Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions

Lancaster, G. A.; Campbell, M. J.; Eldridge, S.; Farrin, A.; Marchant, M.; Muller, S.; Perera, R.; Peters, T. J.; Prevost, A. T.; Rait, G.
August 2010
Statistical Methods in Medical Research;Aug2010, Vol. 19 Issue 4, p349
Academic Journal
Trials carried out in primary care typically involve complex interventions that require considerable planning if they are to be implemented successfully. The role of the statistician in promoting both robust study design and appropriate statistical analysis is an important contribution to a multi-disciplinary primary care research group. Issues in the design of complex interventions have been addressed in the Medical Research Council’s new guidance document and over the past 7 years by the Royal Statistical Society’s Primary Health Care Study Group. With the aim of raising the profile of statistics and building research capability in this area, particularly with respect to methodological issues, the study group meetings have covered a wide range of topics that have been of interest to statisticians and non-statisticians alike. The aim of this article is to provide an overview of the statistical issues that have arisen over the years related to the design and evaluation of trials in primary care, to provide useful examples and references for further study and ultimately to promote good practice in the conduct of complex interventions carried out in primary care and other health care settings. Throughout we have given particular emphasis to statistical issues related to the design of cluster randomised trials.


Related Articles

  • e-prescribing relies on paper scripts. Marriner, Katie // New Zealand Doctor;6/15/2011, p26 

    The article reports on the community trial of the national e-prescribing plan in primary care project in New Zealand and its reliance on signed paper prescription, which patients need to present to the pharmacist when collecting their medication.

  • Clinical trials in psychiatry: background and statistical perspective. Johnson, T. // Statistical Methods in Medical Research;1998, Vol. 7 Issue 3, p209 

    There have been many hundreds of studies which have examined the efficacy of different forms of treatment of psychiatric disorders over the past 40 years. This paper presents some background to these studies for statisticians, illustrating and discussing some of the difficult problems which...

  • Proper Reporting of Statistical Parameters in Clinical Trials Published in Indian Medical Journals. Is Inclusion of Statistician Play any Significant Role? Chavda, N.; Yadav, P. // Journal of Young Pharmacists;2011, Vol. 3 Issue 2, p167 

    A letter to the editor is presented which discusses a study on the role of a statistician in appropriate reporting of statistics in clinical trials published in Indian medical journals.

  • Flow Cytometry. Strate, Barry van der // Applied Clinical Trials;Sep2012, Vol. 21 Issue 9, p6 

    The article focuses on the use of flow cytometry in clinical studies. It mentions that flow cytometry can be utilized in the development and validation of assays which demonstrate compound efficacy. Furthermore, it says that flow cytometric approaches are fast, quantitative, and has the ability...

  • Tyranny of the p-Value: The Conflict between Statistical Significance and Common Sense. Barnett, Michael L.; Mathisen, Annette // Journal of Dental Research;Jan1997, Vol. 76 Issue 1, p534 

    The author discusses the use of statistical method in science research and clinical study reports. It is argued that scientists often use p-value as an excuse not to perform actual scientific research and critically assess decisions. The need to find balance between statistical analyses and...

  • Randomised controlled trial of effect of leaflets to empower patients in consultations in primary care. Little, Paul; Dorward, Martina; Stephens, Katharine; Senior, Jane; Kendrick, Tony; Warner, Greg; Moore, Michael // BMJ: British Medical Journal (International Edition);2/21/2004, Vol. 328 Issue 7437, p441 

    Abstract Objective: To assess the impact of leaflets encouraging patients to raise concerns and to discuss symptoms or other health related issues in the consultation. Design: Randomised controlled trial. Setting: Five UK general practices in three settings. Participants: 635 consecutive...

  • What does it cost to establish a practice-nurses-led clinical trial in general practice? Blackberry, Irene D.; Furler, John S.; Young, Doris; Best, James D. // Medical Journal of Australia;11/2/2009, Vol. 191 Issue 9, p492 

    The article discusses the results of a study to determine the costs of engaging the services of practice nurses (PNs) involved in randomised controlled clinical trials of diabetes in Australia. The role of PNs in primary care research is expected to increase but the costs of employing PNs in...

  • Figures Fool when Fools Figure. Fisher, Nick // Australasian Science;Apr2004, Vol. 25 Issue 3, p43 

    Warns against believing in poor statistical practice. Characteristics of a typical professionally accredited statistician; Intrinsic factors to all stages of major scientific and technological projects; Example of events which have resulted from failure to deal with statistical issues.

  • The Pulse on Study Conduct. Weeks-Rowe, Elizabeth // CenterWatch Weekly;6/16/2014, Vol. 18 Issue 24, p5 

    The article offers offers the author's insights regarding the struggles in conducting clinical trials. Topics discussed include monitoring for research practices, the importance of clinical research associate (CRA) for clinical practices and clinical research reporting, and the role of site...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics