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Table 3 Round 1 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 symptoms of upper airway disease which include facial pressure/pain, nasal obstruction/congestion, discharge or a loss of smell or severe/uncontrolled asthma should be evaluated for upper airway disease. Clinician(s) evaluating for upper airway disease should evaluate the nose with endoscopy or a CT sinus scan

Mean = 7.63 (Agree), Median = 8, Mode = 8

Total voters = 32

Fleiss’ Kappa = 0.617 (Substantial agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

2

All endotypes of CRSwNP confirmed by endoscopy or anterior rhinoscopy are considered eligible except for primary ciliary dyskinesia and cystic fibrosis. CT reports indicating polyps is not sufficient in making the diagnosis of CRSwNP

Mean = 7.35 (Agree), Median = 8, Mode = 8

Total voters = 31

Fleiss Kappa = 0.598 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

3

Biologics should only be considered for those who have undergone adequate sinus surgery and failed appropriate medical therapy (AMT) following surgery. Patients unfit for surgery who have failed AMT may also be considered candidates for biologic therapy. The adequacy of previous surgery matters in determining subsequent surgical management versus initiation of biologic therapy. Prior to initiation of biologics, there needs to be documentation on endoscopy and/or CT scan that all the partitions preventing adequate medical delivery to the sinuses had been achieved prior to polyp recurrence

Mean = 5.87 (Neutral), Median = 6, Mode = 9

Total voters = 31

Fleiss Kappa = 0.539 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

4

Patients with CRSwNP do not need co-existing Type 2 inflammatory condition such as asthma to be considered for biologic therapy

Mean = 8.38 (Agree), Median = 9, Mode = 9

Total voters = 32

Fleiss Kappa = 0.772 (Substantial agreement)

Agreed upon; No vote required in Round 2 Modified Delphi Process

5

The severity of subjective CRSwNP symptoms needs to be moderate to severe based on the clinicians choosing of a validated patient reported outcome measure (PROM) for chronic sinus disease to warrant the use of biologics

Mean = 7.53 (Agree), Median = 8, Mode = 9

Total voters = 32

Fleiss Kappa = 0.584 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

6

All CRSwNP patients should be evaluated for possible asthma. Patients with possible lower airway disease based on history should be referred to clinician(s) that can provide a systematic evaluation for asthma and allergy. Patients should be referred preferentially to clinicians who can organize pulmonary function tests, blood work for IgE and eosinophils levels, perform skin prick test and pulmonary FeNO levels as well as conduct a validated disease specific questionnaire for asthma

Mean = 6.84 (Neutral), Median = 7, Mode = 8

Total voters = 32

Fleiss Kappa = 0.561 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

7

There is insufficient evidence to make a recommendation for providing biologics to patients with CRSsNP without asthma

Mean = 7.38 (Agree), Median = 8, Mode = 8

Total voters = 32

Fleiss Kappa = 0.583 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

8

Patients with severe uncontrolled asthma or any other severe type 2 conditions in the setting of CRSsNP can be considered for biologics use based on their respective Canadian guidelines

Mean = 8.09 (Agree), Median = 8, Mode = 9

Total voters = 32

Fleiss Kappa = 0.640 (Substantial agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

9

Biologics should not be provided to those suffering with recurrent acute bacterial sinusitis

Mean = 8.52 (Agree), Median = 9, Mode = 9

Total voters = 31

Fleiss Kappa = 0.749 (Substantial agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

10

Where possible, if adequate surgery has been performed on CRSwNP patient, the patient should be assessed by an individual who can perform extended surgical approaches for further aeration of the sinuses. This surgeon can then determine if the patient would benefit from surgery or should proceed to starting a biologic

Mean = 5.74 (Neutral), Median = 6, Mode = 8

Total voters = 31

Fleiss Kappa = 0.537 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

11

Patients with Aspirin Exacerbated Respiratory Disease (AERD) should be preferentially managed in centres with specialists who can perform advanced aeration surgeries for CRSwNP, manage severe/uncontrolled asthma, and provide possible aspirin desensitization

Mean = 6.42 (Agree), Median = 7, Mode = 8

Total voters = 31

Fleiss Kappa = 0.541 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

12

Patients with CRSwNP who must wait longer than the provincial benchmark for undergoing sinus surgery should be allowed to initiate biologic therapy as a bridge to surgical management. Biologics are discontinued following surgery and only re-started if fits appropriate criteria based on these guidelines

Mean = 5.26 (Neutral), Median = 5, Mode = 7

Total voters = 31

Fleiss Kappa = 0.546 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

13

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)

Mean = 6.0 (Neutral), Median = 6, Mode = 5

Total voters = 31

Fleiss Kappa = 0.535 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

14

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 = 7.13 (Agree), Median = 7.5, Mode = 7

Total voters = 32

Fleiss Kappa = 0.583 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

15

Response to biologics is based on subjective and objective improvement by 16 weeks. Patients should experience an improvement to some or all of their major upper airway symptoms which include sense of smell, nasal obstruction, nasal discharge, and facial pain. Furthermore, there should also be objective improvement on endoscopy or CT scan by 16 weeks and this should be re-evaluated at 1 year

Mean = 7.0 (Agree), Median = 7, Mode = 8

Total voters = 32

Fleiss Kappa = 0.595 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

16

Clinicians using biologics to manage the both upper and lower airway disease should achieve MCID in both upper and lower airway validated questionnaires. If not, clinicians should discuss with one another if another biologic would benefit both the upper and lower airways better

Mean = 6.50 (Neutral), Median = 7, Mode = 7

Total voters = 32

Fleiss Kappa = 0.589 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

17

Providers have the option of providing another biologic therapy if patients fail to respond to one biologic agent but continue to fit the inclusion criteria for biologic therapy. At this time, there are no biological markers to determine the best biological agent to use. There is no current literature to advise biological switching

Mean = 7.03 (Agree), Median = 7, Mode = 7

Total voters = 32

Fleiss Kappa = 0.612 (Substantial agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

18

CRSwNP and asthma who have exhausted biologic switching and not achieved adequate response in either the upper or lower airways may consider dual biologic therapy. Dual biologic response should be evaluated at 16 weeks. If there are additional subjective/objective improvements, dual biologic therapy may be continued and re-evaluated at 1 year

Mean = 5.94 (Neutral), Median = 6, Mode = 8

Total voters = 32

Fleiss Kappa = 0.546 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

19

The short-term use of biologics (12 months) in CRSwNP is considered safe. In other Type 2 inflammatory conditions, biologics have been shown to be safe long term

Mean = 7.06 (Agree), Median = 7.5, Mode = 8

Total voters = 32

Fleiss Kappa = 0.563 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process

20

Cost and access to biologics matters in the decision making of the use of biologics for CRSwNP patients with or without another Type 2 inflammatory condition

Mean = 7.23 (Agree), Median = 8, Mode = 9

Total voters = 32

Fleiss Kappa = 0.594 (Moderate agreement)

Revised and re-assessed in Round 2 of the Modified Delphi Process