The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators...

To explore cancer trial coordinators' roles and challenges in administering patient-reported outcome (PRO) questionnaires, and establish what PRO-specific training and guidance they received and needed.

Eligible cancer trial coordinators experienced with PRO assessment from approved Australian sites participated in an audio-recorded, semi-structured interview (transcribed verbatim). Recruitment continued until data saturation. Transcripts underwent content analysis.

Twenty coordinators participated (professional training: nursing (n = 12), science/research (n = 4), both (n = 4)). PRO administration formed a minor component of most (85%) coordinators' roles. PRO administration challenges included managing 'English second language' participants, participants' companions who attempted to complete questionnaires, burdensome questionnaires, and balancing their duty of care against trial requirements. Coordinators reported inconsistencies in PRO administration, which appeared to arise as a result of confusion and inconsistent or contradictory PRO training. Inconsistencies concerned whether/when they explained the purpose of PRO assessment, which participants they approached to complete PROs, and whether they used PRO trial data to inform care.Coordinators received PRO training from various sources; most commonly study-specific start-up meetings (45%) or from colleagues (30%). Two received no PRO-specific training. Despite the challenges reported, many (55%) felt they did not need further PRO training.

Trial coordinators receive inconsistent PRO-specific training and are often unclear how to prioritise different aspects of data quality when faced with everyday challenges, leading to inconsistent methods, missing data, poor quality data, and even bias. Agreement on how coordinators should prioritise the requirements of PRO studies is a necessary pre-requisite for the development of much-needed, consensus-based PRO administration guidelines.