scholarly journals Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Helen Blackshaw ◽  
Jane Vennik ◽  
Carl Philpott ◽  
Mike Thomas ◽  
Caroline Eyles ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Expert Panel ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).

2019 ◽  
Author(s):  
Jane Vennik ◽  
Helen Blackshaw ◽  
Carl Philpott ◽  
Mike Thomas ◽  
Caroline Eyles ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Trial Design ◽  
Review Process ◽  
Expert Panel ◽  
Controlled Trial ◽  
Best Management ◽  
Oral Steroids ◽  
Panel Review ◽  
Randomised Controlled

Abstract Background MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. Methods An expert panel consisting of the MACRO programme management group, independent advisors, and patient contributors, was convened to review current evidence and the mixed method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of oral steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. Results A 12-week course of clarithromycin was agreed as the main trial comparator, due to its increasing use as a first and second line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Oral steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure the MACRO trial is both pragmatic and generalisable to primary care. A modified 3-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that patients recruited would be considered eligible for the treatment offered in the trial, due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. Conclusion The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.

scholarly journals Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme).

2018 ◽  
Author(s):  
Jane Vennik ◽  
Stephen Durham ◽  
Jim Boardman ◽  
Kim Airey ◽  
Steffi Le Conte ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Chronic Rhinosinusitis ◽  
Trial Design ◽  
Review Process ◽  
Expert Panel ◽  
Controlled Trial ◽  
Best Management ◽  
Oral Steroids ◽  
Panel Review ◽  
Randomised Controlled

Abstract Background MACRO (Defining best Management for Adults with Chronic RhinOsinusitis) is an NIHR-funded programme of work designed to establish best practice for adults with chronic rhinosinusitis (CRS). The 7-year programme comprises three consecutive workstreams, designed to explore NHS care pathways through analysis of primary and secondary data sources, and to undertake a randomised controlled trial to evaluate a longer-term course of macrolide antibiotics and endoscopic sinus surgery for patients with CRS. A number of outstanding elements still required clarification at the funding stage. This paper reports an expert panel review process designed to agree and finalise the MACRO trial design, ensuring relevance to patients and clinicians whilst maximising trial recruitment and retention. Methods An expert panel consisting of the MACRO programme management group, independent advisors, and patient contributors, was convened to review current evidence and the mixed method data collected as part of the programme, and reach agreement on MACRO trial design. Specifically, agreement was sought for selection of macrolide antibiotic, use of oral steroids, inclusion of CRS phenotypes (with/without nasal polyps), and overall trial design. Results A 12-week course of clarithromycin was agreed as the main trial comparator, due to its increasing use as a first and second line treatment for patients with CRS, and the perceived need to establish its role in CRS management. Oral steroids will be used as a rescue medication during the trial, rather than routinely either pre or post trial randomisation, to limit any potential effects on surgical outcomes and better reflect current UK prescribing habits. Both CRS phenotypes will be included in a single trial to ensure the MACRO trial is both pragmatic and generalisable to primary care. A modified 3-arm trial design was agreed after intense discussions and further exploratory work. Inclusion criteria were amended to ensure that patients recruited would be considered eligible for the treatment offered in the trial, due to having already received appropriate medical therapy as deemed suitable by their ENT surgeon. A proposed 6-week run-in period prior to randomisation was removed due to the new criteria prior to randomisation. Conclusion The expert panel review process resulted in agreement on key elements and an optimal design for the MACRO trial, considered most likely to be successful in terms of both recruitment potential and ability to establish best management of patients with CRS.

scholarly journals Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042413
Author(s):  
Shaun Kilty ◽  
Kednapa Thavorn ◽  
Arif Janjua ◽  
John Lee ◽  
Kristian MacDonald ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Chronic Rhinosinusitis ◽  
Nasal Polyps ◽  
Controlled Trial ◽  
Sinus Surgery ◽  
Endoscopic Polypectomy ◽  
Research Ethics Board ◽  
Randomised Controlled

IntroductionChronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.Methods and analysisWe designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.Ethics and disseminationThis study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.Trial registration numberNCT02975310.

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