Literature DB >> 35673504

Rating the importance of outcomes from diabetes trials. A survey of patients' and doctors' opinions.

Sam Kafai Yahyavi1, Peter Lommer Kristensen2,3, Zainab Gassem Nagras4, Carsten Hjorthøj5,6, Jesper Krogh7.   

Abstract

Purpose: To investigate and compare how patients with diabetes mellitus and doctors rate the importance of outcomes used as part of composite endpoints in clinical diabetes trials. Secondly, to compare the ratings of outcomes between patients with low and high education.
Methods: Using a pre-piloted questionnaire, patients with diabetes and doctors working with diabetes were asked to rate the importance of 36 different outcomes commonly used in trials assessing intervention effects in patients with diabetes. The respondents were asked to rate individual outcomes as being either critical, of major importance, of moderate importance, or of minor importance.
Results: The study population consisted of 139 patients with a mean age of 56.6 years and an average duration of diabetes for 13.6 years and 45 doctors with a mean time of practice of 19.6 years. There was no difference between patients' and doctors' rating of risk of mortality and non-fatal myocardial infarction, and percutaneous coronary intervention (all p-values > 0.34). Non-fatal stroke, admission for heart failure or angina was perceived more severely by patients compared to doctors (all p-values < 0.03). Patients rated risk of foot-ulcers, amputations and quality of life as more important compared to doctors (p-values < 0.01).
Conclusion: The current study suggest that patients and doctors weigh some diabetic outcomes used as part of composite endpoints in clinical diabetes trials differently. These findings call for more studies on patient reported outcomes and patient education for improved personal care. Highlights: • We performed this study to assess how patients and practicing physicians rate the importance of outcomes commonly used in diabetes trials.• We found that patients and doctors rate the importance of some outcomes used in clinical diabetes trials differently.• These findings suggest that shared decision making is pivotal when taking clinical decisions and that future diabetes studies incorporate end points relevant to both patients and clinicians and do not combine end points which are not equally important. © Springer Nature Switzerland AG 2021.

Entities:  

Keywords:  Clinical trials ; Education; Macrovascular disease; Microvascular disease; Other complications

Year:  2021        PMID: 35673504      PMCID: PMC9167357          DOI: 10.1007/s40200-021-00934-9

Source DB:  PubMed          Journal:  J Diabetes Metab Disord        ISSN: 2251-6581


  25 in total

Review 1.  Validity of composite end points in clinical trials.

Authors:  Victor M Montori; Gaietà Permanyer-Miralda; Ignacio Ferreira-González; Jason W Busse; Valeria Pacheco-Huergo; Dianne Bryant; Jordi Alonso; Elie A Akl; Antònia Domingo-Salvany; Edward Mills; Ping Wu; Holger J Schünemann; Roman Jaeschke; Gordon H Guyatt
Journal:  BMJ       Date:  2005-03-12

2.  Understanding interobserver agreement: the kappa statistic.

Authors:  Anthony J Viera; Joanne M Garrett
Journal:  Fam Med       Date:  2005-05       Impact factor: 1.756

Review 3.  Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials.

Authors:  Ignacio Ferreira-González; Jason W Busse; Diane Heels-Ansdell; Victor M Montori; Elie A Akl; Dianne M Bryant; Pablo Alonso-Coello; Jordi Alonso; Andrew Worster; Suneel Upadhye; Roman Jaeschke; Holger J Schünemann; Gaietà Permanyer-Miralda; Valeria Pacheco-Huergo; Antònia Domingo-Salvany; Ping Wu; Edward J Mills; Gordon H Guyatt
Journal:  BMJ       Date:  2007-04-02

4.  Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences.

Authors:  Mohammad H Murad; Nilay D Shah; Holly K Van Houten; Jeanette Y Ziegenfuss; James R Deming; Timothy J Beebe; Steven A Smith; Gordon H Guyatt; Victor M Montori
Journal:  J Clin Epidemiol       Date:  2010-12-15       Impact factor: 6.437

5.  Prevalence of neuropathy in newly diagnosed NIDDM and nondiabetic control subjects.

Authors:  J M Lehtinen; M Uusitupa; O Siitonen; K Pyörälä
Journal:  Diabetes       Date:  1989-10       Impact factor: 9.461

6.  Combined endpoints: can we use them?

Authors:  Jacobus Lubsen; Bridget-Anne Kirwan
Journal:  Stat Med       Date:  2002-10-15       Impact factor: 2.373

Review 7.  Shared Decision-Making and Patient Empowerment in Preventive Cardiology.

Authors:  Swetha Kambhampati; Tamara Ashvetiya; Neil J Stone; Roger S Blumenthal; Seth S Martin
Journal:  Curr Cardiol Rep       Date:  2016-05       Impact factor: 2.931

8.  Patient-important outcomes in registered diabetes trials.

Authors:  Gunjan Y Gandhi; M Hassan Murad; Akira Fujiyoshi; Rebecca J Mullan; David N Flynn; Mohamed B Elamin; Brian A Swiglo; William L Isley; Gordon H Guyatt; Victor M Montori
Journal:  JAMA       Date:  2008-06-04       Impact factor: 56.272

9.  Rethinking composite end points in clinical trials: insights from patients and trialists.

Authors:  Joshua M Stolker; John A Spertus; David J Cohen; Philip G Jones; Kaushik K Jain; Emily Bamberger; Brady B Lonergan; Paul S Chan
Journal:  Circulation       Date:  2014-09-08       Impact factor: 29.690

10.  A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study.

Authors:  Molly Byrne; Anthony O'Connell; Aoife M Egan; Sean F Dinneen; Lisa Hynes; Mary Clare O'Hara; Richard I G Holt; Ingrid Willaing; Michael Vallis; Christel Hendrieckx; Imelda Coyne
Journal:  Trials       Date:  2017-12-19       Impact factor: 2.279

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