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Item Public acceptability of financial incentives for smoking cessation in pregnancy and breast feeding : a survey of the British public(2014-07-18) Hoddinott, Pat; Morgan, Heather; MacLennan, Graeme; Sewel, Kate; Thomson, Gill; Bauld, Linda; Yi, Deokhee; Ludbrook, Anne; Campbell, Marion Kay; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Health Economics Research Unit; University of Aberdeen.CLSM College Office; University of Aberdeen.Institute of Applied Health SciencesItem Reasons for participating in randomised controlled trials : conditional altruism and considerations for self(2010-03-22) McCann, Sharon Katrina; Campbell, Marion Kay; Entwistle, Vikki Ann; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Institute of Applied Health Sciences; University of Aberdeen.Aberdeen Centre for EvaluationItem Meaning behind measurement : self-comparisons affect responses to health related quality of life questionnaires(Springer, 2009) Robertson, Clare; Langston, Anne L.; Stapley, Sally; McColl, Elaine; Campbell, Marion Kay; Fraser, William D.; MacLennan, Graeme Stewart; Selby, Peter L.; Ralston, Stuart H.; Fayers, Peter M.; PRISM Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesPurpose The subjective nature of quality of life is particularly pertinent to the domain of health-related quality of life (HRQOL) research. The extent to which participants’ responses are affected by subjective information and personal reference frames is unknown. This study investigated how an elderly population living with a chronic metabolic bone disorder evaluated self-reported quality of life. Methods Participants (n = 1,331) in a multi-centre randomised controlled trial for the treatment of Paget’s disease completed annual HRQOL questionnaires, including the SF-36, EQ-5D and HAQ. Supplementary questions were added to reveal implicit reference frames used when making HRQOL evaluations. Twenty-one participants (11 male, 10 female, aged 59–91 years) were interviewed retrospectively about their responses to the supplementary questions, using cognitive interviewing techniques and semi-structured topic guides. Results The interviews revealed that participants used complex and interconnected reference frames to promote response shift when making quality of life evaluations. The choice of reference frame often reflected external factors unrelated to individual health. Many participants also stated that they were unclear whether to report general or disease-related HRQOL. Conclusions It is important, especially in clinical trials, to provide instructions clarifying whether ‘quality of life’ refers to disease-related HRQOL. Information on selfcomparison reference frames is necessary for the interpretation of responses to questions about HRQOL.Item Single imputation methods were inadequate for missing not at random (MNAR) quality of life data(BMC, 2008-08-04) Fielding, Shona; Fayers, Peter; McDonald, Alison Mary; McPherson, Gladys Campbell; Campbell, Marion Kay; RECORD Study Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjective: QoL data were routinely collected in a randomised controlled trial (RCT), which employed a reminder system, retrieving about 50% of data originally missing. The objective was to use this unique feature to evaluate possible missingness mechanisms and to assess the accuracy of simple imputation methods. Methods: Those patients responding after reminder were regarded as providing missing responses. A hypothesis test and a logistic regression approach were used to evaluate the missingness mechanism. Simple imputation procedures were carried out on these missing scores and the results compared to the actual observed scores. Results: The hypothesis test and logistic regression approaches suggested the reminder data were missing not at random (MNAR). Reminder-response data showed that simple imputation procedures utilising information collected close to the point of imputation (last value carried forward, next value carried backward and last-and-next), were the best methods in this setting. However, although these methods were the best of the simple imputation procedures considered, they were not sufficiently accurate to be confident of obtaining unbiased results under imputation. Conclusion: The use of the reminder data enabled the conclusion of possible MNAR data. Evaluating this mechanism was important in determining if imputation was useful. Simple imputation was shown to be inadequate if MNAR are likely and alternative strategies should be considered.Item Protocol for stage 2 of the GaP study (genetic testing acceptability for Paget's disease of the bone) : a questionnaire study to investigate whether relatives of people with Paget's disease would accept genetic testing and preventative treatment if they were available(BioMed Central, 2008-05-29) Langston, Anne L.; Johnston, Marie; Francis, Jillian Joy; Robertson, Clare; Campbell, Marion Kay; Entwistle, Vikki; Marteau, Theresa; MacLennan, Graeme Stewart; Weinman, John; McCallum, Marilyn; Miedzybrodzka, Zosia; Charnock, Keith; Ralston, Stuart H.; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground: Paget's disease of bone (PDB) disrupts normal bone architecture and causes pain, deformity, deafness, osteoarthritis, and fractures. Genetic factors play a role in PDB and genetic tests are now conducted for research purposes. It is thus timely to investigate the potential for a clinical programme of genetic testing and preventative treatment for people who have a family history of PDB. This study examines the beliefs of relatives of people with PDB. It focuses particularly on illness and treatment representations as predictors of the acceptability and uptake of potential clinical programmes. Illness representations are examined using Leventhal's Common Sense Self-Regulation Model while cognitions about treatment behaviours (acceptance of testing and treatment uptake) are conceptualised within the Theory of Planned Behaviour. Methods/Design: A postal questionnaire of non-affected relatives of people with Paget's disease. The sample will include relatives of Paget's patients with a family history of Paget's disease and relatives of Paget's patients without a family history of Paget's disease. The questionnaire will explore whether a range of factors relate to acceptability of a programme of genetic testing and preventive treatment in relatives of Paget's disease sufferers. The questionnaire will include several measures: illness representations (as measured by the Brief Illness Perceptions Questionnaire); treatment representations (as measured by Theory of Planned Behaviour-based question items, informed by a prior interview elicitation study); descriptive and demographic details; and questions exploring family environment and beliefs of other important people. Data will also be collected from family members who have been diagnosed with Paget's disease to describe the disease presentation and its distribution within a family. Discussion: The answers to these measures will inform the feasibility of a programme of genetic testing and preventive treatment for individuals who are at a high risk of developing Paget's disease because they carry an appropriate genetic mutation. They will also contribute to theoretical and empirical approaches to predicting diagnostic and treatment behaviours from the combined theoretical models.Item Marketing and clinical trials : a case study(BioMed Central, 2007-11-20) Francis, David; Roberts, Ian; Elbourne, Diana R.; Shakur, Haleema; Knight, Rosemary C.; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki; McDonald, Alison Mary; Grant, Adrian Maxwell; Campbell, Marion Kay; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results: The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion: The performance of future clinical trials could be enhanced if trialists routinely considered these factors.Item Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study(Gray Publishing, 2007-11) Campbell, Marion Kay; Snowdon, Claire; Francis, David; Elbourne, Diana R.; McDonald, Alison Mary; Knight, Rosemary C.; Entwistle, Vikki; Garcia, Jo; Roberts, Ian; Grant, Adrian Maxwell; STEPS Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjectives: To identify factors associated with good and poor recruitment to multicentre trials. Data sources: Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology Assessment Programmes. Part B: interviews with people playing a wide range of roles within four trials that their funders identified as ‘exemplars’. Part C: a large multicentre trial (the CRASH trial) of treatment for head injury. Review methods: The study used a number of different perspectives (‘multiple lenses’), and three components. Part A: an epidemiological review of a cohort of trials. Part B: case studies of trials that appeared to have particularly interesting lessons for recruitment. Part C: a single, in-depth case study to examine the feasibility of applying a businessorientated analytical framework as a reference model in future trials. Results: In the 114 trials found in Part A, less than one-third recruited their original target within the time originally specified, and around one-third had extensions. Factors observed more often in trials that recruited successfully were: having a dedicated trial manager, being a cancer or drug trial, and having interventions only available inside the trial. The most commonly reported strategies to improve recruitment were newsletters and mailshots, but it was not possible to assess whether they were causally linked to changes in recruitment. The analyses in Part B suggested that successful trials were those addressing clinically important questions at a timely point. The investigators were held in high esteem by the interviewees, and the trials were firmly grounded in existing clinical practices, so that the trial processes were not alien to clinical collaborators, and the results could be easily applicable to future practice. The interviewees considered that the needs of patients were well served by participation in the trials. Clinical collaborators particularly appreciated clear delineation of roles, which released them from much of the workload associated with trial participation. There was a strong feeling from interviewees that they were proud to be part of a successful team. This pride fed into further success. Good groundwork and excellent communications across many levels of complex trial structures were considered to be extremely important, including training components for learning about trial interventions and processes, and team building. All four trials had faced recruitment problems, and extra insights into the working of trials were afforded by strategies invoked to address them. The process of the case study in Part C was able to draw attention to a body of research and practice in a different discipline (academic business studies). It generated a reference model derived from a combination of business theory and work within CRASH. This enabled identification of weaker managerial components within CRASH, and initiatives to strengthen them. Although it is not clear, even within CRASH, whether the initiatives that follow from developing and applying the model will be effective in increasing recruitment or other aspects of the success of the trial, the reference model could provide a template, with potential for those managing other trials to use or adapt it, especially at foundation stages. The model derived from this project could also be used as a diagnostic tool if trials have difficulties and hence as a basis for deciding what type of remedial action to take. It may also be useful for auditing the progress of trials, such as during external review. Conclusions: While not producing sufficiently definitive results to make strong recommendations, the work here suggests that future trials should consider the different needs at different phases in the life of trials, and place greater emphasis on ‘conduct’ (the process of actually doing trials). This implies learning lessons from successful trialists and trial managers, with better training for issues relating to trial conduct. The complexity of large trials means that unanticipated difficulties are highly likely at some time in every trial. Part B suggested that successful trials were those flexible and robust enough to adapt to unexpected issues. Arguably, the trialists should also expect agility from funders within a proactive approach to monitoring ongoing trials. Further research into different recruitment patterns (including ‘failures’) may help to clarify whether the patterns seen in the ‘exemplar’ trials differ or are similar. The reference model from Part C needs to be further considered in other similar and different trials to assess its robustness. These and other strategies aimed at increasing recruitment and making trials more successful need to be formally evaluated for their effectiveness in a range of trials.Item Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.(Trials, 2006-12-21) Snowdon, Claire; Elbourne, Diana R.; Garcia, Jo; Campbell, Marion Kay; Entwistle, Vikki; Francis, David; Grant, Adrian Maxwell; Knight, Rosemary C.; McDonald, Alison Mary; Roberts, Ian; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesItem What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.(Trials, 2006-04-07) McDonald, Alison Mary; Knight, Rosemary C.; Campbell, Marion Kay; Entwistle, Vikki; Grant, Adrian Maxwell; Cook, Jonathan Alistair; Elbourne, Diana R.; Francis, David; Garcia, Jo; Roberts, Ian; Snowdon, Claire; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesItem Protocol for stage 1 of the GAP study (Genetic testing acceptability for Paget's disease of bone):an interview study about genetic testing and preventive treatment(BMC Health Services Research, 2006-06-08) Langston, Anne L.; Johnston, Marie; Robertson, Clare; Campbell, Marion Kay; Entwistle, Vikki; Marteau, T M; McCallum, M; Ralston, S H; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences