The Saudi Clinical Practice Guideline for the treatment of venous thromboembolism

 

## Question 1: should home treatment versus hospital treatment be used for patients with acute dvt of the leg?
The summary of evidence on this question was based on a systematic review by Othieno et al.The updated literature search identified one new study conducted in KSA by Algahtani et al.This new study was included in the updated meta-analysis. The summary of findings is provided in.Benefits and harms of the option. The meta-analysis of 7 trials )total of 1769 participants( found moderate quality evidence that home treatment of DVT reduces recurrent VTE )risk ratio Values and preferences. The SEP judged that the values and preferences may vary. Some patients and carers would prefer for the patient to be admitted. Some others would prefer to be discharged if they know they could easily access a physician.
Resource use. Health economic evaluations in settings different from that of KSA conclude that home treatment is cost-saving of approximately US$500-US$2500 per patient.Other considerations. The SEP judged home treatment of DVT to be acceptable to physicians and the Saudi MoH. However, they were concerned with the lack of ultrasound service after 4:30 P.M. and on weekends in emergency rooms. Implementation considerations. The SEP thought that there is a need to have ultrasound services to diagnose DVT available 24 hours per day 7 days per week, and to have 24-hour clinic coverage for these patients )for example, thrombosis services -Interpretation of strong and conditional )weak( recommendations.

## Implications

## Strong recommendation conditional (weak) recommendation for patients
Most individuals in this situation would want the recommended course of action and only a small proportion would not. Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences.
Most individuals in this situation would want the suggested course of action, but many would not.

## For clinicians
Most individuals should receive the intervention. Adherence to this recommendation according to the guideline could be used as a quality criterion or performance indicator.
Recognize that different choices will be appropriate for individual patients and that you must help each patient arrive at a management decision consistent with his or her values and preferences. Decision aids may be useful helping individuals making decisions consistent with their values and preferences.

## For policy makers
The recommendation can be adapted as policy in most situations Policy making will require substantial debate and involvement of various stakeholders. CI -confidence interval, LMWH -low molecular weight heparin, PE -pulmonary embolism, RCT -randomized controlled trial, RR -risk ratio, UFH -unfractionated heparin, *The basis for the assumed risk )for example, the median control group risk across studies( is provided in footnotes. The corresponding risk )and its 95% CI( is based on the assumed risk in the comparison group and the relative effect of the intervention )and its 95% CI(. * RCTs included recruited patients "whose home circumstances were adequate",  RCTs included patients with leg DVT. They excluded those with PE and pregnant women,  Four RCTs had partial hospital treatment for some participants in the home group: Levine et alCI -confidence interval, ITT -intention to treat, RRrisk ratio, *The basis for the assumed risk )for example, the median control group risk across studies( is provided in footnotes. The corresponding risk )and its 95% CI( is based on the assumed risk in the comparison group and the relative effect of the intervention )and its 95% CI(, * The 2 trials included patients at low risk: low risk on clinical prediction rule ) Monitoring and evaluation. The SEP proposed monitoring the percentage of patients treated at home versus hospital and studying the impact of implementing this recommendation on outcomes and costs. The recomendation for question one is presented in.

## Question 2: should early discharge versus standard discharge be used for patients with acute pe?
The summary of evidence is based on a systematic review Otero et al,and a more recent trial by Aujesky et al.The updated literature search identified one new systematic review by Piran et al,which did not identify any trial not already considered. The summary of findings is provided in.Benefits and harms of the option. The meta-analysis of 2 trials )total of 471 participants( found moderate quality evidence of possible increase in VTE )RR 1.23; 95% CI: 0.25-6.03( and major bleeding )RR 2.74; 95% CI: 0.45-16.71However, any absolute increase in these outcomes would be of small size given the low baseline risks )2 more VTE per 1000 and 8 more major bleeding per 1000 over a 3 months period(. Observational data confirm low risk of recurrent VTE in patients with low risk acute PE.Values and preferences. The SEP judged that values and preferences may vary. Some patients and carers would prefer for the patient to be admitted. Some others would prefer to be discharged if they know they could easily access a physician.
Resource use. We did not identify any studies directly related to PE, so the SEP relied on indirect evidence related to DVT. As stated earlier, health economic evaluations in both KSAand non-KSA settingsconclude that home treatment of DVT is cost-saving.
Other considerations. The SEP advocated assessing PE severity using a validated tool such as the Pulmonary Embolism Severity Index.The SEP also judged that the acceptability of early discharge might vary by physician. Some of them might be apprehensive to releasing patients early given the gravity of the condition. Implementation considerations. Early discharge is potentially feasible but requires 24-hour clinic coverage for the patients )for example, thrombosis services(.
Monitoring and evaluation. The SEP proposed auditing the percentage of patients discharged early versus late and studying the impact of implementing this recommendation on outcomes and costs. The recommendation for question 2 is presented in.
Discussion. The purpose of this clinical practice guideline is to provide guidance on selected clinical questions related to the management of acute DVT and PE, and the best and safe management settings. This guideline is a part of a larger initiative of the Saudi MoH aiming at providing evidence-based guidance for clinicians and reducing variability in clinical practice in This guideline was the first from KSA and the region on this topic. As it took into consideration the local context, it has higher chance of acceptance by HCP working in the area, which may improve health care quality and promote efficient use of the available resources. The recommendations in this guideline shared similarities with other recommendations. For example, the 9th Edition of Antithrombotic Therapy by the American College of Chest Physicians recommended initial treatment at home over treatment in hospital for patients with acute DVT of the leg, and who had adequate home circumstances )namely, strong recommendationThe European Society of Cardiology guideline stated that early discharge and continuation of treatment at home should be considered for patients with acute low risk PE if proper outpatient care and anticoagulant treatment can be provided.The 9th Edition of Antithrombotic Therapy suggested early discharge over standard discharge in patients with low risk PE and whose home circumstances are adequate )namely, conditional recommendationIt should be noted that this guideline did not address all the questions related to VTE treatment. For instance, the use of direct oral anticoagulants for the initial management of VTE is not addressed. Based on recent randomized controlled trials, the 2014 European Society of Cardiology guideline on acute PE treatment recommended the new direct oral anticoagulants as alternatives to the combination of parenteral anticoagulation with a vitamin K antagonist.In addition, the SEP suggested local research on the values and preferences of the Saudi population regarding VTE in general, its treatment with the various modalities and the potential side effects from such treatments. The SEP advocated the performance of studies that compare the impact of early versus late hospital discharge on various outcomes, such as recurrent VTE, post-thrombotic syndrome, bleeding and mortality, and the effectiveness of newer oral anticoagulants versus the different heparins.
In conclusion, this Saudi clinical practice is on outpatient versus inpatient VTE management. The SEP suggests home treatment over hospital treatment for patients with simple acute DVT, and suggests early discharge over late discharge for patients with low risk acute PE.