Indications for consideration
The core group defined what symptoms, past medical history and relevant diagnostic tests might influence the decision regarding whether biologic prescription might be appropriate. Their responses were used to form a series of matrixes that categorise patients according to these key indications. Specific combinations of associated comorbidities and previous treatment were considered, alongside wider statements concerning the delivery of biologics. One hundred clinical scenarios were considered, stratified by the presence of co-morbid asthma, N-ERD or AFRS, the number of previous surgeries (or if a patient was unfit surgery), and the use of INCS or OCS (or if a patient was unable to use them). Other characteristics such as baseline symptom scores, the importance of radiological imaging and the extent of disease on radiological imaging were also considered.
Consensus process We used the RAND/UCLA methodology with a multi-step process (www.rand.org)(10). Our expert panel undertook a 2 round modified Delphi process of ranking and classifying appropriateness of different investigations and treatment options. Using a 9-point Linkert scale, for each indication the panellists scored whether a treatment was either:
Free text comments were encouraged if greater context was required, if the question was ambiguous or if anything had been overlooked.
The final recommendation was based on the median ranking scores collated from each clinical scenario provided that there was consensus. Consensus was defined as the requirement for more than 70% of responses to fall into the category defined by the median, and when this score fell in either recommended or not recommended, less than 15% of responses were scored as the opposite.
The scores at the end of round 1 were analysed and presented back to the group, with the distribution of scores summarised for each question. The panel was then asked to repeat the scoring for any items where consensus has not been reached having considered if they wished to revise their previous score.
Round 2 scores were evaluated in the same way. When the median fell between 4-6, or if the median fell in either 1-3 or 6-9 and the definition of consensus was not met, no recommendation was made, and the use of biologics for the given indication was considered uncertain.