395 research outputs found
Impact of patient and public involvement on enrolment and retention in clinical trials: Systematic review and meta-analysis
Ā© Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to. Objective To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI. Design Systematic review and meta-analysis. Data sources Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries. Eligibility criteria Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement). Data extraction and analysis Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses. Results 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis). Conclusions These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention. Systematic review registration PROSPERO CRD42016043808
Features of 20ā133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol:prospective observational cohort study
Objective: To characterise the clinical features of patients admitted to hospital with coronavirus disease 2019 (covid-19) in the United Kingdom during the growth phase of the first wave of this outbreak who were enrolled in the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study, and to explore risk factors associated with mortality in hospital. Design: Prospective observational cohort study with rapid data gathering and near real time analysis. Setting: 208 acute care hospitals in England, Wales, and Scotland between 6 February and 19 April 2020. A case report form developed by ISARIC and WHO was used to collect clinical data. A minimal follow-up time of two weeks (to 3 May 2020) allowed most patients to complete their hospital admission. Participants: 20 133 hospital inpatients with covid-19. Main outcome measures: Admission to critical care (high dependency unit or intensive care unit) and mortality in hospital. Results: The median age of patients admitted to hospital with covid-19, or with a diagnosis of covid-19 made in hospital, was 73 years (interquartile range 58-82, range 0-104). More men were admitted than women (men 60%, n=12 068; women 40%, n=8065). The median duration of symptoms before admission was 4 days (interquartile range 1-8). The commonest comorbidities were chronic cardiac disease (31%, 5469/17 702), uncomplicated diabetes (21%, 3650/17 599), non-asthmatic chronic pulmonary disease (18%, 3128/17 634), and chronic kidney disease (16%, 2830/17 506); 23% (4161/18 525) had no reported major comorbidity. Overall, 41% (8199/20 133) of patients were discharged alive, 26% (5165/20 133) died, and 34% (6769/20 133) continued to receive care at the reporting date. 17% (3001/18 183) required admission to high dependency or intensive care units; of these, 28% (826/3001) were discharged alive, 32% (958/3001) died, and 41% (1217/3001) continued to receive care at the reporting date. Of those receiving mechanical ventilation, 17% (276/1658) were discharged alive, 37% (618/1658) died, and 46% (764/1658) remained in hospital. Increasing age, male sex, and comorbidities including chronic cardiac disease, non-asthmatic chronic pulmonary disease, chronic kidney disease, liver disease and obesity were associated with higher mortality in hospital. Conclusions: ISARIC WHO CCP-UK is a large prospective cohort study of patients in hospital with covid-19. The study continues to enrol at the time of this report. In study participants, mortality was high, independent risk factors were increasing age, male sex, and chronic comorbidity, including obesity. This study has shown the importance of pandemic preparedness and the need to maintain readiness to launch research studies in response to outbreaks. Study registration: ISRCTN66726260
Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study
Objectives: 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 āexemplarsā. Part C: a large multicentre trial (the CRASH trial) of treatment for head injury.
Review methods: The study used a number of different perspectives (āmultiple lensesā), 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 āconductā (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 āfailuresā) may help to clarify whether the patterns seen in the āexemplarā 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.Not peer reviewedPublisher PD
Role of Causal Information in Patient Education: An Experimental and Clinical Approach
Abstract
It is somewhat paradoxical that few patient education interventions actually consider the processes by which individuals best learn health-related information. The paucity of empirically validated teaching strategies impedes efforts to improve the delivery of care in cardiovascular rehabilitation and secondary prevention (CRSP) programs. The main goal of this dissertation was to examine whether explaining how illness pathophysiology, symptoms and health behaviour are interconnected (i.e., causal information) enhances the effectiveness of patient education materials.
This question was first addressed in a laboratory setting (Study 1) in which younger and older adults read about a fictitious disease under two conditions. Younger participants who read about how health behaviours were causally linked to illness pathophysiology and symptom reduction were better able to apply their knowledge than those who read this information in a non-integrated manner. However, this effect was not observed in the older sample. These findings were followed up in a cluster randomized controlled trial, in which causal information about connections among endothelial pathophysiology, cardiac risk factors, symptoms and health behaviours were integrated into a group education session at a Cardiac Rehabilitation and Secondary Prevention (CRSP) program. Results from Study 2 indicated that the addition of causal information was associated with deeper levels of knowledge about cardiovascular management and enhanced efficacy beliefs about the CRSP program. Study 3, which focused on participantsā behaviours, showed that the intervention did not impact patientsā likelihood to enroll into CRSP nor their physical activity levels four months into the program. The intervention group was marginally faster at completing prerequisites for program entry, but baseline characteristics, including anxiety and male gender, were stronger predictors of this behavior.
The present dissertation is the first to provide empirical support for the inclusion of causal information into patient education curricula. Findings indicate that patientsā depth of understanding warrants more attention in patient education contexts. Taken together, results from this dissertation serve as a stepping-stone towards enhancing provider-patient collaboration by demonstrating that patients have a better understanding when they are told why they are being asked to follow the cardiovascular management recommendations rather than simply being told what to do
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Between Protection and Participation : Moral promises and perils in pediatric clinical research
This thesis aims to contribute to the optimal inclusion of children in pediatric clinical research in such a way that we can further clinical research to advance scientific knowledge and develop much-needed treatment options for children while protecting children against harm from research.
Why do children and parents want to participate (or not)? What are their motivations and what is important to them in their decision? What expectations do they have of participation? Answers to these questions are indispensable in order to incorporate their views into the pediatric research enterprise and tailor the process of recruitment and informed consent to their needs and perspectives. When we know why children and parents consent or dissent to research and what elements they use in their decision, we know what they attach importance to in their decision. From this data, we learn which information they want and need to make a valid informed decision. This information helps us to increase both the moral and instrumental value of informed consent in pediatric clinical research; we obtain more informed consent and probably more informed consent.
The main research aims of this thesis are as follows:
1. To explore childrenās and their parentsā motivations, views and expectations during recruitment and informed consent processes in pediatric clinical research.
2. To analyze these motivations, views and expectations and the factors that shape them from an ethical and legal perspective.
3. To develop a normative framework to support research professionals in the ethically sound inclusion of children in pediatric clinical research. This framework tailors the proc
Biobank participation of persons with epilepsy in South Wales
Introduction: The Swansea Neurology Biobank (SNB) has collected thousands of DNA bio-samples from people with epilepsy in South Wales. Analysis of biobank participation is important to optimise future recruitment for epilepsy research, meta-data analysis and gene / biomarker discovery. This will lead to a high-quality platform for the collection of biological specimens and data. Method: Participation data was extracted from over 2,500 patient records during SNB screening between 2016 and 2018. Biobank participation rates were calculated and linked to epilepsy prevalence using linked, anonymised primary care within the Secure Anonymised Information Linkage databank. Demographics, epilepsy characteristics and social deprivation status (measured using the Welsh Index of Multiple Deprivation ā WIMD) were combined at a small geographical (Lower Super Output Area) scale. Factors hypothesised to influence biobank participation were analysed using bivariate and multivariate statistics. A proportion of biobank participants completed a questionnaire assessing attitudes to biobank consent. Results: 12.5% of people with epilepsy seen at epilepsy clinics within the Swansea area were represented in the SNB in 2018. Epilepsy prevalence in the study area (0.92%) was higher than the all Wales epilepsy prevalence (0.85%) and was highest in the most deprived areas. Older patients were more likely to donate compared to the youngest age grouping. Generalised onset epilepsy was underrepresented in the SNB with only 19% having generalised epilepsy. Nearly 20% of patients did not attend their appointment with the majority (59%) coming from the most deprived areas. A large proportion of non-attenders who had generalised epilepsy were diagnosed with Juvenile Myoclonic Epilepsy. Participation rates were lower in more deprived areas when compared to less deprived areas (36% WIMD quintile 1 compared to 41% quintile 4 and 5). Biobank participants were generally positive about biobank donation but there were uncertainties related to the broad reach of the consent process. Conclusion: Our results highlight the difficulty in encouraging research participation at levels representative of the local epilepsy population. Despite higher epilepsy prevalence in more deprived areas, participation rates are lower and non-attendance rates are higher. Mapping of epilepsy participation enables the identification of these low participation areas enabling focused recruitment strategies. Working with primary care and bringing services to the community may improve recruitment when compared to hospital clinic based recruitment
Health Sciences undergraduate handbook
1999 undergraduate handbook for the faculty of Health Science
Health Sciences undergraduate handbook
1999 undergraduate handbook for the faculty of Health Science
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