Jill Carlton, PhD
University of Sheffield

This research is part of the international Hypoglycaemia – REdefining SOLutions for better liVEs (Hypo-RESOLVE) project.  Hypo-RESOLVE brings together 23 partners from 9 European countries and the United States. Comprising leading academic experts, pharmaceutical and device manufacturers, as well as patient organisation, the Hypo-RESOLVE consortium includes the full expertise needed to lift the understanding of hypoglycaemia to the next level.

 Why do we need research on hypoglycaemia?

Diabetes is a global pandemic, currently affecting around 60 million people in Europe alone.  Hypoglycaemia is a common and serious complication of diabetes, particularly affecting people on insulin therapy. Consisting of very low levels of blood glucose, hypoglycaemia may lead to cognitive decline, cardiovascular events and even death. Experiencing and managing hypoglycaemia on a day-to-day basis has an impact on people’s quality of life (QOL). Despite the potentially dramatic consequences for people living with diabetes, very little is known about hypoglycaemia – a fact resulting in a lack of intervention, prevention, and treatment.

Why do we need a new PRO to measure the impact of hypoglycaemia on QOL?

A recent systematic review examined the content validity and psychometric properties of existing hypoglycaemia-specific patient-reported outcomes (PROs).  It found them limited in terms of their content and structural validity for assessing the impact of hypoglycaemia on QOL, suggesting a new PRO is required. Further, there is a lack of specialised measures (‘preference-based measures’) that can be used in the cost-effectiveness analyses of new treatments for hypoglycaemia. The Hypo-RESOLVE QoL will fill these evidence gaps.

 How is the new PRO being developed?

The development of the Hypo-RESOLVE QoL follows three key stages.

  1. Stage 1 (concept elicitation): Semi-structured interviews with people with diabetes to identify themes and subthemes of how hypoglycaemia impacts individuals’ QOL. The results will be used to develop an initial item pool.
  2. Stage 2 (refining the measure): Cognitive interviews with people with diabetes and healthcare professionals will assess the content validity of the draft questionnaire. This is followed by a survey to assesses the psychometric performance of the refined questionnaire to inform final question selection.
  3. Stage 3 (valuation): A discrete choice experiment with a large sample from the United Kingdom (UK) public produces utility weights needed for the preference-based measure.

What have we learnt so far?

Collecting data during a global pandemic has been challenging! One of the positives is that we have learnt that online interviews allow for greater inclusivity for potential participants.  One of the disadvantages is that obtaining necessary governance approvals has been a lengthy process (due to reduced staff capacity).

Where should research on this topic go from here?

All research leads to more research!  Future studies could include suitability of the Hypo-RESOLVE QoL in different cultures and countries (i.e., cultural assessment), independent assessment of the psychometric properties of the Hypo-RESOLVE QoL including sensitivity to change analyses, and suitability of the instrument in children and adolescents.

Abstract will be presented in the Friday Morning Poster Presentations: Slot 1 on 21 October, 9:35 am – 9:50 am.

This newsletter editorial represents the views of the author and do not necessarily reflect the views of ISOQOL. 

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