Table 1.

Factors that may predict recruitment success[10].

Relevant factors	PATCH II
Quality of Study team/multi-disciplinary team	Experienced multi-disciplinary team including dermatologists, trialists, statistician and health economist. Independent Chair of Steering Committee and independent Data Monitoring Committee.
Involvement of a Clinical Trials Unit	Yes - Nottingham Clinical Trials Unit (CTU)
Trial Manager	Yes - based at co-ordinating centre
Local recruitment co-ordinators	No - this was a major weakness for PATCH II. Local research nurses, with dedicated time to work on the study could have made a real difference to recruitment.
Feasibility work	Twelve-month feasibility study conducted prior to starting trial.
Peer reviewed study protocol	Protocol peer reviewed by UK DCTN and Nottingham CTU
Simple study design	Simple parallel group study (but complicated by recruitment into a similar study that was being run in parallel).
Service user input	Focus group discussions as part of feasibility study & through discussion with the Lymphoedema Support Network
Important research question with support of the clinical community	Identified as a priority trial by the UK Dermatology Clinical Trials Network
Drug trial/intervention only available in study	Yes. Some may have felt that prophylactic antibiotics were only available to them within the trial, although this depended very much on local practice of the treating physician.
Appropriately funded	Limited funding available due to charity as the source of funding.