Evidence map›Paper›PMID 39976863›Full record

ReviewJournal of patient-reported outcomes2025

The evaluation of clinical outcomes assessments and digital health technologies in clinical trials for obesity.

Iris A Goetz, Carolyn Sutter, Traci Abraham, Chisom Kanu, Kristina S Boye, Tara Symonds

Abstract readReview
In one paragraph

Review in Journal of patient-reported outcomes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

6 authors.

Iris A GoetzEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN, 46285, USA. Goetz_iris@lilly.com.ORCID http://orcid.org/0000-0003-0898-9530
Carolyn SutterClinical Outcomes Solutions, 53 West Jackson Boulevard, Chicago, IL, 60604, USA.
Traci AbrahamClinical Outcomes Solutions, 53 West Jackson Boulevard, Chicago, IL, 60604, USA.
Chisom KanuEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN, 46285, USA.
Kristina S BoyeEli Lilly and Company, Lilly Corporate Center Indianapolis, Indianapolis, IN, 46285, USA.
Tara SymondsClinical Outcomes Solutions Ltd, Unit 68 Basepoint, Shearway Business Park, Shearway Road, Folkestone, UK.

Funding

Eli Lilly and Company Eli Lilly and Company
6 · The paper itself

Abstract

backgroundClinical trials for obesity have traditionally focused on weight loss and resolution of comorbidities as primary outcomes. However, secondary outcomes, such as the impact of weight reduction on patient experience, like health-related quality of life (HRQoL), have increasingly been recognized as important. Therefore, a review was conducted to determine the Clinical Outcome Assessments (COAs) and Digital Health Technologies (DHTs) used in clinical trials for obesity to assess the patient experience.

methodsTwo clinical trial databases (United States & European Union) were reviewed to identify Phase 2-4 clinical trials for obesity (2018-2023). A targeted literature review was also conducted using the OVID database to identify clinical trial for obesity publications which included COAs/DHTs (2010-2023).

resultTrials from the databases (n = 53) and publications (n = 42) were included in data extraction (N = 73). This resulted in identification of 108 COAs, the majority being patient-reported outcome (PRO) measures (n = 83), but also 24 performance outcomes (PerfO) measures, and 1 composite PRO-clinician-reported outcomes (ClinRO) measure, as well as 2 DHTs. The most frequently identified PRO measures were the Short Form 36 and the Impact of Weight on Quality of Life Lite Clinical Trials. Twenty-four PerfO measures were also identified, with the 6-minute walk test being most common. These measures were most often used to construct secondary endpoints, with physical function (PF) being the most frequently specified domain. PRO measures assessing eating-related thoughts/behaviours, physical activity, and disordered eating were also frequently included, although individual measures varied widely across trials.

conclusionReview of COAs and DHTs in registered clinical trials and publications for obesity found that PRO measures were the most common type of COA used to develop endpoints with current use of DHTs limited. Specifically, the physical function domain of multidimensional patient-reported outcome measures assessing health-related quality of life were often used to construct secondary endpoints. Further work is warranted to assess how the COAs and DHT data collected in clinical trials are viewed by regulators and payers.

Indexed as

Biomedical TechnologyClinical Trials as TopicDigital TechnologyObesityOutcome Assessment, Health CarePatient Reported Outcome MeasuresDigital HealthHumansQuality of LifeWeight LossChronic weight managementClinical outcome assessmentsClinical trialsDigital health technologiesHealth-related quality of lifeObesityPatient reported outcomesPerformance outcomePhysical function

Identifiers

PMID39976863
PMCPMC11842654

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.