Abstract:
OBJECTIVES:To assess aspects of the internal validity of recently published cluster randomised trials and explore the reporting of information useful in assessing the external validity of these trials. DESIGN:Review of 34 cluster randomised trials in primary care published in 2004 and 2005 in seven journals (British Medical Journal, British Journal of General Practice, Family Practice, Preventive Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Pediatrics). DATA SOURCES:National Library of Medicine (Medline) via PubMed. DATA EXTRACTION:To assess aspects of internal validity we extracted data on appropriateness of sample size calculations and analyses, methods of identifying and recruiting individual participants, and blinding. To explore reporting of information useful in assessing external validity we extracted data on cluster eligibility, cluster inclusion and retention, cluster generalisability, and the feasibility and acceptability of the intervention to health providers in clusters. RESULTS:21 (62%) trials accounted for clustering in sample size calculations and 30 (88%) in the analysis; about a quarter were potentially biased because of procedures surrounding recruitment and identification of patients; individual participants were blind to allocation status in 19 (56%) and outcome assessors were blind in 15 (44%). In almost half the reports, information relating to generalisability of clusters was poorly reported, and in two fifths there was no information about the feasibility and acceptability of the intervention. CONCLUSIONS:Cluster randomised trials are essential for evaluating certain types of interventions. Issues affecting their internal validity, such as appropriate sample size calculations and analysis, have been widely disseminated and are now better addressed by researchers. Blinding of those identifying and recruiting patients to allocation status is recommended but is not always carried out. There may be fewer barriers to internal validity in trials in which individual participants are not recruited. External validity seems poorly addressed in many trials, yet is arguably as important as internal validity in judging quality as a basis for healthcare intervention.
journal_name
BMJjournal_title
BMJ (Clinical research ed.)authors
Eldridge S,Ashby D,Bennett C,Wakelin M,Feder Gdoi
10.1136/bmj.39517.495764.25subject
Has Abstractpub_date
2008-04-19 00:00:00pages
876-80issue
7649eissn
0959-8138issn
1756-1833pii
bmj.39517.495764.25journal_volume
336pub_type
杂志文章,评审abstract:OBJECTIVE:To evaluate the association between consumption of ultra-processed foods and all cause mortality. DESIGN:Prospective cohort study. SETTING:Seguimiento Universidad de Navarra (SUN) cohort of university graduates, Spain 1999-2018. PARTICIPANTS:19 899 participants (12 113 women and 7786 men) aged 20-91 years ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.l1949
更新日期:2019-05-29 00:00:00
abstract:OBJECTIVE:To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home. DESIGN:Individually randomised, blinded, three arm trial. SETTING:Primary care and househol...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.a1302
更新日期:2008-09-02 00:00:00
abstract::The rapid aging of populations in developing countries as compared to those in the developed world has implications for medical training in these places. Moreover, the growing globalization of employment for many health professionals means that demographic shifts have implications for the training of health professio...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.319.7221.1358
更新日期:1999-11-20 00:00:00
abstract:OBJECTIVE:To determine if the Food Standards Agency nutrient profiling system (FSAm-NPS), which grades the nutritional quality of food products and is used to derive the Nutri-Score front-of-packet label to guide consumers towards healthier food choices, is associated with mortality. DESIGN:Population based cohort stu...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.m3173
更新日期:2020-09-16 00:00:00
abstract:OBJECTIVE:To assess the effects of Helicobacter pylori treatment, vitamin supplementation, and garlic supplementation in the prevention of gastric cancer. DESIGN:Blinded randomized placebo controlled trial. SETTING:Linqu County, Shandong province, China. PARTICIPANTS:3365 residents of a high risk region for gastric ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,随机对照试验
doi:10.1136/bmj.l5016
更新日期:2019-09-11 00:00:00
abstract:OBJECTIVE:This study updates work published in 1998, which found that of 47 rating instruments appearing on websites offering health information, 14 described how they were developed, five provided instructions for use, and none reported the interobserver reliability and construct validity of the measurements. DESIGN:...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.324.7337.569
更新日期:2002-03-09 00:00:00
abstract:OBJECTIVE:To investigate the risk factors for HIV infection in patients attending clinics for sexually transmitted diseases in India. DESIGN:Descriptive study of HIV serology, risk behaviour, and findings on physical examination. SUBJECTS:2800 patients presenting to outpatient clinics between 13 May 1993 and 15 July ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.311.7000.283
更新日期:1995-07-29 00:00:00
abstract::I have attempted to adopt the perspective of a patient--albeit one with a rather atypical background--to explore what I want from health research and researchers. This has left me with the impression that health researchers could serve the interests of the public more effectively in a variety of ways, and that they wo...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.310.6990.1315
更新日期:1995-05-20 00:00:00
abstract:OBJECTIVE:To characterise the functional morphology of the nasal microcirculation in humans in comparison with reindeer as a means of testing the hypothesis that the luminous red nose of Rudolph, one of the most well known reindeer pulling Santa Claus's sleigh, is due to the presence of a highly dense and rich nasal mi...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.e8311
更新日期:2012-12-14 00:00:00
abstract:OBJECTIVE:To evaluate the clinical benefit of lipid lowering drug treatment in patients with and without diabetes mellitus, for primary and secondary prevention. DESIGN:Systematic review and meta-analysis. DATA SOURCES:Cochrane, Medline, Embase, and reference lists up to April 2004. STUDY SELECTION:Randomised, place...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,meta分析,评审
doi:10.1136/bmj.38793.468449.AE
更新日期:2006-05-13 00:00:00
abstract:OBJECTIVE:To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm. DESIGN:Randomised controlled trial. SETTING:30 vascular centres (29 UK, 1 Canadian), 2009-13. ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.f7661
更新日期:2014-01-13 00:00:00
abstract::Robots designed for surgery have three main advantages over humans. They have greater three dimensional spatial accuracy, are more reliable, and can achieve much greater precision. Although few surgical robots are yet in clinical trials one or two have advanced to the stage of seeking approval from the UK's Medical De...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.311.7018.1479
更新日期:1995-12-02 00:00:00
abstract::Eleven euthyroid patients with severe Graves' eye disease were treated with intravenous methylprednisolone and followed up for six months or more by ophthalmological assessment, orbital computed tomography (CT), photographs, and antibody measurements. Papilloedema resolved in the single patient in whom it was present;...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.297.6663.1574
更新日期:1988-12-17 00:00:00
abstract:OBJECTIVE:To assess the association of lichen planus with liver complaints and with known aetiological factors of liver diseases. DESIGN:Multicentre case-control study. Interviews were conducted by trained medical investigators on the basis of a structured questionnaire. At the interview patients and controls were ask...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1136/bmj.300.6719.227
更新日期:1990-01-27 00:00:00
abstract::Hepatorenal syndrome (HRS), the extreme manifestation of renal impairment in patients with cirrhosis, is characterized by reduction in renal blood flow and glomerular filtration rate. Hepatorenal syndrome is diagnosed when kidney function is reduced but evidence of intrinsic kidney disease, such as hematuria, proteinu...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.m2687
更新日期:2020-09-14 00:00:00
abstract::The World Health Organization's (WHO) definition of health as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity" had the merit of widening concepts of health to include psychological and social aspects, but is of no practical use. In fact, this statement m...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.314.7091.1409
更新日期:1997-05-10 00:00:00
abstract:OBJECTIVES:To determine the prevalence of drug and alcohol use among newly remanded prisoners, assess the effectiveness of prison reception screening, and examine the clinical management of substance misusers among remand prisoners. DESIGN:A consecutive case study of remand prisoners screened at reception for substanc...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.315.7099.18
更新日期:1997-07-05 00:00:00
abstract:OBJECTIVE:To identify additional factors, such as maternal age or factors related to previous reproductive outcome or family history, and the corresponding probability of carrying a chromosome abnormality in couples with two or more miscarriages. DESIGN:Nested case-control study. SETTING:Six centres for clinical gene...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.38498.669595.8F
更新日期:2005-07-16 00:00:00
abstract:OBJECTIVES:To investigate the effect of milk supplementation on total body bone mineral acquisition in adolescent girls. DESIGN:18 month, open randomised intervention trial. SUBJECTS:82 white girls aged 12.2 (SD 0.3) years, recruited from four secondary schools in Sheffield. INTERVENTION:568 ml (one pint) of whole o...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.315.7118.1255
更新日期:1997-11-15 00:00:00
abstract:OBJECTIVE:To assess the effectiveness of teaching general practitioners skills in brief cognitive behaviour therapy. DESIGN:Parallel group, cluster randomised, controlled trial of an educational package on cognitive behaviour therapy. SETTING:General practices in north London. PARTICIPANTS:84 general practitioner pr...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.324.7343.947
更新日期:2002-04-20 00:00:00
abstract:OBJECTIVE:To assess the impact of construction of microdams on the incidence of malaria in nearby communities in terms of possibly increasing peak incidence and prolonging transmission. DESIGN:Four quarterly cycles of malaria incidence surveys, each taking 30 days, undertaken in eight at risk communities close to dams...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.319.7211.663
更新日期:1999-09-11 00:00:00
abstract:OBJECTIVE:To compare the effect on prevalence of diarrhoea and mortality of household based treatment of drinking water with flocculant-disinfectant, sodium hypochlorite, and standard practices in areas with turbid water source in Africa. DESIGN:Cluster randomised controlled trial over 20 weeks. SETTING:Family compou...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.38512.618681.E0
更新日期:2005-09-03 00:00:00
abstract:OBJECTIVE:To identify historical and clinical findings at emergency department presentation associated with severe H1N1 outcome in children presenting with influenza-like illness. DESIGN:Multicentre retrospective case-control study. SETTING:79 emergency departments of hospitals associated with the Pediatric Emergency...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.f4836
更新日期:2013-08-12 00:00:00
abstract:OBJECTIVES:To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN:Prospective, randomized, 52 week, single blind comparative effec...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,随机对照试验
doi:10.1136/bmj.k851
更新日期:2018-03-21 00:00:00
abstract::Environmental issues tend to greater political attention than do environmental health aspects. Therefore, when conflicts of interest occur with other environmental concerns, negative consequences for public health may result. For example, a strategy to substantially reduce indoor ventilation in many dwellings in Sca...
journal_title:BMJ (Clinical research ed.)
pub_type: 社论
doi:10.1136/bmj.318.7199.1636
更新日期:1999-06-19 00:00:00
abstract:OBJECTIVE:To estimate the risk of having a low birthweight infant associated with changes in social, environmental, and genetic factors. DESIGN:Population based, historical cohort study using the Danish medical birth registry and Statistic Denmark's fertility database. SUBJECTS:All women who had a low birthweight inf...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.315.7121.1498
更新日期:1997-12-06 00:00:00
abstract:OBJECTIVE:To compare blood pressure control, satisfaction, and adherence to drug treatment in patients with treated hypertension followed up by their family physicians either every three months or every six months for three years. DESIGN:Randomised equivalence clinical trial. Settings 50 family practices in south east...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.37967.374063.EE
更新日期:2004-01-24 00:00:00
abstract::The results of the work of the Edinburgh Rehabilitation Medicine Service in one year were evaluated. Over 1400 new patients were seen, of whom 525 were in hospital at the time. Patients most often referred were those who had had cardiovascular accidents, back pain, lower limb amputations, and head injuries and those c...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.297.6648.601
更新日期:1988-09-03 00:00:00
abstract:OBJECTIVES:To quantify the relative contribution of premorbid and episode specific factors in determining the long term persistence of disabling symptoms of low back pain. DESIGN:Prospective cohort study. SETTING:Two general practices in the south Manchester area. PARTICIPANTS:180 patients, who previously participat...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.318.7199.1662
更新日期:1999-06-19 00:00:00
abstract::Lung cancer, the most prevalent cancer in the Western world, is mainly caused by smoking. Nevertheless, only 20% of smokers develop lung cancer and while prevention is important, environmental factors are expected to contribute to the predicted rise in the incidence of lung cancer in the next 25 years. Survival of lun...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.314.7081.652
更新日期:1997-03-01 00:00:00