Table 1: Study characteristics and results
Author, Study Design Intervention Condition Population Outcome(s) Test & Device Duration Results
Shiach (6), Randomised PoCT Anti-coagulant 46 patients, age and Clinical effectiveness INR 12 mths No difference in time spent in
2002 Crossover Trial Computer Decision Support therapy gender not reported (Between group CoaguChek INR target range between
differences) groups (60.9% PoCT vs.
Patients had greater
Safety satisfaction with PoCT
Bland Altman plot showed
that the INR difference
increased as the average INR
No significant difference
between geometric mean INR
with PoCT and laboratory
systems (2.48 versus 2.50
INR values >4.0 were less
No difference in the
dependability of the two INR
Claes (7), 2005 Randomised Four interventions: Anti-coagulant 834 patients, mean Clinical effectiveness INR 12 mths (6 mths All four interventions resulted
Controlled Trial therapy age = 70.2, 455 retrospective in significant increase in %
Education; Education + Feedback; (Between and within CoaguChek
Education + PoCT; Education + males, 379 females group differences) and 6 mths time spent within 0.5 INR
Computer Decision Support prospective) from target (49.5% at
baseline to 60% after
No difference in % in target
range or event rates between
Claes (8), 2006 Randomised Four interventions: Anti-coagulant 834 patients; data Cost-effectiveness INR 12 mths (6 mths PoCT + education resulted in
Controlled Trial Education; Education + Feedback; therapy used from a larger CoaguChek retrospective net savings and quality
Education + PoCT; Education + trial 7 and 6 mths improvement. The cost per
prospective) test was reduced to €14.13
Computer Decision Support Of 66 practices 16 GP and accounted for €36.74 per
interviews; 5 persons patient per month.
involved in the
organisation of study The Incremental Cost-
effectiveness Ratio for
interviewed, age and
gender not reported education + PoCT were
dominant over usual care. In
a sensitivity analysis when
overhead costs were varied
the dominance of this
intervention versus usual
care was lost (at an overhead
cost of €8 instead of €10.05).
Fitzmaurice (9), Randomised PoCT Anti-coagulant 224 patients, age not Clinical effectiveness INR 12 mths No difference in level of
2000 Controlled Trial therapy reported, 55% male control of INR (point
Computer Decision Support (Between and within Thrombotrak
and 45% female group differences) prevalence) between groups.
PoCT group had an
improvement in the
proportion of time in INR
range (as did all groups) but
not significantly different from
the control practices.
Parry (10), Randomised PoCT Anti-coagulant 224 patients, data Cost-effectiveness INR 12 mths Cost of PoCT was £170 (95%
2000 Controlled Trial therapy used from a larger CI £149-190) vs. £69 (95% CI
Computer Decision Support Thrombotrak
trial9, age = 67 £57-81) in primary care
intervention versus 68 (p<0.01).
control, 45% female Sensitivity analysis indicated
versus 42% cost of PoCT could be
reduced to below £100.
Khunti (11), Prospective PoCT Type 2 Diabetes 681 patients (319 Clinical effectiveness HbA1c 12 mths Proportion of patients with
2006 Randomised intervention and 319 (Between group Bayer DCA HbA1C <7.0% not statistically
Controlled Trial control), age = 65.7, different between two groups.
57% males versus Difference in cost of care in
two groups not statistically
Stone (12), Prospective PoCT Type 2 Diabetes 410 patients, 11 staff Patient satisfaction HbA1c 12 mths No increase in patient
2007 Randomised interviews, 15 patient satisfaction in PoCT group.
GP and device Bayer DCA
Controlled Trial interviews, age and operator satisfaction 2000 Interviews showed that
gender not reported, nurses found equipment easy
participants part of
to use. GPs saw the cost of
larger trial10 equipment and consumables
as a disadvantage.
Usefulness of having an
immediate result differed
between practices (reflecting
the manner PoCT in which
PoCT was set up and the
nurse’s level of responsibility
for making management
Miller (13), Prospective PoCT Type 2 Diabetes 597 patients (317 Clinical effectiveness HbA1c 188 days PoCT led to more
2003 Controlled Trial intervention and 280 intensification of therapy in
GP education re: diabetes before (Between, within Bayer DCA
(Quasi- start of study control), age = 61, group differences and 2000 patients with HbA1C ≥7.0 at
78.8% female versus baseline (51 versus 32,
randomised) impact on clinical
78.6% decisions) p=0.01), more so when
HbA1C > 8.0.
In PoCT group HbA1C fell
from 8.4 to 8.1% (p=0.04) but
not in routine group – 8.1 to
No statistically significant
changes in HbA1c between
Ruffin (14), Randomised PoCT Hyperlipidaemia 35 patients (19 Clinical effectiveness TC Unknown Significantly more CHD risk
1997 Parallel Group intervention and 16 assessments in the PoCT
(Impact on clinical HDL-C
Control Design control), no age and decisions) (68%) group than the control
gender reported (only TG group (19%) (p=0.0001).
that men >45 years or Cholestech No difference in therapeutic
women >55 years) LDX interventions between groups
No difference in the process
of care (with regard to
study doctors (p=0.3027).