COSMIN database

A systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitus

Vieta, A., Badia, X., and Sacristan, J. A.
BACKGROUND: The need for an approach to measuring health results that incorporates patients' and payers' perspectives has generated a wide range of health care outcomes (HCOs), but it is yet unknown whether these HCOs are appropriate or valid for the health care decision-making process.

OBJECTIVE: The goal of this study was to assess HCOs, patient-reported outcomes (PROs), and economic outcomes in terms of validity and appropriateness to health care decision making in type 2 diabetes mellitus (T2DM).

METHODS: This systematic review of studies published between January 1, 1996, and November 1, 2010, comprised an electronic literature search of MEDLINE and Centre for Reviews and Dissemination databases. Studies included were clinical trials, observational studies, economic analyses, and studies on the development and validation of HCOs in T2DM in the adult population. HCOs were assessed and classified according to their relevance for decision makers in terms of feasibility for routine use, validity, sensitivity, reliability, understanding, and scope.

RESULTS: Two independent reviewers screened 4497 citations. Of these, 281 potentially eligible full articles were retrieved, and 185 met the inclusion criteria. A total of 121 HCOs in T2DM were identified: 80 (66.1%) PROs and 41 (33.9%) economic outcomes. Only 44.6% of the outcomes assessed were appropriate and valid for health care decision making. Greater deficiencies in evidence were found for PROs (61.3%), followed by economic outcomes (43.9%).

CONCLUSIONS: A large number of HCOs are being used in the health care decision-making process, but a significant proportion of these new outcomes have not been properly validated. Despite the fact that appropriate measures will depend on the specific needs of the decision makers, researchers need to use HCOs for which evidence of quality and appropriateness is available.
Clin Ther
1879-114X (Electronic)
Publication year:
Symptom status:
Cognitive/mental state
Emotional state
Physical state
Functional status:
Physical functioning
General health perceptions / HRQoL:
Health-related quality of life
Overall quality of life:
Overall quality of life
Adults (18-65)
Children (0-18)
Seniors (65+)
Endocrine, nutritional and metabolic diseases and related symptoms
PRO / non-PRO:
Patient Reported Outcome
Type of measurement instrument:
1 - Questionnaires
ADDQoL - Audit of Diabetes Dependent Quality of Life    | 
ADL items
ADS - Appraisal of Diabetes Scale   
BSI - Brief Symptom Inventory
COOP/WONCA charts - COOP/WONCA Functional Healh assessment charts   
D-39 - Diabetes-39
DAS - Diabetes Attitude Scale (versions: DAS-3 - Third version)
DCP - Diabetes Care Profile (Diabetes Educational Profile (originally))
DDS - Diabetes Distress Scale
DES - Diabetes Empowerment Scale
DFBC - Diabetes Family Behavior Checklist (versions: DFBC-II)
D-FISQ - Diabetes Fear of Injecting and Self-testing Questionnaire
DFS - Diabetes Fatalism Scale
DFS - Diabetic Foot Ulcer Scale
DHP - Diabetes Health Profile (versions: DHP-3D; DHP-5D)
Diabetes Diet-Related Quality-of-Life Scale
DiabMedSat - Diabetes Medication Satisfaction
Disease-Specific Adherence Scale
DKQ - Diabetes Knowledge Questionnaire (DKQ-24- DKQ-24 items)
DKT - Diabetes Knowledge Test [alias: DMKT - Diabetes Mellitus Knowledge Test]
DLF - Diabetes Lifestyle Form
DNT - Diabetes Numeracy Test
DOQ - Diabetes Obstacles Questionnaire (versions: DOQ-30)
DQLCTQ - Diabetes Quality of Life Clinical Trial Questionnaire
DQOL - Diabetes Quality of Life
DSC - Diabetes Symptom Checklist (versions: DSC-Type 2 - Type 2 diabetes; DSC-R - DSC-revised)
DSI - Diabetes Severity Index
DSM - 21-item Diabetes Coping Measure
DSMP - Diabetes Self-Management Profile
DSQOLS - Diabetes Specific Quality of Life Scale
DSSCI - Diabetes Symptom Self-care Inventory Index
DTMQ - Diabetes Time Management Questionnaire
DTSQ - Diabetes Treatment Satisfaction Questionnaire
EQ-5D - EuroQoL-5 Dimensions   
GHQ-12 - General Health Questionnaire 12 items
HFS - Hypoglycemia Fear Survey
HUI-2 - Health Utilities Index Mark 2
HUI-3 - Health Utilities Index-Mark 3
IAD-R - Ideas About Diabetes–Revised scale
ICP-D1 - Diabetes Locus of Control Questionnaire
IDDM - Barriers to Adherence Scale for adults and adolescents with insulin-dependent diabetes mellitus
IDSRQ - Insulin Delivery System Rating Questionnaire
IPQ - Illness Perceptions Questionnaire (versions: IPQ-R - IPQ revised; IPQ-R BCRL - Revised breast cancer-related lymphoedema)
Lawton IADL - Lawton Instrumental Activities of Daily Living Scale   
LQD - Quality of Life with Diabetes
MARS - Medication Adherence Report Scale (versions: MARS-5; MARS-9)
MDQ - Multidimensional Diabetes Questionnaire
MMAS/Morisky Scale - Morisky Medication Adherence Scale [alias: MAS] (MIAS - MMAS adapted to specify insuline adherence)
MOS-Social Support Survey Scale - Medical Outcomes Study (MOS) Social Support Survey Scale
Nagi physical performance measure
Neuropathy- and Foot Ulcer-Specific Quality of Life instrument
NHP - Nottingham Health Profile   
NWBQ - Negative Well-Being questionnaire
PAID - Problem Areas in Diabetes scale
PDSMS - Perceived Diabetes Self-Management Scale
Percentage of patients with adequate adherence
Persistence rate
PGI - Patient Generated Index
PGWBI - Psychological General Well-Being index [alias: PGWB] (versions: PGWBI-S - short form)
PLD - Problem Areas in Life with Diabetes
PRISM-RII - Pictorial Representation of Illness and Self Measure Revised II
PRQ85 - Personal Resource Questionnaire
PSIT - Patient Satisfaction with Insulin Therapy questionnaire
QWB-SA - Quality of Well Being Self-administered Scale
SASS - Self-anchoring Striving Scale
SDSCA - Summary of Diabetes Self-Care Activities   
Self-reported 7-day adherence rates
SF-12 - 12-item Short Form Health Survey [alias: RAND-12]
SF-20 - MOS short-form general health survey 20 item
SF-36 - 36-item Short Form Health Survey [alias: RAND-36][alias: Medical Outcomes Study (MOS) SF-36]]    |  | also see:
SF-8 - 8-item Short Form Health Survey [alias: Medical Outcomes Study (MOS) SF-8]
SIP - Sickness Impact Profile   
SOADAS - Satisfaction with Oral Anti- Diabetic Agent Scale
TSQM version 1.4 - Treatment Satisfaction Questionnaire for Medication
WBQ-12 - 12-items Well-being Questionnaire
WBQ-22 - 22-item Well-Being Questionnaire
WHO-5 - WHO-5 Well-Being Scale
WHOQOL-BREF - World Health Organization Quality of Life questionnaire–Abbreviated Questionnaire [alias: WHO-QOL BREF]