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Clinical practice guidelines for acute diarrhea in children ...

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<strong>Cl<strong>in</strong>ical</strong> <strong>practice</strong> <strong>guidel<strong>in</strong>es</strong> <strong>for</strong> <strong>acute</strong> <strong>diarrhea</strong><br />

<strong>in</strong> <strong>children</strong>: Methodological quality<br />

Iván D. Flórez 1 . Javier Contreras 1 Javier Sierra 1 ,<br />

María E. Tamayo 1 , Luz H. Lugo 1 , Claudia Granados 2 , Germán<br />

Briceño 3 , Juan M. Lozano 4 , Jorge L. Acosta 5<br />

1- Universidad de Antioquia; Medellín, Colombia<br />

2. Pontificia Universidad Javeriana; Bogotá, Colombia<br />

3. Fundación Cardio-<strong>in</strong>fantil; Bogotá, Colombia<br />

4. University of Florida, Miami, USA<br />

5. Universidad del Norte, Barranquilla, Colombia


Background<br />

• Acute <strong>diarrhea</strong> (AD) is the second most common disease <strong>in</strong><br />

<strong>children</strong><br />

• AD is globally associated with high morbidity <strong>in</strong> developed<br />

countries and with high mortality <strong>in</strong> undeveloped countries.<br />

• The Colombian M<strong>in</strong>istry of Health f<strong>in</strong>anced the development<br />

CPG of some diseases <strong>in</strong> order to improve health care system<br />

and to do cost-effectiveness analysis. Diarrhea <strong>in</strong> <strong>children</strong> was<br />

one of them<br />

• We <strong>for</strong>med a guidel<strong>in</strong>e developer group (GDG) <strong>in</strong> order to<br />

develop the <strong>Cl<strong>in</strong>ical</strong> Practice Guidel<strong>in</strong>es (CPG) of prevention,<br />

diagnosis and treatment of <strong>diarrhea</strong>l diseases <strong>in</strong> <strong>children</strong>


Background<br />

• Be<strong>for</strong>e develop<strong>in</strong>g a de novo-CPG it is<br />

recommended to assess published <strong>guidel<strong>in</strong>es</strong> <strong>in</strong><br />

order to consider adaptation of a high quality CPG<br />

• There were a lot of CPG of <strong>diarrhea</strong> and<br />

gastroenteritis <strong>in</strong> <strong>children</strong> available <strong>in</strong> the literature<br />

• The quality of published <strong>guidel<strong>in</strong>es</strong> on childhood<br />

<strong>diarrhea</strong> was assessed by Lo Veccio et al. <strong>in</strong> 2011,<br />

but it had some flaws


Evaluation of the Quality of Guidel<strong>in</strong>es <strong>for</strong> Acute<br />

Gastroenteritis <strong>in</strong> Children With the AGREE Instrument<br />

ABSTRACT<br />

Evaluation of the Quality of Guidel<strong>in</strong>es <strong>for</strong> A<br />

Andrea Lo Vecchio, Antonietta Giannattasio, y Christopher Duggan, z Gastroenteritis <strong>in</strong> Children With the AGREE Ins<br />

Salvatore De Masi,<br />

§ jj<br />

Maria Teresa Ortisi, Luciana Parola, and Alfredo Guar<strong>in</strong>o<br />

Problems:<br />

Conclusions: The overall quality of CPGs on <strong>acute</strong> gastroenteritis<br />

Aim: The aim of the study was to assess the quality of cl<strong>in</strong>ical <strong>practice</strong><br />

management <strong>in</strong> <strong>children</strong> is fair. Aims, target population, synthesis of<br />

<strong>guidel<strong>in</strong>es</strong> (CPGs) us<strong>in</strong>g the Appraisal of Guidel<strong>in</strong>es <strong>for</strong> Research and<br />

evidence, <strong>for</strong>mulation of recommendations, and clarity of presentation<br />

Evaluation (AGREE) <strong>in</strong>strument, a validated <strong>in</strong>ternational tool.<br />

are po<strong>in</strong>ts of strength. Weak issues are applicability, <strong>in</strong>clud<strong>in</strong>g identifica-<br />

Materials and Methods: CPGs were identified by search<strong>in</strong>g MEDLINE<br />

tion of organizational barriers and adherence parameters, and cost/efficacy<br />

(1966–January 2009) and Embase (1988–January 2009), CPG databases,<br />

analysis.<br />

and relevant Web sites of agencies and organizations that produce and/or<br />

endorse • First <strong>guidel<strong>in</strong>es</strong>. version Included <strong>in</strong> the of study were the CPGsAGREE <strong>in</strong> English § that Key Words: <strong>acute</strong> gastroenteritis, AGREE <strong>in</strong>strument, child, <strong>guidel<strong>in</strong>es</strong><br />

addressed the management of <strong>acute</strong> gastroenteritis <strong>in</strong> <strong>children</strong>. Retrieved<br />

CPGs were evaluated with the AGREE <strong>in</strong>strument <strong>for</strong> quality assessment Maria <strong>in</strong>strument jj<br />

Teresa (JPGN 2011;52: Ortisi, 183–189) Luciana Parola, and Alfredo Guar<strong>in</strong>o<br />

by 6 <strong>in</strong>dependent reviewers. AGREE consists of 6 doma<strong>in</strong>s <strong>for</strong> a total of<br />

23 • items. Search was limited to English Clanguage Results: N<strong>in</strong>e CPGs were identified. Four were evidence based (EB) and<br />

l<strong>in</strong>ical <strong>practice</strong> <strong>guidel<strong>in</strong>es</strong> CPG (CPGs) are systematically devel-<br />

2 of these <strong>in</strong>cluded tables of evidence. Eight CPGs (88%) scored


Objective<br />

• To assess the quality of CPG on <strong>acute</strong><br />

<strong>diarrhea</strong> or gastroenteritis <strong>in</strong> <strong>children</strong> us<strong>in</strong>g<br />

the AGREE-II <strong>in</strong>strument (Spanish version).


Methods<br />

• Systematic review of CPG<br />

• Databases:<br />

o Electronic databases: EMBASE, MEDLINE, LILACS<br />

o National clear<strong>in</strong>ghouses<br />

o Non-electronic sources: Hand-search<strong>in</strong>g:<br />

• Known CPG by authors, researchers, members of the<br />

group and cl<strong>in</strong>ical experts<br />

• Pediatrics, gastroenterology, familiar medic<strong>in</strong>e and<br />

nurs<strong>in</strong>g congresses and textbooks<br />

• We searched from June to August of 2011


Methods<br />

• We exclude <strong>guidel<strong>in</strong>es</strong> that:<br />

o Were not Evidence-based<br />

o Had a different scope<br />

o Exclusive adult population<br />

o Diarrhea <strong>in</strong> <strong>children</strong> with chronic diseases<br />

• Each EB-guidel<strong>in</strong>e was <strong>in</strong>dependently assessed us<strong>in</strong>g<br />

AGREE-II (Spanish version) by three (3) cl<strong>in</strong>ical<br />

epidemiologists<br />

• Appraisers (MSc <strong>in</strong> <strong>Cl<strong>in</strong>ical</strong> epidemiology)<br />

o Genera practicioner (1), Pediatrician (6)


Methods<br />

• The assesment was made based on the <strong>in</strong><strong>for</strong>mation<br />

presented <strong>in</strong> the published version of the CPG and<br />

on the web site of the organization, <strong>in</strong>stitution or<br />

journals<br />

• We acceded when possible to evidence tables and<br />

search strategies by contact<strong>in</strong>g authors and<br />

<strong>in</strong>stitution by mail.


Methods<br />

• Spanish-AGREE II <strong>in</strong>strument has 23 items grouped <strong>in</strong><br />

6 doma<strong>in</strong>s and 2 f<strong>in</strong>al items <strong>for</strong> the global evaluation.<br />

• The score is calculated with proportions <strong>for</strong> each<br />

doma<strong>in</strong><br />

• There is not a m<strong>in</strong>imum score to recommend a CPG<br />

• Rigor of development was chosen as the most<br />

important doma<strong>in</strong> based on Colombian <strong>guidel<strong>in</strong>es</strong><br />

methodology manual<br />

• 60% was the cut off po<strong>in</strong>t to consider a high quality<br />

guidel<strong>in</strong>e


Methods<br />

• The score of each doma<strong>in</strong> was calculated based <strong>in</strong><br />

the 3 appraisers evaluation<br />

• Differences between the scores <strong>in</strong> each items were<br />

analyzed by one of the appraisers.<br />

• When differences between appraisers were more<br />

than 4 po<strong>in</strong>ts, they were asked to revaluate their<br />

score, <strong>in</strong> order to get a consensus<br />

• We calculated medians and <strong>in</strong>terquartile ranges<br />

(IQR) of the scores <strong>in</strong> each doma<strong>in</strong>


APPRAISAL OF GUIDELINES<br />

fOR RESEARCH & EVALUATION II<br />

INSTRUMENT<br />

___________________________________________________________________________________<br />

INSTRUMENTO AGREE II<br />

The AGREE Next Steps Consortium<br />

May 2009<br />

INSTRUMENTO PARA LA EVALUACIÓN<br />

DE GUÍAS DE PRÁCTICA CLÍNICA


Results<br />

• We found 63 <strong>diarrhea</strong> <strong>guidel<strong>in</strong>es</strong><br />

• 17 of which (26.9%) were evidence-based.<br />

• The rest (46 CPG) were: protocols, narrative reviews, Non<br />

evidence –based <strong>guidel<strong>in</strong>es</strong>, experts consensus, <strong>guidel<strong>in</strong>es</strong> of<br />

associations and organizations (WHO), cost-effectiveness<br />

studies<br />

• 10 <strong>in</strong> English language: Canada, India, UK, USA, Europe,<br />

Australia<br />

• 7 <strong>in</strong> Spanish language: Colombia, México, Guatemala, Costa<br />

Rica, Spa<strong>in</strong><br />

• Peer-reviewed journals-databases (6), textbooks (2), guidel<strong>in</strong>e<br />

developer web-site (1), academic <strong>in</strong>stitutions or scientific<br />

association (4) or government organizations (4)


Results<br />

• Doma<strong>in</strong>s 1 (scope and purpose) and 4 (clarity of<br />

presentation) had the highest scores: 74 (60-94%)<br />

and 78 (56,5-91%), respectively<br />

• Doma<strong>in</strong>s 5 (applicability) and 6 (editorial<br />

<strong>in</strong>dependence), had the lowest: 13 (2-24,5%) and 8<br />

(0-58%), respectively<br />

• Only five <strong>guidel<strong>in</strong>es</strong> scored over 60% <strong>in</strong> the third<br />

doma<strong>in</strong> (rigour of development) and were<br />

considered as “recommended”.


Results<br />

Recommended (5) Not recommended (12)<br />

• Doma<strong>in</strong> 5 : 31 (6-69%)<br />

• Doma<strong>in</strong> 6: 54 (0-97%)<br />

• Doma<strong>in</strong> 1: 93,5 (89-100%)<br />

• Doma<strong>in</strong> 4: 93,5 (89-95%)<br />

• Doma<strong>in</strong> 3: 70 (60-42%)<br />

• Doma<strong>in</strong> 2: 65 (42-95%)<br />

• Doma<strong>in</strong> 5 : 10 (0-15%)<br />

• Doma<strong>in</strong> 6: 8 (8-13%)<br />

• Doma<strong>in</strong> 1: 63 (17-79%)<br />

• Doma<strong>in</strong> 4: 69 (57-80%)<br />

• Doma<strong>in</strong> 3: 27 (20-40%)<br />

• Doma<strong>in</strong> 2: 26 (18-32%)


Discussion<br />

• There is an urgent need to improve the quality of<br />

CPGs <strong>in</strong> <strong>acute</strong> <strong>diarrhea</strong> <strong>in</strong> <strong>children</strong> by <strong>in</strong>corporat<strong>in</strong>g<br />

high quality standards <strong>in</strong> the development process<br />

based on the key po<strong>in</strong>ts of a high-quality CPG<br />

• Most of CPG were from developed countries<br />

• There are several <strong>diarrhea</strong> CPG available <strong>in</strong> Spanish<br />

language but its quality is quite low <strong>in</strong> comparison<br />

to English languages ones<br />

• Two CPG were retrieved <strong>for</strong>m Spanish textbooks


Discussion<br />

• There are a lot of CPG that are called EB-<strong>guidel<strong>in</strong>es</strong><br />

and they are not.<br />

• We retrieved CPG from databases, textbooks,<br />

developers websites, national clear<strong>in</strong>ghouses. The<br />

search of CPG must be much wider than that <strong>for</strong><br />

primary studies<br />

• Diarrhea is a common disease <strong>in</strong> <strong>children</strong>. It is<br />

desirable to have the best evidence-based<br />

recommendation available.


Discussion<br />

• First (1th) and 4th doma<strong>in</strong>s scored high (upper 60%) <strong>in</strong><br />

both recommended and not recommended CPG<br />

• Fifth and 6 th doma<strong>in</strong>s scored low <strong>in</strong> both recommended<br />

and not recommended CPG<br />

• Third doma<strong>in</strong> must be the one that makes the difference<br />

• Developers are concerned about describ<strong>in</strong>g Scope and<br />

objectives and about the clarity of presentation, <strong>in</strong>stead<br />

of be<strong>in</strong>g rigorous <strong>in</strong> methodology<br />

• We must be alert about the 3rd doma<strong>in</strong> better than<br />

others that seem “attractive”: Clarity of<br />

recommendations and scope


Limitations<br />

• We have conclusions that could not be reproducible<br />

<strong>in</strong> other diseases<br />

• We had a low number of CPG<br />

• The 60% as a cut-po<strong>in</strong>t was recommended by the<br />

Colombian <strong>guidel<strong>in</strong>es</strong>, and the group agreed with<br />

this score.<br />

• What about another cut-po<strong>in</strong>ts? 70 – 75 – 80 % ?<br />

• AGREE collaboration doesn’t recommend a score,<br />

so it could be controversial our cut-off po<strong>in</strong>t


Conclusions<br />

• There is low quality <strong>in</strong> Spanish language CPG on<br />

<strong>diarrhea</strong><br />

• Most of CPG on <strong>diarrhea</strong> were not evidence based<br />

• Most of evidence based CPG had low to moderate<br />

quality<br />

• In AGREE-II, Third doma<strong>in</strong> makes the difference<br />

• Scope and purpose, and clarity could be good<br />

even <strong>in</strong> low quality <strong>guidel<strong>in</strong>es</strong>


Danke!<br />

ivoflorez@gmail.com

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