Patient and Healthcare Professional (HCP; General Practitioner [GP] and Practice Manager [PM]) Insights to Facilitate Engagement in Future Effectiveness Studies: Learnings from the Salford Lung Studies (SLS)

Gemzoe, Kim; Crawford, Ronald L.; Caress, A.; Rushton, Ruth; Shah, Anjan; Collier, Sonya; Doward, Lynda; Vekaria, Renu M.; Worsley, Sally; Leather, David

doi:10.1164/ajrccm-conference.2019.199.1_meetingabstracts.a6227

Cited by 1 publication

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“…The key was the involvement of patients' own GPs in recruitment and obtaining of consent. Following on from SLS, additional qualitative research has been conducted to understand the drivers for patient and HCP engagement in the studies and how participation in future effectiveness trials might be enhanced [37]. Though key learnings from SLS will be the subject of a separate publication, our findings should be highlighted around the overall positive experience of patients and HCPs who participated in SLS and the importance of (1) local advertising to raise community awareness of study recruitment; (2) site/investigator engagement, ensuring that through extensive training on Good Clinical Practice, the study design and delivery was aligned with routine care;…”

Section: Patient and Hcp Engagementmentioning

confidence: 99%

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Real-World Data and Randomised Controlled Trials: The Salford Lung Study

et al. 2020

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Traditional efficacy double-blind randomised controlled trials (DBRCTs) measure the benefit a treatment produces under near-ideal test conditions in highly selected patient populations; however, the behaviour of patients and investigators in such trials is highly controlled, highly compliant and adherent, and non-representative of routine clinical practice. Pragmatic effectiveness trials measure the benefit a treatment produces in patients in everyday ''real-world'' practice. Ideally, effectiveness trials should recruit patients as similar as possible to those who will ultimately be prescribed the medicine, and create freedom within the study design to allow normal behaviours of patients and healthcare professionals (HCPs) to be expressed. The Salford Lung Study (SLS) was a world-first, prospective, phase III, pragmatic randomised controlled trial (RCT) programme in patients with chronic obstructive pulmonary disease and asthma to evaluate the effectiveness of a pre-licensed medication (fluticasone furoate/vilanterol) in real-world practice using electronic health records and through collaboratively engaging general practitioners and community pharmacists in clinical research. The real-world aspect of SLS was unique, requiring careful planning and attention to the goals of maximising the external validity of the Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11336171.

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Section: Patient and Hcp Engagementmentioning

confidence: 99%

“…(3) provision of research nurse support at study sites, which was key to study delivery; (4) ease and convenience of study assessments; and (5) a need for improved study results dissemination [37].…”

Section: Patient and Hcp Engagementmentioning

confidence: 99%