Abstract：
BACKGROUND AND OBJECTIVES:To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. MATERIALS AND METHODS:Using PubMed, we identified empirical studies, anecdotal reports, and opinion pieces addressing the process of obtaining initial IRB approval for multicenter clinical trials and observational studies. We also reviewed relevant information from federal and other national sources. RESULTS:A total of 40 peer-reviewed articles were synthesized, plus six reports from commissions or other key sources. These sources identified numerous challenges that researchers may encounter when multicenter studies undergo review by multiple IRBs, such as added time for initial review and approval and different requirements across IRBs. Strategies to alleviate these challenges include planning to accommodate multiple reviews and determining upfront whether certain variations to study protocols are tolerable across sites. Many researchers and commissions have proposed comprehensive reforms, such as centralized review for multicenter projects. CONCLUSION:Policy-makers, researchers, and IRBs should convene to specifically discuss optimal approaches for multicenter review. However, until structural changes are implemented, observational researchers should develop and implement strategic plans for obtaining IRB approval in multicenter studies, including adopting models successfully employed by clinical trials.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Greene SM,Geiger AMdoi
10.1016/j.jclinepi.2005.11.018subject
Has Abstractpub_date
2006-08-01 00:00:00pages
784-90issue
8eissn
0895-4356issn
1878-5921pii
S0895-4356(06)00007-2journal_volume
59pub_type
杂志文章,评审abstract：:We assessed the relationship between characteristics of stroke victims and the risk of early death from coronary or cerebrovascular disease (CCVD) among their children. For each of 55 stroke patients selected from a registry which enrolled patients between 1969 and 1973, an index of their progeny's survival was calcul...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90055-t
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVES:Understanding patterns of maternity care requires knowing which women have given birth previously, but this information is typically unavailable in administrative hospital data sets. We assessed how well parity can be derived using linked historical records. STUDY DESIGN AND SETTING:Using Hospital Episode S...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2013.10.011
更新日期：2014-05-01 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：: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：:To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We use...
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(01)00477-2
更新日期：2002-03-01 00:00:00
abstract：:The study assesses the reliability, validity and responsiveness of the UK version of the Seattle Angina Questionnaire (SAQ-UK). The instrument was anglicised and administered by self-completed postal questionnaire to 959 patients recruited from general practices in the North East of England. A total of 655 (68.3%) pat...
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(01)00352-3
更新日期：2001-09-01 00:00:00
abstract：:Associations of baseline one-hour postload plasma glucose with 22-year coronary heart disease, stroke, cardiovascular diseases, and all cause mortality were assessed in five age-specific cohorts of nondiabetic men and women from the Chicago Heart Association Detection Project in Industry: 10,269 men ages 18-39 years; ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00201-1
更新日期：1997-12-01 00:00:00
abstract：OBJECTIVES:To examine whether the number of early online accesses to medical research articles predicts citations in the scientific literature over time. STUDY DESIGN AND SETTING:Cohort study of research articles published in the BMJ between January and June 1999. The number of online assesses within 1 week of publica...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.01.024
更新日期：2015-12-01 00:00:00
abstract：:Randomized trials are the optimal approach for evaluations of treatment efficacy but may not always be feasible. We study the adequacy of the case-control design in evaluating efficacy in a situation where the investigated therapy, namely the administration of magnesium sulfate for the prevention of eclampsia in patie...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(96)00421-0
更新日期：1997-04-01 00:00:00
abstract：OBJECTIVES:To evaluate the effectiveness of pre-notification and pleading invitations in Web surveys by embedding a randomized controlled trial (RCT) in a Web-based survey. STUDY DESIGN AND SETTING:E-mail addresses of 569 authors of published maternal health research were randomized in a 2×2 factorial trial of a pre-n...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2010.06.001
更新日期：2011-05-01 00:00:00
abstract：:A literature search identified eight articles containing data on both baldness and coronary artery disease (CAD). Three of these articles described case-control studies that showed a positive relationship between baldness and CAD when controlling for CAD risk factors. Three other case-control studies showed no such re...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/0895-4356(90)90026-l
更新日期：1990-01-01 00:00:00
abstract：:Evaluating the incremental cost-effectiveness of a technology is critical to understanding the impact of its adoption. The purpose of this study was to evaluate, using a particular example, how the specific alternatives selected for a cost-effectiveness analysis may influence the results of the analysis. In this examp...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00021-9
更新日期：1999-06-01 00:00:00
abstract：OBJECTIVE:Graphical methods for generating explanatory hypotheses from limited categorical data are described and illustrated. STUDY DESIGN AND SETTING:Univariate, bivariate, multivariate, and multiplicative graphical methods were applied to clinical data regarding very ill older persons. The data to which these metho...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2011.06.007
更新日期：2012-02-01 00:00:00
abstract：OBJECTIVES:Case-mix adjustment is difficult for stroke outcome studies using administrative data. However, relevant prescription, laboratory, procedure, and service claims might be surrogates for stroke severity. This study proposes a method for developing a stroke severity index (SSI) by using administrative data. ST...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.01.009
更新日期：2015-11-01 00:00:00
abstract：OBJECTIVES:To develop a scale and survey the measurement of patient adherence and patient recruitment, and to explore how these methods impact the results in randomized controlled trials of interventions to improve patient adherence to medications. STUDY DESIGN:Analytic survey of a purposively selected sample of patie...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2014.06.008
更新日期：2014-10-01 00:00:00
abstract：OBJECTIVES:Elderly patients are inordinately affected by surgical site infections (SSIs). This study derived and internally validated a model that used routinely collected health administrative data to measure the probability of SSI in elderly patients within 30 days of surgery. STUDY DESIGN AND SETTING:All people exc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.05.010
更新日期：2016-09-01 00:00:00
abstract：OBJECTIVE:To provide information concerning the magnitude of the intraclass correlation coefficient (ICC) for cluster-based studies set in primary care. STUDY DESIGN AND SETTING:Reanalysis of data from 31 cluster-based studies in primary care to estimate intraclass correlation coefficients from random effects models u...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析,评审
doi：10.1016/j.jclinepi.2003.12.013
更新日期：2004-08-01 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:To assess the impact of including unpublished data on adverse effects in systematic reviews. STUDY DESIGN AND SETTING:We carried out a systematic review of methodological evaluations that compared the quantitative reporting of adverse effects data between published and unpublished sources, in particular, the...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.02.009
更新日期：2010-10-01 00:00:00
abstract：:To identify characteristics of certifying physicians and the deceased that are associated with errors in death certificate completion in Taiwan, we retrospectively reviewed 4123 systematically sampled death certificates issued in 1994. Multivariate analyses were used to assess the associations of various characteristi...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00299-7
更新日期：2001-03-01 00:00:00
abstract：:Recently, there has been a great deal of discussion regarding the use of administrative databases to study outcomes of medical care. A major issue in this discussion is how to classify patients in terms of characteristics such as disease-severity, comorbidities, resource needs, stability, etc. Different indices have b...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)00202-2
更新日期：1995-07-01 00:00:00
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...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00069-3
更新日期：1997-07-01 00:00:00
abstract：OBJECTIVES:The objective of this study was to assess if there is evidence of publication bias in prognostic accuracy studies of middle cerebral artery (MCA) or cerebroplacental ratio (CPR) for adverse perinatal outcome. STUDY DESIGN AND SETTING:We queried PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov an...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2019.07.016
更新日期：2019-12-01 00:00:00
abstract：OBJECTIVE:To illustrate and discuss current and proposed new concepts of effect size (ES) quantification and significance, with a focus on statistical and clinical/subjective interpretation and supported by empirical examples. STUDY DESIGN AND SETTINGS:Different methods for determining minimal clinically important dif...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.11.016
更新日期：2017-02-01 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：OBJECTIVE:To describe the pain decrease considered as clinically relevant when designing a trial and reporting its results. METHODS:A systematic review of the literature in MEDLINE was conducted to select randomized controlled trials (RCTs) with pain as a primary outcome. Data extracted included the definition (terms ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.06.008
更新日期：2011-05-01 00:00:00
abstract：OBJECTIVES:To review James Jackson's analysis of bloodletting among pneumonitis patients at the newly founded Massachusetts General Hospital, in which he implemented the numerical method advocated by Pierre-Charles-Alexandre Louis. STUDY DESIGN AND SETTING:The study sample included 34 cases of clinically diagnosed pne...
journal_title：Journal of clinical epidemiology
pub_type： 传,历史文章,杂志文章
doi：10.1016/j.jclinepi.2014.10.013
更新日期：2015-04-01 00:00:00
abstract：OBJECTIVES:To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries analogous to interim m...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2007.10.007
更新日期：2008-08-01 00:00:00
abstract：OBJECTIVE:To test the effect of postal randomization on recruitment of patients into a randomized trial in primary care. STUDY DESIGN AND SETTING:General practices used a telephone service to randomize patients in our trial. Delays in the start of recruitment at some sites led us to modify the randomization procedure....
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2007.04.003
更新日期：2007-10-01 00:00:00
abstract：:The incidence and mortality due to the major cancers such as lung, breast, colon-rectum, prostate, and ovary have changed very little over the past 20-30 years, in spite of the introduction of important new treatments and apparent prolongation of survival of patients with these cancers. The new strategies focus on ear...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90205-4
更新日期：1994-06-01 00:00:00
