Randomised controlled trials in primary care: scope and application.

There is now widespread acknowledgement of the absence of a sound evidence base underpinning many of the decisions made in primary care. Randomised controlled trials represent the methodology of choicefor determining efficacy and effectiveness of interventions, yet researchers working in primary care have been reluctant to use intervention studies, favouring observational study designs. Unfamiliarity with the different trial designs now available, and the relative advantages and disadvantages conferred by each, may be one factor contributing to this paradox. In this paper, we consider the principal trial designs available to primary care researchers, discussing the contexts in which a particular design may prove most useful. This information will, we hope, also prove useful to primary care clinicians attempting to interpret trial findings.

[1]  Michael J. Campbell,et al.  Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial , 1999, BMJ.

[2]  D. Mant,et al.  Effectiveness of a nicotine patch in helping people stop smoking: results of a randomised trial in general practice. Imperial Cancer Research Fund General Practice Research Group. , 1993, BMJ.

[3]  D. Torgerson,et al.  Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences , 1999, BMJ.

[4]  P. Shepherd,et al.  Controlled-release indomethacin and sustained-release diclofenac sodium in the treatment of osteoarthritis: a comparative controlled clinical trial in general practice. , 1990, Current Medical Research and Opinion.

[5]  Allan Donner,et al.  Methods in health service research: Evaluation of health interventions at area and organisation level , 1999 .

[6]  P Marsh,et al.  Preventing injuries in children: cluster randomised controlled trial in primary care , 1999, BMJ.

[7]  S. Dovey,et al.  A Comparison of Tiaprofenic Acid, Mefenamic Acid and Placebo in the Treatment of Dysmenorrhoea in General Practice , 1992, The Australian & New Zealand journal of obstetrics & gynaecology.

[8]  S. Pocock,et al.  Clinical Trials: A Practical Approach , 1984 .

[9]  A Donner,et al.  Statistical considerations in the design and analysis of community intervention trials. , 1996, Journal of clinical epidemiology.

[10]  A. Steptoe,et al.  Behavioural counselling in general practice for the promotion of healthy behaviour among adults at increased risk of coronary heart disease: randomised trial. , 1999, BMJ.

[11]  S. Kerry,et al.  Randomized controlled trial of the effect of the Royal College of Radiologists' guidelines on general practitioners' referrals for radiographic examination. , 1994, The British journal of general practice : the journal of the Royal College of General Practitioners.

[12]  M. Bachmann,et al.  Design and analysis of studies evaluating smoking cessation interventions where effects vary between practices or practitioners. , 1996, Family practice.

[13]  P. Tfelt-Hansen,et al.  Introduction of a Novel Self-Injector for Sumatriptan. A Controlled Clinical Trial in General Practice , 1995, Cephalalgia : an international journal of headache.

[14]  Douglas G. Altman,et al.  Practical statistics for medical research , 1990 .

[15]  J. G. Williams,et al.  The two-period crossover design in medical research. , 1989, Annals of internal medicine.

[16]  J. Karnon,et al.  Economic evaluation alongside n-of-1 trials: getting closer to the margin. , 2001, Health economics.

[17]  G. Guyatt,et al.  A clinician's guide for conducting randomized trials in individual patients. , 1988, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[18]  Douglas G Altman,et al.  Statistics Notes: Units of analysis , 1997, BMJ.

[19]  Richard J Lilford,et al.  Ethical issues in the design and conduct of cluster randomised controlled trials , 1999, BMJ.

[20]  P. Glasziou,et al.  Managing ADHD in general practice. N of 1 trials can help! , 2000, Australian Family Physician.

[21]  N. Kerse,et al.  Improving the health behaviours of elderly people: randomised controlled trial of a general practice education programme , 1999, BMJ.

[22]  L. Solberg,et al.  Improving prevention systems in primary care practices: the Health Education and Research Trial (HEART) , 2000, The Journal of family practice.

[23]  M J Buxton,et al.  Evaluating patient-based outcome measures for use in clinical trials. , 1998, Health technology assessment.

[24]  Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy, and usual general practitioner care for patients with depression. II: Cost effectiveness , 2000, BMJ : British Medical Journal.

[25]  D. Torgerson,et al.  Understanding controlled trials: What is a patient preference trial? , 1998, BMJ.

[26]  C. Grant,et al.  Independent parental administration of prednisone in acute asthma: a double-blind, placebo-controlled, crossover study. , 1995, Pediatrics.

[27]  I. Chalmers What do I want from health research and researchers when I am a patient? , 1995, British medical journal.

[28]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[29]  G. Lip How the Read a Paper: The Basics of Evidence Based Medicine , 1998, Journal of Human Hypertension.

[30]  Allan Donner,et al.  Design and Analysis of Cluster Randomization Trials in Health Research , 2001 .

[31]  Douglas G Altman,et al.  How to randomise , 1999, BMJ.

[32]  L. March,et al.  n of 1 trials comparing a non-steroidal anti-inflammatory drug with paracetamol in osteoarthritis , 1994, BMJ.

[33]  P. Miller,et al.  Antidepressant drugs and generic counselling for treatment of major depression in primary care: randomised trial with patient preference arms , 2001, BMJ : British Medical Journal.

[34]  P. Roderick,et al.  A randomized trial to evaluate the effectiveness of dietary advice by practice nurses in lowering diet-related coronary heart disease risk. , 1997, The British journal of general practice : the journal of the Royal College of General Practitioners.

[35]  N. Black Why we need observational studies to evaluate the effectiveness of health care , 1996, BMJ.

[36]  J. Last,et al.  Making the Dictionary of Epidemiology. , 1996, International journal of epidemiology.

[37]  C. Brewin,et al.  Patient preferences and randomised clinical trials. , 1989, BMJ.

[38]  David J Torgerson,et al.  Contamination in trials: is cluster randomisation the answer? , 2001, BMJ : British Medical Journal.

[39]  R. Horton Evidence and primary care , 1999, The Lancet.

[40]  A. Laupacis,et al.  Theophylline for irreversible chronic airflow limitation: a randomized study comparing n of 1 trials to standard practice. , 1999, Chest.

[41]  L. V. Bortel,et al.  Impact of antihypertensive treatment on quality of life: comparison between bisoprolol and bendrofluazide , 1999, Journal of Human Hypertension.

[42]  J M Bland,et al.  The intracluster correlation coefficient in cluster randomisation , 1998, BMJ.

[43]  P. Glasziou,et al.  Preliminary experiences with a single‐patient trials service in general practice , 2000, The Medical journal of Australia.

[44]  M J Campbell,et al.  Choosing between randomised and non-randomised studies: a systematic review , 1998, BMJ.

[45]  C. Redman,et al.  An N‐of‐1 trial for treatment of hyperemesis gravidarum , 1996, British journal of obstetrics and gynaecology.

[46]  N E Day,et al.  The design of case-control studies: the influence of confounding and interaction effects. , 1984, International journal of epidemiology.

[47]  J. Mcewen,et al.  Measuring Health—A Review of Quality of Life Measurement Scales , 1992 .

[48]  D. Torgerson,et al.  Patient Preferences in Randomised Trials: Threat or Opportunity? , 1996, Journal of health services research & policy.

[49]  P. Glasziou,et al.  N of 1 trials. Practical tools for medication management. , 2000, Australian family physician.

[50]  S. Eckstein Ethical principles for medical research involving human subjects. , 2001, European journal of emergency medicine : official journal of the European Society for Emergency Medicine.

[51]  J. Olesen,et al.  A Randomized Double-Blind Placebo-Controlled Crossover Study of Subcutaneous Sumatriptan in General Practice , 1994, Cephalalgia : an international journal of headache.

[52]  Paul Dieppe,et al.  Relation between agendas of the research community and the research consumer , 2000, The Lancet.

[53]  D. Wood,et al.  Randomised controlled trial evaluating cardiovascular screening and intervention in general practice: principal results of British family heart study , 1994 .

[54]  P. Johansen,et al.  Prophylactic treatment of adult nocturia with bumetanide. , 1988, British journal of urology.

[55]  T. Fahey,et al.  The content and methodology of research papers published in three United Kingdom primary care journals. , 1998, The British journal of general practice : the journal of the Royal College of General Practitioners.

[56]  N. Tarrier,et al.  General practice Randomised controlled trial of non-directive counselling , cognitive-behaviour therapy , and usual general practitioner care for patients with depression . I : Clinical effectiveness , 2022 .

[57]  W M Tierney,et al.  Effectiveness of Computer-Generated Reminders for Increasing Discussions about Advance Directives and Completion of Advance Directive Forms , 1998, Annals of Internal Medicine.

[58]  The use of an N-of-1 randomised clinical trial in resolving therapeutic doubt. The case of a patient with an 'attention disorder'. , 1998, Australian family physician.

[59]  J. Sterne,et al.  Methods for evaluating area-wide and organisation-based interventions in health and health care: a systematic review. , 1999, Health technology assessment.

[60]  W. Hepburn,et al.  14 years of follow-up from the Edinburgh randomised trial of breast-cancer screening , 1999, The Lancet.

[61]  T. Kendrick,et al.  Randomised controlled trial of teaching general practitioners to carry out structured assessments of their long term mentally ill patients , 1995, BMJ.

[62]  R. D'Agostino,et al.  Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. , 1997, Journal of clinical epidemiology.

[63]  M K Campbell,et al.  Extending the CONSORT statement to cluster randomized trials: for discussion. , 2001, Statistics in medicine.

[64]  C. Camfield,et al.  Double-blind methylphenidate trials: practical, useful, and highly endorsed by families. , 1999, Archives of Pediatrics & Adolescent Medicine.

[65]  Tom Fahey,et al.  Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial , 2000, BMJ : British Medical Journal.