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Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results.

Castellini G, Gianola S, Banzi R, Corbetta D, Gatti R, Sirtori V, Gluud C, Moja L - Trials (2014)

Bottom Line: We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries.We included data from 14 RCTs.Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.

View Article: PubMed Central - PubMed

Affiliation: Health Professional Science of Rehabilitation, University of Milan, Via Festa del Perdono, 7, 20122 Milan, Italy. gre.caste@gmail.com.

ABSTRACT

Background: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients.

Methods: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries.

Results: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62).

Conclusions: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.

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Related in: MedlinePlus

Meta-analysis constraint-induced movement therapy (CIMT) versus control on arm motor function (ARAT). Effect of CIMT compared with usual care on arm motor function, assessed using Action Research Arm Test (ARAT) in adult stroke patients. The meta-analysis included 199 stroke patients. The black diamond does not cross the vertical line and showed an effect size of 7.78 (95% CI 1.19 to 14.37), which is significant (P = 0.02) using conventional meta-analytic methods. Heterogeneity expressed as I2 85% was high. Abbreviations: CIMT, Constraint induced movement therapy; ARAT, action research arm test.
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Fig4: Meta-analysis constraint-induced movement therapy (CIMT) versus control on arm motor function (ARAT). Effect of CIMT compared with usual care on arm motor function, assessed using Action Research Arm Test (ARAT) in adult stroke patients. The meta-analysis included 199 stroke patients. The black diamond does not cross the vertical line and showed an effect size of 7.78 (95% CI 1.19 to 14.37), which is significant (P = 0.02) using conventional meta-analytic methods. Heterogeneity expressed as I2 85% was high. Abbreviations: CIMT, Constraint induced movement therapy; ARAT, action research arm test.

Mentions: Nine trials [41–43, 45, 49, 52–55], totaling 199 patients, assessed arm motor function using ARAT; five RCTs were excluded because one [48] assessed motor function through the Wolf Motor Function Test (WMFT) and four trials did not assess arm motor function [44, 46, 47, 50]. Meta-analyses showed a statistically significant CIMT effect on arm motor function (random effects, MD 7.78 points, 95% CI 1.19 to 14.37; I2 = 85%) (Figure 4).Figure 4


Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results.

Castellini G, Gianola S, Banzi R, Corbetta D, Gatti R, Sirtori V, Gluud C, Moja L - Trials (2014)

Meta-analysis constraint-induced movement therapy (CIMT) versus control on arm motor function (ARAT). Effect of CIMT compared with usual care on arm motor function, assessed using Action Research Arm Test (ARAT) in adult stroke patients. The meta-analysis included 199 stroke patients. The black diamond does not cross the vertical line and showed an effect size of 7.78 (95% CI 1.19 to 14.37), which is significant (P = 0.02) using conventional meta-analytic methods. Heterogeneity expressed as I2 85% was high. Abbreviations: CIMT, Constraint induced movement therapy; ARAT, action research arm test.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4307139&req=5

Fig4: Meta-analysis constraint-induced movement therapy (CIMT) versus control on arm motor function (ARAT). Effect of CIMT compared with usual care on arm motor function, assessed using Action Research Arm Test (ARAT) in adult stroke patients. The meta-analysis included 199 stroke patients. The black diamond does not cross the vertical line and showed an effect size of 7.78 (95% CI 1.19 to 14.37), which is significant (P = 0.02) using conventional meta-analytic methods. Heterogeneity expressed as I2 85% was high. Abbreviations: CIMT, Constraint induced movement therapy; ARAT, action research arm test.
Mentions: Nine trials [41–43, 45, 49, 52–55], totaling 199 patients, assessed arm motor function using ARAT; five RCTs were excluded because one [48] assessed motor function through the Wolf Motor Function Test (WMFT) and four trials did not assess arm motor function [44, 46, 47, 50]. Meta-analyses showed a statistically significant CIMT effect on arm motor function (random effects, MD 7.78 points, 95% CI 1.19 to 14.37; I2 = 85%) (Figure 4).Figure 4

Bottom Line: We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries.We included data from 14 RCTs.Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.

View Article: PubMed Central - PubMed

Affiliation: Health Professional Science of Rehabilitation, University of Milan, Via Festa del Perdono, 7, 20122 Milan, Italy. gre.caste@gmail.com.

ABSTRACT

Background: Trial sequential analysis (TSA) may establish when firm evidence about the efficacy of interventions is reached in a cumulative meta-analysis, combining a required information size with adjusted thresholds for conservative statistical significance. Our aim was to demonstrate TSA results on randomized controlled trials (RCTs) included in a Cochrane systematic review on the effectiveness of constraint-induced movement therapy (CIMT) for stroke patients.

Methods: We extracted data on the functional independence measure (FIM) and the action research arm test (ARAT) from RCTs that compared CIMT versus other rehabilitative techniques. Mean differences (MD) were analyzed using a random-effects model. We calculated the information size and the cumulative Z-statistic, applying the O'Brien-Fleming monitoring boundaries.

Results: We included data from 14 RCTs. In the conventional meta-analysis (seven trials, 233 patients), the effect of CIMT on FIM was reported as significant (MD 2.88, 95% CI 0.08 to 5.68; P = 0.04). The diversity-adjusted required information size was 142 patients, and the cumulative Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.02 to 5.78). The effect of CIMT on ARAT (nine trials, 199 patients) was reported as significant (MD 7.78, 95% CI 1.19 to 14.37; P = 0.02). However, the diversity-adjusted required information size was 252 patients, and the Z-score did not cross the trial sequential monitoring boundary for benefit (adjusted 95% CI -0.06 to 15.62).

Conclusions: Although conventional meta-analyses of CIMT reached statistical significance, their overall results remain inconclusive and might be spurious. Researchers should not be overconfident on CIMT efficacy based on the results of meta-analyses and derived recommendations.

Show MeSH
Related in: MedlinePlus