Expert Review Gastroenterology Hepatology Upload Table Instructios
Pediatr Gastroenterol Hepatol Nutr. 2022 Mar;25(two):109-120. English. Published online Mar 10, 2022. https://doi.org/10.5223/pghn.2022.25.ii.109 | |
Copyright © 2022 by The Korean Society of Pediatric Gastroenterology, Hepatology and Nutrition |
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Jacob Harris ,1 Kevin Chorath ,i Eesha Balar ,1 Katherine Xu ,ane Anusha Naik ,i Alvaro Moreira ,2 and Karthik Rajasekaran 1 , 3 | |
1Department of Otorhinolaryngology, University of Pennsylvania, Philadelphia, PA, United states of america. | |
2Department of Pediatrics, University of Texas Wellness-San Antonio, San Antonio, TX, Usa. | |
3Leonard Davis Found of Wellness Economics, University of Pennsylvania, Philadelphia, PA, USA. | |
Correspondence to Karthik Rajasekaran. Department of Otorhinolaryngology, University of Pennsylvania, 800 Walnut Street, 18th Floor, Philadelphia, PA 19107, United states of america. | |
Received July 03, 2021; Revised October 28, 2021; Accepted February 06, 2022. | |
This is an open-admission article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by- | |
Go to: Abstract | |
Purpose While regurgitation is a common and often benign phenomenon in infants and younger children, it can besides be a presenting symptom of gastroesophageal reflux disease (GERD). If untreated, GERD can lead to dangerous or lifelong complications. Clinical exercise guidelines (CPGs) accept been published to inform clinical diagnosis and management of pediatric GERD, but to date in that location has been no comprehensive review of guideline quality or methodological rigor. Methods A systematic literature search was performed, and a full of eight CPGs pertaining to pediatric GERD were identified. These CPGs were evaluated using the Appraisal of Guidelines for Research and Evaluation musical instrument. Results Three CPGs were plant to exist "loftier" quality, with 5 of vi domains scoring >lx%, one "average" quality, with 4 of six domains coming together that threshold, and the remaining iv "low" quality. Conclusion Areas of strength amongst the CPGs included "Scope and Purpose" and "Clarity and Presentation," as they tended to be well-written and easily understood. Areas in need of improvement were "Stakeholder Involvement," "Rigor of Development," and "Applicability," suggesting these CPGs may not exist appropriate for all patients or providers. This assay found that while strong CPGs pertaining to the diagnosis and treatment of pediatric GERD exist, many published guidelines lack methodological rigor and wide applicability. |
Gastroesophageal reflux (GER) is the passage of gastric contents into the esophagus or oropharynx. Though usually benign, these events tin crusade troublesome symptoms or complications in the example of gastroesophageal reflux disease (GERD) [ i]. Knowing when and how to diagnose and treat reflux is challenging, particularly in pediatrics, where children often present with nonspecific symptoms [ 2 , 3].
The handling of reflux in children has historically been characterized past overdiagnosis and over-prescription of medications [ iv , v]. Both pediatric GER and GERD are relatively common, and it is important for clinicians to know how to differentiate normal from pathological reflux. Effortless airsickness or regurgitation are feature of GER, while symptoms such as failure to thrive, feeding refusal, and Sandifer Syndrome, a stereotyped stretching and arching movement, all suggest GERD [ 6]. GER occurs daily in 50% of infants [ 7] and resolves in 95% of patients past 12-18 months of age [ 8]. Almost of these cases are the consequence of physiological immaturity of the gastro-esophageal junction and do non require intervention [ 9]. However, if untreated, GERD, which is estimated to bear upon 26.9% of infants and as high as 10.1% of children older than ten years of historic period [ ten], can pb to morbidities include dental erosion, reflux esophagitis, Barrett esophagus, and adenocarcinoma [ 11]. Treating GERD aggressively in young children tin prevent lifelong symptoms and worrisome sequelae [ 12].
At that place are many possible treatments for pediatric GERD, ranging from nonpharmacological interventions such every bit thickened formula, slumber position change in older patients, and weight management, to pharmacological and surgical treatment [ 13]. Although contempo studies evidence many advantages in non-pharmacological lifestyle changes, pediatricians oft confront intense pressure from parents to prescribe medications and invasive testing [ 14].
The challenges inherent in diagnosing and treating GERD in the pediatric population suggest the use of clinical do guidelines (CPGs). CPGs are systematically developed statements that enable informed dr.- and patient-decision making by providing explicit and evidence-based recommendations [ 9]. It is essential that CPGs are clear, practical, and free from bias [ 15], and the Appraisal of Guidelines for Research and Evaluation (AGREE II) collaboration has developed a system past which to evaluate the quality of CPGs. Reviewers assign CPGs numeric scores, evaluating the scope, developmental rigor, clarity, and applicability of the guidelines, among other criteria [ sixteen]. The AGREE instrument has been externally validated as being reliable and transparent and the best available CPG appraisal tool [ 17].
To the authors' knowledge there has been no comprehensive review of CPGs relating to the intendance of pediatric patients with GERD. The goal of this paper is to assess and quantify the quality and developmental rigor of the existing exercise guidelines for the diagnosis and clinical management of pediatric GERD using the AGREE II tool.
MATERIALS AND METHODS
Literature search
A systematic literature search was performed using the Scopus, PubMed, and Embase databases. The search terms were (((("newborn" OR "infant" OR "neonate" OR "pediatric" OR "child") AND ("Gastro-oesophageal AND Reflux" OR "gastric AND acid AND reflux" OR "gastroesophageal AND reflux AND illness" OR "gerd" OR "acrid AND reflux" OR "heartburn" OR "regurgitation" OR "dyspepsia") AND ("guideline" OR "consensus AND statement" OR "recommendation")))) and all manufactures from database inception to Feb 1, 2021 were selected for initial review. An additional Google search was performed to identify other CPGs.
The compiled literature was screened for guidelines that addressed the diagnosis or treatment of pediatric GERD. Articles were screened by title and and then past abstruse. The authors excluded primary studies, summaries, and not-English linguistic communication publications. Guidelines that discussed pediatric GERD in the broader context of adult GERD were excluded. If the same society or group published multiple guidelines, just the most recent was used. Both national and international guidelines were included, as were those written for either general medical or specialized audiences. The selected articles were discussed by the authors (JH, KC, and KR) and any discrepancies in inclusion criteria were addressed.
Information extraction
From each CPG the following data were recorded: the development body, publication, publication yr, publication country, development method, central developers, target users, number of references, and any reported relevant funding source.
Quality appraisement
All investigators completed the complimentary, online training available on the AGREE website (www.agreetrust.org). Independent assessments of each selected CPG using the Concord Two tool were performed by 4 authors (JH, EB, KX, and AN). The AGREE Ii instrument measures a CPG on the following domains: (1) Telescopic and Purpose, (2) Stakeholder Involvement, (3) Rigor of Development, (four) Clarity of Presentation, (five) Applicability, and (6) Editorial Independence. Investigators assigned a score from 1-7 for each of the 23 criteria across these domains, with a score of vii if the criterion was fully addressed and a score of one if non at all addressed. The line-detail scores from the iv authors were averaged, and and so as per the guidelines in the AGREE II manual (Hold Next Steps Consortium), domains were scored using the post-obit formula:
Scaled domain score=([obtained score–minimum possible score] / [maximum possible score– minimum possible score]×100)
The Concur II tool characterizes a scaled domain score of 60 or greater equally high quality. Overall scores for each domain were calculated, and CPG quality was rated as "high" if 5 or more domains scored ≥60, "boilerplate" if 3–4 domains scored ≥threescore, and "low" if 2 or fewer domains scored ≥threescore.
Statistical assay
An intraclass correlation coefficient (ICC) analysis was performed using RStudio to appraise the consistency between the four reviewers. ICC was calculated every bit poor (<0.20), off-white (0.21–0.41), moderate (0.41–0.60), skilful (0.61-0.lxxx), and very good (0.81–i.00) according to previous literature [ 18 , 19].
The initial database search yielded one,015 not-indistinguishable results, which were then screened for exclusion criteria, leaving 25 articles for total review. Of these, six met the inclusion criteria described above. The Google search yielded an additional two CPGs, for a total of eight. This process is illustrated in Fig. ane.
Guideline characteristics
Table i summarizes the evolution and methodology of the eight CPGs. 4 guidelines were developed in the Usa past the following institutions: the International Pediatric Endosurgery Grouping (IPEG) [ xx], the National Association of Pediatric Nurse Practitioners (NAPNAP) [ 21 , 22], the American College of Chest Physicians (CHEST) [ 23], and the Dell Children'south Medical Middle (DCMC) [ 24]. Out of the remaining five guidelines, one was developed in Canada (University of Toronto) [ 25], 1 in the United Kingdom by the National Constitute for Wellness and Care Excellence (Dainty) [ 26], one in Australia by the Royal Children's Hospital of Melbourne (RCHM) [ 27], and i that was a collaboration betwixt the North American Society for Pediatric Gastroenterology, Hepatology & Diet (NASPGHAN) and the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) [ 28]. The CPGs were published betwixt 2008 and 2019, with one undated (DCMC). RCHM and DCMC published their guidelines on their hospital website and were identified by Google search. The other six CPGs were published in peer-reviewed journals.
Five of the guidelines were adult based on both expert stance and systematic literature reviews, with the other 3 based either on expert opinion alone (RCHM and DCMC) or did non specify (NAPNAP). The experts involved in the evolution of CPGs varied. In one-half of the CPGs, the experts consisted of pediatricians or gastroenterologists. Out of the remaining four, i CPG consisted of surgeon experts solitary (IPEG), one CPG consisted of nurse practitioners (NAPNAP), and three consisted of a panel of experts but their professions were not specified. Target users in most instances were get-go-line medical caregivers such as pediatricians and nurses, though Dainty targeted a wider range of public health and policy makers, and the University of Toronto targeted futurity CPG developers. Only three of the viii CPGs explicitly stated their funding sources (University of Toronto, NAPNAP, and NASPGHAN & ESPGHAN).
Guideline appraisal
Table 2 reports the domain scores for the CPGs. "Clarity and Presentation" and "Scope and Purpose" had the highest overall scaled scores, of 80.56 and 65.97 respectively. With a score of 27.86, "Applicability" scored the lowest. "Editorial Independence" had the greatest variability between CPGs, with a standard deviation of 44.14, while "Clarity and Presentation" had the least variability, with a standard deviation of 9.47. Three CPGs (University of Toronto, NICE, and NASPGHAN & ESPGHAN) were establish to be high quality with 5/vi domains scoring ≥threescore. CHEST's CPG was scored as average in quality, and the remaining 4 were deemed equally low quality based on the domain scores.
Intraclass reliability
The ICCs for the vi domains are presented in Table 3. The ICCs reflect the degree of consensus between the 4 reviewers (JH, EB, AN, and KX). "Scope and Practice", "Stakeholder Involvement", "Rigor of Development", and "Editorial Independence" achieved "very good" intraclass reliability. "Clarity and Presentation" and "Applicability" achieved "good" intraclass reliability.
GERD can be difficult to diagnose, unpleasant and concerning for both patients and parents, and untreated can pb to long-term health morbidities. GER and GERD can be difficult to distinguish, and with many treatment options available, generating a diagnosis and treatment program can be challenging for clinicians. CPGs, written by experts versed in the best available bear witness, can aid clinicians navigate challenging cases and provide standardized and cost-effective intendance [ 19]. Unfortunately, many published CPGs are of lower quality, contradictory, or outdated [ 29]. This study is the kickoff to use the AGREE II tool to methodologically evaluate the quality of CPGs relating to the care of pediatric patients with GERD. Eight CPGs from around the world were identified and evaluated across the half dozen Agree 2 domains.
Scope and purpose
Domain 1, "Scope and Purpose," asks whether a guideline clearly states its objectives, highlights the health questions, and describes the target population. Five out of the six CPGs scored highly in this domain. While almost all CPGs stated their objective, few specifically listed the wellness questions that they proposed to address. NASPGHAN & ESPGHAN, which was the highest scoring CPG in this domain, specifically stated each question they sought to respond. This type of system immune for a very clear understanding of the clinical decision making and practice recommendations.
Stakeholder interest
Domain ii, "Stakeholder Involvement," evaluates the authorship of the CPGs. Most CPGs performed poorly, suggesting that these development groups tended to prove limited professional diverseness. The three CPGs that cleared the loftier-quality threshold in this domain (University of Toronto, NICE, and NASPGHAN & ESPGHAN) included professionals from all relevant healthcare fields. This is necessary considering each medical specialty manages GERD differently. A survey of gastroenterologists and otolaryngologists, for example, constitute differences between the two specialties with regards to diagnostic criteria, handling dose and duration, and patient response for GERD [ 30]. Interestingly, general pediatricians were just involved in the development of one-half of the CPGs. This is unfortunate when considering that pediatricians are often the first clinician to run across infants and children with GERD, and discuss reflux at one-quarter of infants' routine 6-month visits [ 7].
Merely one guideline (NICE) adequately sought public feedback on their recommendations before publishing. Patients' expectations and experiences with wellness intendance are an important consideration for guideline development [ 16], and simple methods such equally soliciting patient advocacy organizations or patients referred by clinicians tin can assist patients' voices be heard in the evolution process [ 31].
Rigor of development
Domain iii, "Rigor of Evolution," is considered the strongest predictor for overall guideline quality, as it quantifies the evidentiary basis for published guidelines [ 32]. But three CPGs (University of Toronto, NASPGHAN & ESPGHAN, and Chest) scored equally high quality in this domain. These three groups performed systematic literature reviews (including multiple databases, specific search terms, and clearly divers exclusion and inclusion criteria) and reported the quality of the show for each individual recommendation using the GRADE (Grading of Recommendations, Cess, Development, and Evaluation) method, a well-validated tool used to assess a body of evidence [ 33]. Weaker scoring CPGs relied exclusively on practiced stance or non-systematic literature reviews. While there is a role for adept stance in CPGs [ 34], a systematic review ensures the literature has been appropriately consulted. A review of Concur 2 analyses since the tool's inception noted consistently low scores for "Rigor of Development" [ 35]. This again suggests the demand for a multidisciplinary evolution team: research librarians tin can bring expertise in systematic literature reviews and can ensure proper documentation of search strategies [ 36].
Other areas where guidelines fell short were in review by outside experts (only ii/8 CPGs) and explicit procedures for updates (2/8 CPGs). These are relatively elementary areas for improvement that could greatly improve guideline quality.
Clarity and presentation
Domain 4, "Clarity and Presentation," was the domain in which the CPGs performed the best, with all 8 rated as loftier quality. This domain evaluates the language, structure, and format of the guidelines. A survey of pediatricians' attitudes and practices regarding CPGs found simplicity to be the greatest contained predictor of guideline apply [ 37], further validating the importance of this domain. Strategies employed past the appraised CPGs include listing key recommendations at the start of the document [ 21 , 22 , 23 , 26] and providing menstruation charts that walk clinicians through diagnostic and handling decisions [ 21 , 22 , 25 , 26 , 27 , 28].
Applicability
Domain 5, "Applicability," reflects the extent to which the guidelines are valid in settings with unlike resources and barriers to implementation, and best-selling, for case, the challenges faced in applying these guidelines with underinsured or otherwise disadvantaged populations. This is the domain in which the CPGs performed the worst, with only i guideline (NICE) achieving a high-quality rating. No CPG was found to adequately address the resource implications of their recommendations, and just a few provided tools or advice on how their guidelines could be put into do [ 26 , 27 , 28]. For example, multiple guidelines called for long-term monitoring of symptoms either as a diagnostic criterion or to determine treatment but did not provide tools for clinicians when patients are likely to exist lost to follow up [ 26 , 27 , 28]. Additionally, the CPGs did not account for minority populations or populations with language barriers or lower socioeconomic course.
The combination of scores from this domain and the "Stakeholder Development" domain reveal a lack of variety both in the developers and in the populations to which these guidelines might apply. The NICE guideline was the only CPG to score highly on both these domains. The NICE CPG included in its developing committee not only representatives from many fields of medicine only also experts in policy and social work likewise as members of the public. They likewise specifically articulated the importance of cost-effective interventions and provided tools for calculating monthly costs for patients on dissimilar therapies. Emphasizing affordability is critical, as loftier price is i of the primary reasons pediatricians practice non attach to CPGs [ 38].
Editorial independence
The greatest variability was noted in Domain six, "Editorial Independence," a measure out of transparency in research funding. Three guidelines scored >90 points, while the guidelines overall averaged a score of 51.82 with a standard deviation of 44.xiv. This phenomenon has been seen in other Hold II analyses [ 18 , 19], perhaps because some societies report funding data on their websites and non in the guidelines themselves. All other academic publications and presentations crave disclosures and CPGs should be held to the same standards. Directly reporting this data in the guidelines is less ambiguous and ensures that users have this information when making clinical decisions.
Recommendations
Three CPGs were validated by this Concur II analysis: those developed by the University of Toronto, Overnice, and NASPGHAN & ESPGHAN. All scored "loftier quality" on five of the 6 domains and were thus found to be "high quality" guidelines. A summary of the key recommendations for the diagnosis and treatment of GERD from these three "high quality" guidelines is presented in Tabular array 4. These recommendations emphasize the importance of differentiating GER from GERD, ruling out other diagnoses, understanding the variability in presenting symptoms at different ages, and the roles for various interventions.
Concord Two and pediatrics
The publication of a CPG is not itself enough to improve clinical intendance. Post-obit the publication of the 2009 NASPGHAN & ESPGHAN reflux guidelines, it was institute that fewer than ii% of pediatricians followed the guidelines strictly, and proton pump inhibitors continued to exist overprescribed at rates exceeding eighty% [ 39]. An analysis of AGREE Two papers within pediatrics showed that the quality of pediatric CPGs are generally mediocre, specially in "Applicability" and "Editorial Independence" [ 40]. Improving this body of literature is essential, and the AGREE II tool can deed as a guide for CPG developers. It is notable that the CPG by NASPGHAN & ESPGHAN, which was the CPG with the highest total score, performed an AGREE Ii analysis as part of their literature search; familiarity with the format and methodology suggested by the AGREE collaboration can lead to more than rigorous and applicable guidelines.
Limitations
This study has several limitations. The AGREE 2 tool evaluates the presentation and methodological rigor of CPGs but not the accuracy of the medical information they incorporate. It is possible that well-developed and clear CPGs could nowadays inaccurate data, or that the Concur 2 analysis could fail to place CPGs that provide helpful and relevant guidance. More specific investigation is needed to confirm that the guidelines rated "high quality" are in fact indicated. Secondly, the Concur II tool weighs all domains equally, despite evidence that "Rigor of Development" and "Editorial Independence" are more than strongly associated with effective clinical guidelines. Thirdly, the Hold II tool relies on subjective ratings from the reviewers; although statistical techniques were used to generate consensus ratings, these numbers reverberate the opinions of four authors. Lastly, the literature search could have missed applicable guidelines, particularly those in not-English language languages, despite the potential significance of these internationally.
In determination, CPGs can facilitate evidence-based clinical determination making. However, information technology is important that they are methodologically rigorous and offer high-quality guidance. Based on our analysis using the AGREE II instrument, only three of the eight (37.5%) identified CPGs pertaining to pediatric reflux are high quality. Areas for improvement include the domains of "Stakeholder Involvement," "Applicability," and "Editorial Independence."
Funding:AM reports a grant from the Parker B. Francis Foundation and a enquiry grant from 2R25-HL126140, outside the submitted work. All other authors declare no competing interests.
Conflict of Interest:The authors have no financial conflicts of involvement.
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