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  1. Article ; Online: Safety data in randomised real-world evidence studies

    Catherine Harvey / Ashley Woodcock / Jørgen Vestbo / Courtney Crim / Lucy Frith / Nawar Diar Bakerly / John P. New / Claire Williams / Hanaa Elkhenini / Nasir Majeed / Glenn Cardwell / Susan Collier / Loretta Jacques / Joanne Fletcher

    ERJ Open Research, Vol 7, Iss

    Salford Lung Study learnings

    2021  Volume 2

    Abstract: Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of ... ...

    Abstract Evidence to support clinical decision making must be based on safety data that have been captured, analysed and interpreted in a robust and reliable way. Randomised real-world evidence (RRWE) studies provide the opportunity to evaluate the use of medicines in patients and settings representative of routine clinical practice. However, elements that underpin the design of RRWE studies can have a significant impact upon the analysis, interpretation and implications of safety data. In this narrative review, we use data from the Salford Lung Study; two prospective, 12-month, open-label, parallel-group, phase III randomised controlled trials conducted in primary care in the UK; to highlight the importance of capturing treatment modifications when attempting to evaluate safety events according to actual treatment exposure. We demonstrate that analysing safety data by actual treatment received (i.e. accounting for the treatment modifications that occur routinely in the primary care setting) provides additional insight beyond analysing according to randomised treatment strategy only. It is therefore proposed that understanding of safety data from RRWE trials can be optimised by analysing both by randomised group and by actual treatment received.
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2021-05-01T00:00:00Z
    Publisher European Respiratory Society
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Impact of socioeconomic status on participation and outcomes in the Salford Lung Studies

    Rupert Jones / Andy Nicholls / Dominy Browning / Nawar Diar Bakerly / Ashley Woodcock / Jørgen Vestbo / David A. Leather / Loretta Jacques / James Lay-Flurrie / Henrik Svedsater / Susan Collier

    ERJ Open Research, Vol 6, Iss

    2020  Volume 1

    Abstract: COPD and asthma prevalence is associated with socioeconomic status (or “deprivation”), yet deprivation is rarely considered in typical large-scale efficacy randomised controlled trials that recruit highly selected patient populations. In this post hoc ... ...

    Abstract COPD and asthma prevalence is associated with socioeconomic status (or “deprivation”), yet deprivation is rarely considered in typical large-scale efficacy randomised controlled trials that recruit highly selected patient populations. In this post hoc analysis of the Salford Lung Studies in COPD and asthma (two 12-month, open-label, effectiveness randomised controlled trials conducted in UK primary care), we evaluated the impact of patient deprivation on clinical outcomes with initiating fluticasone furoate/vilanterol versus continuing usual care. Patients were categorised into deprivation quintiles based on postcode and a countrywide database of indices of deprivation, and trial outcomes by quintile were assessed. 52% of patients in the COPD study were included in the most deprived quintile, contrasting with 20% in the asthma study. Greater deprivation was associated with higher rates of primary/secondary healthcare contacts and costs. However, the treatment effect of fluticasone furoate/vilanterol versus usual care for primary (COPD: moderate/severe exacerbations; asthma: Asthma Control Test responders at week 24) and secondary/other (healthcare consumption, adherence, treatment modifications, study withdrawals, exacerbations, serious adverse events) outcomes was similar across deprivation quintiles. Our findings support the recruitment of participants from all socioeconomic strata to allow assessment of data generalisability to routine clinical practice.
    Keywords Medicine ; R
    Subject code 610
    Language English
    Publishing date 2020-03-01T00:00:00Z
    Publisher European Respiratory Society
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  3. Article ; Online: Patient and healthcare professional experiences of the Salford Lung Studies

    Kim Gemzoe / Rebecca Crawford / Ann Caress / Sheila McCorkindale / Rebecca Conroy / Susan Collier / Lynda Doward / Renu M. Vekaria / Sally Worsley / David A. Leather / Elaine Irving

    Trials, Vol 21, Iss 1, Pp 1-

    qualitative insights for future effectiveness trials

    2020  Volume 12

    Abstract: Abstract Background Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved understanding of the ... ...

    Abstract Abstract Background Randomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved understanding of the challenges/opportunities for patient and healthcare professional (HCP) engagement in clinical research is needed to enhance participation and trial experience. In this study, we explored patient and HCP drivers for, and experiences of, participation in the Salford Lung Studies (SLS), and their views on future trial participation and the overall value of such trials. Methods This was a qualitative study set in Salford, UK, comprising patient telephone interviews (N = 10) and HCP advisory boards (one with general practitioners [GPs], one with practice managers [PMs]); all individuals had participated in the SLS. Semi-structured telephone interviews were recorded, transcribed and analysed thematically. Advisory board meetings were analysed based on transcriptions of audio recordings and field notes. Results For patients, key positive aspects of the SLS were the ease/convenience of study assessments and excellent relationships with study nurses. GPs and PMs considered the SLS to be well-organized and highlighted the value of research nurse support; they also described minor challenges relating to trial systems, initial financial strain on practices and staff turnover. All participants indicated that they were very likely to participate in future trials, citing a design closely aligned with routine care practice as essential. Several strategies to encourage trial participation were suggested, such as clearly communicating benefits to patients and ensuring flexible study assessments. Conclusions Patients and HCPs had positive experiences of the SLS. The study design, closely aligned with routine care, was considered important to their high likelihood of participating in future trials. The experiences of patients and HCPs in the SLS provide valuable insights that will help ...
    Keywords Salford Lung Studies (SLS) ; Effectiveness trial ; Trial experience ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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