Abstract
Objective: To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. Data Sources: The Cochrane Database of Systematic Reviews was searched through February 2015. Study Selection: We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. Data Extraction: Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. Data Synthesis: Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. Conclusions: Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.
| Original language | English |
|---|---|
| Journal | Archives of Physical Medicine and Rehabilitation |
| DOIs | |
| Publication status | Accepted/In press - 2016 |
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Keywords
- Methods
- Randomized controlled trial
- Randomized controlled trials as topic
- Rehabilitation
- Sample size
ASJC Scopus subject areas
- Rehabilitation
- Physical Therapy, Sports Therapy and Rehabilitation
Cite this
Improving Power and Sample Size Calculation in Rehabilitation Trial Reports : A Methodological Assessment. / Castellini, Greta; Gianola, Silvia; Bonovas, Stefanos; Moja, Lorenzo.
In: Archives of Physical Medicine and Rehabilitation, 2016.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Improving Power and Sample Size Calculation in Rehabilitation Trial Reports
T2 - A Methodological Assessment
AU - Castellini, Greta
AU - Gianola, Silvia
AU - Bonovas, Stefanos
AU - Moja, Lorenzo
PY - 2016
Y1 - 2016
N2 - Objective: To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. Data Sources: The Cochrane Database of Systematic Reviews was searched through February 2015. Study Selection: We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. Data Extraction: Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. Data Synthesis: Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. Conclusions: Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.
AB - Objective: To systematically assess the reporting of sample size calculation in randomized controlled trials (RCTs) on rehabilitation interventions for mechanical low back pain. Data Sources: The Cochrane Database of Systematic Reviews was searched through February 2015. Study Selection: We conducted an electronic database search for RCTs published from January 1, 1968 to February 28, 2015 and included in the Cochrane Systematic Reviews. Data Extraction: Two investigators independently used an ad hoc 6-item checklist derived from the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement recommendations to extract data on sample size calculation. The primary outcome was the proportion of RCTs that reported sample size calculation; the secondary outcome was the completeness of sample size analysis reporting. We also evaluated improvement in reporting of sample size calculation over time. Data Synthesis: Sample size calculation was reported in 80 (36.0%) of the 222 eligible RCTs included in 14 Cochrane Systematic Reviews. Only 13 (16.3%) of these RCT reports gave a complete description, and about half reported ≥4 of the 6 elements of sample size calculation (median, 4; interquartile range, 3-5). Completeness of reporting of sample size calculation improved from 1968 to 2013; since 2005, the number of RCTs reporting sample size calculation has increased compared with the number of RCTs not reporting it. Conclusions: Despite improvement, reporting of sample size calculation and power analysis remains inadequate, limiting the reader's ability to assess the quality and accuracy of rehabilitation studies.
KW - Methods
KW - Randomized controlled trial
KW - Randomized controlled trials as topic
KW - Rehabilitation
KW - Sample size
UR - http://www.scopus.com/inward/record.url?scp=84970016297&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84970016297&partnerID=8YFLogxK
U2 - 10.1016/j.apmr.2016.02.013
DO - 10.1016/j.apmr.2016.02.013
M3 - Article
AN - SCOPUS:84970016297
JO - Archives of Physical Medicine and Rehabilitation
JF - Archives of Physical Medicine and Rehabilitation
SN - 0003-9993
ER -