Using agile development methodology to develop a decision aid for complex rectal cancer

Approximately 5-10% of rectal cancer diagnoses are locally advanced (LARC) at presentation and between 4 and 8% recur locally after initial treatment, locally recurrent rectal cancer (LRRC). For patients diagnosed with LARC/LRRC pelvic exenteration (PE) may be potentially curative, but is likely to impact on subsequent quality of life (QoL). To make optimal decisions about their treatment options patients need high quality detailed comprehensible information. To date there are no validated patient decision aids (PtDA) to facilitate the process of shared decision making (SDM) for PE patients. The aim of this study was to develop a PtDA in line with international minimum standards.

A national, multi-centre mixed methods study was designed in keeping with guidance from the International Patient Decision Aids Standard (IPDAS). Ethical approval was obtained. A PtDA was developed by a multidisciplinary committee of clinicians and patient advocates using Agile Cycle Development (ADM). Content was informed by literature review and qualitative patient and clinician interviews. Face validity and field testing were undertaken using mixed-methods of interviews and questionnaires; QQ-10, EORTC PATSAT-C33 and Preparation for Decision-Making Scale (Prep-DM).

Six sprint cycles were used to develop the content of the PtDA. Qualitative interviews were undertaken with 19 patients and 9 clinicians resulting in 50 changes. Mean scores for value and burden were 89% (SD = 12.1) and 8% (SD = 8.5), respectively, suggesting high value and low burden for most patients. PtDA use resulted in improved satisfaction in all domains (p < 0.05). Pre and post implementation Prep-DM score was 66.8% (SD = 11.8) and 91.5% (SD = 8.9%), respectively (p < 0.001).

This validated PtDA supports SDM for patients considering PE. A future study on implementation once the PtDA is used in routine practice will determine any further barriers to implementation.