To investigate the feasibility of performing a future real-world randomised controlled trial to determine the clinical effectiveness of ArtiQ.Spiro in supporting diagnostic performance of primary care staff in the interpretation of spirometry
This is a feasibility study for a larger multicentre randomised controlled trial (RCT) assessing the impact of the ArtiQ.Spiro software on diagnostic accuracy, care processes, patient and health economic outcomes. The primary objective of this study is to assess the feasibility of a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. Endpoints of the current study will be focused on feasibility and acceptability outcomes. Secondary objectives of this study are to collect data on potential clinical and health economic endpoints for a future randomised controlled trial designed to evaluate the real-world clinical effectiveness of an artificial intelligence enabled software to support the diagnostic interpretation and quality assessment of primary care spirometry. This will help determine the primary endpoint for a future trial and provide data to support a sample size calculation to ensure that any future trial will have adequate power. This is a mixed methods randomised controlled feasibility trial. In PICO format: Population: Individuals with respiratory symptoms referred clinically for primary care spirometry in Hillingdon, Leicestershire, West Hampshire. Intervention: Local primary care spirometry pathway supported by additional artificial intelligence enabled software (ArtiQ.Spiro) Control: Local primary care spirometry alone. Outcomes: Feasibility outcomes with a particular focus on recruitment and retention, and acceptability of intervention and trial design. Clinical outcomes including referrer diagnostic performance and patient health status. Health economic outcomes including health care usage and economic modelling. All participants will undergo their locally agreed spirometry pathway.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
63
ArtiQ.Spiro is a decision support software that combines two sub-components - one focussing on quality assessment (ArtiQ.QC), and one on spirometry interpretation (ArtiQ.PFT). It is intended to be used as an adjunct to spirometry to assist with the grading of spirometry quality and the interpretation of spirometry by providing the probability of six disease / or no disease categories.
Gillian Doe
Leicester, United Kingdom
Harefield Hospital
Uxbridge, United Kingdom
Identification and recruitment of eligible participants
Contributing data: Screening \& recruitment log and trial consort diagram. Progression criteria: Green (≥80% screened eligible, ≥60% eligible recruited), Amber (60-79% screened eligible, 40 - 59% eligible recruited), Red (\<60% screened eligible, \<40% eligible recruited)
Time frame: Six months
Participant retention at follow-up
Contributing data: Participation data and Trial Consort diagram. Progression criteria: Green (≥75% retained at 3 months, ≥60% retained at 6 months), Amber (60-75% retained at 3 months, 40-59% retained at 6 months), Red (\<60% retained at 3 months, \<40% retained at 6 months).
Time frame: Six months
Fidelity of randomisation
Contributing data: Numbers randomised to control/intervention groups and baseline distribution of characteristics of intervention and control groups. Progression criteria: Green: \<10% difference in sample size, proportion of women, proportion of non-white ethnicity, proportion of \> 65 years between control/intervention for each site. Amber: \<15% difference in above criteria; Red: \>15% difference in above criteria.
Time frame: Six months
Fidelity of intervention delivery
Contributing data: Email Logs, and Primary Care Referrer Questionnaire. Progression Criteria: Green (≥90% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, ≥90% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Amber (85-94% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, 75-89% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation). Red (\<85% primary care referrers of the participants in the intervention group sent ArtiQ.Spiro report, \<75% primary care referrers of the participants in the intervention group accessed ArtiQ.Spiro report for interpretation).
Time frame: Six months
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Contamination of control groups
Contributing data: Email Logs. Progression Criteria: Green (≤10% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report). Amber (11-15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report) Red (\>15% primary care referrers of the participants in the control group receiving ArtiQ.Spiro report)
Time frame: Six months
Acceptability of the intervention to referrers, spirometry practitioners and participants
Contributing data: Stakeholder focus groups. Progression criteria: Green (Reported as acceptable (or can be with minimal modification). Amber (Reported as acceptable with modification).Red (Intervention not acceptable).
Time frame: Six months
Acceptability of outcome measures and their timing
Contributing data: Stakeholder focus groups, and Clinical Outcome Measure collection. Progression criteria: Green (Reported as acceptable or can be with minimal modification, Missing data of ≤10% for each measure).Amber (Reported as acceptable with modification, 11-25% missing data for each measure). Red: (Intervention not acceptable, \>25% missing data for each measure).
Time frame: Six months
Diagnostic accuracy of ArtiQ.Spiro compared with reference standard
Contributing data: Diagnostic accuracy of ArtiQ.Spiro compared with reference standard. Progression criteria: Green: ≥ 80%, Amber: 65-79%, Red: \<65%.
Time frame: Six months
Data collector blinding
Contributing data: Participation data. Progression criteria: Green (Blinding maintained for ≥85% participants), Amber (Blinding maintained for 84-70%), Red (Blinding maintained for \<70%).
Time frame: Six months
Spirometry Quality Assessment Performance (vs Reference Standard)
Referrers will be asked to rate the quality of the spirometry of the participant (Acceptable, usable, unusable/unacceptable) based on spirometry report (with or without ArtiQ.Spiro report). This will the be compared with Reference Standard(panel of specialists)
Time frame: Six months
Primary Care Referrer Quality Assessment Confidence
Referrers will be asked to rate the confidence in their quality assessment on a Likert scale (from 0: Very unsure to 10: Very confident).
Time frame: Six months
Primary Care Referrer Technical/Pattern Interpretation
Referrer will be asked to provide their Technical/Pattern Interpretation of the spirometry report received (Normal, Obstructive, Restrictive, Mixed), and their confidence in their technical/pattern interpretation.
Time frame: Six months
Primary Care Referrer Technical/Pattern Interpretation Confidence
Referrers will be asked to rate their confidence in their Technical/Pattern Interpretation on a Likert scale (from 0: Very unsure to 10: Very confident).
Time frame: Six months
Primary Care Referrer Diagnostic Performance (versus Reference Standard)
Referrers will be asked to provide a preferred diagnosis based on spirometry report (with/without ArtiQ.Spiro report) and information from primary care records.
Time frame: Six months
Primary Care Referrer Diagnostic Confidence
Referrers will be asked to rate the confidence in their diagnosis on a continuous visual analogue scale (from 0: Very unsure to 10: Very confident).
Time frame: Six months
Patient health status
Health Status will be measured by the EQ5D5L at baseline, 3 and 6 months post spirometry.
Time frame: Six months
Heath and social care usage
This will be measured using a Patient Healthcare Resource Use Questionnaire at baseline, 3 and 6 months post spirometry.
Time frame: Six months
Health economic modelling
The health economic analysis will compare health-related costs and benefits of ArtiQ.Spiro supported spirometry with standard spirometry pathways, as observed within the study.
Time frame: Six months
Focus groups
Three focus groups will be conducted, comprising trial patient participants, primary care referrers and spirometry practitioners. These will be used to assess feasibility and acceptability of the trial procedures, intervention, trial outcomes.
Time frame: Six months.