Dataset Information

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.

ABSTRACT:

Importance

Cancer immunotherapy causes a wide range of immune-related adverse events (irAEs) that require close and timely follow-up.

Objectives

To compare the efficiency between electronic patient-reported outcomes (ePRO) and traditional follow-up models in cancer immunotherapy.

Design, setting, and participants

This open-label randomized clinical trial was performed from September 1, 2019, to March 31, 2021. Patients were randomized to the ePRO model intervention or a control group by a computer system. A total of 28 Chinese tertiary care hospitals participated. Patients who were receiving cancer immunotherapy and could use smartphones or computers were eligible. A total of 300 patients were screened and 278 (92.7%) were enrolled.

Interventions

The control group was followed up using traditional methods, including clinic visits every 21 days and telephone follow-up every 3 months. In the intervention group, the ePRO follow-up model included a questionnaire of common symptoms and an image recognition function to evaluate grades of typical irAEs. Patients completed questionnaires weekly and uploaded pictures of results between visits. When grade 1 or 2 irAEs occurred, standardized advice was sent automatically. If grade 3 or 4 irAEs were reported, the model alerted the health care team for assessment and intervention immediately. All patients were followed up for 6 months or until treatment completion.

Main outcomes and measures

Incidence of serious (grades 3 to 4) irAEs, emergency department (ED) visits, quality of life (QOL), time spent implementing the ePRO model, rate of treatment discontinuation, and death were compared between groups post intervention.

Results

A total of 278 patients (mean [SD] age, 58.8 [12.7 (range, 27-78)] years; 206 men [74.1%]) were included in the analysis, consisting of 141 in the intervention group and 137 in the control group. At the postintervention evaluation, the intervention group showed a reduced incidence of serious irAEs (29 of 141 [20.6%] vs 46 of 137 [33.6%]; hazard ratio [HR], 0.51 [95% CI, 0.30-0.88]; P = .01), fewer ED visits (23 of 141 [16.3%] vs 41 of 137 [29.9%]; HR, 0.46 [95% CI, 0.26-0.81]; P = .01), a lower rate of treatment discontinuation (5 of 141 [3.6%] vs 15 of 137 [11.0%]; HR, 0.30 [95% CI, 0.11-0.85]; P = .02), a higher QOL level (mean [SD] score, 74.2 [15.1; 95% CI, 71.7-76.9] vs 64.7 [28.5; 95% CI, 61.0-68.4]; P = .001), and less time implementing follow-up (mean [SD], 8.2 [3.9; 95% CI, 5.0-10.6] minutes vs 36.1 [15.3; 95% CI, 33.6-38.8] minutes; P < .001). However, there were no significant differences between groups in death rates (2 of 141 [1.4%] vs 5 of 137 [3.6%]; HR, 0.38 [95% CI, 0.07-1.99]; P = .28).

Conclusions and relevance

This randomized clinical trial found that the ePRO follow-up model can improve safety and QOL of patients receiving cancer immunotherapy as well as reduce time spent monitoring. This model may provide reliable information and management recommendations.

Trial registration

Chinese Clinical Trial Registry Identifier: ChiCTR2100052819.

SUBMITTER: Zhang L

PROVIDER: S-EPMC8972037 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.

Zhang Liyan L Zhang Xiaotian X Shen Lin L Zhu Dan D Ma Saili S Cong Lin L

JAMA network open 20220301 3

<h4>Importance</h4>Cancer immunotherapy causes a wide range of immune-related adverse events (irAEs) that require close and timely follow-up.<h4>Objectives</h4>To compare the efficiency between electronic patient-reported outcomes (ePRO) and traditional follow-up models in cancer immunotherapy.<h4>Design, setting, and participants</h4>This open-label randomized clinical trial was performed from September 1, 2019, to March 31, 2021. Patients were randomized to the ePRO model intervention or a con ...[more]

PMID: 35357459

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Project description:ImportanceElectronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.ObjectiveTo evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.Design, setting, and participantsReport of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021.InterventionsIn the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care.Main outcomes and measuresThe 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available.ResultsAmong 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006).Conclusions and relevanceIn this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival.Trial registrationClinicalTrials.gov Identifier: NCT03249090.

Project description:PurposeDespite evidence for clinical benefits, recommendations in guidelines, and options for electronic data collection, routine assessment of patient-reported outcomes (PROs) is mostly not implemented in clinical practice. This study aimed to plan, conduct and evaluate the implementation of electronic PRO (e-PRO) assessment in the clinical routine of an inpatient radiation oncology clinic.MethodsThe guideline- and evidence-based, stepwise approach of this single-center implementation study comprised preparatory analyses of current practice, selection of assessment instruments and times, development of staff training, and evidence-based recommendations regarding the use of the e-PRO assessment, as well as on-site support of the implementation. Process evaluation focused on potential clinical benefit (number of documented symptoms and supportive measures), feasibility and acceptance (patient contacts resulting in completion/non-completion of the e-PRO assessment, reasons for non-completion, preconditions, facilitators and barriers of implementation), and required resources (duration of patient contacts to explain/support the completion).ResultsSelection of instruments and assessment times resulted in initial assessment at admission (EORTC QLQ-C30, QSR 10), daily symptom monitoring (EORTC single items), and assessment at discharge (EORTC QLQ-C30). Recommendations for PRO-based clinical action and self-management advice for patients concerning nine core symptoms were developed. Staff training comprised group and face-to-face meetings and an additional e-learning course was developed. Analyses of clinical records showed that e-PRO assessment identified more symptoms followed by a higher number of supportive measures compared to records of patients without e-PRO assessment. Analysis of n = 1597 patient contacts resulted in n = 1355 (84.9%) completed e-PROs (initial assessment: n = 355, monitoring: n = 967, final assessment: n = 44) and n = 242 (15.2%) non-completions. Instructions or support to complete e-PROs took on average 5.5 ± 5.3 min per patient contact. The most challenging issue was the integration of the results in clinical practice.ConclusionE-PRO assessment in oncologic inpatient settings is acceptable for patients and can support symptom identification and the initiation of supportive measures. The challenge of making the "data actionable" within the clinical workflow and motivating clinical staff to use the results became evident.

Project description:Rationale & objectiveElectronic health record portals are increasingly emphasized in chronic kidney disease (CKD). However, associations of portal use with clinical and patient-centered outcomes remain unknown.Study designCross-sectional survey (April 2015 to March 2018).Setting & participantsNondialysis patients with CKD from nephrology clinics within 1 academic medical center.ExposuresPatient demographics (age, sex, race, ethnicity, education, and income), kidney function.OutcomesAssociation between portal use as an outcome and exposures. Additionally, associations of portal use and patient demographics with 4 patient-centered outcomes (CKD-specific knowledge, stress, and 2 self-ratings of health).Analytic approachLogistic regression to examine associations between patient portal use, demographics, and kidney function. Linear regression to examine associations between portal use and patient-centered outcomes.ResultsOf 245 participants, mean age was 60 ± 17 (SD) years, 182 (77%) were White, 121 (49%) were women, 230 (96%) had a high school education or higher, and 96 (45%) had <$50,000 annual income. Examining portal use, 159 (65%) used the portal as follows: checking laboratory test results, 157 (99%); managing appointments, 133 (84%); messaging providers, 131 (82%); viewing medical history, 127 (80%); reviewing educational resources, 113 (71%); and renewing prescriptions, 98 (62%). African Americans (OR, 0.34; 95% CI, 0.16-0.72 vs White patients), patients with less formal education (OR, 0.06; 95% CI, 0.01-0.36), and those with lower income (OR, 0.28; 95% CI, 0.13-0.60; and OR, 0.26; 95% CI, 0.12-0.54 comparing income < $25,000 and $25,000-$50,000, respectively, with ≥$50,000) had lower odds of using the portal. In adjusted analysis, only lower income predicted lower portal use. Examining patient-centered outcomes in univariable analysis, portal users had higher knowledge (β = 4.89; P = 0.02), higher ratings of current health (β = 0.28; P = 0.03), and lower CKD-related stress (β = -0.18; P = 0.05). In adjusted analysis, only patient demographics and/or kidney function remained independent predictors of patient-centered outcomes.LimitationsCross-sectional study design, cannot determine causality.ConclusionsInterventions are needed to ensure that all patients have access to portals to mitigate disparities in care.

Dataset Information

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.

Importance

Objectives

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial.

Similar Datasets

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