The Saudi Clinical Practice Guideline for the treatment of venous thromboembolism

قيمعلا ديرولا طلتج اهيف ابم ةيديرولا ةيعولأا دادسناو طلتج دعي ةيريرسلا ةسراملما يف ةعئاشلا ضارملأا نم ةيوئرلا تاطللجاو هذه ةلجاعمو مكحتلا نوكي ام اًبلاغ صيخشتلا دعبو .ةيمويلا ينيحصلا ينسراملما اهجاوي يتلا ةبعصلا تايدحتلا نم تلاالحا ريغلا ةقيرطلاب ةقيمعلا ةدرولأا طلتج جلاع يدؤي دقو .اًيموي دق ةريطخ تافعاضم ىلإ بسانم ريغلا ناكلما يف وأ ةبسانم ةيبرعلا ةكلملما يف ةحصلا ةرازو نم ةرداببمو .ضيرلما ةايح ددهت ةيدوعسلا ةيعملجا نم ءاربلخا نم قيرف عمتجا دقف ةيدوعسلا ةعباتلا( ةيديرولا تاطلجلل ةيدوعسلا ةعومجلماو ،مدلا ضارملأ ريبخ قيرف نم معدب )ردصلا ةحارجو بطل ةيدوعسلا ةيعمجلل لجأ نم رتسامكام ةعماج نم ينهاربلا ىلع ينبلما بطلا يف ةدعاسلم ةيللمحا ةيريرسلا ةيداشرلإا ةلدلأا نم ةعومجم ةغايص بسانلما جلاعلا رايتخا ىلع ةكلملما يف ينيحصلا ينسراملما يعوضوم انوكتل ينتلأسم ديدتح تم دقلو .تلاالحا هذه لثلم عم يديرولا طلجتلا ىضرم جلاعب قلعتت ىلولأا :تايصوتلا قلعتت ةيناثلاو ،اهجراخ جلاعلا لباقم ىفشتسلما يف يمونتلا لباقم ىفشتسلما نم ركبلما جورلخا عم ةيوئرلا تاطللجا جلاعب GRADE جهن بسح تايصوتلا تمدق دقو .يدايتعلاا جورلخا .)جئاتنلا ليلتحو اهتغايصو ،اهمييقتو ،تايصوتلا ةسارد( Venous thromboembolism )VTE( including deep vein thrombosis )DVT( and pulmonary embolism )PE( is commonly encountered in daily clinical practice. After diagnosis, its management frequently carries significant challenges to the clinical practitioner. Treatment of VTE with the inappropriate modality and/or in the inappropriate setting may lead to serious complications and have life-threatening consequences. As a result of an initiative of the Ministry of Health of the Kingdom of Saudi Arabia, an expert panel led by the Saudi Association for Venous ThromboEmbolism )a subsidiary of the Saudi Thoracic Society( and the Saudi Scientific Hematology Society with the methodological support of the McMaster Clinical Practice Guidelines University Guideline working group, this clinical practice guideline was produced to assist health care providers in VTE management. Two questions were identified and were related to the inpatient versus outpatient treatment of acute DVT, and the early versus standard discharge from hospital for patients with acute PE. The corresponding recommendations were made following the GRADE )Grading of Recommendations, Assessment, Development, and Evaluation( approach. Saudi Med J 2015; Vol. 36 (8): 1004-1010 doi: 10.15537/smj.2015.8.12024 From the Intensive Care Department (Al-Hameed), College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, National Guard Health Affairs, Jeddah, the Intensive Care Department (Al-Dorzi), College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, National Guard Health Affairs, the Department of Hematology (Al-Momen, Algahtani, Al-Saleh), King Saud University, and the Department of Hematology (Al-Zahrani, Owaidah), King Faisal Specialist Hospital and Research Center, the Department of Medicine (Al-Sheef ), King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia, and the Department of Clinical Epidemiology and Biostatistics (Alhazzani, Neumann, Wiercioch, Brozek, Schünemann, Akl), McMaster University, Hamilton, Canada, and the Department of Internal Medicine (Akl), American University of Beirut, Beirut, Lebanon. Address correspondence and reprint request to: Dr. Fahad M. Al-Hameed, College of Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdulaziz Medical City, National Guard Health Affairs, Jeddah, Kingdom of Saudi Arabia. E-mail: [email protected] OPEN ACCESS V thromboembolism )VTE( comprised of deep vein thrombosis )DVT( and pulmonary embolism )PE( is a relatively common disease affecting approximately 100 per 100,000 people per year.1-3 It is estimated that approximately 25,000 people 1004 Saudi Med J 2015; Vol. 36 )8( www.smj.org.sa 1005 www.smj.org.sa Saudi Med J 2015; Vol. 36 )8( KSA Guideline for VTE treatment ... Al-Hameed et al are affected in the Kingdom of Saudi Arabia )KSA( annually. The major risk factors of VTE include age, surgery, hospitalization, immobility, trauma, cancer, pregnancy, and puerperium, hormone use, obesity, and inherited and acquired hypercoagulable states.4 The venous thromboembolism is associated with significant morbidity and mortality,5 especially when not treated appropriately. The standard treatment of acute DVT had been hospital admission and anticoagulation with unfractionated heparin intravenously for approximately 5-7 days. With the introduction of low molecular weight heparin )LMWH(, which proved to be effective when given subcutaneously, the setting for acute DVT treatment became an issue of investigation. Recent evidence supports the use of direct oral anticoagulants in the initial VTE treatment with safe outcomes compared with conventional therapy.6 Additionally, the duration of hospitalization needed to safely and successfully manage acute PE had been another area of consideration taking into account the increasing costs of health care and the need for optimal resource utilization. There is a lack of previous guidelines on VTE management from KSA. Given the importance of this topic, the Saudi Ministry of Health )MoH( produced this clinical practice guideline on the management of VTE to assist health care providers )HCP( in evidence-based clinical decision-making. In this document, we report the recommendations of the Saudi Expert Panel )SEP( for the inpatient versus outpatient VTE treatment. The full guideline is available at: http://www.moh.gov.sa/depts/ Proofs/Pages/Guidelines.aspx7 Methods. This clinical practice guideline was a part of a larger initiative by the Saudi MoH to ensure quality care and reduce variability in clinical practice across the Kingdom through proper adaptation and de novo development of practice guidelines. In 2013, the Saudi MoH, through the Saudi Center for Evidence Based Healthcare, partnered with the McMaster University guidelines group and contacted the Saudi Scientific Hematology Society and the Saudi Association for VTE )SAVTE( to nominate a group of clinicians to serve as expert panelists for guideline development on VTE treatment. The methodology used to develop recommendations and grade the quality of the supporting evidence is briefly described below. Its details are available in a separate publication.8 The overall process. The guideline panel selected the clinical questions of this guideline by a formal prioritization process based on a 9-point Likert scale ranking of several questions on VTE management. The McMaster University guideline group updated the systematic reviews that were related to the selected questions by searching for trials that were subsequently published in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE until November 2013. When relevant, the meta-analyses were updated. The group also conducted systematic searches for information that was specific to the Saudi context, such as patients’ values and preferences, and cost. Next, the McMaster guideline leader developed a summary of findings and evidence-to-recommendation tables for each question, and shared them with the SEP members. The guideline panel was asked to provide additional information, including unpublished data. The guideline panel met in Riyadh, KSA on December 3, 2013, and developed the final recommendations using a structured consensus process with voting used to reach consensus in some cases.8 Transparent documentation of all decisions was performed. The SEP members reported their potential conflicts of interests, which were managed according to the World Health Organization guidelines.9 The selected questions. The following are the 2 clinical questions that were selected by the KSA guideline panel and addressed in this guideline. For details on the process by which the questions were selected, please refer to the separate methodology publication:10 1( Should home treatment versus hospital treatment be used for patients with acute DVT of the leg?; 2( Should early discharge versus standard discharge from hospital be used for patients with acute PE? Grading the quality of evidence. The SEP assessed the quality of evidence using the GRADE )Grading of Recommendations, Assessment, Development, and Evaluation( approach.11 The quality of evidence was classified as “high”, “moderate”, “low”, or “very low” according to the following definitions:12 High: We are very confident that the true effect lies close to that of the estimate of the effect;12 Moderate: We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different;12 Low: Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect;12 and Very low: We have very little confidence in the effect estimate. The true effect Disclosure. Authors have no conflict of interests, and the work was not supported or funded by any drug company. This clinical practice guideline was funded by the Ministry of Health, Riyadh, Kingdom of Saudi Arabia.