Original Title: Recomendaciones de uso adecuado de pruebas y suplementos de vitamina D en población general

Authors' objectives: To develop guidelines for the appropriate use of serum VitD quantification and supplementation in the general healthy adult population.

Authors' results and conclusions: The general search for reviews and guidelines identified a SR published in 2014 by the Task Force (4), which was adopted to answer the two questions as a starting point.

Authors' recommendations: Based on the evidence reviewed, the working group has issued the following recommendations regarding the appropriate use of VitD level determination and indication for supplementation in a healthy general population. Question 1: On VitD quantification in a healthy general population •In asymptomatic healthy adults without risk factors for VitD deficiency, determination of VitD values is not necessary. For the purpose of this recommendation, both extrinsic risk factors (e.g. inadequate intake or skin hyperpigmentation) and intrinsic risk factors (e.g. advanced age or malabsorption: gastrectomy, intestinal diseases or primary biliary cirrhosis) are considered. Question 2: On VitD supplementation in a healthy general population • In asymptomatic healthy adults, pharmacological supplementation has so far shown no benefit, irrespective of VitD levels. • Supplementation could be considered in the institutionalised population over 70 years of age, without the need for determination. Three indicators have been proposed by the development group, one structure and two process indicators. The structure indicator aims to determine the number of laboratories with updated protocols for VitD determination requests. The process indicators aim, on the one hand, to determine the number of VitD determinations requested and, on the other hand, the pharmaceutical expenditure on VitD supplements in the general healthy population.

Authors' methods: A systematic review (SR) of the existing scientific literature was carried out and the results of the review were analysed by a multidisciplinary group of experts. This expert working group was composed by clinical professionals from different specialties relevant to the topic, including rheumatology, nephrology, family medicine, primary care pharmacy, clinical analysis laboratory, internal medicine, endocrinology, rehabilitation and oncology from different health centres. This expert group was responsible for formulating and prioritizing the research questions approached in the guideline. Data sources. The literature search was conducted in a stepwise manner. The first phase focused on the search for clinical practice guidelines (CPG) and SR, published up to May 2018. We searched specific databases such as the National Guideline Clearinghouse, Guidelines International Network (GIN), TRIPDatabase, Cochrane Library and general databases such as PubMed and Embase, among others. Key words included were: vitamin D deficiency, adult*, general population, screening, 25-hydroxyvitamin, etc. The second phase consisted of a specific search for each of the research questions, which was carried out in general databases (Cochrane Library, CRD Databases, Medline and Embase) using specific keywords for each of the questions. This search covered the period up to 2019. 27 RECOMENDACIONES DE USO ADECUADO DE PRUEBAS Y SUPLEMENTOS DE VITAMINA D EN POBLACIÓN GENERAL Selection of key research questions. After a critical reading of CPG and SR, the group prioritised two of the 10 questions initially formulated, to answer in this document. • Question 1: What is the association between serum 25(OH)D levels and health outcomes including mortality, cancer, fractures, falls, cardiovascular disease, diabetes, depression, cognitive functioning, functional status, etc.? • Question 2: What is the effectiveness of vitamin D on hard/end variables including cardiovascular disease, obesity, cancer, immune system, osteoporotic fracture, renal failure and/or soft tissue calcification? The analysis and selection of studies was performed by at least two independent reviewers. Risk of bias assessment of the studies was performed using different instruments: AGREE-II (for CPGs), AMSTAR-2 (for SRs), the Cochrane Collaboration tool (for RCTs) and ROBINS-1 (studies of non-randomised interventions). The quality of the evidence was assessed using the GRADE (Grade of Recommendations, Assessment, Development and Evaluation) methodology. The multidisciplinary expert group analysed the results of the review and achieved consensus recommendations through face-to-face and online discussions. To reach consensus on the definition of optimal serum total 25(OH)D levels or deficiency, a modified Delphi was conducted including two rounds of remote voting and a roundtable meeting. In addition, the group developed evaluation indicators that were also established consensus. The draft document underwent an external review by experts proposed by the main scientific societies.

Project Status: Completed

Year Published: 2021

URL for published report: https://runa.sergas.gal/xmlui/handle/20.500.11940/15081

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: <p>Galician Agency for Health Technology Assessment (AVALIA-T)</p>