Definitions for the recommendation grades (A, B, C, D, Insuff) and quality of evidence (good, fair, poor) are provided at the end of the "Major Recommendations" field.
Diagnosis and Initial Therapy
- What Is an Operational Definition of Gastroesophageal Reflux Disease (GERD)? What Is the Distinction Between GERD and Episodic Heartburn?
- There can be no criterion standard definition of GERD because the threshold distinction between physiologic reflux and reflux disease is ultimately arbitrary. Hence, these questions can only be answered by opinion (USPSTF grade not applicable). Fortuitously, a recent consensus in defining GERD (the Montreal consensus) emanated from a panel of world experts. The Montreal definition was adopted in the technical review as a suitable framework upon which to build management recommendations. The Montreal consensus defined GERD as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications." Symptoms are "troublesome" if they adversely affect an individual's well-being.
- What Is the Efficacy of Lifestyle Modifications for GERD? Which Elements Should Be Recommended and in Which Circumstances?
Grade B: recommended with fair evidence that it improves important outcomes:
- Weight loss should be advised for overweight or obese patients with esophageal GERD syndromes.
- Elevation of the head of the bed for selected patients who are troubled with heartburn or regurgitation when recumbent. Other lifestyle modifications including, but not limited to, avoiding late meals, avoiding specific foods, or avoiding specific activities should be tailored to the circumstances of the individual patient.
Grade Insuff: no recommendation, insufficient evidence to recommend for or against
- Broadly advocating lifestyle changes for all (as opposed to selected) patients with GERD.
- How Do Antisecretory Therapies Compare in Efficacy and Under What Circumstances Might One Be Preferable to Another? What Is an Acceptable Upper Limit of Empirical Therapy in Patients With Suspected Typical Esophageal GERD Syndromes Before Performing Esophagogastroduodenoscopy?
Grade A: strongly recommended based on good evidence that it improves important health outcomes:
- Antisecretory drugs for the treatment of patients with esophageal GERD syndromes (healing esophagitis and symptomatic relief). In these uses, proton pump inhibitors (PPIs) are more effective than histamine2 receptor antagonists (H2RAs), which are more effective than placebo.
Grade B: recommended with fair evidence that it improves important outcomes:
- Twice-daily PPI therapy for patients with an esophageal syndrome with an inadequate symptom response to once-daily PPI therapy.
- A short course or as-needed use of antisecretory drugs in patients with a symptomatic esophageal syndrome without esophagitis when symptom control is the primary objective. For a short course of therapy, PPIs are more effective than H2RAs, which are more effective than placebo.
Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits:
- Metoclopramide as monotherapy or adjunctive therapy in patients with esophageal or suspected extraesophageal GERD syndromes.
- What Is the Role and Priority of Diagnostic Tests (Endoscopy With or Without Biopsy, Esophageal Manometry, Ambulatory pH Monitoring, Impedance-pH Monitoring) in the Evaluation of Patients With Suspected Esophageal GERD Syndromes?
Grade B: recommended with fair evidence that it improves important outcomes:
- Endoscopy with biopsy for patients with an esophageal GERD syndrome with troublesome dysphagia. Biopsies should target any areas of suspected metaplasia, dysplasia, or in the absence of visual abnormalities, normal mucosa (at least 5 samples to evaluate for eosinophilic esophagitis).
- Endoscopy to evaluate patients with a suspected esophageal GERD syndrome who have not responded to an empirical trial of twice-daily PPI therapy. Biopsies should target any area of suspected metaplasia, dysplasia, or malignancy.
- Manometry to evaluate patients with a suspected esophageal GERD syndrome who have not responded to an empirical trial of twice-daily PPI therapy and have normal findings on endoscopy. Manometry will serve to localize the lower esophageal sphincter for potential subsequent pH monitoring, to evaluate peristaltic function preoperatively, and to diagnose subtle presentations of the major motor disorders. Evolving information suggests that high-resolution manometry has superior sensitivity to conventional manometry in recognizing atypical cases of achalasia and distal esophageal spasm.
- Ambulatory impedance-pH, catheter pH, or wireless pH monitoring (PPI therapy withheld for 7 days) to evaluate patients with a suspected esophageal GERD syndrome who have not responded to an empirical trial of PPI therapy, have normal findings on endoscopy, and have no major abnormality on manometry. Wireless pH monitoring has superior sensitivity to catheter studies for detecting pathological esophageal acid exposure because of the extended period of recording (48 hours) and has also shown superior recording accuracy compared with some catheter designs.
Grade Insuff: no recommendation, insufficient evidence to recommend for or against:
- Using alarm symptoms (other than troublesome dysphagia) as a screening tool to identify patients with GERD at risk for esophageal adenocarcinoma.
- Combined impedance-pH, catheter pH, or wireless pH monitoring studies to distinguish hypersensitivity syndromes from functional syndromes, the distinction being that in hypersensitivity syndromes symptoms are attributable to reflux events, whereas in functional syndromes they are not.
- Combined impedance-pH, catheter pH, or wireless pH esophageal monitoring studies performed while taking PPIs.
- What Are the Unique Management Considerations in Patients With Suspected Reflux Chest Pain Syndrome?
Grade A: strongly recommended based on good evidence that it improves important health outcomes:
- Twice-daily PPI therapy as an empirical trial for patients with suspected reflux chest pain syndrome after a cardiac etiology has been carefully considered.
- What Is the Best Initial Management for Patients With Suspected Extraesophageal Reflux Syndromes (Asthma, Laryngitis, Cough)? What Are the Unique Management Considerations With Each? What Is the Appropriate Dose and Course of Antisecretory Therapy in Each?
Grade B: recommended with fair evidence that it improves important outcomes:
- Acute or maintenance therapy with once- or twice-daily PPIs (or H2RAs) for patients with a suspected extraesophageal GERD syndrome (laryngitis, asthma) with a concomitant esophageal GERD syndrome.
Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits:
- Once- or twice-daily PPIs (or H2RAs) for acute treatment of patients with potential extraesophageal GERD syndromes (laryngitis, asthma) in the absence of a concomitant esophageal GERD syndrome.
Grade Insuff: no recommendation, insufficient evidence to recommend for or against:
- Once- or twice-daily PPIs for patients with suspected reflux cough syndrome.
Chronic Management
- Does GERD Progress in Severity, Such That Symptomatic Patients Without Esophagitis Develop Esophagitis and Barrett's Metaplasia, or Are These Distinct Disease Manifestations That Do Not Exist Along a Continuum? If Patients Do Progress, at What Rate Does This Occur, and Does It Warrant Endoscopic Monitoring?
Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits:
- Routine endoscopy in subjects with erosive or nonerosive reflux disease to assess for disease progression.
- What Maintenance Therapy Is Indicated for Patients With the Typical Esophageal Reflux Syndrome (With or Without Esophagitis)? When and How Should Antisecretory Therapy Be Decreased or Discontinued? What, If Any, Risks Are Associated With This?
Grade A: strongly recommended based on good evidence that it improves important health outcomes:
- Long-term use of PPIs for the treatment of patients with esophagitis once they have proven clinically effective. Long-term therapy should be titrated down to the lowest effective dose based on symptom control.
Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits:
- Less than daily dosing of PPI therapy as maintenance therapy in patients with an esophageal syndrome who previously had erosive esophagitis.
- What Maintenance Therapy Is Indicated for Patients With Suspected Extraesophageal Reflux Syndromes (Asthma, Laryngitis, Cough)? When and How Should Antisecretory Therapy Be Decreased or Discontinued?
Grade B: recommended with fair evidence that it improves important outcomes:
- Acute or maintenance therapy with once- or twice-daily PPIs (or H2RAs) for patients with a suspected extraesophageal GERD syndrome (laryngitis, asthma) with a concomitant esophageal GERD syndrome.
Grade Insuff: no recommendation, insufficient evidence to recommend for or against
- Maintenance therapy with once- or twice-daily PPIs (or H2RAs) for patients with potential extraesophageal GERD syndromes (laryngitis, asthma) in the absence of a concomitant esophageal GERD syndrome.
- Once- or twice-daily PPIs for patients with suspected reflux cough syndrome.
- What Are the Clinical Consequences of Chronic Potent Acid Inhibition? Do These Potential Side Effects Warrant Specific Testing (e.g., Bone Density Studies, Calcium Supplementation, Helicobacter pylori Screening, and so on)?
Grade Insuff: no recommendation, insufficient evidence to recommend for or against
- Advocating bone density studies, calcium supplementation, Helicobacter pylori screening, or any other routine precaution because of PPI use.
- What Is the Role of Endoscopy in Long-term Management of Patients With GERD, and Under What Circumstances Should Mucosal Biopsy Specimens Be Obtained When Endoscopy Is Performed?
Grade B: recommended with fair evidence that it improves important outcomes:
- Endoscopy with biopsy for patients with an esophageal GERD syndrome with troublesome dysphagia. Biopsies should target any areas of suspected metaplasia, dysplasia, or in the absence of any visual abnormalities, normal mucosa (at least 5 samples to evaluate for eosinophilic esophagitis).
Grade Insuff: no recommendation, insufficient evidence to recommend for or against:
- Routine upper endoscopy in the setting of chronic GERD symptoms to diminish the risk of death from esophageal cancer.
- Endoscopic screening for Barrett's esophagus and dysplasia in adults 50 years or older with >5–10 years of heartburn to reduce mortality from esophageal adenocarcinoma.
- What Are Indications for Antireflux Surgery, and What Is the Efficacy of This Therapy?
Grade A: strongly recommended based on good evidence that it improves important health outcomes:
- When antireflux surgery and PPI therapy are judged to offer similar efficacy in a patient with an esophageal GERD syndrome, PPI therapy should be recommended as initial therapy because of superior safety.
- When a patient with an esophageal GERD syndrome is responsive to, but intolerant of, acid suppressive therapy, antireflux surgery should be recommended as an alternative.
Grade B: recommended with fair evidence that it improves important outcomes:
- Antireflux surgery for patients with an esophageal GERD syndrome with persistent troublesome symptoms, especially troublesome regurgitation, despite PPI therapy. The potential benefits of antireflux surgery should be weighed against the deleterious effect of new symptoms consequent from surgery, particularly dysphagia, flatulence, an inability to belch, and postsurgery bowel symptoms.
Grade C: balance of benefits and harms is too close to justify a general recommendation:
- Patients with an extraesophageal GERD syndrome with persistent troublesome symptoms despite PPI therapy should be considered for antireflux surgery. The potential benefits of antireflux surgery should be weighed against the deleterious effect of new symptoms consequent from surgery, particularly dysphagia, flatulence, an inability to belch, and postsurgery bowel symptoms.
Grade D: recommend against, fair evidence that it is ineffective or harms outweigh benefits:
- Antireflux surgery for patients with an esophageal syndrome with or without tissue damage who are symptomatically well controlled on medical therapy.
- Antireflux surgery as an antineoplastic measure in patients with Barrett's metaplasia.
Grade Insuff: no recommendation, insufficient evidence to recommend for or against:
- The use of currently commercially available endoluminal antireflux procedures in the management of patients with an esophageal syndrome.
Definitions:
Strength of Recommendations
Grade A: The United States Preventive Services Task Force (USPSTF) strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms.
Grade B: The USPSTF recommends that clinicians provide [this service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms.
Grade C: The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation.
Grade D: The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits.
Grade Insuff: The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that the [service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined.
NOTE. The USPSTF grades its recommendations according to one of 5 classifications (A, B, C, D, Insuff) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms). The USPSTF grades the quality of the overall evidence for a service on a 3-point scale (good, fair, poor).
Quality of Evidence
Good: Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes.
Fair: Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies, generalizability to routine practice, or indirect nature of the evidence on health outcomes.
Poor: Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.
