BENCHMARK ASSIGNMENT-EVALUATION OF CLINICAL PRACTICE GUIDELINE

Running head: EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 1

Evaluation of Hypertension Clinical Practice Guideline

Carla J. Aldaz, RN, BSN

United States University: FNP591

06/28/2021

Professor: Dr. Mary Boateng

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 2

Abstract

Hypertension is characterized by chronicly high blood pressure (BP) in a patient's circulatory

system. It is highly prevalent in the US, with data from the recent survey data from the CDC

suggesting that 49.6% of US adults aged 20 years and older had hypertension in 2017-2018,

while approximately 36,524 individuals died from the condition. Despite its increased

prevalence, its management has been controversial in the US, with the recommendation that

the threshold for blood pressure treatment being <130/80 mmHg highly criticized. This

underscores the possibility of concluding whether the available guideline is trustworthy.

Therefore, it needs further revision to direct the delivery of care to hypertension patients

effectively.

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 3

Evaluation Hypertension Clinical Practice Guideline

1. Healthcare Problem

i. Description of Hypertension

Hypertension is characterized by chronically high blood pressure (BP) in a patient's

circulatory system (Oparil et al., 2018). Majorly, blood pressure is expressed as the ratio of

systolic blood pressure and diastolic blood pressure. The threshold of BP that defines

hypertension depends on the measurement method used, including Office BP, Ambulatory

BP, and Home BP, among other relevant measurement techniques. In addition, various

etiologies potentially underlie the disease. For example, most hypertension patients are

characterized by a highly heterogeneous primary hypertension comprising a multi-factorial

gene-environment etiology (Taddei et al., 2018). Besides, the frequent occurrence of the

disease is also linked to a positive family history of hypertension. Ideally, research studies

have estimated the heritability of the disease to range between 35% and 50% (Oparil et al.,

2018). Thus, the condition is regarded as among the most common preventable

cardiovascular disease risk factor (Oparil et al., 2018; Taddei et al., 2018). The morbidity data

from the Centers for Disease Control and Prevention (CDC) provides that 49.6% of US adults

aged 20 years and older had hypertension in 2017-2018 while approximately 36,524

individuals died from the condition; providing an estimated 11.1 deaths per 100,000 people

died from essential hypertension and hypertensive disease (CDC, 2021).

ii. Epidemiology of Hypertension

The definition of hypertension varies depending on guidelines; for instance, Whelton

et al. (2018) note that the American guidelines provide the threshold for the diagnosis of the

disease to values of at least 80 mmHg during diastole and values of at least 130 mmHg

during systole (130/80 mmHg). On the contrary, the 2018 European guideline on

hypertension recommended a threshold of 140/90 mmHg (Taddei et al., 2018). Furthermore,

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 4

data provides that hypertension-related deaths occur due to ischemic heart disease, ischemic

stroke, and hemorrhagic stroke, which according to estimates, account for 4.9 million, 1.5

million, and 2 million deaths in that order (Forouzanfar et al., 2017). Beyond the impact of

the disease on mortality, higher systolic blood pressure is regarded as the leading cause of

disability globally; accounting for approximately 218 million global disability-adjusted life

years (DALYs) (GBD 2017 Risk Factor Collaborators, 2018). Consequently, data also

provides that there has been an increasing burden of hypertension-related CVD, which also

accounts for a significant increase in the number of disability-adjusted life years. For

instance, Taddei et al. (2018) demonstrate that between 2007 and 2017, there was

approximately a 31% increase in the number of DALYs as a result of the increase of

hypertension-related cardiovascular diseases.

According to a survey conducted by the Centers for Disease Control and Prevention

(CDC) in 2017/2018, age-adjusted hypertension is 45.4% prevalent among American adults,

with the condition highly prevalent among men (51.0%) compared to women (39.7%)

(Ostchega et al., 2020). The survey also provided that the condition's prevalence increased

with age, where it is slightly less prevalent among the younger adults compared to the elderly.

In terms of races, the CDC survey provided that hypertension is highly prevalent among the

non-Hispanic Black (57.1%) compared to the Hispanic white (43.6%) and the Hispanic adults

(43.7%). Nonetheless, the survey showed a decrease in the prevalence of hypertension from

47% in 1999/2000 to 41.7% in 2013/2014 before an increase to 45.4% in 2017/2018

(Ostchega et al., 2020).

iii. Pathophysiology of Hypertension

a. Blood Pressure Regulation

Maintenance of the physiological blood pressure level requires an integrated interplay

of several elements of normal physiologic processies, including the sympathetic nervous

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 5

system, the endothelium, the immune system, and the renin-angiotensin-aldosterone system

(Oparil et al., 2018). Therefore, possible disruption or malfunction of the factors involved in

blood pressure hemostasis can increase the mean blood pressure; thereby, leading to a

possible target organ damage (Hall & Hall, 2018). The pathophysiological mechanism related

to hypertension is highly integrated and acts on a genetic foundation, where the genetic

predisposition and various environmental factors risk factors such as high intake of Na+ and

sleep apnea contribute to hypertension development (Hall & Hall, 2018). Consequently, the

probability of individual developing hypertension is also linked to aging (Mikael et al., 2017).

Besides, immunological factors also play a significant role in an individual developing the

condition, especially rheumatological diseases like rheumatoid arthritis and the background

of the disease.

b. Regulation of Sodium Homeostasis

The function of sodium (Na+) in the human body is to regulate hydration levels; thus,

high sodium concentration in the body facilitates the retention of water, which causes an

increase in blood pressure and volume (Oparil et al., 2018). An increase in sodium, especially

in normotensive people, leads to compensatory hemodynamic changes in the body to

maintain constant blood pressure. The changes include a decrease in peripheral and renal

vascular resistance as well as an escalated production of nitric oxide. In the process, if the

effects of the produced nitric oxide are absent or impaired (endothelial dysfunction), an

increase in blood pressure is experienced; thereby, leading to the development of

hypertension and salt sensitivity (Feng et al., 2017). Salt-sensitive individuals manifest an

escalated production of the transforming growth factor β (TGF-β) in response to a high salt

load (Wilk et al., 2017). This increases their oxidative stress, risk of fibrosis, as well as a

limited bioavailable nitric oxide. Consequently, a higher salt intake induces the T helper 17

(TH17) cells, thereby driving autoimmunity. Therefore, a moderate intake of salt in humans

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 6

helps reduce the survival of Lactobacillus spp in intestines, increase blood pressure and the

activity of T (TH17) cells; thereby, leading to the pathogenesis of hypertension.

c. Renin-angiotensin-aldosterone system (RAAS)

The RAAS has several effects on BP regulation, including mediation of Na+ retention,

salt sensitivity, pressure natriuretic, vascular injury, endothelial dysfunction, and

vasoconstriction, all of which are significant in hypertension pathogenesis (Hall & Hall,

2018). It is present at the cellular level in organs and aids in regulating pressure-volume

homeostasis in the human kidney. This is achieved by maintaining perfusion in volume worn-

out states and is suppressed when there is a volume expanded condition. Renin cleaves

angiotensinogen to produce angiotensin I, which is then cleaved to form angiotensin II (exists

at the center of the pathogenetic function of the renin-angiotensin-aldosterone system in

hypertension) as stated by Dunphy et al. (2019). The process occurs in response to various

stimuli that necessitate the release of renin and its precursor pro-renin from the

juxtaglomerular kidney cells, where they are synthesized and stored. The role of angiotensin

II is to enhance the reabsorption of Na+ in the proximal tubule by escalating the activity of

sodium-bicarbonate exchanger, sodium-hydrogen exchanger, and sodium-potassium ATPase

as well as by inducing the release and synthesis of aldosterone from the adrenal glomerulosa

(Hall & Hall, 2018).

The angiotensin-converting enzyme 2 (ACE2) is a significant modulator in

hypertension pathophysiology since it plays a crucial role in metabolizing angiotensin II to

angiotensin (1-7), which induces regional and systemic vasodilation, natriuresis, and diuresis,

and also exerts antigrowth and antiproliferative effects on the cardiac myocytes, vascular

smooth muscle cells, proximal and glomerular tubular cells as well as the fibroblasts (Oparil

et al., 2018). On the other hand, aldosterone binds to the mineralocorticoid receptor and

induces non-genomic effects, including activation of the epithelial sodium channel leading to

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 7

the stimulation of the reabsorption of renal Na+ in the cortical collecting duct. Consequently,

it also leads to various non-epithelial effects that facilitate vasoconstriction, hypertension, and

endothelial dysfunction (Oparil et al., 2018).

d. Sympathetic Nervous System

During sympathetic stimulation, BP increase, especially in patients with hypertension

and blood pressure. Research has failed to whether the hyperresponsiveness resides in the

myocardium, sympathetic nervous system, or the vascular smooth muscle (Bakris, 2021).

However, it has been established that a higher resting pulse rate potentially results from an

escalated sympathetic nervous activity, which is a common hypertension predictor. An

elevated blood pressure stretches the internal carotid artery, which then sends messages

through the nerve bundles projected from the baroreceptors in the carotid sinus to the human

brain to lower sympathetic outflow of the nerve traffic or the nerve impulse; thereby, leading

to blood pressure (de Leeuw et al., 2017). Many hypertensive patients are in an autonomic

imbalance state with low parasympathetic and high sympathetic activity (Oparil et al., 2018).

As a result, they experience an escalated severity of hypertension, linked to rising

sympathetic activity levels (Dunphy et al., 2019). The sympathetic nervous system has been

proved as highly significant in hypertension pathogenesis since a high increase in the renal

sympathetic nerve activity escalates renal sodium reabsorption; thereby, facilitating the

maintenance of sustained hypertension.

2. Clinical Practice Guideline

The current clinical practice guideline for hypertension recommends diuretics,

angiotensin receptor blockers (ARBs) or inhibitors, angiotensin-converting enzyme (ACE),

calcium channel blockers (CCB), and beta-blockers as the first-line medications for

hypertension treatment, with some patients requiring two or more antihypertensive

medications to achieve their blood pressure clinical target (Dunphy et al., 2019). Despite

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constant updates and revisions, the available clinical practice guideline for hypertension still

has various controversial recommendations, especially on salt, dietary, and blood pressure

recommendations. This underscores the possibility of concluding whether the available

guideline is trustworthy. An effective clinical practice guideline aims to set the standard for

practice and should be accepted by the healthcare provider, disease advocacy groups,

patients, healthcare stakeholders, and professional organizations (Dunphy et al., 2019). This

means that for a clinical practice guideline to be regarded as effective and adequate for

clinical practice, it needs to be driven by solid scientific documentation and carefully

appraised high-quality evidence. The guideline provides the standard blood pressure

treatment recommendation of <130/80 mm Hg and <140/90 mm Hg for patients with

significant comorbidities over 65 years. The supporting evidence for this treatment goal was

derived from a meta-analysis study comprising of 9 trials, and it demonstrated that reducing

the systolic blood pressure to <130 mm Hg led to an absolute reduction of approximately

1.1% in adverse cardiovascular events and 0.5% absolute reduction in stroke (Unger et al.,

2020). However, this did not have any impacts on heart failure, myocardial infarction, renal

events, as well as cardiovascular deaths, and all-cause mortality.

From this perspective, it is debatable whether supporting evidence and treatment

benefit is statistically and clinically significant to support medical practice and public policy.

Consequently, the systematic review that provided the recommendation for BP 130/80 mm

Hg did not formally consider the factors that modify evidence quality and the possible harm

that can lead to adverse effects on the benefit-risk trade-off. Besides, it fails to utilize current

hypertensive evidence; therefore, it does not adequately address the need for hypertension

treatment and management. Moreover, other professional societies such as the European

Society of Hypertension, the position statement by the American Diabetes Association, the

American Academy of Family Physicians, and the American College of Physicians have

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 9

declined to universally endorse the blood pressure recommendation (Messerli & Bangalore,

2018).

The meta-analysis study used for the guideline evaluated 6 cardiovascular outcomes

across approximately 8 trials (Unger et al., 2020). The results provided about 6 out of 33

outcomes to lower the mean blood pressure. 4 of the 6 outcomes were reduced in the SPRINT

trial while stroke was reduced in 1 trial. None of the trials failed to demonstrate a reduction in

myocardial infarction. Therefore, the guideline specifically uses the SPRINT trial as evidence

to support the <130/80 mm Hg blood pressure treatment goal. Nonetheless, the guideline

complies with the Institute of Medicine (IOM) standards for developing reliable clinical

practice guidelines to optimize care. As such, the challenge regarding the quality of evidence

used for the guideline adequately directs the healthcare practitioners in the management of

hypertension.

The hypertension clinical practice guideline provides that antihypertensive drug

treatment should be lowered for Diabetes mellitus patients if the patient has ≥140/90 mm Hg

and treated at a medical objective of <130/80 mmHg (Unger et al., 2020). In adults with

hypertension and diabetes mellitus, all the first-line antihypertensive agents such as ARBs

and diuretics are regarded as effective. Nonetheless, for the treatment of stroke patients, the

guideline recommends that an immediate lowering of blood pressure to <130/80 mm Hg and

<140/90 mm Hg for patients with significant comorbidities over 65 years, which is less

effective and can even lead to the death of the patient. Furthermore, the benefit of lowering

the systolic blood pressure is not clear. Based on these scenarios, the effectiveness of the

guideline in the management of hypertension patients is hard to grade, but it is clear that it is

not entirely adequate.

3. Analysis

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 10

The current clinical practice guidelines for hypertension needs revision to help

adequately optimize patient care. The supporting evidence provided by the guideline for

<130/80 mm Hg BP level recommendation and the dietary and salt recommendations for the

management and treatment of hypertension is insufficient to warrant the change from the

previous <140/90 mm Hg recommendation. Based on the results of the meta-analysis study

that led to the recommendation, the guideline failed to formally consider the factors that

modify evidence quality and the possible harm that can lead to adverse effects on the benefit-

risk trade-off. This means that as it is currently designed, it recommends clinical practices

inadequately supported with evidence for the treatment and management of hypertension. For

instance, Unger et al. (2020) states that while treating hypertension and previous stroke

patients, an immediate lowering of blood pressure >140/90 mm Hg to a target <130/80 mm

Hg (<140/80 for the elderly patients) is recommended. However, this is less effective and can

even lead to the death of the patient.

To make the guideline effective for clinical practice, the methodology of the guideline

should be revised to include a more rigorous, systematic review of the literature and define

the standards for the assessment of individual scholarly studies. Consequently, other issues

that need consideration, such as the factors that modify evidence quality and the possible

harm that can lead to adverse effects on the benefit-risk trade-off, should be rigorously,

explicitly, and consistently considered in the guideline to refine the evaluation process. As

currently designed, the guideline shows important limitations such as the utilization of soft

endpoints and missing data, which weakens the evidence; thus, downgrading the

recommendations. Also, it would be imperative to avoid overreliance on meta-analysis that is

founded on a p-value threshold of <0.05 to determine the statistical and clinical significance

of the guideline. On the contrary, a p-value of 0.01 or lower should be used to reduce false

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 11

positives that emerge from multiple comparisons. This should also compensate for the

unknown and known factors of risk and potential biases (Lietzan, 2018).

Additionally, it would be ideal for providing clarity between the medically significant

benefits and harms to influence the strength of the recommendations in the guideline

(Dunphy et al., 2019). Although the current guideline clearly defines the strength of the

recommendation criterion based on the benefit-risk trade-off, a standardized and transparent

benefit-risk evaluation is less routinely considered in the recommendation development.

Lastly, an effective practice guideline should be user-friendly, efficient, timely, cost-effective,

and embedded in the electronic medical record system (Dunphy et al., 2019).

The new version of the guideline will provide a justification of whether the <130/80

mm Hg BP should be adopted or abolished in practice. This is because, from a health care

provider's point of view, the guideline provides limited evidence to support the decision to

utilize a lower blood pressure, especially in regards to the management of myocardial

infarction, renal adverse events, heart failure, and cardiovascular events. Consequently, the

guideline also provides a controversial recommendation on the risk-based treatment for grade

1 hypertension, which limits pharmacological therapy to patients with blood pressure 130 to

159/85 to 99 mm Hg and a 10-year ASCVD (atherosclerotic cardiovascular disease) risk of

>10% (Whelton et al., 2018). The guideline estimated the 10-year risk from a study cohort

that was never used in a medical trial where the blood pressure was lowered to the suggested

values of 130 to 159/85 to 99 mm Hg.

Changes in healthcare reforms and U.S demographics can potentially have impacts on

the application of the revised hypertension guideline. This is because the US healthcare needs

experience constant evolution, especially in response to the need for quality and advanced

care provision. In the US, various factors and evolving trends constantly impact its healthcare

system, for instance, the increasing aging population, the increased demand for IT in

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healthcare, rising clinical costs, rising number of patients, and the escalating population of

uninsured patients. Based on these demographical factors, the new guideline would need

constant and frequent revisions to keep up with the demand for care in the nation. This is the

only way the guideline would continue to adapt to the US demographics and policy reforms

to adequately and effectively provide care to the US hypertension patients.

Far from being affected by the US demographics and policy reforms, the guideline

would first need to be adopted and used in clinical practice. According to Farrell et al. (2016),

clinical practice guidelines bridge the gap between research and the provision of healthcare

services; thereby, reducing unsuitable practice variability. Successful implementation of the

revised hypertension practice guideline hugely relies on the implementation strategies of the

guideline and must be grounded on the evidence and knowledge of the intervention as well as

barriers to its suitable utilization. As such, identifying potential barriers to the implementation

of the guideline leads to the development of a tailored plan and strategies for its

implementation, thereby leading to the guideline's effectiveness (Fischer et al., 2016).

This new hypertension guideline will involve a wide range of specialists,

methodology experts, clinical professionals, and care consumers to enhance its effectiveness

and the possibility of being accepted and used to treat and manage hypertension. They will

aid in making relevant contributions and formulating the implementation suitable

implementation strategies for the target audience. Other implementation strategies that will be

used to ensure the guideline is accepted and used in the treatment and management of

hypertension include;

 Utilizing short summaries of the new hypertension guideline in forums.

 Involving the potential target population in all the stages of the guideline

development. This will be achieved through consultative and direct

involvement to encourage participation and ownership.

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 13

 Utilization of media platforms to publicize the newly revised hypertension

guideline.

 Usage of professional journals and magazines to involve and inform care

stakeholders and professionals about the changes made to the new

hypertension guideline.

 Using all the available channels of communication created by the allied care

firms, the state, care research institutes, and regional societies to publicize the

changes.

 Utilization of academic processes provided by the relevant consumer groups

and institutions such as seminars to inform the world on the new hypertension

clinical practice guidelines.

4. Evaluation

It is imperative to assess the effectiveness of a new/revised clinical practice guideline

to determine the extent to which it affects care delivery and the practitioner's behavior and

knowledge and the factors, if any, that contribute to non-compliance. The results from the

assessment inform whether the revised clinical practice guideline produced the projected care

outcomes and is effective for the treatment and management of hypertension. Farrell et al.

(2016) indicate that changes in care provision will occur when healthcare practitioners are

involved. However, effective implementation of care guideline strategies directly improves

the influence of care practitioners on the delivery of care services. Therefore, for the

successful implementation of new/revised care guidelines, they need to be embedded in the

care system and be founded on clinical aspects.

For the degree of effectiveness, various evaluation processes have been discussed in

the literature to determine the level of acceptance and the extent to which the revised practice

standards aid to care provision. As such, the revised clinical practice guideline is evaluated to

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 14

determine whether it serves its purpose of improving healthcare outcomes. To determine the

effectiveness of the revised hypertension clinical practice guideline, the strategies below are

utilized:

i. The first step in evaluating the effectiveness of the revised guideline is to

assess the possible changes in care delivery and practice caused by the new

guideline standards. This is achieved by comparing the transformation in

clinical practice and health outcomes in areas with the remarkably high

promotion of the guideline with the transformation in areas with the low

promotion of the guideline.

ii. The next step is to compare healthcare outcomes transformation in areas that

experienced high intake of the guidelines against those that had a low

guideline intake. This can be achieved by using a focus group to elucidate the

main aspects that have influenced the intake of the guideline.

5. Learning Points

 Hypertension is a healthcare problem affecting a larger adult population throughout

the globe. In the US alone, data shows that 49.6% of US adults aged 20 years and

older had hypertension in 2017-2018 while approximately 36,524 individuals died

from the condition; providing an estimated 11.1 deaths per 100,000 people who died

from essential hypertension hypertensive disease.

 Why the recommended threshold of <130/80 mm Hg for blood pressure treatment has

been considered controversial in the management and treatment of hypertension.

 The impact of the recommended <130/80 mm Hg and <140/90 mm Hg for patients

with significant comorbidities over 65 years for the treatment of hypertensive stroke

cases is less effective and can even lead to death.

EVALUATION HYPERTENSION CLINICAL PRACTICE GUIDELINE 15

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