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Article ; Online: Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study.

King, Anthony J / Hudson, Jemma / Azuara-Blanco, Augusto / Burr, Jennifer / Kernohan, Ashleigh / Homer, Tara / Shabaninejad, Hosein / Sparrow, John M / Garway-Heath, David / Barton, Keith / Norrie, John / Davidson, Tracey / Vale, Luke / MacLennan, Graeme

Ophthalmology

2024

Abstract: Purpose: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma.: Design: Multicenter randomized controlled ... ...

Abstract	Purpose: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. Design: Multicenter randomized controlled trial. Participants: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. Methods: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. Main outcome measures: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. Results: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare. Conclusions: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Language	English
Publishing date	2024-01-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	392083-5
ISSN	1549-4713 ; 0161-6420
ISSN (online)	1549-4713
ISSN	0161-6420
DOI	10.1016/j.ophtha.2024.01.007
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Article ; Online: Three-year cost utility analysis of mini versus standard slings: A trial based economic evaluation.

Kilonzo, Mary / Boyers, Dwayne / Cooper, David / Davidson, Tracey / Bhal, Kiron / N'Dow, James / MacLennan, Graeme / Norrie, John / Abdel-Fattah, Mohamed

BJUI compass

2023 Volume 5, Issue 2, Page(s) 230–239

Abstract: Objective: To report on the cost-effectiveness of adjustable anchored single-incision mini-slings (mini-slings) compared with tension-free standard mid-urethral slings (standard slings) in the surgical management of female stress urinary incontinence ( ... ...

Abstract	Objective: To report on the cost-effectiveness of adjustable anchored single-incision mini-slings (mini-slings) compared with tension-free standard mid-urethral slings (standard slings) in the surgical management of female stress urinary incontinence (SUI). Patients and methods: Data on resource use and quality were collected from women aged ≥18 years with predominant SUI undergoing mid-urethral sling procedures in 21 UK hospitals. Resource use and quality of life (QoL) data were prospectively collected alongside the Single-Incision Mini-Slings versus standard synthetic mid-urethral slings Randomised Control Trial (SIMS RCT), for surgical treatment of SUI in women. A health service provider's (National Health Service [NHS]) perspective with 3-year follow-up was adopted to estimate the costs of the intervention and all subsequent resource use. A generic instrument, EuroQol EQ-5D-3L, was used to estimate the QoL. Results are reported as incremental costs, quality adjusted life years (QALYs) and incremental cost per QALY. Results: Base case analysis results show that although mini-slings cost less, there was no significant difference in costs: mini-slings versus standard slings: £-6 [95% CI -228-208] or in QALYs: 0.005 [95% CI -0.068-0.073] over the 3-year follow-up. There is substantial uncertainty, with a 56% and 44% probability that mini-slings and standard slings are the most cost-effective treatment, respectively, at a £20 000 willingness-to-pay threshold value for a QALY. Conclusions: At 3 years, there is no significant difference between mini-slings and standard slings in costs and QALYs. There is still some uncertainty over the long-term complications and failure rates of the devices used in the treatment of SUI; therefore, it is important to establish the long-term clinical and cost-effectiveness of these procedures.
Language	English
Publishing date	2023-11-13
Publishing country	United States
Document type	Journal Article
ISSN	2688-4526
ISSN (online)	2688-4526
DOI	10.1002/bco2.303
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Article ; Online: Patient preferences for stress urinary incontinence treatments: a discrete choice experiment.

Boyers, Dwayne / Kilonzo, Mary / Davidson, Tracey / Cooper, David / Wardle, Judith / Bhal, Kiron / N'Dow, James / MacLennan, Graeme / Norrie, John / Abdel-Fattah, Mohamed

BMJ open

2023 Volume 13, Issue 8, Page(s) e066157

Abstract: Objectives: To elicit and value patient preferences for the processes and outcomes of surgical management of stress urinary incontinence in women.: Design: A discrete choice experiment survey to elicit preferences for type of anaesthesia, ... ...

Abstract	Objectives: To elicit and value patient preferences for the processes and outcomes of surgical management of stress urinary incontinence in women. Design: A discrete choice experiment survey to elicit preferences for type of anaesthesia, postoperative recovery time, treatment success, adverse events, impact on daily activities and cost. An experimental design generated 40 choice tasks, and each respondent completed 1 block of 10 and 2 validity tests. Analysis was by multinomial logistical regression. Setting: N=21 UK hospitals. Participants: N=325 adult women who were a subsample of those randomised to the single-incision mini-slings clinical trial. Outcomes: Patient preferences; valuation obtained using willingness to pay. Results: N=227 of 325 (70%) returned a questionnaire, and 94% of those completed all choice tasks. Respondents preferred general anaesthesia, shorter recovery times, improved stress urinary incontinence symptoms and avoidance of adverse events. Women were willing to pay (mean (95% CI)) £76 (£33 to £119) per day of reduction in recovery time following surgery. They valued increases in Patient Global Impression of Improvement, ranging from £8173 (£5459 to £10 887) for 'improved' to £11 706 (£8267 to £15 144) for 'very much improved' symptoms, compared with no symptom improvement. This was offset by negative values attached to the avoidance of complications ranging between £-8022 (£-10 661 to £-5383) and £-10 632 (£-14 077 to £-7187) compared to no complications. Women valued treatments that reduced the need to avoid daily activities, with willingness to pay ranging from £-967 (£-2199 to £266) for rarely avoiding activities to £-5338 (£-7258 to £-3417) for frequently avoiding daily activities compared with no avoidance. Conclusion: This discrete choice experiment demonstrates that patients place considerable value on improvement in stress urinary incontinence symptoms and avoidance of treatment complications. Trade-offs between symptom improvement and adverse event risk should be considered within shared decision-making. The willingness to pay values from this study can be used in future cost-benefit analyses. Trial registration number: ISRCTN: 93264234; Post-results.
MeSH term(s)	Adult ; Humans ; Female ; Patient Preference ; Urinary Incontinence, Stress/surgery ; Anesthesia, General ; Anesthesiology ; Cost-Benefit Analysis
Language	English
Publishing date	2023-08-29
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2022-066157
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Article ; Online: Single-Incision Mini-Slings for Stress Urinary Incontinence in Women.

Abdel-Fattah, Mohamed / Cooper, David / Davidson, Tracey / Kilonzo, Mary / Hossain, Md / Boyers, Dwayne / Bhal, Kiron / Wardle, Judith / N'Dow, James / MacLennan, Graeme / Norrie, John

The New England journal of medicine

2023 Volume 386, Issue 13, Page(s) 1230–1243

Abstract: Background: Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of ... ...

Abstract	Background: Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. Methods: We performed a pragmatic, noninferiority, randomized trial comparing mini-slings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. Results: A total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, -1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. Conclusions: Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up. (Funded by the National Institute for Health Research.).
MeSH term(s)	Dyspareunia/etiology ; Female ; Humans ; Patient Reported Outcome Measures ; Pragmatic Clinical Trials as Topic ; Prosthesis Implantation/adverse effects ; Prosthesis Implantation/methods ; Quality of Life ; Reoperation ; Suburethral Slings/adverse effects ; Surgical Mesh ; Treatment Outcome ; United Kingdom ; Urinary Incontinence, Stress/surgery
Language	English
Publishing date	2023-02-05
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2111815
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Article ; Online: Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT.

Abdel-Fattah, Mohamed / Cooper, David / Davidson, Tracey / Kilonzo, Mary / Boyers, Dwayne / Bhal, Kiron / McDonald, Alison / Wardle, Judith / N'Dow, James / MacLennan, Graeme / Norrie, John

Health technology assessment (Winchester, England)

2022 Volume 26, Issue 47, Page(s) 1–190

Abstract: Background: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable ...

Abstract	Background: Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. Objective: The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. Design: This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Setting: The trial was set in 21 UK hospitals. Participants: Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. Interventions: Single-incision mini-slings, compared with standard mid-urethral slings. Main outcome measures: The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. Results: A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; Limitations: Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. Conclusions: Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. Future work: Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. Trial registration: This trial was registered as ISRCTN93264234. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in
MeSH term(s)	Female ; Humans ; Male ; Suburethral Slings ; Urinary Incontinence, Stress/surgery ; Quality of Life ; Urinary Incontinence/surgery ; Pain ; Cost-Benefit Analysis
Language	English
Publishing date	2022-12-15
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2006765-3
ISSN	2046-4924 ; 1366-5278
ISSN (online)	2046-4924
ISSN	1366-5278
DOI	10.3310/BTSA6148
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Article ; Online: How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt.

Constable, Lynda / Davidson, Tracey / Breeman, Suzanne / Cotton, Seonaidh / McDonald, Alison / Wileman, Samantha / Norrie, John

Trials

2020 Volume 21, Issue 1, Page(s) 765

Abstract: Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the ... ...

Abstract	Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.
MeSH term(s)	Betacoronavirus/pathogenicity ; COVID-19 ; Coronavirus Infections/diagnosis ; Coronavirus Infections/epidemiology ; Coronavirus Infections/transmission ; Coronavirus Infections/virology ; Early Termination of Clinical Trials ; Humans ; Pandemics ; Patient Safety ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/transmission ; Pneumonia, Viral/virology ; Public Opinion ; Randomized Controlled Trials as Topic/methods ; Research Design ; Risk Assessment ; Risk Factors ; SARS-CoV-2 ; Time Factors
Keywords	covid19
Language	English
Publishing date	2020-09-05
Publishing country	England
Document type	Letter
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-020-04705-4
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Article: How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt

Constable, Lynda / Davidson, Tracey / Breeman, Suzanne / Cotton, Seonaidh / McDonald, Alison / Wileman, Samantha / Norrie, John

Trials

Abstract	Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #745677
Database	COVID19

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Article ; Online: How to Deal with a Temporary Suspension and Restarting Your Trial

Constable, Lynda / Davidson, Tracey / Breeman, Suzanne / Cotton, Seonaidh / McDonald, Alison / Wileman, Samantha / Norrie, John

Our Experiences and lessons Learnt

2020

Abstract: Funding: VUE is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project reference 11/129/183). The views expressed are those of the author(s) and not necessarily those of the NIHR or the ... ...

Abstract	Funding: VUE is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project reference 11/129/183). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Peer reviewed Publisher PDF
Keywords	Temporary suspension ; suspend ; randomised controlled tria ; RCT ; covid-19 ; Betacoronavirus/pathogenicity ; Pandemics ; Public Opinion ; Risk Assessment ; Humans ; Randomized Controlled Trials as Topic/methods ; Risk Factors ; Coronavirus Infections/diagnosis ; Early Termination of Clinical Trials ; Time Factors ; Patient Safety ; Research Design ; Pneumonia ; Viral/diagnosis ; Randomised controlled trial ; R Medicine ; Pharmacology (medical) ; Medicine (miscellaneous) ; National Institute for Health Research (NIHR) ; 11/129/183 ; Supplementary data available ; R ; covid19
Language	English
Publishing date	2020-09-05
Publishing country	uk
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Use of a birth plan within woman-held maternity records: a qualitative study with women and staff in northeast Scotland.

Whitford, Heather M / Entwistle, Vikki A / van Teijlingen, Edwin / Aitchison, Patricia E / Davidson, Tracey / Humphrey, Tracy / Tucker, Janet S

Birth (Berkeley, Calif.)

2014 Volume 41, Issue 3, Page(s) 283–289

Abstract: Background: Birth plans are written preferences for labor and birth which women prepare in advance. Most studies have examined them as a novel intervention or "outside" formal care provision. This study considered use of a standard birth plan section ... ...

Abstract	Background: Birth plans are written preferences for labor and birth which women prepare in advance. Most studies have examined them as a novel intervention or "outside" formal care provision. This study considered use of a standard birth plan section within a national, woman-held maternity record. Methods: Exploratory qualitative interviews were conducted with women (42) and maternity service staff (24) in northeast Scotland. Data were analyzed thematically. Results: Staff and women were generally positive about the provision of the birth plan section within the record. Perceived benefits included the opportunity to highlight preferences, enhance communication, stimulate discussions, and address anxieties. However, not all women experienced these benefits or understood the birth plan's purpose. Some were unaware of the opportunity to complete it or could not access the support they needed from staff to discuss or be confident about their options. Some were reluctant to plan too much. Staff recognized the need to support women with birth plan completion but noted practical challenges to this. Conclusions: A supportive antenatal opportunity to allow discussion of options may be needed to realize the potential benefits of routine inclusion of birth plans in maternity notes.
MeSH term(s)	Adult ; Communication ; Decision Making ; Delivery, Obstetric/methods ; Female ; Humans ; Interviews as Topic ; Labor, Obstetric ; Longitudinal Studies ; Maternal Health Services/trends ; Patient Participation ; Patient Preference ; Pregnancy ; Prenatal Care ; Qualitative Research ; Scotland ; Young Adult
Language	English
Publishing date	2014-04-21
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604869-9
ISSN	1523-536X ; 0730-7659
ISSN (online)	1523-536X
ISSN	0730-7659
DOI	10.1111/birt.12109
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Article ; Online: The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial.

Abdel-Fattah, Mohamed / MacLennan, Graeme / Kilonzo, Mary / Assassa, R Phil / McCormick, Kirsty / Davidson, Tracey / McDonald, Alison / N'Dow, James / Wardle, Judith / Norrie, John

BMJ open

2017 Volume 7, Issue 8, Page(s) e015111

Abstract: Introduction: Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced ... ...

Abstract	Introduction: Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. Methods and analysis: A pragmatic, multicentre, non-inferiority randomised controlled trial. Primary outcome measure: The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. Secondary outcome measures: The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. Statistical analysis: The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. Ethics and dissemination: The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. Trial registration number: ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.
MeSH term(s)	Anesthesia/methods ; Coitus/physiology ; Cost-Benefit Analysis ; Female ; Humans ; Postoperative Complications/physiopathology ; Quality of Life ; Reoperation/statistics & numerical data ; Risk Factors ; Suburethral Slings/economics ; Treatment Outcome ; United Kingdom ; Urinary Incontinence, Stress/economics ; Urinary Incontinence, Stress/physiopathology ; Urinary Incontinence, Stress/surgery ; Urination/physiology ; Urologic Surgical Procedures/economics ; Urologic Surgical Procedures/methods
Language	English
Publishing date	2017-08-11
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Pragmatic Clinical Trial ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2016-015111
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In stock of ZB MED Cologne/Königswinter

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