Evidence mapPaperPMID 24369764Full record

Observational studyHealth and quality of life outcomes2013

Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study.

Matthew Reaney, Chantal Mathieu, Claes-Göran Ostenson, Stephan Matthaei, Thure Krarup, Jacek Kiljański, Carole Salaun-Martin, Hélène Sapin, Michael Theodorakis, Bruno Guerci

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Health and quality of life outcomes, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00635492 (CHOICE), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT00635492 completednot on this map

CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months

TypeobservationalSponsorAstraZenecaRan2008 to 2011Enrolled2,515ConditionsType 2 Diabetes MellitusArmsexenatide, any human insulin or analog insulin(s) given in any regimen by subcutaneous injection
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
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.

Matthew Reaney
Chantal Mathieu
Claes-Göran Ostenson
Stephan Matthaei
Thure Krarup
Jacek Kiljański
Carole Salaun-Martin
Hélène Sapin
Michael TheodorakisDepartment of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece. mtheod@ebie.gr.
Bruno Guerci

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImprovements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study.

methodsCHOICE was a 24-month, prospective observational study conducted in six European countries. Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement. Clinical and PRO data were collected at baseline (injectable therapy initiation) and after approximately 3, 6, 12, 18 and 24 months. The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.

resultsThere were 2388 patients eligible for analysis (exenatide BID cohort, n = 1114; insulin cohort, n = 1274). Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation. Patients who experienced weight loss (≥ 1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change. Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes.

conclusionsThese data from a clinical practice study support those from clinical trials, suggesting that PROs are not adversely affected, and may be improved, by injectable therapy initiation. PRO data may aid appropriate treatment selection for individual patients.

trial registrationClinicalTrials.gov, NCT00635492.

Indexed as

Patient Outcome AssessmentAgedDiabetes Mellitus, Type 2EuropeExenatideFemaleGreeceHumansHypoglycemic AgentsInsulinMaleMiddle AgedMonte Carlo MethodPeptidesProspective StudiesVenomsExenatideHypoglycemic AgentsInsulinPeptidesVenoms

Identifiers

PMID24369764
PMCPMC3900476

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.