ABSTRACT

Background:

World Health Organization deem Chronic Obstructive Pulmonary Disease as the fourth leading cause of death in the world. Because of its impact on Public Health, it represents a great burden from an international economic point of view, despite it is an avoidable and treatable disease. Hence it is suitable to use Clinical Practice Guidelines which are recommendations systematically developed to aid decision making about health care to improve quality, and they must be subject to a review and update of an enriching methodological rigor. There is currently many Clinical Practice Guidelines for Chronic Obstructive Pulmonary Disease but there is insufficient evidence to determine if they have the degree of methological quality for been used in clinical practice. For which, we have evaluated the quality of these Clinical Practice Guidelines in Spanish using the AGREE II instrument.

Methods:

We carried out a systematic search to find the Clinical Practice Guidelines for Chronic Obstructive Pulmonary Disease published in Spanish between 2010-2017 and put a quality evaluation into effect by means of AGREE II instrument.

Results:

We got six guidelines wich achieved inclusion criteria of the study and we draw the compliance of the domains in these guidelines by means of AGREE II instrument: Scope and purpose (55.56-92.59%), Stakeholder involvement (37.04-79.63%), Rigour of development (29.86-84.72%), Clarity of presentation (90.74-100%), Applicability (5.56-63.89%) and Editorial independence (5.56-94.44%).

Conclusions:

Only one guideline got the score to classify as Very Good Fulfilling/Very Hight Score; another four got Good Fulfilling/Hight Score; and last one got Low Fulfilling/Low Score.

Key words:
Clinical Practice Guideline; Chronic Obstructive Pulmonary Disease; Evaluation and AGREE

INTRODUCTION

Chronic Obstructive Pulmonary Disease (COPD) is deemed as a pathologic condition characterized by an air flow limitation not completely reversible. The air flow limitation is usually progressive and connected with an anormal inflammatory answer of the lungs against nocive particles or gases¹1. Ministerio de Sanidad y Consumo. Grupo de trabajo de la Guía de Práctica Clínica para el Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Guía de Práctica Clínica para el Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Servicios Sociales e Igualdad. Unidad de Evaluación de Tecnologías Sanitarias de la Agencia Laín Entralgo; 2012. Guías de Práctica Clínica en el SNS: UETS Nº 2011/6..

In 2010, 210 million people in the world suffered from COPD²2. Bousquet J, Kiley J, Bateman ED et al. Prioritised research agenda for prevention and control of chronic respiratory diseases. Eur Respir J. 2010;36:995-1001.. Its being nowadays the fourth cause of death in the world, predicted as third in 2030³3. WHO. World health statistics 008. 2010. Disponible en http://www.who.int/whosis/whostat/EN_WHS08_Full.pdf.
http://www.who.int/whosis/whostat/EN_WHS... .

In 2007 Spanish study EPI-SCAN showed that prevalence rate of COPD in our country rose to 10,2% (15,1% men and 5,7% women) to population between 40 and 80 years⁴4. Ancochea J, Badiola C, Duran-Tauleria E, Rio FG, Miravitlles M, Muñoz L et al. Estudio EPI-SCAN: resumen del protocolo de un estudio para estimar la prevalencia de EPOC en personas de 40 a 80 años en España. Archivos de Bronconeumología. 2009;45(1),41-47..

Practice Clinic Guidelines (PCG) are documents which, by means of a deep analysis of the scientific evidence about an relevance clinic trouble for a determinated population or institution, look for draw recomendations up since different perspectives (preventive, diagnostic, treatment and rehabilitation)⁵5. Pardo R. Manual metodológico para la elaboración y adaptación de guías de práctica clínica basadas en la evidencia 1ra ed. Bogotá: Universidad Nacional quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care. 2003; 12: 18-23., with the objective of optimize health care to the patients⁶6. Steinberg E, Greenfield S, Mancher M, Wolman DM, Graham R. Clinical practice guidelines we can trust. National Academies Press; 2011..

For its part, Health and Consumption Ministry published the Quality Plan for the National Health System in which 10th strategy promotes the quality promotion by means of the elimination of professional practice variability. Nevertheless, there is observed that exists a great variability in content and scope of these documents. This is due to that a lot of PCGs lack of appropriate methodological rigor which guarantee quality of analyzed information and drawn recommendations up⁷7. Shaneyfelt TM, Mayo-Smith MF Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed medical literature. JAMA. 1999;281:1900-5..

For solving this problem, in 1998 it was created the international researchers and developers of guidelines group, The AGREE collaboration (Appraisal of Guidelines, Research and Evaluation) which principal objective was the creation of a tool which evaluate the development and report of PCGs. The first version of AGREE tool, published in 2003, was consolidated as an useful and easy application tool⁸8. AGREE Collaboration. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care. 2003 Feb;12(1):18-23.. The original AGREE tool was redesigned in 2009 and, as outcome, was developed AGREE II tool which principal features are⁹9. Brouwers M, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna S, Littlejohns P, Makarski J, Zitzelsberger L for the AGREE Next Steps Consortium. AGREE II: Advancing guideline development, reporting and evaluation in healthcare. Can Med Assoc J. 2010. doi:10.1503/cmaj.090449.
https://doi.org/10.1503/cmaj.090449... :

There are many studies which used AGREE II to evaluate PCGs works quality like Parra-Anguita¹⁰10. Parra-Anguita L, Granero-Moya N, Pancorbo-Hidalgo PL. Calidad de las guías de práctica clínica españolas sobre la enfermedad de Alzheimer y otras demencias. Rev Esp Salud Pública Internet. 2016 citado 2017 Sep 04; 90: e30005. Disponible en: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1135-57272016000100204&lng=es.
http://scielo.isciii.es/scielo.php?scrip... , Uzeloto¹¹11. Uzeloto JS, et al. The quality of clinical practice guidelines for chronic respiratory diseases and thereliability of the AGREE II: an observational study. Physiotherapy. 2016. DOI: 10.1016/j.physio.2016.11.002.
https://doi.org/10.1016/j.physio.2016.11... , which included COPD, and Acevedo¹²12. Acevedo JC, Sardi JP; Gempeler A. Revisión sistemática de la literatura y evaluación metodológica de guías de manejo invasivo de dolor lumbar. Rev Soc Esp Dolor. 2016; 23(5): 243-255. DOI: 10.20986/resed.2016.3424/2016.
https://doi.org/10.20986/resed.2016.3424... .

The principal objective of this study was: to evaluate and analyse the quality of PCG in Spanish for COPD. As secondary objectives we proposed: know which PCGs for COPD was published in the last 7 years in spanish; to develop a comparison between PCGs with respect to its quality; and to organize and Rank PCGs with respect to its quality.

MATERIAL AND METHODS

We performed a systematic research to locate PCGs for COPD published in Spanish in the last 7 years (2010-2017) and ran a quality evaluation through AGREE II tool.

We carried out a systematic research at Medline database, at Índice Bibliográfico Español en Ciencias de la Salud (IBECS) and at Índice de Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS), also at webs of agencies and institutions such as: Guía de la salud del Sistema Nacional de Salud; Google Scholar; la Biblioteca Internacional de Guías (G-I-N); Database of PCGs held by Canadian Medical Association; and the social scientific network ResearchGate.

The quality analysis of PCGs was performed using AGREE II tool, which is a tool to evaluate methodological rigor and transparency with which this guideline was developed. Consist of 23 items included in 6 Domains of Quality. Each item is qualified with values from 1 (very disagree) to 7 (very agree). The six Domains described are

Data collecting was carried out by the three members of the work group and authors of this paper, which independently checked every selected guideline. Before this collecting, group members accomplished a face to face training with the guideline, approaching and solving in accord with the doubts raised in guideline.

For the methodological quality evaluation also we followed the rules of using of the AGREE II handbook (traduced to Spanish by Health Guideline of the SNS)¹⁵15. Grupo de Trabajo de GesEPOC. Guía de Práctica Clínica para el Diagnóstico y Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) - Guía Española de la EPOC (GesEPOC). Arch Bronconeumol. 2012;48(Supl 1):2-58. (Más actualización posterior).. The steps followed were:

Even though AGREE II tool does not have got an established cut point to choose if a guideline is good or not, experts consensus suggest to be considered a good quality guideline should obtain a percentage higher than 60-70%, so that group decided take as cut point a 60%¹⁹19. Hoz AM, Ávila MJ, Bohórquez AP, García J, Arenas AE, Vélez A, Jaramillo LE, Gómez-Restrepo C. Guías de práctica clínica en esquizofrenia: evaluación mediante AGREE II. Rev Colomb Psiquiatr. 2014;44 Supl 1:3-12 - DOI: 10.1016/j.rcp.2015.05.002.
https://doi.org/10.1016/j.rcp.2015.05.00... .

The data were processed with Microsoft Excel (version 15).

RESULTS

We obtained six guidelines which fulfilled the inclusion criteria in the study, and which were not approached by previous authors, and over which we applied the AGREE II method which we describe then. The six guidelines below: Quality Plan Guideline for the National Health System by the Spanish Ministry of Health¹1. Ministerio de Sanidad y Consumo. Grupo de trabajo de la Guía de Práctica Clínica para el Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Guía de Práctica Clínica para el Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Servicios Sociales e Igualdad. Unidad de Evaluación de Tecnologías Sanitarias de la Agencia Laín Entralgo; 2012. Guías de Práctica Clínica en el SNS: UETS Nº 2011/6.; by the Spanish Society of Family Medicine and the Spanish Society of Pneumology and Thoracic Surgery¹³13. Grupo de trabajo de la guía de práctica clínica sobre Atención Integral al paciente con Enfermedad Pulmonar Obstructiva Crónica (EPOC). Desde la Atención Primaria a la Especializada. Sociedad Española de Medicina de Familia (semFYC) y Sociedad Española de Neumología y Cirugía Torácica (SEPAR); 2010.; by the Mexican Institute of Social Security¹⁴14. Diagnóstico y Tratamiento de la Enfermedad Pulmonar Obstructiva, México: Instituto Mexicano del Seguro Social; 2010.; by the Work Group of GesEPOC¹⁵15. Grupo de Trabajo de GesEPOC. Guía de Práctica Clínica para el Diagnóstico y Tratamiento de Pacientes con Enfermedad Pulmonar Obstructiva Crónica (EPOC) - Guía Española de la EPOC (GesEPOC). Arch Bronconeumol. 2012;48(Supl 1):2-58. (Más actualización posterior).; by the Colombian Health Ministry and Social Protection¹⁶16. Londoño D et al. Guía de práctica clínica basada en la evidencia para la prevención, diagnóstico, tratamiento y seguimiento de la enfermedad pulmonar obstructiva crónica (EPOC) en población adulta. Ministerio de Salud y Protección Social. Guía nº 28. Colciencias. Bogotá; 2014.; and by Argentinian Health Ministry¹⁷17. Videla AJ et al. Guía de práctica clínica nacional de diagnóstico y tratamiento de la enfermedad pulmonar obstructiva crónica. Ministerio de Sanidad. Presidencia de la Nación. Buenos Aires; 2015.. All of them specified in the table 1.

First way, we can watch in the table 2 the valuations broken down into Domains each guideline, pointing the maximum individual Rank which every Domain can rate, the Rank rated by evaluators, the mean of the ratings assigned and the global summation of the ratings of the three guidelines. Second way, reflected in the table 3, showed up the mean per Domains and the total of each PCG. Third way, showed up in the table 4, it´s reflected its mean and Standard Deviation expressed in percentage. Fourth way, the next data depicted in the figure 1:

DISCUSSION

The obtained results served us to categorize and Rank which guidelines achieved the higher quality. Argentinean guideline is the only with very high score / very good compliance; followed by SNS, SEPAR, Colombian and Mexican with high score / good compliance; and, finally, GesEPOC with down score / down compliance.

Nowadays there is a great inconsistency in how “developers of clinic guidelines” of all the world sort out quality of the available and strength of recommendations²⁰20. Pérsico D, Torres D. Niveles de evidencia y grados de recomendación: el sistema GRADE. Rev chil anest. 2014; 43(4)357-360., even though the most researchers are adapting GRADE system when they prepare manuscript about clinic guidelines²⁰20. Pérsico D, Torres D. Niveles de evidencia y grados de recomendación: el sistema GRADE. Rev chil anest. 2014; 43(4)357-360.. Although the analysis of GRADE system²¹21. Sanabria AJ, Rigau D, Rotaeche R, Selva A, Marzo-Castillejo M y Alonso-Coello P. Sistema GRADE: metodología para la realización de recomendaciones para la práctica clínica. Atención Primaria. 2015; 47, 1, 48-55. was not the objective of this study, seems reasonable reaching this point to describe this one.

Four of the six guidelines consulted in this study expressly mentioned using GRADE system to endorse quality of evidence found, as well as the grade of its recommendations. Four guidelines which use GRADE are Argentinean, SNS, SEPAR and Colombian. In other way, GesEPOC and Mexican guidelines do not expressly allude to the method used to achieve the evidence grade.

Seems reasonable to think that using GRADE system is a good strategy to save the quality of the guidelines because of, if we take the obtained data in our study, authors that establish the evidence with GRADE obtained a higher score before evaluation with AGREE II, both in the rigor of development domain and the global score.

In the other way, three of the looked at guidelines reference the using AGREE II method and the application of its recommendations during developing. These are: Argentinean, Colombian and SEPAR.

In one hand, we can derive that the better score Domains were the 4^th(clarity of presentation) and 1^st(scope and purpose of the guideline), being too which have less standard deviation and coincide with very high score category. These results are similar of the obtained by Parra-Anguita¹⁰10. Parra-Anguita L, Granero-Moya N, Pancorbo-Hidalgo PL. Calidad de las guías de práctica clínica españolas sobre la enfermedad de Alzheimer y otras demencias. Rev Esp Salud Pública Internet. 2016 citado 2017 Sep 04; 90: e30005. Disponible en: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1135-57272016000100204&lng=es.
http://scielo.isciii.es/scielo.php?scrip... and Uzeloto¹¹11. Uzeloto JS, et al. The quality of clinical practice guidelines for chronic respiratory diseases and thereliability of the AGREE II: an observational study. Physiotherapy. 2016. DOI: 10.1016/j.physio.2016.11.002.
https://doi.org/10.1016/j.physio.2016.11... as to the valoration of the Domains 1 and 4. Even though with Parra-Anguita¹⁰10. Parra-Anguita L, Granero-Moya N, Pancorbo-Hidalgo PL. Calidad de las guías de práctica clínica españolas sobre la enfermedad de Alzheimer y otras demencias. Rev Esp Salud Pública Internet. 2016 citado 2017 Sep 04; 90: e30005. Disponible en: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1135-57272016000100204&lng=es.
http://scielo.isciii.es/scielo.php?scrip... in categories they do not match, but there is a trend. This high score show a good management of the objectives development, choice of the target population, clarity and the limited o null ambiguity of the recommendations issued by guidelines.

In the other hand, we reflect low score achieved in Domains 5 (applicability of the guideline) and 6 (editorial independence) by the most guidelines (except Argentinean), which achieved a standard deviation between 20-30%, with a score mean with the low compliance category. Mean and deviation of Domain 5 are similar to the outcomes of Uzeloto¹¹11. Uzeloto JS, et al. The quality of clinical practice guidelines for chronic respiratory diseases and thereliability of the AGREE II: an observational study. Physiotherapy. 2016. DOI: 10.1016/j.physio.2016.11.002.
https://doi.org/10.1016/j.physio.2016.11... and Acevedo¹²12. Acevedo JC, Sardi JP; Gempeler A. Revisión sistemática de la literatura y evaluación metodológica de guías de manejo invasivo de dolor lumbar. Rev Soc Esp Dolor. 2016; 23(5): 243-255. DOI: 10.20986/resed.2016.3424/2016.
https://doi.org/10.20986/resed.2016.3424... (this one, specially, deviation higher than our study). Again, with Parra-Anguita¹⁰10. Parra-Anguita L, Granero-Moya N, Pancorbo-Hidalgo PL. Calidad de las guías de práctica clínica españolas sobre la enfermedad de Alzheimer y otras demencias. Rev Esp Salud Pública Internet. 2016 citado 2017 Sep 04; 90: e30005. Disponible en: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1135-57272016000100204&lng=es.
http://scielo.isciii.es/scielo.php?scrip... outcomes do not match, but there is a trend; and both being the lowest score. This evidence the necessity of improve aspects related to implementation in practice of the guidelines, audit of PCGs, conflict of interests between professionals and independence with entities which help funding these studies.

After valuing results, we observed the most differences between guidelines affect, to a larger extent, in methodology and, lesser degree, to quality recommendations that provide.

We find interesting to mention that two guidelines with better score in Domain 5 (implementation), more than double, have used during developing a Guideline Implementability Appraisal (GLIA) tool to identify intrinsic barriers of PCGs reference to recommendations implementation.

The limitations we found in our study emerge in difficulty to obtain PCGs with search methods described in Methods, as well as limitation around language point due to limited number of evaluators used in this study. These factors excluded the evaluations of other guidelines like used by Uzeloto¹¹11. Uzeloto JS, et al. The quality of clinical practice guidelines for chronic respiratory diseases and thereliability of the AGREE II: an observational study. Physiotherapy. 2016. DOI: 10.1016/j.physio.2016.11.002.
https://doi.org/10.1016/j.physio.2016.11... .

Finally, we want to bring out that is not our purpose disparage and disqualify using any evaluated PCGs, but show up aspects of developing of these which, in our judgment and backed by the AGREE II tool, should correct to increase quality and continuing developing these so valuable instruments for sanitary professionals.

References

Publication Dates

History