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.

Castellini, G., Gianola, S., Banzi, R., Corbetta, D., Gatti, R., Sirtori, V., et al. (2014). Constraint-induced movement therapy: Trial sequential analysis applied to Cochrane collaboration systematic review results. TRIALS, 15(1), 512 [10.1186/1745-6215-15-512].

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

Gianola, Silvia;Corbetta, Davide;
2014

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.
Articolo in rivista - Articolo scientifico
Constraint-induced movement therapy; Meta-analysis; Random error; Stroke; Trial sequential analysis; Chi-Square Distribution; Data Interpretation, Statistical; Disability Evaluation; Exercise Therapy; Humans; Motor Activity; Predictive Value of Tests; Randomized Controlled Trials as Topic; Recovery of Function; Reproducibility of Results; Research Design; Stroke; Time Factors; Treatment Outcome; Evidence-Based Medicine; Stroke Rehabilitation; Medicine (miscellaneous); Pharmacology (medical)
English
2014
15
1
512
512
open
Castellini, G., Gianola, S., Banzi, R., Corbetta, D., Gatti, R., Sirtori, V., et al. (2014). Constraint-induced movement therapy: Trial sequential analysis applied to Cochrane collaboration systematic review results. TRIALS, 15(1), 512 [10.1186/1745-6215-15-512].
File in questo prodotto:
File Dimensione Formato  
Castellini 2014.pdf

accesso aperto

Dimensione 1.12 MB
Formato Adobe PDF
1.12 MB Adobe PDF Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/193161
Citazioni
  • Scopus 5
  • ???jsp.display-item.citation.isi??? ND
Social impact