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1. Collagenase injection versus limited fasciectomy surgery to treat Dupuytren's contracture in adult patients in the UK: DISC, a non-inferiority RCT and economic evaluation.

Author

Dias, Joseph, Tharmanathan, Puvan, Arundel, Catherine, Welch, Charlie, Wu, Qi, Leighton, Paul, Armaou, Maria, Corbacho, Belen, Johnson, Nick, James, Sophie, Cooke, John, Bainbridge, Christopher, Craigen, Michael, Warwick, David, Brady, Samantha, Flett, Lydia, Jones, Judy, Knowlson, Catherine, Watson, Michelle, and Keding, Ada

Published
2024
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4. Dupuytren’s interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial

Author

Dias, Joseph, Arundel, Catherine, Tharmanathan, Puvan, Keding, Ada, Welch, Charlie, Corbacho, Belen, Armaou, Maria, Leighton, Paul, Bainbridge, Christopher, Craigen, Michael, Flett, Lydia, Gascoyne, Samantha, Hewitt, Catherine, James, Elaine, James, Sophie, Johnson, Nick, Jones, Judy, Knowlson, Catherine, Radia, Priya, Torgerson, David, Warwick, David, and Watson, Michelle

Published
2021
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10. 174 The EXTEND Trial: EXTENDed Antibiotics to Improve Outcomes in Patients with Complicated Intra-Abdominal Infection

Author

O'Connor, Olivia, primary, Kirby, Andrew, additional, Ahmed, Shadia, additional, Harmston, Rebecca, additional, Hewitt, Catherine, additional, Knowlson, Catherine, additional, Pinkney, Thomas, additional, Szakmany, Tamas, additional, Tharmanathan, Puvan, additional, Vargas-Palacios, Armando, additional, Welch, Charlie, additional, and Burke, Dermot, additional

Published
2022
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12. Can learnings from the COVID-19 pandemic improve trial conduct post-pandemic? A case study of strategies used by the DISC trial

Author

Knowlson, Catherine, Tharmanathan, Puvan, Arundel, Catherine, James, Sophie, Flett, Lydia, Gascoyne, Samantha, Welch, Charlie, Warwick, David, and Dias, Joseph

Abstract

Background RCTs often face issues such as slow recruitment, poor intervention adherence and high attrition, however the 2020/2021 COVID-19 pandemic intensified these challenges. Strategies employed by the DISC trial to overcome pandemic-related barriers to recruitment, treatment delivery and retention may be useful to help overcome routine problems.Methods A structured survey and teleconference with sites was undertaken. Key performance indicators in relation to recruitment, treatment delivery and retention were compared descriptively before and after the pandemic started. This was situated also in relation to qualitative opinions of research staff.Results Prior to the pandemic, retention was 93.6%. Increased support from the central trial management team and remote data collection methods kept retention rates high at 81.2% in the first 6 months of the pandemic, rising to 89.8% in the subsequent 6 months. Advertising the study to patients resulted in 12.8 patients/month enquiring about participation, however only six were referred to recruiting sites. Sites reported increased support from junior doctors resolved research nurse capacity issues. One site avoided long delays by using theatre space in a private hospital.Conclusions Recruitment post-pandemic could be improved by identification of barriers, increased support from junior doctors through the NIHR associate PI scheme and advertising. Remote back-up options for data collection can keep retention high while reducing patient and site burden. To future proof studies against similar disruptions and provide more flexibility for participants, we recommend that RCTs have a back-up option of remote recruitment, a back-up location for surgeries and flexible approaches to collecting data.

Published
2023
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13. Additional file 1 of Dupuytren’s interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial

Author

Dias, Joseph, Arundel, Catherine, Tharmanathan, Puvan, Keding, Ada, Welch, Charlie, Corbacho, Belen, Armaou, Maria, Leighton, Paul, Bainbridge, Christopher, Craigen, Michael, Flett, Lydia, Gascoyne, Samantha, Hewitt, Catherine, James, Elaine, James, Sophie, Johnson, Nick, Jones, Judy, Knowlson, Catherine, Radia, Priya, Torgerson, David, Warwick, David, and Watson, Michelle

Abstract

Additional File 1. DISC Trial Participating Sites.

Published
2021
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15. Supplementary_Figures_and_Tablesv2 – Supplemental material for Pin1 plays a key role in the response to treatment and clinical outcome in triple negative breast cancer

Author

Knowlson, Catherine, Haddock, Paula, Bingham, Victoria, McQuaid, Stephen, Mullan, Paul B., and Buckley, Niamh E.

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, Supplementary_Figures_and_Tablesv2 for Pin1 plays a key role in the response to treatment and clinical outcome in triple negative breast cancer by Catherine Knowlson, Paula Haddock, Victoria Bingham, Stephen McQuaid, Paul B. Mullan and Niamh E. Buckley in Therapeutic Advances in Medical Oncology

Published
2020
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19. Collagenase Injection versus Limited Fasciectomy for Dupuytren's Contracture.

Author

Dias, Joseph, Tharmanathan, Puvanendran, Arundel, Catherine, Welch, Charlie, Qi Wu, Leighton, Paul, Armaou, Maria, Johnson, Nick, James, Sophie, Cooke, John, Bainbridge, Lionel, Craigen, Michael, Warwick, David, Brady, Samantha, Flett, Lydia G., Jones, Judy, Knowlson, Catherine N., Watson, Michelle, Keding, Ada, and Hewitt, Catherine E.

Subjects
*COLLAGENASES, *THERAPEUTIC complications, *CONFIDENCE intervals
Abstract

BACKGROUND Treatments for Dupuytren's contracture include limited fasciectomy and collagenase injection. Comparisons of the effectiveness of these treatments have been limited. METHODS We performed an unblinded, multicenter, pragmatic, two-group, randomized, controlled noninferiority trial comparing collagenase injection with limited fasciectomy in persons with moderate Dupuytren's contracture. The primary outcome was the score on the Patient Evaluation Measure-Hand Health Profile (PEM), questionnaire for assessing hand health as reported by the patient, at 1 year after treatment. Scores on the PEI\4 range from 0 to 100, with higher scores indicating worse outcomes. The prespecified noninferiority margin was 6 points. RESULTS A total of 672 persons (336 per group) were assigned to receive collagenase injection or to undergo limited fasciectomy. The primary analysis included 599 persons: 314 in the collagenase group and 285 in the limited-fasciectomy group. The mean score on the PEM at lyear was 17.8 among the 284 patients with available data the collagenase group and 11.9 among the 250 patients with available data in the limited-fasciectomy group (estimated difference, 5.9 points; 95°/o confidence interval ICI], 3.l to 8.8; one-sided P=0.49 for noninferiority). Among the patients with available data (229 patients in the collagenase group and 197 patients in the limited-fasciectomy group), the estimated difference in the mean score on the PEM at 2 years was 7. 2 points (95% CI, 4.2 to 10.9). Moderate or severe complications of treatment occurred in 1.8% of the patients in the collagenase group and in 5.1° of those in the limited-fasciectomy group; recurrent contracture resulted in reintervention in 14.6% and 3.4%, respectively. CONCLUSIONS Collagenase injection was not noninferior to limited fasciectomy with respect the score on the PEM at 1 year after treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Effects of rapid recruitment and dissemination on Covid-19 mortality: the RECOVERY trial

Author

Knowlson, Catherine Nicolle and Torgerson, David John

Abstract

The RECOVERY trial is a large multi-armed, adaptive randomised controlled trial of treatments for Covid-19. It has rapidly recruited and demonstrated that hydroxychloroquine is ineffective in reducing mortality for hospitalised patients, whilst dexamethasone significantly reduces mortality among those patients using supplemental oxygen or on a ventilator. We estimate that the speed of recruitment and dissemination has probably decreased mortality in the UK by at least 200 hospitalised patients in the first month since the British Prime Minister announced the results. Despite its impressive speed, the trial only recruited about 15% of eligible patients, with recruitment rates ranging between 3% to 80% at participating hospitals. Had the trial recruited 50% of the eligible patients then our analysis suggests that more than 2,000 additional lives could have been saved. In a pandemic, rapid recruitment with high centre recruitment is absolutely essential to reduce deaths. Methods of improving site specific recruitment rates need investigating urgently. Key Words: Covid-19; RECOVERY trial; recruitment.

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