Selecting the appropriate PROM for your diabetes clinical trial

DHP Manual front cover

Click the image to download a free copy of the DHP User Guide Summary

With the recognition of the importance of understanding the psychological impact on living with diabetes, there is now a range of diabetes specific patient re- ported outcome measures (PROMs) designed to assess the various constructs associated with the impact of living with diabetes and its treatment on quality of life, well-being, health status and treatment satisfaction.

One such instrument is the Diabetes Health Profile (DHP-18) which was developed for people with Type 1 and Type 2 diabetes to measure the psychological impact of living with diabetes. It comprises 18 items which capture the three key domains based on a clearly defined conceptual model and conceptual framework. These are:

  • Psychological distress – 6-items (dysphoric mood, feelings of hopelessness, irritability);
  • Barriers to activity 7-items ( perceived limitation to activity, operant anxiety)
  • Disinhibited eating 5-items (lack of eating control, response to food cues and emotional arousal).

The DHP-18 has demonstrated very good measurement properties including reliability coefficient >0.70, the ability to discriminate between different treatment groups and patient groups experiencing severe hypoglycaemic episodes. The DHP-18 has been used in community surveys, clinical trials, research studies and educational interventions both in the UK and Europe and is currently in use in a variety of settings involving in total over 4000 patients. User acceptability of the DHP-18 is high with item completion rates ≥90% and return rates > 60%.

In addition the DHP has a number of distinct advantages over other diabetes-specific measures of the psychological and behavioural impact of living with diabetes. This includes an “author approved eDHP-18 resulting in a reduction 5-6 weeks in completing transfer from paper to electronic data collection.

Other key features of the DHP-18 include: include:

  • A clearly defined conceptual framework of the measurement model which conforms to the FDA Final guidance for Industry
  • The measurement of eating problems in diabetes – which despite its importance in the management of diabetes is absent in other scales
  • Content reported by patients as highly relevant to the psychological impact of living with diabetes
  • The exclusion of hypothetical questions e.g. “if you did not have diabetes…”
  • The use of straight forward language and simple phrasing
  • A simple scoring algorithm
  • Norm referenced database

 

The DHP-18 is available in the following languages:

Bulgarian, Croatian, Czech, Danish, Dutch, Dutch (Belgium), English (Canada), English (USA), Finish, French, French (Belgium), French (Canada), French (Swiss), German, German (Austria), German (Swiss), Hungarian, Italian, Italian (Swiss), Manderin, Norweigen, Polish, Romanian, Turkish (German), Slovak, Slovenian, Spanish, Spanish (USA),Swedish.

For more information on the Diabetes Health Profile visit now: www.diabetesprofile.com

To obtain a licence for the Diabetes Profile visit:

http://process.isis-innovation.com/

Email: healthoutcomes@isis.ox.ac.uk
Tel: +44 (0)1865 614417

Some of our recent DHP research:

It is important to know what patient reported outcome measure (PROM) scores relate to a meaningful change in health status across time. The aim of this study was to investigate the minimally important difference (MID) of the Diabetes Health Profile (DHP-18), EQ-5D and SF-6D in a Type 1 and Type 2 diabetes patient sample.

A longitudinal dataset including a UK community sample of people with Type 1 and Type 2 diabetes was used for the analysis. A combination of anchor and distribution methods was used to investigate the MID. For the anchor based method, a global health change indicator was used if it correlated with the PROM scores at baseline and follow up. To calculate the anchor based MID, the change in PROM score for those reporting no change on the anchor was subtracted from those reporting small change. For the distribution based estimation, the 1 Standard Error of Measurement, 0.5 and 0.33 standard deviation methods were used.

DHP-18, MID estimates for the Psychological Distress domain ranged from 6.99 to 10.59, the Barriers to Activity domain ranged from 6.48 to 9.89, and the Disinhibited Eating domain range from 7.52 to 11.39. The EQ-5D estimations range from 0.058 to 0.158, and the SF-6D estimations ranged from 0.038 to 0.081. The 0.5 SD and 1SEM estimations are of a similar magnitude across the three measures.

This study has derived a range of values for each measure that may correspond to an important change in health status. The MID values may guide researchers who are using the measures as part of their assessment of both Type 1 and Type 2 patients with diabetes mellitus.

Click here to view the full paper. Minimally Important Difference,

DHP-18, EQ-5D, SF-6D, Diabetes Mellitus, PROMS, Psychometrics



Categories: Diabetes Health Profile, Patient reported outcomes

Tags: , , , , , , ,

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