NEW ORLEANS — Validated quality of life measures need to be incorporated into mainstream diabetes care and equated with the same level of importance as behavior change or HbA1c level, according to a speaker at the American Diabetes Association Scientific Sessions.
In a detailed literature review, Lawrence Fisher, PhD, professor emeritus in the department of family and community medicine at the University of California, San Francisco, found 1,273 studies in 2015 alone addressing diabetes and health-related quality of life. Yet nearly all studies shared a common “striking” element, he said.
“In almost all of [the literature], quality of life variables or measures were deemed secondary or tertiary,” Fisher said during a press conference. “They were never primary.”
Health-related quality of life reflects the personal and emotional side of diabetes, Fisher said, and is too often the “neglected offspring” in diabetes research and care. The primary goal of health care providers and clinical researchers is to help people live a long, healthy and happy life with diabetes, yet often too much time is spent analyzing glucose numbers vs. putting the numbers into context, Fisher said.
“Frankly, I think we’re doing a really good job with the long and healthy, I don’t think we’re doing as good of a job with the happy,” Fisher said.
There is no external criterion for health-related quality of life, which is made up of many factors that often don’t interact with one another, Fisher said.
“That means that there are often changes in quality of life that are not following changes in [HbA1c],” Fisher said. “It means you can get dramatic changes in health-related quality of life over time without corresponding changes in disease, treatment or functional status. All of this argues for the careful consideration of health-related quality of life constructs.”
Creating reliable measures
An effort is currently underway to create a validated suite of health-related quality of life measures for people with type 1 diabetes across the lifespan. As part of the Diabetes Quality of Life Study, Marisa E. Hilliard, PhD, assistant professor of pediatrics at Baylor College of Medicine, and colleagues conducted interviews with 81 people with diabetes and their family members (37 pediatric patients; five providers) to draft 14 modules to measure health-related quality of life. A module for children aged 8 years and younger, for example, will include a parent self-report, but no child self-report, whereas a module for young adults aged 18 to 25 years includes a patient self-report, parent self-report and a partner or spouse self-report. A module for adults aged 60 years and older includes a partner or adult caregiver self-report. Questions and language were tailored for the various age groups, Hilliard said.
Researchers then conducted a pilot survey with 41 people with diabetes and their family members to get feedback on the questionnaires.
“Diabetes happens all the time; it doesn’t just happen when you’re checking your blood sugar or administering insulin,” Hilliard said during her presentation. “It happens at school, at work, with family and friends. It impacts your mood, and happens when you’re practicing self-management and treatment. We want to make sure that when we talk about diabetes-related health-related quality of life, we talk about all of these different domains.”
Starting next week, the researchers plan to enroll 3,600 participants from six Type 1 Diabetes Exchange sites (three pediatric sites) to complete the questionnaires for criterion validity.
“We selected these sites to have demographic and geographic diversity to maximize our relevance and generalizability of our findings,” Hilliard said.
Marisa E. Hilliard
Once validated, Hilliard said the researchers hope to incorporate the questionnaires into clinical interventions, trials and therapies.
“Our goal is to use this suite of measures to improve quality of life in people living with diabetes and their families through rigorous research and human-centered practice,” Hilliard said.
mpact on outcomes
An intensive lifestyle intervention was recently shown to produce modest, but significant long-term improvements in two elements of health-related quality of life: physical function and depressive symptoms, according to Gareth R. Dutton, PhD, associate professor of medicine in the division of preventive medicine at the University of Alabama.
In the NIH-funded Look AHEAD trial, adults with diabetes and obesity were randomly assigned to intensive lifestyle intervention (healthy eating and physical activity; n = 2,570) or a control group (diabetes support and education; n = 2,575). After a mean follow-up time of 9.6 years, the study did not meet its primary outcome of reducing CV events in participants assigned to intervention.
“But, one of the secondary outcomes ... was quality of life, and the findings there were much more encouraging,” Dutton said during a press conference.
Patients assigned to intensive lifestyle intervention, Dutton said, experienced a 48% lower risk for loss of mobility vs. controls, and were 15% less likely to experience elevated depressive symptoms. Improvements were greatest during the first year of weight loss, but trended back down during the course of the study for both the intervention and control groups, Dutton said.
“The encouraging thing for the lifestyle intervention was that that initial bump during the first year sort of gave them a cushion,” Dutton said, “So even 8 years out, they were still reporting higher levels of quality of life vs. the control group.” – by Regina Schaffer
Fisher L, Hilliard ME, Dutton GR. Beyond A1c — Why Quality of Life Matters. Presented at: American Diabetes Association Scientific Sessions; June 10-14, 2016; New Orleans.
Disclosure: Fisher reports serving as a speaker, consultant or on an advisory board for Abbott Diabetes Care, Eli Lilly and Sanofi, and has received research support from Sanofi. Dutton and Hilliard report no relevant financial disclosures.