Clinical practice guidelines for acute diarrhea in children: Methodological quality Iván D. Flórez1. Javier Contreras1 Javier Sierra1, María E. Tamayo1, Luz H. Lugo1, Claudia Granados2, Germán Briceño3, Juan M. Lozano4, Jorge L. Acosta5 1- Universidad de Antioquia; Medellín, Colombia 2. Pontificia Universidad Javeriana; Bogotá, Colombia 3. Fundación Cardio-infantil; Bogotá, Colombia 4. University of Florida, Miami, USA 5. Universidad del Norte, Barranquilla, Colombia Background • Acute diarrhea (AD) is the second most common disease in children • AD is globally associated with high morbidity in developed countries and with high mortality in undeveloped countries. • The Colombian Ministry of Health financed the development CPG of some diseases in order to improve health care system and to do cost-effectiveness analysis. Diarrhea in children was one of them • We formed a guideline developer group (GDG) in order to develop the Clinical Practice Guidelines (CPG) of prevention, diagnosis and treatment of diarrheal diseases in children Background • Before developing a de novo-CPG it is recommended to assess published guidelines in order to consider adaptation of a high quality CPG • There were a lot of CPG of diarrhea and gastroenteritis in children available in the literature • The quality of published guidelines on childhood diarrhea was assessed by Lo Veccio et al. in 2011, but it had some flaws Evaluation of the Quality of Guidelines for A Gastroenteritis in Children With the AGREE Ins Evaluation of the Quality of Guidelines for Acute Gastroenteritis in Children With the AGREE Instrument ! Andrea Lo Vecchio, !Antonietta Giannattasio, yChristopher Duggan, zSalvatore De Masi, § Maria Teresa Ortisi, jjLuciana Parola, and !Alfredo Guarino ABSTRACT Problems: Aim: The aim of the study was to assess the quality of clinical practice guidelines (CPGs) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument, a validated international tool. Materials and Methods: CPGs were identified by searching MEDLINE (1966 – January 2009) and Embase (1988 – January 2009), CPG databases, and relevant Web sites of agencies and organizations that produce and/or endorse guidelines. Included in the study were CPGs in English that addressed the management of acute gastroenteritis in children. Retrieved CPGs were evaluated with the AGREE instrument for quality assessment by 6 independent reviewers. AGREE consists of 6 domains for a total of 23 items. Results: Nine CPGs were identified. Four were evidence based (EB) and 2 of these included tables of evidence. Eight CPGs (88%) scored <50% for ‘‘applicability,’’ 7 (77%) for ‘‘stakeholder involvement,’’ and 6 (66%) for ‘‘editorial independence.’’ Compared with non-EB CPGs, EB CPGs had higher quality scores for all AGREE domains, with a better score for ‘‘rigor of development’’ (P < 0.001), ‘‘stakeholder involvement’’ and ‘‘clarity of presentation’’ (P < 0.01), and applicability (P < 0.05). Over time, the quality of guidelines tended to improve. The main recommendations of CPGs were similar. However, there were differences in the treatment of diarrhea, namely based on the settings and circumstances in which CPGs were produced. • • • • • Conclusions: The overall quality of CPGs on acute gastroenteritis management in children is fair. Aims, target population, synthesis of evidence, formulation of recommendations, and clarity of presentation are points of strength. Weak issues are applicability, including identification of organizational barriers and adherence parameters, and cost/efficacy analysis. Andrea Lo Vecchio, !Antonietta Giannattasio, yChristopher Duggan, zSalvatore § jj First version of the AGREE instrument Maria Teresa Ortisi, Luciana Parola, and !Alfredo Guarino ! Key Words: acute gastroenteritis, AGREE instrument, child, guidelines Search was limited to English language CPG C Databases and five web-sites of CPG or associations Date search limit: 2008 ABSTRACT In 2009 were published: 1 guideline in Colombia Conclusions: The overall quality of CPGs Aim: The aim of the study was to assess the quality of clinical practice and 2 guidelines from NICE and ESPGHAN management in children is fair. Aims, target guidelines (CPGs) using the Appraisal of Guidelines for Research and evidence, formulation of recommendations, and • In 2009, were published some Cochrane Systematic Evaluation (AGREE) instrument, a validated international tool. are points of strength. Weak issues are applicabi reviews about in bydiarrhoea Materials andtreatments Methods: CPGs were identified searching MEDLINE tion of organizational barriers and adherence para (1966–January 2009) non-evidence and Embase (1988–January 2009), CPG databases, CPG • Authors included based analysis. and relevant Web sites of agencies and organizations that produce and/or • This paper was not enough for us to do an assessment endorse guidelines. Included in the study were CPGs in English that Key Words: acute gastroenteritis, AGREE instru of the quality theses addressed theof management of acute CPG gastroenteritis in children. Retrieved CPGs were evaluated with the AGREE instrument for quality assessment (JPGN 2011;52: 183–189) Received February 12, 2010; accepted April 2, 2010. From the !Department of Pediatrics University of Naples ‘‘Federico II,’’ Naples, Italy, the yDivision of Gastroenterology and Nutrition, Children’s Hospital Boston, and Department of Pediatrics, Harvard Medical School, Boston, MA, the zDepartment of Epidemiology and Guidelines of the Italian Institute of Health (Istituto Superiore di Sanità), Rome, Italy, the §Hospital of Sant’Anna of Como, Italy and member of the Accreditation and Quality Improvement Working Group of Italian Society of Pediatrics, and the jjHospital of Magenta, Azienda Ospedaliera ‘‘Ospedale Civile di Legnano’’ Italy and member of the Accreditation and Quality Improvement Working Group of the Italian Society of Pediatrics. Address correspondence and reprint requests to Prof Alfredo Guarino, Department of Pediatrics University of Naples ‘‘Federico II,’’ Via Pansini 5, 80131 Naples, Italy (e-mail: [email protected]). Two of the authors have been involved in the production of 2 guidelines that were included in this study (A.G. and C.D.). Neither guideline ranked first in the AGREE evaluation, and in addition, the concordance between raters was good, suggesting that there were no biases in the evaluation. In addition, A.G. promoted and coordinated the present study but did not take part in the guideline assessment as evaluator. The authors report no conflicts of interest. There is no potential conflict of interest in any part of the study and there was no form of payment given to anyone to produce the manuscript. Copyright # 2011 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0b013e3181e233ac JPGN " Volume 52, Number 2, February 2011 (JPGN 2011;52: 183 – 189) linical practice guidelines (CPGs) are systematically developed statements to assist practitioners in making decisions about appropriate health care in specific clinical circumstances (1). Their purpose is to make explicit recommendations with a definite intent to influence what clinicians do. The primary goal of CPGs in pediatrics is to improve the health of infants and children by ensuring that they receive up-to-date, evidence-based (EB) care. CPGs are a major tool to improve the quality of care. Several studies have shown that adherence to EB guidelines leads to improvement in the quality of care provided (2,3). For many health conditions, there is a gap between what medical science has shown to be effective practice and what is actually done (4). The number of CPGs is rapidly mounting also in pediatrics. However, the plethora of CPGs has been accompanied by growing concern about differences among guideline recommendations and about the quality of guidelines (5 – 8). How does one define the quality of guidelines? A ‘‘good’’ guideline should be scientifically valid, usable, and reliable, and should improve the outcome of patients; however, it is rarely known how a guideline performs in clinical practice. Evaluation of CPGs should include both methods used to develop recommendations and applicability of recommendations (benefits, adverse effects, and costs). An international group of researchers, the Appraisal of Guidelines for Research and Evaluation (AGREE) Collaboration, developed and validated a specific instrument to assess the quality of CPGs based on theoretical assumptions (9). A recent assessment of the quality of pediatric guidelines with the AGREE instrument demonstrated better results for pediatric than for adult CPGs (10). The best performers were CPGs published and endorsed by the American Academy of Pediatrics (AAP) or registered in the National Guidelines Clearinghouse (NGC). Acute gastroenteritis (AGE) remains a common cause of morbidity and mortality among infants and children worldwide. In industrialized countries, the disease is relatively mild and generally self-limiting, but nevertheless can have a major effect on the quality of life of infected children and their families. AGE is a major cause of outpatient visits and hospital admissions in developed countries, and consequently it has a substantial effect on health costs. Several guidelines for the management of AGE in children are available. However, only a minority of physicians fully comply 183 Objective • To assess the quality of CPG on acute diarrhea or gastroenteritis in children using the AGREE-II instrument (Spanish version). Methods • Systematic review of CPG • Databases: o Electronic databases: EMBASE, MEDLINE, LILACS o National clearinghouses o Non-electronic sources: Hand-searching: • Known CPG by authors, researchers, members of the group and clinical experts • Pediatrics, gastroenterology, familiar medicine and nursing congresses and textbooks • We searched from June to August of 2011 Methods • We exclude guidelines that: o Were not Evidence-based o Had a different scope o Exclusive adult population o Diarrhea in children with chronic diseases • Each EB-guideline was independently assessed using AGREE-II (Spanish version) by three (3) clinical epidemiologists • Appraisers (MSc in Clinical epidemiology) o Genera practicioner (1), Pediatrician (6) Methods • The assesment was made based on the information presented in the published version of the CPG and on the web site of the organization, institution or journals • We acceded when possible to evidence tables and search strategies by contacting authors and institution by mail. Methods • Spanish-AGREE II instrument has 23 items grouped in 6 domains and 2 final items for the global evaluation. • The score is calculated with proportions for each domain • There is not a minimum score to recommend a CPG • Rigor of development was chosen as the most important domain based on Colombian guidelines methodology manual • 60% was the cut off point to consider a high quality guideline Methods • The score of each domain was calculated based in the 3 appraisers evaluation • Differences between the scores in each items were analyzed by one of the appraisers. • When differences between appraisers were more than 4 points, they were asked to revaluate their score, in order to get a consensus • We calculated medians and interquartile ranges (IQR) of the scores in each domain APPRAISAL OF GUIDELINES fOR RESEARCH & EVALUATION II INSTRUMENT ___________________________________________________________________________________ INSTRUMENTO AGREE II The AGREE Next Steps Consortium May 2009 INSTRUMENTO PARA LA EVALUACIÓN DE GUÍAS DE PRÁCTICA CLÍNICA Results • We found 63 diarrhea guidelines • 17 of which (26.9%) were evidence-based. • The rest (46 CPG) were: protocols, narrative reviews, Non evidence –based guidelines, experts consensus, guidelines of associations and organizations (WHO), cost-effectiveness studies • 10 in English language: Canada, India, UK, USA, Europe, Australia • 7 in Spanish language: Colombia, México, Guatemala, Costa Rica, Spain • Peer-reviewed journals-databases (6), textbooks (2), guideline developer web-site (1), academic institutions or scientific association (4) or government organizations (4) Results • Domains 1 (scope and purpose) and 4 (clarity of presentation) had the highest scores: 74 (60-94%) and 78 (56,5-91%), respectively • Domains 5 (applicability) and 6 (editorial independence), had the lowest: 13 (2-24,5%) and 8 (0-58%), respectively • Only five guidelines scored over 60% in the third domain (rigour of development) and were considered as “recommended”. Results Recommended (5) Not recommended (12) • Domain 5 : 31 (6-69%) • Domain 5 : 10 (0-15%) • Domain 6: 54 (0-97%) • Domain 6: 8 (8-13%) • Domain 1: 93,5 (89-100%) • Domain 1: 63 (17-79%) • Domain 4: 93,5 (89-95%) • Domain 4: 69 (57-80%) • Domain 3: 70 (60-42%) • Domain 3: 27 (20-40%) • Domain 2: 65 (42-95%) • Domain 2: 26 (18-32%) Discussion • There is an urgent need to improve the quality of CPGs in acute diarrhea in children by incorporating high quality standards in the development process based on the key points of a high-quality CPG • Most of CPG were from developed countries • There are several diarrhea CPG available in Spanish language but its quality is quite low in comparison to English languages ones • Two CPG were retrieved form Spanish textbooks Discussion • There are a lot of CPG that are called EB-guidelines and they are not. • We retrieved CPG from databases, textbooks, developers websites, national clearinghouses. The search of CPG must be much wider than that for primary studies • Diarrhea is a common disease in children. It is desirable to have the best evidence-based recommendation available. Discussion • First (1th) and 4th domains scored high (upper 60%) in both recommended and not recommended CPG • Fifth and 6th domains scored low in both recommended and not recommended CPG • Third domain must be the one that makes the difference • Developers are concerned about describing Scope and objectives and about the clarity of presentation, instead of being rigorous in methodology • We must be alert about the 3rd domain better than others that seem “attractive”: Clarity of recommendations and scope Limitations • We have conclusions that could not be reproducible in other diseases • We had a low number of CPG • The 60% as a cut-point was recommended by the Colombian guidelines, and the group agreed with this score. • What about another cut-points? 70 – 75 – 80 % ? • AGREE collaboration doesn’t recommend a score, so it could be controversial our cut-off point Conclusions • There is low quality in Spanish language CPG on diarrhea • Most of CPG on diarrhea were not evidence based • Most of evidence based CPG had low to moderate quality • In AGREE-II, Third domain makes the difference • Scope and purpose, and clarity could be good even in low quality guidelines Danke! ivofl[email protected]
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