Assessing the Quality of Clinical Practice Guidelines in the Middle East and North Africa (MENA) Region: A Systematic Review
Received 7 October 2020
Accepted for publication 18 December 2020
Published 9 February 2021 Volume 2021:14 Pages 297—309
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Saja H Almazrou,1 Layan A Alsubki,1 Norah A Alsaigh,1 Wadha H Aldhubaib,1 Sharifah M Ghazwani2
1Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 2College of Pharmacy, Jazan University, Jazan, Saudi Arabia
Correspondence: Saja H Almazrou
Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, 14511, Saudi Arabia
Email [email protected]
Aim: Clinical practice guidelines (CPGs) have progressively become a popular tool for making optimal clinical decisions. The literature shows that the poor quality of CPGs can form a barrier against adhering to them, resulting in a suboptimal level of healthcare. The objective of this systematic review is to evaluate the quality of CPGs in the Middle East and North Africa (MENA) region using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) Instrument.
Methods: The authors searched in the MEDLINE and EMBASE databases through the Ovid interface on May 25, 2019. Keywords relating to CPGs and MENA countries were combined using Boolean search operators. The search was not limited to specific diseases. The quality of guidelines was appraised by two reviewers independently using the AGREE II Instrument. Discrepancies within a group were resolved through the involvement of a principle investigator.
Results: A total of 61 CPGs were appraised. These guidelines were mainly from Saudi Arabia, and the most covered disease topic was cancer. Among the six domains of the AGREE II Instrument, CPGs scored the highest on clarity of presentation (mean 82%), while the lowest score was granted to the rigor of development domain (mean 28%). This indicates substantial deficiencies in reporting the developmental processes of CPGs and the resources used for the synthesis of evidence.
Conclusion: From this review, it was found that the number of retrieved guidelines published in the MENA region is limited considering the large geographical area of the MENA region. The main domains that have higher quality scores were clarity of presentation and scope and purpose, whereas domains with the lowest scores were rigor of development and applicability. The authors’ findings will help policymakers identify areas for improvement in CPGs, which can lead them to implement strategies such as the training of individuals and recruitment of international experts to ultimately develop high-quality CPGs.
Keywords: AGREE II Instrument, clinical practice guideline, MENA, Middle East, quality
Clinical practice guidelines (CPGs) are defined by the Institute of Medicine (IOM) as statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.1 CPGs can provide several benefits to clinicians, institutions, and patients. The use of recommendations from CPGs assists clinicians in making decisions about individual patient management.2 On an institutional level, the use of CPGs allows the provision of standardized care to patients with the aim of decreasing variations in clinical practice.3 They also improve the quality of care and reduce preventable errors in medication.3 These possible benefits can eventually promote cost-effective care.4 Also, patients can benefit from some CPGs that are accompanied by “consumer” versions, which include a simple summary of the benefits and harms of available options.5 Thus, it empowers patients to make more informed healthcare choices and to consider their personal needs and preferences in selecting the best option.5 Nowadays, the number of published CPGs is progressively expanding.6 However, the quality of those guidelines is still inconclusive.7–9
The AGREE II Instrument (Appraisal of Guidelines for Research & Evaluation II) is one of the widely used, validated tools for evaluating CPGs. The instrument includes specific assessment questions that cover many aspects of the quality of guidelines with a focus on methodological rigor.10 It has been widely used to assess guidelines in various clinical conditions.11–16 High-quality clinical practice guidelines could have substantial positive impact on patients and healthcare providers. Evidence suggests that high quality could improve patients’ clinical outcomes, provide an equitable clinical recommendation that are effective, safe and appropriate to the target population.17,18
To our knowledge, there is no study that reviews the quality of published guidelines for clinical practice in the Middle East and North Africa (MENA) region. Several systematic reviews have been conducted to compare the quality of guidelines among high-income countries including the United states19–21 and Europe.22–26 Similar systematic reviews were also performed for low- and middle-income countries including Turkey,7 China,9 and Sri Lanka.8 The quality of clinical practice guidelines varies across countries. In the United States and Europe, lowest scores were assigned to “applicability” and “editorial independence”, whereas, in other developing countries including Turkey, China and Sri Lanka, the rigour of development received low scores on AGREE II Instrument.
The MENA region consists of high-, middle-, and low-income countries.27,28 In addition, there are variations in the financing of healthcare and the socioeconomic contexts in these countries.29 Therefore, conclusions from the previously mentioned systematic reviews cannot be generalized to the MENA region. The aim of this study is to assess the quality of CPGs in the MENA region using the validated AGREE II Instrument.10
The review’s protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019132437).
Identification of Guidelines
The sources were the MEDLINE and EMBASE databases through the Ovid interface, and the review was conducted on May 25, 2019, to identify CPGs. Additionally, gray literature has been manually searched to identify CPGs in all relevant health organization websites including those of the ministries of health and medical organizations of the MENA countries involved (Appendix 1). Keywords and terms relating to CPGs and all the MENA countries were combined using Boolean search operators (Appendix 2).
Selection of Guidelines
We used the institution of medicine (IOM) definition for clinical practice guidelines:
Statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.1
Therefore, the included guidelines should fulfil the following criteria:
- Guidelines are developed by medical societies or governmental institutions.
- Guidelines should describe the methods used to search the literature and identify eligible studies.
- Guidelines should provide structured recommendations based on reviewed studies.
We included English language guidelines that were produced by countries with MENA region organizations.27,28 Short summaries, narrative and systematic reviews, abstracts, and posters were excluded. The detailed criteria are listed in Table 1.
Table 1 Eligibility Criteria
Data Collection Process
One author (N. A.) conducted the search of electronic databases. Three authors—L. S., N. A., and W. H.—searched and screened the gray literature. Afterwards, two independent authors were involved in screening the results from the electronic databases by title, abstract, and then full text to select eligible guidelines. Conflicts and disagreements were resolved by discussion or by the involvement of an independent reviewer, if necessary. Also, two authors independently extracted and assessed the quality of the selected CPGs. Extracted data included the CPG name, specialty, year of publication, and country.
AGREE II Instrument Domain Descriptions
The AGREE II Instrument consists of six major domains that include a total of 23 different items.10 The domains includes, scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability and editorial independence. Following these domains, there are two general rating items also known as overall assessments. The first overall assessment question requires the user to make a judgment regarding the overall quality of a guideline, taking into consideration the criteria considered in the assessment process. In the second overall assessment question, the user is asked whether she/he recommends using the CPG or not.10
Each of the 23 items of the six domains and the overall assessment questions were rated as a part of the quality assessment. The AGREE II Instrument provides a rating scale from 1 to 7 with 1 indicating strong disagreement and 7 indicating strong agreement. The points between 2 and 6 can be chosen depending on the quality of reporting and its completeness. After rating the items, the score of each domain should be calculated independently. This is done by the summation of each item’s score in the domain and then calculating the total by scaling the domain’s score as percentage of the maximum possible score. The formula for calculating the scaled score is as follows:
Obtained score – Minimum possible score/Maximum possible score – Minimum possible score.
No specific score is defined as a minimum score by the AGREE II consortium. Thus, determining whether a CPG is of high or low quality is the decision of the user of the instrument. Consequently, for this review, a quality score threshold was selected considering all six domain scores to be 60% and above based on consensus among the authors. Therefore, high-quality guidelines will be those in which all domains score 60% or more.10
We used descriptive statistics with mean (SD), median, and range for each domain score, calculated using Microsoft Excel (2016).30
Selection of CPGs
Following the authors’ systematic search strategy, a total of 346 records were identified in the previously described databases, with an additional 19 papers identified through the gray literature search. After removing duplicates, the number of guidelines was 314, of which 235 were found to be irrelevant after screening by title and abstract, and 6 were excluded as duplicates. Therefore, 73 guidelines were considered for full-text screening, and 12 of these were excluded for different reasons mentioned in the flow chart (Figure 1). The final number of included guidelines was 61.
Figure 1 Flow diagram of the selection process of CPGs.
Clinical Practice Guidelines Characteristics
The description of the general characteristics of the assessed guidelines including the date and origin is illustrated in (Table 2). Among the 61 selected CPGs, 34 guidelines were from Saudi Arabia,31–64 12 were from multiple MENA countries,65–76 eight were from Lebanon,77–84 three were from Bahrain,85–87 and one was from each of the following countries: Iran,88 Egypt,89 and Jordan.90
Table 2 Characteristics of CPGs
AGREE II Appraisal Results
The main domains that had higher scores were clarity of presentation (mean 82%, range 39–100%) and scope and purpose (mean 63%, range 3–100%); meanwhile, domains with the lowest scores were rigor of development (mean 28%, range 0–71%), applicability (mean 29%, range 0–75%), stakeholders’ involvement (mean 53%, range 14–97%), and editorial independence (mean 59%, range 0–100%).
Out of the 61 guidelines, 58 (95%) guidelines scored >60% in the clarity of presentation domain, whereas only 5 (8%) and 7 (11.5%) scored >60% in applicability and rigor of development, respectively. The summary statistics for CPG quality assessment are presented in Table 3. The detailed assessment is presented in Appendix 3.
Table 3 Summary of the Domain Scores of CPGs Using the AGREE II Instrument (N = 61)
This study was performed to examine the quality of CPGs in the MENA region using the AGREE II Instrument. In this review, a total of 61 guidelines were suitable for inclusion, and their quality varied. Among the six domains of the AGREE II Instrument, CPGs scored the highest on clarity of presentation (mean 82%), while the lowest score was granted to the rigor of development domain (mean 28%).
Our results were consistent with those of similar reviews assessing CPGs in Turkey, Sri Lanka, and China.7–9 The similarities were that the lowest scores were attributed to the rigor of development and applicability domains, whereas the highest scores were attained in the clarity of presentation followed by the scope and purpose domain. As opposed to the findings of Hu et al9, editorial independence, which includes the role of funding bodies and potential conflicts of interest, was sufficiently reported in 50% of the included guidelines. This indicates the transparency of the guideline development process in the MENA region.
The impact of economic status on clinical practice and research has been widely investigated.91–93 Few systematic reviews have been conducted to compare and identify the gaps in several guidelines in low-income and middle-income countries compared with high-income countries.94–96 Since some of the MENA countries are classified as low-income and middle-income, as described in the data of the World Bank, the results of such research can be taken into consideration.28 Results from those reviews found several factors in the CPGs of low- and middle-income countries that had an impact on their quality and resulted in less clear and applicable guidelines.28,95 These factors can be broadly classified into evidence-related and contextual-related.97,98 Regarding evidence-related factors, the ability to search and critique clinical evidence is limited in developing countries.97,98 Moreover, Baradaran-Seyed et al state that despite the awareness of health-research priorities and needs, using existing knowledge from daily practice to inform larger clinical studies is suboptimal.97 Additionally, Owolabi et al found that there is a lack of compliance with the trustworthiness standards as defined in the Institute of medicine for guideline development.95 One of the quality assessment items within the rigor of development domain was procedure for updating.10 Some reviews showed that most of these guidelines were outdated, older than 5 years, which is an issue since medical knowledge is evolving and many updates occur regularly.28,95
Contextual-related factors mainly affect the applicability of guidelines.10 Healthcare policies and economic and contextual factors vary among different countries of the MENA region.99 For example, the access and efficient utilization of primary healthcare services in the region is suboptimal.100 In addition, despite the global reduction of communicable disease and the increasing rate of non-communicable diseases, some countries in the MENA region, such as Egypt and Morocco, have an increasing trend for both types.99 Workforce in the region is a major concern, and the number of physicians per 1000 people is lower than expected for middle-income countries such as Yemen, Morocco, the West Bank and Gaza, and Iraq. This factor is also superimposed with a lack of training and professional development, especially in rural regions.101 Finally, out-of-pocket expenditures account for 74% of private health expenditures, a factor that negatively affects the disadvantaged population. This may explain the reasons behind the poor quality of CPGs in the MENA region, especially in the development and applicability domains.
Strengths and Limitations
To the authors’ knowledge, this is the first review performed on the assessment of the quality of CPGs in the MENA region. The search for clinical practice guidelines extends beyond medical journals, and this breadth enhances the inclusiveness of the search strategy.
A major limitation in this study is that our search strategy excludes non-English language studies, and this exclusion may result in language and publication bias. Moreover, poorly indexed studies and those not indexed in PubMed, EMBASE, databases might be missed. In addition, the included clinical practice guidelines have several weaknesses in their design and reporting that may limit the conclusions of this systematic review. The quality assessment of guidelines was assessed by two appraisers, according to the AGREE II guidance, the preferred number of appraisers is four which increases the reliability.
Finally, we could not access the hard copies published by governmental bodies and ministries of health, this could limit the comprehensiveness of grey literature search.
Identifying weaknesses and areas for improvement in CPGs of the MENA region can guide policymakers and organizations, such as the ministries of health, to implement several strategies to develop high-quality CPGs.
First, a guideline development group should consist of a multidisciplinary team including clinicians, epidemiologists and statisticians, policymakers, and patients’ advocates. These members need to receive special training in the development process for guidelines, which includes but is not limited to effective searching in medical databases, critical appraisal, and utilization of The Grading of Recommendations Assessment, Development, and Evaluation (GRADE tool).102
In addition, the strengthening of collaboration between clinicians, researchers, professional societies, and stakeholders in the MENA region is urgently needed.103 This can be achieved by inviting clinicians and researchers to join guideline development groups, thereby creating a healthy environment where local and international experts meet and share their experience. The involvement of patients and the general public is important in the guideline development phase as it enhances the shared decision-making process and thus improves patient outcomes.104,105 Despite the importance of such involvement, studies have reported suboptimal engagement. Therefore, effective utilization of patient support groups and health charity associations as a potential source for targeted patients is warranted. Tackling these issues could potentially enhance the quality of local guidelines and thus increase their implementation and potential impact.
From this review, it was found that the number of retrieved guidelines published in the MENA region is limited considering the large geographical area of the MENA region. The main domains with higher quality scores were clarity of presentation and scope and purpose, whereas domains with the lowest scores were rigor of development and applicability. The authors’ findings will help policymakers identify areas for improvement in CPGs, and this identification can lead them to implement strategies such as the training of individuals and the recruitment of international experts to ultimately develop high-quality CPGs.
The authors report no conflicts of interest for this work.
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