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Assessment on quality care management of hypertension in

Primary Care Unit, Songklanagarind hospital

Banthita Boonmart
Natapon Rattanamusik
Nuttaphon Kittarnthong
Pattanop Ngaodulyawat
Poramin Kanyakool
Somjintana Phochanatarn
Tipyada Sriwachirawat
Wuttiphong Putthasorn

Group Advisor
Rattanaporn Chootong M.D.

No.388-541 and 388-542 Family and community medicine III,IV


Department of Family and Preventive Medicine, Faculty of Medicine
Prince of Songkla University, Hatyai, Songkhla, Thailand
Academic Year 2017
A

Preface
Hypertension is a major public health challenge with its prevalence rising alarmingly
worldwide. The estimated number of adults with raised blood pressure increased from 594
million in 1975 to 1.13 billion in 2015, with the largely increased in low-income and middle-
income countries. Raised blood pressure is estimated to cause 7.5 million deaths, about 12.8%
of the total of all death. This accounts for 57 million disability adjusted life years (DALYS) or
3.7% of total DALYS worldwide. Raised blood pressure is a major risk factor for coronary heart
disease and ischemic as well as hemorrhagic stroke. Blood pressure levels have been shown
to be positively and continuously related to the risk for stroke and coronary heart disease.
In addition to coronary heart disease and stroke, complications of raised blood pressure include
heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage and visual
impairment.
In Thailand, prevalence of hypertension shows that there is amount of uncontrolled
hypertension patients more than controlled hypertension patients among the older people. 56.1
percent of hypertension patients are unaware of their condition. Among the patients who aware
of hypertension, only 36.1 percent has been treated and 10.6 percent has their BP controlled.
This study is the one part of Family and Community medicine 3,4 that studied about quality
care management of hypertension in primary care unit, Songklanagarind hospital and to
determine the association between factors and blood pressure control. This data will be the
direction for planning the program of prevention and management which will be use in the
patients in the soon future for improving quality of care
The authors really hope this study will be useful to those who interested and can apply
this study to the other plans or will further develop in the future.

The authors
17th July 2017

Acknowledgement
B

We would like to express our deep gratitude to our research advisor, Rattanaporn
Chootong M.D., for her patient guidance, enthusiastic encouragement and useful critiques of
this research work. We are most grateful for her teaching and advice, especially research
methodologies. This research would not have been completed without all the support from her.
In addition, we thank the doctor of Songklanagarind hospital, Faculty of Medicine,
Songklanagarind University, for their care of the patients, the medical record and Mr.Andrew
Jonathan Tait, an English teacher, for assistance with the English-language presentation of the
manuscript and correcting words of this report.

The authors 17th July 2017

Content

Page
C

Preface A
Acknowledgement B
Content C
Content of figure F
Content of table G
Research checklist H
Abstract J
Chapter 1: Introduction
Background and Rationale 1
Research question 2
Objective 2
Expected benefit 2
Conceptual framework 3
Chapter 2: Literature Reviews
Definition of hypertension 3
Classification of office blood pressure levels 3
The burden of hypertension 4
Treatment of hypertension 5
Outcomes of blood pressure lowering 5
Indicator of quality care management of hypertension 6
Factors of uncontrolled hypertension 7
Quality care of hypertension management 8
Chapter 3: Research Methodology
Study design 8
Study setting 8
Target population 8
D

Variables and operational definition 10


Study tools and outcome measurement 10
Data collection 10
Data analysis 10
Procedure and data management 11
Ethics 11
Bias 12
Chapter 4: Result
Descriptive study result 13
Socio-demographic characteristics of hypertensive patients 13
Clinical characteristics of hypertensive patients’treatment 13
Demographic of Indicators of standard hypertensive care 13
Indicators of hypertensive treatment results 14
Inferential study result 14
Univariate analysis result 14
Multivariate analysis result 14
Chapter 5: Discussion
Discussion of the study tools and outcome measurement 15
Discussion of the research and methodology 15
Discussion of the result 16
Factors of bood pressure control 18
Limitation 19
Suggestions for further research 19
Conclusion 20
References 20
Appendix A
E

Demographic characteristics of hypertensive patients 23


Clinical characteristics of hypertensive patients’ treatment 24
Indicators of standard hypertensive care 25
Indicators of hypertensive treatment result 26
Univariate analysis of the factors affecting blood pressure control 27
in hypertensive patients
Gantt chart 28
Appendix B
Submission form 29
Extraction form 35
Variable definition 39
CITI program certification 43

Content of figure
Page
Figure 1:conceptual framework 3
Figure 2: Enrollment, exclusion criteria, and target population. 12
F

Content of table
Page
Table 6: Multivariate analysis of the factors affecting blood pressure 15
control in hypertensive patients
Table1: Demographic characteristics of hypertensive patients 23
Table2: Clinical characteristics of hypertensive patients’ treatment 24
Table 3: Indicators of standard hypertensive care 25
Table 4: Indicators of hypertensive treatment result 26
Table 5: Univariate analysis of the factors affecting blood pressure 27
G

control in hypertensive patients

Research checklist
H

YES/NO
Y
Y

Y
Y

Y
Y

Y
Y
Y
Y
Y
Y
Y
Y

Y
N
Y
Y
N
Y
Y

N
Y
I

Y
Y
Y

Assessment on quality care management of hypertension in


Primary Care Unit, Songklanagarind Hospital :
Cross-sectional study
Background : Hypertension is a major public health challenge with its prevalence rising
alarmingly worldwide. In Thailand, the health survey guides that there are over 11,000,000
J

people with over 15 years old having underlying disease as hypertension. But only one-fourth of
the patients with treatment have well controlled blood pressure. Reduction of blood pressure
can reduce many complications such as cardiovascular mortality, stroke, renal complication,
and retinopathy
Objective : To determine the quality care management of hypertension in Primary Care Unit,
Songklanagarind Hospital and to determine the factor associated uncontrolled hypertension.
Method: An Observational descriptive study; Cross-sectional study from medical review from 1
January to 31 December, 2016. We study in patients ≥ 18 years old with diagnosis of primary
hypertension as ICD-10 and followed up in Primary Care Unit, Songklanagarind Hospital. The
collected data was analyzed by Program R version 3.4.1.
Result : From 400 of sample size, 7 people were excluded from exclusion criteria. The majority
of hypertensive patients were female 235 patients (60%). The most population of hypertensive
patients were between 65-69 years in range. The mean of BMI in hypertensive patients were
25.3 kg/m2. The median of SBP was 133 mmHg and mean of DBP was 75.8 mmHg. Patients
who followed up <2 episodes were 13 patients (3.3%). The results of indicators of standard
hypertensive care show performed physical examination 322 patients (81.9%) and had
completely performed laboratory test 33 patients (8.4%) include FBS (79.4%), electrolyte
(62.8%), renal function test (85.4%), HDL-C (78.1%), LDL-C (90%), total cholesterol (90%),
triglyceride (90%), CBC (52.4%), albuminuria (34.9%) and EKG (29.7%). There were controlled
blood pressure 204 patients (51.9%). Goal of blood pressure is 140/90 mmHg in HT patients
and 130/80 mmHg in HT with DM patients. Patients in our study had complication from
hypertension include 19 patients had cerebrovascular accident (18%), 27 patients had
cardiovascular disease (25%) and 57 patients had renal complication (57%). From multivariate
analysis, there were 2 variables associated with developing uncontrolled hypertension; 1) BMI
≥ 35 kg/m2 (OR = 3.75; 95%CI = 1.16-12.11), 2) Diabetes mellitus (DM) (OR = 4.44; 95% CI =
2.71-7.28).
Conclusion : The results of our study show the amount of uncontrolled hypertensive patients in
Primary Care Unit, Songklanagarind Hospital is nearly half of all and show incomplete physical
examination and annual laboratory tests in each hypertensive patient. Furthermore, the study
shows uncontrolled hypertension associated with DM and grade 2 obesity (BMI≥35 kg/m2) so
the doctors should pay attention in controlling FBS and weight reduction for the best quality of
treatment in hypertensive patients. Finally, the doctors should create a checklist form to remind
doctors for complete physical examination and annual laboratory tests and promote
hypertensive patients to improve their lifestyle modification for better blood pressure control and
decrease risk of complication.
Keywords : Assessment, Hypertension, Management, Quality of care
K
1

Chapter 1: Introduction
Background and rationale
Hypertension is a major public health challenge with its prevalence rising alarmingly
worldwide. The estimated number of adults with raised blood pressure increased from 594
million in 1975 to 1.13 billion in 2015, with the largely increased in low-income and middle-
income countries1. Raised blood pressure is estimated to cause 7.5 million deaths, about 12.8%
of the total of all deaths2. This accounts for 57 million disability adjusted life years (DALYS) or
3.7% of total DALYS worldwide2. Raised blood pressure is a major risk factor for coronary heart
disease and ischemic as well as hemorrhagic stroke. Blood pressure levels have been shown
to be positively and continuously related to the risk for stroke and coronary heart disease. In
addition to coronary heart disease and stroke, complications of raised blood pressure include
heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage and visual
impairment.
Thailand is undergoing a health-risk transition which increases chronic diseases,
particularly hypertension, as a result of a rapid transition from a developing to a developed
country1. From Bureau of Policy and Strategy, the Ministry of Health are talking about the
mortality rate of hypertension per 100,000 people from 2013 to 2015 are 8.09, 18.24, 25.32
respectively. Mortality rate in 2015 is about 3 times compared with 2013. 18 Thai health survey
guides that there are over 11,000,000 people with over 15 years old having underlying disease
as hypertension.18 Something that we concern is 60% of hypertensive patients, 40% of this
group are men have not be diagnosed before. 8-9%of this group are diagnosed without any
treatment result in increased severity and only one-fourth of the patients with treatment have
well controlled blood pressure.18
Reduction of systolic blood pressure and diastolic blood pressure until they are less
than 140/90 mmHg is associated with 29% reduction in major adverse cardiac event, 33% in
cardiovascular mortality and 37% in heart failure3, in addition each 10 mmHg lower blood
pressure is associated with significantly lower mortality risk of stroke (RR, 0.73 [95%CI, 0.64-
0.83]), albuminuria (RR, 0.83 [95%CI, 0.79-0.87]), and retinopathy (RR, 0.87 [95%CI, 0.76-
0.99]).4
A study in Thailand5 shows that the prevalence of hypertension shows that there is
amount of uncontrolled hypertensive patients more than controlled hypertensive patients among
the older people. 56.1% of hypertensive patients are unaware of their condition. Among the
2

patients who aware of hypertension, only 36.1% has been treated and 10.6% has their blood
pressure controlled.
In Songklanagarind Hospital, there is no study about quality care management of
hypertension. So, the aims of our study are to assess the component of quality care
management of hypertension according to indicators of National Health Security Office (NHSO)
20
in Primary Care Unit and the association between the factors and blood pressure control. The
result of this study will be used for develop the Patient Care Team (PCT) of hypertension and
promoting better quality care management of hypertension in Primary Care Unit.
Research questions
1. How is the quality care management of hypertension in Primary Care Unit at
Songklanagarind Hospital?
2. What are the factors that effect blood pressure control in uncontrolled hypertensive
patients?
Main Objectives
1. To determine the quality care management of hypertension in Primary Care Unit,
Songklanagarind Hospital.
2. To determine the factor associated uncontrolled hypertension.
Expected benefits and applications
1. To help knowing the quality care management of hypertension in Primary Care Unit
at Songklanagarind Hospital.
2. To help knowing the factors of blood pressure control.
Conceptual framework
3

Figure1: Conceptual framework

Chapter 2: Literature reviews


1. Definition of hypertension:
The 2015 Thai Hypertension Guidelines6 and 2013 ESH/ESC Guidelines for the
management of arterial hypertension5 show that the definition of hypertension is well accepted
at systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg at least two
consecutively visits at out-patient clinic of 1-2 weeks apart.
2. Classification of office blood pressure levels 6,7
 Optimal: Systolic <120 mmHg and Diastolic <80 mmHg
 Normal: Systolic 120-129 mmHg and/or Diastolic 80-84 mmHg
 High normal: Systolic 130-139 mmHg and/or Diastolic 85-89 mmHg
 Grade 1 Hypertension: Systolic 140-159 mmHg and/or Diastolic 90-99 mmHg
 Grade 2 Hypertension: Systolic 160-179 mmHg and/or Diastolic 100-109 mmHg
 Grade 3 Hypertension: Systolic≥180 mmHg and/or Diastolic≥110 mmHg
 Isolated systolic hypertension: Systolic≥140 mmHg and Diastolic<90 mmHg
The blood pressure category is defined by the highest level of blood pressure, whether
systolic or diastolic. Isolated systolic hypertension should be graded 1, 2, or 3 according to
systolic blood pressure values in the ranges indicated above.
4

3. The burdens of hypertension6


Extension of target organ damage from hypertensive cause heralds a poorer prognosis
and may present in the heart, blood vessels, kidneys, brain or eyes. For the detail;
cardiovascular disease, such as myocardial infarction, angina, coronary revascularization,
congestive heart failure. Cerebrovascular disease, such as ischemic stroke, cerebral
hemorrhage, transient ischemic attack. Renal disease, such as diabetic nephropathy, chronic
kidney disease, microalbuminuria or macroalbuminuria. Peripheral vascular diseases.
Retinopathy, such as hemorrhage, exudate and papilledema.
 A study8 that reviewed the association between elevated blood pressure and the
burden of disease from 154 countries that included 8.69 million participants shows the
estimated annual death rate per 100,000 associated with systolic blood pressure of 110 to 115
mmHg increased from 135.6 to 145.2 and the systolic blood pressure of 140 mmHg or higher
increased from 97.9 to 106.3. Loss of disability-adjusted life-years (DALYs) associated with
systolic blood pressure of at least 110 to 115 mmHg increased from 148 to 211 million, and for
systolic blood pressure of 140 mmHg or higher. The largest numbers of systolic blood pressure-
related deaths were caused by ischemic heart disease 4.9 million, hemorrhagic stroke 2.0
million and ischemic stroke 1.5 million.
Another study in China9 shows that hypertension, smoking, and size of the aneurysms
were significantly associated with intracranial aneurysmal rupture (P < 0.05). The comparisons
showed that the risk of rupture of intracranial aneurysms in the uncontrolled hypertensive group
(51.0%) was significantly greater than that in the normotensive group (30.6%) and in the
controlled hypertensive group (34.7%).
Another study in the northwest England10 shows that the risk of stroke was clearly
related to quality of control of blood pressure with treatment. The patient whose average pre-
event systolic blood pressure was controlled to <140 mmHg had an adjusted odd ratio for
stroke of 1.3 (95%C.I.; 0.6 to 2.7). Those fairly well controlled (140-149 mm Hg), moderately
controlled (150-159 mm Hg), or poorly controlled (>160 mm Hg) or untreated had progressively
raised odd ratios of 1.6, 2.2, 3.2, and 3.5 respectively.
4. Treatment of hypertension6
1. Lifestyle modification has to be pursued in all potential and established hypertensive
patients to prevent hypertension and to reduce blood pressure, respectively.
5

The followings are example of efficacy of lifestyle modification in blood pressure reduction
- Weight reduction (in patient with BMI > 25 Kg/m2) can reduce systolic blood pressure
5-20 mmHg.
- DASH diet can reduce systolic blood pressure 8-14 mmHg.
- Sodium intake restriction < 2,300 mg/day can reduce systolic blood pressure 2-8
mmHg.
- Regular aerobic exercise can reduce systolic blood pressure 4 mmHg and diastolic
blood pressure 2-5 mmHg.
- Alcohol restriction can reduce systolic blood pressure 2-4 mmHg.
2. Pharmacological therapy 6,7
Pharmacological therapy is not needed in those with high normal blood pressure no
matter what level of total CVD risk. Those patients with low to moderate risk, lifestyle
modification should be adopted first for 2-4 months or 2-4 weeks, respectively. Lastly, those
patients with high to very high risk, pharmacological therapy has to be initiated promptly with
lifestyle modification.
Four groups of antihypertensive drugs; thiazide-type diuretic, CCB, ACEI, and ARB can
be used as initial and maintenance therapy according to compelling indications in both
monotherapy or combination therapy depending on the severity.
5. Outcomes of blood pressure lowering
A study in the United States3 shows that intensive blood pressure lowering (systolic
blood pressure <140 mmHg) was associated with a 29% reduction in major adverse
cardiovascular events (MACE), 33% in cardiovascular mortality, and 37% in heart failure
compared with standard blood pressure lowering.
There is another systematic review and meta-analysis in the United States. 4The results
show that forty trials judged to be of low risk of bias were included. Each 10 mmHg lower
systolic blood pressure was associated with a significantly lower risk of mortality (RR 0.87),
cardiovascular events (RR 0.89), coronary heart disease (RR 0.88), stroke (RR 0.73),
albuminuria (RR 0.83) and retinopathy (RR 0.87).
6. Indicator of quality care management of hypertension
The quality care management of hypertension is the patient’s blood pressure achieved
at goal and performed complete annual initial laboratory investigation. The indicators of quality
6

care includes 7 indicators according to National Health Security Office (NHSO)20 and the 2015
Thai Hypertension Guidelines6 in the following.
1. A rate of general hypertensive patients with blood pressure level < 140/90 mmHg.
(But the goal of blood pressure level in the patients with hypertension and diabetes is <130/80
mmHg)
2. A rate of followed up hypertensive patients at least twice a year.
3. A rate of hypertensive patients that received annual physical examination and
laboratory checkup.
4. A rate of cardiovascular disease in hypertensive patients.
5. A rate of cerebrovascular accident in hypertensive patients.
6. A rate of abnormal renal function in hypertensive patients.
7. A rate of hypertensive patients that was advised smoking cessation.
But we do not include the last indicator in our study because the Primary Care Unit at
Songklanagarind Hospital does not have protocol for smoking cessation.
The detail of indicators, can see at variable definition. (Appendix B)
We have reviewed studies about quality of care for hypertension in order to compare
the results with our study. The results from literatures review can conclude below.
A study from NHSO20 from Thailand in 2015 included 32,420 patients reveals that rate
of well blood pressure control in general hypertensive patients and patients with hypertension
and diabetes is 60.9%, rate of hypertensive patients that received annual laboratory checkup is
95.5%, rate of cardiovascular disease is 7.0%, rate of cerebrovascular accident is 3.9%, and
rate of abnormal renal function is 13.1%.
A study in the United States11shows 42% of 1,953 hypertensive patients had controlled
hypertension, 14% were received examination of the fundi, 35% were received examination of
neurologic system, 71% were received examination of heart sounds, 32% were received
examination of peripheral arterial pulses, 30% were sent for urinalysis, 65% were sent for blood
glucose level, and 62% were sent for creatinine level.
A study in Spain12 shows that 55.4% of the 10,743 patients had controlled blood
pressure.
7

A study in Algeria13 included 3,622 patients with 42% males and 58% female reveals
that 22% of males had controlled BP and 35.6% of females were with controlled blood
pressure.
7. Factors of Uncontrolled hypertension
A study at Department of Community Medicine, University of Zimbabwe14 shows that the
factors associated with uncontrolled hypertension are those who were age≥65 (OR2.37),
visiting a traditional healer in the past 12 months (OR 3.47), taking traditional herbs in the past
12 months (OR 1.60), being diabetic (OR 1.98), obesity (OR 2.98), adding salt to food (OR
5.56), currently smoking (OR 3.85) and alcohol consumption (OR 1.94) were risk factors for
uncontrolled hypertension.
A study from Iran15in 2007 shows that the factors associated with uncontrolled
hypertension are male (OR 2.38), diabetes (OR 2.48) and smoking habits (OR 1.88).
A Study from Spain12 in 2010 shows that the factors associated with uncontrolled
hypertension patient are obesity (BMI>30) (OR 1.35), abdominal obesity (waist circumference
was >102 cm in men or >88 cm in women) (OR 1.38), and smoker (OR1.2).
And another study from Spain16 in 2016 shows that the factors associated with
uncontrolled hypertension are coffee drinker by 1 cup of coffee per day (OR 1.95), 2 cups of
coffee per day (OR 1.41), and 3 cups of coffee per day (OR 2.55).
A study from New England journal study17 in 1992 shows that drug abuse is the factor
related to uncontrolled hypertension (OR 3.6).
8. Quality care of hypertension management
A study In the United States11, shows that higher Quality of care for hypertensive
patients is associated with better BP control.
A study in China shows13 that patients with controlled BP received more indicated
process care than patients with uncontrolled BP, suggesting a relationship between process
and outcome of hypertensive care. Linking process and outcome is an important goal of quality
of care assessment.
The study about quality of control in the United States in 2003 showed in 1999-200021,
68.9 % all of hypertensive participants were aware of their hypertension, and 58.4% were
receiving BP medication. Hypertension was controlled in 53.1 % of those taking medication,
and among all hypertensive participants BP was controlled in only 31.0%.
8

Another study in the United states in 199522, result from Third National Health and
Nutrition Examination Survey, 1988-1991 showed about two thirds of the population with
hypertension were aware of their diagnosis (69%), and a majority were taking prescribed
medication (53%). Only one third of Mexican Americans with hypertension were being treated
(35%), and only 14% achieved control in contrast to 25% and 24% of the non-Hispanic black
and non-Hispanic white populations with hypertension

Chapter 3: Research Methodology


1. Study design: Observational descriptive study; Cross-sectional study from medical review,
1 Jan – 31 Dec 2016.
2. Study setting: Primary Care Unit of Songklanagarind hospital, Hatyai, Songkhla, Thailand.
3. Target population:
The patients who were ≥ 18 years old and followed up in Songklanagarind Hospital.
Study population
The patients who were ≥ 18 years old and followed up in Primary Care Unit,
Songklanagarind Hospital.
Inclusion criteria
The patients who were ≥ 18 years of age, with diagnosis of primary hypertension as ICD-
10 (I-10) and followed up in Primary Care Unit, Songklanagarind Hospital.
Exclusion criteria
1. The patients who were below 18 years old
2. Followed up in Primary Care Unit, Songklanagarind Hospital less than 12 months
3. Did not measure blood pressure in last visit in 2016.
Sample size
In the first main objective, the sample size was calculated by using infinite population
formula (W. G. Cochran).
9

When Z² = The abscissa of the normal curve that cuts off an area α at the tails (Z=1.96
at α=0.05), e = The acceptable sampling error (acceptable error is 5%, e=0.05), p = the
estimated proportion of an attribute that is present in the population (maximum prevalence is
50%, P=0.5). An adequate sample size in hypertensive patients which unknown population was
384. So our group will collect sample size as 400 patients.
The second main objective, the sample size was calculated by using logistic regression
method by program G power version 3.1.9.2. 18
The factor that was used to calculate is age that over 65 years old. Odd ratio is 2.37.
The type I error is 0.05 and power is 80%. The type of distribution of factors is binomial
distribution. An adequate sample size to determine factor associated uncontrolled hypertension
is 218 patients. So, we will use the sample size as 400 patients.
4. Variables and operational definition
Independent variables: age, sex, health insurance, occupation, religion, hypertensive
drugs, diabetic medication, dyslipidemic medication, BMI, weight, height, history of smoking,
history of alcohol drinking, traditional herbal usage and comorbidity.
Dependent variables: quality of hypertensive care; complication of hypertension, blood
pressure level, fundoscopic examination, heart sound and/or PMI, pitting edema, neurological
examination, peripheral arteries (pulse palpation and/or carotid bruit), albuminuria test, fasting
plasma sugar, electrolyte, renal function, lipid profile, CBC and EKG.
The detail of indicator and operational definition, can see at variable definition.(appendix
B)
5. Study tools and outcome measurement
The data was recorded with data extraction form following concepts of National Health
Security Office (NHSO)20 and the 2015 Thai Hypertension Guidelines6. The data extraction form
compose of demographic characteristics, clinical characteristics of hypertensive patients’
treatment, blood pressure measurement, physical examination, and laboratory investigation which
available in appendixB. The data extraction form (appendixB) was assessed content validity using
the Indexes of Item-Objective Congruence (IOC) by 3 experts from Department of Family and
Preventive Medicine, Songklanagarind Hospital (Dr. Narucha Komonsuradej, Dr. Aurapun
10

Fumaneechort and Dr.Panitan Wajanacomkul) and we adjusted the form follow their advices
before using it.
6. Data collection
The data of this study was recorded in the Data extraction form in Microsoft Excel®
2013.
7. Data analysis
1. Descriptive statistics
In demographic data, continuous data will be summarized into mean and standard
deviation (S.D.) or median and interquartile range (IQR) according to data distribution.
Categorical data will be summarized into percentage (%).
2. Analytic statistics
The association between related factors and uncontrolled blood pressure will be
analyzed by Program R version 3.4.1. The distribution of each related factor will be analyzed by
Shapiro-Wilk test and summarized into normal distribution or non-normal distribution. Category
variables will be univariated by Chi-squared test if it is normally distributed or by group variance
test if is not normally distributed. Continuous variables will be univariated by T-test if it is
normally distributed or by Wilcoxon Rank-Sum test if is not normally distributed. Then,
multivariated by logistic regression analysis.
8. Procedure and data management
1. Preparation: Review literature, establish methodology, establish research proposal,
create data extraction form and variable definition which were approved by 3 experts from
Department of Family and Preventive Medicine and send ethics committee.
2. After EC approved, we collect the data: send the letter with EC official for searching
HN (from Hospital Information System) of primary hypertensive patients in 1 Jan – 31 Dec 2016
that followed up in Primary Care Unit, Songklanagarind Hospital. The amount of patients that
we receive information is 1,713 patients.
3. After receive information from 1,713 hypertensive patients in Primary Care Unit,
Songklanagarind Hospital, then we random the 400 sample patients by using Microsoft Excel®
2013. We collect data of sample patients by searching history of hypertensive treatment follow-
up between 1 Jan – 31 Dec 2016 in Primary Care Unit, Songklanagarind Hospital. We exclude
the visit that does not routine hypertensive care. We gather information: last visit blood pressure
in 2016, physical examination in 2016, last laboratory tests in 2016, etc.
11

4. Process and analysis the data: Data analysis and data conclusion in Program R
version 3.4.1.
5. Report: Prepare report and present research.
Gantt chart was shown in appendix A
9. Ethics
The data of hypertensive patients who followed up at Primary Care Unit at
Songklanagarind hospital was collected from HIS (Hospital Information System). We contacted
the research management information system to ask for HN (hospital number) of hypertensive
patients.
We did the protocol and certificate of NIH for asking ethics committee approval at
Institute Ethics Committee before collect the data, then we received project number
60-247-09-1.
We linked HN with ID number in the extraction form and did not reveal name of the
patients.
According to our study is retrospective study, so inform consent is not necessary.
The data extraction forms (appendix B) will be destroyed immediately after finished this
study. The result of this study does not have information that identify any patient.
10. Bias
This study was a retrospective study based on medical records review, which might
have led to information bias due to insufficient and/or incorrect documentation.
Chapter 4: Result
In 2016, hypertensive patients who were >18 years old and followed up in
Songklanagarind Hospital were 1,713 people. The sample size was 400 people but they were
excluded 7 people from exclusion criteria which consist of followed up in Primary Care Unit,
Songklanagarind Hospital less than 12 months was 5 people and loss follow up at Primary Care
Unit was 2 people. Results were shown in figure 2.
Hypertensive patients (ICD-10) in Primary
care unit at Songklanagarind Hospital
From 1 Jan- 31 Dec 2016
Exclude from exclusion criteria N = 7
 Followed up less than 12 month
5 people
 Loss follow up 2 people
12

Final sample size after exclusion


N = 393

Figure 2: Enrollment, exclusion criteria, and target population.


The results compose of descriptive study result and inferential study results as follows.
1. Descriptive study result
1.1 Socio-demographic characteristics of hypertension patients
The majority of hypertensive patients were female (60.0%) and male (40.0%). The
average age of hypertensive patients were 65.3 years. The most population of hypertensive
patients were between 65-69 years in range. The mean of body weight and height in
hypertensive patients were 64.5 kilograms and 156.9 centimeters. The majority of hypertensive
patients had BMI in obesity grade 1 (38.2%) and The mean of BMI in hypertensive patients
were 25.3 kg/m2. Most of hypertensive patients were Buddhism (94.1%). Most of hypertensive
patients were no occupation (39.4%). Health insurance in hypertensive patients consisted of
Government enterprise officer (50.6%), Universal coverage scheme (33.1%), Pay cash (9.4%),
Social security scheme (3.6%) and State enterprise officer (3.3%) and most of cases were no
data about smoking history (66.9%) same as alcohol drinking were no data (80.7%) and
traditional herbal usage were no data (94.0%). Results were shown in Table 1(Appendix A)
1.2 Clinical characteristics of hypertensive patients’ treatment
The most patients developed hypertension for 5-15 years (56%), The majority of
hypertensive patients had followed up 4 episodes in 2016 (38.1%) by the way this study has
showed that patients who followed up <2 episodes was 3.3%. Some of hypertensive patients
had comorbid diseases include hyperlipidemia in most cases (64.4%), diabetes mellitus type 2
(36.1%), chronic kidney disease (1.3%), other diseases (11%) and diabetes mellitus type 1
(1%). Hypertensive drugs using were calcium channel blocker (49.9%), angiotensin receptor
blockers (21.4%), diuretics (27.2%), beta blockers (22.4%), angiotensin converting enzyme
inhibitors (28.5%), alpha blockers (2.5%) and no hypertensive drug using (9.2%). Most cases of
hypertensive patients who were diabetes mellitus used biguanides (83.6%) and most cases of
hypertensive patients who were hyperlipidemia used statins (82.6%). Results were shown in
Table 2.(Appendix A)
1.3 Demographic of Indicators of standard hypertensive care
Demographic data of several laboratory and physical examination results applied to
follow up treatment of hypertension. This research showed that 3 indicators consist of 1)
physical examination 2) performed laboratory test and 3) type of laboratory test which were
13

used in evaluating quality of standard hypertensive care. The majority of hypertensive patients
had performed physical examination (81.9%) consist of fundoscopic examination by
ophthalmoscope (2.8%), heart sound and/or PMI (73.8%), pitting edema (67.8%), neurological
examination (14.5%), peripheral arteries (29.2%) and not performed (18.1%). Most of physical
examination was heart sound and/or PMI (73.8%) and least of physical examination was
fundoscopic examination by ophthalmoscope (2.8%). In part of the laboratory tests, the majority
of hypertensive patients had incompletely performed (85.2%), completely performed (8.4%) and
not performed any test (6.4%). Type of laboratory tests consists of fasting plasma glucose
(79.4%), electrolyte (62.8%), renal function test; serum creatinine and eGFR (85.4%), lipid
profile consist of HDL-C (78.1%), LDL-C (90%), total cholesterol (90%), triglyceride (90%) ,CBC
(52.4%) albuminuria (34.9%) and least of performed initial laboratory tests was EKG (29.7%).
This demographic data of this study was illustrated in Table 3 in appendix A
1.4 Indicators of hypertensive treatment results
Our hypertensive patients have more controlled blood pressure patients (51.9%) in last
visit than uncontrolled blood pressure patient (48.1%) in last visit. The median of systolic blood
pressure was 133 mmHg and mean of diastolic blood pressure was 75.8 mmHg. Some patients
in study had complication from hypertension include cerebrovascular accident (18%),
cardiovascular disease (25%) and renal complication (57%). Most of cerebrovascular accident
was stroke (52.6%). Most of cardiovascular disease was left ventricular hypertrophy (33.3%).
Most of renal complication was decrease eGFR lower than 60 mL/min/1.73 m2 (44.6%). The
results were shown in Table 4 in appendix A
2. Inferential study results
2.1 Univariate analysis results
The clinical variables most common associated with uncontrolled hypertension on
univariate analysis were BMI > 35 kg/m2 (OR=22.5 ; 95%CI=2.0-249.2, p-value=0.01), using
hypertension drugs 3 types (OR=3.3; 95% CI=1.3-8.6, p-value=0.02), using hypertension drugs
4 types (OR=10.4; 95%CI=1.9-55.2, p-value=0.006), diabetes mellitus (OR=5.2; 95%CI=3.4-8.2,
p-value<0.001), fasting plasma glucose 100-125 mg/dL (OR=1.8; 95%CI=1.0-3.0, p-
value=0.03), fasting plasma glucose ≥126 mg/dL (OR=6.6; 95%CI=3.5-12.6, p-value=<0.001)
but cardiovascular disease was a protective factor for uncontrolled hypertension (OR=0.4;
95%CI=0.2-0.9, p-value=0.03). The results were shown in Table 5.
2.2 Multivariate analysis results
We found the following 2 factors to be associated with uncontrolled blood pressure
were: 1. Body mass index ≥ 35 kg/m2 was a factor associated with uncontrolled blood
pressure 3.75 times compared to Body mass index <35 kg/m2 (Adjusted OR = 3.75; 95%CI =
1.16-12.11; P-value = 0.027)
14

2. Diabetes mellitus was a factor associated with uncontrolled blood pressure 4.44
times compared to non-diabetic patients. (Adjusted OR = 4.44; 95% CI = 2.71-7.28; P-value
<0.001)
Other factors; using ≥3 hypertensive drugs (Adjusted OR = 1.8; 95%CI = 0.89-3.62; P-
value =0.102), cardiovascular disease (Adjusted OR = 0.62; 95%CI = 0.25-1.54; P-value =
0.307), fasting plasma glucose ≥100 mg/dL were not factors associated with uncontrolled blood
pressure (Adjusted OR = 1.06; 95%CI = 0.66-1.7; P-value = 0.802). The results were shown in
Table 6 .
Table 6 Multivariate analysis of the factors affecting blood pressure control in hypertensive patients
Indicators Univariate 95%C.I. Adjusted 95%C.I. P-value P-value
OR OR (Wald’s test)*** (LR-test)***
BMI ≥ 35 kg/m2 4.94 1.63-14.96 3.75 1.16-12.11 0.027# 0.017#
≥ 3 hypertensive drugs 2.39 1.27-4.53 1.8 0.89-3.62 0.102 0.098
Cardiovascular disease 0.66 0.29-1.48 0.62 0.25-1.54 0.307 0.301
DM 4.97 3.18-7.77 4.44 2.71-7.28 <0.001# <0.001#
Fasting plasma sugar ≥100 mg/dL 1.97 1.32-2.95 1.06 0.66-1.7 0.802 0.802
Chapter 5: Discussion
Discussion of the study tools and outcome measurement
We collected the data with the data extraction form and recorded in Microsoft Excel ®
2013. We consulted 3 experts from Department of Family and Preventive Medicine,
Songklanagarind Hospital to assess content validity of extraction form using Indexes of Item-
Objective Congruence (IOC) and we adjusted the form following their advices before using it.
Before recording the data, we clarified term of the variables to collect data in the same way and
to reduce errors.
Discussion of the research methodology
The strengths of cross-sectional study from medical record review are less cost, spend
less time studying, popular methodology for quality assessment and may be used as the initial
study generating hypotheses to be studied further by larger prospective studies.
For weaknesses, this study was a retrospective study based on medical records review,
which might have led to incomplete data and/or incorrect documentation.
And we might have recall bias because the quality of the data depends on the patient’
s ability to accurately recall their symptoms and the physician’s ability to recall the patient’s
symptoms to record in medical record.
Moreover, some insufficient data e.g. smoking history may affect blood pressure control
and lead to under-estimation of factors that were associated with uncontrolled hypertension.
Our study might have selection bias because we gathered information from
hypertensive patients who followed up in hospital that may be have worse symptoms than
those who followed up in other medical centers. So the result may have the association
between variables higher than normal population.
15

All of the excluded medical records were reviewed again to ensure that records are not
unnecessarily being excluded. We clarified the definition of variables for guide systematic data
collection to reduce error in data collection. We had a meeting to discuss or clarify any issues
that may have occurred during the coding process.
Discussion of the result
Indicators of standard hypertensive care
We have compared the study results with a study conducted by NHSO20 in 2015 and a
study in United States11 in 2005 due to the research methodology and indicators are resemble
in many ways. The NHSO’s study20 included 996 hospitals from every city in Thailand. The total
number of patients was 32,420. The study in United States21,22 included 12 communities with
populations greater than 200,000. The total included 1,953 patients.
A rate of complete laboratory tests in PCU(appendix A) is very low (8.4%). But when
focus on each laboratory tests, some have higher rate than both NHSO’s study 20 and a study in
United States21 e.g. electrolyte, total cholesterol and triglyceride.
A rate of patients measured electrolyte in PCU(appendix A) is higher than the results
from NHSO’s study20 in 2015 (62.8% vs. 44.5%) and a study in United States21 (62.8% vs.
59%).
A rate of patients measured complete lipid profile in PCU(appendix A) is higher than
the results from NHSO’s study20 in 2015 (78.1% vs. 75.1%).
A rate of patients measured HDL-C in PCU(appendix A) is higher than the results from
NHSO’s study20 in 2015 (78.1% vs. 76.7%).
A rate of patients measured total cholesterol in PCU(appendix A) is higher than the
results from NHSO’s study20 in 2015 (90.0% vs. 81.8%) and a study in United States (90.0%
vs. 58%).
A rate of patients measured LDL-C in PCU(appendix A) is higher than the results from
NHSO’s study20 in 2015 (90.0% vs. 86.4%). The mean LDL-C level in patients from
PCU(appendix A) is higher than the results from NHSO20 in 2015 (120.85±34.8 vs. 114.6±36.9
mg/dL).
A rate of patients measured triglyceride in PCU(appendix A) is higher than the results
from NHSO’s study20 in 2015 (90.0% vs. 86.1%) and a study in United States21 (90.0% vs.
60%).
A rate of patients measured EKG in PCU(appendix A) is higher than the results from
NHSO’s study20 in 2015 (29.7% vs. 16.1%).
A rate of patients that was measured fasting plasma glucose in PCU(appendix A) is
lower than results from NHSO20 (79.4% vs. 86.1%) but higher than a study in United States21
(79.4%. vs. 65%).
16

A rate of patients measured serum creatinine in PCU(appendix A) is lower than the


results from NHSO’s study20 (85.4% vs. 89.2%) but higher than a study in USA21 (85.4% vs.
62%).
A rate of patients calculated eGFR in PCU(appendix A) is higher than the results from
NHSO’s study20 (85.4% vs. 76.5%).
A rate of hypertensive patients that received annual physical examination is 81.9%
which complete examination only 0.25% and many indicators(appendix A) are worse than a
study in United States22.
A rate of examination of heart sounds in PCU(appendix A) is higher than a study in
United States21 (73.8% vs. 71%).
A rate of patients that received fundoscopic examination by ophthalmoscope in
PCU(appendix A) is lower than a study in United States21 (2.8% vs. 14%).
A rate of examination of peripheral arterial pulses in PCU(appendix A) is lower than a
study in United States21 (29.2% vs. 32%).
A rate of examination of neurological system in PCU(appendix A) is lower than a study
in United States21 (14.5% vs. 35%).
From our study, the outcome shows that PCU of Songklanagarind Hospital have low
quality of care management of hypertension in many aspects e.g. fasting plasma glucose,
serum creatinine, fundoscopic examination, peripheral arterial pulses examination and
neurological examination. The physicians should pay more attention to improve quality of care
of hypertension in PCU.
From our study 51.9% of hypertensive patients are controlled which are lower than
NHSO’s study20. A rate of cerebrovascular accident complication, cardiovascular disease
complication, and renal complication is higher than NHSO’s study as following.
A rate of patients with uncontrolled blood pressure in PCU(appendix A) is higher than
NHSO’s study20 (48.1% vs. 39.1%) but mean SBP and mean DBP are not different in both
patient groups (133.5±13.6/75.8±12.0 vs. 133.2±15.2/76.3±10.7 mmHg). When compared with a
study in Morocco in 2011, a rate of PCU’s patients with uncontrolled blood pressure is lower
(48.1% vs. 53.2%). When compared with a study in the United States 11, a rate of our patients
with uncontrolled blood pressure is lower (48.1% vs. 58%). When compared with a study in
Spain12 in 2009, a rate of our patients with uncontrolled blood pressure is higher (48.1% vs.
44.6%).
A rate of total patients with proven cerebrovascular accident complication is higher than
NHSO’s study20 (18% vs. 3.9%) which stroke is the most common complication in both patient
groups. And a rate from our study is higher that a study in Morocco (18% vs. 2.1%).
A rate of total patients with cardiovascular disease complication is higher than the
results from NHSO’s study20 (25% vs.7.0%) which left ventricular hypertrophy is the most
17

common complication in PCU’s patients(appendix A), while chronic ischemic heart disease is
the most common complication in NHSO’s study20.
A rate of total patients with renal complication is higher than the results from NHSO’s
study (57% vs.13.1%) which eGFR < 60 mL/min/1.73 m2 is the most common complication in
20

PCU’s patients(appendix A), while renal insufficiency is the most common complication in
NHSO’s study20.
A rate of followed up hypertensive patients at least twice a year is 96.7% and followed
up episodes range from 1 to 13 episodes per years which average 4 episodes per year. When
compared with a study in United States21 that hypertensive patients should visit the provider at
least once each year, our result is higher (100% vs. 94%). These outcomes show that PCU of
Songklanagarind Hospital has high quality of continuity care of hypertensive patients.
Most of our study’s patients are older than from NHSO’s study20, so may affect
increasing rate of uncontrolled hypertension, cerebrovascular accident complication,
cardiovascular disease complication, renal complication in our study’s patients.
Factors of blood pressure control
This study shows factors associated with uncontrolled blood pressure are diabetes
mellitus and grade 2 obesity (Body mass index≥35 kg/m2).
Obesity was a factor that associated with uncontrolled blood pressure (Adjusted OR =
3.75; 95%CI = 1.16-12.11; P-value = 0.027), the result was same as cross-sectional study of
Rev Esp Cardiol., Spain12, 2011 (Adjusted OR = 1.35; 95%CI = 1.21-1.51; P<0.01) and study of
Goverwa et al., Zimbabwe14, 2012 (Adjusted OR = 3.28; 95%CI = 1.39-7.75; P<0.05) in contrast
with retrospective cohort study of Iran15 (Adjusted OR = 0.92; 95%CI = 0.69-1.22; P = 0.558).
Causes of obesity were a lot of food consumption and lack of exercise that increased adipose
tissue. After that, it increased vascular resistance and increased blood pressure. Moreover,
obesity improved risk of other metabolic syndromes such as diabetes mellitus and dyslipidemia.
Diabetes mellitus was a factor that associated with uncontrolled blood pressure
(Adjusted OR = 4.44; 95% CI 2.71-7.28; P-value <0.001) same as, analytic cross-sectional
study of Rev Esp Cardiol., Spain12, 2011 (Adjusted OR = 1.16; 95%CI = 1.01-1.34; P = 0.04)
and retrospective cohort study of Iran15, 2014 (Adjusted OR = 2.48; 95%CI = 1.77-3.48;
P<0.001). Because diabetic patients had increase in total body fluid volume from
hyperglycemia, decrease in arterial compliance and diabetic patients tended to be poor lifestyle
modification include improper food consumption and lack of exercise and activity.
But using cardiovascular disease was not factors of uncontrolled blood pressure same
as study of retrospective cohort study of Iran15, 2014. Fasting plasma glucose≥100mg/dL and
≥3 hypertensive drugs using were not factors of uncontrolled blood pressure too but not the
same as study of retrospective cohort study of Iran15, 2014 in contrast with analytic cross-
sectional study of Rev Esp Cardiol., Spain12, 2011 (only hypertensive drugs using issue).
18

Limitation
The type of this study is a cross-sectional retrospective study from medical review, so it
has a limitation of some information including missing data, small number of subject and time
limitation.
Missing data was caused by data collection retrospectively. Some clinicians did not
record total information such as the history of smoking, height, herbal use. Some patients did
not have all of symptoms, physical examination and laboratory results recorded.
Some information, such as complication of hypertension, cannot indicate that caused
from hypertension or other diseases. So we regard as complication that occurred after
diagnosis of hypertension as complication of hypertension.
Numbers of subjects were too small to calculate OR and 95%CI of some factors.
Because this study has to be done in 7 weeks, it has time limitation to do prospectively
that has more reliable and more accuracy than retrospective.
Suggestions for Further Research
Because this study has too small numbers of subjects and has missing data, for further
study should be prospective.
This study is conducted in hypertensive patients who followed up in Primary Care Unit,
that may not represent all hypertensive patients in Songklanagarind Hospital. For further study
should be conducted in all hypertensive patients in Songklanagarind Hospital, it will help us
adjust problem size and develop the Patient Care Team (PCT) of hypertension and promote
better quality care management of hypertension in Songklanagarind Hospital.
Conclusion
In our study, the result shows the amount of uncontrolled hypertensive patients in
Primary Care Unit, Songklanagarind Hospital is nearly half of all and shows incomplete annual
physical examination and laboratory tests in each hypertensive patient.
All of above indicate defect of standard hypertensive care process in Primary Care Unit,
Songklanagarind Hospital that may be caused by doctors did not record total information or
forgot to complete physical examination and laboratory tests.
Furthermore, the study shows uncontrolled hypertension was associated with diabetes
mellitus and grade 2 obesity (BMI≥35 kg/m2). For diabetic risk factors in hypertensive patients,
doctors should perform fasting plasma glucose test annually for secondary prevention, early
detection and realizing of proper caring themselves. Moreover, hypertensive patients with
diabetes mellitus should pay attention in controlling their blood sugar in range.
For obesity risk factors in hypertensive patients, doctors should concern about
calculating BMI in every patient for evaluate obesity, searching intervention for weight reduction
and promoting patients to do the intervention. All of above methods help patients to control
their blood pressure in proper range.
19

For proper management of hypertensive patients, we suggest doctors to update their


clinical knowledge such as updating the guideline and create a checklist form to remind doctors
for complete physical examination and annual laboratory tests.
Finally, the doctors should promote hypertensive patients in weight reduction, exercise,
controlling blood sugar, reducing salt intake and proper using antihypertensive drug
simultaneously for better blood pressure control.
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19. อัจฉรา ภักดีพนิ ิจ, ศกลวรรณ แก้วกลิน่ , สุภาพร พรมจีน. ประเด็นสารรณรงค์วนั ความดันโลหิตสูง
ปี 2559 [Internet]. [cited 2017 Jul 13]. Available from:
http://www.thaincd.com/document/file/info/non-communicable-disease/
21

20.ราม รังสินธุ,์ ปิยทัศน์ ทัศนาวิวฒ


ั น์ , เครือข่ายวิจยั กลุ่มสถาบันแพทยศาสตร์แห่งประเทศไทย. การ
ประเมินผลการดูแลผูป้ ว่ ยโรคเบาหวานชนิดที่ 2 และโรคความดันโลหิตสูงของโรงพยาบาลในสังกัด
กระทรวงสาธารณสุขและโรงพยาบาลในพืน้ ทีก่ รุงเทพมหานครปี 2558. กรุงเทพฯ. สนับสนุ นโดย
สำนักงานหลักประกันสุขภาพแห่งชาติ (สปสช.).

21.Ihab Hajjar, MD, MS; Theodore A. Kotchen, MD. Trends in Prevalence, Awareness,
Treatment, and Control of Hypertension in the United States, 1988-2000.JAMA.
2003;290(2):199-206
22

22. Vicki L. Burt, Paul Whelton, Edward J. Variables N (%)


Roccella, Clarice Brown, Jeffrey A. Cutler, Diabetic medication
None 12 (8.2)
Millicent Higgins, Michael J. Horan, Darwin Biguanides 122 (83.6)
Labarthe. Prevalence of Hypertension in the Sulfonylurea 66 (45.2)
Thiazolidinodione 31 (21.2)
Table 2 Clinical characteristics of hypertensive patients’ treatment Alpha-glucosidase inhibitor 0 (0)
Variables N (%) DDP-4 Inhibitor 3 (2.1)
Developed hypertension time (years) Insulin 13 (9)
<5 59 (15) Other Variables 0 (0) N (%)
5-15 219 (56) Occupation
Total 247
> 15 28 (7) DyslipidemicNone
medication 155 (39.4)
No data 87 (22) NoneFarmer/Agriculturalist 38 (15) 69 (17.6)
Total 393 (100) StatinGovernment official 209 (82.6)42 (10.7)
Follow up episodes in 2016 (times) Fisherman
Fibrates 6 (2.4) 2 (0.5)
1 1 Demographic characteristics of hypertensive
Table 13 (3.3) patients NiacinBusiness owner 0 (0) 47 (12.0)
2 31 (7.8) OtherCompany employee 0 (0) 2 (0.5)
Variables N (%)
3 82 (20.8) Total Laborer 253 70 (17.8)
Sex
4
Male
150 (38.1)
158 (40) ComorbidityState enterprise officer 6 (1.5)
5
Female
59 (15.0)
235 (60) NoneTotal 33 (8.4) (100)
393
6 28 (7.1) Diabetes mellitus
Total 393 (100) Healthtype
insurance
7 15 (3.8) 1 4 (1)
Age
8 (years) 9 (2.3) type 2 coverage scheme
Universal 142 (36.1)130 (33.1)
35-39 3 (0.76) Social security scheme
9
40-44
3 (0.7)
5 (1.27)
Hyperlipidemia 253 (64.4) 14 (3.6)
12 1 (0.55) CKD Government enterprise officer 5 (1.3) 199 (50.6)
45-49 15 (3.8)
13 1 (0.55) OtherState enterprise officer 43 (11) 13 (3.3)
50-54 23 (6.36) Pay cash
Total
55-59
393 (100) Total 480 37 (9.4)
Median (Q1-Q3) 4 (3-5)(15)
59 Total 393 (100)
60-64
Hypertensive medication 80 (21.1) Smoking
None 65-69 3681(9.2)
(21.6) Current smoker 16 (4.1)
ARB70-74 8460(21.4)
(15.3) Former smoker 31 (7.9)
CCB 75-79 45 (11.5)
196 (49.9) Non-smoker 83 (21.1)
≥ 80
Diuretics 22
107 (27.2)(5.6) No data 263 (66.9)
Total
Beta blocker 393
88 (22.4)(100) Total 393 (100)
ACE inhibitors 112 (28.5) Alcohol drinking
AlphaMean
blocker
± SD 10
65.28(2.5)± 9.88 Current alcohol drinker 21 (5.3)
Other
Body weight (kg) 0 (0) Former alcohol drinker 16 (4.1)
TotalMedian (Q1-Q3) 636
64.5 (55.8-72.78) No alcohol drinking 39 (9.9)
Body Height (cm)µ No data 317 (80.7)
Median (Q1-Q3) 156.9 (152-165) Total 393 (100)
BMI (kg/m )2µ Traditional herbal usage
< 18.5 (underweight) 6 (1.5) Used 6 (2)
18.5-22.9 (normal) 85 (21.6) Not used 17 (4)
23.0-24.9 (overweight) 61 (15.5) No data 370 (94)
25.0-34.9 (obesity grade 1) 150 (38.2) Total 393 (100)
35.0-39.9 (obesity grade 2) 21 (5.3) US Adult Population Results From the
≥ 40 (obesity grade 3) 1 (0.3)
No data 69 (17.6) Third National Health and Nutrition
Total 393 (100)
Examination Survey, 1988-1991.
Median (Q1-Q3) 25.3 (22.65-28.78)
Religion Hypertension 1995;25:305-31
Buddhism 370 (94.1)
Christianity 1 (0.3) Appendix A
Islamism 18 (4.6)
Hinduism 2 (0.5)
No data 2 (0.5)
Total 393 (100)
23

Table 3 Indicators of standard hypertensive care


Indicators N (%)
Physical examination in 2016 393 (100)
Not performed 71 (18.1)
Performed 322 (81.9)
Fundoscopic examination by ophthalmoscope 11 (2.8)
Heart sound and/or PMI 288 (73.8)
Pitting edema 265 (67.8)
Neurological examination (motor power and/or sensation 57 (14.5)
and/or cranial nerve)
Peripheral arteries (Pulse palpation and/or carotid bruit) 115 (29.2)

Performed laboratory tests in 2016 393 (100)


Completely performed all tests 33 (8.4)
Incompletely performed 335 (85.2)
Not performed any test 25 (6.4)
Type of laboratory tests in 2016 N (%) Median
(Q1-Q3)
24

Fasting plasma glucose 312 (79.4) 106 (96-127.2)


Electrolyte 247 (62.8)
Renal function
Serum creatinine 336 (85.4)
eGFR 336 (85.4)
Lipid profile
HDL-C 307 (78.1) 53.5 (45.1-62.05)
LDL-C 354 (90.0) 116.1 (96.53-140.3)
Total cholesterol 354 (90.0) 179.5 (161-203)
Triglyceride 354 (90.0) 118 (91-162)
CBC 206 (52.4)
Albuminuria 137 (34.9)
< 30 99 (72.3)
30-300 34 (24.8)
> 300 4 (1.9)
EKG 117 (29.7)
26

Table 4 Indicators of hypertensive treatment result


Indicators N (%)
Last visit blood pressure in 2016
Controlled blood pressure 204 (51.9)
Uncontrolled blood pressure 189 (48.1)
SBP 391
Median (Q1-Q3) 133 (125-140)
DBP 391
Mean ± SD 75.8 ± 12.1

Complication 106 (27)


None 287 (73)
Cerebrovascular accident 19 (18)
Cerebral hemorrhage 1 (5.3)
Cerebral infarction 3 (15.8)
Stroke 10 (52.6)
Pre-cerebral or cerebral occlusion/stenosis of arteries 2 (10.5)
Cerebral aneurysm, non-ruptured 1 (5.3)
Cerebral atherosclerosis 0 (0)
Transient cerebral ischemic attack 2 (10.5)
Cardiovascular disease 27 (25)
Angina pectoris 5 (18.6)
Acute myocardial infarction 4 (14.8)
Chronic ischemic heart disease, Atherosclerosis 3 (11.1)
heart disease 3 (11.1)
Cardiomyopathy 1 (3.7)
Atrial fibrillation and flutter 2 (7.4)
Congestive heart failure 0 (0)
Left ventricular hypertrophy 9 (33.3)
Coronary revascularization 0 (0)
Renal complication 74 (57)
eGFR < 60 mL/min/1.73 m2 33 (44.6)
Serum creatinine > 1.5 mg/dL in males, > 1.4 mg/dL 10 (13.5)
in females
Microalbuminuria 31 (41.9)
Macroalbuminuria 11 (14.9)
27

Table 5 Univariate analysis of the factors affecting blood pressure control in hypertensive patients
Variables Controlled Uncontrolled OR 95% C.I. P-value
BP BP ***
(n=204) (n=189)
Male, n (%) 80 (39.2) 78 (41.2) 1.1 0.7-1.6 0.67
Female, n (%) 124 (60.8) 111 (58.8) 1
Age (years), n (%)
<50 8 (4.3) 15 (7.5) 1
50-59 42 (20.3) 40 (21.5) 0.6 0.24-1.57 0.31
60-69 90 (44.0) 71 (37.6) 0.5 0.20-1.21 0.12
70-79 55 (27.1) 50 (26.3) 0.6 0.22-1.41 0.22
≥80 9 (4.3) 13 (7.1) 0.9 0.28-3.06 0.9
BMI (kg/m2)µ
<18.5 5 (2.9) 1 (0.7) 1
18.5-22.9 49 (28.7) 36 (23.5) 3.7 0.4-32.8 0.24
23-24.9 35 (20.5) 26 (17.0) 3.7 0.4-33.7 0.24
25-34.9 78 (45.6) 72 (47.1) 4.6 0.5-40.5 0.17
35-39.9 4 (2.3) 17 (11.1) 2.1 0.6-236 0.01
≥40.0 0 (0) 1 (0.7) 1.1 0-infinity 0.99
Developed hypertension time (years)
<5 68 (33.3) 78 (41.2) 1
5-15 125 (59.8) 94 (49.7) 0.8 0.5-1.2 0.21
>15 11 (6.9) 17 (9.1) 1.6 0.7-3.7 0.25
Follow up episodes (times)
≥6 29 (14.2) 28 (14.8) 1
4-5 116 (56.8) 93 (49.2) 0.8 0.4-1.4 0.41
≤3 59 (29.0) 65 (36.0) 1.1 0.6-2.1 0.68
Type of drugs
0 25 (12.2) 12 (6.3) 1
1 87 (42.6) 87 (46.0) 2.1 0.9-4.4 0.06
2 76 (37.2) 58 (30.6) 1.6 0.7-3.4 0.23
3 14 (6.8) 22 (11.6) 3.3 1.3-8.6 0.02
4 2 (1.2) 10 (5.5) 10.4 1.9-55.2 0.006##
Diabetes mellitus 41 (25.0) 105 (55.5) 5.2 3.4-8.2 <0.001
Hyperlipidemia 139 (68.1) 114 (60.3) 0.8 0.5-1.2 0.31
CKD 3 (1.5) 2 (1.0) 0.8 0.1-4.5 0.75
Cerebrovascular accident 24 (11.8) 15 (8.0) 0.6 0.3-1.2 0.12
Cardiovascular disease 25 (12.3) 10 (5.3) 0.4 0.2-0.9 0.03
Renal complication 45 (22.0) 38 (20.1) 0.9 0.6-1.5 0.8
Fasting plasma glucose (mg/dL) 162 150
<100 76 (46.9) 35 (23.3) 1
100-125 66 (40.7) 54 (36.0) 1.8 1.0-3.0 0.03
≥126 20 (12.4) 61 (40.7) 6.6 3.5-12.6 <0.001
Cholesterol (mg/dL)
<200 129 (69.7) 121 (71.6) 1
200-239 43 (23.2) 32 (18.9) 0.8 0.5-1.3 0.38
≥240 13 (7.1) 16 (9.5) 1.3 0.6-2.8 0.49
HDL-C (mg/dL)
>60 55 (33.5) 42 (29.4) 1
40-60 92 (56.1) 76 (53.1) 1.1 0.7-1.7 0.75
<40 17 (10.4) 25 (17.5) 1.9 0.9-4.0 0.08
28

LDL-C (mg/dL)
<100 57 (30.8) 52 (30.8) 1
100-199 125 (67.6) 109 (64.5) 1 0.6-1.5 0.84
>=200 3 (1.6) 8 (4.7) 2.9 0.7-11.6 0.12
Triglyceride (mg/dL)
<150 129 (70.1) 115 (67.6) 1
150-199 36 (19.6) 37 (21.8) 1.1 0.7-1.9 0.59
200-499 18 (9.8) 18 (10.6) 1.1 0.6-2.3 0.74
≥500 1 (0.5) 0 (0) 1.4 - -
Albuminuria (mg albumin/g Cr)
<30 52 (75.4) 47 (69.1) 1
30-300 15 (21.7) 19 (27.9) 1.4 0.6-3.1 0.40
>300 2 (2.9) 2 (3.0) 1.1 0.1-8.2 0.90

Gantt chart
Practical 11-17 Jul 2017 18-24 Jul 2017 25 -31 Jul 1-7 Aug 2017 8-14 Aug 15-22 Aug 2017
2017 2017

1. Preparation
1.1. Review literature
1.2. Establish methodology
1.3. Establish research proposal
1.4. Send ethics committee
2. Collection the data
2.1. Send the letter with EC official
for find HN of hypertensive
patients in 2016
2.2. Collect the data in Microsoft
Excel
3. Process and analysis the data
3.1. Data analysis
3.2. Data conclusion

4. Report
4.1. Prepare report
4.2. Present research

Appendix B

บันทึกข้อความ
ส่วนงาน............................................................................... โทร...................................................................
ที่ ……………/............................................ วันที่..............................................................................
29

เรื่อง ขอเสนอโครงการวิจยั ประเภท Retrospective study/Medical record review/Case report เพือ่ ขอรับการ
พิจารณาจริยธรรมการวิจยั ในมนุษย์

เรียน ประธานคณะกรรมการพิจารณาจริยธรรมการวิจยั ในมนุษย์ คณะแพทยศาสตร์ มหาวิทยาลัยสงขลานครินทร์

ข้าพเจ้า นายณัฐพล กิจธารทอง สังกัด ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะ


แพทยศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ขอเสนอโครงการวิจยั เรือ่ ง การประเมินคุณภาพการจัดการผูป้ ว่ ยโรค
ความดันโลหิตสูงในหน่วยบริการปฐมภูมโิ รงพยาบาลสงขลานครินทร์ (Assessment on quality care management of
hypertension in Primary Care Unit, Songklanagarind hospital) เพือ่ ขอรับการพิจารณาจริยธรรมการวิจยั ในมนุษย์
และได้แนบเอกสารประกอบการพิจารณา ดังนี้
1. หลักฐานการลงทะเบียนในฐานข้อมูล RMIS 1 ชุด
2. แบบเสนอเพือ่ ขอรับการพิจารณาจริยธรรมการวิจยั ในมนุษย์ (submission form AP-007) 3 ชุด
3. โครงร่างการวิจยั ฉบับสมบูรณ์ (protocol) 3 ชุด
4. ประวัตแิ ละความรูค้ วามชำนาญของนักวิจยั ภาษาไทยหรือภาษาอังกฤษ 3 ชุด
5. หลักฐานการอบรมจริยธรรมการวิจยั ในมนุษย์ของนักวิจยั ทุกคน (ไม่เกิน 2 ปี) 3 ชุด
6. เครือ่ งมือการวิจยั ได้แก่ แบบสอบถาม แบบเก็บข้อมูล 3 ชุด
7. แผ่นบรรจุขอ้ มูลโครงการวิจยั ทัง้ หมด (CD/DVD) 1 แผ่น
จึงเรียนมาเพือ่ โปรดพิจารณา

ลงชือ่ …………………………………………… ลงชือ่ ……………………………………………


(แพทย์หญิงรัตนาภรณ์ ชูทอง) (นายณัฐพล กิจธารทอง)
อาจารย์ทป่ี รึกษาโครงการ หัวหน้าโครงการวิจยั
กรณีหวั หน้าโครงการวิจยั เป็ นนักศึกษา

ลงชือ่ ………………………………….………….……………
(ผศ.นพ.กฤษณะ สุวรรณภูม)ิ
หัวหน้าภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน
30

แบบเสนอเพื่อขอรับการพิ จารณาด้านจริ ยธรรมการวิ จยั ในมนุษย์


สำหรับโครงการที่ใช้วิธีรวบรวมข้อมูลที่มีอยู่เดิ ม
Submission Form for Retrospective Study/Medical Record Review/Case Report
1. ชื่อโครงการวิ จยั การประเมินคุณภาพการจัดการผูป้ ว่ ยโรคความดันโลหิตสูงในหน่วยบริการปฐมภูมิ โรงพยาบาล
สงขลานครินทร์ (Assessment on quality care management of hypertension in Primary Care Unit,
Songklanagarind hospital)

2. หัวหน้ าโครงการวิ จยั และหน่ วยงานที่สงั กัด


ชือ่ -สกุล นายณัฐพล กิจธารทอง (Mr. Nuttaphon Kittarnthong)
หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์
3. ผูร้ ่วมโครงการวิ จยั และหน่ วยงานที่สงั กัด
1.1. ชือ่ -สกุล นายณฐพล รัตนมูสกิ (Mr. Natapon Rattanamusik)
หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.2. ชือ่ -สกุล นางสาวบัณฑิตา บุญมาศ (Ms. Banthita Boonmart)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.3. ชือ่ -สกุล นายภัททนพ เงาดุลยวัต (Mr. Pattanop Ngaodulyawat)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.4. ชือ่ -สกุล นายปรมินทร์ แก่นยะกูล (Mr. Poramin Kanyakool)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.5. ชือ่ -สกุล นางสาวสมจินตนา โภชนาธาร (Ms. Somjintana Phochanatarn)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.6. ชือ่ -สกุล นางสาวทิพญาดา ศรีวชิรวัฒน์ (Ms. Tipyada Sriwachirawat)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

1.7. ชือ่ -สกุล นายวุฒพิ งศ์ พุทธสอน (Mr. Wuttiphong Putthasorn)


หน่วยงาน ภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน คณะแพทยศาสตร์ มหาวิทยาลัยสงขลา
นครินทร์

4. โครงการโดยสรุป (Executive summary) ความยาวไม่เกิ น 2 หน้ า A4


 วัตถุประสงค์
31

วัตถุประสงค์หลัก 1. เพือ่ ศึกษาคุณภาพการจัดการผูป้ ว่ ยโรคความดันโลหิตสูงในหน่วยบริการปฐมภูมิ


โรงพยาบาลสงขลานครินทร์
2. เพือ่ ศึกษาปจั จัยทีม่ ผี ลต่อการควบคุมระดับความดันโลหิต
 รวบรวมข้อมูล
เก็บรวบรวมข้อมูลของผูป้ ว่ ยทีไ่ ด้รบั การวินิจฉัยว่าเป็ นโรคความดันโลหิตสูงปฐมภูมใิ นหน่วยบริการ
ปฐมภูมิ โรงพยาบาลสงขลานครินทร์ทม่ี าเข้ารับการรักษากับแพทย์ทโ่ี รงพยาบาลสงขลานครินทร์ในช่วง
1 ปี (1 มกราคม – 31 ธันวาคม พ.ศ. 2559) จากฐานข้อมูลเวชระเบียนโรงพยาบาลสงขลานครินทร์ โดย
เก็บข้อมูลตามแบบกรอกข้อมูลทีส่ ร้างไว้
 ช่วงระยะเวลาทีต่ อ้ งการรวบรวมข้อมูล
1 ปี (1 มกราคม – 31 ธันวาคม พ.ศ. 2559)
 หัวข้อของข้อมูลทีจ่ ะนำมาใช้ในการวิจยั มีอะไรบ้าง
ข้อมูลของผูป้ ว่ ยทีไ่ ด้รบั การวินิจฉัยว่าเป็ นโรคความดันโลหิตสูงปฐมภูมใิ นหน่วยบริการปฐมภูมิ โรง
พยาบาลสงขลานครินทร์ทม่ี าเข้ารับการรักษากับแพทย์ทโ่ี รงพยาบาลสงขลานครินทร์ในช่วง 1 ปี
(1 มกราคม – 31 ธันวาคม พ.ศ. 2559) จากฐานข้อมูลเวชระเบียนโรงพยาบาลสงขลานครินทร์ โดยเก็บ
ข้อมูลตัวชีว้ ดั ทีบ่ ่งบอกคุณภาพการจัดการผูป้ ว่ ยโรคความดันโลหิตสูง และปจั จัยทีส่ ง่ ผลต่อการควบคุม
ระดับความดันโลหิต ประกอบด้วย อายุ เพศ น้ำหนัก ส่วนสูง ศาสนา สิทธิ ์การรักษา อาชีพ โรคประจำ
ตัวร่วม ประวัตกิ ารดืม่ สุรา สูบบุหรี่ ยาประจำตัว ภาวะแทรกซ้อนทางหลอดเลือด ระบบไหลเวียนโลหิต
และไต การตรวจร่างกาย การตรวจทางห้องปฏิบตั กิ ารประจำปี
 การคำนวณขนาดตัวอย่างเพื่อตอบคำถามการวิจยั
คำนวณขนาดตัวอย่างในวัตถุประสงค์หลักข้อทีห่ นึ่ง โดยใช้สตู ร infinite population formula(W. G.
Cochran) ได้จำนวนขนาดตัวอย่างเท่ากับ 384 คน
คำนวณขนาดตัวอย่างในวัตถุประสงค์หลักข้อทีส่ อง ด้วยวิธี logistic regression โดยใช้โปรแกรม G
power version 3.1.9.2 ซึง่ ใช้สตู ร Hsieh et al. formula ในการคำนวณ ได้จำนวนขนาดตัวอย่างเท่ากับ
218 คน โดยสรุปแล้ว จึงใช้ขนาดตัวอย่างในการวิจยั นี้ เท่ากับ 400 คน
 แผนการวิเคราะห์ขอ้ มูล การนำเสนอข้อมูล การตีพมิ พ์
นำข้อมูลคุณภาพการจัดการผูป้ ว่ ยโรคความดันโลหิตสูงในหน่วยบริการปฐมภูมิ โรงพยาบาลสงขลา
นครินทร์ มาวิเคราะห์ขอ้ มูลสถิตเิ ชิงพรรณนาและสถิตเิ ชิงวิเคราะห์ ด้วยโปรแกรม R version 3.4.1 และ
Microsoft Excel 2013 เพือ่ นำเสนอข้อมูล ร้อยละ(percent) ของ และนำเสนอข้อมูลในรูปแบบรูปเล่ม
รายงานวิจยั และการนำเสนอด้วยโปรแกรม Microsoft PowerPoint 2013

5. ประเด็นทางจริ ยธรรมการวิ จยั


ข้อมูลทีไ่ ด้จากระบบฐานข้อมูลเวชระเบียนโรงพยาบาลสงขลานครินทร์จะถูกเก็บเป็ นความลับ
สำหรับผูเ้ ข้าร่วม ผูว้ จิ ยั และผูทำ
้ การวิเคราะห์ขอ้ มูล และใช้สำหรับการวิจยั นี้เท่านัน้ มีการควบคุมการเก็บรักษา
และการแจกจ่ายข้อมูลส่วนบุคคล โดยมีคำชีแ้ จงอย่างชัดเจนว่าจะนำเสนอเป็ นข้อมูลโดยรวมจากการวิจยั
เท่านัน้ ไม่เผยแพร่ต่อสาธารณะเป็ นรายบุคคล ไม่มกี ารเปิดเผยข้อมูลทีร่ ะบุตวั ตน มีการใช้ตวั เลขสมมติเพือ่ เป็ น
รหัสแทนผูป้ ว่ ยแต่ละคน
ข้าพเจ้าขอรับรองว่าข้อความข้างต้นเป็ นความจริง และเข้าใจความหมายโดยชัดเจนทุกประการ

ลงชือ่ ..........................................................
( นายณัฐพล กิจธารทอง )
หัวหน้าโครงการวิจยั
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ลงชือ่ ..................................................... ลงชือ่ ..........................................................


(นายณฐพล รัตนมูสกิ ) (นายภัททนพ เงาดุลยวัต)
ผูร้ ว่ มโครงการวิจยั ผูร้ ว่ มโครงการวิจยั

ลงชือ่ .......................................................... ลงชือ่ ..........................................................


( นางสาวบัณฑิตา บุญมาศ ) (นางสาวสมจินตนา โภชนาธาร)
ผูร้ ว่ มโครงการวิจยั ผูร้ ว่ มโครงการวิจยั

ลงชือ่ .......................................................... ลงชือ่ ..........................................................


( นายปรมินทร์ แก่นยะกูล ) (นายวุฒพิ งศ์ พุทธสอน)
ผูร้ ว่ มโครงการวิจยั ผูร้ ว่ มโครงการวิจยั

ลงชือ่ ..........................................................
( นางสาวทิพญาดา ศรีวชิรวัฒน์ )
ผูร้ ว่ มโครงการวิจยั

โครงการวิ จยั นี้ ได้ผา่ นความเห็นชอบ


จากหน่ วยงานต้นสังกัดแล้ว

ลงชือ่ ………………………………….………….……………
(ผศ.นพ.กฤษณะ สุวรรณภูม)ิ
หัวหน้าภาควิชาเวชศาสตร์ครอบครัวและเวชศาสตร์ป้องกัน
33
34
35

ID Number [ ] [ ] [ ] [ ]
The data extraction form for assessment on quality care management of
hypertension in Primary Care Unit, Songklanagarind hospital
Sex  Male  Female
Age ______years old
Year when diagnosed hypertension__________, Developed hypertension for_____years
Hypertension follow up in 2016_______times
Last weight in 2016 _____kg No data
Height ______cm. No data
BMI _____kg/m 2

Religion Buddhism Christianity Islamism Hinduism


No data Other…………………………
Occupation None Farmer/Agriculturalist Government official
Fisherman Monk/Nun Business owner
Laborer State enterprise officer Company employee
Student No data Other…………………………
Health insurance Universal Coverage Scheme Social Security Scheme
Government Enterprise Officer State Enterprise Officer
Pay cash Other…………………………
Past History
Smoking Current smoker Former smoker
Non-smoker No data
Alcohol drinking Current alcohol drinker Former alcohol drinker
No alcohol drinking No data
Traditional herbal usage Yes No No data

ID Number [ ] [ ] [ ] [ ]
Current medication
1. Hypertensive medication None ARB CCB Diuretics
(can choose more than one) Beta blocker ACE inhibitors
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Alpha blocker Other…………………


2. Diabetic medication None Biguanides Sulfonylurea
(can choose more than one) Thiazolidinedione
Alpha-glucosidase Inhibitor (α-Gl) DDP-4
Inhibitor
Insulin Other ……………….
3. Dyslipidemic medication None Statin Fibrates Niacin Other………
Co-morbidity Diabetes mellitus Type 1(IDDM) E10 Type 2(NIDDM) E11
Hyperlipidemia E785
CKD stage 1-5 N181-N185, N189
Other……………………..
Complication Cerebrovascular accident (CVA)
No Yes; please identify
1. Cerebral hemorrhage I60-I62
2. Cerebral infarction I63
3. Stroke I64
4. Pre-cerebral or cerebral occlusion/stenosis of arteries I65-I66
5. Cerebral aneurysm, non-ruptured I671
6. Cerebral atherosclerosis I672
7. Transient cerebral ischemic attack G45
Cardiovascular disease (CVD)
No Yes; please identify
1. Angina pectoris I20

ID Number [ ] [ ] [ ] [ ]

2. Acute myocardial infarction I21-22


3. Chronic ischemic heart disease, Atherosclerosis
Heart disease I25
4. Cardiomyopathy I42
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5. Atrial fibrillation and flutter I48


6. Congestive heart failure I500
7. Left ventricular hypertrophy I517
8. Coronary revascularization
Renal complication (From lab results)
No Yes; please identify
eGFR< 60 mL/min/1.73m2
Serum creatinine >1.5 mg/dL in males, >1.4 mg/dL in females
Microalbuminuria
Macroalbuminuria

Blood pressure measurement


Last visit date ____/____/2016 BP level____/____mmHg
Physical examination in 2016
Fundoscopic examination by ophthalmoscope  Yes  No
Heart sound and/or PMI  Yes  No
Pitting edema  Yes  No
Neurological examination (motor power and/or sensation  Yes  No
and/or cranial nerve)
Peripheral arteries (Pulse palpation and/or carotid bruit)  Yes  No

ID Number [ ] [ ] [ ] [ ]

Last initial laboratory tests in 2016


1. Fasting plasma glucose  No Yes Result:_____mg/dL Date ____/____/2016
2. Electrolyte  No Yes Date ____/____/2016
3. Renal function
a) Serum creatinine  No Yes Date ____/____/2016
b) eGFR  No Yes Date ____/____/2016
4. Lipid profile
a) HDL-C  NoYes Result:________mg/dL Date ____/____/2016
b) LDL-C  NoYes Result:________mg/dL Date ____/____/2016
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c) Total cholesterol  NoYes Result:________mg/dL Date ____/____/2016


d)Triglyceride  NoYes Result:________mg/dL Date ____/____/2016
5. CBC  No Yes Date ____/____/2016

6. Albuminuria  No Yes


Result: <30 30-300 >300 mg/L Date ____/____/2016

7. EKG  No Yes Date ____/____/2016

Variable definition
1. Age: ให้ดจู ากเวชระเบียนเป็นสำคัญ
2. Weight: ให้กรอกข้อมูลล่าสุดในเวชระเบียน แต่ตอ้ งอยูใ่ นช่วง 1 มกราคม – 31 ธันวาคม 2559 กรณี
ไม่มขี อ้ มูลบันทึกในเวชระเบียนให้เลือกตอบ “No data”
3. Height: ให้ดจู ากเวชระเบียนเป็นสำคัญ หรือประมาณจากรูปในบัตรประชาชน หากไม่มขี อ้ มูลให้เลือก
ตอบ “No data”
4. BMI: คำนวณจากน้ำหนัก (หน่วยกิโลกรัม) หารด้วยส่วนสูง (หน่วยเมตร) กำลังสอง
BMI< 18.5: น้ำหนักตัวน้อย (low weight)
BMI 18.5-22.9: ปกติ (normal)
BMI 23.0-24.9: น้ำหนักเกิน (over weight)
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BMI 25.0-29.9: เริม่ อ้วน (pre-obesity)


BMI ≥ 30.0: โรคอ้วน (obesity)
5. Occupation: ให้เลือกตอบอาชีพปจั จุบนั เพียงข้อเดียว กรณีไม่มขี อ้ มูลบันทึกในเวชระเบียนให้เลือก
ตอบ “No data”
6. Health insurance: ให้ดจู ากเวชระเบียนเป็ นสำคัญ
7. Smoking: การสูบบุหรีห่ มายถึง การสูบมวนยาเส้นใบจากห่อยาเส้น การสูบไปป์ หรือวิธกี ารใดๆ ทีม่ ี
การเผาไหม้ยาเส้นและมวนยาสูบ โดยไม่รวมการเหนียดยาเส้นในช่องปาก
Current smoker: หมายถึง ผูท้ เ่ี คยสูบบุหรีม่ าอย่างน้อย 100 มวน และยังคงสูบอยูใ่ นช่วง 28
วัน (1 เดือน) ทีผ่ า่ นมา
Former smoker: หมายถึง ผูท้ เ่ี คยสูบบุหรีม่ ามากกว่า 100 มวน แต่หยุดสูบแล้วอย่างน้อย 28
วัน (1 เดือน)
Non-smoker: หมายถึง ผูท้ ส่ี บู บุหรีม่ าไม่เกิน 100 มวน และปจั จุบนั ไม่ได้สบู แล้ว
8. Alcohol drinking
Current alcohol drinker: หมายถึง ผูท้ เ่ี คยดืม่ แอลกอฮอล์มาอย่างน้อย 12 ดืม่ มาตรฐาน
(Standard drink) และอย่างน้อย 1 ดืม่ มาตรฐานในช่วงปี ทผ่ี า่ นมา
Former alcohol drinker: หมายถึง ผูท้ เ่ี คยดืม่ แอลกอฮอล์มาอย่างน้อย 12 ดืม่ มาตรฐาน
(Standard drink) และไม่ได้ดม่ื แอลกอฮอล์เลยในช่วงปี ทผ่ี า่ นมา
หมายเหตุ : 1 ดืม่ มาตรฐาน (Standard drink) หมายถึง เครือ่ งดืม่ ทีม่ แี อลกอฮอล์ 10 กรัม
ตัวอย่างเครือ่ งดืม่ แอลกอฮอล์ทน่ี บั เป็น 1 ดืม่ มาตรฐาน ได้แก่
- เบียร์ 5% จำนวน 1 กระป๋อง (375 mL)
- ไวน์แดง 13% จำนวน 1 แก้ว (100 mL)
- สุรา 40% จำนวน 3 ฝา (30 mL)
9. Hypertensive medication ประกอบด้วยกลุ่มยาและชือ่ ยา ดังต่อไปนี้
- CCB: Amlodipine besylate, Diltiazem hydrochloride, Felodipine, Isradipine, Nicardipine,
Nifedipine, Nisodipine, Verapamil hydrochloride
- ACEI: Benazepril hydrochloride, Captopril, Enalapril maleate, Fosinopril sodium,
Lisinopril, Moexipril, Quinapril hydrochloride, Ramipril, Trandolapril
- ARB: Candesartan, Irbesarten, Losartan potassium, Valsartan
- Diuretics: Chlorthalidone, Hydrochlorothiazide, Indapamide, Metolazone, Furosemide,
Amiloride hydrochloride, Spironolactone, Triamterene
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- Beta-blocker: Acebutolol, Atenolol, Betaxolol, Bisoprolol fumarate, Carteolol


hydrochloride, Metoprolol tartrate, Metoprolol succinate, Nadolol, Penbutolol sulfate, Pindolol
Propranolol hydrochloride, Timolol maleate
10. Diabetic medication ประกอบด้วยกลุ่มยาและชือ่ ยา ดังต่อไปนี้
- Biguanides: Metformin, Buformin และ Phenformin
- Sulfonylureas: Chlorpopamide, Tobutamine, Glimepiride, Glipizide, Glyburide
- Glitazones/Thiazolidinediones: pioglitazone,rosiglitazone
- DPP-4 inhibitors: Linagliptin, Saxagliptin, Sitagliptin, Alogliptin
- Alpha-glucosidase inhibitor (α-Gl): Acarbose, Miglitol และ Voglibose
- Insulin: ยาฉีด Insulin ทุกประเภท
11. Dyslipidemicmedication ประกอบด้วยกลุ่มยาและชือ่ ยา ดังต่อไปนี้
- HMG-CoA reductase inhibitor: Lovastatin, Pravastatin, Simvastatin, Atorvastatin,
Rosuvastatin
- Fibrate: Gemfibrozil, Clofibrate, Benzafibrate, Fenofibrate
- Niacin
12. Comorbidity: โรคร่วมอื่นๆ หมายถึง โรคทีเ่ ป็ นอยูร่ ว่ มกับโรคความดันโลหิตสูง และได้รบั การ
วินิจฉัยก่อนหรือพร้อมกับความดันโลหิตสูง
12.1. Diabetes mellitus: วินิจฉัยเมือ่ Fasting Plasma Glucose มากกว่า 126 mg/dL หรือ
Hemoglobin A1c มากกว่าหรือเท่ากับ 6.5% หรือ 75 g Oral Glucose Tolerance Test มากกว่าหรือ
เท่ากับ 200 mg/dL หรือมีอาการของโรคเบาหวานร่วมกับมีค่า Random Plasma Glucose มากกว่า
หรือเท่ากับ 200 mg/dL
12.2. Hyperlipidemia: เมือ่ มีคา่ ใดค่าหนึ่งผิดปกติใน lipid profile
13. Complication of hypertension: เกิดหลังจากได้รบั การวินิจฉัยความดันโลหิตสูง
13.1. Cerebrovascular accident (CVA): กลุ่มอาการทีเ่ กิดจากการสูญเสียหน้าทีข่ องสมอง
(Neurological deficit) ทีเ่ กิดขึน้ ทันทีทนั ใด และมีสาเหตุจากความผิดปกติของหลอดเลือดสมอง
(vascular origin) เท่านัน้ ได้แก่ เลือดออกในสมอง (Cerebral hemorrhage), โรคเนื้อสมองตายจากการ
ขาดเลือด (Cerebral infarction), อัมพาตเฉียบพลัน (Stroke) โดยไม่ระบุว่าเกิดจากเลือดออกหรือเนื้อ
สมองตาย, การอุดตันและตีบของหลอดเลือดแดง ทัง้ ก่อนถึงสมองหรือในสมอง (Pre-cerebral or
cerebral occlusion/stenosis of arteries), หลอดเลือดสมองโปง่ พอง ไม่แตก (Cerebral aneurysm
without rupture), หลอดเลือดแดงของสมองตีบแข็ง (Cerebral atherosclerosis) และ ภาวการณ์อุดตัน
ของหลอดเลือดสมองไม่เกิน 24 ชัวโมงแล้ ่ วกลับเป็ นปกติ (Transient ischemic attack; TIA)
13.2. Cardiovascular disease (CVD):ได้แก่ อาการเจ็บแน่ นหน้าอกจากหลอดเลือดหัวใจ
ตีบ(Angina pectoris), กล้ามเนื้อหัวใจตายเฉียบพลัน (Acute myocardial infarction), กล้ามเนื้อหัวใจ
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ขาดเลือดเรือ้ รัง (Chronic ischemic heart disease and atherosclerotic heart disease), โรคกล้ามเนื้อ
หัวใจขาดเลือดผิดปกติ(Cardiomyopathy), ภาวะหัวใจเต้นผิดจังหวะชนิดสันพลิ ่ ว้ (Atrial fibrillation and
flutter), ภาวะหัวใจล้มเหลว (Congestive heart failure), ภาวะหัวใจห้องล่างซ้ายโต (Left ventricular
hypertrophy) และได้รบั การขยายหลอดเลือด (Coronary revascularization)
13.3. Renal complication: ได้แก่ eGFR<60 ml/min/1.73m2, serum creatinine>1.5
mg/dL ในผูช้ าย และ >1.4 mg/dL ในผูห้ ญิง, พบ microalbuminuria (albuminuria 30-300 mg/L) หรือ
พบ macroalbuminuria (albuminuria > 300 mg/L)
14. Physical examination ต้องมีการตรวจร่างกายอย่างน้อย 1 ครัง้ ในปี 2559
14.1. Blood pressure: ให้กรอกข้อมูลล่าสุดทีม่ าติดตามการรักษาโรคความดันโลหิตสูง แต่ตอ้ ง
อยูใ่ นช่วง 1 มกราคม – 31 ธันวาคม 2559 และระบุวนั เดือนปี ทม่ี าติดตามการรักษา โดยยึดจากค่าทีว่ ดั
โดยพยาบาลใน vital signs
14.2. Fundoscopic examination ตรวจโดยใช้ ophthalmoscope
14.3. Heart sound and/or PMI: มีการบันทึกในเวชระเบียนเรือ่ งการฟงั เสียงหัวใจและ/หรือ
คลำหาตำแหน่งทีม่ กี ารเต้นของหัวใจชัดเจนทีส่ ดุ
14.4. Pitting edema: มีการบันทึกในเวชระเบียนว่า พบหรือไม่พบการกดบุ๋มบนผิวหนัง
14.5. Neurological examination
- Motor power: มีการบันทึกในเวชระเบียนเรือ่ ง กำลังของกล้ามเนื้อ
- Sensation: มีการบันทึกในเวชระเบียนเรือ่ งการรับความรูส้ กึ
- Cranial nerve: มีการบันทึกในเวชระเบียน เรือ่ งการทำงานของเส้นประสาทสมองคูท่ ่ี
7 เป็ นอย่างน้อย
15. Laboratory: ให้กรอกข้อมูลล่าสุดทีม่ าติดตามการรักษา แต่ตอ้ งอยูใ่ นช่วง 1 มกราคม – 31 ธันวาคม
2559 และระบุวนั เดือนปีทเ่ี จาะเลือดตรวจด้วยสำหรับการเลือกตอบข้อ “No” จะหมายถึง การไม่ปรากฏ
ข้อมูลในเวชระเบียน
15.1. Fasting plasma glucose (ควรงดอาหารอย่างน้อย 8 ชัวโมงก่
่ อนการเจาะเลือด)
- ต้องเจาะผ่านหลอดเลือดดำ (Vein) เท่านัน้ (ไม่ใช่จากปลายนิ้ว)
- ต้องผ่านการตรวจด้วยเครื่องอัตโนมัติ
ทัง้ นี้ ไม่นบั รวมผลการตรวจหาระดับน้ำตาลทีเ่ จาะจากหลอดเลือดดำ แล้วมาหยดเลือด
ลงบน Dipstick
ให้กรอกข้อมูลล่าสุดทีม่ าติดตามการรักษา แต่ตอ้ งอยูใ่ นช่วง 1 มกราคม – 31 ธันวาคม 2559
และระบุวนั เดือนปีทเ่ี จาะเลือดตรวจด้วย กำหนดให้หน่วยเป็ น mg/dL
42

15.2. HDL-C: การเจาะเลือดตรวจ HDL Cholesterol กำหนดให้หน่ วยเป็ น mg/dL


15.3. LDL-C: การเจาะเลือดตรวจ LDL Cholesterol กำหนดให้หน่วยเป็ น mg/dL
15.4. TG: การเจาะเลือดตรวจ Triglyceride กำหนดให้หน่ วยเป็ น mg/dL
15.5. Total cholesterol: การเจาะเลือดตรวจ Total cholesterol กำหนดให้หน่วยเป็ น mg/dL
15.6. Albuminuria: ให้ระบุผลการตรวจ
15.7. Electrolyte: การเจาะเลือดตรวจค่า Na+, K+, Cl-, HCO-3 โดยใน 1 ปี ตอ้ งมีครบทัง้ 4 ตัว
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45
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