Dhyanesh A. Patel

Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation

OBJECTIVE Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. DESIGN MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. RESULTS Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinsons Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. CONCLUSION This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We identified several instruments with robust measurement properties in multiple diseases including achalasia, oropharyngeal dysphagia, post-surgical dysphagia, esophageal cancer, and dysphagia related to neurological diseases. Findings herein can assist clinicians and researchers in making more informed decisions in selecting the most fundamentally sound PRO measure for a given clinical, research, or quality initiative.

Patient-Reported Outcome Measures Related to Laryngopharyngeal Reflux A Systematic Review of Instrument Development and Validation

Objectives Patient-reported outcome (PRO) measures are often used to diagnose laryngopharyngeal reflux (LPR) and monitor treatment outcomes in clinical and research settings. The present systematic review was designed to identify currently available LPR-related PRO measures and to evaluate each measure’s instrument development, validation, and applicability. Data Sources MEDLINE via PubMed interface, CINAHL, and Health and Psychosocial Instrument databases were searched with relevant vocabulary and key terms related to PRO measures and LPR. Review Methods Three investigators independently performed abstract review and full text review, applying a previously developed checklist to critically assess measurement properties of each study meeting inclusion criteria. Results Of 4947 studies reviewed, 7 LPR-related PRO measures (publication years, 1991-2010) met criteria for extraction and analysis. Two focused on globus and throat symptoms. Remaining measures were designed to assess LPR symptoms and monitor treatment outcomes in patients. None met all checklist criteria. Only 2 of 7 used patient input to devise item content, and 2 of 7 assessed responsiveness to change. Thematic deficiencies in current LPR-related measures are inadequately demonstrated: content validity, construct validity, plan for interpretation, and literacy level assessment. Conclusion Laryngopharyngeal reflux is often diagnosed according to symptoms. Currently available LPR-related PRO measures used to symptomatically identify suspected LPR patients have disparate developmental rigor and important methodological deficiencies. Care should be exercised to understand the measurement characteristics and contextual relevance before applying these PRO measures for clinical, research, or quality initiatives.

Normal Esophageal Physiology and Laryngopharyngeal Reflux

Understanding the basic anatomy and physiology contributing to esophageal peristalsis can help with comprehension of esophageal disease states. Laryngopharyngeal reflux (LPR), an extraesophageal variant of gastroesophageal reflux disease, is retrograde movement of gastric contents into the laryngopharynx and is associated with hoarseness, chronic cough, throat clearing, sore throat, and dysphagia. Various direct and indirect mechanisms have been proposed to contribute to LPR. The current diagnostic tests for LPR have significant shortcomings. This article reviews the anatomy and physiology of upper esophageal sphincter, esophagus, and lower esophageal sphincter, and discusses current understanding of pathophysiology, evaluation, and management of LPR.

A Spiraling Case of Persistent Dysphagia

Question: A 77-year-old woman with gastroesophageal reflux disease, hypertension, and recurrent aspiration pneumonias presented as a referral for evaluation and management of persistent dysphagia. She reported having dysphagia to liquids more than solids for last 8-9 years with associated heartburn, regurgitation, and chest pain. She had 25-lb weight loss over the last 6 months and had 4 hospitalizations over the last 4 years for volume depletion and 2 hospitalizations for aspiration pneumonia. She underwent multiple empiric esophageal dilatations (Maloney 49-50 Fr dilators) over last several years without any improvement. Barium swallow study (Figure A) showed a corkscrew esophagus with patent gastroesophageal junction. High resolution manometry (Figure B) revealed 6 simultaneous contractions and 40% peristaltic contractions with high lower esophageal sphincter pressure, but normal relaxation in 80% of swallows. Esophagogastroduodenoscopy images are also shown (Figure C). She was referred for further management after no improvement in symptoms despite empiric dilatations and medical management with high-dose proton pump inhibitor therapy and nifedipine. What is the most likely diagnosis? What is the next step in management for this patient? Look on page 299 for the answer and see the Gastroenterology web site (www.gastrojournal.org) for more information on submitting your favorite image to Clinical Challenges and Images in GI.

Parenteral Nutrition: Indications, Access, and Complications

Parenteral nutrition (PN) is a life-sustaining therapy in patients with intestinal failure who are unable to tolerate enteral feedings. Patient selection should be based on a thorough assessment to identify those at high nutrition risk based on both disease severity and nutritional status. This article reviews both the acute and chronic indications for PN as well as special formulation consideration in specific disease states, vascular access, and complications of both short-term and long-term PN.

Proton pump inhibitor non-responsive gastroesophageal reflux disease: unraveling an enigma?

Gastroesophageal reflux disease (GERD) affects 10–20% of adults in Western countries (1,2) and 13% of Americans use medications for GERD at least twice weekly (3). In the USA alone, it is estimated that the annual direct and indirect costs incurred due to GERD is approximately

Achalasia: It’s Not All About the Lower Esophageal Sphincter

10 billion (4).

Testing to no avail? the diagnostic and treatment conundrum in patients with extraesophageal manifestations of gastroesophageal reflux disease

DIS 5.4.0 DTD YGAST60911 proof 29 June 2017 5:58 pm ce 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 Question: A 66-year-old man with cirrhosis secondary to hepatitis C (complicated with development of esophageal varices) and achalasia (diagnosed in 1980s, failed Botox injections, pneumatic dilatation, calcium channel blockers, and now status post percutaneous endoscopic gastrostomy tube placement for feedings) presented as a referral for evaluation and management of achalasia. He was deemed to be a very high-risk surgical myotomy 86 87 88 89 90 91 92 93 94 95 96 97 98 99 candidate owing to cirrhosis and signs of portal hypotension (platelets of 55,000 and International Normalized Ratio of 1.4). He was now also thought to be a high-risk candidate for repeat pneumatic dilatation and Botox injections given his coagulopathy and distal esophageal varices. He subsequently had lower esophageal sphincter dilatations using 20 mm through the scope dilators every 6 months for 2 years. His dysphagia would briefly improve for approximately 4-6 months, but then would have recurrence of symptoms (as expected, because through the scope dilators do not effectively disrupt the lower esophageal sphincter muscle, which is the underlying culprit in achalasia). Barium esophagram showed smooth tapering of the lower esophagus leading to a closed lower esophageal sphincter, resembling a “bird’s beak.” Proximal and mid esophageal body also showed signs of nodularity (Figure A). He otherwise denied any weight loss or new changes in his symptoms, but repeat endoscopy showed new irregular nodular mucosa with white exudates throughout the mid to distal esophageal body (Figure B). Social history was unremarkable for any history of alcohol use and reported rare use of tobacco >20 years ago. What is the most likely diagnosis? See the Gastroenterology web site (www.gastrojournal.org) for more information on submitting your favorite image to Clinical Challenges and Images in GI. 100 101 102 103 104 105 106 Conflicts of interest The authors disclose no conflicts.

Mo1124 Gastroesophageal Reflux Disease: Can We Predict Who Will Develop Esophagitis?

Extraesophageal reflux (EER), which includes cough, asthma, and laryngopharyngeal reflux (LPR), is an important and prevalent disease state with a large economic burden of up to fifty billion dollars, largely due to the pharmaceutical costs of empiric treatment (1).

Idiopathic (primary) achalasia: a review

1512.7) V at 5 cm, and 2222.4 (1511.6 to 2734.3) V at the most proximal impedance recording site. All these BI values were lower than those observed in NERD patients, not only in the distal esophagus [at 3cm 1409.2 (1264.1 to 2118.6) V, p=0.0065; at 5 cm 1650.1 (1228.4 to 2266.4) V, p=0.0054], but also in the proximal esophagus [at 17cm 2678.7 (2183.0 to 3309.1) V, p=0.036]. They are displayed in the figure. Conclusion: Despite the lesser percentage of patients with abnormal AET, all BI values in SSc patients were lower than in NERD patients, suggesting that BI levels are related not only to oesophageal AET, but also to oesophageal tissue SSc-related damage. This finding is further corroborated by the differences observed at the proximal oesophagus. Thus, BI levels may be used as indirect markers of alteration of the oesophageal wall and, therefore, of oesophageal involvement in patients with SSc.