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Article ; Online: Remdesivir for COVID-19: challenges of underpowered studies.

Norrie, John David

2020 Volume 395, Issue 10236, Page(s) 1525–1527

MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Antiviral Agents/therapeutic use ; Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Double-Blind Method ; Pandemics ; Pneumonia, Viral ; Randomized Controlled Trials as Topic ; SARS-CoV-2
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-04-29
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(20)31023-0
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Article: Remdesivir for COVID-19: challenges of underpowered studies

Norrie, John David

Lancet

Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #141678
Database	COVID19

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Article ; Online: Remdesivir for COVID-19

Norrie, John David

The Lancet

challenges of underpowered studies

2020 Volume 395, Issue 10236, Page(s) 1525–1527

Keywords	General Medicine ; covid19
Language	English
Publisher	Elsevier BV
Publishing country	us
Document type	Article ; Online
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/s0140-6736(20)31023-0
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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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: Clinical endpoint adjudication.

Meah, Mohammed N / Denvir, Martin A / Mills, Nicholas L / Norrie, John / Newby, David E

Lancet (London, England)

2020 Volume 395, Issue 10240, Page(s) 1878–1882

MeSH term(s)	Clinical Trials as Topic/standards ; Documentation ; Endpoint Determination/economics ; Endpoint Determination/standards ; Humans
Language	English
Publishing date	2020-06-15
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(20)30635-8
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Article: Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Date, Kathryn / Williams, Bronwen / Cohen, Judith / Chaudhuri, Nazia / Bajwah, Sabrina / Pearson, Mark / Higginson, Irene / Norrie, John / Keerie, Catriona / Tuck, Sharon / Hall, Peter / Currow, David / Fallon, Marie / Johnson, Miriam

ERJ open research

2023 Volume 9, Issue 4

Abstract: Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the ... ...

Abstract	Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.
Language	English
Publishing date	2023-08-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2827830-6
ISSN	2312-0541
ISSN	2312-0541
DOI	10.1183/23120541.00167-2023
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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: A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

Simpson, A Hamish R W / Clement, Nicholas D / Simpson, Sharon A / Pandit, Hemandt / Smillie, Susie / Leeds, Anthony R / Conaghan, Philip G / Kingsbury, Sarah R / Hamilton, David / Craig, Peter / Ray, David / Keerie, Catriona / Kinsella, Elaine / Bell-Higgs, Anna / McGarty, Arlene / Beadle, Christine / Howie, Colin R / Norrie, John

The Lancet. Rheumatology

2024 Volume 6, Issue 4, Page(s) e237–e246

Abstract: Background: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the ... ...

Abstract	Background: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. Methods: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. Findings: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. Interpretation: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. Funding: Versus Arthritis.
MeSH term(s)	Aged ; Female ; Humans ; Male ; Analgesia ; Feasibility Studies ; Osteoarthritis/therapy ; Quality of Life ; Weight Loss
Language	English
Publishing date	2024-02-26
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(23)00337-5
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