Understanding the humanistic and economic burden of illness when the literature is scarce: Ask the Clinical Outcomes Assessment Team!

02-10-17Natalie Aldhouse

A plethora of research has been conducted in type 1 diabetes mellitus (T1DM) – just a quick PubMed search for ‘type 1 diabetes’ returns almost 80,000 results – and with approximately 400,0001 people living with T1DM in the United Kingdom (UK) alone, this is unsurprising. And yet, many aspects relating to the patient experience of T1DM have not been researched, and are not understood.

Ketosis is a state of metabolic deficiency that can be experienced by type 1 diabetics during periods of insulin deficiency. Second only to hypoglycaemia, ketosis is one of the most prevalent acute complications of T1DM. However, while the patient experience of hypoglycaemia is well-documented in the literature, extremely little is known about how patients manage and treat episodes of ketosis.

One of DRG’s recent clients client sought to understand the economic impact of ketosis on the National Health Service (NHS). Easier said than done! –  how does one calculate this if it’s not known whether, or the extent to which, patients are self-administering treatment or whether patients are seeking assistance from health care professionals (HCPs) during such events?

In response to our client’s request, the Clinical Outcomes Assessment team at DRG Abacus proposed conducting a mixed-methods qualitative and quantitative research study – and asking the patients themselves. After a series of interviews with HCPs specialising in T1DM to further our understanding of ketosis and inform our interview guide, we spoke with 10 adult patients and 11 carers of paediatric patients of a wide range of ages, and asked them to describe their most recent episode of ketosis. Patients and carers talked us through their recent episode step-by-step, and described the healthcare resources they made use of and all of the different types of help that they sought. Often, the accounts patients gave us were very different to the descriptions provided by the HCPs – for example, most HCPs significantly underestimated the negative impact of ketosis on a patient’s work or education. We learned that different healthcare resources were accessed by adults versus paediatrics, and that the severity of ketosis was variable – with different resources required for mild versus severe events.

Armed with all of this information, we developed an online quantitative survey and circulated it to over 200 adult patients and paediatric carers, and over 50 HCPs. We provided a list of all of the healthcare resources, as reported in the interviews, and asked respondents: ‘How serious was your most recent episode of ketosis? Did you use any of these resources? If so, how many of each did you use?’

Following statistical analysis to calculate the average quantity of resource use per type of patient and per type of ketosis event, we shared the data with the DRG Abacus Health Economics team, who retrieved resource cost data from a variety of sources and calculated the cost of ketosis in the UK.

We were surprised to discover that episodes of ketosis in the UK cost as much as ~£2,500,000 a year!  Given that so little research has previously explored the humanistic and economic burden of ketosis, our findings highlight the need for treatments and educational programs that may help to reduce the incidence of ketosis in patients with T1DM. The success of this project, the results of which are published in Diabetes Therapy2, demonstrates that when it is unclear how patients are managing their illness and literature is scarce, it’s easiest to just ask the patients themselves!

The Health Economic and Outcomes Research (HEOR) team at DRG Abacus understand the importance of understanding, documenting, and quantifying the humanistic and economic burden of disease. Feel free to contact us if you feel we could be of assistance at access@teamdrg.com


1 Diabetes UK. Facts and Stats. Available online at: https://www.diabetes.org.uk/professionals/position-statements-reports/statistics (Last accessed 18-August-2017). 2015.

2 Thalange, N. et al. Healthcare Resource Utilization and Costs Associated with Ketosis Events in Pediatric and Adult Patients with Type 1 Diabetes Mellitus in the UK. Diabetes Therapy 2017. Available online, DOI 10.1007/s13300-017-0305-0. https://link.springer.com/article/10.1007/s13300-017-0305-0

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