当前位置： SCI文献检索 > BMC Medical Research Methodology期刊下所有文献 > Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity.

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity.

Abstract：

BACKGROUND:Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. DISCUSSION:External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. SUMMARY:Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results) and external validity (generalizability). The attempt to achieve methodological purity can result in clinically meaningless results, while attempting to achieve full generalizability can result in invalid and unreliable results. Achieving a creative tension between the two is crucial.

journal_name

BMC Med Res Methodol

journal_title

BMC medical research methodology

authors

Godwin M,Ruhland L,Casson I,MacDonald S,Delva D,Birtwhistle R,Lam M,Seguin R

doi

10.1186/1471-2288-3-28

keywords:

subject

Has Abstract

pub_date

2003-12-22 00:00:00

pages

28

issn

1471-2288

pii

1471-2288-3-28

journal_volume

3

pub_type

杂志文章

相关文献

BMC Medical Research Methodology文献大全
  • A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.

    abstract：BACKGROUND:Exposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children's health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effect...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-020-00950-y

    authors： Hartinger SM,Nuño N,Hattendorf J,Verastegui H,Karlen W,Ortiz M,Mäusezahl D

    更新日期：2020-04-02 00:00:00

  • Forecasts of COPD mortality in Australia: 2006-2025.

    abstract：BACKGROUND:Chronic Obstructive Pulmonary Disease (COPD) is currently the fifth leading cause of death in Australia, and there are marked differences in mortality trends between men and women. In this study, we have sought to model and forecast age related changes in COPD mortality over time for men and women separately...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-12-17

    authors： Erbas B,Ullah S,Hyndman RJ,Scollo M,Abramson M

    更新日期：2012-02-21 00:00:00

  • Best practice for analysis of shared clinical trial data.

    abstract：BACKGROUND:Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm shift with the aim of maximising the value of patient-level data from clinical trials for the benefi...

    journal_title：BMC medical research methodology

    pub_type： 信件

    doi：10.1186/s12874-016-0170-y

    authors： Hollis S,Fletcher C,Lynn F,Urban HJ,Branson J,Burger HU,Tudur Smith C,Sydes MR,Gerlinger C

    更新日期：2016-07-08 00:00:00

  • Recruiting and motivating black subjects to complete a lengthy survey in a large cohort study: an exploration of different strategies.

    abstract：BACKGROUND:The effectiveness of multiple innovative recruitment strategies for enrolling Black/African American participants to the Adventist Health Study-2 (AHS-2) is described. The study's focus is diet and breast, prostate and colon cancer. METHODS:Promotions centered on trust, relationship building and incentives ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-14-46

    authors： Herring P,Butler T,Hall S,Bennett H,Montgomery SB,Fraser G

    更新日期：2014-04-03 00:00:00

  • The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews.

    abstract：BACKGROUND:In the era of evidence based medicine, with systematic reviews as its cornerstone, adequate quality assessment tools should be available. There is currently a lack of a systematically developed and evaluated tool for the assessment of diagnostic accuracy studies. The aim of this project was to combine empiri...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-3-25

    authors： Whiting P,Rutjes AW,Reitsma JB,Bossuyt PM,Kleijnen J

    更新日期：2003-11-10 00:00:00

  • Workplace restructurings in intervention studies - a challenge for design, analysis and interpretation.

    abstract：BACKGROUND:Interventions in occupational health often target worksites rather than individuals. The objective of this paper is to describe the (lack of) stability in units of analysis in occupational health and safety intervention projects directed toward worksites. METHODS:A case study approach is used to describe na...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-8-39

    authors： Olsen O,Albertsen K,Nielsen ML,Poulsen KB,Gron SM,Brunnberg HL

    更新日期：2008-06-13 00:00:00

  • Data enhancement for co-morbidity measurement among patients referred for sleep diagnostic testing: an observational study.

    abstract：BACKGROUND:Observational outcome studies of patients with obstructive sleep apnea (OSA) require adjustment for co-morbidity to produce valid results. The aim of this study was to evaluate whether the combination of administrative data and self-reported data provided a more complete estimate of co-morbidity among patien...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-9-50

    authors： Ronksley PE,Tsai WH,Quan H,Faris P,Hemmelgarn BR

    更新日期：2009-07-15 00:00:00

  • Clinical trial simulation to evaluate power to compare the antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect models: a viral kinetic approach.

    abstract：BACKGROUND:Models of hepatitis C virus (HCV) kinetics are increasingly used to estimate and to compare in vivo drug's antiviral effectiveness of new potent anti-HCV agents. Viral kinetic parameters can be estimated using non-linear mixed effect models (NLMEM). Here we aimed to evaluate the performance of this approach ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-13-60

    authors： Laouénan C,Guedj J,Mentré F

    更新日期：2013-04-25 00:00:00

  • Maximising response from GPs to questionnaire surveys: do length or incentives make a difference?

    abstract：BACKGROUND:General Practitioners (GPs) respond poorly to postal surveys. Consequently there is potential for reduced data quality and bias in the findings. In general population surveys, response to postal questionnaires may be improved by reducing their length and offering incentives. The aim of this study was to inve...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-15-3

    authors： Cottrell E,Roddy E,Rathod T,Thomas E,Porcheret M,Foster NE

    更新日期：2015-01-06 00:00:00

  • A methodological systematic review of what's wrong with meta-ethnography reporting.

    abstract：BACKGROUND:Syntheses of qualitative studies can inform health policy, services and our understanding of patient experience. Meta-ethnography is a systematic seven-phase interpretive qualitative synthesis approach well-suited to producing new theories and conceptual models. However, there are concerns about the quality ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,评审

    doi：10.1186/1471-2288-14-119

    authors： France EF,Ring N,Thomas R,Noyes J,Maxwell M,Jepson R

    更新日期：2014-11-19 00:00:00

  • Estimating required information size by quantifying diversity in random-effects model meta-analyses.

    abstract：BACKGROUND:There is increasing awareness that meta-analyses require a sufficiently large information size to detect or reject an anticipated intervention effect. The required information size in a meta-analysis may be calculated from an anticipated a priori intervention effect or from an intervention effect suggested b...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-9-86

    authors： Wetterslev J,Thorlund K,Brok J,Gluud C

    更新日期：2009-12-30 00:00:00

  • Telephone and face to face methods of assessment of veteran's community reintegration yield equivalent results.

    abstract：BACKGROUND:The Community Reintegration of Service Members (CRIS) is a new measure of community reintegration developed to measure veteran's participation in life roles. It consists of three sub-scales: Extent of Participation (Extent), Perceived Limitations with Participation (Perceived), and Satisfaction with Particip...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,随机对照试验

    doi：10.1186/1471-2288-11-98

    authors： Resnik LJ,Clark MA,Borgia M

    更新日期：2011-06-25 00:00:00

  • Simulation-based estimation of mean and standard deviation for meta-analysis via Approximate Bayesian Computation (ABC).

    abstract：BACKGROUND:When conducting a meta-analysis of a continuous outcome, estimated means and standard deviations from the selected studies are required in order to obtain an overall estimate of the mean effect and its confidence interval. If these quantities are not directly reported in the publications, they must be estima...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-015-0055-5

    authors： Kwon D,Reis IM

    更新日期：2015-08-12 00:00:00

  • Assessing genetic polymorphisms using DNA extracted from cells present in saliva samples.

    abstract：BACKGROUND:Technical advances following the Human Genome Project revealed that high-quality and -quantity DNA may be obtained from whole saliva samples. However, usability of previously collected samples and the effects of environmental conditions on the samples during collection have not been assessed in detail. In fi...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-11-170

    authors： Nemoda Z,Horvat-Gordon M,Fortunato CK,Beltzer EK,Scholl JL,Granger DA

    更新日期：2011-12-19 00:00:00

  • Randomised controlled comparison of the Health Survey Short Form (SF-12) and the Graded Chronic Pain Scale (GCPS) in telephone interviews versus self-administered questionnaires. Are the results equivalent?

    abstract：BACKGROUND:The most commonly used survey methods are self-administered questionnaires, telephone interviews, and a mixture of both. But until now evidence out of randomised controlled trials as to whether patient responses differ depending on the survey mode is lacking. Therefore this study assessed whether patient res...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,随机对照试验

    doi：10.1186/1471-2288-7-50

    authors： Lungenhausen M,Lange S,Maier C,Schaub C,Trampisch HJ,Endres HG

    更新日期：2007-11-22 00:00:00

  • Writing a discussion section: how to integrate substantive and statistical expertise.

    abstract：BACKGROUND:When discussing results medical research articles often tear substantive and statistical (methodical) contributions apart, just as if both were independent. Consequently, reasoning on bias tends to be vague, unclear and superficial. This can lead to over-generalized, too narrow and misleading conclusions, es...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,评审

    doi：10.1186/s12874-018-0490-1

    authors： Höfler M,Venz J,Trautmann S,Miller R

    更新日期：2018-04-17 00:00:00

  • The methods and baseline characteristics of a VA randomized controlled study evaluating supported employment provided in primary care patient aligned care teams.

    abstract：BACKGROUND:This article describes the design and baseline sample of a single-site trial comparing Individual Placement and Support (IPS) supported employment delivered within a Veterans Health Administration (VHA) primary care Patient Aligned Care Team (PACT) to treatment-as-usual vocational rehabilitation (TAU-VR) tha...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,随机对照试验

    doi：10.1186/s12874-020-0919-1

    authors： Davis LL,Blansett CM,Mumba MN,MacVicar D,Toscano R,Pilkinton P,Gay W,Bartolucci A

    更新日期：2020-02-17 00:00:00

  • Psychometric analysis of the brief symptom inventory 18 (BSI-18) in a representative German sample.

    abstract：BACKGROUND:The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R, but its psychometric properties have not been sufficien...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-016-0283-3

    authors： Franke GH,Jaeger S,Glaesmer H,Barkmann C,Petrowski K,Braehler E

    更新日期：2017-01-26 00:00:00

  • Protecting patient privacy when sharing patient-level data from clinical trials.

    abstract：BACKGROUND:Greater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies....

    journal_title：BMC medical research methodology

    pub_type： 信件

    doi：10.1186/s12874-016-0169-4

    authors： Tucker K,Branson J,Dilleen M,Hollis S,Loughlin P,Nixon MJ,Williams Z

    更新日期：2016-07-08 00:00:00

  • Imputation by the mean score should be avoided when validating a Patient Reported Outcomes questionnaire by a Rasch model in presence of informative missing data.

    abstract：BACKGROUND:Nowadays, more and more clinical scales consisting in responses given by the patients to some items (Patient Reported Outcomes - PRO), are validated with models based on Item Response Theory, and more specifically, with a Rasch model. In the validation sample, presence of missing data is frequent. The aim of...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-11-105

    authors： Hardouin JB,Conroy R,Sébille V

    更新日期：2011-07-14 00:00:00

  • A proof of principle for using adaptive testing in Routine Outcome Monitoring: the efficiency of the Mood and Anxiety Symptoms Questionnaire -Anhedonic Depression CAT.

    abstract：BACKGROUND:In Routine Outcome Monitoring (ROM) there is a high demand for short assessments. Computerized Adaptive Testing (CAT) is a promising method for efficient assessment. In this article, the efficiency of a CAT version of the Mood and Anxiety Symptom Questionnaire, - Anhedonic Depression scale (MASQ-AD) for use ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-12-4

    authors： Smits N,Zitman FG,Cuijpers P,den Hollander-Gijsman ME,Carlier IV

    更新日期：2012-01-10 00:00:00

  • Obstacles to recruitment in paediatric studies focusing on mental health in a physical health context: the experiences of clinical gatekeepers in an observational cohort study.

    abstract：BACKGROUND:Studies in both paediatric and psychiatric settings often experience problems in recruitment. This can compromise the ability of the study to recruit to target, meaning studies are potentially underpowered. It can also result in a biased sample if a non-representative group are selectively recruited. Recruit...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-019-0730-z

    authors： Loades ME,Smith L,Higson-Sweeney N,Beasant L,Stallard P,Kessler D,Crawley E

    更新日期：2019-04-27 00:00:00

  • Optimal likelihood-ratio multiple testing with application to Alzheimer's disease and questionable dementia.

    abstract：BACKGROUND:Controlling the false discovery rate is important when testing multiple hypotheses. To enhance the detection capability of a false discovery rate control test, we applied the likelihood ratio-based multiple testing method in neuroimage data and compared the performance with the existing methods. METHODS:We ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-15-9

    authors： Lee D,Kang H,Kim E,Lee H,Kim H,Kim YK,Lee Y,Lee DS

    更新日期：2015-01-30 00:00:00

  • Adaptive propensity score procedure improves matching in prospective observational trials.

    abstract：BACKGROUND:Randomized controlled trials are the gold-standard for clinical trials. However, randomization is not always feasible. In this article we propose a prospective and adaptive matched case-control trial design assuming that a control group already exists. METHODS:We propose and discuss an interim analysis step...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-019-0763-3

    authors： Weber D,Uhlmann L,Schönenberger S,Kieser M

    更新日期：2019-07-16 00:00:00

  • Validity of the International Physical Activity Questionnaire (IPAQ) for assessing moderate-to-vigorous physical activity and sedentary behaviour of older adults in the United Kingdom.

    abstract：BACKGROUND:In order to accurately measure and monitor levels of moderate-to-vigorous physical activity (MVPA) and sedentary behaviour (SB) in older adults, cost efficient and valid instruments are required. To date, the International Physical Activity Questionnaire (IPAQ) has not been validated with older adults (aged ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,多中心研究

    doi：10.1186/s12874-018-0642-3

    authors： Cleland C,Ferguson S,Ellis G,Hunter RF

    更新日期：2018-12-22 00:00:00

  • Combining estimates of interest in prognostic modelling studies after multiple imputation: current practice and guidelines.

    abstract：BACKGROUND:Multiple imputation (MI) provides an effective approach to handle missing covariate data within prognostic modelling studies, as it can properly account for the missing data uncertainty. The multiply imputed datasets are each analysed using standard prognostic modelling techniques to obtain the estimates of ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章,实务指引

    doi：10.1186/1471-2288-9-57

    authors： Marshall A,Altman DG,Holder RL,Royston P

    更新日期：2009-07-28 00:00:00

  • The use of individual cut points from treadmill walking to assess free-living moderate to vigorous physical activity in obese subjects by accelerometry: is it useful?

    abstract：BACKGROUND:Variation in counts between subjects at a given speed or work rate are the most important source of error in physical activity (PA) measurements with accelerometers. The aim of this study was to explore how the use of individual accelerometer cut points (ICPs) affected the analysis of PA field data. METHODS...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/1471-2288-12-172

    authors： Aadland E,Steene-Johannessen J

    更新日期：2012-11-15 00:00:00

  • Onset of persistent pseudomonas aeruginosa infection in children with cystic fibrosis with interval censored data.

    abstract：BACKGROUND:Persistent Pseudomonas aeruginosa (PPA) infection promotes lung function deterioration in children with cystic fibrosis (CF). Although early CF diagnosis through newborn screening (NBS) has been shown to provide nutritional/growth benefit, it is unclear whether NBS lowers the risk of PPA infection and how th...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-016-0220-5

    authors： Wang W,Chen MH,Chiou SH,Lai HC,Wang X,Yan J,Zhang Z

    更新日期：2016-09-17 00:00:00

  • The need to balance merits and limitations from different disciplines when considering the stepped wedge cluster randomized trial design.

    abstract：BACKGROUND:Various papers have addressed pros and cons of the stepped wedge cluster randomized trial design (SWD). However, some issues have not or only limitedly been addressed. Our aim was to provide a comprehensive overview of all merits and limitations of the SWD to assist researchers, reviewers and medical ethics ...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-015-0090-2

    authors： de Hoop E,van der Tweel I,van der Graaf R,Moons KG,van Delden JJ,Reitsma JB,Koffijberg H

    更新日期：2015-10-30 00:00:00

  • Estimating cardiovascular disease incidence from prevalence: a spreadsheet based model.

    abstract：BACKGROUND:Disease incidence and prevalence are both core indicators of population health. Incidence is generally not as readily accessible as prevalence. Cohort studies and electronic health record systems are two major way to estimate disease incidence. The former is time-consuming and expensive; the latter is not av...

    journal_title：BMC medical research methodology

    pub_type： 杂志文章

    doi：10.1186/s12874-016-0288-y

    authors： Hu XF,Young K,Chan HM

    更新日期：2017-01-23 00:00:00