Clinical Pathways for the Management of Dyspepsia in...

130 THE FILIPINO FAMILY PHYSICIAN

CLINICAL UPDATE

Clinical Pathways for the Management of Dyspepsia in Family and Community Practice

Noel L. Espallardo MD, MSc, FPAFP; Ma. Teresa Tricia Guison-Bautista, MD, FPAFP; Ma Elinore Alba-Concha, MD, FPAFP and Louie R. Ocampo, MD, FPAFP

Background: Dyspepsia is any chronic or recurrent discomfort in the epigastric area described as bloatedness, fullness, gnawing or burning continuously or intermittently for at least 2 weeks. About 40% of the adult population may suffer from dyspeptic symptoms but most of them are un-investigated because only about 2% consult their physician.Method: The general objective of this clinical pathway is to improve outcomes of patients with dyspepsia in family and community practice.Method: The PAFP Clinical Pathways Group reviewed the previous Clinical Practice Guideline for the Treatment of Dyspepsia in Family Practice, a local guideline developed by the Family Medicine Research Group and adopted as policy statement by the Philippine Health Insurance Corporation. The reviewers then developed a time-related representation of recommendations on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions as well as social and community strategies to treat hypertension and prevent complications.Recommendation: All patients with upper gastrointestinal pain or discomfort should have a detailed history focusing on weight loss, hematemesis, hematochezia, melena, dysphagia, odynophagia, vomiting, NSAID intake, alcohol intake, smoking, frequent medical complaints, depression, anxiety, personal or family history of gastrointestinal disease using family genogram. Physical examination findings provide minimal information but should be done to rule out an organic pathology and to look for alarm clinical features like anemia, abdominal tenderness or mass, jaundice, melena etc. If the patient is with history of previous dyspepsia treatment, more than 45 years old or long-term use of NSAID, the physician may request for non-invasive H. pylori test. Upper abdominal ultrasound, liver function test, pancreatic amylase may be done if organic problem is considered. Start therapeutic trial of prokinetic treatment for 1-2 weeks or proton-pump inhibitor depending on the symptoms. Fixed drug combination may be used if symptoms are undifferentiated. The patient should be educated about upper gastrointestinal disorders and dyspepsia, risk factors and complications. If medications were prescribed, explain the dose, frequency, intended effect, possible side effects and importance of medication adherence. Lifestyle modifications focusing on low fat meals, weight reduction, avoidance of alcohol intake and smoking cessation, eating way before bedtime, elevated head while sleeping, etc. may also be done. Recommendations were also made on subsequent visits. Implementation:Quality improvement strategy is recommended for implementation of this pathway. This will involve pre- and post-intervention data collection using records review. Intervention strategies may be feedback, group consensus or incentive mechanisms.

VOL. 55 NO. 3 JULY - SEPTEMBER, 2017 131

IntroductIon

Our previous guideline in family medicine, defined dyspepsia as any chronic or recurrent discomfort in the epigastric area described as bloatedness, fullness, gnawing or burning continuously or intermittently for at least 2 weeks. Concomitant symptoms like anorexia, early satiety, belching, nausea, regurgitation or vomiting may also be present.1 This is a very common symptom complaint in family and community medicine practice. About 40% of the adult population may suffer from dyspeptic symptoms but most of them are un-investigated because only about 2% consult their physician. Based on systematic reviews, the pooled prevalence of un-investigated dyspepsia was 21% (95% confidence interval, 18% to 24%). The risk is higher among females and those with Helicobacter pylori (H pylori) infection, smokers, and non-steroidal anti-inflammatory drug users.2 Even after endoscopy, more than 75% with dyspepsia don’t have obvious structural abnormality. Among those with abnormality, the most common findings are esophagitis (13%) and peptic ulcer (8%).3 There is high direct and indirect costs due to dyspepsia because of its prevalent, recurrent and chronic condition. Fortunately there is no mortality associated with dyspepsia symptoms.4 Several treatment guidelines have been developed for the management of dyspepsia. The American and European multidisciplinary working group as well as a local Family Medicine Research Group, Inc. have also developed clinical practice guideline for the management of dyspepsia in Philippine family and community medicine practice.1,5,6

The main recommendations were basically similar in terms of indication for prompt endoscopy, the application of diagnostic tests and treatment of recurrent symptoms. In summary the recommendations were: 1) patients with alarm symptoms should undergo prompt endoscopy, 2) those without alarm symptoms non-invasive testing for H pylori is recommended, 3) empiric trial of acid suppression with a proton pump inhibitor is recommended if H pylori testing is not feasible, 5) prokinetics are not currently recommended as first-line therapy for un-investigated dyspepsia, 6) test-

and-treat is preferable in patients with moderate to high prevalence of H. pylori infection (specialist practice) and empiric proton pump inhibitor low prevalence situations (family and community practice), 7) if empiric treatment with proton pump inhibitor fails, consider changing or adding another drug class or increase dose, 8) If the patient still fails to respond testing for H pylori and endoscopy may be considered, and 9) If there is improvement in symptoms patients may be treated on either on demand or intermittent basis.5,6 The general objective of this clinical pathway is to improve outcomes of patients with dyspepsia in family and community practice. It hopes to achieve this by:

o Promoting a standardized management of patients with dyspepsia

o Promoting quality improvement initiatives at the clinic and organizational level

Methods of Development and Implementation

The PAFP Clinical Pathways Group reviewed the previous Clinical Practice Guideline for the Treatment of Dyspepsia in Family Practice, a local guideline developed by the Family Medicine Research Group and adopted as policy statement by the Philippine Health Insurance Corporation. The group also reviewed published medical literature to identify, summarize, and operationalize the clinical content of diagnostics, interventions and clinical indicators or outcomes to develop an evidence-based clinical pathway in family medicine practice. The reviewers then developed a time-related representation of recommendations on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions as well as social and community strategies to treat hypertension and prevent complications. The group adopted several strategies in developing the recommendations. The first strategy is emphasizing on evidence-based recommendations as recommended assessments and interventions. The second strategy is recognition of potential variations between-patient and


between specific practice settings. The third strategy is the recognition of “stakeholder groups” outside of family and community practice with careful attention to getting their opinion and support but without sacrificing the objectives of the project. The fourth strategy is emphasis on the commitment to establishment of the ultimate goal of improving the effectiveness, efficiency and quality of patient care in family and community practice. The evidences for the patient care processes were reviewed and summarized as notes on the recommendations. The clinical pathway was then disseminated to selected PAFP chapters and members and other stakeholders for consensus development. Dissemination was publication in the Filipino Family Physician journal, conference presentations and focused group discussions. The implementation of clinical pathways to be adopted by the PAFP will be quality improvement activities in a form of patient record reviews, audit and feedback. Audit standards will be the assessment and intervention recommendations in the clinical pathway. Implementation of clinical pathways will be at the practice level and the organizational level. Practice level can be a simple count of family and community medicine practitioners using and applying the clinical pathways. Organizational outcomes can be activities of the PAFP devoted to the promotion, development, dissemination and implementation of clinical pathways.

Grading of the Recommendations

The PAFP QA Committee met as a panel and graded the recommendations as shown in Table 1. The grading system was a mix of the strength of the reviewed published evidence and the consensus of a panel of experts. In some cases the published evidence may not be applicable if Philippine family practice setting, so a panel grade based on the consensus of clinical experts was also used. Thus if the recommendation was based on a published evidence that is a well done randomized controlled trial and the panel of expert voted unanimously for the recommendation, it was given a grade of A-I. If the level of evidence is based

on an observational study but the panel still unanimously considered the recommendation, the grade given was A-II and if the level of evidence is just an opinion but the panel still unanimously recommended it, the grade was A-III.

Table 1. Grading of the recommendations.

Panel Grade Level Evidence Grade Level 1 2 3

A A-I A-II A-III B B-I B-II B-III C C-I C-II C-III

Panel Grade Levels

A - All the panel members agree that the recommendation should be adopted because it is relevant, applicable and will benefit many patients.

B - Majority of the panel members agree that the recommendation should be adopted because it is relevant, applicable in many areas and will benefit many patients.

C - Panel members were divided that the recommendation should be adopted and is not sure if it will be applicable in many areas or will benefit many patients.

Evidence Grade Levels

I - The best evidence cited to support the recommendation is a well-conducted randomized controlled trial. The CONSORT standard may be used to evaluate a well-conducted randomized controlled trial.

II - The best evidence cited to support the recommendation is a well-conducted observational study i.e. match control or before and after clinical trial, cohort studies, case control studies and cross-sectional studies. The


STROBE statement may be used to evaluate a well-conducted observational study.

III - The best evidence cited to support the recommendation is based on expert opinion or observational study that did not meet the criteria for level 2.

In the implementation of the clinical pathways, the PAFP QA committee strongly recommends compliance to guideline recommendations that are graded as either A-I, A-II or B-I. However, the committee also recommends using sound clinical judgment and patient involvement in the decision making before applying the recommendations.

Pathway Recommendations

Visit

First Visit

Variations

History and Physical Examination

__All patients with upper gastrointestinal pain or discomfort should have a detailed history focusing on weight loss, hematemesis, hematochezia, melena, dysphagia, odynophagia, vomiting, NSAID intake, alcohol intake, smoking, frequent medical complaints, depression, anxiety, personal or family history of gastrointestinal disease using family genogram. (A-II)__ Physical examination findings provide minimal information but should be done to rule out an organic pathology and to look for alarm clinical features like anemia, abdominal tenderness or mass, jaundice, melena etc. (A-II)

Pathway decisions__If there is organic/structural problem based on significant physical examination finding, refer to specific clinical pathway (A-III)__Probably motility problem if prominent history of bloatedness, dysphagia and vomiting (A-III)__Probable acid-related problem if prominent history of epigastric pain, NSAID and alcohol intake and reflux symptoms (A-III)__Undifferentiated upper gastrointestinal problem (A-III)

Laboratory

__Request for non-invasive H. pylori test if with history of previous dyspepsia treatment, more than 45 years old or long-term use of NSAID (A-II)

__ Upper abdominal ultrasound, liver function test, pancreatic amylase if organic problem is considered (A-II)

Pharmacologic Intervention

Probably motility problem__Start therapeutic trial of prokinetic treatment for 1-2 weeks (A-I)

Probably acid-related problem__Start therapeutic trial with proton-pump inhibitor or H2 blocker for 1-2 weeks (A-I)

Undifferentiated upper gastrointestinal problem__Start therapeutic trial with combination of prokinetic and proton-pump inhibitor or H2 blocker for 1-2 weeks (A-I)

Non-pharmacologic Interventions

Patient interventions__Educate the patient about upper gastrointestinal disorders and dyspepsia, risk factors and complications (A-II)__If medications were prescribed, explain the dose, frequency, intended effect, possible side effects and importance of medication adherence (A-II)__Lifestyle modifications focusing on low fat meals, weight reduction, avoidance of alcohol intake and smoking cessation, eating way before bedtime, elevated head while sleeping, etc. (A-II) Family interventions __Inquire and recommend family members’ lifestyle activities (A-III) Community interventions __Inquire for community lifestyle activities (A-III)

Continuing Care__Follow-up after 1-2 weeks__Offer family wellness package (A-III)

Patient Outcomes

__Aware of initial diagnosis (A-III)__Aware of risk factors and complications (A-III)__Aware of importance of adherence to diagnostics and interventions (A-III)

Pathway Tasks


Visit

Second Visit

Variations


__Review and note any change in history focusing on weight loss, hematemesis, melena, dysphagia, odynophagia, vomiting, NSAID intake, alcohol intake, smoking frequent medical complaints, depression, anxiety, personal or family history of gastrointestinal disease using family genogram. (A-II)__Repeat and note any change in physical examination focusing on the upper gastrointestinal tract (A-II)__Review the results of laboratory tests and response to empiric treatment (A-II)

Pathway decisions__If there is symptom improvement with the therapeutic trial, continue until 4 weeks (A-III)__If no symptom improvement, refer for gastrointestinal endoscopy (A-III)__If the H pylori test is positive, start eradication treatment (A-III)__If ultrasound and other laboratory tests are positive manage accordingly (A-III)

Laboratory

__Request for endoscopy if symptoms did not improve with therapeutic trial for 2-4 weeks (A-II)

__Complete request for upper abdominal ultrasound, liver function test and pancreatic amylase if organic problem is considered (A-II)


Improved symptoms__Continue medications until 4 weeks (A-I)

With upper gastrointestinal organic problem__Refer to gastroenterologist or manage according to available clinical pathway (A-III)


Patient interventions__Enhance education about upper gastrointestinal disorders and dyspepsia, risk factors and complications (A-II)__If medications were prescribed, enhance explanation on the dose, frequency, intended effect, possible side effects and importance of medication adherence (A-II)__Enhance lifestyle modifications focusing on low fat meals, weight reduction, avoidance of alcohol intake and smoking cessation, eating way before bedtime, elevated head while sleeping, etc. (A-II)

Family interventions __Enhance recommendation for family members’ appropriate lifestyle activities (A-III) Community interventions __Recommend participation in appropriate community lifestyle activities like alcohol anonymous (A-III)

Continuing care__Follow-up after 1 month until upper gastrointestinal symptom is resolved and every 3-6 months if BP target is already achieved (A-III)

Patient Outcomes

__Improved symptom control (A-I)__Modification of risk factors i.e. diet, lifestyle, smoking and alcohol intake (A-I)__Absence of new complications (A-III)__Adherence to diagnostics and interventions (A-II) __Agreed plan for family intervention (A-III)

Pathway Tasks


Visit

Continuing Visit

Variations


__Review and note any change in history focusing on weight loss, hematemesis, melena, dysphagia, odynophagia, vomiting, NSAID intake, alcohol intake, smoking frequent medical complaints, depression, anxiety, personal or family history of gastrointestinal disease using family genogram. (A-II)__Repeat and note any change in physical examination focusing on the upper gastrointestinal tract (A-II)__Review the results of endoscopy and other laboratory tests (A-II)

Pathway decisions__If endoscopy was positive for bleeding peptic ulcer and other serious organic problem consider transfer of care to gastroenterologist (A-III)__If there is continued positive response to therapeutic trial and H. pylori eradication continue with current care (A-III)

Laboratory

__Repeat request H pylori test, endoscopy or upper abdominal ultrasound, liver function test and pancreatic amylase if organic problem was considered after 3-6 months to monitor response to treatment (A-II)


Improved symptoms__Self-management with the same medications for symptom recurrence (A-I)

With upper gastrointestinal organic problem__Refer to gastroenterologist or manage according to available clinical pathway (A-III)


Patient interventions__Enhance education about upper gastrointestinal disorders and dyspepsia, risk factors and complications (A-II)__Educate the patient on self-management for symptom recurrence (A-II)__Enhance lifestyle modifications focusing on low fat meals, weight reduction, avoidance of alcohol intake and smoking cessation, eating way before bedtime, elevated head while sleeping, etc. (A-II) Family interventions__Enhance recommendation for family members’ appropriate lifestyle activities (A-III) Community interventions__Recommend participation in appropriate community lifestyle activities like alcohol anonymous (A-III)

Continuing care__Follow-up after 1 month until upper gastrointestinal symptom is resolved and every 6-12 months (A-III)

Patient Outcomes

__Improved symptom control (A-I)__Modification of risk factors i.e. diet, lifestyle, smoking and alcohol intake (A-I)__Absence of new complications (A-III)__Adherence to diagnostics and interventions (A-II) __Implemented plan for family and community intervention (A-III)

Pathway Tasks


Notes on the Recommendations

Guidelines and clinical pathways are important tools in family and community practice. These are usually based on published evidence. But when evidence is limited, guidelines have to rely on the opinions and experience of physicians and arrive at a consensus.7 This pathway contains specific recommendations for decisions to be made during the first, second and continuing visits that are based on published clinical evidence as well as consensus.

First Visit


Patients with dyspepsia will be consulting a physician’s clinic for the following symptoms; recurrent epigastric pain, heartburn or acid regurgitation, with or without bloating, nausea or vomiting. These symptoms fit in the definition of dyspepsia adopted by the National Institute of Health Care and Clinical Excellence (NICE) in the United Kingdom.8 The clinical history and physical examination must focus on investigating for the presence of age at onset greater than 45 years old, weight loss, anemia, hematemesis, melena, hematochezia, dysphagia, odynophagia, persistent vomiting, abdominal mass, jaundice, chronic NSAID intake, chronic alcohol intake and previous history of ulcer. These were considered alarm features in previous guidelines and may signify that the patient may be at high risk. Other features like frequent medical complaints, depression, anxiety, family history of dyspepsia or peptic ulcer disease and smoking should also be obtained.1 It is also recommended to review medications for possible causes of dyspepsia for example, calcium antagonists, nitrates, theophylline, bisphosphonates, corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDs).8

Gastrointestinal complaints are common among patients with somatization and anxiety disorders. A cohort study showed that certain personality characteristics like trait anger reactivity and stress proneness, frequent use of coping strategies and social stress predispose individuals

to develop functional gastrointestinal disease including dyspepsia. It was noted that patients with functional gastrointestinal disease had more stressors (98% vs 36% compared to normal healthy controls) and that the greater the number of stressors is also associated with greater severity of the disease.9 Physical examination rarely helps in establishing the etiology of dyspepsia. The usual PE for patients with dyspepsia will usually show no masses, no organomegaly and variable epigastric tenderness.10,11 After conducting a history and physical examination, the patient’s dyspepsia may be classified into the following symptom syndrome that may guide initial choice of diagnostic and therapeutic management.

• Dysmotility like dyspepsia - Agreus and Talley bothdescribed this subgroup by naming the following most bothersome symptoms: Upper abdominal discomfort (not pain); early satiety, bloating in upper abdomen, post-prandial fullness, and nausea, retching or vomiting.12

• Ulcer-like dyspepsia – Barbara’s article succinctlydescribed the symptoms as suggestive of peptic ulcer diseases. Talley and Agreus agreed on the following symptomatology: relapsing epigastric pain, aggravated by hunger and relieved by antacids.12

• Reflux-like dyspepsia – Talley and Agreus describedthe most bothersome symptom as heartburn and acid regurgitation which may awaken patient at night.12

• Functional dyspepsia – Barbara briefly described thissubgroup as patients who report dyspeptic symptoms in whom no disease can be identified by any clinical, biochemical, endoscopic, ultrasonographic pathology. The diagnosis is usually made after an extensive gastrointestinal diagnostic work-up.13

Aside from the four symptom syndromes mentioned, family and community medicine practitioners may also


limit the diagnosis to just two types i.e. post-prandial dysmotility syndrome (motility-related dyspepsia) or epigastric pain syndrome (acid-related dyspepsia). This has around 70% pre-test probability as a provisional diagnosis after a thorough history and physical examination. Although overlapping symptoms may be present, these two syndromes separate out more clearly and can guide the initial diagnostic and therapeutic decisions.14 The possibility of cardiac or biliary disease should also be part of the differential diagnosis.8 Some authors make mention of those chronically abusing alcohol being at a higher risk for developing conditions such as chronic pancreatitis which may present as dyspepsia. After making a provisional diagnosis, the family and community physician has two main options. The first option is empiric medical therapy based the dominant symptom or symptom complex i.e. motility-related dyspepsia and acid-related dyspepsia with further investigation reserved for ‘empiric treatment failures’ for low risk patients (no alarm features). The previous guideline on dyspepsia recommended that the presence of alarm symptoms physician should warrant prompt referral. However, there is little evidence in the literature of the exact predictive value of these alarm features in the diagnosis of cancer or other serious diseases causing dyspepsia.15 Acid-related and gastroesophageal reflux disease (GERD) can be diagnosed clinically if the patient’s dominant symptoms are heartburn or acid regurgitation, or both. Individuals who reflux gastric contents into the esophagus may cause symptoms sufficient to reduce quality of life. They may be treated empirically with proton pump inhibitors or H2 blockers without further investigation provided there are no alarm features.16 Dysmotility-related dyspepsia may be treated with prokinetic drugs. There are available fixed dose combination of acid suppression and dysmotility drugs or acid suppression and anti-H pylori drugs that family physicians can also use for empiric treatment. The second option is immediate referral for diagnostic evaluation like endoscopy for high risk patients.17 Alarm features like melena, hematochezia, anemia and

significant weight loss are listed because intuitively they are indicators of the presence of either a malignancy or a peptic ulcer disease that may warrant prompt endoscopy and referral.8 The decision of prompt referral may depend on the clinical judgment of the family physician, the availability of the specialist facility and a shared decision with the patient.

Laboratory Tests

Most patients with dyspepsia may undergo empiric treatment for 2-4 weeks. However, a “test and treat” strategy for Helicobacter pylori (H pylori) may be done among uninvestigated dyspepsia in people over 45 years of age or long-term non-steroidal anti-inflammatory drug treatment.8,18,19 There may be a need for a 1-week washout period after proton pump inhibitor (PPI) use before testing for H pylori. The urea breath and fecal antigen tests are acceptable for diagnosis of H. pylori but is not yet readily available in family and community practice in the Philippines. Ultrasonography is a non-invasive and readily available diagnostic procedure in most parts of the country. Ultrasonography shows 100% sensitivity and 87.5% specificity compared to ambulatory gastro-oesophageal reflux disease diagnosis. It can estimate whole gastric volume, antral area or diameters, and transpyloric flow in fasting state and in response to test meal. Gallbladder, liver and pancreas ultrasonography is reliable to determine structural problems in these organs. All these make ultrasound an appealing diagnostic test to assess upper gastrointestinal disease.20 A special group of patients may also need psychiatric testing especially if the physician suspects that the dyspeptic patient has some underlying psychological disturbance. Drossman recommended psychiatric testing if there are: 1) complains of chronic pain, 2) longer pain history, 3) abnormal illness behavior - relentless search to validate the disease, 4) family dysfunction, 5) disorder affects QOL and daily function, 6) history of psychiatric diagnosis, and 7) poor coping strategies.21


Pharmacologic Interventions

Before starting empiric treatment, the family and community physician must first ensure the following: 1) the symptoms originate in the upper gastrointestinal tract and cardiac, biliary or pancreatic problem was clinically ruled out, 2) alarm features associated with bleeding peptic ulcer or cancer are absent, 3) discontinued use of non-steroidal anti-inflammatory drugs, and 5) H. pylori infection is not highly considered. The family physician must discuss with patients over 45 years of age who present with dyspepsia and alarm features associated with bleeding peptic ulcer or cancer to get prompt investigation, preferably endoscopy. Patients who use NSAIDs regularly are recommended to stop NSAID. If NSAID therapy cannot be stopped, prophylactic therapy or enteric coated NSAID may be tried. Non-steroidal anti-inflammatory drugs, acetylsalicylic acid and cyclooxygenase-2-selective inhibitors can all cause dyspepsia. Combination therapy with either a proton pump inhibitor or high-dose H2RA is recommended.22 If practically feasible, patients who had history of chronic dyspepsia, NSAID use but without alarm symptoms warranting endoscopy should be tested for H. pylori infection, and those with a positive result should be treated with H. pylori-eradication therapy. Those with a negative result should have their symptoms treated with optimal anti-secretory therapy or a prokinetic agent or a combination of both.21 Most patients with dyspepsia may be offered acceptable symptomatic management. As there is no single ideal first choice drug, selection is often empiric after considering the following: level of contact and care, dominant dyspepsia symptom, availability and cost of medicines, individual preferences. Most guidelines recommend empirical full-dose PPI therapy for 2-4 weeks to people with dyspepsia.8

H2-receptor antagonists and prokinetic agents may be considered as second-line or alternative empiric medication.24,25,26 Drug treatment should continue for a finite period (2-4 weeks) and response should be monitored. All patients should be given advice on lifestyle changes.17 For frequent or severe GERD symptoms, proton pump inhibitors for 2-4 weeks are recommended for GERD. Over-

the-counter antacids or H2 blockers may be effective for some patients with mild or infrequent symptoms. Routine testing for Helicobacter pylori infection is unnecessary before starting treatment. Endoscopic screening for Barrett’s epithelium may be considered in adults with GERD for more than 10 years.27


Once a patient is diagnosed with dyspepsia, the family and community physician should carefully explain the pathophysiology and benign nature of this condition. To avoid anxiety and further cost of diagnosis and treatment, the patient must be re-assured about the disease. Recurrence is common and self-management is essential for adequate control of symptoms. The physician must establish a good doctor-patient relationship.28 The following points must be emphasized. Offer simple lifestyle advice, including advice on healthy eating, weight reduction and smoking cessation. Advise people to avoid known precipitants they associate with their dyspepsia where possible. These include smoking, alcohol, coffee, chocolate, fatty foods and being overweight. Raising the head of the bed and having a main meal well before going to bed may help some people. Provide people with access to educational materials to support the care they receive. Recognize that psychological therapies, such as cognitive behavioural therapy and psychotherapy, may reduce dyspeptic symptoms in the short term in individual people.8

Patient Outcomes

At the end of the consultation, the patient must be aware of the diagnosis of dyspepsia and its recurrent nature. The patient must also be aware of the potential complications and differential diagnosis. The patient must agree to follow the recommended lifestyle changes. If the patient was given empiric treatment, the patient must also be aware of its dose, frequency of intake, expected effect and potential side effects. A baseline symptom score or quality of life score should also be obtained as baseline.


Second Visit


Evaluate the patient’s response to empiric treatment. If laboratory evaluation was requested, evaluate the results. Review the history and physical examination and correlate with results of laboratory and response to empiric treatment. Consider referral to a specialist service for patients of any age with gastro-oesophageal symptoms that are non-responsive to treatment.8

Laboratory Tests

If empiric treatment or after a trial of a second drug fails, then further investigation should be considered. Upper gastrointestinal endoscopy and H pylori testing are valuable diagnostic tools that can guide future clinical decisions. The need for endoscopy is a difficult decision in patients with dyspepsia. It is costly and not readily available in family and community practice. However early endoscopy will often prove more cost effective than delaying until the indications are clearer.29 H. pylori testing is another test to be considered. There is now direct clinical evidence supporting a test-and-treat approach in patients with dyspepsia symptoms.22 Empiric H. pylori eradication therapy is not recommended. The role of H. pylori is an important development in gastroduodenal disease. It has changed our understanding of the pathophysiology of diseases in the in the upper gastrointestinal tract. It may also have a role in un-investigated and functional dyspepsia and ulcer risk in patients taking low-dose aspirin or starting therapy with a non-steroidal anti-inflammatory medication.30 Eradication of the bacterium resulted to faster cure of peptic ulcer disease and decreased the symptoms of non-ulcer dyspepsia.31

H. pylori infection can be accurately diagnosed with urea breath test or a stool antigen test. It can also be diagnosed invasively by histology or culture.32 Proton pump inhibitor therapy should be stopped at least 1 week prior to H pylori testing.33


If the initial empiric treatment fails a trial of an additional second drug may be done. H2 blocker therapy if there is an inadequate response to a PPI may be added.8

Cure of H. pylori infection decreases recurrence rates and facilitates healing. Thus antibiotic therapy is indicated for all H. pylori-infected patients. No optimal, simple antibiotic regimen has yet emerged. While choosing a treatment regimen for H. pylori, patients should be asked about previous antibiotic exposure and this information should be incorporated into the decision-making process. For first-line treatment, clarithromycin triple therapy should be confined to patients with no previous history of macrolide exposure who reside in areas where clarithromycin resistance amongst H. pylori isolates is known to be low. Most patients will be better served by first-line treatment with bismuth quadruple therapy or concomitant therapy consisting of a PPI, clarithromycin, amoxicillin, and metronidazole.30 The Asia-Pacific Consensus Conference recommended H. pylori eradication among infected patients with functional dyspepsia and those receiving long-term maintenance proton pump inhibitor for gastroesophageal reflux disease. In Asia, the currently recommended first-line therapy for H. pylori infection is PPI-based triple therapy with amoxicillin/metronidazole and clarithromycin for 7 days, while bismuth-based quadruple therapy is an effective alternative. There appears to be an increasing rate of resistance to clarithromycin and metronidazole in parts of Asia, leading to reduced efficacy of PPI-based triple therapy.34 The recommended doses are a twice daily, seven-day regimen of a proton pump inhibitor (omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg) or ranitidine bismuth citrate 400 mg, plus clarithromycin 500 mg and amoxicillin 1000 mg, or plus clarithromycin 500 or 250 mg and metronidazole 500 mg.35,36 This usually result to eradication of H. pylori infection in 80-90% of cases. In case of lack of efficacy, the 7-14 day treatment may be repeated using triple therapies (PPI + 2 antibiotics) substituting the antibiotic with the metronidazole or tetracycline, or


quadruple therapies (PPI + bismuth citrate + 2 antibiotics). Side effects during eradicative treatments occur in about 15 to 30% of patients.37


Reinforce advice on diet and lifestyle modification.

Patient Outcomes

On second visit, the patient must have improvement in symptoms and must be able to do usual activities of daily living or work. An improved quality of life may also be achieved based on simple instrument.

Continuing Visit


Evaluate the full 4 week treatment. If there is improvement but not total resolution of symptoms, the family physician may extend treatment until 8 weeks. Consider referral to a specialist service for patients of any age with gastro-oesophageal symptoms that are non-responsive to treatment or with H pylori that has not responded to second-line eradication therapy.8

Laboratory Tests

If there is response to treatment, the laboratory tests that showed positive results may be repeated after 3-6 months to monitor cure or further response to treatment. For patients on long-term NSAID therapy fecal occult blood testing may be done. Renal function may also be monitored in high-risk patients.38


Dyspepsia is a recurrent illness. Some people may need long-term and intermittent management of dyspepsia symptoms. Patients may need to be taught on self-

management when appropriate. PPI or H2 blocker therapy to the lowest dose needed to control symptoms should be adviced on an ‘as needed’ basis with people to manage their own symptoms. Patients on long-term management self-management should have an annual review of their condition.8

Recommendations for Implementation

Clinic Level

Quality improvement strategy is recommended for implementation of this pathway. This will involve pre- and post-intervention data collection using records review. Intervention strategies may be feedback, group consensus or incentive mechanisms. This strategy has been shown to be effective in improving the quality of care for patients with dyspepsia. Adherence to guideline criteria increased significantly among family physicians after the intervention (from 55% to 75%).39

references

1. Espallardo N and Alba ME. Management of Dyspepsia in Family Practice. Family Medicine Research Group. 2000.

2. Ford AC, Marwaha A, Sood R, Moayyedi P. Global prevalence of, and risk factors for, uninvestigated dyspepsia: a meta-analysis. Gut 2015; 64: 1049-57.

3. Ford AC, Marwaha A, Lim A, Moayyedi P. What is the prevalence of clinically significant endoscopic findings in subjects with dyspepsia? Systematic review and meta-analysis. Clin Gastroenterol Hepatol 2010; 8: 830-837.e2.

4. Chang JY, Locke GR 3rd, McNally MA, et al. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol 2010; 105: 822-32.

5. Talley NJ, Vakil N. Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol 2005; 100(10): 2324-37.

6. de Wit NJ, van Barneveld TA, Festen HP, Loffeld RJ, van Pinxteren B, Numans ME. NHG-CBO-werkgroep ‘Maagklachten’. [Guideline “Dyspepsia”]. [Article in Dutch] Ned Tijdschr Geneeskd. 2005; 149(25): 1386-92.

7. Rubin G, Meineche-Schmidt V, Roberts A, de Wit N. The use of consensus to develop guidelines for the management of Helicobacter pylori infection in primary care. European Society for Primary Care Gastroenterology. Fam Pract 2000; 17 Suppl 2:S21-6.


8. National Institute of Health Care and Clinical Excellence. Dyspepsia and gastro-oesophageal reflux disease. Investigation and management of dyspepsia, symptoms suggestive of gastro-oesophageal reflux disease, or both. 2014.

9. Bennet EJ, Piesse C, Palmer K, et al. Functional gastrointestinal disorders: psychological social and somatic features. Gut 1998; 42: 414-20.

10. Thompson. British Society of Gastroenterology. Dyspepsia Management Guidelines, September 1996.

11. American Gastroenterological Association. AGA Technical Review: Evaluation of Dyspepsia. Gastroenterology 1998; 114: 582-95.

12. Agreus L, Talley NJ. Challenges in managing dyspepsia in general practice. Br Med J 1997; 315: 1284-8.

13. Barbara L, Cammileri R, et al. Definition and investigation of dyspepsia: Consensus of An International Ad-Hoc Working Party. Digestive Diseases Science August 1989; 34(8): 1272-6.

14. Talley NJ. Functional dyspepsia: Advances in diagnosis and therapy. Gut Liver 2017; 11(3): 349-57.

15. Talley NJ, Lam SK, Foch KM. Management Guideline for Uninvestigated and Functional Dyspepsia in the Asia Pacific Region: 1st Asian Working Party on Functional Dyspepsia. J Gastroenterol Hepatol 1998; 13(4): 335-53.

16. Armstrong D, Marshall JK, Chiba N, Enns R, Fallone CA, Fass R, Hollingworth R, Hunt RH, Kahrilas PJ, Mayrand S, Moayyedi P, Paterson WG, Sadowski D, van Zanten SJ. Canadian Association of Gastroenterology GERD Consensus Group. Canadian Consensus Conference on the management of gastroesophageal reflux disease in adults - update 2004. Can J Gastroenterol 2005; 19(1): 15-35.

17. [No authors listed] Diagnosis and management of dyspepsia--clinical guideline, 1999. Dyspepsia Working Group, South African Medical Association, South African Gastroenterology Society Working Group. S Afr Med J 1999; 89(8 Pt 2): 897-903.

18. Dzieniszewski J, Jarosz M. Guidelines in the medical treatment of Helicobacter pylori infection. J Physiol Pharmacol 2006; 57 Suppl 3: 143-54.

19. Goh KL, Mahendra Raj S, Parasakthi N, Kew ST, Kandasami P, Mazlam Z. Management of Helicobacter pylori infection--a Working Party Report of the Malaysian Society of Gastroenterology and Hepatology. Med J Malaysia 1998; 53(3): 302-10.

20. Portincasa P, Colecchia A, Di Ciaula A, Larocca A, Muraca M, Palasciano G, Roda E, Festi D. Standards for diagnosis of gastrointestinal motility disorders. Section: ultrasonography. A position statement from the Gruppo Italiano di Studio Motilità Apparato Digerente. Dig Liver Dis 2000; 32(2): 160-72.

21. Drossman, D. Diagnosis and treatment of patients with refractory functional gastrointestinal disorders. Ann Int Med 1995; 123(9): 688-97.

22. Veldhuyzen van Zanten SJ, Bradette M, Chiba N, Armstrong D, Barkun A, Flook N, Thomson A, Bursey F. Canadian Dyspepsia Working Group. Evidence-based recommendations for short- and long-term management of uninvestigated dyspepsia in primary care: an update of the Canadian Dyspepsia Working Group (CanDys) clinical management tool. Can J Gastroenterol 2005; 19(5): 285-303.

23. Veldhuyzen van Zanten SJ, Flook N, Chiba N, Armstrong D, Barkun A, Bradette M, Thomson A, Bursey F, Blackshaw P, Frail D, Sinclair P. An evidence-based approach to the management of uninvestigated dyspepsia in the era of Helicobacter pylori. Canadian Dyspepsia Working Group. CMAJ. 2000; 162(12 Suppl): S3-23.

24. Paikka N. [Update on current care guidelines. A current care guideline: recurrent upper gastrointestinal symptoms]. [Article in Finnish] Duodecim 2012; 128(22): 2376-7.

25. Miwa H, Kusano M, Arisawa T, Oshima T, Kato M, Joh T, Suzuki H, Tominaga K, Nakada K, Nagahara A, Futagami S, Manabe N, Inui A, Haruma K, Higuchi K, Yakabi K, Hongo M, Uemura N, Kinoshita Y, Sugano K, Shimosegawa T. Japanese Society of Gastroenterology. Evidence-based clinical practice guidelines for functional dyspepsia. J Gastroenterol 2015; 50(2): 125-39. doi: 10.1007/s00535-014-1022-3. Epub 2015 Jan 14.

26. Jee SR, Jung HK, Min BH, Choi KD, Rhee PL, Kang YW, Lee SI. Korean Society of Neurogastroenterology and Motility. [Guidelines for the treatment of functional dyspepsia]. [Article in Korean] Korean J Gastroenterol 2011; 57(2): 67-81.

27. Armstrong D, Marshall JK, Chiba N, Enns R, Fallone CA, Fass R, Hollingworth R, Hunt RH, Kahrilas PJ, Mayrand S, Moayyedi P, Paterson WG, Sadowski D, van Zanten SJ. Canadian Association of Gastroenterology GERD Consensus Group. Canadian Consensus Conference on the management of gastroesophageal reflux disease in adults - update 2004. Can J Gastroenterol 2005; 19(1): 15-35.

28. Miwa H, Kusano M, Arisawa T, Oshima T, Kato M, Joh T, Suzuki H, Tominaga K, Nakada K, Nagahara A, Futagami S, Manabe N, Inui A, Haruma K, Higuchi K, Yakabi K, Hongo M, Uemura N, Kinoshita Y, Sugano K, Shimosegawa T. Japanese Society of Gastroenterology. Evidence-based clinical practice guidelines for functional dyspepsia. J Gastroenterol 2015; 50(2): 125-39. doi: 10.1007/s00535-014-1022-3. Epub 2015 Jan 14.

29. Axon AT, Bell GD, Jones RH, Quine MA, McCloy RF. Guidelines on appropriate indications for upper gastrointestinal endoscopy. Working Party of the Joint Committee of the Royal College of Physicians of London, Royal College of Surgeons of England, Royal College of Anaesthetists, Association of Surgeons, the British Society of Gastroenterology, and the Thoracic Society of Great Britain. BMJ 1995; 310(6983): 853-6.

30. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol 2017; 112(2): 212-39. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10.

31. Buckley M, Culhane A, Drumm B, Keane C, Moran AP, O’Connor HJ, Collins J, Kelleher D, McAvinchey D, Sloan J, O’Morain C. Guidelines for the management of Helicobacter pylori-related upper gastrointestinal diseases. Irish Helicobacter Pylori Study Group. Ir J Med Sci 1996; 165 Suppl 5: 1-11.

32. Fischbach W, Malfertheiner P, Hoffmann JC, Bolten W, Kist M, Koletzko S. Association of Scientific Medical Societies. Helicobacter pylori and gastroduodenal ulcer disease. Dtsch Arztebl Int 2009; 106(49): 801-8. doi: 10.3238/arztebl.2009.0801. Epub 2009 Dec 4.


33. Bytzer P, Dahlerup JF, Eriksen JR, Jarbøl DE, Rosenstock S, Wildt S. Danish Society for Gastroenterology. Diagnosis and treatment of Helicobacter pylori infection. Dan Med Bull 2011; 58(4): C4271.

34. Fock KM, Katelaris P, Sugano K, Ang TL, Hunt R, Talley NJ, Lam SK, Xiao SD, Tan HJ, Wu CY, Jung HC, Hoang BH, Kachintorn U, Goh KL, Chiba T, Rani AA; Second Asia-Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol 2009; 24(10): 1587-600. doi: 10.1111/j.1440-1746.2009.05982.x.

35. Hunt RH, Fallone CA, Thomson AB. Canadian Helicobacter pylori Consensus Conference update: infections in adults. Canadian Helicobacter Study Group. Can J Gastroenterol. 1999; 13(3): 213-7.

36. Goh KL, Mahendra Raj S, Parasakthi N, Kew ST, Kandasami P, Mazlam Z. Management of Helicobacter pylori infection--a Working Party Report of the Malaysian Society of Gastroenterology and Hepatology. Med J Malaysia. 1998; 53(3): 302-10.

37. Dzieniszewski J, Jarosz M. Guidelines in the medical treatment of Helicobacter pylori infection. J Physiol Pharmacol 2006; 57 Suppl 3:143-54.

38. Bush TM, Shlotzhauer TL, Imai K. Nonsteroidal anti-inflammatory drugs. Proposed guidelines for monitoring toxicity. West J Med. 1991; 155(1): 39-42.

39. Elwyn G, Owen D, Roberts L, Wareham K, Duane P, Allison M, Sykes A. Influencing referral practice using feedback of adherence to NICE guidelines: a quality improvement report for dyspepsia. Qual Saf Health Care 2007; 16(1): 67-70.


CLINICAL UPDATE

Clinical Pathways for the Management of Hypertension in Family and Community Practice

Noel L. Espallardo, MD, MSc, FPAFP; Limuel Anthony B. Abrogena, MD, FPAFP; Marishiel Mejia-Samonte, MD, DFM Anna Guia O. Limpoco, MD, FPAFP and Ryan Jeanne V. Ceralvo, MD, FPAFP

Background: Hypertension is a major risk factor for cardiovascular disease. The prevalence of hypertension in the Western Pacific Region is 37% of adults older than 24, while in the Philippines it is 25% of adults 21 years old and above. Several guidelines have been developed for the management of hypertension. All these guidelines have recommendations for assessment and treatment. Objectives: The overall objective of the development and implementation of this clinical pathway is to improve outcomes of patients with hypertension seen in family and community practice. Methods: The PAFP Clinical Pathways Group reviewed published medical literature to identify, summarize, and operationalize the clinical content of diagnostics, interventions and clinical indicators or outcomes to develop an evidence-based clinical pathway in family medicine practice. The group developed a time-related representation of recommendations on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions as well as social and community strategies to treat hypertension and prevent complications.Recommendations: Recommendations were made based on the number of visits. During the first visit, all adult patients consulting at the clinic should be screened for hypertension with appropriate BP measurement. A thorough history focusing on symptoms, family history using genogram, smoking and other lifestyle and co-existing chronic disease and a thorough physical examination focusing on the weight/BMI, waist/hip ratio, funduscopy, neurological, cardiac, renal and peripheral arteries should be done. For the laboratory, request for 12-lead ECG, urinalysis, FBS, creatinine, serum K and lipid profile to determine co-morbidities and baseline values. If the patient is already diagnosed hypertensive, start/continue medications with either or a combination of thiazide-type diuretic, calcium channel blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blocker depending on co-morbidities or side effects. But if there is a need for further confirmation, no medication is warranted. Educate the patient about hypertension, risk factors and complications. If medications were prescribed, explain the dose, frequency, intended effect, possible side effects and importance of medication adherence. Lifestyle modifications focusing on weight control, exercise and smoking cessation should be adviced. During the first visit it is expected that the patient is aware of the diagnosis of hypertension, its risks factors and complications to encourage compliance. Implementation: Education, training and audit are recommended strategies to implement the clinical pathway.


IntroductIon

Hypertension is a condition of persistently high systemic arterial blood pressure. It is currently defined as a systolic pressure consistently greater than 140 mm Hg or diastolic pressure is consistently 90 mm Hg or more in multiple readings.1 Blood pressure measurement should be taken on two separate occasion at least one week apart. Hypertension is a major risk factor for cardiovascular disease. Worldwide, it is estimated that almost half of deaths due to stroke and heart disease are cause by hypertension. Adequate management of hypertension may lead to a significant decrease in stroke and myocardial infarction. The prevalence of hypertension in the Western Pacific Region is 37% of adults older than 24, while in the Philippines it is 25% of adults 21 years old and above.2 This is approximately 10 million adults in 2008 and the incidence is increasing.3 In 2010, hypertension is the leading single risk factor for global burden of disease.4 The annual mortality per 100,000 people from hypertensive heart disease in Philippines has increased by an average of 3.9% a year since 1990. In 2013 there were 696 deaths per 100,000 among men 690 deaths per 100,000 among women. The mortality rate is highest at age 80 and above in both sexes.5 The cost of treatment is usually attributed to antihypertensive drugs (42.7%), followed by hospital admission (28.4%), clinic visits (15.1%) and laboratory tests (10.6%).6 Several guidelines have been developed for the management of hypertension. All these guidelines have recommendations for assessment and treatment. Aside from pharmacologic treatment, they also recommended lifestyle interventions like smoking cessation, reduction of sodium and fat intake, aerobic exercise, maintenance of ideal body mass index and moderation of alcohol intake. For patients with co-morbidity like diabetes and dyslipidemia, pharmacologic treatment to control blood sugar and cholesterol is adviced.7 These guideline recommendations are published in several medical journals from Canada, USA, Europe and UK. This clinical pathway for hypertension is an attempt to implement these recommendations in family and community medicine practice in the Philippines.

The overall objective of the development and implementation of this clinical pathway is to improve outcomes of patients with hypertension seen in family and community practice. This is expected to be achieved by: 1) Improving the quality of care for patients with hypertension in individual clinic of family and community medicine practitioners, 2) Standardizing the quality of care among the members of the Philippine Academy of Family Physicians, Inc., 3) Implementing organizational and health system strategies to promote the use of this clinical pathway.

Methods of Development and Implementation

The PAFP Clinical Pathways Group reviewed published medical literature to identify, summarize, and operationalize the clinical content of diagnostics, interventions and clinical indicators or outcomes to develop an evidence-based clinical pathway in family medicine practice. The group developed a time-related representation of recommendations on patient care processes, in terms of history and physical examination, laboratory tests, pharmacologic and non-pharmacologic interventions as well as social and community strategies to treat hypertension and prevent complications. The group adopted several strategies in developing the recommendations. The first strategy is emphasizing on evidence-based recommendations as recommended assessments and interventions. The second strategy is recognition of potential variations between-patient and between specific practice settings. The third strategy is the recognition of “stakeholder groups” outside of family and community practice with careful attention to getting their opinion and support but without sacrificing the objectives of the project. The fourth strategy is emphasis on the commitment to establishment of the ultimate goal of improving the effectiveness, efficiency and quality of patient care in family and community practice. The evidences for the patient care processes were reviewed and summarized as notes on the recommendations. The clinical pathway was then disseminated to the selected PAFP chapters and members and other stakeholders for


consensus development. Dissemination was publication in the Filipino Family Physician journal, conference presentations and focused group discussions. The implementation of clinical pathways to be adopted by the PAFP will be quality improvement activities in a form of patient record reviews, audit and feedback. Audit standards will be the assessment and intervention recommendations in the clinical pathway. Implementation of clinical pathways will be at the practice and organizational levels. Practice level can be a simple count of family and community medicine practitioners using and applying the clinical pathways. Organizational outcomes can be activities of the PAFP devoted to the promotion, development, dissemination and implementation of clinical pathways.

Grading of the Recommendations

The PAFP QA Committee met as a panel and graded the recommendations as shown in Table 1. The grading system was a mix of the strength of the reviewed published evidence and the consensus of a panel of experts. In some cases, the published evidence may not be applicable if Philippine family practice setting, so a panel grade based on the consensus of clinical experts was also used. Thus if the recommendation was based on a published evidence that is a well done randomized controlled trial and the panel of expert voted unanimously for the recommendation, it was given a grade of A-I. If the level of evidence is based on an observational study but the panel still unanimously considered the recommendation, the grade given was A-II and if the level of evidence is just an opinion but the panel still unanimously recommended it, the grade was A-III.

Table 1. Grading of the recommendations.

Panel Grade Level Evidence Grade Level 1 2 3

A A-I A-II A-III B B-I B-II B-III C C-I C-II C-III

Panel Grade Levels

A - All the panel members agree that the recommendation should be adopted because it is relevant, applicable and will benefit many patients.

B - Majority of the panel members agree that the recommendation should be adopted because it is relevant, applicable in many areas and will benefit many patients.

C - Panel members were divided that the recommendation should be adopted and is not sure if it will be applicable in many areas or will benefit many patients.

Evidence Grade Levels

I - The best evidence cited to support the recommendation is a well-conducted randomized controlled trial. The CONSORT standard may be used to evaluate a well-conducted randomized controlled trial.

II - The best evidence cited to support the recommendation is a well-conducted observational study i.e. match control or before and after clinical trial, cohort studies, case control studies and cross-sectional studies. The STROBE statement may be used to evaluate a well-conducted observational study.

III - The best evidence cited to support the recommendation is based on expert opinion or observational study that did not meet the criteria for level 2.

In the implementation of the clinical pathways, the PAFP QA committee strongly recommend compliance to guideline recommendations that are graded as either A-I, A-II or B-I. However, the committee also recommend using sound clinical judgment and patient involvement in the decision making before applying the recommendations.


Pathway Recommendations

Visit

First Visit

Variations


__All adult patients consulting at the clinic should be screened for high blood pressure with appropriate BP measurement (A-III)__Make a thorough history focusing on symptoms, family history using genogram, smoking and other lifestyle and co-existing chronic disease (A-II)__Make thorough physical examination focusing on the weight/BMI, waist/hip ratio, funduscopy, neurological, cardiac, renal and peripheral arteries (A-II)

Pathway decisions__If BP is ≥ 140/90 mmHg with signs and symptoms of acute end-organ damage, consider referral to hospital (A-III)__If the initial BP is ≥ 180/110 mmHg consider hypertension and start medication. (A-III)__IF BP is ≥ 140/90 mmHg and with previous history of high BP taken by another health professional within the month consider hypertension and start medication. (A-III)__If BP is ≥ 140/90 mmHg and first time high BP confirm with home BP measurements or second visit within 4 weeks (A-III)

Laboratory

Diagnosed hypertension__Request for 12-lead ECG, urinalysis, FBS, creatinine, serum K and lipid profile to determine co-morbidities and baseline values (B-II)

Pathway decisions__ For patients with previously diagnosed co-morbidities, refer to specific pathway for management of co-morbidity (A-III)


Diagnosed hypertension__Start/continue medications with either or a combination of thiazide-type diuretic, calcium channel blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blocker depending on co-morbidities or side effects (A-I)

Need to confirm hypertension__No medications are warranted (A-III)

Patients for emergency referral__Consider giving a single dose of anti-hypertensive prior to transport (A-I)


Patient interventions__Educate the patient about hypertension, risk factors and complications (A-I)__If medications were prescribed, explain the dose, frequency, intended effect, possible side effects and importance of medication adherence (A-I)__Lifestyle modifications focusing on weight control, exercise and smoking cessation (A-I) Family interventions __Inquire and recommend family members’ lifestyle activities (A-I) Community interventions __Inquire for community lifestyle activities (A-III)

Continuing care__Follow-up after 1-2 weeks (A-II)__Offer family wellness package (A-III)

Patient Outcomes

__Aware of initial diagnosis (A-III)__Aware of risk factors and complications (A-III)__Aware of importance of adherence to diagnostics and interventions (A-III)

Pathway Tasks


Visit

Second Visit

Variations


__Review and note any change in history focusing on symptoms, family history using the genogram, smoking and other lifestyle and co-existing chronic disease (A-II)__Repeat and note any change in physical examination focusing on the weight/BMI, waist/hip ratio, funduscopy, neurological, cardiac, renal and peripheral arteries (A-II)__Review BP monitoring if available (A-II)__Review laboratory results and establish the presence of other risk factors and co-morbidities (A-II)

Pathway decisions__If home BP and/or second visit BP are ≥ 140/90 mmHg diagnose as hypertension (A-II)__If home BP and/or second visit BP are < 140/90 mmHg rule out hypertension but monitor after 6-12 months (A-III)

Laboratory

Diagnosed hypertension__Complete request for 12-lead ECG, urinalysis, FBS, creatinine, serum K and lipid profile to determine co-morbidities and baseline values (B-II)



Diagnosed hypertension__Start/continue medications with either or a combination of thiazide-type diuretic, calcium channel blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blocker depending on co-morbidities or side effects (A-I)

With co-morbidities__Refer to clinical pathway of the co-morbidity (A-III)


Patient interventions__Enhance education about hypertension, risk factors and complications (A-I)__If medications were prescribed, repeat explanation about the dose, frequency, intended effect, possible side effects and importance of medication adherence (A-I)__Enhance advice on lifestyle modifications focusing on weight control, exercise and smoking cessation (A-I) Family interventions __Enhance recommendation for family members’ appropriate lifestyle activities (A-I) Community interventions __Recommend participation in appropriate community lifestyle activities (A-III)

Continuing care__Follow-up after 1 month until BP target is achieved and every 3-6 months if BP target is already achieved (A-III)

Patient Outcomes

__Improved BP control (Age 18 to 59: <140/90 mmHg; Age > 60: <150/90 mmHg) (A-II)__ Body mass index between 18.5-24.9 kg/m2 (A-II)__Modification of risk factors i.e. diet, lifestyle, smoking and exercise (A-II) __Absence of new complications (A-III) __Adherence to diagnostics and interventions (A-II) __Agreed plan for family intervention (A-III) __Agreed plan for community involvement (A-III)

Pathway Tasks


Visit

Continuing Visit

Variations


__Review and note any change in history focusing on symptoms, family history using genogram, smoking and other lifestyle and co-existing chronic disease (A-II)__Repeat and note any change in physical examination focusing on the weight/BMI, waist/hip ratio, funduscopy, neurological, cardiac, renal and peripheral arteries (A-II)__Review laboratory results and establish the presence of other risk factors and co-morbidities (A-II)

Pathway decisions__Enhance/revise pharmacologic and non-pharmacologic interventions until BP control is achieved (Age 18 to 59: <140/90 mmHg;Age > 60: <150/90 mmHg) (A-III)

Laboratory

Diagnosed hypertension__After 6-12 months repeat for 12-lead ECG, urinalysis, FBS, creatinine, serum K and lipid profile (B-II)



Diagnosed hypertension__Continue/revise medications with either or a combination of thiazide-type diuretic, calcium channel blockers, angiotensin-converting enzyme inhibitors and angiotensin receptor blocker depending on co-morbidities or side effects (A-I)

With co-morbidities__Refer to clinical pathway of the co-morbidity (A-III)


Patient interventions__Enhance education about hypertension, risk factors and complications (A-I)__If medications were prescribed, repeat explanation about the dose, frequency, intended effect, possible side effects and importance of medication adherence (A-I)__Enhance advice on lifestyle modifications focusing on weight control, exercise and smoking cessation (A-I) Family interventions __Enhance recommendation for family members’ appropriate lifestyle activities (A-I) Community interventions __Recommend participation in appropriate community lifestyle activities (A-III)

Continuing care__Follow-up after 1 month until BP target is achieved then every 3-6 months if BP target is already achieved (A-III)

Patient Outcomes

__Improved BP control (Age 18 to 59: <140/90 mmHg; Age > 60: <150/90 mmHg) (A-II)__ Body mass index between 18.5-24.9 kg/m2 (A-II)__Modification of risk factors i.e. diet, lifestyle, smoking and exercise (A-II) __Absence of new complications (A-III) __Adherence to diagnostics and interventions (A-II) __Agreed plan for family intervention (A-III) __Agreed plan for community involvement (A-III)

Pathway Tasks


Notes on the Recommendations

The subsequent sections discuss the clinical evidences to support the recommendations in this clinical pathway. The recommendations are packages of health care interventions designed to improve clinical outcomes of patients with hypertension. This is supposed to be implemented by family and community doctors in their outpatient clinics. The recommendations cover history and physical examination, laboratory, pharmacologic and non-pharmacologic intervention. Pharmacologic interventions include prescription of anti-hypertensive drugs. Non-pharmacologic interventions include health education, lifestyle modification, and family and community intervention. The interventions are designed to achieve patient outcomes that include blood pressure control, control of risk factors, prevention of complications and improved quality of life. The current evidences on hypertension treatment look at the effectiveness of individual intervention. Currently, a package of interventions including: 1) healthy lifestyle counseling (smoking cessation, and salt, oil, and alcohol reduction); 2) prescription of a combination of drugs (antihypertensives, aspirin, and statin); and 3) adherence support for drug compliance and healthy lifestyle change is now being tested in a cluster randomized controlled trial. The primary outcome is the incidence of severe cardiovascular events over 24 months of follow-up. This trial will show the effectiveness of the comprehensive cardiovascular event reduction package for hypertensive patients in routine practice. This will also identify the barriers and facilitators to implementation and get informed advise on policy and practice change.8

First Visit


It is recommended that a blood pressure measurement should be done to all patients consulting in a family or community clinic. It is however not necessary to measure

the blood pressure of every patient at every clinic visit. The Canadian Hypertension Education Program recommended measurement only during appropriate visits that include periodic health examinations, urgent office visits for neurologic or cardiovascular-related issues, medication renewal visits, and other visits where the primary care practitioner deems it an appropriate opportunity to monitor blood pressure.9 History and physical examination should be done to all patients suspected or diagnosed with hypertension. History should include checking for family history using the genogram. Family history of hypertension, cardiovascular and cerebrovascular disease and diabetes should be actively elicited. The physical examination should focus not only on the blood pressure measurement but also with the body mass index. Organ system that may be damaged by high blood pressure should be examined like the central nervous system, retina, heart, kidneys and peripheral arteries. All these findings should be clearly written in the patient’s clinical record.

Checkbox for History

• Whatisyourhighest/lowestbloodpressureinthepast?Whatisyour usual blood pressure?

• When did it start? When did it happen? When were youdiagnosed as hypertensive?

• Obtain following information: extent of end-organ damage(eg, heart, brain, kidneys, eyes), assessment of patients’ cardiovascular risk status and exclusion of secondary causes of hypertension

• What happened during that time?Whatwere the triggering/contributory factors? What were you doing that time?

• What symptoms did you experience? Headache, dizziness,blindness/blurring of vision, chest pain/discomfort, difficulty of breathing/shortness of breath, epigastric pain, difficulty in urination, hematuria, edema (face, upper and lower extremities), leg/foot pain?

• Aside from hypertension what other diseases/illnesses doesthe patient have?

• Past Medical History: If the patient is a male, ask if he tookany pill/powder form for protein building? If the patient is a female, did she take any oral contraceptive pill? Intake of other maintenance drugs/vitamins/herbal medicines/supplements


• Family History: hypertension, coronary artery disease,sudden death, cerebrovascular accident, diabetes mellitus, hyperthyroidism, cancer. Draw genogram.

• Lifestyle:diet:whatdoyouusuallyeat?Whatareyoufondof?Do you have food preferences? Do you eat fish, vegetables and fruits? If yes, how many servings do you get per meal? Do you use condiments? Give a sample menu for a day. Are you taking any supplements? Any weight gain/loss? Exercise/any form of physical activity? Sports? How often?

• Substance use/abuse: smoking/tobacco alcohol illicit drugsenergy drinks caffeine/coffee. If yes, ask for the amount, how often? What does he feel after?

• Occupation: time of work?What are his preparations beforegoing to work? Is he pressured? Do you work overtime? How often? Was there any instance that you were late or absent due to high blood or any other disease? When was the last time you were on a vacation?

• Last check-up? Last blood chemistry done? What were theresults? Increased total cholesterol/LDL and decreased HDL

Checkbox for Physical Examination

• Bloodpressuremeasurement:botharmsandiffeasibleinoneleg

• Officereading(clinic):• Other vital signs: cardiac rate, respiratory rate, temperature,

BMI• General: conscious, coherent, oriented to time, person and

place• Skin:color(cyanosis)• Fundoscopic exam: floaters, arteriovenous nicking, exudates,

hemorrhages, papilledema• Examinetheneck:distendedveins,enlargedthyroidglandand

listen for carotid bruits• Cardiac exam: displacement of apex, sustained and enlarged

apical impulse, presence of heaves, thrills, murmurs• Abdomen: waist circumference, waist to hip ratio,

organomegaly, mass, listen for renal artery bruit• Extremity: edema, deformity, palpation of pulses (absent,

weak, delayed), mid-upper arm circumference • Neurologic exam: cranial nerves, cerebellar function, motor

and sensory • For adults, Beck’s Depression Scale may be used to assess

possible psychosocial stressors*• FortheelderlypleasedoMini-MentalStatusExaminationand

Geriatric Depression Scale*

* These may be done in cases where compliance to medication may be affected by these findings.

The history and physical examination must be written legibly in a clinical record. A random sample of 18 general practice in London showed that 340 (47%) of 716 patients consulting in a 10 year period had no blood pressure readings in their records. Of 84 hypertensive patients with records, 62 (74%) had no physical examination performed by the physician. Absence of data from the records may suggest deficiencies in the management of hypertension in general practice.10 This should be avoided in the Philippine family and community medicine practice. Assessment of absolute cardiovascular risk is a rational method of managing hypertension. Determination of the presence or absence of these factors must be the focus of history taking. The CONTROLRISK study was designed to determine how the cardiovascular risk profile of the hypertensive patients were being conducted at primary care and specialist setting in Spain. In this study, target organ damage and associated clinical conditions were more frequently obtained in specialist setting. The most common risk factor was age. The most frequently reported target organ damage was left ventricular hypertrophy. Ischemic heart disease was the most common associated clinical condition. In this study, physicians tend to underestimate the cardiovascular risk in daily clinical practice.11 A similar study in UK also showed that risk was correctly estimated in 21% of patients, underestimated in 63% of patients, and overestimated in 16% of patients. It is therefore recommended that family and community medicine practitioners use cardiovascular risk charts or tables in the management of hypertensive patients.12 Office BP measurement (OBPM) should be performed using an electronic oscillometric device. Measurement by aneroid sphygmomanometers has not been found to be accurate. Maintenance of the quality of aneroid sphygmomanometers has also been low. A study to check the instruments against British Hypertension Society guidelines, only 38.8% of anaeroid instruments were accurate at all test pressure levels. The defects noted could have an impact on diagnosis and monitoring of hypertension.13 If a patient has elevated blood pressure reading readings in the office (≥ 140/90), a series of standardized out-of-office blood


pressure measurements should be performed in order to rule out white-coat hypertension.14

Laboratory Tests

Most studies on hypertension profiling include not only history and physical examination but also laboratory evaluation. In one study, medical examination included weight, height, blood pressure and laboratory analyses including fasting blood glucose, serum cholesterol, serum triglycerides, electrocardiogram and simple spirometry.15

Caution must be raised against over requesting for laboratory tests. In clinics where office chemistry machine is available, the test requests increased but the level of blood pressure control was the same.16 Since most outpatient treatment is out-of-pocket, it is better to save some money for drugs. Pharmacologic Interventions

There is enough evidence that pharmacologic treatment of hypertension prevents stroke, congestive heart failure, and other blood pressure-related complications. Even among the elderly, the Systolic Hypertension in the Elderly Program (SHEP) also showed a reduction in myocardial infarction and other coronary

events in older patients. Similar findings of cardiovascular mortality reduction was also seen in the Swedish STOP-Hypertension Trial and the British MRC Trial in Older Patients. These studies have in common the use of diuretics and/or beta blockers.17 In general, the initial antihypertensive treatment should include one or a combination of thiazide-type diuretic, calcium channel blocker, angiotensin-converting enzyme inhibitor, or angiotensin receptor blocker. But angiotensin-converting enzyme inhibitor and angiotensin receptor blocker cannot be combined.18 The choice of drug class will depend on the co-morbid condition, cost and patient preference after these have been explained. After deciding on what drug class to prescribe, the next is to choose the specific drug. The choice of individual drugs depend on efficacy, safety, suitability, and cost. There are number of options within each class. It may be good for the family and community doctor to narrow their choice to only 1-2 preferred options for a particular patient based on the above factors. This may be included into a personal formulary or essential drug list. This will allow the physician to have more experience and become more familiar with the expected drug effect, adverse effects, and interactions. A new drug also needs to be evaluated before it is added to the personal formulary.19

Table 1. Antihypertensive Drugs for Maintenance

ACE Inhibitors (ACEIs)

Captopril*

Enalapril*

Drugs Dose

25 mg tab25-50 mg per dayBID

5, 10 and 20 mg tab5-40 mg per dayBID

Indication

Heart failure, left ventricular (LV) dysfunction, diabetic, myocardial infarction (MI)

Adverse Reaction

Cough, hyperkalemia

Headache, dizziness, fatigue, nausea, diarrhea, decreased hgb/hct, cough, hyperkalemia

Remarks

Contraindicated in pregnancy and lactation


Angiotensin II Receptor Antagonists (ARBs)

Candesartan*

Irbesartan*

Losartan*+

Olmesartan

Telmisartan*

Valsartan*

Drugs Dose

8 and 16 mg tab8 – 16 mg per dayOD

150 and 300 mg tab150 – 300 mg per dayOD

50 and 100 mg tab 50 – 100 mg per dayOD

10, 20 and 40 mg tab10 – 40 mg per day OD

40 and 80 mg tab40 – 80 mg per day OD

80, 160 and 320 mg tab 80 – 320 mg per dayOD for maintenance BID for HF and MI°40 mg per day for children <35 kg

Indication

Heart failure and impaired LV systolic function

Diabetics and mild renal disease

LVH and for renal protection in Type 2 diabetic patients

Prevention of cardiovascular morbidity and mortality in patients > 55 y/o with high CV risk

Heart failure, post-MI, delay of diabetes progression in hypertensives at CV risk and children 6 – 18 y/o

Adverse Reaction

Angioedema, hyperkalemia, hypoglycemia, acute renal failure, hepatic dysfunction, agranulocytosis, rhabdomyolysis, interstitial pneumonia

Fatigue, edema, nausea, vomiting, dizziness, headache

Diarrhea, abdominal pain, nausea, headache, dizziness, hyperkalemia, hypotension, URI symptoms, angioedema, anemia, liver function abnormalities, vomiting, myalgia, arthralgia, photosensitivity

Dizziness

Diarrhea, abdominal pain, nausea, headache, dizziness, fatigue, light-headedness, hypotension, URI symptoms, hyperkalemia, intermittent claudication and skin ulcer

Dizziness, postural dizziness, hypotension, renal failure and impairment

Remarks

Contraindicated in pregnancy and lactation

Contraindicated in moderate to severe renal impairment, pregnancy and lactation

Contraindicated in pregnancy and co-administration with aliskiren in diabetic patients

Contraindicated in pregnancy (2nd & 3rd trimester) and lactation

Contraindicated in cholestasis, biliary tract disorder, severe hepatic impairment, pregnancy and lactationFood decrease bioavailability

Contraindicated in pregnancy

Cardioselective Beta-blockers (BBs)

Atenolol*

Metoprolol*

25, 50 and 100 mg tablet25 – 100 mg per dayOD

50 and 100 mg tablet100 – 400 mg per dayBID

Angina, MI or heart failure

Angina, MI or heart failure

Bradycardia, decreased libido

Fatigue, weakness, orthostatic hypotension, impotence, drowsiness, bradycardia, pulmonary edema, CHF

Contraindicated in sinus bradycardia, cardiogenic shock, acute unstable HF

Contraindicated in sinus bradycardia, cardiogenic shock, acute unstable HF


Propranolol

Drugs Dose

10 and 40 mg tab160-320 mg per dayBID

Indication

Angina, anxiety, migraine, post-MI, arrhythmia

Adverse Reaction

Fatigue, weakness, orthostatic hypotension, impotence, drowsiness, bradycardia, pulmonary edema, CHF

Remarks

Take before mealsContraindicated in patients with history of bronchial asthma or bronchospasm, cardiogenic shock, tachycardia, 2nd and 3rd degree block

Calcium Channel Blockers (CCBs)

Nifedipine

Amlodipine*+

Felodipine*

5, 30 mg cap5-30 mg per day

5 and 10 mg tab5-10 mg per dayOD

2.5, 5 and 10 mg tab2.5 – 10 mg per dayOD

Headache, vomiting

Peripheral edema, headache, sleep, urinary, visual and taste disturbance, abdominal pain, nausea, palpitations, flushing

Peripheral edema, headache, flushing, palpitations

5 mg preparation is short-acting30 mg preparation is extended-release

Contraindicated for unstable angina, uncompensated heart failure, acute MI, pregnancy

Contraindicated for unstable angina, uncompensated heart failure, acute MI, pregnancy

Combined Alpha & Beta Blocker

Carvedilol* 6.25 and 25 mg tab6.25 – 50 mg per dayOD - BID

Angina and mild to moderate heart failure

Diarrhea, nausea, dizziness, abnormal or blurred vision

Contraindicated in unstable heart failure, 2nd or 3rd degree AV block, severe bradycardia or hypotension, history of COPD or bronchospasm

Thiazide Diuretics

Hydrochlorothiazide 12.5 and 25 mg tab12.5 - 100 mg per dayOD

Edema and nephrogenic diabetes insipidus

Dry mouth, thirst, weakness, lethargy, muscle pain, cramps, hypotension

Contraindicated in renal impairment, can cause hyperglycemia

Combination drugs

Hydrochlorothiazide-losartan

Hydrochlorothizide (50-100mg)-losartan (12.5-25mg)

Dry mouth, thirst, weakness, lethargy, muscle pain, cramps, hypotension diarrhea, abdominal pain, nausea, headache, dizziness, URI symptoms, cough

Contraindicated in renal impairment, can cause hyperglycemia, pregnancy

* Drugs included in PNDF 2008+ Available at local health centers under the DOH program for noncommunicable diseases

CSAP – Chronic Stable Angina PectorisDM – Diabetes MellitusHCTZ – HydrochlorothiazideHF – Heart FailureMI – Myocardial Infarction



Knowledge about patient-related determinants of adherence to interventions (pharmacologic and non-pharmacologic) is needed to improve the management and outcomes of hypertensive patients. One study tried to measure the association between patient-related determinants (medication self-efficacy, beliefs about medication and hypertension, social support, and satisfaction with care) and treatment adherence. Medication self-efficacy and fewer concerns about medication use were associated with improved pharmacologic and non-pharmacologic intervention adherence. Family and community doctors should support medication adherence by paying attention to patients’ medication self-efficacy, the concerns they may have about medication use and patients’ perceptions on hypertension.20 This can be achieved by patiently explaining hypertension as a health problem and the risks associated with it. The medication dose, effect, potential side effect and cost should also be explained. This will eventually lead to adherence to interventions. A cross sectional study in family practice clinics showed that two-thirds of patients described hypertension based on biomedical definition. Half of them believed that stress was a cause of their high blood pressure; two-thirds were aware that stroke and heart attack respectively are possible consequences of hypertension. As a result, three-quarters were fully adherent to their medications in the preceding month.21 This study showed that appropriate awareness of hypertension and its consequences resulted to an improved adherence to interventions. Despite the absence of strong evidence, most family physicians should still offer non-pharmacological management at the first consultation before prescribing medication. However, few offered detailed and structured interventions. Dietary therapy, restriction of alcohol consumption and exercise were suggested by most. Restriction of sodium intake and behavioural therapy were less popular non-pharmacological interventions. These non-pharmacologic advices were consistent with current guidelines on the treatment of hypertension.22 In order to

accommodate cultural variations, it is advised that family and community medicine practitioners should develop a structured non-pharmacologic intervention program. Use of flyers, audio visual presentation at the waiting room and face-to-face health education may be used. The purpose of patient information leaflets is to inform patients about the administration, precautions and potential side effects of their prescribed medication. However, this must be prepared carefully. One study showed that current description of potential risk information caused feelings of fear and anxiety to the patients. Flyers need to convey potential risk information in a language that is less frightening while retaining the necessary information.23 Dietary fat plays a major role in the development of cardiovascular disease. Modification of fat intake could have a preventive potential. The guideline of the German Nutrition Society recommended to reduce total and saturated fat intake. It also recommended increased intake of polyunsaturated fatty acids. A high fat intake increases the risk of obesity with probable evidence when total energy intake is not controlled for. When energy intake is controlled for, there is probable evidence for no association between fat intake and risk of obesity.24 There should be a balance between calorie source from fats and carbohydrates. There are few randomized controlled trial studies on the effectiveness of dietary intervention for hypertensive patients in family practice. But family and community practice is an ideal setting for the provision of lifestyle interventions for patients with hypertension. There is currently an ongoing randomized controlled trial that may release its results soon. The trial will test a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake. The results will provide scientific rationale for the implementation of this lifestyle intervention in primary care.25 With regards to advice on exercise, the results of a systematic review suggested that physical activity of moderate intensity involving rhythmic movements with the lower limbs for 50-60 minutes, 3 or 4 times per week, reduces blood pressure and appears to be more effective


than vigorous exercise. With this type of exercise, harm is uncommon and is generally restricted to musculoskeletal strain. Injury occurs more often with jogging than with walking, cycling or swimming. People with mild hypertension should engage in 50-60 minutes of brisk walking or cycling, 3 or 4 times per week to reduce blood pressure. Exercise should be prescribed as an adjunctive intervention to pharmacologic therapy for hypertension. People who do not have hypertension should also participate in regular exercise as it reduce the risk of coronary artery disease.26

A systematic review of randomized clinical trials was conducted to evaluate the acceptability and usefulness of computerized patient education interventions. Most interventions used instructional programs for educational intervention. Others used information support networks and computer systems for health assessment and history-taking. Most studies reported positive results for interactive educational intervention. Computerized educational interventions can lead to improved health status in several major areas of care and serve as a valuable supplement to face-to-face education with physicians.27

Table 2. Patient-directed Non-pharmacologic Interventions.

Health Education

BP controlBP goal

BP monitoring

Compliance

Target weight

Diet

Fitness

Moderation of alcohol intake and smoking cessation

Others

Follow up

Goals Recommendations: EDUCATE patients on the following

Lifetime risk of hypertensionhypertension increases with advancing age The higher the BP, the greater the chance of heart attack, HF, stroke, and kidney diseases

For those >50 years of age, will reach the DBP goal once the SBP goal is achieved, the primary focus should be on attaining the SBP goalIn patients with hypertension and diabetes or renal disease, the BP goal is <130/80 mmHg Treating SBP and DBP to targets that are <140/90 mmHg is associated with a decrease in CVD complications Goal blood pressure targets should be reached within a month of starting treatment either by increasing the dose of an initial drug or by using a combination of medications*

Clinicians should provide to patients, verbally and in writing, their specific BP numbers and the BP goal of their treatment

Emphasize that antihypertensive therapy has been associated with reductions in (1) stroke incidence, (2) myocardial infarction (MI), and (3) Heart Failure (HF), hence importance of compliance

Maintain normal body weight (body mass index 18,5-24.9 kg/m2

Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension in a large proportion of overweight persons

Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Consume a diet rich in fruits, vegetables, and low fat dairy products with a reduced content of saturated and total fat Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium or 6 g sodium chloride) Decrease portion sizes for meals and snacksDecrease frequency and consumption of –containing beverages

(when able) Engage in regular aerobic physical activity such as brisk walking at least 30 minutes per day most days of the week ormoderate to vigorous activity 3-4 days a week averaging 40 min per session*Increase physical activity such as walking, biking, aerobic dancing basketball and other sports Decrease time in sedentary activities such as watching television, playing videogames or on line

Alcohol intake should be limited to no more than 1 oz (30 mL) of ethanol, the equivalent of two drinks per day in most men and no more than 0.5 oz of ethanol (one drink) per day in women and lighter weight persons Patients should be strongly counseled to quit smoking

Control blood glucose and lipids*

most patients should return for follow up and adjustment of medications at monthly intervals or until the BP goal is reached


Table 3. Family-directed Non-pharmacologic Interventions.

LifestyleFamily Diet

Fitness

Goals Recommendations

Encourage family meals adhering to DASH eating plan, wherein food served should be HIGH in: Fruits and vegetables (4-5 servings each per day; fiber (7-8 servings per day); low fat dairy products (2-3 servings per day); lean meat (2 servings per day); calcium; magnesium; potassiumLOW in saturated fat, cholesterol, salt such as unsalted nuts, almonds, peanuts, chocolate, cocoa butter, coconutIncrease intake of polyunsaturated fatty acids such as *Foods and oils including walnuts, sunflower seeds, fish such as salmon, mackerel, corn oil, soybean oil

Encourage family members engaging in physical activitiesFamily members should have physical activity of moderate intensity involving rhythmic movements with the lower limbs for 50-60 minutes, 3 or 4 times per week Family members with mild hypertension should engage in 50-60 minutes of brisk walking or cycling, 3 or 4 times per weekFamily members who do not have hypertension should also participate in regular exercise as it reduce the risk of coronary artery disease.

Table 4. Community-directed Non-pharmacologic Interventions

LifestyleFamily Diet

Community Programs

Goals Recommendations

Inquire if patient and family aware of existing community lifestyle activities

Inquire if patient and family aware and willing to participate in existing local health center and programs on hypertension in the community

Patient Outcomes

Awareness by the patient on the diagnosis of hypertension and its consequences is an important patient outcome during the first visit. A study looked at the association between patient-related determinants (medication self-efficacy, beliefs about medication and hypertension, social support, and satisfaction with care) and treatment adherence. After follow-up medication self-efficacy and fewer concerns about medication use were associated with improved medication adherence. Self-efficacy was also associated with adherence to lifestyle recommendations at baseline.20 Thus an initial and continuing adequate knowledge about the disease and the purpose of the interventions lead to better adherence and eventually control of hypertension.

Second Visit

History and Physical Examination and Laboratory Tests

The family doctors should review and complete the needed information based on the checklist. The needed laboratory and its results should be completed and reviewed.


Based on the initial response to medications, the physician may use the stepped care approach to control the blood pressure.



During the second and continuing visits, repeated delivery of educational intervention should be done. During the first and second visits face-to-face, paper-based or digital method of health education should be done. But when opportunity arise, behavioral intervention such as counselling may be done later. The use of patient diaries may be helpful to monitor adherence. With regards to exercise, once the patient is used to rhythmic lower limb exercise, the patient may move up to moderate to vigorous aerobic (endurance) activity up to 5 days/week. Resistance training (strength) on 2 or more non-consecutive days/week. Vigorous exercise training is generally safe and well tolerated by most people, including those with hypertension, although some special considerations are required for safety.28 The effectiveness of educational and organizational strategies used to improve control of blood pressure was examined in a systematic review of randomized controlled trials. The following interventions were evaluated: self-monitoring and educational interventions directed to the patient. The results showed that a system of regular review and self-monitoring of antihypertensive drug therapy was shown to reduce blood pressure and all-cause mortality at 5 years follow-up. Antihypertensive drug therapy should be monitored closely and adopt a stepped care approach when patients do not reach target blood pressure levels.29

Patient Outcomes

During the second visit, the patient should have increased awareness about the diagnosis and potential risks associated with hypertension. As a result of this awareness, adherence to interventions should be achieved. Adherence can be achieved by repeating/enhancing the interventions done during the earlier visits. Adherence to intervention may be a surrogate outcome leading to successful management of hypertension. One study evaluated the effect of adherence on cardiovascular disease mortality, cerebral hemorrhage and cerebral infarction. Adherence were classified into good (cumulative medication adherence, ≥80%), intermediate (cumulative medication adherence, 50%-80%), and poor (cumulative medication adherence, <50%) adherence groups. The results showed that patients with poor medication adherence had worse mortality from ischemic heart disease (hazard ratio, 1.64; 95% confidence interval, 1.16-2.31; P for trend=0.005), cerebral hemorrhage (hazard ratio, 2.19; 95% confidence interval, 1.28-3.77; P for trend=0.004), and cerebral infarction (hazard ratio, 1.92; 95% confidence interval, 1.25-2.96; P for trend=0.003) than those with good adherence. Similar findings were also noted with hazard ratio for hospitalization.30 For those already prescribed with medications, the goal should be a blood pressure lower than the baseline. Based on guideline recommendations the goal differ among patients above or below 60 years old. For patients less than

Table 5. Reinforcement of Goals.

Reinforce BP goals, self-monitoring and recording

Reinforce compliance to antihypertensives

Reinforce adherence to lifestyle modification (targeted weight, diet and fitness)

Patient Family

Encourage family members to adhere to healthy lifestyle

Compliance to healthy family meals

Adherence to family fitness activities

Community

Encourage family members to join programs on hypertension in the community

Enrolment in existing community lifestyle activities

Actively participating in hypertension support groups in the community


60 years old, it is less than 140/90 mmHg and for 60 and above, the goal is less than 150/90 mmHg towards a normal of 120/80 mmHg. This goal is also implemented by several outpatient Kaiser Permanente cliinics in the US.31 This goal is similar for all other specialties taking care of hypertensive patients. In one study, there was no difference in patient outcomes achieved in 2-year or 4-year outcomes for patients with hypertension whether they were being treated by endocrinologists, cardiologists or internal medicine specialists. These findings must be viewed in light of the historically higher costs of fee-for-service in subspecialty physician practice.32

Continuing Visit


During the continuing visit blood pressure monitoring and continuing review of history and physical examination should be done. Changes must be noted. Among those with co-morbidity, adequate treatment of co-morbid condition using the applicable clinical pathway should be done.


Pharmacologic treatment of hypertension reduces risks of stroke, congestive heart failure, renal failure and mortality. However there is a question of once blood pressure is already controlled, can pharmacologic treatment be discontinued? A survey of a random sample of practicing physicians indicated that 79% tried to withdraw treatment. Studies of antihypertensive medication withdrawal also showed success rates of 40.3 percent after 1 year of follow-up and 27.7 percent after 2 years of follow-up were achieved. Similar findings were noted among elderly patients where an average success rate of 26.2 percent was obtained for periods of 2 or more years.33 It is therefore recommended that after 1-2 years of follow-up and the blood pressure is controlled with no symptoms attributed to hypertension or to a target organ damage, the physician may try step down or withdrawal treatment.


During first few visits, the physician is advised to continue repeating and reinforcing health education and non-pharmacologic intervention. During the continuing visit, there may be a shift to peer-led or family treatment partner interventions to improve self-management. In one randomized controlled trial peer-led interventions were found to have similar effect as physician-led intervention. However, this may lower the cost of treatment.34 Health coaching by medical assistants can also be an alternative to physician-led health education. In one study, in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. Patients who were given health coaching were more likely to achieve the treatment goals. Many coached patients achieved the hemoglobin A1c goal, the LDL cholesterol goal and the systolic blood pressure goal.35

Patient Outcomes

The Eighth Joint National Committee (JNC 8) guidelines for blood pressure management recommend a blood pressure goal of less than 140/90 mm Hg for all adults except those 60 years or older. For those who are ≥60 years a systolic blood pressure goal of less than 150 mm Hg is recommended.36 The assessment of the risk of a cardiovascular’ event is the most reliable and accurate way to measure the benefits of anti-hypertensive therapy. Most studies that have examined control of hypertension have relied solely on the blood pressure level attained after treatment. Aside from blood pressure, it is also recommended to control the other risk factors. This is due to a finding in one study where 40.9% of the hypertensive still had an absolute risk exceeding 20% of having a cardiovascular event. The factors independently associated with uncontrolled hypertension were age, sex, past history of stroke, ischemic heart disease and transient ischemic attack, a body mass index greater than 30, diabetes, and current smoking.37 While age, sex


and past history are non-modifiable, body mass index, blood sugar and smoking can be modified.

Recommendations for Implementation

Clinic Level

Education, training and audit has been used to improve the quality of physician’s practice. In one randomized controlled trial, an educational intervention designed to improve the management of hypertension in the elderly was tested in family practice. Educational visits, discussion of barriers to implementing change in practice were done. At the end of the educational visits, there was a significant difference in the stated threshold for treating systolic hypertension between intervention and control groups. There was also a statistically significant difference between the two groups, in their willingness to treat a 70-year-old male with mild hypertension. The effectiveness of an educational intervention is significantly improved by addressing the barriers preventing practitioners from implementing the recommendations.38 Self-audit of medical records may also be an effective way of implementing the clinical pathways. In this activity, a family or community doctor randomly select medical records of 10 hypertensive patients. Then he/she evaluates the record if there is evidence that the recommendations in the clinical pathway were followed. This method has been shown to be a reliable way of identifying patients with optimal or suboptimal management of blood pressure.39 After self-audits, a full quality improvement activity may be done. In quality improvement, the family or community medicine practitioner performs self-audit at baseline. Then based on the self-audit he/she identifies suboptimal performance based on the clinical pathway recommendations. Self-initiated change in clinical practice is then implemented to address the suboptimal performance. This is followed by a repeat self-audit after a period of time. This two-stage quality improvement approach has been shown to be effective in achieving blood pressure control among hypertensive patients.40

Health System Level

The effectiveness of educational and organizational strategies at the health system level to improve control of blood pressure was examined in a systematic review of randomized controlled trials. The following interventions were evaluated: (1) educational interventions directed to the health professional, (4) health professional (nurse or pharmacist) led care, (5) organizational interventions that aimed to improve the delivery of care, (6) appointment reminder systems. The results showed that an organized system of regular review allied to vigorous antihypertensive drug therapy was shown to reduce blood pressure and all-cause mortality at 5 years follow-up. These findings have important implications for recommendations concerning implementation of structured delivery of care in hypertension guidelines.41

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