Supplement
Table S1 Contents of the informed consent packages sent by mail to eligible patients on behalf of their GP
Informed consent package contents
A cover letter from the patient’s GP, explaining why patients were being contacted, what they were being asked to do and how they would be compensated for participating;
A phone number they could use to ask questions/request additional information (managed by a third party to reduce burden on the GP sites);
A Patient Information Leaflet, which described the study in greater detail;
An Informed Consent Form whereby the patient could indicate their agreement to participate in the study (including completion of the disease-specific questionnaire and sharing their historical and future EHR data to be used for research purposes), detailing who will have access to their information;
A previously piloted disease-specific (COPD or asthma) patient questionnaire booklet for capture of historical demographic data and COPD/asthma risk factor information, specifically formatted to optimise self-completion by patients and including validated patient-reported outcome tools;
A pre-paid return envelope
COPD, chronic obstructive pulmonary disease; EHR, electronic health record; GP, general practitioner.
Table S2 Variables assessing whether primary care data were extracted appropriately
*Years based on the minimum age that patients could be at randomisation to SLS COPD/Asthma;
†Dates based on the period of the SLS.
COPD, chronic obstructive pulmonary disease; Ext-SLS, Extended Salford Lung Study.
Table S3 Medication prescriptions one year (days 0 to 365) post-SLS randomisation date as recorded in Ext-SLS primary care EHR data
Assigned Treatment Arm in
the SLS
Prescriptions
Total number of prescriptions
in period
Number of patients with a prescription
Mean
number of prescriptions per patient Asthma (N=192)
FF/VI
(n=88) FF/VI 46 45 1.02
Any respiratory
therapy* 618 78 7.92
Usual Care
(n=104) FF/VI 0 0 0
Any respiratory
therapy* 1279 104 12.3
COPD (N=136) FF/VI
(n=71) FF/VI 19 18 1.06
Any respiratory
therapy* 1096 68 16.12
Usual Care
(n=65) FF/VI 0 0 0
Any respiratory
therapy* 1542 64 24.09
*Includes: inhaled corticosteroids, long-acting β-agonists, long-acting muscarinic antagonists, short- acting β-agonists, short-acting muscarinic antagonists and any combinations of these drug classes.
COPD, chronic obstructive pulmonary disease; EHR, electronic health record; Ext-SLS, Extended Salford Lung Study; FF/VI, fluticasone furoate/vilanterol; SLS, Salford Lung Studies.
