Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Dysphagia
Published in: Dysphagia 6/2022

22-02-2022 | Motility Disorder | Original Article

Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials

Authors: Jordan Staggs, Cole Williams, Mitchell Love, Abbey Renner, Micah Kee, Cody Hillman, Samuel Shepard, Benjamin Heigle, Shelby Rauh, Ryan Ottwell, Micah Hartwell, Matt Vassar

Published in: Dysphagia | Issue 6/2022

Login to get access

Abstract

Esophageal motility disorders (EMD) can have significant effects on quality of life. Patient-reported outcomes (PROs) provide valuable insight into the patient’s perspective on their treatment and are becoming increasingly used in randomized controlled trials (RCTs). Thus, our investigation aims to evaluate the completeness of reporting of PROs in RCTs pertaining to EMDs. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials for published RCTs focused on EMDs. Included RCTs were published between 2006 and 2020, reported a primary outcome related to an EMDs, and listed at least one PRO measure as a primary or secondary outcome. Investigators screened and extracted data in a masked, duplicate fashion. Data extraction was carried out using both the CONSORT-PRO adaptation and Cochrane Collaboration Risk of Bias 2.0 tool. We assessed overall mean percent completion of the CONSORT-PRO adaptation and a bivariate regression analysis was used to assess relationships between trial characteristics and completeness of reporting. The overall mean percent completion of the CONSORT-PRO checklist adaptation was 43.86% (SD = 17.03). RCTs with a primary PRO had a mean completeness of 47.73% (SD = 17.32) and RCTs with a secondary PRO was 35.36% (SD = 13.52). RCTs with a conflict of interest statement were 18.15% (SE = 6.5) more complete (t = 2.79, P = .009) than trials lacking a statement. No additional significant associations between trial characteristics and completeness of reporting were found. PRO reporting completeness in RCTs focused on EMDs was inadequate. We urge EMD researchers to prioritize complete PRO reporting to foster patient-centered research for future RCTs on EMDs.
Literature
1.
Aithal GP, Nylander D, Dwarakanath AD, Tanner AR. Subclinical esophageal peristaltic dysfunction during the early phase following a stroke. Dig Dis Sci. 1999;44(2):274–8.CrossRefPubMed
2.
Kuribayashi Y, et al. Esophageal motility after extensive circumferential endoscopic submucosal dissection for superficial esophageal cancer. Digestion. 2018;98(3):153–60.CrossRefPubMed
3.
Goyal M, Nagalli S. Esophageal motility disorders in StatPearls. Treasure Island (FL): StatPearls Publishing; 2021.
4.
Rommel N, Hamdy S. Oropharyngeal dysphagia: manifestations and diagnosis. Nat Rev Gastroenterol Hepatol. 2016;13(1):49–59.CrossRefPubMed
5.
6.
McGinnis CM, et al. Dysphagia: interprofessional management, impact, and patient-centered care. Nutr Clin Pract. 2019;34(1):80–95.CrossRefPubMed
7.
Ekberg O, Hamdy S, Woisard V, Wuttge-Hannig A, Ortega P. Social and psychological burden of dysphagia: its impact on diagnosis and treatment. Dysphagia. 2002;17(2):139–46.CrossRefPubMed
8.
9.
Cui Y, Xia L, Li L, Zhao Q, Chen S, Gu Z. Anxiety and depression in primary Sjögren’s syndrome: a cross-sectional study. BMC Psychiatry. 2018;18(1):131.CrossRefPubMedPubMedCentral
10.
Eslick GD, Talley NJ. Dysphagia: epidemiology, risk factors and impact on quality of life—a population-based study. Aliment Pharmacol Ther. 2008;27(10):971–9.CrossRefPubMed
11.
Anker SD, et al. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014;35(30):2001–9.CrossRefPubMed
12.
Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-reported outcomes in cancer clinical trials: measuring symptomatic adverse events with the national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Am Soc Clin Oncol Educ Book. 2016;35:67–73.CrossRefPubMed
13.
Izadi Z, Gandrup J, Katz PP, Yazdany J. Patient-reported outcome measures for use in clinical trials of SLE: a review. Lupus Sci Med. 2018;5(1):e000279.CrossRefPubMedPubMedCentral
14.
Franco P, et al. Prospective assessment of oral mucositis and its impact on quality of life and patient-reported outcomes during radiotherapy for head and neck cancer. Med Oncol. 2017;34(5):81.CrossRefPubMed
15.
16.
17.
Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins GS, editor. Cochrane handbook for systematic reviews of interventions version 5.1.0. London: The Cochrane Collaboration; 2011.
18.
C. Hillman, et al. Esophageal motility disorders. https://​osf.​io/​mjgvp/​.​ Accessed 21 Jul 2021
19.
Kahrilas PJ, et al. The chicago classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015;27(2):160–74.CrossRefPubMed
20.
Mercieca-Bebber R, et al. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res. 2017;26(6):1427–37.CrossRefPubMed
21.
Calvert M, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814–22.CrossRefPubMed
22.
23.
24.
25.
26.
27.
Fielding S, Maclennan G, Cook JA, Ramsay CR. A review of RCTs in four medical journals to assess the use of imputation to overcome missing data in quality of life outcomes. Trials. 2008;9:51.CrossRefPubMedPubMedCentral
28.
Karahalios A, Baglietto L, Carlin JB, English DR, Simpson JA. A review of the reporting and handling of missing data in cohort studies with repeated assessment of exposure measures. BMC Med Res Methodol. 2012;12:96.CrossRefPubMedPubMedCentral
29.
Lee KJ, et al. Framework for the treatment and reporting of missing data in observational studies: the treatment and reporting of missing data in observational studies framework. J Clin Epidemiol. 2021;134:79–88.CrossRefPubMedPubMedCentral
30.
Masconi KL, Matsha TE, Echouffo-Tcheugui JB, Erasmus RT, Kengne AP. Reporting and handling of missing data in predictive research for prevalent undiagnosed type 2 diabetes mellitus: a systematic review. EPMA J. 2015;6(1):7.CrossRefPubMedPubMedCentral
31.
Fielding S, Ogbuagu A, Sivasubramaniam S, MacLennan G, Ramsay CR. Reporting and dealing with missing quality of life data in RCTs: has the picture changed in the last decade? Qual Life Res. 2016;25(12):2977–83.CrossRefPubMedPubMedCentral
32.
Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013;86(3):343–58.PubMedPubMedCentral
33.
34.
Wayant C, Aran G, Johnson BS, Vassar M. Evaluation of selective outcome reporting bias in efficacy endpoints in print and television advertisements for oncology drugs. J Gen Intern Med. 2020;35(10):2853–7.CrossRefPubMedPubMedCentral
35.
36.
Saric F, Barcot O, Puljak L. Risk of bias assessments for selective reporting were inadequate in the majority of Cochrane reviews. J Clin Epidemiol. 2019;112:53–8.CrossRefPubMed
37.
Rankin J, Ross A, Baker J, O’Brien M, Scheckel C, Vassar M. Selective outcome reporting in obesity clinical trials: a cross-sectional review. Clin Obes. 2017;7(4):245–54.CrossRefPubMed
38.
39.
Khorsan R, Crawford C. How to assess the external validity and model validity of therapeutic trials: a conceptual approach to systematic review methodology. Evid Based Complement Alternat Med. 2014;2014:694804.CrossRefPubMedPubMedCentral
40.
Metadata
Title
Evaluating Reporting Completeness of Patient-Reported Outcomes in Esophageal Motility Disorders: A Cross-Sectional Analysis of Randomized Controlled Trials
Authors
Jordan Staggs
Cole Williams
Mitchell Love
Abbey Renner
Micah Kee
Cody Hillman
Samuel Shepard
Benjamin Heigle
Shelby Rauh
Ryan Ottwell
Micah Hartwell
Matt Vassar
Publication date
22-02-2022
Publisher
Springer US
Published in
Dysphagia / Issue 6/2022
Print ISSN: 0179-051X
Electronic ISSN: 1432-0460
DOI
https://doi.org/10.1007/s00455-022-10415-7

Other articles of this Issue 6/2022

Dysphagia 6/2022 Go to the issue

Original Article

Exploring the Use of the Current Perception Threshold in Pharyngeal Paresthesia Patients

Original Article

A New Therapeutic Approach for Dystussia and Atussia in Neurogenic Dysphagia: Effect of Aerosolized Capsaicin on Peak Cough Flow

Original Article

Videofluoroscopic Profiles of Swallowing and Airway Protection Post-traumatic Cervical Spinal Cord Injury

Original Article

Zenker’s Diverticulum: Readability and Quality of Online Written Education Materials

Original Article

Effect of Intensive Oropharyngeal Training on Radiotherapy-Related Dysphagia in Nasopharyngeal Carcinoma Patients

Original Article

Implementation of Pediatric Flexible-Endoscopic Evaluation of Swallowing: A Systematic Review and Recommendations for Future Research