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Table 69Self monitoring or self management vs routine laboratory monitoring–quality assessment

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Recurrent VTE24,70,71,159,210,212,2567RCTSerious limitations(a, h)Serious inconsistency(f)Serious indirectness(d,h)Serious imprecision(e)
Major Bleeding24,41,46,63,70,71,74,94,113,121,132,157,159,210,213,225,226,240,256,26521RCTSerious limitations(a, b, c)No serious inconsistencySerious indirectness(d)Serious imprecision(e)
Minor Bleeding
 Subgroup-minor Bleeding-self management(i)41,70,71,159,212,2256RCTSerious limitations(a)Serious inconsistency(f)Serious indirectness(d)Serious imprecision(e)
 Subgroup-minor Bleeding-self monitoring(i)46,76,113,121,157,2656RCTSerious limitations(a)Serious inconsistency(f)Serious indirectness(d)Serious imprecision(e)
Percentage of time INR in range
 Subgroup-percentage of time INR in range-self management(i)35,70,71,159,225,226,2397RCTSerious limitations(b)Serious inconsistency(f)No serious indirectnessSerious imprecision(e)
 Subgroup-percentage of time INR in range-self monitoring(i)24,46,76,113,121,157,210,2658RCTSerious limitations(a, b)Serious inconsistency(f)No serious indirectnessNo serious imprecision
% of INR measurements out of range41,63,70,71,74,94,113,132,159,210,212,225,240,256,26515RCTSerious limitations(a, b)No serious inconsistencyNo serious indirectnessVery serious imprecision(g)
a

Randomisation, allocation concealment or blinding not reported.

b

One large study with 2922 patients contributed to most of the information. It was unclear whether ITT analysis was used and the drop-out rate was also unclear157 For various other studies it was unclear whether ITT analysis was used, and they also had unclear reporting of numbers of dropouts or large numbers of dropouts.

c

Six studies had no definition of major bleeding63,74,94,113,121,157. Six studies reported adverse events individually and described occurrences of bleeding but did not define major bleeding, and the 8 studies that provided a definition of major bleeding had minor variation in the definition of major bleeding.

d

The population included a mixture of people with VTE, atrial fibrillation or people undergoing heart valve implantation. The range of patients with VTE ranged from 7.1- 64% in these studies. The average age of this population was 61.9 years, which is older than most VTE populations. The GDG noted that these patients are at a higher risk of bleeding.

e

CI crosses MID making the effect size uncertain. For the percentage of INR within outcome, the GDG decided that the MID is about 10%. In addition, there were 7 studies (3 in self management subgroup and 4 in self monitoring subgroup) where data cannot be pooled.

f

Heterogeneity within and/or between groups. Subgroup heterogeneity was apparent in the outcome recurrent VTE (I2= 47 %) and subgroup heterogeneity was significant for the outcome percentage of time INR in range (I2= 77.4 %). I2 values for overall heterogeneity were significant for minor bleeding (I2= 80 %) and for percentage of time INR in range (I2= 95%). All outcomes were analysed using random effects.

g

11 out of 15 studies reported percentage of INR in range therefore percentage of INR out of range calculated by NCGC for these studies. This data could not be pooled or meta-analysed.

h

Few studies reported recurrent VTE as a direct outcome due to the varying population, therefore sparse data was available. Most data obtained was extracted from those papers that reported individual thomboembolic events. Furthermore, of the studies that did report this as an outcome, there were large numbers lost to follow-up, one trial was a crossover trial and one trial was stopped early.

i

Subgroup analysis of 2 pre-specified subgroups for the percentage of time INR in range and minor bleeding outcome was carried out due to heterogeneity between subgroups.

Randomisation, allocation concealment or blinding not reported.

One large study with 2922 patients contributed to most of the information. It was unclear whether ITT analysis was used and the drop-out rate was also unclear157 For various other studies it was unclear whether ITT analysis was used, and they also had unclear reporting of numbers of dropouts or large numbers of dropouts.

Six studies had no definition of major bleeding63,74,94,113,121,157. Six studies reported adverse events individually and described occurrences of bleeding but did not define major bleeding, and the 8 studies that provided a definition of major bleeding had minor variation in the definition of major bleeding.

The population included a mixture of people with VTE, atrial fibrillation or people undergoing heart valve implantation. The range of patients with VTE ranged from 7.1- 64% in these studies. The average age of this population was 61.9 years, which is older than most VTE populations. The GDG noted that these patients are at a higher risk of bleeding.

CI crosses MID making the effect size uncertain. For the percentage of INR within outcome, the GDG decided that the MID is about 10%. In addition, there were 7 studies (3 in self management subgroup and 4 in self monitoring subgroup) where data cannot be pooled.

Heterogeneity within and/or between groups. Subgroup heterogeneity was apparent in the outcome recurrent VTE (I2= 47 %) and subgroup heterogeneity was significant for the outcome percentage of time INR in range (I2= 77.4 %). I2 values for overall heterogeneity were significant for minor bleeding (I2= 80 %) and for percentage of time INR in range (I2= 95%). All outcomes were analysed using random effects.

11 out of 15 studies reported percentage of INR in range therefore percentage of INR out of range calculated by NCGC for these studies. This data could not be pooled or meta-analysed.

Few studies reported recurrent VTE as a direct outcome due to the varying population, therefore sparse data was available. Most data obtained was extracted from those papers that reported individual thomboembolic events. Furthermore, of the studies that did report this as an outcome, there were large numbers lost to follow-up, one trial was a crossover trial and one trial was stopped early.

Subgroup analysis of 2 pre-specified subgroups for the percentage of time INR in range and minor bleeding outcome was carried out due to heterogeneity between subgroups.

From: 12, Self-management and self-monitoring for patients treated with a vitamin K antagonist

Cover of Venous Thromboembolic Diseases
Venous Thromboembolic Diseases: The Management of Venous Thromboembolic Diseases and the Role of Thrombophilia Testing [Internet].
NICE Clinical Guidelines, No. 144.
National Clinical Guideline Centre (UK).
Copyright © 2012, National Clinical Guideline Centre.

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