Patient Decision Aid for Chemotherapy or Exclusion in Cisplatin-Intolerant Patients With Locally Advanced Cervical Cancer: Development, Alpha Testing, and Peer Validation

PURPOSE: In locally advanced cervical cancer (LACC), adding cisplatin to radiotherapy (RT) improves survival but increases toxicity. Among patients with cisplatin contraindications, RT compliance may be compromised by toxicity because of cisplatin or a substitute. In shared decision making, a patient decision aid (PtDA) may decrease decisional conflict and attitudinal barriers, thereby improving treatment compliance. METHODS: Following International Patient Decision Aid Standards (IPDAS) guidelines, a steering committee of two radiation oncologists, a gynecologic oncologist, an oncology nurse, a clinical psychologist, a cancer survivor, and a caregiver developed the chemotherapy or exclusion in cisplatin-intolerant patients with LACC (CECIL) prototype, a PtDA for cisplatin-intolerant patients with LACC deciding about adding chemotherapy to RT. The prototype was alpha-tested using the e-Delphi method. The patient decision aid research group Ottawa Acceptability Questionnaire was used to evaluate comprehensibility, length, amount of information, neutrality, and overall suitability for decision making. The prototype was then independently evaluated by local internal, local external, and international reviewers using the IPDAS checklist version 4, which encompasses information, probabilities, values, guidance, development, evidence, disclosure, plain language, and evaluation. RESULTS: Alpha testing showed high practitioner acceptability (all items with mean and median scores ≥4; overall mean score 4.70 of 5.00) and good patient acceptability (all items rated good to excellent). Content validation showed that the PtDA satisfied all IPDAS six qualifying and six certification criteria, with high overall mean score (3.63 of 4.00) for all 17 applicable quality criteria. CONCLUSION: The CECIL prototype shows good practitioner and patient acceptability, and content validity on peer review. Clinical testing to determine its effectiveness in reducing decisional conflict is ongoing.