A Randomized Controlled Trial Evaluating Electronic Outpatient Symptom Monitoring After Ambulatory Cancer Surgery

Pusic, Andrea L.; Temple, Larissa K.; Carter, Jeanne; Stabile, Cara; Assel, Melissa; Niehaus, Kate; Ancker, Jessica S.; McCready, Taylor; Stetson, Peter D.; Simon, Brett A.

doi:10.1097/sla.0000000000005005

Cited by 27 publications

(27 citation statements)

References 25 publications

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“…23 Additionally, a trial randomizing ambulatory cancer surgery patients to daily PROMs vs enhanced PROMs with immediate normative feedback regarding expected symptoms significantly decreased nursing calls, which may offset some of the burden on clinical staff. 24 The prospective nature of this pilot mirrors realtime data collection during the 30-day home recovery phase after cystectomy. However, its small sample size limits quantitative correlation of clinical outcomes with symptoms scores and biometric phenotypes.…”

Section: Discussionmentioning

confidence: 99%

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Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility

et al. 2023

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Purpose: Mobile health technology and integration of patient-reported outcome measures into clinical interventions have the potential to transform patient care. Though patient-reported outcome measure management has been shown to improve outcomes in ambulatory care settings, few studies have examined remote patient-reported outcome measure assessment after major cancer surgery. Materials and Methods: A multiphased feasibility and usability study was designed. A mobile app-based postoperative symptom intervention tool was developed and evaluated by a focus group of bladder cancer patients and caregivers. Patients were prospectively accrued prior to cystectomy and asked to complete the daily mobile postoperative symptom intervention tool and wear biometric monitoring devices for 30 days post discharge. Retention, postoperative symptom intervention tool completion, and usability were assessed. Exploratory analysis of daily symptoms and patient-generated health information correlated signals with postsurgical complications and hospital readmission. Results: Fifteen patients with a median age of 72 years completed 78% of daily surveys over the 30-day recovery period. Average time to complete the postoperative symptom intervention tool was 152 seconds. All patients agreed that the daily survey was easy to use, and most reported it would be a better way to communicate with the care team about symptoms than calling the clinic. Frequency and severity of patient-reported symptoms appeared to cluster prior to or at the time of complication or unplanned health care encounters on visual-analogue mapping. Conclusions: Using smartphone and wearable technology to capture patientreported symptoms and biometric data is feasible and rated as highly usable by bladder cancer patients after cystectomy. Symptom scores may signal developing complications and help clinicians identify postsurgical patients who may benefit from intervention.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility

et al. 2023

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“…The RCT reported by Pusic et al5 did not reject the null hypothesis that patients in the enhanced feedback group did not have different avoidable UCC visits compared with those in the team monitoring group. Although the between-group difference was not statistically significant, the enhanced feedback group tended to have more avoidable UCC visits (4.6% vs. 3.4%).…”

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confidence: 90%

“…It demonstrated that electronic symptom monitoring with intervention in response to alerts reduced potentially avoidable urgent care center (UCC) visits compared with the usual care, but increased the number of nursing calls 6. This RCT included a large sample size of 2624 patients undergoing ambulatory cancer surgery and revealed that providing patients with automated normative feedback regarding their symptom severity reduced patient anxiety and nursing calls compared with providing patients with remote symptom management via team monitoring, but the rates of UCC visits between the 2 groups were not significantly different 5…”

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confidence: 98%

“…The authors used nurse phone calls to quantify the clinical staff burden. The article mentioned that a clinical team was responsible for handling alerts 5. It would be interesting to know whether surgeons in the clinical team were involved and their roles in the management of the alerts, given that these details would be useful to inform future symptom monitoring practices in other centers.…”

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Comment on: “A Randomized Controlled Trial Evaluating Electronic Outpatient Symptom Monitoring After Ambulatory Cancer Surgery”

et al. 2022

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Patient and Family Representation in Randomized Clinical Trials Published in 3 Medical and Surgical Journals

et al. 2022

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IMPORTANCEPatient and family engagement in research may improve the design, conduct, and dissemination of clinical research, but little is known about whether these stakeholder groups are involved in the design and conduct of randomized clinical trials. OBJECTIVE To characterize the involvement and role of patient and family representatives in the design and conduct of randomized clinical trials by reviewing randomized clinical trials from 3 peerreviewed medical and surgical journals with high impact factors. EVIDENCE REVIEWIn this systematic review, the first 50 consecutive randomized clinical trials published on or after January 1, 2021, until September 30, 2021, from each of 3 medical and surgical journals with high impact factors were reviewed for patient or family involvement in trial design and/or conduct. The manuscript, supplemental data, and trial registry records were searched for trial design and governance structures. Two independent, blinded reviewers screened citations and extracted data. This study followed the Preferred Reporting Items for Systematic Reviews and Metaanalyses (PRISMA) guidelines. FINDINGS Only 7 of 150 randomized clinical trials (5%) reported patient or family representation in their study design or conduct. Most studies with patient or family representation (n = 5) were from a single journal. Stakeholder involvement was mainly in the execution phase (n = 7), although in 2 studies stakeholders were also involved in the translation phase. CONCLUSIONS AND RELEVANCEThe findings of this systematic review suggest that patient or family involvement in the design and conduct of randomized clinical trials in the publications with high impact factors is lacking. We found that when patient or family groups are involved in research, the focus was mainly on the execution phase of research design. There is a need to increase stakeholder involvement in the research design, conduct, and translation of randomized clinical trials.

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A Randomized Controlled Trial Evaluating Electronic Outpatient Symptom Monitoring After Ambulatory Cancer Surgery

Cited by 27 publications

References 25 publications

Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility

Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility

Comment on: “A Randomized Controlled Trial Evaluating Electronic Outpatient Symptom Monitoring After Ambulatory Cancer Surgery”

Patient and Family Representation in Randomized Clinical Trials Published in 3 Medical and Surgical Journals

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