Primary Care ClinicalResearch & Trials Unit

Prof Richard LilfordOutgoing Director PC-CRTU

What makes a great Primary Care Trial?

Trials Unit

Clever & Imaginative

Clinicians

Network of Collaborating

Practices

1. Clever & Imaginative Clinicians

2. Trials UnitClever statisticians Fastidious

data-management

Trial governance

Leader of the orchestra

3. Primary Care Research Network

• Hub and spoke model

• Extending across England

• NIHR funded

• Local network– 3 000 GPs– 685 practices– 4 000 000 patients

Iconic Studies

BMJ. 2005; 331: 1057.

Self management of oral anticoagulation: randomised trialFitzmaurice DA, Murray ET, McCahon D, Holder R, Raferty JP, Hussain S, Sandhar H, Hobbs FDR.

Conclusion With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control.

Lancet. 2007; 370: 493-503.

Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial.Mant J, Hobbs FD, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Murray E; BAFTA investigators; Midland Research Practices Network.

Interpretation These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation, unless there are contraindications or the patient decides that the benefits are not worth the inconvenience.

Lancet. 2010 376: 163-172.

Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trialMcManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Banting M, Bryan S, Little P, Williams B, Hobbs FDR.

Interpretation Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care.

NEJM. 2011; 365: 1193-1200.

Placebo-Controlled Trial of Cytisine for Smoking CessationWest R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard P, Stapleton J.

Conclusions In this single-center study, cytisine was more effective than placebo for smoking cessation. The lower price of cytisine as compared with that of other pharmacotherapies for smoking cessation may make it an affordable treatment to advance smoking cessation globally.

The Future

Methodological Development

Broaden Subject Matter

Innovative Trial Management

Broaden Subject Matter1. Consolidate Primary Care Studies;2. Include Public Health Studies;

e.g. Peymane Adab’s HTA Cluster Trial of >100 schools.

3. Service delivery interventions;e.g. Tom Marshall’s case-finding study, Marshall et al. BMC Public Health. 2012; 12: 908.

4. Non-health care interventions:– Social services;– Criminal justice;– Education;– Agriculture;– International.

Home

Out-patients

Admission

Primary Care

Long-term outcomes

Patient sensed outcomes

Clinical outcomesStudy outcomes

Clinical featuresSuitability for study

Study data(Randomisation)

Innovative Trial Management

Methodological Development

2. Cluster studies & step wedgeMarshall et al. BMC Public Health. 2012; 12:908.Brown & Lilford. BMC Med Res Methodol. 2006; 6:54.Brown et al. Qual Saf Health Care. 2008; 17:163-9.Hemming & Marsh. STATA Journal. 2013; 13(1): 114-35.

3. Supply side health economics and Value of Information

Girling et al. Health Econ. 2012; 21(12): 1502-7. Hemming et al. BMC Med Res Methodol. 2011; 11: 102.Girling et al. Int J Technol Assess Health Care. 2007; 23(2):269-77.Girling et al. Clin Trials. 2007; 4(1): 15-24.

4. Service delivery interventions and Bayesian methods

Yao et al. BMJ Qual Saf. 2012; 21(s1): i29-38.Hemming et al. PLoS One. 2012; 7(6): e38306.Lilford et al. BMJ. 2010; 341: c4413.

1. Pre-implementation evaluations – NIHR CLAHRC WM.

Systematic Reviews1. Panoramic meta-analysis

Bowater et al. Ann Surg Oncol. 2012; 19(11):3343-50.

2. Network meta-analysis

Chen Y-F. Evaluating Evidence of Medical Devices – International Experiences. ISPOR 5th Asia-Pacific Conference. 2012.

Managing Science