From: Canadian multidisciplinary expert consensus on the use of biologics in upper airways: a Delphi study
 | Statement | Descriptive Statistics | Inter-rater Reliability | Decision |
---|---|---|---|---|
1 | Patients with chronic symptoms of upper airway disease which include facial pressure/pain, nasal obstruction/congestion, nasal discharge or a loss of smell should be evaluated for upper airway disease | Mean 2.94, Median 3, Mode 3 Total voters 32 | Fleiss’ Kappa = 0.84 (Perfect Agreement) | Revised and included in guidelines |
2 | Patients with asthma and chronic symptoms of upper airway disease despite appropriate therapy should be referred for further evaluation of upper airway disease | Mean 2.69, Median 3, Mode 3 Total voters 27 | Fleiss’ Kappa = 0.82 (Perfect Agreement) | Revised and included in guidelines |
3 | Clinician(s) evaluating for upper airway disease should evaluate the nose with nasal endoscopy or in communities where no nasal endoscopy is available, anterior rhinoscopy is acceptable when the diagnosis of nasal polyps is apparent | Mean 2.68, Median 3, Mode 3 Total voters 27 | Fleiss’ Kappa = 0.81 (Pefect Agreement) | Revised and included in guidelines |
4 | If nasal endoscopy is unremarkable or unavailable, a CT scan could be ordered to rule out sinus disease without polyps | Mean 2.77, Median 3, Mode 3 Total voters 22 | Fleiss’ Kappa = 0.78 (Substantial Agreement) | Revised and included in guidelines |
5 | All endotypes of CRSwNP confirmed by endoscopy or anterior rhinoscopy are considered eligible for a trial of biologic therapy | Mean 2.44, Median 3, Mode 3 Total voters 25 | Fleiss’ Kappa = 0.71 (Substantial Agreement) | Revised and included in guidelines |
6 | A Nasal Polyp Score (NPS) of 5 is required to be considered eligible to biologic therapy | Mean 1.30, Median 1, Mode 1 Total voters 23 | Fleiss’ Kappa = 0.79 (Substantial Agreement) | Removed |
7 | CT reports indicating polyps are not sufficient to make the diagnosis of CRSwNP and starting on biologics | Mean 2.76, Median 3, Mode 3 Total voters 25 | Fleiss’ Kappa = 0.83 (Perfect Agreement) | Revised and included in guidelines |
8 | Biologics should be principally considered for those who have undergone adequate sinus surgery within the past 5 years and are refractory to oral and nasal steroids | Mean 2.52, Median 3, Mode 3 Total voters 25 | Fleiss’ Kappa = 0.69 (Substantial Agreement) | Revised and included in guidelines |
9 | Patients unfit for surgery who have failed medical therapy may also be considered candidates for biologic therapy based on shared patient decision making | Mean 2.83, Median 3, Mode 3 Total voters 24 | Fleiss’ Kappa =  > 0.84 (Perfect Agreement) | Revised and included in guidelines |
10 | The adequacy of previous surgery matters in determining if subsequent surgical management is required versus initiation of biologic therapy. This should be evaluated with a CT scan and endoscopy to determine if each of the diseased sinus cavities can receive appropriate topical drug delivery | Mean 2.90, Median 3, Mode 3 Total voters 21 | Fleiss’ Kappa = 0.91 (Perfect Agreement) | Revised and included in guidelines |
11 | Patients with CRSwNP do not need co-existing Type 2 inflammatory condition such as asthma to be considered for biologic therapy | Mean 2.90, Median 3, Mode 3 Total voters 21 | Fleiss’ Kappa = 0.91 (Perfect Agreement) | Revised and included in guidelines |
12 | For most patients, CRSwNP symptoms need to be severe based on the clinician’s choice of a validated patient reported outcome measure (PROM) for chronic sinus disease to warrant the use of biologics | No vote required | N/A | Included in guidelines |
13 | There are a subgroup of patients that may score lower than severe disease on a patient-reported outcome measure (PROM) due to acclimatization to their symptoms (i.e. allergic fungal rhinosinusitis and chronic prednisone users) and these cases should be considered for biologics based on shared decision making | Mean 2.84, Median 3, Mode 3 Total voters 31 | Fleiss’ Kappa = 0.86 (Perfect Agreement) | Revised and included in guidelines |
14 | All CRSwNP patients with lower respiratory symptoms who have not previously been evaluated for asthma should be evaluated for possible asthma and referred to a clinician who can provide a systematic evaluation | No vote required | N/A | Included in guidelines |
15 | In a patient with CRSwNP qualifying for biologic therapy and severe asthma, a consultation with a specialist who can manage asthma is recommended before choosing the most appropriate biologic | No vote required | N/A | Included in guidelines |
16 | There is insufficient evidence to make a recommendation for providing biologics to patients with CRSsNP | No vote required | N/A | Included in guidelines |
17 | Patients with asthma or any other type 2 conditions in the setting of CRSsNP can be considered for biologics use outside of clinical research trials, for those conditions other than CRSsNP, if they meet eligibility criteria for biologic therapy for another type 2 condition based on their respective Canadian guidelines | Mean 1.67, Median 1, Mode 1 Total voters 22 | Fleiss’ Kappa = 0.73 (Substantial Agreement) | Removed |
18 | Biologics should not be provided to those with recurrent acute bacterial sinusitis without CRSwNP | No vote required | N/A | Removed |
19 | Patients with refractory CRSwNP after surgery should be counselled regarding their options which include revision sinus surgery or biologics. Referral to a sub-specialist that can counsel and/or perform extended surgical procedures should be sought | Mean 2.90, Median 3, Mode 3 Total voters 31 | Fleiss’ Kappa = 0.91 (Perfect Agreement) | Revised and included in guidelines |
20 | Where possible, patients with Aspirin Exacerbated Respiratory Disease (AERD) should be preferentially managed by a multidisciplinary team | Mean 2.66, Median 3, Mode 3 Total voters 22 | Fleiss’ Kappa =  > 0.60 (Substantial Agreement) | Revised and included in guidelines |
21 | Patients with CRSwNP who must wait longer than 6 months for undergoing primary sinus surgery should be allowed to initiate biologic therapy as a bridge to surgical management | Mean 1.23, Median 1, Mode 1 Total voters 24 | Fleiss’ Kappa = 0.74 (Substantial Agreement) | Removed |
22 | If a patient achieves desired symptom control on biologics prior to surgery, a patient may choose not to do surgery and continue with biologics | Mean 1.23, Median 1, Mode 1 Total voters 24 | Fleiss’ Kappa = 0.74 (Substantial Agreement) | Removed |
23 | Biologics can be uniquely considered for hyposmic patients where their sense of smell function is required for safety reasons or for their job if they have a history CRSwNP treated with surgery with adequate control of their disease and no evidence of polyps on endoscopy. Objective testing must be performed (UPSIT \(\le 33\) or Sniffin’ Sticks Test \(\le\) 30) | No vote required | N/A | Removed |
24 | At the time of writing, there are no biological markers required to start CRSwNP patients on biologics nor any markers to indicate best biologic to use | Mean 2.68, Median 2, Mode 2 Total voters 20 | Fleiss’ Kappa = 0.76 (Substantial Agreement) | Revised and included in guidelines |
25 | Nasal response to biologics should be assessed by 16 weeks after initiating therapy | Mean 3, Median 3, Mode 3 Total voters 21 | Fleiss’ Kappa = 1.0 (Perfect Agreement) | Revised and included in guidelines |
26 | Patients should experience an improvement and achieve a documented minimal clinical important difference (MCID) using a validated disease specific questionnaire or the biologic should be re-evaluated | Mean 2.58, Median 3, Mode 3 Total voters 19 | Fleiss’ Kappa = 0.69 (Substantial Agreement) | Revised and included in guidelines |
27 | Patients should be evaluated every 6 months in the first two years of biologic initiation and every 1 year thereafter | Mean 2.79, Median 3, Mode 3 Total voters 19 | Fleiss’ Kappa = 0.79 (Substantial Agreement) | Revised and included in guidelines |
28 | When treating co-existing CRSwNP and asthma, an attempt should be made to obtain optimal results with a single biologic in both diseases | Mean 3, Median 3, Mode 3 Total voters 18 | Fleiss’ Kappa = 1.0 (Perfect Agreement) | Revised and included in guidelines |
29 | Pre-biologic criteria may be used to qualify a patient for a second or subsequent biologic therapies in case of sub-optimal response to the first biologic | Mean 3, Median 3, Mode 3 Total voters 18 | Fleiss’ Kappa = 1.0 (Perfect Agreement) | Revised and included in guidelines |
30 | In case of failure to respond to biologic therapy in the case of nasal polyps, obtaining biologic markers may help a clinician pick the next appropriate biologic to use | Mean 1.42, Median 1, Mode 1 Total voters 12 | Fleiss’ Kappa = 0.63 (Substantial Agreement) | Removed |
31 | CRSwNP who have exhausted biologics and not achieved simultaneous adequate response in both the upper and lower airways could be evaluated for possible revision sinus surgery | Mean 2.54, Median 3, Mode 3 Total voters 13 | Fleiss’ Kappa = 0.71 (Substantial Agreement) | Revised and included in guidelines |
32 | CRSwNP and asthma patients who have exhausted biologic switching and not achieved simultaneous adequate response in both the upper and lower airways and in which surgery is not indicated may be started on dual biologic therapy that is best suited for the sinuses and lungs independent of each other. These decisions may be best done in multidisciplinary clinics (MDC) or if MDC not available, in consult with other specialists taking care of this patient | Mean 1.29, Median 1, Mode 1 Total voters 14 | Fleiss’ Kappa = 0.76 (Substantial Agreement) | Removed |
33 | The risk of side effects is low in the short-term use of biologics in CRSwNP | Mean 2.29, Median 3, Mode 3 Total voters 14 | Fleiss’ Kappa = 0.66 (Substantial Agreement) | Revised and included in guidelines |
34 | Cost and access to biologics should be considered in the decision making of the use of biologics for CRSwNP patients with or without another Type 2 inflammatory condition | Mean 2.53, Median 3, Mode 3 Total voters 15 | Fleiss’ Kappa = 0.71 (Substantial Agreement) | Revised and included in guidelines |
35 | Patient preference should also be considered when considering initiation of biologics | Mean 1.14, Median 1, Mode 1 Total voters 14 | Fleiss’ Kappa = 0.93 (Perfect Agreement) | Removed |