Recruitment of women with a Urinary Tract Infection to a herbal IMP trial in Primary Care: Challenges encountered (based on the ATAFUTI Trial) and recommendations for future recruitment for studies of acute conditions.

Problem

Opportunistic recruitment into trials often proves challenging for many GP practices, resulting in slower recruitment trajectories, which can then have a knock on effect to trial timelines and budgets. This poster reflects on the methodological challenges to recruiting women with a UTI, opportunistically in primary care and the strategies employed to address them.

Approach

ATAFUTI was a trial investigating alternative treatments for adult female urinary tract infection. Women were screened opportunistically, which involved routine clinical examinations, consultation of the patient’s medical notes, asking the patient questions and if eligible a pregnancy test was required for women of child bearing potential. A urine sample was also requested and baseline symptoms were collected. Recruitment difficulties were encountered in many practices as it could often take up to 40 minutes due to the complexity of trial paperwork and often women just wanted immediate antibiotics. A number of strategies were employed to try to increase recruitment at these sites. Strategies were developed through discussion with the highest performing sites.

Findings

Successful strategies included improving GP/nurse engagement in the trial by using a video about the trial from the Chief Investigator; ensuring reception and triage staff are aware of the trial so that potential patients can be identified at initial presentations; setting up a prompt within practice’s IT system to flag up patients with a UTI; providing clinicians with endorsement statements (e.g “The pain and urine frequency in cystitis result from bladder inflammation.” “On average the bad symptoms of cystitis last 3 days after starting antibiotics and around one day more without antibiotics.”) to explain to patients that antibiotics do not alleviate symptoms of a UTI. As a result, 382 patients were recruited over a period of 15 months. 57 sites were open to recruitment, however, only 41 (~70%) recruited patients into ATAFUTI and the majority of patients (68 %) were recruited by only 11 sites.

Consequences

The lessons learnt from ATAFUTI can be used when designing future trials of acute conditions in primary care, involving opportunistic recruitment methods. Seeking advice at an early stage from experienced GP sites on recruitment strategies, which can then be tailored to suit individual GP practice and included in site specific training, is important for successful recruitment from the start of a trial.