Scientific summary
Appendix 3 The data extraction variables used for the study results
TABLE 30 Data extraction variables for study results (Microsoft Excel®2010, Microsoft Corporation, Redmond, WA, USA)
Variable Description
Study Author, date
N_Treat Number of participants in treatment arm
N_Treat2 Number of participants in second treatment arm (if applicable) N_Treat3 Number of participants in third treatment arm (if applicable) N_Control Number of participants in control arm
Followup Baseline ‘0’
Followup1 Final follow-up point for which subsequent data are being extracted (e.g. 12 weeks, 10 days)
Mean0_combined Baseline mean score for crossover trials Mean0_treat Baseline mean score for treatment arm
LowerCI0_treat Lower CI for baseline mean score for treatment arm UpperCI0_treat Upper CI for baseline mean score for treatment arm SD0_combined SD for baseline mean score for crossover trials SD0_treat SD for baseline mean score for treatment arm SE0_treat SE for baseline mean score for treatment arm Median0_treat Baseline median score for treatment arm Min0_treat Baseline minimum score for treatment arm Max0_treat Baseline maximum score for treatment arm Range0_treat Baseline range score for treatment arm Q250_treat Baseline lower quartile for treatment arm Q750_treat Baseline upper quartile for treatment arm IQR0_treat Baseline interquartile range for treatment arm Mean0_plac Baseline mean score for control/placebo arm
LowerCI0_ plac Lower CI for baseline mean score for control/placebo arm UpperCI0_ plac Upper CI for baseline mean score for control/placebo arm SD0_ plac SD for baseline mean score for control/placebo arm SE0_ plac SE for baseline mean score for control/placebo arm Median0_ plac Baseline median score for control/placebo arm Min0_ plac Baseline minimum score for control/placebo arm Max0_ plac Baseline maximum score for control/placebo arm Range0_ plac Baseline range score for control/placebo arm Q250_ plac Baseline lower quartile for control/placebo arm
continued DOI: 10.3310/hta22600 HEALTH TECHNOLOGY ASSESSMENT 2018 VOL. 22 NO. 60
© Queen’s Printer and Controller of HMSO 2018. This work was produced by Beresford et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
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TABLE 30 Data extraction variables for study results (Microsoft Excel®2010, Microsoft Corporation, Redmond, WA, USA) (continued )
Variable Description
Q750_ plac Baseline upper quartile for control/placebo arm IQR0_ plac Baseline interquartile range for control/placebo arm Mean1_treat Follow-up mean score for treatment arm
LowerCI1_treat Lower CI for follow-up mean score for treatment arm UpperCI1_treat Upper CI for follow-up mean score for treatment arm SD1_treat SD for follow-up mean score for treatment arm SE1_treat SE for follow-up mean score for treatment arm Median1_treat Follow-up mean median score for treatment arm Min1_treat Follow-up mean minimum score for treatment arm Max1_treat Follow-up mean maximum score for treatment arm Range1_treat Follow-up mean range score for treatment arm Q251_treat Follow-up mean lower quartile for treatment arm Q751_treat Follow-up mean upper quartile for treatment arm IQR1_treat Follow-up mean interquartile range for treatment arm Mean1_ plac Follow-up mean score for control/placebo arm
LowerCI1_ plac Lower CI for follow-up mean score for control/placebo arm UpperCI1_ plac Upper CI for follow-up mean score for control/placebo arm SD1_ plac SD for follow-up mean score for control/placebo arm SE1_ plac SE for follow-up mean score for control/placebo arm Median1_ plac Follow-up mean median score for control/placebo arm Min1_ plac Follow-up mean minimum score for control/placebo arm Max1_ plac Follow-up mean maximum score for control/placebo arm Range1_ plac Follow-up mean range score for control/placebo arm Q251_ plac Follow-up mean lower quartile for control/placebo arm Q751_ plac Follow-up mean upper quartile for control/placebo arm IQR1_ plac Follow-up mean interquartile range for control/placebo arm TimeEffect_F ANOVA f-value for time effect
TimeEffect_P ANOVA p-value for time effect GroupEffect_F ANOVA f-value for group effect GroupEffect_P ANOVA p-value for group effect GroupTimeEffect_F ANOVA f-value for interaction effect GroupTimeEffect_P ANOVA p-value for interaction effect
ChangeBL1_Mean_Treat Mean change from baseline to follow-up for treatment arm ChangeBL1_SD_Treat SD of mean change from baseline to follow-up for treatment arm ChangeBL1_SE_Treat SE of mean change from baseline to follow-up for treatment arm ChangeBL1_range_Treat Range score in change from baseline to follow-up for treatment arm ChangeBL1_LowerCI_Treat Lower CI in change value from baseline to follow-up for treatment arm
APPENDIX 3
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TABLE 30 Data extraction variables for study results (Microsoft Excel®2010, Microsoft Corporation, Redmond, WA, USA) (continued )
Variable Description
ChangeBL1_UpperCI_Treat Upper CI in change value from baseline to follow-up for treatment arm ChangeBL1_P_Treat p-value for change from baseline to follow-up for treatment arm ChangeBL1_%_Treat Percentage change from baseline to follow-up for treatment arm ChangeBL1_Mean_plac Mean change from baseline to follow-up for control/placebo arm ChangeBL1_SD_ plac SD of mean change from baseline to follow-up for control/placebo arm ChangeBL1_SE_ plac SE of mean change from baseline to follow-up for control/placebo arm ChangeBL1_range_ plac Range score in change from baseline to follow-up for control/placebo arm ChangeBL1_LowerCI_ plac Lower CI in change value from baseline to follow-up for control/placebo arm ChangeBL1_UpperCI_ plac Upper CI in change value from baseline to follow-up for control/placebo arm ChangeBL1_P_ plac p-value for change from baseline to follow-up for control/placebo arm ChangeBL1_%_ plac Percentage change from baseline to follow-up for control/placebo arm
Diff_Treat_Plac Raw value/score of the difference between the treatment and control/placebo arm Diff_Treat_Plac_mean MD between the treatment and control/placebo arm
Diff_Treat_Plac_SD SD of the MD between the treatment and control/placebo arm Diff_Treat_Plac_test_statistic
(DF)
Test statistic of the difference between the treatment and control/placebo arm
Diff_Treat_Plac_ES Effect size of the difference between the treatment and control/placebo arm Diff_Treat_Plac_P p-value of the difference between the treatment and control/placebo arm CarryOverEffect_P Carry-over effect for crossover trials
Period_effect_P Period effect for crossover trials
Period_T-P_Mean Mean period effect in order of treatment to control/placebo for crossover trials
Period_T-P_SD SD of the mean period effect in order of treatment to control/placebo for crossover trials Period_P-T_Mean Mean period effect in order of control/placebo to treatment for crossover trials
Period_P-T_SD SD of the mean period effect in order of control/placebo to treatment for crossover trials Period_diff_P p-value for period effect
DiffChange_Mean Difference in mean change from baseline to follow-up between the treatment and control/
placebo arm
DiffChange_SD SD of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
DiffChange_SE SE of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
DiffChange_LowerCI Lower CI of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
DiffChange_UpperCI Upper CI of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
DiffChange_P p-value of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
DiffChange_PES Effect size of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
continued DOI: 10.3310/hta22600 HEALTH TECHNOLOGY ASSESSMENT 2018 VOL. 22 NO. 60
© Queen’s Printer and Controller of HMSO 2018. This work was produced by Beresford et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
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TABLE 30 Data extraction variables for study results (Microsoft Excel®2010, Microsoft Corporation, Redmond, WA, USA) (continued )
Variable Description
AdjustedDiff_Mean Adjusted difference in mean change from baseline to follow-up between the treatment and control/placebo arm
AdjustedDiff_SD Adjusted SD of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
AdjustedDiff_SE Adjusted SE of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
AdjustedDiff_LowerCI Adjusted lower CI of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
AdjustedDiff_UpperCI Adjusted upper CI of the difference in mean change from baseline to follow-up between the treatment and control/placebo arm
AdjustedDiff_P p-value of the adjusted difference in mean change from baseline to follow-up between the treatment and control/placebo arm
Notes Any additional notes of relevance
ANOVA, analysis of variance.
Note
Each variable was listed as the column heading in a spreadsheet, with data for each study extracted on each row underneath. One spreadsheet was used for each outcome reported.
APPENDIX 3
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