Survival analysis for time to publication from completion of RCTs, using the Kaplan–Meier method and Cox proportional hazards models
| Characteristic . | Unadjusted HR (95% CI) . | Unadjusted P-value . | Adjusted HR (95% CI) . | Adjusted P-value . |
|---|---|---|---|---|
| Study outcome | ||||
| Negative | 1 (reference) | 0.006 | 1 (reference) | |
| Positive | 1.56 (1.12, 2.16) | 1.55 (1.09, 2.22) | <0.05 | |
| Registration before study start | ||||
| No | 1 (reference) | 0.6 | ||
| Yes | 1.09 (0.79, 1.51) | |||
| Registration before study completion | ||||
| No | 1 (reference) | 0.04 | 1 (reference) | |
| Yes | 1.74 (0.99, 3.09) | 1.67 (0.89, 3.13) | 0.11 | |
| Year of study completion | ||||
| Before 2005 | 1 (reference) | 0.5 | ||
| 2005–2009 | 0.99 (0.45, 2.17) | |||
| 2010–2014 | 0.94 (0.45, 1.98) | |||
| 2015–2018 | 1.21 (0.58, 2.53) | |||
| Study sponsor | ||||
| Industry | 1 (reference) | 0.8 | ||
| Non-industry | 0.96 (0.68, 1.35) | |||
| Primary disease state | ||||
| Lupus | 1 (reference) | 0.3 | ||
| Spondyloarthritis | 1.43 (0.94, 2.18) | |||
| Sjögren's syndrome | 0.93 (0.47, 1.85) | |||
| Vasculitis | 1.33 (0.83, 2.13) | |||
| Psoriatic arthritis | 1.41 (0.93, 2.15) | |||
| Experimental interventional agent | ||||
| b/tsDMARDs | 1 (reference) | 0.4 | ||
| csDMARDS | 0.65 (0.35, 1.21) | |||
| NSAIDs | 0.77 (0.19, 3.14) | |||
| Corticosteroids | 0.79 (0.29, 2.14) | |||
| PDE inhibitors | 0.69 (0.36, 1.32) | |||
| Other | 0.65 (0.38, 1.09) | |||
| Non-pharmacological | 0.57 (0.18, 1.80) | |||
| Comparator effectiveness | ||||
| Yes | 1 (reference) | 0.8 | ||
| No | 1.09 (0.65, 1.85) | |||
| Phase | ||||
| II | 1 (reference) | 0.1 | 1 (reference) | |
| II–III | 0.75 (0.37, 1.52) | 0.85 (0.40, 1.82) | 0.68 | |
| III | 1.28 (0.93, 1.77) | 1.12 (0.80, 1.58) | 0.50 | |
| Masking | ||||
| Double blind | 1 (reference) | 0.3 | ||
| Open label/blinded assessor | 0.70 (0.44, 1.12) | |||
| Single blind | 0.67 (0.16, 2.71) | |||
| Results posted on ClinicalTrials.gov | ||||
| No results posted | 1 (reference) | 0.04 | 1 (reference) | |
| Posted | 1.54 (1.10, 2.16) | 1.22 (0.83, 1.79) | 0.32 | |
| Submitted without posting | 1.19 (0.47, 2.98) | 1.20 (0.47, 3.04) | 0.71 |
| Characteristic . | Unadjusted HR (95% CI) . | Unadjusted P-value . | Adjusted HR (95% CI) . | Adjusted P-value . |
|---|---|---|---|---|
| Study outcome | ||||
| Negative | 1 (reference) | 0.006 | 1 (reference) | |
| Positive | 1.56 (1.12, 2.16) | 1.55 (1.09, 2.22) | <0.05 | |
| Registration before study start | ||||
| No | 1 (reference) | 0.6 | ||
| Yes | 1.09 (0.79, 1.51) | |||
| Registration before study completion | ||||
| No | 1 (reference) | 0.04 | 1 (reference) | |
| Yes | 1.74 (0.99, 3.09) | 1.67 (0.89, 3.13) | 0.11 | |
| Year of study completion | ||||
| Before 2005 | 1 (reference) | 0.5 | ||
| 2005–2009 | 0.99 (0.45, 2.17) | |||
| 2010–2014 | 0.94 (0.45, 1.98) | |||
| 2015–2018 | 1.21 (0.58, 2.53) | |||
| Study sponsor | ||||
| Industry | 1 (reference) | 0.8 | ||
| Non-industry | 0.96 (0.68, 1.35) | |||
| Primary disease state | ||||
| Lupus | 1 (reference) | 0.3 | ||
| Spondyloarthritis | 1.43 (0.94, 2.18) | |||
| Sjögren's syndrome | 0.93 (0.47, 1.85) | |||
| Vasculitis | 1.33 (0.83, 2.13) | |||
| Psoriatic arthritis | 1.41 (0.93, 2.15) | |||
| Experimental interventional agent | ||||
| b/tsDMARDs | 1 (reference) | 0.4 | ||
| csDMARDS | 0.65 (0.35, 1.21) | |||
| NSAIDs | 0.77 (0.19, 3.14) | |||
| Corticosteroids | 0.79 (0.29, 2.14) | |||
| PDE inhibitors | 0.69 (0.36, 1.32) | |||
| Other | 0.65 (0.38, 1.09) | |||
| Non-pharmacological | 0.57 (0.18, 1.80) | |||
| Comparator effectiveness | ||||
| Yes | 1 (reference) | 0.8 | ||
| No | 1.09 (0.65, 1.85) | |||
| Phase | ||||
| II | 1 (reference) | 0.1 | 1 (reference) | |
| II–III | 0.75 (0.37, 1.52) | 0.85 (0.40, 1.82) | 0.68 | |
| III | 1.28 (0.93, 1.77) | 1.12 (0.80, 1.58) | 0.50 | |
| Masking | ||||
| Double blind | 1 (reference) | 0.3 | ||
| Open label/blinded assessor | 0.70 (0.44, 1.12) | |||
| Single blind | 0.67 (0.16, 2.71) | |||
| Results posted on ClinicalTrials.gov | ||||
| No results posted | 1 (reference) | 0.04 | 1 (reference) | |
| Posted | 1.54 (1.10, 2.16) | 1.22 (0.83, 1.79) | 0.32 | |
| Submitted without posting | 1.19 (0.47, 2.98) | 1.20 (0.47, 3.04) | 0.71 |
b/tsDMARD: biologic or targeted synthetic DMARD; csDMARD: conventional synthetic DMARD; PDE: phosphodiesterase; RCT: randomized controlled trial.
Survival analysis for time to publication from completion of RCTs, using the Kaplan–Meier method and Cox proportional hazards models
| Characteristic . | Unadjusted HR (95% CI) . | Unadjusted P-value . | Adjusted HR (95% CI) . | Adjusted P-value . |
|---|---|---|---|---|
| Study outcome | ||||
| Negative | 1 (reference) | 0.006 | 1 (reference) | |
| Positive | 1.56 (1.12, 2.16) | 1.55 (1.09, 2.22) | <0.05 | |
| Registration before study start | ||||
| No | 1 (reference) | 0.6 | ||
| Yes | 1.09 (0.79, 1.51) | |||
| Registration before study completion | ||||
| No | 1 (reference) | 0.04 | 1 (reference) | |
| Yes | 1.74 (0.99, 3.09) | 1.67 (0.89, 3.13) | 0.11 | |
| Year of study completion | ||||
| Before 2005 | 1 (reference) | 0.5 | ||
| 2005–2009 | 0.99 (0.45, 2.17) | |||
| 2010–2014 | 0.94 (0.45, 1.98) | |||
| 2015–2018 | 1.21 (0.58, 2.53) | |||
| Study sponsor | ||||
| Industry | 1 (reference) | 0.8 | ||
| Non-industry | 0.96 (0.68, 1.35) | |||
| Primary disease state | ||||
| Lupus | 1 (reference) | 0.3 | ||
| Spondyloarthritis | 1.43 (0.94, 2.18) | |||
| Sjögren's syndrome | 0.93 (0.47, 1.85) | |||
| Vasculitis | 1.33 (0.83, 2.13) | |||
| Psoriatic arthritis | 1.41 (0.93, 2.15) | |||
| Experimental interventional agent | ||||
| b/tsDMARDs | 1 (reference) | 0.4 | ||
| csDMARDS | 0.65 (0.35, 1.21) | |||
| NSAIDs | 0.77 (0.19, 3.14) | |||
| Corticosteroids | 0.79 (0.29, 2.14) | |||
| PDE inhibitors | 0.69 (0.36, 1.32) | |||
| Other | 0.65 (0.38, 1.09) | |||
| Non-pharmacological | 0.57 (0.18, 1.80) | |||
| Comparator effectiveness | ||||
| Yes | 1 (reference) | 0.8 | ||
| No | 1.09 (0.65, 1.85) | |||
| Phase | ||||
| II | 1 (reference) | 0.1 | 1 (reference) | |
| II–III | 0.75 (0.37, 1.52) | 0.85 (0.40, 1.82) | 0.68 | |
| III | 1.28 (0.93, 1.77) | 1.12 (0.80, 1.58) | 0.50 | |
| Masking | ||||
| Double blind | 1 (reference) | 0.3 | ||
| Open label/blinded assessor | 0.70 (0.44, 1.12) | |||
| Single blind | 0.67 (0.16, 2.71) | |||
| Results posted on ClinicalTrials.gov | ||||
| No results posted | 1 (reference) | 0.04 | 1 (reference) | |
| Posted | 1.54 (1.10, 2.16) | 1.22 (0.83, 1.79) | 0.32 | |
| Submitted without posting | 1.19 (0.47, 2.98) | 1.20 (0.47, 3.04) | 0.71 |
| Characteristic . | Unadjusted HR (95% CI) . | Unadjusted P-value . | Adjusted HR (95% CI) . | Adjusted P-value . |
|---|---|---|---|---|
| Study outcome | ||||
| Negative | 1 (reference) | 0.006 | 1 (reference) | |
| Positive | 1.56 (1.12, 2.16) | 1.55 (1.09, 2.22) | <0.05 | |
| Registration before study start | ||||
| No | 1 (reference) | 0.6 | ||
| Yes | 1.09 (0.79, 1.51) | |||
| Registration before study completion | ||||
| No | 1 (reference) | 0.04 | 1 (reference) | |
| Yes | 1.74 (0.99, 3.09) | 1.67 (0.89, 3.13) | 0.11 | |
| Year of study completion | ||||
| Before 2005 | 1 (reference) | 0.5 | ||
| 2005–2009 | 0.99 (0.45, 2.17) | |||
| 2010–2014 | 0.94 (0.45, 1.98) | |||
| 2015–2018 | 1.21 (0.58, 2.53) | |||
| Study sponsor | ||||
| Industry | 1 (reference) | 0.8 | ||
| Non-industry | 0.96 (0.68, 1.35) | |||
| Primary disease state | ||||
| Lupus | 1 (reference) | 0.3 | ||
| Spondyloarthritis | 1.43 (0.94, 2.18) | |||
| Sjögren's syndrome | 0.93 (0.47, 1.85) | |||
| Vasculitis | 1.33 (0.83, 2.13) | |||
| Psoriatic arthritis | 1.41 (0.93, 2.15) | |||
| Experimental interventional agent | ||||
| b/tsDMARDs | 1 (reference) | 0.4 | ||
| csDMARDS | 0.65 (0.35, 1.21) | |||
| NSAIDs | 0.77 (0.19, 3.14) | |||
| Corticosteroids | 0.79 (0.29, 2.14) | |||
| PDE inhibitors | 0.69 (0.36, 1.32) | |||
| Other | 0.65 (0.38, 1.09) | |||
| Non-pharmacological | 0.57 (0.18, 1.80) | |||
| Comparator effectiveness | ||||
| Yes | 1 (reference) | 0.8 | ||
| No | 1.09 (0.65, 1.85) | |||
| Phase | ||||
| II | 1 (reference) | 0.1 | 1 (reference) | |
| II–III | 0.75 (0.37, 1.52) | 0.85 (0.40, 1.82) | 0.68 | |
| III | 1.28 (0.93, 1.77) | 1.12 (0.80, 1.58) | 0.50 | |
| Masking | ||||
| Double blind | 1 (reference) | 0.3 | ||
| Open label/blinded assessor | 0.70 (0.44, 1.12) | |||
| Single blind | 0.67 (0.16, 2.71) | |||
| Results posted on ClinicalTrials.gov | ||||
| No results posted | 1 (reference) | 0.04 | 1 (reference) | |
| Posted | 1.54 (1.10, 2.16) | 1.22 (0.83, 1.79) | 0.32 | |
| Submitted without posting | 1.19 (0.47, 2.98) | 1.20 (0.47, 3.04) | 0.71 |
b/tsDMARD: biologic or targeted synthetic DMARD; csDMARD: conventional synthetic DMARD; PDE: phosphodiesterase; RCT: randomized controlled trial.
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