Evidence map›Paper›PMID 37986191›Full record

Trial reportBMC health services research2023

The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial.

Megan S Zhou, Tanya Jain, Nick Hardy, Alejandro Perez-Segura, Jasmine Hickman, Laurey Leopold, Kerry Qualliotine, Raagini S Yedidi, Matthew Whetsell, Lauren Broffman

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC health services research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05895539 (The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05895539 nacompletednot on this map

The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation: an Iterative Plan-Do-Study-Act (PDSA) Approach

TypeinterventionalSponsorRoRan2020 to 2020Enrolled2,000ConditionsInternet-based Intervention, Web-based Intervention, Online Intervention, Erectile DysfunctionArmsAn automated patient-reported outcome data collection and adverse event surveillance tool
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Megan S ZhouRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Tanya JainRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Nick HardyRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Alejandro Perez-SeguraRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Jasmine HickmanRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Laurey LeopoldRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Kerry QualliotineRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Raagini S YedidiRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Matthew WhetsellRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Lauren BroffmanRoman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA. lauren.broffman@ro.co.ORCID http://orcid.org/0000-0003-0048-4474

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform.

methodsWe used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool-a short prompt for patients to provide information on treatment satisfaction and side effects-impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.

resultsCompared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005).

conclusionsPrompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment.

trial registrationThis trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).

Indexed as

Patient Reported Outcome MeasuresData CollectionHumansMaleAdverse eventsHealthcare quality improvementPatient-reported experience measuresPatient-reported outcomesSide effectsTelemedicine

Identifiers

PMID37986191
PMCPMC10658802

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.