Abstract：
:To determine eligibility for a (randomized) clinical trial, measuring the inclusion and exclusion criteria can be extended over a period of time. During this period, known as the selection period, a patient is repeatedly examined at certain time intervals. This study describes an approach for optimizing the efficiency of the selection period. Efficiency is defined as the costs of randomizing one patient. The objective is to construct prediction models based on data obtained early in the selection period to predict subsequent exclusions. A prediction model increases the efficiency if after its application the costs per randomization are lower. The approach is illustrated using data from the selection period of the Rotterdam Cardiovascular Risk Intervention (ROCARI) trial which was composed of five consecutive patient visits. At each visit, data to determine eligibility was obtained. We found that logistic regression models based on data of the first and second visit could predict exclusions during the third visit. Application of the prediction models suggested that in this particular trial the costs per randomization would decrease by $52. As the initial costs per randomization were $1444, there would be a 3.6% (52/1444) savings in recruitment costs under the prediction models, accounting for a savings of more than $450,000. We conclude that the use of data obtained early in a selection period can predict subsequent exclusions, and therefore could increase the efficiency of such a period. The approach could be applied to data obtained in a pilot study as well as data obtained in the beginning of a prolonged intake period.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Moons CK,van Es GA,Stijnen T,Bak AA,Hofman A,Jonker JJ,Habbema JD,Grobbee DEdoi
10.1016/s0895-4356(97)00069-3subject
Has Abstractpub_date
1997-07-01 00:00:00pages
793-800issue
7eissn
0895-4356issn
1878-5921pii
S0895435697000693journal_volume
50pub_type
杂志文章abstract：:In middle-aged people, social class is one of the strongest predictors of mortality. However, to date, research prospectively evaluating the relationship between social class and mortality in the older persons has produced conflicting results. This may be due to the lack of clinical covariates in many analyses. The ob...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(02)00464-x
更新日期：2002-10-01 00:00:00
abstract：OBJECTIVE:To assess the consistency of an index of the scientific quality of research overviews. DESIGN:Agreement was measured among nine judges, each of whom assessed the scientific quality of 36 published review articles. ITEM SELECTION: An iterative process was used to select ten criteria relative to five key tasks...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析
doi：10.1016/0895-4356(91)90205-n
更新日期：1991-01-01 00:00:00
abstract：OBJECTIVE:In lifestyle intervention trials, participants of the control group often change their behavior despite the request to maintain their usual lifestyle pattern. These changes in the control group and changes in addition to the intended in the intervention group can lead to undesirable confounding effects. STUD...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2009.10.007
更新日期：2010-08-01 00:00:00
abstract：OBJECTIVES:The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING:Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., jour...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2017.07.014
更新日期：2017-11-01 00:00:00
abstract：OBJECTIVES:To evaluate the presence of extreme findings and fluctuation in effect size in endocrinology. STUDY DESIGN AND SETTINGS:We systematically identified all meta-analyses published in 2014 in the field of endocrinology. Within each meta-analysis, the effect size of the primary binary outcome was compared across...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.jclinepi.2015.10.015
更新日期：2016-04-01 00:00:00
abstract：:Community intervention evaluations that measure changes over time may conduct repeated cross-sectional surveys, follow a cohort of residents over time, or (often) use both designs. Each survey design has implications for precision and cost. To explore these issues, we assume that two waves of surveys are conducted, an...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00055-0
更新日期：1995-12-01 00:00:00
abstract：OBJECTIVES:To systematically evaluate the use of Framingham Risk Score (FRS) in the medical literature and specifically examine the use of FRS in different populations and settings and for different outcomes than the ones originally developed for. STUDY DESIGN AND SETTING:We identified all the citations to the article...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2013.10.021
更新日期：2014-05-01 00:00:00
abstract：OBJECTIVE:To explore designs for evaluating the prognostic and predictive value of medical tests and their effect on patient outcome. STUDY DESIGN:Theoretical analysis with examples from the medical literature. RESULTS:For evaluating the prognostic value of a test, one can include the test at baseline in prognostic s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.06.017
更新日期：2009-04-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:Psychometrically sound questionnaires for the assessment of vision-related quality of life (QOL) are scarce. Therefore, the objective was to further validate two vision-related QOL questionnaires in a Dutch population of visually impaired elderly. METHODS:A total of 329 visually impaired older...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.04.007
更新日期：2005-12-01 00:00:00
abstract：OBJECTIVE:Risk difference (RD) is often estimated from relative association measures generated by meta-analysis and a particular group's baseline risk. We describe a problematic situation in using this approach. STUDY DESIGN AND SETTING:We encountered a meta-analysis in which a confidence interval (CI) of relative ris...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.11.005
更新日期：2009-08-01 00:00:00
abstract：:The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method implementation evidence. Choice of appropriate methodologies, methods, and tools is essential when developing a rigorous protocol and conducting the synthesis. Cochrane authors who...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2017.06.020
更新日期：2018-05-01 00:00:00
abstract：:We performed analyses to examine the structure, validity, and responsiveness to change of the Marks Asthma Quality of Life Questionnaire (AQLQ), originally validated in Australia in a self-administered format, among 539 U.S. subjects with asthma. Subjects were interviewed twice by telephone over an 18-month period. Ba...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00026-8
更新日期：1999-07-01 00:00:00
abstract：:For deaths during the first 13 years of follow-up of the Minnesota Colon Cancer Control Study, an expert committee using numerous medical documents, and a nosologist using only the death certificate independently determined whether colorectal cancer caused the death and, if not, whether the disease was present at deat...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00016-5
更新日期：1999-05-01 00:00:00
abstract：OBJECTIVE:The Kaplan-Meier method may overestimate absolute mortality risk (AMR) in the presence of competing risks. Urgent heart transplantation (UHT) and ventricular assist device implantation (VADi) are important competing events in heart failure. We sought to quantify the extent of bias of the Kaplan-Meier method i...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.07.006
更新日期：2018-11-01 00:00:00
abstract：:The associations between nine domain-specific measures of health (e.g., depressive symptoms, psychological distress, mental health, physical functioning, role functioning, social functioning, bodily pain, somatic symptoms, and chronic medical morbidity) and a single-item measure for perceived overall health were studi...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00234-5
更新日期：1998-01-01 00:00:00
abstract：:This paper reports a prospective study, carried out in elderly patients hospitalized for acute illness, designed to evaluate the effectiveness of medical treatment from the point of view of quality of life (QoL). Patient's autoperception and satisfaction with health, the most relevant subjective estimates of QoL, were...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)00237-k
更新日期：1995-08-01 00:00:00
abstract：BACKGROUND:Recently updated guidelines by the American College of Cardiology/American Heart Association and the European Society of Cardiology recommend at least 12 hours bed rest in patients with uncomplicated myocardial infarction. METHODS:We performed a systematic literature review and meta-analysis of randomized a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析,评审
doi：10.1016/s0895-4356(03)00121-5
更新日期：2003-08-01 00:00:00
abstract：OBJECTIVES:New evidence continues to emerge and requires attention after the release of a clinical practice guideline (CPG). The objective of this article is to describe the Document Assessment and Review (DAR) strategy designed to ensue that the CPGs remain current and their quality maintained and to present the resul...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2014.06.013
更新日期：2014-12-01 00:00:00
abstract：OBJECTIVES:To present estimates of clinically meaningful or minimal important changes for the Oxford Hip Score (OHS) and the Oxford Knee Score (OKS) after joint replacement surgery. STUDY DESIGN AND SETTING:Secondary data analysis of the NHS patient-reported outcome measures data set that included 82,415 patients list...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2014.08.009
更新日期：2015-01-01 00:00:00
abstract：:A prospective study on the effects of occupational and individual factors on neck trouble was carried out among 1832 men representing static work with whole-body vibration (machine operators), dynamic physical work (construction carpenters) and sedentary work (office workers). Neck trouble and occupational and individ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90085-x
更新日期：1994-12-01 00:00:00
abstract：:This paper focuses on the appropriateness of outcome measures to evaluate trauma care. The preventable death rate (PDR), based on the study of deceased patients only, has been the traditional measure of the impact of trauma care on improving the survival of patients with severe trauma. Another measure frequently used ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90125-9
更新日期：1990-01-01 00:00:00
abstract：:The aim of this study was to investigate the relationship between history of selected diseases, genital traumas, and Peyronie's disease. A hospital-based case-control study was conducted at the Andrologic and Surgical Outpatient Units of the Policlinico Gemelli, Rome, where 134 men with Peyronie's disease and 134 male...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(98)00015-8
更新日期：1998-06-01 00:00:00
abstract：:We studied the relationship between age at natural menopause and total mortality as well as mortality from ischemic heart disease in a cohort of 6182 California Seventh-Day Adventist women who reported a natural menopause. During follow-up from 1976 through 1988, there were 1831 deaths. A total of 308 deaths due to is...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(98)00170-x
更新日期：1999-04-01 00:00:00
abstract：OBJECTIVES:Previous mathematical analyses of diagnostic tests based on the categorization of a continuous measure have found that test sensitivity and specificity varies significantly by disease prevalence. This study determined if the accuracy of diagnostic codes varied by disease prevalence. STUDY DESIGN AND SETTING...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.05.009
更新日期：2016-11-01 00:00:00
abstract：:Articles alleging hazards of electric or magnetic fields, based on epidemiologic studies, have appeared in the popular press. Some of these articles, which contain distortions of the scientific evidence, have been cited in the scientific and medical literature, thereby being given some degree of apparent legitimacy. I...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90154-f
更新日期：1992-10-01 00:00:00
abstract：OBJECTIVE:Research on emotional distress and mortality has largely focused on depression in men and in elderly populations. We examined the relation between anxiety and mortality in women at midlife, adjusting for depression. STUDY DESIGN AND SETTING:At baseline, 5,073 healthy Dutch women aged 46-54 years (mean=50.4+/...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.08.006
更新日期：2009-04-01 00:00:00
abstract：:Early identification of pregnant women infected with the human immunodeficiency virus (HIV) is becoming increasingly important in light of recent findings that interventions during and shortly after pregnancy can reduce the rates of vertical transmission. The ability of patients to accurately self-report previous HIV ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(96)00301-0
更新日期：1997-01-01 00:00:00
abstract：:With advances made in the treatment of people with HIV/AIDS, there is an increasing number of persons who are reaching old age. This is a heterogeneous group. Yet, all of these diverse patients share in common the challenge of aging successfully despite their condition. There is little room in most gerontological conc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/s0895-4356(01)00447-4
更新日期：2001-12-01 00:00:00
abstract：:To assess fracture risk following bilateral oophorectomy, we conducted a population-based retrospective cohort study among the 463 Rochester, Minnesota women who underwent bilateral oophorectomy for benign ovarian conditions in 1950-1979. During 7220 person-years of observation, there appeared to be a modest increase ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(96)00211-9
更新日期：1996-10-01 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
