The emotional impact of diabetes effects the individual and family leading to denial, poor treatment adherence, eating problems, restrictions in daily living, fears of hypoglycemia and complications such as blindness, heart disease, sexual dysfunctioning and premature death – just to mention a few.
The influence of psychosocial factors on the patient’s motivation to adhere to treatment is a key hurdle facing the pharmaceutical industry which is only likely to be surmounted if patients believe that taking medication will lead to immediate benefits, such as reduction of symptoms, improvement in physiological functioning and quality of life. Therefore, measurement of the patient’s reported outcomes is increasingly being recognised, particularly as therapeutic options are likely to focus more on frequency and method of administration which are clinically relevant to the patient. One diabetes-specific patient reported outcome measure is the Diabetes Health Profile
The Diabetes Health Profile (DHP)
Developed in accordance with FDA guidelines the DHP measure of the psychological and behavioural impact of living with diabetes and available in two formats which are the DHP-1 comprising 32 items and the DHP-18 18 items.
While the 3 dimensions and response options are common across both the DHP-1 and DHP-18, the DHP-1 is specific for use with Type1 and insulin requiring and while the DHP-18 can be used for both Type 1 and Type 2. This enables the same instrument to be used for assessing outcomes between different patient groups or when patients transfer from tablet to insulin.
A particularly unique feature of both the DHP-1 and 18 is the assessment of disinhibited eating behaviour which although is important in the management of diabetes not found in other diabetes specific PROs.
Completed globally by more than 10,000 patients the DHP has been extensively used in a range of settings, including clinical trials, epidemiological and community surveys, clinical audit and research programmers, and in 2010 the DHP-18 was adopted by the UK Department of Health for their Long Term Conditions national patient reported outcome study. The DHP is now available in 30 languages
From paper to eDHP-18
Following an extensive evaluation of the DHP we were approached by CRF Health early in 2013 with a view of collaborating to produce an author pre-approved version of the DHP-18, which we think is the first available diabetes-specific author-pre-approved eCOA.
We defined author pre-approved as:
An Author pre-approved instrument qualifies the migrated instrument to the author’s level of quality and expectation. Having followed good practices in instrument migration, it is considered that an Author pre-approved instrument would, with reasonable testing (in line with industry guidelines), demonstrate equivalence”.
What does an author approved eCOA offer?
Most importantly it reduces the timeline from client initiation to equivalence testing by as much we believe as 5-6 weeks and of course reduced costs for the sponsor.
What are the advantages of the eDHP?
Clearly an eDHP opens up a range of opportunities for the patient, sponsor and payer that would not be possible with a paper version. For example, we are working with SHARR at the University of Sheffield to develop a computerised adaptive scoring system which will enable patients to be routed through different questions depending on the severity of response to specific questions as well developing a health state classification system that will enable utility scores to be calculated from any completion of the DHP-18.
Our current work on establishing the minimal important difference (MID) in DHP scores – that is the change in score that is clinically meaningful to the patient – remote monitoring will enable significant changes in DHP-18 scores to be picked up, but will also provide information as to changes in score that are clinically meaningful as well as identifying which particular items have contributed to the change, such as increased reporting of dysphoric mood or increased dysfunctional eating behaviour.
Ongoing reporting will help identify whether an intervention or change in treatment results in reduced or increased burden of managing the disease not only in terms of changes which are clinically meaningful but, in relation to standardised scores. Are specific patient groups reporting a more positive outcome than others for example compared to standardised norms for that group of patients?
Getting the patient to complete the eDHP-18 just prior to consultation can provide the clinician with a real time assessment of the patient’s behavioural and psychological state which can guide the consultation to some extent. This application of the eDHP could also be extended to site visits during participation in a trial enabling real time reported problems to be discussed with the patient and hopefully contribute to high retention rates.
Linking automated blood glucose readings with remote reported DHP-18 scores and other information will enable us to develop tailored therapeutic algorithms or personalised action plans for specific patient phenotypes, for example taking into consideration, age, body mass index, complications and hypoglycaemic risk that lead to substantial benefits in the ratio of benefit to risk for the individual patient.
The eDHP opens up new avenues for predictive outcomes
Routinely collected eDHP-18 data can help identify patients more likely to have a positive outcome resulting from intervention. Already from our developing database we are beginning to be able to understand which variables are most predictive of clinical success.
The eDHP also offers the opportunity to screen prior to trial recruitment or an intervention programme can help identify with greater specificity, not only the right patients who will most likely have a positive therapeutic response, but those less likely. For example we’ve started to look at the possibility of profiling patients who are at higher risk of dropping out of a clinical trial using databank based on the their DHP scores.
We believe the advantages of moving from paper to an eDHP can be summarised as follows:
- Accelerate treatment and intervention evaluation
- Enhance treatment adherence
- Open up new avenues for predictive outcomes and tailored therapeutics
- Improve understanding of patient populations and compare subgroups
For more information on the Diabetes Health Profile visit www.diabetesprofile.com
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