Main Title
|
|
Abstract
|
|
1 Introduction
|
|
2 Methods
2.1 Protocol and registration
None
2.2 Eligibility criteria
2.2.1 Inclusion criteria
2.2.2 Exclusion criteria
2.3 Information sources
2.4 Search
2.4.1 Search string
2.4.2 Search limits
None.
2.5 Study selection
The titles and abstracts of the search results were independently assessed for suitability. Full-text articles were retrieved if the titles or abstracts met the eligibility criteria or if there was uncertainty. The rationale for excluding articles was documented.
2.6 Data collection process
A data collection form was created using the Cochrane Data Extraction and Assessment Form template.
2.7 Data items
2.8 Risk of bias in individual studies
The PEDro scale was used to assess the internal validity of the studies included in the review. The PEDro scale is a 10-point ordinal scale used to determine specific methodological components including: randomization, concealed allocation, baseline comparison, blind participants, blind therapists, blind assessors, adequate follow-up, intention-to-treat analysis, between group comparisons, point estimates and variability (21). Participant eligibility is also a component of the PEDro scale, however it is not included in the final 10-point score.
2.9 Summary of measures
2.10 Synthesis of results
Group data is reported as means and standard deviations with pooled data reported as the standardized mean difference and its 95 percent confidence intervals. The standardized mean difference, adjusted to account for small sample size bias, was calculated to establish an effect size (Hedges’ adjusted g) (14). Effect size values of 0.2, 0.6 and 1.2 were interpreted as small, moderate and large effect sizes, respectively (17).
The authors of the included studies were contacted for data that was not presented in their publications (e.g. pre- and post-test data). Data expressed using the standard error of the mean was converted to the standard deviation. Where possible, between-group comparisons were made by using the difference of means with the standard error expressed as a 90 percent confidence interval. Individual study results were combined using Review Manager 5.3 with a random-effect meta-analysis model. This method considers both within- and between-study variability and was used to accommodate for the differences in the interventions in the individual studies (22). The consistency of the meta-analysis was assessed to determine the variability in excess of that due to chance. A chi-squared statistic (Cochrane Q) was used to evaluate the level of heterogeneity. The I^2 statistic was used to determine the percentage of the total variation in the estimated effect across studies. 2.11 Risk of bias across all studies
The relationship between the effect size and the sample size was determined visually using a funnel plot. Egger’s test was used to quantitatively assess for small sample size bias.
2.12 Additional analysis
No additional analysis was completed.
|
|
3 Results
3.1 Study selection
3.2 Study characteristics
3.3 Risk of bias within studies
3.4 Results of individual studies
3.5 Synthesis of results
3.6 Risk of bias across studies
3.7 Additional analysis
No additional analysis was completed.
|
|
4 Discussion
4.1 Summary of evidence
4.2 Limitations
4.3 Conclusions
|
|
5 Funding
None
|
|
6 References
|
Appendix
Table 1: Study characteristics
Study |
Study Design |
Participant Characteristics |
Group |
Intervention |
Outcomes |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Table 2: Risk of bias in individual studies
Study |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
Score |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
(1) Eligibility criteria, (2) Random allocation, (3) Concealed allocation, (4) Baseline comparison, (5) Blind subjects, (6) Blind therapists, (7) Blind assessors, (8) Adequate follow-up, (9) Intension-to-treat analysis, (10) Between-group comparison, (11) Point estimates and variability. Eligibility is not included in the final 10-point score
Table 3: Results
Study |
Measurement |
Group |
n |
Pre (min ± SD) |
Post (min ± SD) |
Within-Group Change (min ± SD) |
Between-Group Difference (min ± SD) |
Cohen's d |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Value |
Figure 1: PRISMA flow diagram
Figure 2: Forrest plot of results
Figure 3: Funnel plot of results