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Development of an instrument for patient-reported outcomes in Thai patients with type 2 diabetes mellitus (PRO-DM-Thai)


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Figure 1

Boxplots of the PRO-DM-Thai total scores stratified to groups of patients with different levels of disease control assessed by physicians
Boxplots of the PRO-DM-Thai total scores stratified to groups of patients with different levels of disease control assessed by physicians

Characteristics of participants

CharacteristicsStep2 (n = 500)Step3 (n = 200)
Age (range 32–90 and 32–89) (years)66.1 ± 10.867.2 ± 11.0
Duration of type 2 diabetes (years)15.1 ± 8.415.8 ± 7.9
Sex (F/M) (%)66.8/33.268.0/32.0
Marital Status (%)
  Single12.613.5
  Married66.870.0
  Widowed20.616.5
Education level (%)
  Primary school or lower41.246.0
  Secondary school21.623.0
  University or higher37.231.0
Occupation (%)
  Housework / not working48.059.5
  Currently employed by government or private sector12.211.5
  Privately owned business10.410.0
  Retirement23.219.0
  Other6.2
Therapy (%)
  Diet control only2.2
  Oral medicines only62.657.0
  Insulin only2.41.0
  Insulin + oral medicines32.842.0
Type of health insurance coverage (%)
  Universal coverage scheme or Social security scheme10.410.0
  Civil servant medical benefit scheme62.459.0
  Out-of-pocket expense27.231.0
Living status (%)
  Living with family87.486.5
  Living with relative(s)7.67.5
  Living alone5.06.0
Related complications (%)
  Not have complications/comorbidity4.62.0
  Have complications/comorbidity95.498.0
Mean HbAlc (%)7.4 ± 1.47.7 ± 1.7
Mean fasting plasma glucose (FPG) (mg/dl)140.0 ± 51.1146.4 ± 59.7

Goodness-of-fit summary for each dimension and the overall measurement models (n = 500)

Measurement modelIndexReliability coefficient
χ2χ2/dfPGFIAGFIRMSEACronbach’s α
PF model2.340.780.500.9980.9910.0000.82
Sym model14.681.470.140.9920.9770.0310.90
Psycho model1.700.560.640.9990.9930.0000.72
SM model42.071.270.130.9860.9670.0230.85
Soc model0.720.360.700.9990.9960.0000.76
GlobH model0.010.010.951.0001.0000.0000.90
Satis model0.720.240.870.9990.9970.0000.84
PRO-DM-Thai model5.230.870.510.9970.9860.0000.91

Summary of statistical testing of PRO-DM-Thai to discriminate patients with difference levels of disease control assessed by physicians

TechniqueSpearman’s rank correlation (r)Post hoc test and P of one-way ANOVADiscriminant analysis ClassifiedRanking
W > FF > PW > PP
Overall0.27

P < 0.001

P < 0.05

P < 0.05

P < 0.05

0.001

P < 0.05

Yes+++
Dimensions Physical Function0.030.913No0
Symptoms0.29

P < 0.001

P < 0.05

P < 0.05

<0.001

P < 0.001

Yes++
Psychological Well-being0.110.222No0
Self-care management0.25

P < 0.001

P < 0.05

P < 0.05

P < 0.05

0.002

P < 0.05

Yes++
Social well-being0.030.383No0
Global judgments of health0.29

P < 0.001

P < 0.05

P < 0.05

<0.001

P < 0.001

Yes+++
Satisfaction with care and flexibility of treatment0.31

P < 0.001

P < 0.05

P < 0.05

P < 0.05

<0.001

P < 0.001

Yes+++

Summary of content development of PRO-DM-Thai

DimensionsDescriptionQuestions items (abbreviations)Item derivation
I-CVIReviewsPtExp
PhysicalRelating to physical abilityPF1 Self doing activities1.00✓ [7, 10,
Functionand measuring physicalPF2 Self doing activities of daily living1.0021-23,
(PF)functioning e.g., mobility,PF3 Self doing housework0.8328, 33-38]
dexterity, range ofPF4 Self walking more than 500 meter0.83
movement, physical activity,PF5 Self use of public transport1.00
activities of daily living
SymptomsRelating to diabetes-Syml Hypoglycemic symptoms1.00✓ [7, 10,
(Sym)specific symptoms andSym2 Hyperglycemic symptoms1.0021-24,
diabetes-related symptomsSym3 Abnormal sypmtom at foot/feet1.0028, 33,
e.g., hypoglycemia,Sym4 Nephropathy-related symptoms1.0036-39]
hyperglycemia,Sym5 Cardiovascular disease-related1.00
neuropathy, nephropathy,symptoms
retinopathySym6 Have a blurred vision1.00
Sym7 Have infected symptom in the body1.00
PsychologicalRelating to psychologicalPsychol Feel depression and anxiety1.00✓ [7, 10,
Well-beingwell-being especiallyPsycho2 Can find a way to relieve stress1.0021-24, 28
(Psycho)disease-related e.g.,Psycho3 Positive well-being and adjustment1.0033-40]
anxiety, depression, coping,Psycho4 Can live with life satisfaction1.00
positive well-being and adjustment, life satisfaction, concentrationPsycho5 Concentrate on work or activities0.83
Self-careRelating to self-careSM1 Able to look after yourself in time and1.00✓ [7, 10,
managementbehavior managing disease,accurate if hypoglycemia occur21-24,
(SM)able to followSM2 Able to look after yourself in time and1.0027-30,
recommendations,accurate if hyperglycemia occur33,
exercising, check-ups,SM3 Measure blood glucose level once a0.8335-39]
monitoring, diet control,week
drug complianceSM4 Weight control1.00
SM5 Look after feet health1.00
SM6 Sweet meal diet control1.00
SM7 Carbohydrate diet control1.00
SM8 High-fat diet control1.00
SM9 Salty foods diet control1.00
SM10 Avoid beverages contained alcohol1.00
SM11 Drug compliance1.00
SM12 Exercise at least 3–5 times a week1.00
Social well-Relating to family andSoc1 Family relations1.00✓ [7, 10,
being (Soc)intimate relations, socialSoc2 Friends and acquaintances relations1.0023, 24,
contact, integration andSoc3 Attend family activities1.0028,
social opportunities, leisureSoc4 Attend community events1.0033-39]
activities, and satisfaction,Soc5 Give advice to each other with1.00
travellingdiabetes patients
GlobalRelating to overall ofGlobH1 The hypoglycemia occur 3–4 times1.00✓ [7, 10,
judgmentsgeneral quality of life anda week21, 23,
of healththe impact of diabetes onGlobH2 Physical examination to detect1.0024, 28,
(GlobH)general quality of life e.g.,complications of diabetes at least once a year33-40]
current health ratings,GlobH3 The HbA1c more than 9%1.00
diabetes controls life,GlobH4 Have a complication that much1.00
general restrictions,affected on life
diabetes restrictive,GlobH5 Cannot do something due to be1.00
diabetes limits freedomcareful about the level of blood glucose
SatisfactionRelating to satisfactionSatis1 Satisfied with information given by1.00✓ [7, 10,
with care andwith care and treatment ofphysicians and nurses21-24,
flexibility ofpatients and care teams,Satis2 Can apply the knowledge learned1.0028,
treatment(information, time, andfrom doctors and nurses to control diabetes33-40]
(Satis)care), access to careSatis3 Satisfied with physician treatment1.00
Satis4 Medical satisfaction1.00
Satis5 Satisfied with the process of health1.00
care services
Total 7 dimensions, 44 Items, Scale-content validity index average agreement: S-CVI/Ave = 0.96
eISSN:
1875-855X
Language:
English
Publication timeframe:
6 times per year
Journal Subjects:
Medicine, Assistive Professions, Nursing, Basic Medical Science, other, Clinical Medicine