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3. Additional file 1 of Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project

Author

Crowley, Evelyn, Treweek, Shaun, Banister, Katie, Breeman, Suzanne, Constable, Lynda, Seonaidh Cotton, Duncan, Anne, Feky, Adel El, Gardner, Heidi, Kirsteen Goodman, Lanz, Doris, McDonald, Alison, Ogburn, Emma, Starr, Kath, Stevens, Natasha, Valente, Marie, and Fernie, Gordon

Subjects
GeneralLiterature_INTRODUCTORYANDSURVEY
Abstract

Additional file 1. Standard operating procedure for categorising data collected in trials

Published
2020
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4. Additional file 1: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Consent form. (DOCX 167Â kb)

Published
2018
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5. Additional file 2: of Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Author

Constable, Lynda, Cotterill, Nikki, Cooper, David, Glazener, Cathryn, Drake, Marcus, Forrest, Mark, Harding, Chris, Kilonzo, Mary, MacLennan, Graeme, McCormack, Kirsty, McDonald, Alison, Mundy, Anthony, Norrie, John, Pickard, Robert, Ramsay, Craig, Smith, Rebecca, Wileman, Samantha, and Abrams, Paul

Abstract

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (PDF 57 kb)

Published
2018
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6. Additional file 2: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Authorship publication. (DOCX 12Â kb)

Published
2018
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7. Additional file 3: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Authorship policy. (DOCX 15Â kb)

Published
2018
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8. Additional file 1: of Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Author

Constable, Lynda, Cotterill, Nikki, Cooper, David, Glazener, Cathryn, Drake, Marcus, Forrest, Mark, Harding, Chris, Kilonzo, Mary, MacLennan, Graeme, McCormack, Kirsty, McDonald, Alison, Mundy, Anthony, Norrie, John, Pickard, Robert, Ramsay, Craig, Smith, Rebecca, Wileman, Samantha, and Abrams, Paul

Subjects
body regions, nervous system, digestive, oral, and skin physiology, fungi, digestive system
Abstract

Male synthetic sling versus artificial urinary sphincter trial. (PDF 540 kb)

Published
2018
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9. Additional file 4: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

A completed SPIRIT checklist. (PDF 114Â kb)

Published
2018
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10. Additional file 2: of Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Author

Glazener, Cathryn, Constable, Lynda, Hemming, Christine, Breeman, Suzanne, Elders, Andrew, Cooper, Kevin, Freeman, Robert, Smith, Anthony, Hagen, Suzanne, McDonald, Alison, McPherson, Gladys, Montgomery, Isobel, Kilonzo, Mary, Boyers, Dwayne, Goulao, Beatriz, and Norrie, John

Abstract

Protocol for long-term follow-up. (PDF 30 kb)

Published
2016
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11. Additional file 3: of Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Author

Glazener, Cathryn, Constable, Lynda, Hemming, Christine, Breeman, Suzanne, Elders, Andrew, Cooper, Kevin, Freeman, Robert, Smith, Anthony, Hagen, Suzanne, McDonald, Alison, McPherson, Gladys, Montgomery, Isobel, Kilonzo, Mary, Boyers, Dwayne, Goulao, Beatriz, and Norrie, John

Abstract

Publication policy. (PDF 22 kb)

Published
2016
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12. Additional file 1: of Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Author

Glazener, Cathryn, Constable, Lynda, Hemming, Christine, Breeman, Suzanne, Elders, Andrew, Cooper, Kevin, Freeman, Robert, Smith, Anthony, Hagen, Suzanne, McDonald, Alison, McPherson, Gladys, Montgomery, Isobel, Kilonzo, Mary, Boyers, Dwayne, Goulao, Beatriz, and Norrie, John

Abstract

Further background information. (PDF 61 kb)

Published
2016
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13. Additional file 4: of Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Author

Glazener, Cathryn, Constable, Lynda, Hemming, Christine, Breeman, Suzanne, Elders, Andrew, Cooper, Kevin, Freeman, Robert, Smith, Anthony, Hagen, Suzanne, McDonald, Alison, McPherson, Gladys, Montgomery, Isobel, Kilonzo, Mary, Boyers, Dwayne, Goulao, Beatriz, and Norrie, John

Abstract

SPIRIT checklist. (PDF 56 kb)

Published
2016
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15. Internal Limiting Membrane Peeling versus No Peeling for Idiopathic Full-Thickness Macular Hole: A Pragmatic Randomized Controlled Trial

Author

Lois, Noemi, Burr, Jennifer Margaret, Norrie, John, Vale, Luke, Cook, Jonathan, McDonald, Alison, Boachie, Charles, Ternent, Laura, McPherson, Gladys, Full-Thickness Macular Hole, and University of St Andrews. School of Medicine

Subjects
Male, medicine.medical_specialty, genetic structures, Cost-Benefit Analysis, medicine.medical_treatment, Visual Acuity, Vitrectomy, Vitreoretinal Surgery, RE Ophthalmology, law.invention, Contrast Sensitivity, Cost of Illness, Randomized controlled trial, law, Ophthalmology, medicine, Full-thickness macular hole, Humans, Fluorescein Angiography, Aged, Fluorocarbons, Phacoemulsification, business.industry, Internal limiting membrane, Epiretinal Membrane, Stage-2, Odds ratio, Retinal Perforations, eye diseases, Confidence interval, Surgery, Clinical trial, body regions, Health Resources, Female, RE, Quality-Adjusted Life Years, sense organs, Tamponade, business, Removal, Tomography, Optical Coherence, Follow-Up Studies
Abstract

PURPOSE. To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH). METHODS. This was a pragmatic multicenter randomized controlled trial. Eligible participants front nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs. RESULTS. Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (Mean difference, 4.8; 95% confidence interval [CI], -0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64-14.73; P < 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05-0.34; P < 0.001). Peeling the ILM is likely to be cost effective. CONCLUSION. There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.) (Invest Ophthalmol Vis Sci 201152: 1586-1592) DOI:10.1167/iovs.10-6287 Postprint

Published
2011

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