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Table 5 Round 3 of the modified Delphi process for the consensus statements for use of biologics in upper airway disease

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