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POCT Systematic Review Paper -- 200808

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POCT Systematic Review Paper -- 200808 Powered By Docstoc
					Table 1: Study characteristics and results
   Author,         Study Design                 Intervention                Condition              Population         Outcome(s)          Test & Device       Duration                 Results
Reference and
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.
                                                                                                                                                                            59.3% laboratory).
                                                                                                                 Patient satisfaction
                                                                                                                                                                            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
                                                                                                                                                                            different interventions.
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.
                                                                                                                    differences)             2000
                                                                                           57% males versus                                                           Difference in cost of care in
                                                                                           59%                      Costs
                                                                                                                                                                      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
                                                                                                                                                                      8.0 (p=0.31).
                                                                                                                                                                      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).
               (Pilot Study)
                                                         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
                                                                                                                                 hypercholesterolemia) among
                                                                                                                                 study doctors (p=0.3027).

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