Table 67Patient information vs usual care – Quality assessment

OutcomeNumber of studiesDesignLimitationsInconsistencyIndirectnessImprecision
Recurrent VTE134,1872RCTSerious limitations(a)No serious inconsistencySerious indirectness (b)Serious imprecision(c)
Major bleeding134,1872RCTSerious limitations(a)No serious inconsistencySerious indirectness (b)Very serious imprecision(c)
Perception of patients (knowledge)1871RCTSerious limitations (a,e)No serious inconsistencySerious indirectness (b)No serious imprecision
Compliance: % Pill count relative to prescribed dose1341RCTSerious limitations(a)No serious inconsistencySerious indirectness (a)No serious imprecision
Percentage of time within target INR
Subgroup: Brochure vs no intervention171RCTSerious limitations(a),(d)No serious inconsistencySerious indirectness(b)No serious imprecision
Subgroup: Course (group education) vs no intervention171RCTSerious limitations(d)No serious inconsistencySerious indirectness(b)No serious imprecision
Subgroup: Course (group education) vs brochure171RCTSerious limitations(d)No serious inconsistencySerious indirectness(b)No serious imprecision
Subgroup: Intensive individual1341RCTSerious limitations(a)No serious inconsistencySerious indirectness(b)No serious imprecision
PTS0-----
Quality of life0-----
Patient satisfaction0-----
a

One study, which contributed to most of the information, had cluster randomisation187. The other study was conducted as part of the factorial design to compare two oral anticoagulants. An electronic bottle recorded the exact date and time of opening.134

b

The studies were conducted in France and Italy. The types and levels of information provided in the control and intervention arms differ between studies. It was unclear whether the information provided in the control arms would be different from that provided in the UK. Time within INR target is also a surrogate marker for patient outcome. The GDG considered a change of about 10% to be potentially clinically important.

c

The CIs were wide, and the CIs cross thresholds of important benefits and important harms.

d

Randomisation method was unclear 17.

e

For the knowledge outcome: the maximum point was 20 points and it was unclear whether the questionnaire was validated. It is uncertain how the data should be interpreted.

From: 11, Patient information

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).
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