Optimising trial outcomes and patient retention for the macro trial for chronic rhinosinusitis
Optimising trial outcomes and patient retention for the macro trial for chronic rhinosinusitis
Background: This study aimed to evaluate current subjective and objective outcome assessments for the MACRO (defining best Management for Adults with Chronic RhinOsinusitis) Trial which compares antibiotics, placebo and sinus surgery. This was to identify any redundant assessments and to include patient perspectives to determine acceptability for confirmation in the trial. Methods: Adults CRS patients meeting the provisional eligibility criteria for the MACRO trial were recruited to this mixed-method study at 2 sites. Correlations between the objective outcome measures and SNOT-22 scores were evaluated. Selected participants took part in a semi-structured telephone interview to explore their experiences and views of undergoing outcome measures. Results: Seventy patients (37% male) were recruited, 36 had CRS without nasal polyps, 34 had CRS with nasal polyps. There was a weak inverse correlation between the SNOT-22 “Blockage” ratings and Peak Nasal Inspiratory Flow readings, a moderate inverse correlation between the SNOT-22 “Smell” ratings and Sniffin’ Sticks scores, but no significant correlation between the SNOT-22 and Saccharin test results. The participants’ experience of the trial visit was positive with an acceptable duration of trial visit. Most proposed outcome measures were valued by participants with the exception of the Saccharin test. Discussion: The Sniffin’ Sticks test and PNIF correlate with their respective component SNOT-22 scores but are considered important by patients; PNIF is simple, cheap test to perform. The Saccharin test will be removed as participants did not value it and was not highly rated in parallel work on a core outcome set for CRS.
Chronic rhinosinusitis, Endoscopic sinus surgery, Outcome assessment, Patient selection-reported outcome measures, Randomised controlled trial
358-366
Ta, Ngan Hong
410b1394-55f1-4193-b3e4-eea00fbfd57c
Hopkins, Claire
8ed0a5e3-92a3-4988-9c2b-b0e51a8a044c
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Philpott, Carl
3b9f988c-a61e-4736-9b69-6697fb2cdc5b
1 October 2019
Ta, Ngan Hong
410b1394-55f1-4193-b3e4-eea00fbfd57c
Hopkins, Claire
8ed0a5e3-92a3-4988-9c2b-b0e51a8a044c
Vennik, Jane
6ee78166-5a7a-433b-87fc-018771f20b19
Philpott, Carl
3b9f988c-a61e-4736-9b69-6697fb2cdc5b
Ta, Ngan Hong, Hopkins, Claire, Vennik, Jane and Philpott, Carl
(2019)
Optimising trial outcomes and patient retention for the macro trial for chronic rhinosinusitis.
Rhinology, 57 (5), .
(doi:10.4193/Rhin19.142).
Abstract
Background: This study aimed to evaluate current subjective and objective outcome assessments for the MACRO (defining best Management for Adults with Chronic RhinOsinusitis) Trial which compares antibiotics, placebo and sinus surgery. This was to identify any redundant assessments and to include patient perspectives to determine acceptability for confirmation in the trial. Methods: Adults CRS patients meeting the provisional eligibility criteria for the MACRO trial were recruited to this mixed-method study at 2 sites. Correlations between the objective outcome measures and SNOT-22 scores were evaluated. Selected participants took part in a semi-structured telephone interview to explore their experiences and views of undergoing outcome measures. Results: Seventy patients (37% male) were recruited, 36 had CRS without nasal polyps, 34 had CRS with nasal polyps. There was a weak inverse correlation between the SNOT-22 “Blockage” ratings and Peak Nasal Inspiratory Flow readings, a moderate inverse correlation between the SNOT-22 “Smell” ratings and Sniffin’ Sticks scores, but no significant correlation between the SNOT-22 and Saccharin test results. The participants’ experience of the trial visit was positive with an acceptable duration of trial visit. Most proposed outcome measures were valued by participants with the exception of the Saccharin test. Discussion: The Sniffin’ Sticks test and PNIF correlate with their respective component SNOT-22 scores but are considered important by patients; PNIF is simple, cheap test to perform. The Saccharin test will be removed as participants did not value it and was not highly rated in parallel work on a core outcome set for CRS.
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Accepted/In Press date: 17 June 2019
Published date: 1 October 2019
Keywords:
Chronic rhinosinusitis, Endoscopic sinus surgery, Outcome assessment, Patient selection-reported outcome measures, Randomised controlled trial
Identifiers
Local EPrints ID: 436150
URI: http://eprints.soton.ac.uk/id/eprint/436150
ISSN: 0300-0729
PURE UUID: 44b19038-6740-4cda-b8b0-25a11506093b
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Date deposited: 29 Nov 2019 17:30
Last modified: 18 Mar 2024 03:40
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Contributors
Author:
Ngan Hong Ta
Author:
Claire Hopkins
Author:
Carl Philpott
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