BackgroundThe aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer treatment setting.MethodsDanish-speaking men with castration-resistant metastatic prostate cancer receiving treatment at the Department of Oncology, Rigshospitalet, Copenhagen between March 9, 2015 and June 8, 2015 were invited to participate (n = 63 eligible). Participants completed the PRO-CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel, Cabazitaxel, Abiraterone, Alpharadin), were selected. Participants’ PRO-CTCAE responses were presented graphically to their treating oncologists via an AmbuFlex dashboard, for real-time use to enhance the patient-clinician dialogue that occurs during the consultation prior to each treatment cycle. Technical and clinical barriers and acceptability were evaluated through semi-structured interviews with both patients and oncologists. Patients receiving active treatment at the end of the study period completed an evaluation questionnaire.ResultsFifty-four out of sixty-three (86%) eligible patients were enrolled. The PRO-CTCAE questionnaire was completed a total of 168 times by 54 participants (median number per patient was 3, range 1–5). Eight surveys were missed, resulting in a compliance rate of 97%. At the end of the study period, 35 patients (65%) were still receiving active treatment and completed the evaluation questionnaire. Patients reported that their PRO-CTCAE responses served as a communication tool. Oncologists stated that the availability of the PRO-CTCAE self-reports during the consultation improved patient-clinician communication about side effects.ConclusionElectronic capture of symptomatic toxicities using PRO-CTCAE and the submission of self-reports to clinicians prior to consultation were feasible among metastatic prostate cancer patients receiving chemotherapy in an outpatient setting, and this procedure was acceptable to both patients and clinicians. Continued research, including a cluster-randomized trial, will evaluate the effects of submitting patients’ PRO-CTCAE results to clinicians prior to consultation on the quality of side-effects management and resultant clinical outcomes.
Patients with cancer are at risk of injury from cancer treatment procedures and as a consequence of problems related to administrative processes and communication. Types of identified events varied according to the methods used, and each method added new information. Further research on patient safety in cancer care and safety-enhancing activities is needed.
Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in self-reporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers.
The observed variations in antibiotic prescribing may reflect different parental and/or prescriber attitudes towards use of antibiotics and they emphasise that antibiotic prescribing is influenced by factors other than the prevalence of bacterial infections. Relationships between socio-economic position (educational level) and drug utilisation should not be generalised from one area to another.
The Patient‐Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO‐CTCAE) was developed by the National Cancer Institute to capture patient self‐reports of symptomatic toxicities during cancer treatment. The aim of this short communication is to describe the design of a national study, which examine the effect of using patients’ electronic PRO‐CTCAE reporting with real‐time feedback to clinicians on treatment events for breast cancer patients receiving adjuvant chemotherapy. The study's end‐points are defined as dose reduction, hospitalization, and febrile neutropenia. This is the first report on the impact of PRO‐CTCAE in a national breast cancer population during chemotherapy treatment.
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