Exploring how the methods used might influence the results of a pragmatic clinical trial in respiratory care.

*FUNDING CONFIRMED*

“Quality” in clinical trials has been defined as the absence of errors or biases which have a meaningful impact on the safety of trial participants or the credibility of the results (and thereby the care of future patients). More credibility is given to the results of high quality trials when making recommendations for clinical practice. This PhD will provide a coherent programme of research into the role of study participants in various aspects of the methodology of a pragmatic clinical trial in respiratory care.

Many rigorous methodologies (e.g. placebo controlled trials with blinding of patients and outcome assessors) embedded in clinical trials are expensive to implement and there is a dearth of research justifying the actual impact these methodologies have on the final results of the trial. Some methodologies such as the use of placebo or blinded outcome measurement are not always possible (e.g. in studies of physiotherapy or interventions for airway clearance) and more pragmatic study designs are often used to conduct trials that will address important uncertainties in these areas of practice. This PhD will investigate the impact of opting for a pragmatic clinical trial design (instead of a double blind placebo controlled trial) and the possible role of study participants in supporting a range of strategies to optimize scientific rigor.

Clinicians and regulatory authorities are increasingly interested in the use of patient reported outcome measures (PROMs) in trials and, in some trials, PROMs have been considered as the primary outcome. However, there is much debate regarding the validity of PROMs in clinical trials. This PhD will investigate the validity of PROMs in the respiratory setting, by comparing different methods for reporting of pulmonary exacerbations within a pragmatic clinical trial.

It is well documented that adherence is a major determinant of treatment effectiveness. Recently, expensive technology has been developed to measure adherence to treatment interventions in respiratory care but it is unclear how technological adherence data compares to much cheaper methods for measuring adherence, such as simply asking the patient. This PhD will investigate the impact of different methods for collecting adherence data.

REQUIREMENTS

Candidates should have or expect to obtain a 2:1 or higher Honours degree or equivalent in a relevant biomedical or life sciences subject including AHP/nurse or psychology

English Language

Candidates applying from countries where the first language is not English should produce evidence of their competence through a qualification such as IELTS or TOEFL score.

The minimum recommended score for the School of Medicine, Dentistry and Biomedical Science is:
• IELTS score of 6.0 with not less than 5.5 in each of the four component elements of listening, reading, speaking and writing taken within the last 2 years;
• TOEFL score of 80+ (internet basted test), taken within the last 2 years, with minimum component scores of; Listening 17, Reading 18, Speaking 20, Writing 17);
• A valid Certificate of Proficiency in English grade A or B;
• A valid Certificate of Advanced English grade A; or
• A first or upper second class honours degree from a university based in the UK, Republic of Ireland or other suitably quality assured location in a country deemed by the UK Border Agency to be majority English speaking.