Rev Osteoporos Metab Miner. 2018; 10 (1) Supplement: 9-12
Clinical practice guidelines (CPG) are a useful tool in medical practice, because they help guide the doctor in making decisions regarding a certain disease, based on a series of recommendations from the most up-to-date evidence available, combined with the consensus opinion of a group of experts on the subject1.
CPGs not only provide knowledge and recommendations to the clinician in managing a specific ailment, but are also useful for the sustainability of health services, as costs soar in an increasingly aging and more technologically advanced society.
With CPG, heterogeneity in clinical practice is reduced, maintaining the balance between scientific evidence, economic efficiency and competent variability of the medical professional.
This is especially important in the case of osteoporosis. Patients often require multidisciplinary care, participating in different levels of care, so that it is necessary to try to achieve maximum homogeneity in the management of patients.
Despite being governed by a series of statements or recommendations, the CPGs do not have to limit the doctor’s autonomy, as they are usually not binding. That is, they may not be followed in certain cases, if the patient’s specific characteristics or conditions advise another action guideline. In other words, the CPG will not replace the clinical judgment of the doctor who treats the patient.
In short, CPGs aim to maintain the quality of care through the adequate use of available resources, avoiding clinical decisions that are not scientifically based and reducing the variability of the practice.
How are clinical practice guidelines developed?
A CPG is carried out in several stages:
1. Justification, scope and objectives. A document of the scope and objectives of the guide should be drafted. It must be clearly structured and include the justification for the preparation of the guide, its objectives, the description of the patient considered, the clinical aspects to be treated, the scope of application, the final users and those aspects that will not be included in the guide.
2. Composition of the CPG working group. To prepare a guide, a multidisciplinary working group is required, with the participation of all those involved in the process: clinical and methodological coordinators, members of the technical or methodological team, health and non-health professionals, expert collaborators and external reviewers. All personnel must make a declaration of possible conflicts of interest.
3. Formulation of clinical questions. A list of clinical questions that will be answered with scientific evidence should be made. The questions will be formulated whenever possible in a structured format (PICO: patient, intervention, comparator, outcome).
4. Search and selection of evidence. A CPG implies carrying out systematic and exhaustive searches, mainly by searching the large bibliographic databases, such as PubMed/MEDLINE, EMBASE, Web of Science, Scopus, Psycinfo or CINAHL.
5. Evaluation and synthesis of the evidence. Although the quality of the evidence is a continuous spectrum, GRADE (Grading of Recommendations Assessment, Development and Evaluation)2, proposes a simple and explicit classification in four grades: high, moderate, low and very low. The quality of the evidence is determined based on 4 factors: methodological quality, coherence, relevance of the study and sufficiency of the data.
6. Formulation of recommendations. The drafting of a recommendation must be concise, clear (avoiding ambiguities) and easy to transfer to clinical practice. The recommended actions must be established with precision and the strength of the recommendation must be reflected by labels, numbers, letters and symbols. The Scottish Intercollegiate Guidelines Network (SIGN) system is still widely used to establish grades of recommendation (Table 1)3.
7. External review and public exposure. The validation of the CPG by agents who have not participated in its preparation is essential to ensure greater quality, trust and acceptance. External review and public exposure are two processes of external validation that complement each other.
8. Edition of the CPG. CPGs can have different versions and formats depending on the use that they want to give and the users to whom they are addressed: clinicians, managers or patients. In the CPG Program of the National Health System, the following versions are proposed: complete CPG, brief guide, information for patients/citizens, methodological material and digital support.
9. Updating the CPG. To be useful for the decision making of health professionals and citizens, the CPG must be kept up-to-date, and it is recommended that this update be done every 2 or 3 years.
What are the main CPGs on osteoporosis?
CPGs on osteoporosis usually make recommendations for the diagnosis or identification of patients with high risk of fracture and for treatment. In the diagnosis section, the importance of clinical fracture risk factors, including bone mineral density values, is usually reviewed. In the treatment section, CPGs usually review the evidence of each drug in both primary and secondary fracture prevention.
The IOF (International Osteoporosis Foundation) collects on its website a list of the majority of CPGs on European osteoporosis (https://www.Iofbonehealth.org/europe-guidelines) and other countries of the world.
In Spain there are several CPGs on osteoporosis at the national level, some of which are multidisciplinary, such as that of the SEIOMM (Spanish Society of Bone Research and Mineral Metabolism), and others more focused on a specific medical group, such as family medicine, internal medicine, rheumatology, endocrinology, gynecology, traumatology and geriatrics, etc…
Although each guide has its own distinctiveness, there are a series of recommendations that are repeated in all the guides and practically year after year, because some aspects of both osteoporosis diagnosis and treatment do not vary among countries or geographical areas. They change with the years.
Alendronate treatment in the CPGs
The SEIOMM’s most recent CPG on osteoporosis was published in 2014 (with an update in 2015)4. This guide highlights the importance of age, sex, bone mineral density (BMD) and the personal history of fracture as the main risk factors for fracture, exactly the same risk factors of the 2003 SEIOMM CPG5. In the therapeutic recommendations section, there have been new developments, with the incorporation of new treatments and the disappearance of some others no longer on the market. However, the treatment of first choice in patients with osteoporosis is still alendronate.
In the 2003 guide, alendronate and risedronate were the only first-line treatments that were repeated in all patients (with and without fractures, over and under 70 years), on the basis that, as set out in that guideline, “alendronate has a positive effect on lumbar and femoral BMD, and decreases the risk of vertebral, non-vertebral and femur fracture (level of evidence 1a)”. More than 10 years later, the GSE of SEIOMM continues to position oral bisphosphonates (specifically alendronate and risedronate) as first-line treatments. In this guide, it is said that “alendronate at a dose of 70 mg/week reduces vertebral fractures, non-vertebral fractures and hip fractures at around 45, 25-30 and 45-55%, respectively (evidence 1a)” (Figure 1).
Another guide of interesting national scope is the CPG on osteoporosis and prevention of fragility fractures in the SNS of the Ministry of Health6. In this guide, the effectiveness of alendronate in primary prevention of vertebral and secondary fracture of all fractures (vertebral, non-vertebral, hip and wrist) is highlighted from a meta-analysis7.
Finally, there are two additional advantages to the efficacy of alendronate that are also repeated in the guidelines: safety and cost-effectiveness. Although some patients report gastrointestinal symptoms, alendronate is usually well tolerated. It is also the most economical osteoporosis treatment. According to a recent NICE publication (https://www.nice.org.uk/guidance/TA464/chapter/1-Recommendations), alendronate is cost-effective in any male or female with any risk factor for osteoporosis or of fracture and that present a FRAX value for main fracture >1%. In this regard, it should be noted that a cost-utility study carried out in Spain showed that the prevention of hip fracture with alendronate in osteoporotic women over 64 years is cost-effective in the long term (20 years), and particularly profitable in the 75-79-year age group8.
Conflict of interests: The author declares that he has no conflicts of interest.
1. Grupo de trabajo para la actualización del Manual de Elaboración de GPC. Elaboración de Guías de Práctica Clínica en el Sistema Nacional de Salud. Actualización del Manual Metodológico [Internet]. Madrid: Ministerio de Sanidad, Servicios Sociales e Igualdad; Zaragoza: Instituto Aragonés de Ciencias de la Salud (IACS); 2016 [Febrero 2018]. Disponible en: [http://portal.guiasalud.es/emanuales/elaboracion_2/?capitulo]
2. Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, et al. GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016;353:i2016.
3. Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50: a guideline developer’s handbook [Internet]. Edinburgh: SIGN; 2014. Disponible en: http://www. sign.ac.uk/guidelines/fulltext/50/.
(Scottish Intercollegiate Guidelines Network (SIGN). SIGN 50: a guideline developer’s handbook. Edinburgh: SIGN; 2015. (SIGN publication no. 50). [November 2015]. Available from URL: http://www.sign.ac.uk)
4. González-Macías J, Del Pino-Montes J, Olmos JM, Nogués X; en nombre de la Comisión de Redacción de las Guías de Osteoporosis de la SEIOMM. Guías de práctica clínica en la osteoporosis posmenopáusica, glucocorticoidea y del varón. Sociedad Española de Investigación Ósea y del Metabolismo Mineral (3ª versión actualizada 2014). Rev Clin Esp. 2015;215(9):515-26.
5. Grupo de Trabajo de la Sociedad Española de Investigación Ósea y del Metabolismo Mineral (SEIOMM). Osteoporosis postmenopáusica. Guía de práctica clínica. Rev Clin Esp. 2003;203(10):496-506.
6. Grupo de trabajo de la Guía de práctica clínica sobre osteoporosis y prevención de fracturas por fragilidad. Guía de práctica clínica sobre osteoporosis y prevención de fracturas por fragilidad. Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Política Social e Igualdad. Agència d’Informació, Avaluació i Qualitat en Salut (AIAQS) de Cataluña; 2010. Guía de práctica clínica en el SNS: AATRM No 2007/02.
7. Boucher M, Murphy G, Coyle D, Cranney A, Husereau D, Perras C, et al. Bisphosphonates and teriparatide for the prevention of osteoporotic fractures in postmenopausal women [Technology overview no 22]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2006.
8. Pueyo MJ, Larrosa M, Surís X, Garcia-Ruiz AJ. Análisis de coste-utilidad e impacto presupuestario de la prevención primaria con alendronato de la fractura osteoporótica de cadera en Cataluña. Reumatol Clin. 2012;8(2):128-34.