Abstract：
OBJECTIVE:When studying the effects of a non-pharmacologic intervention, the choice of a control group is often difficult. In a study on the effectiveness of increased water intake on voiding dysfunction in elderly men we used an unusual design. This article addresses the internal validty and ethics of this design. STUDY DESIGN AND SETTING:The randomized trial we evaluated had a 6-month follow-up period and was carried out among 141 elderly men with moderate lower urinary tract symptoms. The experimental group was given the instruction to drink more water, the control group received placebo medication. The participants were not informed that there was a 50% chance of receiving placebo. We measured whether the prior expectations and preferences were comparable for the two study groups, whether blinding was preserved throughout the study period, and whether the participants considered this design ethical. RESULTS:Prior to randomization, patients had higher expectations for the experimental intervention, but there was not statistically significant difference in their preference. During the study period, two out of 71 patients in the control group unmasked the placebo. In general, both groups fully agreed with the informed consent procedure. CONCLUSION:This design can be considered when the effects of a non-pharmacologic interventions are studied.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Spigt MG,Knipschild PG,van Schayck CP,Knottnerus JAdoi
10.1016/j.jclinepi.2004.08.009subject
Has Abstractpub_date
2005-04-01 00:00:00pages
350-6issue
4eissn
0895-4356issn
1878-5921pii
S0895-4356(04)00264-1journal_volume
58pub_type
杂志文章abstract：OBJECTIVE:To assess the extent to which meta-analysis publications of drugs and biologics focus on specific named agents or even only a single agent, and identify characteristics associated with such focus. STUDY DESIGN AND SETTING:We evaluated 499 articles with meta-analyses published in 2010 and estimated how many d...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2012.10.014
更新日期：2013-04-01 00:00:00
abstract：OBJECTIVES:The objective of this study was to determine the applicability of utilizing the N-of-1 method for deprescribing trials in older adults. STUDY DESIGN AND SETTING:Systematic review of any human studies conducted in older adults (≥50 years), deprescribing any long-term treatment over less than a year using the...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2017.09.015
更新日期：2018-01-01 00:00:00
abstract：OBJECTIVES:The classical diagnostic cross-sectional study has a focus on one disease only. Generalist clinicians, however, are confronted with a wide range of diagnoses. We propose the "comprehensive diagnostic study design" to evaluate diagnostic tests regarding more than one disease outcome. STUDY DESIGN AND SETTING...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2013.05.019
更新日期：2014-02-01 00:00:00
abstract：OBJECTIVES:Constructs capturing health or functioning can have reflective and/or formative measurement models. Although a construct's measurement model has extensive implications on the construction, validation, and use of a measurement instrument, measurement models are frequently wrongly or not explicitly specified. ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.07.007
更新日期：2018-11-01 00:00:00
abstract：:Laparoscopic cholecystectomy was introduced to Western Australia in 1991 and has become the method of choice for this procedure, although there are concerns about complications, particularly bile duct injuries. Previous studies have investigated this problem but have not confirmed the accuracy of coded information. We...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/s0895-4356(99)00043-8
更新日期：1999-09-01 00:00:00
abstract：OBJECTIVES:Intervention Modeling Experiments (IMEs) are a way of developing and testing behavior change interventions before a trial. We aimed to test this methodology in a Web-based IME that replicated the trial component of an earlier, paper-based IME. STUDY DESIGN AND SETTING:Three-arm, Web-based randomized evaluat...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2016.07.008
更新日期：2016-12-01 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 objective of this study was to assess the determinants and the effect of misclassification in a questionnaire survey of varicose veins. A random sample of 166 individuals aged 50 years in a larger prevalence study (n = 6874) was examined by a surgeon to validate the self-reporting of varicose veins. Varicose veins...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00012-s
更新日期：1995-09-01 00:00:00
abstract：OBJECTIVE:To explore implications of using systematic drug class reviews to develop U.S. Medicaid drug formularies. We assess racial/ethnic, gender, and socioeconomic status (SES) concordance between Medicaid populations and studies synthesized in Drug Effectiveness Review Project (DERP) systematic reviews. STUDY DESI...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2009.01.009
更新日期：2009-12-01 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：BACKGROUND AND OBJECTIVE:A large number of trials remain difficult to locate or unpublished for systematic reviews. The objective of this article was to determine the usefulness of making e-mail contact with authors of clinical trials and literature reviews found in MEDLINE to identify unpublished or difficult to locat...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.11.022
更新日期：2006-07-01 00:00:00
abstract：:Period prevalence is frequently measured in studies based on administrative data such as that from health maintenance organizations. For example, treated prevalence and drug utilization prevalence are important measures that are typically defined in relationship to a specified time period. Often one wishes to compare ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/0895-4356(95)00573-0
更新日期：1996-04-01 00:00:00
abstract：:A visible result of the 20-year old applied ethics movement is the use of moral philosophers as quotable newspaper sources. In situations like the op-ed page, adequate space and time allows for serious reflection, and the columns provide accessible, quality ideas for the general public. Quality usually disappears wh...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90058-u
更新日期：1992-07-01 00:00:00
abstract：:To obtain a relatively true mortality from malignant neoplasms, we studied the frequency of cancers in the different sites and the changing patterns of the frequency and sites over time among residents of the community of Hisayama, where an autopsy-based population survey (autopsy rate, 80%) has been conducted since 1...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00560-9
更新日期：1996-01-01 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：:This article reports on the development and validation of the Italian SF-36 Health Survey using data from seven studies in which an Italian version of the SF-36 was administered to more than 7000 subjects between 1991 and 1995. Empirical findings from a wide array of studies and diseases indicate that the performance ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(98)00094-8
更新日期：1998-11-01 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：: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：:We identified 38 case-control studies investigating possible associations between alcoholic beverage consumption and cancer of the female breast. Each study was characterized according to design features such as: control type (hospital or community based), risk factors controlled for, matching strategy, and statistica...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/0895-4356(94)90026-4
更新日期：1994-02-01 00:00:00
abstract：:The objective of this study was to identify characteristics of nonrespondents and late respondents in a population-based case-control study on lung cancer conducted in the city of Turin (Italy). Information about demographic and socioeconomic variables of 634 cases and 859 controls who responded to an interview, as we...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(02)00455-9
更新日期：2002-10-01 00:00:00
abstract：:Although routinely used in health surveys, the factors affecting maternal perceptions of health in children, especially those with health problems, have received little examination. This question has been addressed using a telephone interview of families of 483 children followed in one of three clinics at Children's H...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90139-4
更新日期：1988-01-01 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：BACKGROUND AND OBJECTIVES:Clinical trials increasingly use results of diagnostic tests as surrogate outcomes. Our objective was to answer the following questions: (1) is the parameter measured by the reference standard a valid surrogate? (2) How does the tests accuracy influence the estimate of the treatment benefit on...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2005.02.024
更新日期：2005-10-01 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
abstract：:To investigate the possible association between changes in coffee consumption and serum cholesterol levels, information was obtained from 2109 healthy nonsmokers aged 25-65 years at two clinic visits to a preventive medical center between 1987 and 1991 (mean interval between visits: 16.7 months). After adjusting for a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00023-w
更新日期：1995-10-01 00:00:00
abstract：OBJECTIVES:The objective of the study is to estimate the proportion of statistically significant survival improvements reported in randomized trials of cancer treatments that are also compatible with a clinically negligible benefit. STUDY DESIGN AND SETTING:This is a cross-sectional study of reports of randomized clin...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2020.06.026
更新日期：2020-11-01 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：:The purpose of this study was to describe patterns of health care use by inner-city patients with asthma and to identify patients at risk for hospitalization. We performed a retrospective cohort study of 1788 patients with asthma aged 5 to 34 years from a large hospital-based multi-specialty practice in inner-city Ind...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(96)00333-2
更新日期：1997-02-01 00:00:00
abstract：BACKGROUND:Longitudinal studies estimating the association between disability and mortality in the elderly population have typically assumed disability constant through the follow-up study period. Current knowledge indicates that such assumptions may not be appropriate. Our purpose was to examine this association (disa...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(03)00201-4
更新日期：2003-12-01 00:00:00
abstract：OBJECTIVES:To examine the validity of (1) maternal questionnaire report of children's use of antiasthmatics using a prescription database as the reference standard and (2) dispensed antiasthmatics as a measure of asthma using maternal report of children's asthma as the reference standard. STUDY DESIGN AND SETTING:A to...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2010.10.014
更新日期：2011-08-01 00:00:00
