Assessing Quality of Life and Other Patient-Reported Outcomes in Diabetes and Other Chronic Medical Conditions
Submitting InstitutionRoyal Holloway, University of London
Unit of AssessmentPsychology, Psychiatry and Neuroscience
Summary Impact TypeEconomic
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences, Nutrition and Dietetics, Public Health and Health Services
Summary of the impact
It is now widely recognised that the evaluation of treatments for chronic
conditions needs to consider impacts on quality of life as well as quality
of health. Research in the Health Psychology Research Unit since 2011, and
for over 20 years previously in the Department of Psychology at Royal
Holloway, has generated a series of Patient-Reported Outcome Measures
(PROMs) validated in over 100 languages. These PROMs have been used by
every major pharmaceutical company in the world to measure the impact of
new treatments on quality of life and other patient reported outcomes, and
have delivered major benefits to people with diabetes and other long-term
medical conditions. These PROMs have also delivered substantial economic
and commercial impacts through cost-saving in the NHS, licence fee income
raised through the spin-off company Health Psychology Research (HPR) Ltd,
and contributions to the development of best-selling drugs.
Pioneering research over the last 20+ years has involved the design and
development of a series of Patient-Reported Outcome Measures (PROMs)
tailor-made to specific conditions. This research has been led by
Professor Clare Bradley, who joined the Department of Psychology in 1989,
and who established an independent research unit at Royal Holloway in
2011. She has been supported by a large team of postgraduate students and
research staff at Royal Holloway including Dr. Jane Speight, Dr. Jan
Mitchell, Dr. Harsimran Singh, Dr. Caroline McMillan, Dr. Leonie Brose,
Dr. Christel Hendrieckx, Mrs. Rosalind Plowright, and Dr. Alison Woodcock
among others. Bradley's approach is based on the belief that treatment is
only successful if it protects or improves both quality of life and
quality of health. Design of her PROMs is underpinned by a rigorous
combination of empirical qualitative and quantitative research using
converging evidence from focus groups, in-depth interviews, and
Bradley's PROMs research began in the 1980s when there were few
condition-specific PROMs and no diabetes-specific PROMs. Her
diabetes-specific PROMs are internationally recognised as a result of her
highly-cited Handbook of Psychology and Diabetes  which
included her Diabetes Treatment Satisfaction Questionnaire (DTSQ, now
validated in over 100 languages) and her Well-Being Questionnaire (W-BQ,
now validated in over 50 languages). Bradley's rigorous approach greatly
improved the psychometric development of PROMs and their linguistic
validation. The latter in particular revolutionised the global reach of
these instruments, making them suitable for worldwide clinical and
research use including multi-national clinical trials.
Bradley's Handbook also referred to the development of the ADDQoL
(Audit of Diabetes-Dependent Quality of Life), an individualised measure
of the impact of diabetes on quality of life . The key insight from the
development of the ADDQoL was that the most damaging aspect of diabetes
treatment to quality of life was the restriction of dietary freedom
(including the requirement to eat at certain times as well as restrictions
on content and amount). The major impact of dietary requirements on
quality of life had not been recognised previously by diabetologists, and
attempts to improve treatments had focused on minimising injections
through the use of premixed insulin in inflexible regimens requiring fixed
meal times and specified carbohydrate content. The ADDQoL demonstrated
that these approaches were misguided. Bradley therefore argued that
alternative approaches to flexible insulin treatment adopted in Dusseldorf
and Vienna which enabled fasting and feasting as desired would yield
significant improvements in quality of life and diabetes control .
This critical insight contributed to the development of the DAFNE (Dose
Adjustment for Normal Eating) approach to Type 1 diabetes control in the
UK, whereby patients are trained to estimate the carbohydrate in each meal
or snack and adjust their insulin dose accordingly. The initial clinical
trial of DAFNE published in the British Medical Journal
demonstrated significant improvements in diabetes control and dramatic
improvements in PROMs (including the ADDQoL) as a result of this approach
. Results showed that patients were willing to inject 4, 5, 6 or more
times daily to obtain the dietary freedom and associated improvements to
quality of life possible with DAFNE. The subsequent longitudinal study led
by Bradley's team showed that benefits to glycaemic control were
maintained and quality of life was further improved after four years .
References to the research
1. Bradley C (Ed) (1994). Handbook of psychology and diabetes: a
guide to psychological measurement in diabetes research and practice.
Chur, Switzerland: Harwood Academic Publishers.
2. Bradley C, Todd C, Gorton T, Symonds E, Martin A and Plowright R
(1999). The development of an individualized questionnaire measure of
perceived impact of diabetes on quality of life: the ADDQoL. Quality
of Life Research, 8, 79-91.
3. Bradley C, Pierce MB, Hendrieckx C, Riazi A and Barendse S (1998).
Diabetes Mellitus. In M Johnston and DW Johnston (Eds) Health
Psychology, Oxford: Elsevier Science, 277-304.
4. DAFNE Study Group (2002). Training in flexible, intensive insulin
management to enable dietary freedom in people with type 1 diabetes: Dose
Adjustment For Normal Eating (DAFNE) randomised controlled trial. British
Medical Journal, 325, 746-749 (full 6 page version of paper
published on BMJ website http://bmj.com/cgi/content/full/325/7367/746).
(DAFNE Study Group includes Amiel S, Beveridge S, Bradley C, Gianfrancesco
C, Heller S, James P, McKeown N, Newton D, Newton L, Oliver L, Reid H,
Roberts S, Robson S, Rollington J, Scott V, Speight J, Taylor C, Thompson
G, Turner E and Wright F. Bradley's role was to lead on questionnaire
design and use and to supervise her PhD student Speight on the analysis of
the psychological data).
5. Speight J, Amiel S, Bradley C, Heller S, Oliver L, Roberts S, Rogers
H, Taylor C, and Thompson G. (2010). Long-term biomedical and psychosocial
outcomes following DAFNE (Dose Adjustment For Normal Eating) structured
education to promote intensive insulin therapy in adults with
sub-optimally controlled Type 1 diabetes. Diabetes Research and
Clinical Practice, 89, 22-29. (Note. Speight was Bradley's PhD
Bradley's research on PROMs has attracted more than £8.6 million in
research grants since 1993. She is currently a Principal Investigator on
two 5-year programme grants from the National Institutes of Health
Research, which are listed below along with selected earlier research
grants important for the design and development of PROMs.
2013-2018, NIHR. `Towards an evidence-based clinical management of visual
hallucinations: prevalence, prognosis, impact and pathophysiology',
£1,998,326 awarded to South London and Maudsley NHS Foundation. Bradley
leads on the patient experience work stream, which uses her existing PROMs
for people with eye conditions and designs new, comparable PROMs for
people with dementia and people with Parkinson's disease.
2011-2016, NIHR. `Access to Transplantation and Transplant Outcome
Measures (ATTOM)', £1,999,709 awarded to Addenbrookes, Cambridge. This
5-year programme employed 20 research nurses to recruit 7,000 patients
from all UK renal transplant units. Bradley leads the team conducting a
detailed PROMs sub-study including patients having or awaiting kidney
transplant or simultaneous kidney and pancreas transplant and the 3% of
patients whose transplants fail in the first year.
2007-2010, Diabetes UK. `Assessing and improving inpatient diabetes
treatment satisfaction in different ethnic groups in the UK', £311,697
(PI). This study worked with 60 UK hospital trusts to use and further
develop a version of the widely used DTSQ suitable for inpatients with
insulin- treated diabetes, including those originating from the Indian
Subcontinent who speak Hindi, Punjabi, Gujarati, Bengali or Urdu.
In addition, Bradley's PROMs attracted approximately £1.47m in licence
fee and consultancy income from 1996-2005 (prior to the incorporation of
spin-off company HPR Ltd which started trading in 2004). HPR Ltd has
generated over £6.1m in licence fee and consultancy income since start of
trading in 2004.
Other Evidence of Quality
Bradley is a Fellow of the British Psychological Society and of the Royal
Society of Medicine, a Chartered Psychologist and a Health Psychologist
(Health and Care Professions' Council registered).
Details of the impact
The research underpinning the development of Bradley's PROMs has yielded
substantial and far-reaching impacts. The main beneficiaries of her
research are (a) patients with chronic medical conditions, who receive
treatments proven to enhance quality of life as well as quality of health;
(b) the NHS, which saves money as a result of treatment developments
associated with these PROMs; (c) pharmaceutical companies, which as a
result of these PROMs are able to assess the impact of newly developed
treatments on patient satisfaction, quality of life, and other patient
reported outcomes; and (d) the economy, which benefits from licence fee
income from spin-off company HPR Ltd as well as downstream revenue from
major pharmaceutical companies.
Patients. Bradley's PROMs have been licensed repeatedly to 20
major pharmaceutical companies, including affiliates in circa 40
countries, and to over 140 charities, universities and hospitals. They
have been linguistically validated in over 100 languages and dialects, and
have been used in more than 60 countries for clinical and research
purposes including multi-national clinical trials. The substantial use and
global reach of these PROMs impacts directly on patients around the world,
because it enables new treatments being developed for chronic medical
conditions to improve patients' quality of life as well as their quality
Bradley's research on quality of life in diabetes in particular has been
fundamental to the DAFNE patient-education approach to treating Type I
diabetes. It was through her research in developing the ADDQoL that the
major negative impact of dietary requirements on quality of life in
diabetes first became apparent , and she and her team were instrumental
in the original trials establishing that the DAFNE training has long-term
positive impacts on glycaemic control and quality of life in Type 1
diabetes [4,5]. DAFNE treatment is now part of the routine care provided
in 75 diabetes centres servicing 138 localities in the UK, and to 23
diabetes centres in Australia, New Zealand, and Singapore, where it has
brought improvements to the quality of life, long-term health, and
longevity to nearly 30,000 people with Type 1 diabetes (www.dafne.uk.com).
NHS. The York Health Economics Consortium demonstrated that DAFNE
is expected to save the NHS £2,237 per patient over a 10 year period
compared to standard diabetes treatment. These savings are largely the
result of the fact that DAFNE treatment is associated with fewer
complications — including blindness, kidney failure and foot ulcers
leading to amputation — than standard diabetes treatment (Shearer et al.,
2004, Diabetic Medicine, 21, 460-467). The quality of life gains
associated with DAFNE demonstrated by Bradley's team [4,5] are a vital
part of the success of this treatment because they enable patients to
adhere to a complex treatment regimen in the long term, and thus allow
patients to reap the benefits of ensuing improvements to diabetes control.
Economy and Commerce. Success in licensing Bradley's PROMs led to
the incorporation of spin-off company HPR Ltd in 2004. During the period
under review (2008-2013), HPR Ltd has issued 2148 commercial and 588
non-commercial licenses for use of these PROMs, yielding a direct
contribution to the economy of over £4m in licence fee income, 86% of
which constitutes foreign investment to the UK. HPR Ltd has issued a
further 369 licence agreements free of charge for use by clinicians and
students around the world.
The downstream commercial impacts of these PROMs on the pharmaceutical
industry are very substantial because drugs become best-sellers partly as
a result of demonstrating benefits to patient satisfaction and other
patient-reported outcomes. Most significantly, Bradley's PROMs were
instrumental from the earliest stages of the development of insulin
glargine (marketed as Lantus by Sanofi-Aventis). In 2012, Lantus was the 6th
best-selling drug in the world (raising nearly €5 billion in sales), and
was prescribed to over 3.5 million patients in over 100 countries.
Bradley's PROMs also contributed to the development of the very first
analogue insulin, insulin lispro (marketed as Humalog by Eli Lilly), which
in 2012 raised over €1.8 billion in sales.
Sources to corroborate the impact
- HPR accounts can be verified by Russell Phillips Accountants.
- HPR licence agreements can be verified by Commercial Director, HPR
- The HPR website (www.healthpsychologyresearch.com)
provides lists of languages in which the ADDQoL and other PROMS are
linguistically validated, details of linguistic validation procedures
used, and lists of references reporting design, development, and use of
- Verification of the use of Bradley's PROMs in the development of
insulin glargine (Lantus) is provided in e.g. Witthaus E, Stewart J,
& Bradley C (2001). Treatment satisfaction and psychological
well-being with insulin glargine compared with NPH in patients with Type
I diabetes. Diabetic Medicine, 18, 619-625.
- Verification of the use of Bradley's PROMs in the development of
insulin lispro (Humalog) is provided in e.g. Howorka K, Pumprla J,
Schlusche C, Wagner-Nosiska D, Schabmann A, and Bradley C (2000) Dealing
with ceiling baseline treatment satisfaction level in patients with
diabetes under flexible, functional insulin treatment: assessment of
improvements in treatment satisfaction with a new insulin analogue. Quality
of Life Research, 9, 915-930.
- The DAFNE website demonstrates the reach and significance of the DAFNE
regimen on quality of life and longevity for patients with Type I
- The NICE website demonstrates that DAFNE provides a cost-effective
means of managing diabetes (see Technical Appraisal 60 "Guidance on the
use of patient education models for diabetes"; http://www.nice.org.uk/nicemedia/pdf/60Patienteducationmodelsfullguidance.pdf).
- The York Health Economics Consortium demonstrated DAFNE cost
effectiveness in Shearer A, Bagust A, Sanderson D, Heller S, and Roberts
S (2004). Cost-effectiveness of flexible intensive insulin management to
enable dietary freedom in people with Type 1 diabetes in the UK. Diabetic
Medicine, 21, 460-467.