonfatal suicidal behavior, clinical samples usually consist of patients with a considerable between-person variability. Second, repeate...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.10.010
更新日期:2006-06-01 00:00:00
abstract::A 110-item food frequency questionnaire was tested among 152 community controls of the Kuopio Breast Cancer Study. They completed the questionnaire twice and kept two 7-day diet records at 3-month intervals. The intraclass correlations for nutrients varied from 0.49 (thiamine with supplements) to 0.81 (lactose), and f...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(95)00551-x
更新日期:1996-04-01 00:00:00
abstract::Mortality in relation to body mass index (BMI) was studied in 17,159 healthy Finnish women aged 25-79 followed up for a median of 12 years. Mortality from all cases was related to BMI only in non-smokers aged 25-64, among whom the mortality pattern was "U"-shaped, with a minimum in the second quintile of BMI (the refe...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90131-r
更新日期:1991-01-01 00:00:00
abstract::This study evaluated the reliability of a new medication appropriateness index. Using the index, independent assessments were made of chronic medications taken by 10 ambulatory, elderly male patients by a clinical pharmacist and an internist-geriatrician. Their overall inter-rater agreement for medication appropriaten...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(92)90144-c
更新日期:1992-10-01 00:00:00
abstract::The aim of this paper was to evaluate the combined effect of alcohol, smoking habits and frequency of consumption of selected dietary items, which are the major sources of retinoids and beta-carotene in the Italian diet, on the risk of esophageal cancer (EC). The adequacy of the multiplicative structure for describing...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(92)90035-l
更新日期:1992-04-01 00:00:00
abstract::Serum hepatitis C virus (HCV) RNA, HCV genotypes and liver function tests were evaluated in a series of 189 unselected, consecutive anti-HCV positive intravenous drug users (IVDUs). Serum HCV RNA was detected in 106/189 patients. Abnormal liver function tests were associated with alcohol abuse, but not with the presen...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(97)00305-3
更新日期:1998-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The level of agreement between index and proxy respondents on assessment of health status of clinical cohorts is variable. There is limited information regarding agreement between cardiac surgery patients and their proxies, and levels of agreement examined across repeated measures. This study e...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.06.010
更新日期:2006-02-01 00:00:00
abstract::The purpose of this study was to relate the 1-year risk of death and development of acute myocardial infarction among diabetics with acute chest pain to whether they had a history of hypertension or not. All patients with a history of diabetes mellitus who, during 21 months, were admitted to the Emergency Room in Sahl...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)90174-0
更新日期:1994-07-01 00:00:00
abstract:OBJECTIVE:To investigate the behavior of predictive performance measures that are commonly used in external validation of prognostic models for outcome at intensive care units (ICUs). STUDY DESIGN AND SETTING:Four prognostic models (Simplified Acute Physiology Score II, the Acute Physiology and Chronic Health Evaluati...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.08.011
更新日期:2007-05-01 00:00:00
abstract:OBJECTIVE:This cohort study investigated potential clinical and biochemical predictors of subsequent preterm birth in women presenting with threatened preterm labor. STUDY DESIGN AND SETTING:Subjects were 218 pregnant women admitted to hospital with a diagnosis of threatened preterm labor at 22-36 weeks gestation. Exc...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.06.015
更新日期:2005-03-01 00:00:00
abstract::The objective of our study was to assess the applicability of using estimates of within-person variance (WPV) from reproducibility studies for a correction of blood pressure values in another study to improve the accuracy of the prevalence estimation of hypertension. Data were collected from two cross-sectional popula...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(00)00228-6
更新日期:2000-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Podiatry (chiropody) services are one of the most frequently requested services in primary care. The elderly are given priority access to podiatry services in the UK blocking access for other priority groups. To evaluate the clinical and cost-effectiveness of a self-management program as a mea...
journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0895-4356(03)00197-5
更新日期:2003-11-01 00:00:00