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. STUDY DESIGN AND SETTING:We address several considerations for study design to prevent noncompliance or minimize its effects. Furthermore, we demonstrate how the instrumental variable method can give insight into the extent of bias introduced by noncompliance in randomized trials, within the context of the Sex Hormones and Physical Exercise study. RESULTS:Noncompliance can be prevented by measures taken in the design phase of a study, for example, limited duration of the study, clear recommendations, power calculation, intensity of the intervention, involvement of the control group, waiting-list control group, and single-consent design nested within an observational study. When nevertheless noncompliance does occur, the instrumental variable method estimates the intervention effect of treatment among the compliers. CONCLUSION:Noncompliance can seriously affect validity of lifestyle trial results. Its occurrence should be prevented by taking measures during the design phase of a study. The instrumental variable method can give insight into confounding by noncompliance in randomized trials.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Hertogh EM,Schuit AJ,Peeters PH,Monninkhof EMdoi
10.1016/j.jclinepi.2009.10.007subject
Has Abstractpub_date
2010-08-01 00:00:00pages
900-6issue
8eissn
0895-4356issn
1878-5921pii
S0895-4356(09)00356-4journal_volume
63pub_type
杂志文章abstract：OBJECTIVES:The aim of this study was to investigate the use of three treatment-effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results. STUDY DESIGN AND SETTING:A recent equivalence trial showed discordant results with the use of different measures....
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2017.12.010
更新日期：2018-04-01 00:00:00
abstract：OBJECTIVES:We sought to identify the proportion of systematic reviews of adverse effects which search for unpublished data and the success rates of identifying unpublished data for inclusion in a systematic review. STUDY DESIGN AND SETTING:Two reviewers independently screened all records published in 2014 in the Datab...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.05.003
更新日期：2016-09-01 00:00:00
abstract：:We examined whether sociodemographic, health, and psychosocial factors predict stage at diagnosis in 444 women aged 55-84 with newly diagnosed, microscopically confirmed breast cancer. Stage was defined as local or advanced (regional or remote). One of the most interesting predictors of disease stage was living arrang...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(93)90021-r
更新日期：1993-05-01 00:00:00
abstract：:Meta-analysis seems to have a potentially useful role in carefully selected situations where the primary literature is of good quality, heterogeneity in the response to treatment of the tested population is small and well-understood, interest centers on estimation of a specific, critical parameter of outcome, and the ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/0895-4356(94)00149-k
更新日期：1995-01-01 00:00:00
abstract：:The relationships between the prevalence of hepatitis B surface antigen (HBsAg), mean annual per capita alcohol consumption and primary liver cancer (PLC) death rates were explored in 30 countries. HBsAg prevalence was associated, significantly, with the logarithm of the primary liver cancer death rate (simple correla...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90165-5
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVE:This study tested the impact of web administration on well-established measures of children's physical function and quality of life. STUDY DESIGN AND SETTING:Participants were recruited from clinics at six hospitals. They completed the Activities Scale for Kids (ASK) and the Pediatric Quality of Life Invento...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2008.06.011
更新日期：2009-03-01 00:00:00
abstract：:This study aims to estimate the prevalence of Helicobacter pylori in Glasgow, and to provide a systematic analysis of factors associated with this prevalence. The data used are from a random population sample of 793 men and 838 women aged 25-64 years conducted in 1995. The prevalence is estimated to be 66% (95% confid...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00171-7
更新日期：2000-02-01 00:00:00
abstract：OBJECTIVE:To determine the frequency of unpublished systematic reviews (SRs) and explore factors contributing to their occurrence. STUDY DESIGN AND SETTING:First or corresponding authors from a sample of SRs published in 2005 were asked to participate in a 26-item survey administered through the Internet, facsimile, a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.09.014
更新日期：2009-06-01 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 develop the first item bank to measure stress resilience (SR) in clinical populations. STUDY DESIGN AND SETTING:Qualitative item development resulted in an initial pool of 131 items covering a broad theoretical SR concept. These items were tested in n = 521 patients at a psychosomatic outpatient clinic. ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.04.004
更新日期：2018-08-01 00:00:00
abstract：:The application of rigorous epidemiologic methods to clinical questions has broadened the scope of research in epidemiology and enhanced the quality of clinical research. The International Clinical Epidemiology Network (INCLEN) has enabled physicians from developing countries to obtain training in epidemiologic method...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(89)90013-9
更新日期：1989-01-01 00:00:00
abstract：OBJECTIVE:Regression discontinuity (RD) is a quasi-experimental design that may provide valid estimates of treatment effects in case of continuous outcomes. We aimed to evaluate validity and precision in the RD design for dichotomous outcomes. STUDY DESIGN AND SETTING:We performed validation studies in three large ran...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.02.015
更新日期：2018-06-01 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：OBJECTIVES:To investigate whether the relationship between demographic and disease-related variables and disability is constant during the first five years of inflammatory polyarthritis (IP) and to identify the contribution from involvement of specific joint areas to overall disability. METHODS:684 patients referred t...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00189-x
更新日期：2000-10-01 00:00:00
abstract：OBJECTIVES:The STAndards for Reporting studies of Diagnostic accuracy (STARD) for investigators and editors and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) for reviewers and readers offer guidelines for the quality and reporting of test accuracy studies. These guidelines address and propose some solu...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.02.007
更新日期：2009-04-01 00:00:00
abstract：OBJECTIVES:To identify key principles of graph construction and to review guidance on graph construction provided by medical journals. STUDY DESIGN AND SETTING:Review of a prevailing model of graph comprehension and survey of authors' instructions for all 120 core medical journals as indexed by PubMed. RESULTS:Graph ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.12.016
更新日期：2006-10-01 00:00:00
abstract：:The "iatrotropic stimulus" is a typical example of Alvan Feinstein's terminology and his clinical way of thinking about medical research. Feinstein specified "interiatric referral" as an additional important factor affecting "the likelihood that patients will appear at the particular setting in which research is being...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(02)00528-0
更新日期：2002-12-01 00:00:00
abstract：:Altogether, 3365 men and 3266 women who attended two cardiovascular screenings in 1974-1975 and 1977-1978, have been followed with respect to death for an average of 15 years. The mortality from coronary heart disease was lower in men who reported being of Lappish origin than in men who reported Norse origin at both s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00021-8
更新日期：1997-06-01 00:00:00
abstract：:This study developed and validated a multidimensional measure of dyspepsia. A questionnaire was administered to 126 patients with dyspepsia who presented for care at a VA outpatient clinic and a family physician's private office. Dyspepsia-specific health was measured by self-report using: (1) an existing dyspepsia sc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00245-x
更新日期：1998-02-01 00:00:00
abstract：:The objective of this study was to identify characteristics of non-respondents and late respondents to a mailed health survey. Persons who returned and those who did not return the questionnaire were compared using health insurance data, which indicated their age, sex, and health care expenditures in the previous year...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00166-2
更新日期：1997-10-01 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：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：:The uses of hypothesis in scientific medicine and in clinical medicine are broadly similar; but they differ in subtle but important logical details. The key distinction is that scientific medicine deals with broad ("public") hypotheses about entire populations; and the predominant problem of inference is statistics in...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(89)90028-0
更新日期：1989-01-01 00:00:00
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：OBJECTIVES:The current format of summary of findings (SoFs) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key information in systematic reviews. Users of SoF tables have demanded alternative formats to express findings from systematic reviews. ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2015.12.007
更新日期：2016-06-01 00:00:00
abstract：OBJECTIVE:To assess the quality of clinical practice guidelines providing recommendations on the frequency of mammography screening in asymptomatic, average-risk women 40-49 years of age. STUDY DESIGN AND SETTING:We searched the National Guideline Clearinghouse and MEDLINE for guidelines published from 2005 to 2010. F...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.12.005
更新日期：2011-09-01 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：:Three acute coronary care surveys (1986, 1990, and 1993) were conducted in the Swiss region of Vaud-Fribourg on all men aged 25 to 64 years hospitalized for a definite myocardial infarction (218, 224, and 167 cases). Nearly all patients received anticoagulants and nitrates. The proportion of patients treated increased...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(98)00049-3
更新日期：1998-09-01 00:00:00
abstract：OBJECTIVE:To compare the discriminatory ability of Rasch-based and summative scoring in the context of assessing upper limb function of patients with stroke. STUDY DESIGN AND SETTING:Data were from a cohort study of 497 adults with stroke undergoing physiotherapy. Upper limb function was assessed at admission and disc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2012.12.014
更新日期：2013-06-01 00:00:00
abstract：:The objective of the study was to determine the sensitivity and specificity of the National Cholesterol Education Program (NCEP) guidelines in identifying at-risk individuals for hypercholesterolemia, using population-based data from the Manitoba Heart Health Survey (MHHS). The MHHS surveyed a representative sample of...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90301-8
更新日期：1994-05-01 00:00:00
