title: Why do - or don't - patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine.
abstract: BACKGROUND
  Insufficient patient recruitment can impair the conduct of clinical trials substantially, not least because a significant number of eligible patients decline trial participation. Though barriers and motivational factors have been worked out for patients with cancer or chronic diseases, little is known about primary care patients' perceptions towards trial participation when visiting their family practitioner (FP) with acute uncomplicated conditions. This study aims to assess primary care patients' motivation and barriers to participate in trials, and to identify factors that optimize patient recruitment in future trials.
  
  
  METHODS
  This study was embedded in a drug trial comparing two treatment strategies for women with uncomplicated urinary tract infection in primary care. Semi-structured telephone interviews both with trial participants and decliners were conducted. The interview guideline focused on patients' personal motivational or hampering factors. Further topics were study theme, FPs' role, randomization, trial procedures, and potential motivational factors or barriers presumed to be relevant for other patients. Transcripts were analyzed by summarizing content analysis.
  
  
  RESULTS
  20 interviews with trial participants and 5 interviews with trial decliners were conducted. RESULTS show various reasons for trial participation from three categories: personal aspects, trial related aspects and patient-physician-relationship. A relevant trial topic and perceived personal benefit promotes participation as well as the wish to support research in general. Additionally, a maximum of safety concerning symptom relief reassures patients significantly. Trust in the FP plays also an important role in the decision process. Trial decliners show strong individual treatment preferences, which, together with individual reasons, lead to trial refusals.
  
  
  CONCLUSIONS
  To optimize recruitment conditions for further clinical trials on acute and common conditions in family medicine, the following key issues should be considered: emphasizing patients' personal benefit, featuring patient relevant trial topics, providing a maximum of safety, keeping effort by trial procedures comfortable.
authors.affiliation: Institute for General Practice, Hannover Medical School, Hannover, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Bleidorn
authors.affiliation: Institute for General Practice, Hannover Medical School, Hannover, Germany.
authors.forename: Sermin
authors.initials: S
authors.lastname: Bucak
authors.affiliation: Institute of General Practice and Family Medicine, University Medical Center, Goettingen, Germany.
authors.forename: Ildikó
authors.initials: I
authors.lastname: Gágyor
authors.affiliation: Institute of General Practice and Family Medicine, University Medical Center, Goettingen, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Hummers-Pradier
authors.affiliation: Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany.
authors.forename: Marie-Luise
authors.initials: ML
authors.lastname: Dierks
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D005194:Family Practice; D005260:Female; D005578:Fosfomycin / Q000627:therapeutic use; D005858:Germany; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008875:Middle Aged; D009042:Motivation; D010358:Patient Participation / Q000523:psychology*; D061214:Patient Safety; D018579:Patient Selection; D010819:Physician's Role; D010817:Physician-Patient Relations; D036301:Qualitative Research; D045808:Refusal to Participate / Q000523:psychology*; D014552:Urinary Tract Infections / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005578:Fosfomycin; D007052:Ibuprofen
keywords: clinical trial; family medicine; motivational factors; non participation; patients attitudes; qualitative research; trial participation; urinary tract infection