Why we do not need a single independent international hypertension clinical practice guideline : Journal of Hypertension

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Why we do not need a single independent international hypertension clinical practice guideline

Kreutz, Reinholda; Kjeldsen, Sverre E.b; Mancia, Giuseppec

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doi: 10.1097/HJH.0000000000002940
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In a recent COMMENT article in Hypertension Research, members of the Cochrane Hypertension Review Group provided a case for an independent international hypertension clinical practice guideline [1]. They also argued in support of the use of systematic reviews and the Cochrane database to a larger extent [1]. This raises an issue of large interest for the medical community, that is, should hypertension guidelines be unified as science data are universally valid, or is this inappropriate and/or unfeasible?

The Cochrane Hypertension Review Group, which is based in Canada, is using the Malaysian guidelines as an example to follow in contrast to the Canadian guidelines. One may wonder why their criticism focuses on guidelines from their own country and whether this is a way of criticizing the Canadian committee for not fully utilizing the Cochrane library. Furthermore, it seems a bit strange to use as a comparator the Malaysian guideline, that is, a guideline solely sponsored by a pharmaceutical company, even though interference is excluded by the authors. This said, the view that guideline committees should more frequently make use of systematic reviews from the Cochrane library is a legitimate one.

The Cochrane Hypertension Review Group also argues, though this is not their most important point, that committee members should have absolutely no conflicts of interest. This is a controversial issue and we respectfully disagree with their position [1] as in our opinion, it is very difficult to establish a global expert writing committee that includes only members who do not have any conflict of interest to report. It is in addition largely unnecessary, given that antihypertensive drugs from all classes are available as generics for more than 10 years. In the United States, there is a set of guidelines written by people without ‘conflicts’ [2], but these guidelines are criticized as they are not written by experts [3]. Nonexperts will not know the field, and will have difficulties to identify the problems to include in the guidelines. They can find a number of systematic reviews and quote them but there is always a variety of problems not addressed by systematic reviews that need to be evaluated and balanced when developing guidelines. In our opinion this is not, or is much less the case when experts are involved.

Experts are in our opinion, people working in the field more or less all the time and through many years. Experts get the feeling of what is right and wrong by regularly following the literature to which they usually contribute in a significant fashion. Experts are of course involved in all kinds of meetings including industry-sponsored activities but these broad engagements are rather an advantage. We admit that we get suspicious if people have ‘no conflict’ -- is this really an expert? This is particularly so for senior people; many young people may of course not yet have been involved.

Experts may also add in relevant literature, including important very recently reported data that have not yet been included into systematic reviews and assess the importance of the additional and supplementary literature. This is particularly important in new developments or new topics. Systematic reviews are not necessarily the answer -- systematic reviews cannot always get around the statement ‘garbage in -- garbage out’ or they are not systematic enough and miss important literature.

Another issue raised by Cochrane Hypertension Review Group is that we should have only one set of hypertension guidelines, valid for the entire world. We believe that this would be impossible. There will always be some international guidelines (ESC/ESH, ISH/WHO, ACC/AHA, etc.) and national guidelines, which adapt international guidelines to their national needs, health care conditions and organizational aspects. For example, there is a 2019 Turkish Hypertension Consensus Report that represents a good example how several groups interested in hypertension care in this country, not only established a document considering international guidelines but also addressed at the same time, national needs and conditions [4]. Our opinion is that this is a good thing; differences between guidelines are usually not major, that is, they rarely involve basic diagnostic and treatment aspects and most of the guidelines follow each other with rather limited variations [5]. In addition, making national guidelines make sure that international diagnostic and treatment recommendations are correctly translated to the local language that medical principles are adapted to local and national rules and conditions, and that education involves key opinion leaders in the various countries, which is good thing not to be criticized. The Cochrane library may be useful in many circumstances but is not the ‘bible’. Making international and national guidelines contribute enormously to the educational process around in the world, which by itself is important.

We have repeatedly thought of the way ESC/ESH is organizing the work that leads to their hypertension guidelines, and believe that what is done has a great merit in the production of the good quality guidelines that the two Societies have issued over the last 18 years [6]. The following text is a citation of the opening text in the 2018 guidelines explaining the working procedures and transparency [6]:

‘Members of the ESC/ESH Task Force were selected by the ESC and ESH to represent professionals involved with the medical care of patients with this pathology. Selected experts in the field undertook a comprehensive review of the published evidence for management of a given condition according to ESC Committee for Practice Guidelines (CPG) policy and approved by the ESH. A critical evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk–benefit ratio. The level of evidence and the strength of the recommendation of particular management options were weighed and graded according to predefined scales here shown in Tables 1 and 2.

Classes of recommendations
Levels of evidence

The experts of the writing and reviewing panels provided declaration of interest forms for all relationships that might be perceived as real or potential sources of conflicts of interest [6]. These forms were compiled into one file and can be found on the ESC website (http://www.escardio.org/guidelines). Any changes in declarations of interest that arise during the writing period were notified to the ESC and ESH and updated. The Task Force received its entire financial support from the ESC and ESH without any involvement from the healthcare industry. The ESC CPG supervises and coordinates the preparation of new Guidelines. The Committee is also responsible for the endorsement process of these Guidelines. The ESC Guidelines undergo extensive review by the CPG and external experts, and in this case by ESH-appointed experts. The Guidelines are approved by all the experts involved in the Task Force after appropriate revisions. The finalized document is approved by the CPG and ESH for publication in the European Heart Journal and in the Journal of Hypertension as well as in a shortened version in Blood Pressure. The Guidelines were developed after careful consideration of the scientific and medical knowledge and the evidence available at the time of their dating. The task of developing ESC and ESH Guidelines also includes the creation of educational tools and implementation programs for the recommendations including condensed pocket guideline versions, summary slides, booklets with essential messages, summary cards for non-specialists and an electronic version for digital applications (smartphones, APPs, etc.). These versions are abridged and thus, if needed, one should always refer to the full text version, which is freely available via the ESC and ESH websites and hosted on the European Heart Journal and Journal of Hypertension websites. The National Societies of the ESC are encouraged to endorse, translate and implement all ESC Guidelines. Implementation programs are needed because it has been shown that the outcome of disease may be favorably influenced by the thorough application of clinical recommendations. Surveys and registries are needed to verify that real-life daily practice is in keeping with what is recommended in the guidelines, thus completing the loop between clinical research, writing of guidelines, disseminating them, and implementing them into clinical practice. Health professionals are encouraged to take the ESC and ESH Guidelines fully into account when exercising their clinical judgement, as well as in the determination and the implementation of preventive, diagnostic, or therapeutic medical strategies. However, the ESC and ESH Guidelines do not override in any way whatsoever the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient or the patient's caregiver where appropriate and/or necessary. It is also the health professional's responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription’.

At the end and in conclusion, to come back to the main question raised by the Cochrane Hypertension Review Group [1] -- should hypertension guidelines be unified -- because science data are universally valid, or is this inappropriate and/or unfeasible? Science data are universally valid and it is not inappropriate to make hypertension guidelines globally unified. But we do not think we can organize the whole world to work together not even near how ESC/ESH do the thorough work to develop the hypertension guidelines of the highest quality. In other words, the suggestion by the Cochrane Hypertension Review Group [1] simply is unfeasible.


Conflicts of interest

R.K. reports support for research by Bayer, honoraria for lectures from Bayer, Berlin-Chemie/Menarini, Daiichi Sankyo, Ferrer, Merck, Sanofi, and Servier. S.E.K. reports ad hoc lecture honoraria from Getz, Intas, Sanofi, and Merck Healthcare KGaA. G.M. has received honoraria from Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, Menarini, Merck, Novartis, Recordati, Sandoz, Sanofi, and Servier.


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