Abstract:
OBJECTIVE:In some trials, the intervention is delivered to individuals in groups, for example, groups that exercise together. The group structure of such trials has to be taken into consideration in the analysis and has an impact on the power of the trial. Our aim was to provide optimal methods for the design and analysis of such trials. STUDY DESIGN AND SETTING:We described various treatment allocation methods and presented a new allocation algorithm: optimal batchwise minimization (OBM). We carried out a simulation study to evaluate the performance of unrestricted randomization, stratification, permuted block randomization, deterministic minimization, and OBM. Furthermore, we described appropriate analysis methods and derived a formula to calculate the study size. RESULTS:Stratification, deterministic minimization, and OBM had considerably less risk of imbalance than unrestricted randomization and permuted block randomization. Furthermore, OBM led to unpredictable treatment allocation. The sample size calculation and the analysis of the study must be based on a multilevel model that takes the group structure of the trial into account. CONCLUSION:Trials evaluating interventions that are carried out in subsequent groups require adapted treatment allocation, power calculation, and analysis methods. From the perspective of obtaining overall balance, we conclude that minimization is the method of choice. When the number of prognostic factors is low, stratification is an excellent alternative. OBM leads to better balance within the batches, but it is more complicated. It is probably most worthwhile in trials with many prognostic factors. From the perspective of predictability, a treatment allocation method, such as OBM, that allocates several subjects at the same time, is superior to other methods because it leads to the lowest possible predictability.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Faes MC,Reelick MF,Perry M,Olde Rikkert MG,Borm GFdoi
10.1016/j.jclinepi.2011.05.007subject
Has Abstractpub_date
2012-02-01 00:00:00pages
138-46issue
2eissn
0895-4356issn
1878-5921pii
S0895-4356(11)00160-0journal_volume
65pub_type
杂志文章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:OBJECTIVE:The uptake of research findings into routine health care is a haphazard and unpredictable process. The usefulness of the results of implementation studies is limited, due in part to the lack of an underlying framework of the important dimensions of research studies in this area and the healthcare settings wit...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.09.002
更新日期:2005-02-01 00:00:00
abstract:OBJECTIVES:To investigate the application of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the quality of evidence ratings in systematic reviews of complex interventions. STUDY DESIGN AND SETTING:This study examined all 40 systematic reviews published in three Cochrane Rev...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.03.014
更新日期:2016-10-01 00:00:00
abstract:OBJECTIVE:To determine the status of dementia care services and workforce in selected public and private hospitals and geriatric care facilities in the Philippines. STUDY DESIGN AND SETTING:Framework analysis of 54 key informant interviews, 4 focus group discussions, and survey of 167 workers in 26 purposively selecte...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2018.06.010
更新日期:2018-10-01 00:00:00
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 dep...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2016.11.001
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a growing evidence base on methods to improve response rates in surveys among patients. This study aimed to determine the additional effect of two intensive follow-up procedures compared to a simple follow-up procedure. METHODS:Randomized controlled trial that compared repeated mailin...
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/j.jclinepi.2005.03.002
更新日期:2005-09-01 00:00:00
abstract::The Indonesian Food and Drug Agency began to evaluate drug applications in the early 1970s through an Advisory Committee. This was in response to the perestroika-like policy applied to our drug industry; nowadays there are more than 300 drug companies formulating some 13,5600 drug products. During 1977-1988, 603 drugs...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90111-l
更新日期:1991-01-01 00:00:00
abstract:OBJECTIVES:Accurately predicting hospital mortality is necessary to measure and compare patient care. External validation of predictive models is required to truly prove their utility. This study assessed the Kaiser Permanente inpatient risk adjustment methodology for hospital mortality in a patient population distinct...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2009.08.020
更新日期:2010-07-01 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:The use of then-test (retrospective pre-test) scores has frequently been proposed as a solution to potential confounding of change scores because of response shift, as it is assumed that then-test and post-test responses are provided from the same perspective. However, this assumption has not been formally te...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2009.01.021
更新日期:2009-11-01 00:00:00
abstract::Breast cancer therapy is often followed by a decline in upper-body function. Women (303) diagnosed with stage I or II breast cancer were interviewed 5 and 21 months after surgery and their medical records were reviewed. Women with cardiopulmonary comorbidity had an odds ratio for decline at the 5-month interview of 2....
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00176-6
更新日期:2000-06-01 00:00:00
abstract::The history of the application of statistical theory to the analysis of clinical trials is reviewed. The current orthodoxy is a somewhat illogical hybrid of the original theory of significance tests of Edgeworth, Karl Pearson, and Fisher, and the subsequent decision theory approach of Neyman, Egon Pearson, and Wald. T...
journal_title:Journal of clinical epidemiology
pub_type: 历史文章,杂志文章
doi:10.1016/s0895-4356(99)00156-0
更新日期:2000-03-01 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: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:BACKGROUND AND OBJECTIVE:To test unidimensionality and local independence of a set of shoulder functional status (SFS) items, develop a computerized adaptive test (CAT) of the items using a rating scale item response theory model (RSM), and compare discriminant validity of measures generated using all items (theta(IRT)...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.08.006
更新日期:2006-03-01 00:00:00
abstract::We analyzed data from outpatients with chronic low back pain (LBP) in the Veterans Health Study (n = 563) to examine the relationship between localized LBP intensity and radiating leg pain in assessing patient functional status, low back disability, and use of diagnostic imaging. Based on the localized LBP intensity, ...
journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/s0895-4356(99)00094-3
更新日期:1999-11-01 00:00:00
abstract::In the Upper Bavarian Field Study a total of 1536 persons (15 years and older) were interviewed by research psychiatrists. 8.1% of all respondents took a psychotropic drug during the 7 days prior to the interview. The consumption rate among women was about three times as high as that for men. The use of psychotropic d...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90042-8
更新日期:1991-01-01 00:00:00
abstract::To assess the independent prognostic role of functional status, as reflected by a measure of an inpatient's global requirement for nursing assistance with basic activities of daily living (Global ADL), we compared Global ADL with three validated AIDS mortality predictors: the Clinical AIDS Prognostic Staging (CAPS); t...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/0895-4356(95)00546-3
更新日期:1996-02-01 00:00:00
abstract:OBJECTIVE:Citations by other researchers are important in the dissemination of research findings. We aimed to investigate whether preferential citation of statistically significant articles exists in the psychiatric literature. STUDY DESIGN AND SETTINGS:We analyzed all original research papers published in 1996 in fou...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.11.014
更新日期:2007-09-01 00:00:00
abstract:OBJECTIVE:A method to generate hypotheses about iatrogenic risk factors and complications from administrative data was developed and tested using hospitalization of the elderly for depression as a model. STUDY DESIGN AND SETTING:Hospital claims were selected for 30,998 elderly inpatients admitted for the first time fo...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.08.002
更新日期:2005-02-01 00:00:00
abstract:OBJECTIVES:The objective of this study was to analyze adequacy of judgments about risk of bias (RoB) for blinding of participants and personnel (performance bias) in Cochrane systematic reviews of randomized controlled trials (RCTs). STUDY DESIGN AND SETTING:We extracted judgments and supporting comments for performan...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.05.012
更新日期:2019-09-01 00:00:00
abstract:UNLABELLED:To systematically investigate location bias of controlled clinical trials in complementary/alternative medicine (CAM). METHODS:Literature searches were performed to identify systematic reviews and meta-analyses, which were used to retrieve controlled clinical trials. Trials were categorised by whether they ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00220-6
更新日期:2000-05-01 00:00:00
abstract:OBJECTIVE:Cochrane acute respiratory infections (ARIs) group conducts systematic reviews of the evidence for treatment and prevention of ARIs. We report the results of a prioritization project, aiming to identify highest priority systematic review topics. STUDY DESIGN/SETTING:The project consisted of two phases. Phase...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2018.05.016
更新日期:2018-10-01 00:00:00
abstract:OBJECTIVES:Recent studies suggest that rating clinical marker states (CMS) does not improve the measurement properties of the standard gamble (SG) and only slightly improves those of the feeling thermometer (FT). The poor intrarater (test-retest) reliability of CMS may explain their meager performance. Further, lack of...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2007.03.010
更新日期:2007-12-01 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:OBJECTIVE:To systematically review methodological articles which focus on nonpublication of studies and to describe methods of detecting and/or quantifying and/or adjusting for dissemination in meta-analyses. To evaluate whether the methods have been applied to an empirical data set for which one can be reasonably conf...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.04.015
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study describes the conceptual foundation and psychometric properties of the Burden of Stroke Scale (BOSS), a patient-reported health status assessment designed to quantify the physical, cognitive, and psychological burden of stroke. METHODS:Qualitative research methods were used to devel...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.11.016
更新日期:2004-10-01 00:00:00
abstract:OBJECTIVE:Cases and controls should be chosen from the same base population to reduce selection bias in case-control studies. For hospital cases, we examined how inferences drawn from a case-control study can differ by choice of hospital- vs. community-based controls. STUDY DESIGN AND SETTINGS:We used data from a case...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2009.11.006
更新日期:2010-08-01 00:00:00
abstract::The effect of age, sex, diabetes, hypertension, pulse rate and cigarette smoking on extracranial carotid artery plaque thickness evaluated by B-mode ultrasonography was investigated in a cross-sectional study of 698 white men, 730 white women, 77 black men and 76 black women as part of a clinical ultrasound registry. ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90151-0
更新日期:1989-01-01 00:00:00
abstract::The present paper analyses the epidemiologic effects of mass breast cancer screening. Mass mammography may possibly achieve a breast cancer mortality reduction in relative risk terms. However, this does not necessarily represent a net benefit. It is argued that the benefits and adverse effects of a screening programme...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/0895-4356(90)90002-7
更新日期:1990-01-01 00:00:00