Journal of Evidence-Based Medicine ISSN 1756-5391
REVIEW ARTICLE
Systematic review of hypertension clinical practice guidelines based on the burden of disease: a global perspective Yin Chen1,2 , Shilian Hu1 , Youping Li2 , Boxi Yan3 , Gan Shen4 and Li Wang2 1
Anhui Evidence-based Medicine Center, Anhui Provincial Hospital, Hefei 230001, China Chinese Evidence-based Medicine Center/Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, China 3 West China Medical School, West China Hospital, Sichuan University, Chengdu 610041, China 4 Department of Geriatrics, Anhui Provincial Party Committee Hospital, Hefei 230001, China 2
Keywords Clinical practice guideline; hypertension; systematic review. Correspondence Youping Li, West China Hospital, Sichuan University, No. 37, Guoxue Xiang, Chengdu 610041, China. Tel: 86-028-8542-2052; Fax: 86-028-8542-3040; Email: [email protected] Received 30 May 2013; accepted for publication 25 January 2014. doi: 10.1111/jebm.12082
Abstract Objective: To perform a systematic review for the development, geographical distribution, and subject classification of clinical practice guidelines (CPGs) for hypertension worldwide. Methods: CPGs for the management of hypertension were identified through the searching of Ovid, EMbase, and Chinese electronic databases. Major guidelines websites such as NGC (National Guideline Clearinghouse), GIN (Guidelines International Network), NICE (National Institute for Health and Clinical Excellence) and CPGN (Clinical Practice Guideline Network), as well as Google Scholar were also screened for additional information. EndNote X3 and Excel 2007 were used for extracting and analyzing the data of included CPGs. Results: A total of 375 hypertension CPGs were included, involving 6 continents, 33 countries, 4 regions, and 3 international organizations. The publication date ranged from the year of 1971 to 2012, with the number of CPGs increased year by year. The CPGs were mainly developed by North America, Europe, and Asia. Their subjects covered 3 categories and 11 sub-classes, which mainly focused on the management of adult hypertension (44.53%). Conclusion: The number of CPGs varies in regions, countries, and academic organizations, with the development process differently. The regional disparity between the number CPGs and burden of hypertension were observed. The CPGs made a point of the management of adult hypertension.
Introduction Hypertension is a major public-health challenge worldwide. About one billion people worldwide suffer from hypertension and one of each four adults had hypertension (1). Hypertension is one of the leading causes of the global burden of disease, of which the direct and indirect healthcare costs expends medical and social resources (2). Clinical practice guidelines (CPGs) have been defined as “systematically developed statements to assist practitioner and patients’ decisions about appropriate health care for specific clinical circumstances” (3, 4). CPGs bridge the gap between policy and practice and should be based on up to date
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research findings to make explicit recommendations with a definite intent to influence what clinicians do. It is recognized that reducing the burden of disease in resource-poor settings relies on the availability of such evidence-based clinical practice guidelines (5). CPGs are believed to improve the quality and costeffectiveness of health care (6, 7), which generated growing interest among professionals in hypertension CPGs production. There are numerous organizations that draft CPGs, which means that there is more and more guidelines worldwide available addressing the management of hypertension. The present study was to evaluate and compare the characteristic of development, geographical distribution, and
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 52–59
Y. Chen et al.
Hypertension clinical practice guidelines based on the burden of disease
subject classification of CPGs for hypertension based on the burden of diseases worldwide.
Material and Methods Inclusion and exclusion criteria CPGs focus on the management of primary hypertension was eligible for inclusion in the present study. Non-primary hypertension, interpretation, and adherence of hypertension as well as conference abstract were excluded.
Search strategy According to a pre-specified protocol, CPGs were identified through searches in MEDLINE (via Ovid, 1946 to March week 2, 2012), EMbase (all years), NGC (National Guidelines Clearinghouses, March), G-I-N (Guidelines International Network, March), NICE (National Institute for Health and Clinical Excellence), CBM (Chinese BioMedical Literature Database), WanFang Data up to April 2013, with no language restriction. The search strategy included MeSH together with free-text words and the following search terms were used: consensus, practice guideline*, high blood pressure, hypertension, guidelines, clinical pathway. In addition, Google Scholar was also used for additional information.
Geographical distribution of guidelines A total of 375 hypertension CPGs that were included, involving 6 continents, 33 countries, 4 regions, and 3 international organizations (WHO, European Society of Hypertension/European Society of Cardiology (ESH/ESC) and Asian Pacific Heart Association) were presented in Figure 2. The majority of hypertension CPGs were mainly developed in North America (USA: n = 95; Canada: n = 62), and in Europe, CPGs were mainly distributed in Germany (n = 23), Spain (n = 17), UK (n = 17), France (n = 11), Italy (n = 7), Finland (n = 4), Czekh (n = 3), Russia (n = 3), Greece (n = 2), Portugal (n = 2), and Sweden (n = 2), with 1 guideline in Austria, Belgium, Bosnia, Croatia, Hungary, Holland, and Norway, respectively. ESH/ESC formulated 22 guidelines. Across the region of Asia, China (n = 26) and Japan (n = 11) took priority over in the development of CPGs, and Asian Pacific Heart Association formulated 2 guidelines. There was only 1 guideline each in the remaining Asia countries including Korea, Malaysia, Saudi Arabia, Singapore, India, and Iran. In South America, guidelines were mainly distributed in Brazil (n = 6), Mexico (n = 5), and Chile (n = 2), with Latin America and Caribbean Area each drafted 1 guideline. The guidelines in Oceania were all formulated by Australia. In Africa, guidelines were mainly distributed in South Africa (n = 11), with Sahara Area and Egypt each established 1 guideline. It should be noted that there are 17 guidelines developed by the WHO.
Data extraction and analysis Two investigators (Yin Chen and Boxi Yan) independently screened the titles and abstracts of the literature for potentially relevant guidelines. Any discrepancy was resolved by consensus. If required, a third person (Shilian Hu) was consulted to resolve disagreements. We designed a data extraction form and collected the baseline information, including date of publication, regional distributions, and subject classification. According to the extracted data, we analyzed descriptively the general characteristic of development process of hypertension CPGs worldwide. The comparison of the number of CPGs and the prevalence of hypertension was performed in different regions.
Results Literature search The search strategy yielded 21,458 (18,174 non-Chinese and 3284 Chinese) records, of which 716 (643 non-Chinese and 73 Chinese) were considered potentially relevant and 375 (347 non-Chinese and 28 Chinese) were finally included for analysis, as summarized in Figure 1.
Development process of CPGs The publishing time of guidelines ranged from the year of 1971 to 2012, which could be divided into 4 stages according to the number of the guidelines, that was, from 1971 to 1988, 1989 to 1998, 1999 to 2006, and 2007 to 2011, as shown in Figure 3. The first stage was 18 years, including 16 guidelines in total, with less than 1 guideline annually in average (ranging from 0 to 2 annually). Fourteen guidelines were developed in North America, 3 in WHO and South America each, and 2 in Europe. It was interesting that there were no guidelines developed in Asian, Oceania, and Africa in this period, which could be called “brew stage”. The second stage was 10 years, involving 65 guidelines in total, with 4 times higher than the first stage, and 6.5 guidelines annually in average (ranging from 4 to 16 annually). Thirty-one guidelines were developed in North America, 18 in Europe, 9 in WHO, 2 in Oceania developed by Australia, and 1 in South America. It should be noted that the first hypertension guideline appeared in Asia, which was developed in Japan. This period could be called “developing stage”. The third stage was 8 years, involving 150 guidelines in total, with 2.5 times higher than the second stage, and
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 52–59
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Hypertension clinical practice guidelines based on the burden of disease
MEDLINE: 3,948 EMbase: 17,459
NGC: 493 NICE: 105 G-I-N: 93
Duplicate: 3,951
Y. Chen et al.
CPGN: 35 Non-Chinese: 27 Chinese: 8
Non-Chinese
WanFang: 3,248 CBM: 130
Chinese
Unique: 18,174
Duplicate: 138
Unique: 3,284
Exclude by tle and abstract: 17,531
Exclude by tle and abstract: 3,211 Poten ally related: 643
Exclude by full text: 246 Different popula on: 122 Interpreta on: 18 Analysis of adherence: 13 Abstract of conferences: 93 Introduc on: 42
Poten ally related: 73
Google Scholar: 28
Guideline (non-Chinese): 347 MEDLINE+EMbase: 249 NGC: 40 G-I-N: 33 Google Scholar: 25
Exclude by full text: 44 Interpreta on: 6 Review of guidelines: 3 Translate: 21 Introduc on: 14
Guideline (Chinese): 28 WanFang+CBM: 25 Google Scholar: 3
Guideline: 375 North America: 157 Europe: 120 Asia: 47 WHO: 17 South America: 15 Oceania: 11 Africa: 8 Figure 1 Flow chart of guidelines selection.
19 guidelines annually in average (ranging from 13 to 24 annually). Sixty-one guidelines were developed in North America, 52 in Europe, 19 in Asia, with 5 guidelines in the WHO, South America and Africa each, and 3 in Oceania developed by Australia. This period could be called the “leaping stage”. The fourth stage was 5 years, including 141 guidelines in total, which was the same as the third stage, with 28.2 guide-
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lines annually in average (ranging from 23 to 38 annually). Fifty-five guidelines were developed in North America, 48 in Europe, 27 in Asia, 8 in South America, 5 in Oceania (developed by Australia), and 1 in Africa. There was no guideline developed in the WHO at this stage (Three guidelines in 2012, which could only reflect the data of just one quarter of the year, were not included in the analysis.).
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Y. Chen et al.
Hypertension clinical practice guidelines based on the burden of disease
Figure 2 Geographical distribution of CPGs worldwide
Figure 3 The development process of CPGs worldwide.
Comparison between geographical distribution of guidelines and prevalence of hypertension Table 1 showed that Europe had the largest burden of hypertension, followed by South America, Asia, Oceania, Africa, and North America successively. Germany had the highest prevalence of hypertension while Greece had the lowest across the 6 continents including 17 countries. The top 10 countries suffered from hypertension were Germany, Italy, Spain, Sweden, Mexico, Japan, UK, China,
and Australia. The largest number of hypertension guidelines was in USA while the least was in Korea and India. The top 10 countries of the number of hypertension guidelines were USA, Canada, Germany, China, Spain, UK, Japan, Australia, and Italy. North America, with the lowest prevalence of hypertension (ranked 14 and 15), developed more than half of the hypertension guidelines (53.58%) in the whole world. Europe, with the largest burden of hypertension, made 15.70% guidelines. The burden of hypertension in South America was just below Europe but only made 2.39%
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Table 1 The comparison between geographical distribution of guidelines and prevalence of hypertension
Continent
Population (0.1 billion)
Population density (/km2 )
North America
5.29
22.9
Europe
7.39
70
Asia
41.40
86.7
South America
3.86
21.4
Oceania Africa
0.36 9.95
4.25 32.7
Country
Age-standardized rate of hypertension Men vs. Women (overall)
Burden ranking
No. of guidelines
Ranking
USA Canada Germany Italy Spain Sweden UK Greece Japan North India (urban) China Taiwan Korea Mexico Caribbean Australia South Africa
21.0 vs.19.7 (20.3) 23.5 vs. 15.6 (21.4) 55.4 vs.56.6 42.0 vs. 43.3 41.7 vs.39.0 (40.0) 39.6 vs. 40.9 34.7 vs. 25.7 (29.6) 18.5 vs. 15.9 (16.9) 42.7 vs. 35.0 (38.3) 24.5 vs. 23.2 (23.8) 28.8 vs. 26.6 (27.7) 27.1 vs. 20.8 (23.7) 21.8 vs. 19.4 38.6 vs. 30.1 (33.5) 47.7 vs. 32.2 (39.7) 30.8 vs.20.1 22.9 vs. 23.4 (23.1)
15 14 1 2 3 4 8 17 6 11 9 12 16 7 5 10 13
95 62 26 7 17 2 17 2 11 1 26 2 1 5 2 11 6
1 2 3 9 5 12 5 12 7 16 3 12 16 11 12 7 10
Note: The data of the prevalence of hypertension were from: Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365(9455): 217–23.
guidelines. Asian countries have the largest number and highest density of population, the burden of hypertension was mainly distributed in Japan, China, and India, and the guidelines in this region represented 14.00% of all. The prevalence of hypertension ranked 10 in Australia, where the density of population was low, but the number of guidelines was still more than that in Africa, accounted for 3.75%.
Subject classification of hypertension guidelines As presented in Table 2, the subjects of global hypertension guidelines covered 3 categories, 11 sub-classes as follows, most of which focused on the management of adult hypertension (44.53%). The I category included 305 (81.33%) hypertension guidelines, contained 8 sub-classes, with 265 guidelines for adult hypertension (70.67%), covering 6 sub-classes, that was, comprehensive management of hypertension (44.53%), pharmacological intervention (9.07%), lifestyle intervention (6.67%), monitoring/prevention (5.33%), diagnosis/screening (5.33%), nursing/education (1.07%). There were 41 guidelines for hypertension complicated with other diseases, which covered 2 sub-classes, hypertension complicated with cardiovascular diseases (23, 6.13%), and hypertension complicated with diabetes mellitus or kidney disease (18, 4.8%). The II category was hypertension guidelines for specific population, including 53 guidelines in total and covering
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3 sub-classes, teenage (20, 5.33%), pregnant women (20, 5.33%), and aged people (13, 3.47%). The III category included guidelines focused on the blood pressure management in cardiovascular diseases (CVD) (17, 4.53%). North America, with the lowest burden of hypertension in the 6 continents (ranked 6), developed the largest number of guidelines which covered all 3 categories and 11 sub-classes. And the guidelines about nursing/education in hypertension could only be found in North America. The number of guidelines developed in Europe, which had the heaviest burden of hypertension, was just smaller than North America, with the majority of guidelines on comprehensive management and hypertension complicated with other cardiovascular diseases. The burden of hypertension in South America was lower than that in Europe, but only 15 guidelines covering 3 sub-classes were developed. The burden of hypertension in Asia was lower than that in South America, and 47 (12.53%) guidelines were developed, of which 24 (51.06%) were about management of hypertension, 8 (17.02%) were about pharmacological intervention, with no guidelines for pregnant women. The guidelines developed in Africa only focused on the comprehensive management of hypertension (8, 2.13%). There were 17 guidelines developed by the WHO in total, of which 14 (82.35%) were on comprehensive management, and 2 (11.76%) were about the complicated with other cardiovascular diseases.
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Hypertension clinical practice guidelines based on the burden of disease
157 120 47 15 11 8 17 375
Discussion
9 4 1 1 3 − − 18 (4.8)
Geographical distribution of guidelines
CVD: cardiovascular disease; DM: diabetes mellitus; KD: kidney disease; A: adolescence; P: pregnancy women; PI: pharmacological intervention; -: None.
9 11 1 − − − 2 23 (6.13) 43 67 24 10 1 8 14 167 (44.53) 4 − − − − − − 4 (1.07) 15 10 8 − 1 − − 34 (9.07) 18 4 2 − 1 − − 25 (6.67) 11 2 1 − − − − 14 (3.73) 8 8 1 2 1 − − 20 (5.33) 4 2 7 − − − − 13 (3.47) 11 5 − 1 3 − − 20 (5.33) 14 4 1 1 − − − 20 (5.33) 11 3 1 − 1 − 1 17 (4.53) 6 1 3 2 4 5 North America Europe Asia South America Oceania Africa WHO Total (%)
Diagnosis/ Screening P Continent
Special population
A Primary prevention Burden ranking
Table 2 The subject classification of hypertension guidelines
Elderly
Monitor/ Prevention
Hypertension
Adult hypertension
intervention
PI
Nursing/ Education
Comprehensive management
With CVD
Complicated with other diseases
With DM or KD
Subtotal
Y. Chen et al.
The number of guidelines developed in North America was about 20 times than that of guidelines in Africa, which indicated that distribution of guidelines among different regions was imbalance. The largest number of hypertension guidelines was established in USA, and 7 countries in Europe and 6 countries in Asia each develop 1 guideline, which demonstrated that there was the extreme disequilibrium of guideline distribution across the 33 countries. Among the 3 organizations involved in the guidelines formulation, the largest number of guidelines was observed in ESH/ESC, followed by the WHO with 17 guidelines. There were only 2 guidelines developed in Asian Pacific Heart Association, which suggested that the number of guidelines was differences. According to the bibliometrics of included guidelines, the development trends of hypertension guidelines worldwide was the same as North American, which suggested that North America played a leading role in the development of hypertension guidelines worldwide. During the first stage, three continents and WHO participated in efforts to develop hypertension guidelines. The first hypertension guideline was developed by ICHD (Inter-Society Commission for Heart Disease Resource) in USA and published in 1971 (8). In 1978, NHLBI (National Heart, Lung, and Blood Institute), affiliated to NIH (National Institutes of Health), was the first to establish the JNC (Joint National Committee), proposed to evaluate and review the evidence for hypertension and published the report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC 1) in 1977. The meeting focused on the community management of hypertension and stroke was held in Tokyo by the WHO in 1974, and then the first guideline was released in 1976 (9). The first hypertension guideline was appeared in Federalist Germany in Europe at the year of 1978 (10). Compared with the second stage, the number of guidelines was 2, 9, and 3 times than that of in North America, Europe, and the WHO with the former stage, respectively. Meanwhile, the hypertension guidelines began to appear in Oceania (Australia) and Asia (Japan) (11, 12). In the third stage, the number of guidelines rose from 1 to 19 in Asia and was 2 and 3 times more than that in North America and Europe at the second stage. In the fourth stage, the decreasing in number of guidelines developed in Africa and the WHO was observed, but with an increasing rate of 1.5 times in Asia, South America and Australia, respectively, and in North America and Europe the number was the same as the previous stage. The number of guidelines developed in the four stages showed that North America was the first to establish hypertension guidelines, followed by the WHO for 5 years, Europe for 7 years, Africa for 21 years, Oceania (Australia) for
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Hypertension clinical practice guidelines based on the burden of disease
22 years, and Asia for 25 years, respectively, which demonstrated that there was apparent variation in the development process of hypertension guidelines, which might be associated with the economic status, burden, and the awareness of hypertension. The number of guidelines increased year by year and the time span of different stages became smaller and smaller, which suggested hypertension had become a growing global public health concern in different world regions.
Burden of hypertension and the number of guidelines The number of hypertension guidelines was not in positive correlation with the burden of hypertension. Further analysis showed that the order from large to small for the number of hypertension guidelines were not consistent with that of the burden of hypertension at the following seven countries, that were America and Canada in North America, England, Austria and Greece in Europe, China in Asia and South Africa in Africa. Likewise, the order from small to large for the number of hypertension guidelines did not match that for the heavy burden of hypertension in South America, Germany, Italy, Spain, and Sweden. It was confirmed that $ 200,000 in USA, while $ 10,000 to $ 25,000 in New Zealand in average was needed for formulating a new guideline (13), indicating that the support from the government, organizations, and manufacturers would actively promote the development of hypertension guideline, which suggested that there was a gap between awareness and action of government for the management of hypertension.
Subject classification of hypertension guidelines The subject of hypertension guidelines covered a wide range of hypertension, among which the majority were the comprehensive management of hypertension, followed by the pharmacological intervention. As far as prevention of adult hypertension guidelines were concerned, lifestyle intervention, prevention and monitoring as well as screening and diagnosis of hypertension were placed as the priority. High-risk population, regarded as patients with hypertension complicated with other diseases, and special population, such as elderly, children, and pregnant woman were concerned in North America and Europe, which developed the guidelines. A statement for health professionals from the subcommittee on atherosclerosis and hypertension in childhood of the council on cardiovascular disease in the young was published for integrated cardiovascular health promotion in childhood by American Heart Association in 1992 (14). One cohort study report indicated that 43% of patients with primary childhood hypertension and 9.5% of that with nor-
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mal childhood had a relative with primary hypertension 20 years later, respectively (15). The overall population is aging. Life expectancy is increasing. Most countries, including developing countries, show a steady increase in longevity (16). In 2006, almost 500 million people worldwide were 65 and older. By 2030, that total is projected to increase to 1 billion-1 in every 8 of the earth’s inhabitants. Significantly, the most rapid increases in the 65and-older population are occurring in developing countries, which will see a jump of 140% by 2030 (17). Framingham study showed that the residual lifetime risk for developing hypertension increased with age over 65 years old (18). Although the management of particular population with hypertension was involved in the hypertension guidelines on comprehensive management, guidelines special for the particular population was regarded as an important part for the guidelines. North America had the smallest burden of hypertension, while the subject of guidelines covered a great range of hypertension, the most common of which was comprehensive management, pharmacological and nonpharmacological intervention. The subject of the hypertension guidelines developed in Europe were focused on the comprehensive management, hypertension complicated with cardiovascular diseases and pharmacological intervention, which indicated that the subject of guidelines was associated with the burden of hypertension and medical resources, and the needs for guidelines with different subjects was not consistent with the burden of hypertension. The burden of hypertension in South America was just be next only to Europe, but there were only 15 guidelines with the subject for comprehensive management, monitoring and prevention, hypertension complicated with other diseases, and the population of teenage and pregnant women, which suggested that the development of guidelines should be based on the epidemiology and control of hypertension. Guidelines developed in Asia mainly focused on the comprehensive management and pharmacological interventions, taking no count of the prevention and lifestyle intervention for hypertension. While in Africa, the comprehensive management of hypertension was the only placed subject. As an international organization, WHO should place more emphasis on the subject of comprehensive management of hypertension.
Limitation The search process of electronic databases and websites for the included guidelines potentially result in a biased, and compared to non-Chinese hypertension guidelines, the detailed search for Chinese hypertension guidelines may lead to the selective bias. Moreover, the subjective judgment, involved in the description of the development, geographical
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distribution, and subject classification of hypertension CPGs are inevitable, which may result in ‘time biases’.
Conclusion The number of hypertension guidelines in order from large to small is North America, Europe, Asia, South America, Oceania, and Africa. The development process of hypertension guidelines is summarized into four stages, with an increasing number of hypertension guidelines in a shorter and shorter interval. The geographical distribution of hypertension guidelines in each stage varies, which may be associated with economic level, the burden, and the awareness of hypertension.
9.
10.
11.
12.
References 1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. JAMA 2003; 289(19): 2560–72. 2. Ezzati M, Vander Hoorn S, Lawes CM, Leach R, James WP, Lopez AD, et al. Rethinking the “diseases of affluence” paradigm: global patterns of nutritional risks in relation to economic development. PLoS Med 2005; 2(5): e133. 3. Committee to Advise the Public Health Service on Clinical Practice Guidelines. Institute of Medicine. In: Field MJ, Lohr KN, eds. Clinical Practice Guidelines: Directions of a New Program. Washington, DC: National Academy Press, 1990; 38. 4. Hayward RS, Wilson MC, Tunis SR, Bass EB, Guyatt G. Users’ guides to the medical literature. VIII. How to use clinical practice guidelines. A. Are the recommendations valid? The Evidence-Based Medicine Working Group. JAMA 1995; 274: 570–4. 5. Chinnock P, Siegfried N, Clarke M. Is evidence-based medicine relevant to the developing world? PLoS Med 2005; 2(5): e107. 6. Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993; 342(8883): 1317–22. 7. McAlister FA, Van Diepen S, Padwal RS, Johnson JA, Majumdar SR. How evidence-based are the recommendations in evidence-based guidelines? PLoS Med 2007; 4(8): e250. 8. Report of Inter-Society Commission for Heart Disease Resources. III. Cardiovascular Disease–long-term care.
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Guidelines for the detection, diagnosis and management of hypertensive populations. Circulation 1971; 44(suppl 5): A263–72. Hypertension and stroke control in the community. In: Hatano S, Shigematsu I, Strasser T, eds. Proceedings of a WHO meeting held in Tokyo. 11–13 March 1974. Geneva: World Health Organization, 1976: 362. Hall D, Goedel-Meinen L, Rudolph W. Guidelines for the medical management of arterial hypertension (author’s transl). Herz 1978; 3(5): 289–99. Consensus statement. Australasian Society for the Study of Hypertension in Pregnancy. Management of hypertension in pregnancy: executive summary. Med J Aust 1993; 158(10): 700–2. Ogihara T, Hiwada K, Matsuoka H, Matsumoto M, Shimamoto K, Ouchi Y, et al. [Guidelines on treatment of hypertension in the elderly, 1995–a tentative plan for comprehensive research projects on aging and health– Members of the Research Group for “Guidelines on Treatment of Hypertension in the Elderly”, Comprehensive Research Projects on Aging and Health, the Ministry of Health and Welfare of Japan]. Nihon Ronen Igakkai Zasshi 1996; 33(12): 945–75. Burgers JS, Grol R, Klazinga NS, M¨akel¨a M, Zaat J. AGREE Collaboration. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs. Int J Qual Health Care 2003; 15(1): 31–45. Strong WB, Deckelbaum RJ, Gidding SS, Kavey RE, Washington R, Wilmore JH, et al. Integrated cardiovascular health promotion in childhood. A statement for health professionals from the Subcommittee on Atherosclerosis and Hypertension in Childhood of the Council on Cardiovascular Disease in the Young, American Heart Association. Circulation 1992; 85(4): 1638–50. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in Children and adolescent. Pediatrics 2004; 114(Suppl 2): 555–76. Oeppen J, Vaupel JW. Demography. Broken limits to life expectancy. Science 2002; 296(5570): 1029–31. United Nations Population Division, Department of Economic and Social Affairs. World Population Prospects: 2004 Revision. New York, United Nations Population Division, Department of Economic and Social Affairs, 2005. Vasan RS, Beiser A, Seshadri S, Larson MG, Kannel WB, D’Agostino RB, et al. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA 2002; 287(8): 1003–10.
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REVIEW ARTICLE
Systematic review of hypertension clinical practice guidelines based on the burden of disease: a global perspective Yin Chen1,2 , Shilian Hu1 , Youping Li2 , Boxi Yan3 , Gan Shen4 and Li Wang2 1
Anhui Evidence-based Medicine Center, Anhui Provincial Hospital, Hefei 230001, China Chinese Evidence-based Medicine Center/Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu 610041, China 3 West China Medical School, West China Hospital, Sichuan University, Chengdu 610041, China 4 Department of Geriatrics, Anhui Provincial Party Committee Hospital, Hefei 230001, China 2
Keywords Clinical practice guideline; hypertension; systematic review. Correspondence Youping Li, West China Hospital, Sichuan University, No. 37, Guoxue Xiang, Chengdu 610041, China. Tel: 86-028-8542-2052; Fax: 86-028-8542-3040; Email: [email protected] Received 30 May 2013; accepted for publication 25 January 2014. doi: 10.1111/jebm.12082
Abstract Objective: To perform a systematic review for the development, geographical distribution, and subject classification of clinical practice guidelines (CPGs) for hypertension worldwide. Methods: CPGs for the management of hypertension were identified through the searching of Ovid, EMbase, and Chinese electronic databases. Major guidelines websites such as NGC (National Guideline Clearinghouse), GIN (Guidelines International Network), NICE (National Institute for Health and Clinical Excellence) and CPGN (Clinical Practice Guideline Network), as well as Google Scholar were also screened for additional information. EndNote X3 and Excel 2007 were used for extracting and analyzing the data of included CPGs. Results: A total of 375 hypertension CPGs were included, involving 6 continents, 33 countries, 4 regions, and 3 international organizations. The publication date ranged from the year of 1971 to 2012, with the number of CPGs increased year by year. The CPGs were mainly developed by North America, Europe, and Asia. Their subjects covered 3 categories and 11 sub-classes, which mainly focused on the management of adult hypertension (44.53%). Conclusion: The number of CPGs varies in regions, countries, and academic organizations, with the development process differently. The regional disparity between the number CPGs and burden of hypertension were observed. The CPGs made a point of the management of adult hypertension.
Introduction Hypertension is a major public-health challenge worldwide. About one billion people worldwide suffer from hypertension and one of each four adults had hypertension (1). Hypertension is one of the leading causes of the global burden of disease, of which the direct and indirect healthcare costs expends medical and social resources (2). Clinical practice guidelines (CPGs) have been defined as “systematically developed statements to assist practitioner and patients’ decisions about appropriate health care for specific clinical circumstances” (3, 4). CPGs bridge the gap between policy and practice and should be based on up to date
52
research findings to make explicit recommendations with a definite intent to influence what clinicians do. It is recognized that reducing the burden of disease in resource-poor settings relies on the availability of such evidence-based clinical practice guidelines (5). CPGs are believed to improve the quality and costeffectiveness of health care (6, 7), which generated growing interest among professionals in hypertension CPGs production. There are numerous organizations that draft CPGs, which means that there is more and more guidelines worldwide available addressing the management of hypertension. The present study was to evaluate and compare the characteristic of development, geographical distribution, and
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 52–59
Y. Chen et al.
Hypertension clinical practice guidelines based on the burden of disease
subject classification of CPGs for hypertension based on the burden of diseases worldwide.
Material and Methods Inclusion and exclusion criteria CPGs focus on the management of primary hypertension was eligible for inclusion in the present study. Non-primary hypertension, interpretation, and adherence of hypertension as well as conference abstract were excluded.
Search strategy According to a pre-specified protocol, CPGs were identified through searches in MEDLINE (via Ovid, 1946 to March week 2, 2012), EMbase (all years), NGC (National Guidelines Clearinghouses, March), G-I-N (Guidelines International Network, March), NICE (National Institute for Health and Clinical Excellence), CBM (Chinese BioMedical Literature Database), WanFang Data up to April 2013, with no language restriction. The search strategy included MeSH together with free-text words and the following search terms were used: consensus, practice guideline*, high blood pressure, hypertension, guidelines, clinical pathway. In addition, Google Scholar was also used for additional information.
Geographical distribution of guidelines A total of 375 hypertension CPGs that were included, involving 6 continents, 33 countries, 4 regions, and 3 international organizations (WHO, European Society of Hypertension/European Society of Cardiology (ESH/ESC) and Asian Pacific Heart Association) were presented in Figure 2. The majority of hypertension CPGs were mainly developed in North America (USA: n = 95; Canada: n = 62), and in Europe, CPGs were mainly distributed in Germany (n = 23), Spain (n = 17), UK (n = 17), France (n = 11), Italy (n = 7), Finland (n = 4), Czekh (n = 3), Russia (n = 3), Greece (n = 2), Portugal (n = 2), and Sweden (n = 2), with 1 guideline in Austria, Belgium, Bosnia, Croatia, Hungary, Holland, and Norway, respectively. ESH/ESC formulated 22 guidelines. Across the region of Asia, China (n = 26) and Japan (n = 11) took priority over in the development of CPGs, and Asian Pacific Heart Association formulated 2 guidelines. There was only 1 guideline each in the remaining Asia countries including Korea, Malaysia, Saudi Arabia, Singapore, India, and Iran. In South America, guidelines were mainly distributed in Brazil (n = 6), Mexico (n = 5), and Chile (n = 2), with Latin America and Caribbean Area each drafted 1 guideline. The guidelines in Oceania were all formulated by Australia. In Africa, guidelines were mainly distributed in South Africa (n = 11), with Sahara Area and Egypt each established 1 guideline. It should be noted that there are 17 guidelines developed by the WHO.
Data extraction and analysis Two investigators (Yin Chen and Boxi Yan) independently screened the titles and abstracts of the literature for potentially relevant guidelines. Any discrepancy was resolved by consensus. If required, a third person (Shilian Hu) was consulted to resolve disagreements. We designed a data extraction form and collected the baseline information, including date of publication, regional distributions, and subject classification. According to the extracted data, we analyzed descriptively the general characteristic of development process of hypertension CPGs worldwide. The comparison of the number of CPGs and the prevalence of hypertension was performed in different regions.
Results Literature search The search strategy yielded 21,458 (18,174 non-Chinese and 3284 Chinese) records, of which 716 (643 non-Chinese and 73 Chinese) were considered potentially relevant and 375 (347 non-Chinese and 28 Chinese) were finally included for analysis, as summarized in Figure 1.
Development process of CPGs The publishing time of guidelines ranged from the year of 1971 to 2012, which could be divided into 4 stages according to the number of the guidelines, that was, from 1971 to 1988, 1989 to 1998, 1999 to 2006, and 2007 to 2011, as shown in Figure 3. The first stage was 18 years, including 16 guidelines in total, with less than 1 guideline annually in average (ranging from 0 to 2 annually). Fourteen guidelines were developed in North America, 3 in WHO and South America each, and 2 in Europe. It was interesting that there were no guidelines developed in Asian, Oceania, and Africa in this period, which could be called “brew stage”. The second stage was 10 years, involving 65 guidelines in total, with 4 times higher than the first stage, and 6.5 guidelines annually in average (ranging from 4 to 16 annually). Thirty-one guidelines were developed in North America, 18 in Europe, 9 in WHO, 2 in Oceania developed by Australia, and 1 in South America. It should be noted that the first hypertension guideline appeared in Asia, which was developed in Japan. This period could be called “developing stage”. The third stage was 8 years, involving 150 guidelines in total, with 2.5 times higher than the second stage, and
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MEDLINE: 3,948 EMbase: 17,459
NGC: 493 NICE: 105 G-I-N: 93
Duplicate: 3,951
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CPGN: 35 Non-Chinese: 27 Chinese: 8
Non-Chinese
WanFang: 3,248 CBM: 130
Chinese
Unique: 18,174
Duplicate: 138
Unique: 3,284
Exclude by tle and abstract: 17,531
Exclude by tle and abstract: 3,211 Poten ally related: 643
Exclude by full text: 246 Different popula on: 122 Interpreta on: 18 Analysis of adherence: 13 Abstract of conferences: 93 Introduc on: 42
Poten ally related: 73
Google Scholar: 28
Guideline (non-Chinese): 347 MEDLINE+EMbase: 249 NGC: 40 G-I-N: 33 Google Scholar: 25
Exclude by full text: 44 Interpreta on: 6 Review of guidelines: 3 Translate: 21 Introduc on: 14
Guideline (Chinese): 28 WanFang+CBM: 25 Google Scholar: 3
Guideline: 375 North America: 157 Europe: 120 Asia: 47 WHO: 17 South America: 15 Oceania: 11 Africa: 8 Figure 1 Flow chart of guidelines selection.
19 guidelines annually in average (ranging from 13 to 24 annually). Sixty-one guidelines were developed in North America, 52 in Europe, 19 in Asia, with 5 guidelines in the WHO, South America and Africa each, and 3 in Oceania developed by Australia. This period could be called the “leaping stage”. The fourth stage was 5 years, including 141 guidelines in total, which was the same as the third stage, with 28.2 guide-
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lines annually in average (ranging from 23 to 38 annually). Fifty-five guidelines were developed in North America, 48 in Europe, 27 in Asia, 8 in South America, 5 in Oceania (developed by Australia), and 1 in Africa. There was no guideline developed in the WHO at this stage (Three guidelines in 2012, which could only reflect the data of just one quarter of the year, were not included in the analysis.).
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Figure 2 Geographical distribution of CPGs worldwide
Figure 3 The development process of CPGs worldwide.
Comparison between geographical distribution of guidelines and prevalence of hypertension Table 1 showed that Europe had the largest burden of hypertension, followed by South America, Asia, Oceania, Africa, and North America successively. Germany had the highest prevalence of hypertension while Greece had the lowest across the 6 continents including 17 countries. The top 10 countries suffered from hypertension were Germany, Italy, Spain, Sweden, Mexico, Japan, UK, China,
and Australia. The largest number of hypertension guidelines was in USA while the least was in Korea and India. The top 10 countries of the number of hypertension guidelines were USA, Canada, Germany, China, Spain, UK, Japan, Australia, and Italy. North America, with the lowest prevalence of hypertension (ranked 14 and 15), developed more than half of the hypertension guidelines (53.58%) in the whole world. Europe, with the largest burden of hypertension, made 15.70% guidelines. The burden of hypertension in South America was just below Europe but only made 2.39%
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Table 1 The comparison between geographical distribution of guidelines and prevalence of hypertension
Continent
Population (0.1 billion)
Population density (/km2 )
North America
5.29
22.9
Europe
7.39
70
Asia
41.40
86.7
South America
3.86
21.4
Oceania Africa
0.36 9.95
4.25 32.7
Country
Age-standardized rate of hypertension Men vs. Women (overall)
Burden ranking
No. of guidelines
Ranking
USA Canada Germany Italy Spain Sweden UK Greece Japan North India (urban) China Taiwan Korea Mexico Caribbean Australia South Africa
21.0 vs.19.7 (20.3) 23.5 vs. 15.6 (21.4) 55.4 vs.56.6 42.0 vs. 43.3 41.7 vs.39.0 (40.0) 39.6 vs. 40.9 34.7 vs. 25.7 (29.6) 18.5 vs. 15.9 (16.9) 42.7 vs. 35.0 (38.3) 24.5 vs. 23.2 (23.8) 28.8 vs. 26.6 (27.7) 27.1 vs. 20.8 (23.7) 21.8 vs. 19.4 38.6 vs. 30.1 (33.5) 47.7 vs. 32.2 (39.7) 30.8 vs.20.1 22.9 vs. 23.4 (23.1)
15 14 1 2 3 4 8 17 6 11 9 12 16 7 5 10 13
95 62 26 7 17 2 17 2 11 1 26 2 1 5 2 11 6
1 2 3 9 5 12 5 12 7 16 3 12 16 11 12 7 10
Note: The data of the prevalence of hypertension were from: Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365(9455): 217–23.
guidelines. Asian countries have the largest number and highest density of population, the burden of hypertension was mainly distributed in Japan, China, and India, and the guidelines in this region represented 14.00% of all. The prevalence of hypertension ranked 10 in Australia, where the density of population was low, but the number of guidelines was still more than that in Africa, accounted for 3.75%.
Subject classification of hypertension guidelines As presented in Table 2, the subjects of global hypertension guidelines covered 3 categories, 11 sub-classes as follows, most of which focused on the management of adult hypertension (44.53%). The I category included 305 (81.33%) hypertension guidelines, contained 8 sub-classes, with 265 guidelines for adult hypertension (70.67%), covering 6 sub-classes, that was, comprehensive management of hypertension (44.53%), pharmacological intervention (9.07%), lifestyle intervention (6.67%), monitoring/prevention (5.33%), diagnosis/screening (5.33%), nursing/education (1.07%). There were 41 guidelines for hypertension complicated with other diseases, which covered 2 sub-classes, hypertension complicated with cardiovascular diseases (23, 6.13%), and hypertension complicated with diabetes mellitus or kidney disease (18, 4.8%). The II category was hypertension guidelines for specific population, including 53 guidelines in total and covering
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3 sub-classes, teenage (20, 5.33%), pregnant women (20, 5.33%), and aged people (13, 3.47%). The III category included guidelines focused on the blood pressure management in cardiovascular diseases (CVD) (17, 4.53%). North America, with the lowest burden of hypertension in the 6 continents (ranked 6), developed the largest number of guidelines which covered all 3 categories and 11 sub-classes. And the guidelines about nursing/education in hypertension could only be found in North America. The number of guidelines developed in Europe, which had the heaviest burden of hypertension, was just smaller than North America, with the majority of guidelines on comprehensive management and hypertension complicated with other cardiovascular diseases. The burden of hypertension in South America was lower than that in Europe, but only 15 guidelines covering 3 sub-classes were developed. The burden of hypertension in Asia was lower than that in South America, and 47 (12.53%) guidelines were developed, of which 24 (51.06%) were about management of hypertension, 8 (17.02%) were about pharmacological intervention, with no guidelines for pregnant women. The guidelines developed in Africa only focused on the comprehensive management of hypertension (8, 2.13%). There were 17 guidelines developed by the WHO in total, of which 14 (82.35%) were on comprehensive management, and 2 (11.76%) were about the complicated with other cardiovascular diseases.
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157 120 47 15 11 8 17 375
Discussion
9 4 1 1 3 − − 18 (4.8)
Geographical distribution of guidelines
CVD: cardiovascular disease; DM: diabetes mellitus; KD: kidney disease; A: adolescence; P: pregnancy women; PI: pharmacological intervention; -: None.
9 11 1 − − − 2 23 (6.13) 43 67 24 10 1 8 14 167 (44.53) 4 − − − − − − 4 (1.07) 15 10 8 − 1 − − 34 (9.07) 18 4 2 − 1 − − 25 (6.67) 11 2 1 − − − − 14 (3.73) 8 8 1 2 1 − − 20 (5.33) 4 2 7 − − − − 13 (3.47) 11 5 − 1 3 − − 20 (5.33) 14 4 1 1 − − − 20 (5.33) 11 3 1 − 1 − 1 17 (4.53) 6 1 3 2 4 5 North America Europe Asia South America Oceania Africa WHO Total (%)
Diagnosis/ Screening P Continent
Special population
A Primary prevention Burden ranking
Table 2 The subject classification of hypertension guidelines
Elderly
Monitor/ Prevention
Hypertension
Adult hypertension
intervention
PI
Nursing/ Education
Comprehensive management
With CVD
Complicated with other diseases
With DM or KD
Subtotal
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The number of guidelines developed in North America was about 20 times than that of guidelines in Africa, which indicated that distribution of guidelines among different regions was imbalance. The largest number of hypertension guidelines was established in USA, and 7 countries in Europe and 6 countries in Asia each develop 1 guideline, which demonstrated that there was the extreme disequilibrium of guideline distribution across the 33 countries. Among the 3 organizations involved in the guidelines formulation, the largest number of guidelines was observed in ESH/ESC, followed by the WHO with 17 guidelines. There were only 2 guidelines developed in Asian Pacific Heart Association, which suggested that the number of guidelines was differences. According to the bibliometrics of included guidelines, the development trends of hypertension guidelines worldwide was the same as North American, which suggested that North America played a leading role in the development of hypertension guidelines worldwide. During the first stage, three continents and WHO participated in efforts to develop hypertension guidelines. The first hypertension guideline was developed by ICHD (Inter-Society Commission for Heart Disease Resource) in USA and published in 1971 (8). In 1978, NHLBI (National Heart, Lung, and Blood Institute), affiliated to NIH (National Institutes of Health), was the first to establish the JNC (Joint National Committee), proposed to evaluate and review the evidence for hypertension and published the report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC 1) in 1977. The meeting focused on the community management of hypertension and stroke was held in Tokyo by the WHO in 1974, and then the first guideline was released in 1976 (9). The first hypertension guideline was appeared in Federalist Germany in Europe at the year of 1978 (10). Compared with the second stage, the number of guidelines was 2, 9, and 3 times than that of in North America, Europe, and the WHO with the former stage, respectively. Meanwhile, the hypertension guidelines began to appear in Oceania (Australia) and Asia (Japan) (11, 12). In the third stage, the number of guidelines rose from 1 to 19 in Asia and was 2 and 3 times more than that in North America and Europe at the second stage. In the fourth stage, the decreasing in number of guidelines developed in Africa and the WHO was observed, but with an increasing rate of 1.5 times in Asia, South America and Australia, respectively, and in North America and Europe the number was the same as the previous stage. The number of guidelines developed in the four stages showed that North America was the first to establish hypertension guidelines, followed by the WHO for 5 years, Europe for 7 years, Africa for 21 years, Oceania (Australia) for
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22 years, and Asia for 25 years, respectively, which demonstrated that there was apparent variation in the development process of hypertension guidelines, which might be associated with the economic status, burden, and the awareness of hypertension. The number of guidelines increased year by year and the time span of different stages became smaller and smaller, which suggested hypertension had become a growing global public health concern in different world regions.
Burden of hypertension and the number of guidelines The number of hypertension guidelines was not in positive correlation with the burden of hypertension. Further analysis showed that the order from large to small for the number of hypertension guidelines were not consistent with that of the burden of hypertension at the following seven countries, that were America and Canada in North America, England, Austria and Greece in Europe, China in Asia and South Africa in Africa. Likewise, the order from small to large for the number of hypertension guidelines did not match that for the heavy burden of hypertension in South America, Germany, Italy, Spain, and Sweden. It was confirmed that $ 200,000 in USA, while $ 10,000 to $ 25,000 in New Zealand in average was needed for formulating a new guideline (13), indicating that the support from the government, organizations, and manufacturers would actively promote the development of hypertension guideline, which suggested that there was a gap between awareness and action of government for the management of hypertension.
Subject classification of hypertension guidelines The subject of hypertension guidelines covered a wide range of hypertension, among which the majority were the comprehensive management of hypertension, followed by the pharmacological intervention. As far as prevention of adult hypertension guidelines were concerned, lifestyle intervention, prevention and monitoring as well as screening and diagnosis of hypertension were placed as the priority. High-risk population, regarded as patients with hypertension complicated with other diseases, and special population, such as elderly, children, and pregnant woman were concerned in North America and Europe, which developed the guidelines. A statement for health professionals from the subcommittee on atherosclerosis and hypertension in childhood of the council on cardiovascular disease in the young was published for integrated cardiovascular health promotion in childhood by American Heart Association in 1992 (14). One cohort study report indicated that 43% of patients with primary childhood hypertension and 9.5% of that with nor-
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mal childhood had a relative with primary hypertension 20 years later, respectively (15). The overall population is aging. Life expectancy is increasing. Most countries, including developing countries, show a steady increase in longevity (16). In 2006, almost 500 million people worldwide were 65 and older. By 2030, that total is projected to increase to 1 billion-1 in every 8 of the earth’s inhabitants. Significantly, the most rapid increases in the 65and-older population are occurring in developing countries, which will see a jump of 140% by 2030 (17). Framingham study showed that the residual lifetime risk for developing hypertension increased with age over 65 years old (18). Although the management of particular population with hypertension was involved in the hypertension guidelines on comprehensive management, guidelines special for the particular population was regarded as an important part for the guidelines. North America had the smallest burden of hypertension, while the subject of guidelines covered a great range of hypertension, the most common of which was comprehensive management, pharmacological and nonpharmacological intervention. The subject of the hypertension guidelines developed in Europe were focused on the comprehensive management, hypertension complicated with cardiovascular diseases and pharmacological intervention, which indicated that the subject of guidelines was associated with the burden of hypertension and medical resources, and the needs for guidelines with different subjects was not consistent with the burden of hypertension. The burden of hypertension in South America was just be next only to Europe, but there were only 15 guidelines with the subject for comprehensive management, monitoring and prevention, hypertension complicated with other diseases, and the population of teenage and pregnant women, which suggested that the development of guidelines should be based on the epidemiology and control of hypertension. Guidelines developed in Asia mainly focused on the comprehensive management and pharmacological interventions, taking no count of the prevention and lifestyle intervention for hypertension. While in Africa, the comprehensive management of hypertension was the only placed subject. As an international organization, WHO should place more emphasis on the subject of comprehensive management of hypertension.
Limitation The search process of electronic databases and websites for the included guidelines potentially result in a biased, and compared to non-Chinese hypertension guidelines, the detailed search for Chinese hypertension guidelines may lead to the selective bias. Moreover, the subjective judgment, involved in the description of the development, geographical
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distribution, and subject classification of hypertension CPGs are inevitable, which may result in ‘time biases’.
Conclusion The number of hypertension guidelines in order from large to small is North America, Europe, Asia, South America, Oceania, and Africa. The development process of hypertension guidelines is summarized into four stages, with an increasing number of hypertension guidelines in a shorter and shorter interval. The geographical distribution of hypertension guidelines in each stage varies, which may be associated with economic level, the burden, and the awareness of hypertension.
9.
10.
11.
12.
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