scholarly journals Comparative analysis of general practice and digital methods to recruit stroke survivors to a clinical mobility study (Preprint)

2021 ◽  
Author(s):  
Katja Reuter ◽  
Chang Liu ◽  
NamQuyen Le ◽  
Praveen Angyan ◽  
James Micah Finley
Keyword(s):  
Clinical Trials ◽  
General Practice ◽  
Cost Effectiveness ◽  
Digital Media ◽  
Acute Stage ◽  
Stroke Survivors ◽  
Recruitment Methods ◽  
Digital Methods ◽  
Study Participants ◽  
Mobility Study

BACKGROUND Participant recruitment remains a barrier to conducting clinical research. The disabling nature of a stroke, which often includes functional and cognitive impairments, and the acute stage of illness at which patients are appropriate for many trials, make recruiting patients particularly complex and challenging. In addition, people aged 65 years and older, which includes most stroke survivors, have been identified as a disadvantaged group that is commonly underrepresented in health research, particularly clinical trials. Digital media may provide effective tools to support enrollment efforts of stroke survivors in clinical trials. OBJECTIVE The objective of this study was to compare the effectiveness of general practice and digital methods to recruit stroke survivors to a clinical mobility study. METHODS Recruitment for a clinical mobility study began in July 2018. Eligible study participants included individuals 18 years and older who had a single stroke and were currently ambulatory in the community. Standard recruiting practice included calling individuals listed in a stroke registry, contacting local physical therapists, and placing study flyers throughout a University Campus. Between May 21, 2019, and June 26, 2019, the study was also promoted digitally using the social network Facebook and the search engine marketing tool Google AdWords. The recruitment ads included a link to the study page to which users who clicked were referred. Primary outcomes of interest for both conventional and digital methods included recruitment speed (enrollment rate) and sample characteristics. The data were analyzed using the Lilliefors test, Welch’s two-sample t-test, and the Mann-Wittney test. Significance was set at P<0.05. All statistical analyses were performed in Matlab 2019b. RESULTS Our results indicate that digital recruitment methods can address recruitment challenges regarding stroke survivors. Digital recruitment methods allowed us to enroll study participants at a faster rate (1.8 participants/week), compared to using general recruitment practice (0.57 participants/week). Our findings also demonstrate that digital and general recruitment practices can achieve an equivalent level of sample representativeness. The characteristics of the enrolled stroke survivors did not differ significantly by age (P=.95) or clinical scores (P=.22; P=.82). Comparing the cost-effectiveness of Facebook and Google, we found that the use of Facebook resulted in a lower cost per click and cost per enrollee per advertisement. CONCLUSIONS Both general practice and digital media recruitment methods will be important to the successful recruitment of stroke survivors. Future studies could focus on testing the effectiveness of additional general practice and digital media approaches and include robust cost-effectiveness analyses. Examining the effectiveness of different messaging and visual approaches tailored to culturally diverse and underrepresented target subgroups could provide further data to move toward evidence-based recruitment strategies.

scholarly journals Use of electronic recruitment methods in a clinical trial of adults with gout

2020 ◽  
pp. 174077452095696
Author(s):  
Hailey N Miller ◽  
Jeanne Charleston ◽  
Beiwen Wu ◽  
Kelly Gleason ◽  
Karen White ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Medical Record ◽  
Electronic Medical Record ◽  
Response Rate ◽  
Cost Effective ◽  
Demographic Characteristics ◽  
Completion Rate ◽  
Patient Portal ◽  
Recruitment Methods

Background/aims: Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods. Methods: We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)–like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record–based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method. Results: Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record–based methods. Patient portal messaging, an electronic medical record–based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record–based methods ($60) were more cost-effective per response than non-electronic medical record–based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans. Conclusion: An electronic medical record–based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

The cost-effectiveness of one-time opportunistic screening for atrial fibrillation in different age cohorts of inhabitants in Denmark aged 65 years and above: a Markov modelled analysis

2020 ◽  
Author(s):  
Lucca Katrine Sciera ◽  
Lars Frost ◽  
Lars Dybro ◽  
Peter Bo Poulsen
Keyword(s):  
Atrial Fibrillation ◽  
General Practice ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Population Data ◽  
National Registry ◽  
Opportunistic Screening ◽  
Age Cohorts ◽  
Life Years ◽  
The Cost

Abstract Aims The objective was to evaluate the cost-effectiveness of one-time opportunistic screening for atrial fibrillation (AF) in general practice in citizens aged ≥65 years in Denmark compared to a no-screening alternative following current Danish practice. Methods and results A decision tree and a Markov model were designed to simulate costs and quality-adjusted life years (QALYs) in a hypothetical cohort of citizens aged ≥65 years equivalent to the Danish population (1 M citizens) over the course of 19 years, using a healthcare and societal perspective. Share of detected AF patients following opportunistic screening was retrieved from a recent Danish screening study, whereas the risk stroke and bleedings in AF patients were based on population data from national registries and their associated costs was obtained from published national registry studies. The present study showed that one-time opportunistic screening for AF was more costly, but also more effective compared to a no-screening alternative. The analysis predicts that one-time opportunistic screening of all Danes aged ≥65 years potentially can identify an additional 10 300 AF patients and prevent 856 strokes in the period considered. The incremental cost of such a screening programme is €56.4 M, with a total gain of 6000 QALYs, resulting in an incremental cost-effectiveness ratio of €9400 per QALY gained. Conclusion Opportunistic screening in general practice in citizens aged ≥65 years in Denmark is cost-effective compared to a willingness-to-pay threshold of €22 000. The study and its findings support a potential implementation of opportunistic screening for AF at the general practitioner level in Denmark.

scholarly journals Cell Therapy for Stroke: A Mechanistic Analysis

Neurosurgery ◽  
2020 ◽  
Author(s):  
Ben Jiahe Gu ◽  
David K Kung ◽  
Han-Chiao Isaac Chen
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Cell Therapy ◽  
Clinical Translation ◽  
Stroke Survivors ◽  
Cell Replacement ◽  
Preclinical Data ◽  
Promising Strategy ◽  
Mechanistic Analysis

Abstract Cell therapy has been widely recognized as a promising strategy to enhance recovery in stroke survivors. However, despite an abundance of encouraging preclinical data, successful clinical translation remains elusive. As the field continues to advance, it is important to reexamine prior clinical trials in the context of their intended mechanisms, as this can inform future preclinical and translational efforts. In the present work, we review the major clinical trials of cell therapy for stroke and highlight a mechanistic shift between the earliest studies, which aimed to replace dead and damaged neurons, and later ones that focused on exploiting the various neuromodulatory effects afforded by stem cells. We discuss why both mechanisms are worth pursuing and emphasize the means through which cell replacement can still be achieved.

DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

2021 ◽  
pp. 136749352110037
Author(s):  
Alison E. Parker ◽  
Tracy M. Scull ◽  
Abigail M. Morrison
Keyword(s):  
Clinical Trials ◽  
Interactive Multimedia ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Satisfaction Questionnaire ◽  
Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

scholarly journals Randomised clinical trials in general practice.

BMJ ◽  
1992 ◽  
Vol 304 (6825) ◽  
pp. 508-508 ◽  
Author(s):  
P. L. Jonker ◽  
C. A. Sumajow
Keyword(s):  
Clinical Trials ◽  
General Practice ◽  
Randomised Clinical Trials

scholarly journals Effectiveness and cost-effectiveness of implementing HIV testing in primary care in East London: protocol for an interrupted time series analysis

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018163 ◽  
Author(s):  
Werner Leber ◽  
Lee Beresford ◽  
Claire Nightingale ◽  
Estela Capelas Barbosa ◽  
Stephen Morris ◽  
...  
Keyword(s):  
Primary Care ◽  
Time Series ◽  
General Practice ◽  
Cost Effectiveness ◽  
Hiv Testing ◽  
Cost Effective ◽  
Interrupted Time Series ◽  
Rapid Hiv Testing ◽  
Post Trial ◽  
Implementation Programme

IntroductionHIV remains underdiagnosed. Guidelines recommend routine HIV testing in primary care, but evidence on implementing testing is lacking. In a previous study, the Rapid HIV Assessment 2 (RHIVA2) cluster randomised controlled trial, we showed that providing training and rapid point-of-care HIV testing at general practice registration (RHIVA2 intervention) in Hackney led to cost-effective, increased and earlier diagnosis of HIV. However, interventions effective in a trial context may be less so when implemented in routine practice. We describe the protocol for an MRC phase IV implementation programme, evaluating the impact of rolling out the RHIVA2 intervention in a post-trial setting. We will use a longitudinal study to examine if the post-trial implementation in Hackney practices is effective and cost-effective, and a cross-sectional study to compare Hackney with two adjacent boroughs providing usual primary care (Newham) and an enhanced service promoting HIV testing in primary care (Tower Hamlets).Methods and analysisService evaluation using interrupted time series and cost-effectiveness analyses. We will include all general practices in three contiguous high HIV prevalence East London boroughs. All adults aged 16 and above registered with the practices will be included. The interventions to be examined are: a post-trial RHIVA2 implementation programme (including practice-based education and training, external quality assurance, incentive payments for rapid HIV testing and incorporation of rapid HIV testing in the sexual health Local Enhanced Service) in Hackney; the general practice sexual health Network Improved Service in Tower Hamlets and usual care in Newham. Coprimary outcomes are rates of HIV testing and new HIV diagnoses.Ethics and disseminationThe chair of the Camden and Islington NHS Research Ethics Committee, London, has endorsed this programme as an evaluation of routine care. Study results will be published in peer-reviewed journals and reported to commissioners.

Sign in / Sign up

Export Citation Format

Share Document