A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan
Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Lawson, Andrew [verfasserIn] Naylor, Justine [verfasserIn] Buchbinder, Rachelle [verfasserIn] Ivers, Rebecca [verfasserIn] Balogh, Zsolt [verfasserIn] Smith, Paul [verfasserIn] Mittal, Rajat [verfasserIn] Xuan, Wei [verfasserIn] Howard, Kirsten [verfasserIn] Vafa, Arezoo [verfasserIn] Yates, Piers [verfasserIn] Rieger, Bertram [verfasserIn] Smith, Geoff [verfasserIn] Elkinson, Ilia [verfasserIn] Kim, Woosung [verfasserIn] Sungaran, Jai [verfasserIn] Latendresse, Kim [verfasserIn] Wong, James [verfasserIn] Viswanathan, Sameer [verfasserIn] Landale, Keith [verfasserIn] Drobetz, Herwig [verfasserIn] Tran, Phong [verfasserIn] Page, Richard [verfasserIn] Hau, Raphael [verfasserIn] Mulford, Jonathan [verfasserIn] Incoll, Ian [verfasserIn] Kale, Michael [verfasserIn] Schick, Bernard [verfasserIn] Higgs, Andrew [verfasserIn] Oppy, Andrew [verfasserIn] Perriman, Diana [verfasserIn] Harris, Ian [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 21(2020), 1 vom: 15. Juli |
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| Übergeordnetes Werk: |
volume:21 ; year:2020 ; number:1 ; day:15 ; month:07 |
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| DOI / URN: |
10.1186/s13063-020-4228-0 |
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| Katalog-ID: |
SPR040351637 |
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| 245 | 1 | 2 | |a A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan |
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| 520 | |a Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. | ||
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| 650 | 4 | |a Fracture fixation |7 (dpeaa)DE-He213 | |
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| 650 | 4 | |a Radius fractures |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Randomised controlled trial |7 (dpeaa)DE-He213 | |
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| 700 | 1 | |a Naylor, Justine |e verfasserin |4 aut | |
| 700 | 1 | |a Buchbinder, Rachelle |e verfasserin |4 aut | |
| 700 | 1 | |a Ivers, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Balogh, Zsolt |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Paul |e verfasserin |4 aut | |
| 700 | 1 | |a Mittal, Rajat |e verfasserin |4 aut | |
| 700 | 1 | |a Xuan, Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Howard, Kirsten |e verfasserin |4 aut | |
| 700 | 1 | |a Vafa, Arezoo |e verfasserin |4 aut | |
| 700 | 1 | |a Yates, Piers |e verfasserin |4 aut | |
| 700 | 1 | |a Rieger, Bertram |e verfasserin |4 aut | |
| 700 | 1 | |a Smith, Geoff |e verfasserin |4 aut | |
| 700 | 1 | |a Elkinson, Ilia |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Woosung |e verfasserin |4 aut | |
| 700 | 1 | |a Sungaran, Jai |e verfasserin |4 aut | |
| 700 | 1 | |a Latendresse, Kim |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, James |e verfasserin |4 aut | |
| 700 | 1 | |a Viswanathan, Sameer |e verfasserin |4 aut | |
| 700 | 1 | |a Landale, Keith |e verfasserin |4 aut | |
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| 700 | 1 | |a Kale, Michael |e verfasserin |4 aut | |
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| 700 | 1 | |a Higgs, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Oppy, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Perriman, Diana |e verfasserin |4 aut | |
| 700 | 1 | |a Harris, Ian |e verfasserin |4 aut | |
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10.1186/s13063-020-4228-0 doi (DE-627)SPR040351637 (SPR)s13063-020-4228-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Lawson, Andrew verfasserin aut A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. Aged (dpeaa)DE-He213 Fracture fixation (dpeaa)DE-He213 Plaster casts (dpeaa)DE-He213 Radius fractures (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Recovery of function (dpeaa)DE-He213 Statistical analysis plan (dpeaa)DE-He213 Naylor, Justine verfasserin aut Buchbinder, Rachelle verfasserin aut Ivers, Rebecca verfasserin aut Balogh, Zsolt verfasserin aut Smith, Paul verfasserin aut Mittal, Rajat verfasserin aut Xuan, Wei verfasserin aut Howard, Kirsten verfasserin aut Vafa, Arezoo verfasserin aut Yates, Piers verfasserin aut Rieger, Bertram verfasserin aut Smith, Geoff verfasserin aut Elkinson, Ilia verfasserin aut Kim, Woosung verfasserin aut Sungaran, Jai verfasserin aut Latendresse, Kim verfasserin aut Wong, James verfasserin aut Viswanathan, Sameer verfasserin aut Landale, Keith verfasserin aut Drobetz, Herwig verfasserin aut Tran, Phong verfasserin aut Page, Richard verfasserin aut Hau, Raphael verfasserin aut Mulford, Jonathan verfasserin aut Incoll, Ian verfasserin aut Kale, Michael verfasserin aut Schick, Bernard verfasserin aut Higgs, Andrew verfasserin aut Oppy, Andrew verfasserin aut Perriman, Diana verfasserin aut Harris, Ian verfasserin aut Enthalten in Trials London : BioMed Central, 2000 21(2020), 1 vom: 15. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:21 year:2020 number:1 day:15 month:07 https://dx.doi.org/10.1186/s13063-020-4228-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 15 07 |
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10.1186/s13063-020-4228-0 doi (DE-627)SPR040351637 (SPR)s13063-020-4228-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Lawson, Andrew verfasserin aut A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. Aged (dpeaa)DE-He213 Fracture fixation (dpeaa)DE-He213 Plaster casts (dpeaa)DE-He213 Radius fractures (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Recovery of function (dpeaa)DE-He213 Statistical analysis plan (dpeaa)DE-He213 Naylor, Justine verfasserin aut Buchbinder, Rachelle verfasserin aut Ivers, Rebecca verfasserin aut Balogh, Zsolt verfasserin aut Smith, Paul verfasserin aut Mittal, Rajat verfasserin aut Xuan, Wei verfasserin aut Howard, Kirsten verfasserin aut Vafa, Arezoo verfasserin aut Yates, Piers verfasserin aut Rieger, Bertram verfasserin aut Smith, Geoff verfasserin aut Elkinson, Ilia verfasserin aut Kim, Woosung verfasserin aut Sungaran, Jai verfasserin aut Latendresse, Kim verfasserin aut Wong, James verfasserin aut Viswanathan, Sameer verfasserin aut Landale, Keith verfasserin aut Drobetz, Herwig verfasserin aut Tran, Phong verfasserin aut Page, Richard verfasserin aut Hau, Raphael verfasserin aut Mulford, Jonathan verfasserin aut Incoll, Ian verfasserin aut Kale, Michael verfasserin aut Schick, Bernard verfasserin aut Higgs, Andrew verfasserin aut Oppy, Andrew verfasserin aut Perriman, Diana verfasserin aut Harris, Ian verfasserin aut Enthalten in Trials London : BioMed Central, 2000 21(2020), 1 vom: 15. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:21 year:2020 number:1 day:15 month:07 https://dx.doi.org/10.1186/s13063-020-4228-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 15 07 |
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10.1186/s13063-020-4228-0 doi (DE-627)SPR040351637 (SPR)s13063-020-4228-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Lawson, Andrew verfasserin aut A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. Aged (dpeaa)DE-He213 Fracture fixation (dpeaa)DE-He213 Plaster casts (dpeaa)DE-He213 Radius fractures (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Recovery of function (dpeaa)DE-He213 Statistical analysis plan (dpeaa)DE-He213 Naylor, Justine verfasserin aut Buchbinder, Rachelle verfasserin aut Ivers, Rebecca verfasserin aut Balogh, Zsolt verfasserin aut Smith, Paul verfasserin aut Mittal, Rajat verfasserin aut Xuan, Wei verfasserin aut Howard, Kirsten verfasserin aut Vafa, Arezoo verfasserin aut Yates, Piers verfasserin aut Rieger, Bertram verfasserin aut Smith, Geoff verfasserin aut Elkinson, Ilia verfasserin aut Kim, Woosung verfasserin aut Sungaran, Jai verfasserin aut Latendresse, Kim verfasserin aut Wong, James verfasserin aut Viswanathan, Sameer verfasserin aut Landale, Keith verfasserin aut Drobetz, Herwig verfasserin aut Tran, Phong verfasserin aut Page, Richard verfasserin aut Hau, Raphael verfasserin aut Mulford, Jonathan verfasserin aut Incoll, Ian verfasserin aut Kale, Michael verfasserin aut Schick, Bernard verfasserin aut Higgs, Andrew verfasserin aut Oppy, Andrew verfasserin aut Perriman, Diana verfasserin aut Harris, Ian verfasserin aut Enthalten in Trials London : BioMed Central, 2000 21(2020), 1 vom: 15. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:21 year:2020 number:1 day:15 month:07 https://dx.doi.org/10.1186/s13063-020-4228-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 15 07 |
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10.1186/s13063-020-4228-0 doi (DE-627)SPR040351637 (SPR)s13063-020-4228-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Lawson, Andrew verfasserin aut A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. Aged (dpeaa)DE-He213 Fracture fixation (dpeaa)DE-He213 Plaster casts (dpeaa)DE-He213 Radius fractures (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Recovery of function (dpeaa)DE-He213 Statistical analysis plan (dpeaa)DE-He213 Naylor, Justine verfasserin aut Buchbinder, Rachelle verfasserin aut Ivers, Rebecca verfasserin aut Balogh, Zsolt verfasserin aut Smith, Paul verfasserin aut Mittal, Rajat verfasserin aut Xuan, Wei verfasserin aut Howard, Kirsten verfasserin aut Vafa, Arezoo verfasserin aut Yates, Piers verfasserin aut Rieger, Bertram verfasserin aut Smith, Geoff verfasserin aut Elkinson, Ilia verfasserin aut Kim, Woosung verfasserin aut Sungaran, Jai verfasserin aut Latendresse, Kim verfasserin aut Wong, James verfasserin aut Viswanathan, Sameer verfasserin aut Landale, Keith verfasserin aut Drobetz, Herwig verfasserin aut Tran, Phong verfasserin aut Page, Richard verfasserin aut Hau, Raphael verfasserin aut Mulford, Jonathan verfasserin aut Incoll, Ian verfasserin aut Kale, Michael verfasserin aut Schick, Bernard verfasserin aut Higgs, Andrew verfasserin aut Oppy, Andrew verfasserin aut Perriman, Diana verfasserin aut Harris, Ian verfasserin aut Enthalten in Trials London : BioMed Central, 2000 21(2020), 1 vom: 15. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:21 year:2020 number:1 day:15 month:07 https://dx.doi.org/10.1186/s13063-020-4228-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 15 07 |
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10.1186/s13063-020-4228-0 doi (DE-627)SPR040351637 (SPR)s13063-020-4228-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Lawson, Andrew verfasserin aut A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. Aged (dpeaa)DE-He213 Fracture fixation (dpeaa)DE-He213 Plaster casts (dpeaa)DE-He213 Radius fractures (dpeaa)DE-He213 Randomised controlled trial (dpeaa)DE-He213 Recovery of function (dpeaa)DE-He213 Statistical analysis plan (dpeaa)DE-He213 Naylor, Justine verfasserin aut Buchbinder, Rachelle verfasserin aut Ivers, Rebecca verfasserin aut Balogh, Zsolt verfasserin aut Smith, Paul verfasserin aut Mittal, Rajat verfasserin aut Xuan, Wei verfasserin aut Howard, Kirsten verfasserin aut Vafa, Arezoo verfasserin aut Yates, Piers verfasserin aut Rieger, Bertram verfasserin aut Smith, Geoff verfasserin aut Elkinson, Ilia verfasserin aut Kim, Woosung verfasserin aut Sungaran, Jai verfasserin aut Latendresse, Kim verfasserin aut Wong, James verfasserin aut Viswanathan, Sameer verfasserin aut Landale, Keith verfasserin aut Drobetz, Herwig verfasserin aut Tran, Phong verfasserin aut Page, Richard verfasserin aut Hau, Raphael verfasserin aut Mulford, Jonathan verfasserin aut Incoll, Ian verfasserin aut Kale, Michael verfasserin aut Schick, Bernard verfasserin aut Higgs, Andrew verfasserin aut Oppy, Andrew verfasserin aut Perriman, Diana verfasserin aut Harris, Ian verfasserin aut Enthalten in Trials London : BioMed Central, 2000 21(2020), 1 vom: 15. Juli (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:21 year:2020 number:1 day:15 month:07 https://dx.doi.org/10.1186/s13063-020-4228-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 15 07 |
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Enthalten in Trials 21(2020), 1 vom: 15. Juli volume:21 year:2020 number:1 day:15 month:07 |
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Aged Fracture fixation Plaster casts Radius fractures Randomised controlled trial Recovery of function Statistical analysis plan |
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Lawson, Andrew @@aut@@ Naylor, Justine @@aut@@ Buchbinder, Rachelle @@aut@@ Ivers, Rebecca @@aut@@ Balogh, Zsolt @@aut@@ Smith, Paul @@aut@@ Mittal, Rajat @@aut@@ Xuan, Wei @@aut@@ Howard, Kirsten @@aut@@ Vafa, Arezoo @@aut@@ Yates, Piers @@aut@@ Rieger, Bertram @@aut@@ Smith, Geoff @@aut@@ Elkinson, Ilia @@aut@@ Kim, Woosung @@aut@@ Sungaran, Jai @@aut@@ Latendresse, Kim @@aut@@ Wong, James @@aut@@ Viswanathan, Sameer @@aut@@ Landale, Keith @@aut@@ Drobetz, Herwig @@aut@@ Tran, Phong @@aut@@ Page, Richard @@aut@@ Hau, Raphael @@aut@@ Mulford, Jonathan @@aut@@ Incoll, Ian @@aut@@ Kale, Michael @@aut@@ Schick, Bernard @@aut@@ Higgs, Andrew @@aut@@ Oppy, Andrew @@aut@@ Perriman, Diana @@aut@@ Harris, Ian @@aut@@ |
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Lawson, Andrew Naylor, Justine Buchbinder, Rachelle Ivers, Rebecca Balogh, Zsolt Smith, Paul Mittal, Rajat Xuan, Wei Howard, Kirsten Vafa, Arezoo Yates, Piers Rieger, Bertram Smith, Geoff Elkinson, Ilia Kim, Woosung Sungaran, Jai Latendresse, Kim Wong, James Viswanathan, Sameer Landale, Keith Drobetz, Herwig Tran, Phong Page, Richard Hau, Raphael Mulford, Jonathan Incoll, Ian Kale, Michael Schick, Bernard Higgs, Andrew Oppy, Andrew Perriman, Diana Harris, Ian |
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combined randomised and observational study of surgery for fractures in the distal radius in the elderly (crossfire): a statistical analysis plan |
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A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan |
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Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. |
| abstractGer |
Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. |
| abstract_unstemmed |
Background We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. |
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This paper describes the statistical analysis plan. Methods/design A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance. Discussion This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients. Trial registration CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460). This manuscript is based on v.11 of the statistical analysis plan. 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