Evidence map›Paper›PMID 31087060›Full record

Observational studyThe Journal of clinical endocrinology and metabolism2019

Estimation of Mortality Risk in Type 2 Diabetic Patients (ENFORCE): An Inexpensive and Parsimonious Prediction Model.

Massimiliano Copetti, Hetal Shah, Andrea Fontana, Maria Giovanna Scarale, Claudia Menzaghi, Salvatore De Cosmo, Monia Garofolo, Maria Rosaria Sorrentino, Olga Lamacchia, Giuseppe Penno and 2 more

Registry-linked trialAbstract readObservational StudyValidation Study
In one paragraph

Observational study in The Journal of clinical endocrinology and metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05261841 (Observational Analysis and Elaboration of a Predictive Model on the Effects of Physical Activity and Individual Lifestyles in the Management of Diabetic Disease Type 2 as Part of the GATEKEEPER H2020 Project.), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT05261841 unknown statusnot on this mapstarted 2021, after this paper: background citation

Observational Analysis and Elaboration of a Predictive Model on the Effects of Physical Activity and Individual Lifestyles in the Management of Diabetic Disease Type 2 as Part of the GATEKEEPER H2020 Project.

TypeobservationalSponsorCasa Sollievo della Sofferenza IRCCSRan2021 to 2023Enrolled100ConditionsType 2 DiabetesArmsStandard care for T2D patients, Smartwatch
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Observational
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

12 authors.

Massimiliano CopettiUnit of Biostatistics, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Hetal ShahResearch Division, Joslin Diabetes Center, Boston, Massachusetts.
Andrea FontanaUnit of Biostatistics, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Maria Giovanna ScaraleResearch Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Claudia MenzaghiResearch Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.
Salvatore De CosmoDepartment of Clinical Sciences, Fondazione IRCCS "Casa Sollievo Della Sofferenza", San Giovanni Rotondo, Italy.
Monia GarofoloDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Maria Rosaria SorrentinoUnit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Olga LamacchiaUnit of Endocrinology and Diabetology, Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
Giuseppe PennoDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Alessandro DoriaResearch Division, Joslin Diabetes Center, Boston, Massachusetts.
Vincenzo TrischittaResearch Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.

Funding

SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI AMY JO WAGERS · 1986 to 2026
$50.5M
Genetic modifiers of the effect of intensive glycemic control on CVD riskR01HL110400 · NHLBI · JOSLIN DIABETES CENTER · PI DORIA, ALESSANDRO · 2011 to 2014
$3.8M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095183 · HC · MINNEAPOLIS MEDICAL RESEARCH FDN, INC. · PI GRIMM, RICHARD H · 1999 to 2000
$1.9M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095181 · HC · CASE WESTERN RESERVE UNIVERSITY · PI THIBONNIER, MARC · 1999 to 2000
$1.8M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095184 · HC · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BIGGER, J T · 1999 to 2000
$1.7M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095182 · HC · WAKE FOREST UNIVERSITY · PI GOFF, DAVID C · 1999 to 2000
$1.6M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUS-N01HC95178N01HC095178 · HC · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI BYINGTON, ROBERT · 1999 to 2006
$1.5M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETER MELLLITN01HC095180 · HC · UNIVERSITY OF WASHINGTON · PI PROBSTFIELD, JEFFREY · 1999 to 2000
$1.5M
PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITUN01HC095179 · HC · MCMASTER UNIVERSITY · PI GERSTEIN, HERTZEL C · 1999 to 2000
$1.3M
NHLBI NIH HHS N01 HC095178NHLBI NIH HHS N01 HC095179NHLBI NIH HHS N01 HC095180NHLBI NIH HHS N01 HC095181NHLBI NIH HHS N01 HC095182NHLBI NIH HHS N01 HC095183NHLBI NIH HHS N01 HC095184NHLBI NIH HHS R01 HL110400NHLBI NIH HHS Y01 HC001010NHLBI NIH HHS Y01 HC009035NIDDK NIH HHS P30 DK036836
6 · The paper itself

Abstract

contextWe previously developed and validated an inexpensive and parsimonious prediction model of 2-year all-cause mortality in real-life patients with type 2 diabetes.

objectiveThis model, now named ENFORCE (EstimatioN oF mORtality risk in type 2 diabetiC patiEnts), was investigated in terms of (i) prediction performance at 6 years, a more clinically useful time-horizon; (ii) further validation in an independent sample; and (iii) performance comparison in a real-life vs a clinical trial setting.

designObservational prospective randomized clinical trial.

settingWhite patients with type 2 diabetes. PATIENTS: Gargano Mortality Study (GMS; n = 1019), Foggia Mortality Study (FMS; n = 1045), and Pisa Mortality Study (PMS; n = 972) as real-life samples and the standard glycemic arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) clinical trial (n = 3150).

main outcome measureThe endpoint was all-cause mortality. Prediction accuracy and calibration were estimated to assess the model's performances.

resultsENFORCE yielded 6-year mortality C-statistics of 0.79, 0.78, and 0.75 in GMS, FMS, and PMS, respectively (P heterogeneity = 0.71). Pooling the three cohorts showed a 6-year mortality C-statistic of 0.80. In the ACCORD trial, ENFORCE achieved a C-statistic of 0.68, a value significantly lower than that obtained in the pooled real-life samples (P < 0.0001). This difference resembles that observed with other models comparing real-life vs clinical trial settings, thus suggesting it is a true, replicable phenomenon.

conclusionsThe time horizon of ENFORCE has been extended to 6 years and validated in three independent samples. ENFORCE is a free and user-friendly risk calculator of all-cause mortality in white patients with type 2 diabetes from a real-life setting.

Indexed as

Models, StatisticalAgedDiabetes Mellitus, Type 2FemaleHumansMaleMiddle AgedPrognosisProspective StudiesRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsStatistics as Topic

Identifiers

PMID31087060
PMCPMC6734484

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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.