GP Participation and Recruitment of Patients to RCTs: Lessons from Trials of Acupuncture and Exercise for Low Back Pain in Primary Care

Table 1

Comparing the methods, including recruitment, in the exercise and acupuncture trials.

Profile	Exercise trial	Acupuncture trial
Brief summary of trial	RCT of progressive exercise programme compared with usual primary care management for patients with low back pain.	Pragmatic RCT evaluating the clinical and economic benefits of offering acupuncture to patients with low back pain, compared to usual GP management.
Inclusion criteria	Age 18–60 years; mechanical low back pain of at least 4 weeks duration but less than 6 months, declared medically fit by their GP to undertake the exercise.	Age 20–65 years; presenting with low back pain or sciatica; up to 12 months pain in current episode and greater than 4 weeks duration Assessed as suitable for management in primary care;
Exclusion criteria	Sciatica; Serious pathology; Unable to attend the exercise classes; Other musculoskeletal activities affecting their ability to cope with the fitness programme; concurrent physiotherapy; major recent surgery; systemic conditions; Spondylolisthesis; engaged in moderately strenuous sporting activities at least twice a week for the previous 6 months; Pregnancy	Possible spinal pathology; Severe or progressive motor weakness or central disc prolapse; Past spinal surgery; Pending litigation; Bleeding disorders; Currently receiving acupuncture treatment.
Financial incentives	None	£5 per patient referred, as compensation for time taken explaining the trial to patients
GP trial advisor	No	Yes
GP recruitment	GPs practices were approached by a letter of introduction from the study team, including a copy of the protocol, procedure and background information. Telephone contact was made with the practice manager and a personal visit was arranged by the project leader in order to explain the study in more detail. Emphasis was placed on the need for all GPs plus the practice manager to be present. A total of 19 practices were recruited in this way, with 87 GPs referring patients.	A GP advisor established initial contacts with a number of individual GPs (𝑛=28), and told them to expect a phone call from the study researcher. The researcher telephoned the GPs and arranged a personal visit to explain the study in more detail. The remaining GPs in York (𝑛=98) were sent a letter of introduction from the study team, inviting them to participate in the study. Fifteen GPs returned a postcard indicating their interest and a personal practice visit was arranged. A total of 39 GPs from 18 practices were recruited.
Patient recruitment	One practice provided a computerised list of names of patients who had recently presented with low back pain. Patients were contacted by letter to assess their suitability for the trial and to gain consent. The other 18 practices manually recorded referrals after the consultation by the GP. Over 24 months, a total of 187 patients were recruited out of a target of 300.	Patients were referred directly to the study researcher immediately after a consultation with their GP for low back pain. Over 18 month's period, a total of 289 patients were referred by the GPs, of whom 241 were recruited to the trial.
Strategies for maximising recruitment	Project logo, project updates, referral forms, project reminder letters, personal practice visits.	Project logo, project updates, patients’ acknowledgement letters, patient discharge letters, project reminder letters, and personal phone calls to study GPs.