VOLUME 8 NUMBER 4 • NOVEMBER 2011
149
SA JOURNAL OF DIABETES & VASCULAR DISEASE
ACHIEVING BEST PRACTICE
Considering the patient perspective for assessing the
outcomes of diabetes lifestyle-modification programmes:
what should we measure, and how?
CARLA DIAS BARBOSA, BENOIT ARNOULD, JEAN BERNARD GRUENBERGER, PETER EH SCHWARZ
Abstract
C
urrent evidence shows that type 2 diabetes can be
effectively prevented and delayed by lifestyle modifi-
cation. After careful development and pilot testing, a
rigorous evaluation of such programmes is crucial to assess
their effectiveness prior to large-scale implementation. Inte-
grating the patient perspective in this evaluation is essential.
In principle, patient-reported outcomes (PRO) questionnaires
can address this key question. However, researchers and
clinicians lack a clear framework to make a sound selection
of appropriate measures among the large set of possible
questionnaires. As a consequence, it is unclear what is the
most useful information to be captured from patients when
assessing a new programme, so that it can be determined
whether the programme can be generalised to a larger
population: is it health-related quality of life, satisfaction or
something different which could predict the long-term suc-
cess of the programme? We recommend a specific approach,
better adapted to the nature of the intervention, and sug-
gest a selection of a few existing PRO measures that could
satisfy the requirements.
Keywords:
diabetes education, lifestyle modification, measure-
ment instruments, patient-reported outcomes, type 2 diabetes
Introduction
Type 2 diabetes has reached epidemic proportions throughout the
world. In 2010, approximately 285 million people worldwide had
diabetes; this number is projected to increase to 438 million by
2030.
1
Major prevention studies have shown that diabetes can be
effectively delayed or prevented in individuals with impaired glu-
cose tolerance using lifestyle intervention and/or treatment.
2-4
We
have learned from these studies that sustained changes in lifestyle
in terms of physical activity and diet are crucial for successful type
2 diabetes prevention. Despite evidence of their effectiveness, it
is questionable whether implementing diabetes prevention pro-
grammes is feasible at a population level.
5,6
Economic evaluation
has demonstrated the cost effectiveness of primary prevention of
type 2 diabetes using lifestyle interventions.
7
However, effective
implementation of diabetes prevention programmes into clinical
practice remains challenging and requires significant financial and
human resources.
6
Rigorous scientific evaluation of the programmes, prior to
large-scale implementation, is fundamental for demonstrating
programme effectiveness and feasibility, determining whether or
not they are cost effective and providing information for improving
existing programmes and designing new ones. Lifestyle modifica-
tion programmes are usually evaluated through randomised con-
trolled trials that compare the effects of the lifestyle programme
versus standard diabetes education using objective measures such
as HbA
1C
, weight reduction and exercise measurement. Unfor-
tunately, many of these evaluation studies do not integrate the
patient perspective in their measurement; however, this perspective
is fundamental to fully understand the benefits of the intervention
programme for patients, increase patient engagement in their care
and, ultimately, to maintain behaviour change. Incorporating well-
designed PRO instruments is the best way to assess the effect of
intervention from a patient perspective.
8
However, to be credible
measures, PRO instruments have to be developed and validated
following a rigorous and standardised process as recommended in
recent US Food and Drug Administration guidelines
8
and a Euro-
pean Medicines Evaluation Agency reflection paper.
9
This paper addresses two questions, firstly what are the relevant
outcomes of diabetes lifestyle intervention programmes from a
patient perspective, and secondly what are the most appropriate
existing PRO instruments to assess these outcomes?
Correspondence to: Carla Dias Barbosa
Mapi Values 27, Rue de la Villette 69003 Lyon, France.
Tel: +33 (0)4 72 13 66 56; Fax: +33 (0)4 72 13 51 40
e-mail:
Benoit Arnould
Mapi Values, Lyon, France.
Jean Bernard Gruenberger
Novartis Pharma AG, Department of Health Economics and Outcomes
Research, Basel, Switzerland.
Peter EH Schwarz
Division of Prevention on Care of Type 2 Diabetes, Department of Internal
Medicine III, Medical Faculty of Carl Gustav Carus, Technical University
Dresden, Germany.
Originally in:
Br J Diabetes Vasc Dis
2011;
11
: 187–192
S Afr J Diabetes Vasc Dis
2011;
8
: 149–153
Abbreviations and acronyms
ADS
Appraisal of Diabetes Scale
ATT
Psychological Adjustment to Diabetes Scale
DES-SF
Diabetes Empowerment Scale, Short Form
DMSES
Diabetes Management Self-Efficacy Scale
HbA
1C
glycated haemoglobin
HCP
healthcare professional
MEI
Motivation and Energy Inventory
PAID
problem areas in diabetes
PRO
patient-reported outcomes
ProQolid
Patient-Reported Outcome and Quality of Life
Instruments Database
