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1.
BMC Prim Care ; 23(1): 95, 2022 04 28.
Article in English | MEDLINE | ID: covidwho-1817185

ABSTRACT

BACKGROUND: Recruiting healthcare providers as research subjects often rely on in-person recruitment strategies. Little is known about recruiting provider participants via electronic recruitment methods. In this study, conducted during the COVID-19 pandemic, we describe and evaluate a primarily electronic approach to recruiting primary care providers (PCPs) as subjects in a pragmatic randomized controlled trial (RCT) of a decision support intervention. METHODS: We adapted an existing framework for healthcare provider research recruitment, employing an electronic consent form and a mix of brief synchronous video presentations, email, and phone calls to recruit PCPs into the RCT. To evaluate the success of each electronic strategy, we estimated the number of consented PCPs associated with each strategy, the number of days to recruit each PCP and recruitment costs. RESULTS: We recruited 45 of 63 eligible PCPs practicing at ten primary care clinic locations over 55 days. On average, it took 17 business days to recruit a PCP (range 0-48) and required three attempts (range 1-7). Email communication from the clinic leaders led to the most successful recruitments, followed by brief synchronous video presentations at regularly scheduled clinic meetings. We spent approximately $89 per recruited PCP. We faced challenges of low email responsiveness and limited opportunities to forge relationships. CONCLUSION: PCPs can be efficiently recruited at low costs as research subjects using primarily electronic communications, even during a time of high workload and stress. Electronic peer leader outreach and synchronous video presentations may be particularly useful recruitment strategies. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04295135 . Registered 04 March 2020.


Subject(s)
COVID-19 , COVID-19/epidemiology , Electronics , Humans , Patient Selection , Primary Health Care , Research Subjects
3.
BMC Cancer ; 22(1): 3, 2022 Jan 03.
Article in English | MEDLINE | ID: covidwho-1605308

ABSTRACT

BACKGROUND: Older patients are underrepresented in the clinical trials that determine the standards of care for oncological treatment. We conducted a review to identify whether there have been age-restrictive inclusion criteria in clinical trials over the last twenty five years, focusing on patients with metastatic gastroesophageal cancer. METHODS: A search strategy was developed encompassing Embase, PubMed and The Cochrane Library databases. Completed phase III randomised controlled trials evaluating systemic anti-cancer therapies in metastatic gastroesophageal malignancies from 1st January 1995 to 18th November 2020 were identified. These were screened for eligibility using reference management software (Covidence; Veritas Health Innovation Ltd). Data including age inclusion/exclusion criteria and median age of participants were recorded. The percentage of patients ≥ 65 enrolled was collected where available. The change over time in the proportion of studies using an upper age exclusion was estimated using a linear probability model. RESULTS: Three hundred sixty-three phase III studies were identified and screened, with 66 trials remaining for final analysis. The majority of trials were Asian (48%; n = 32) and predominantly evaluated gastric malignancies, (86%; n = 56). The median age of participants was 62 (range 18-94). Thirty-two percent (n = 21) of studies specified an upper age limit for inclusion and over half of these were Asian studies. The median age of exclusion was 75 (range 65-80). All studies prior to 2003 used an upper age exclusion (n = 12); whereas only 9 that started in 2003 or later did (17%). Among later studies, there was a very modest downward yearly-trend in the proportion of studies using an upper age exclusion (-0.02 per year; 95%CI -0.05 to 0.01; p = 0.31). Fifty-two percent (n = 34) of studies specified the proportion of their study population who were ≥ 65 years. Older patients represented only 36% of the trial populations in these studies (range 7-60%). CONCLUSIONS: Recent years have seen improvements in clinical trial protocols, with many no longer specifying restrictive age criteria. Reasons for poor representation of older patients are complex and ongoing efforts are needed to broaden eligibility criteria and prioritise the inclusion of older adults in clinical trials.


Subject(s)
Age Factors , Clinical Trials, Phase III as Topic/statistics & numerical data , Esophageal Neoplasms , Randomized Controlled Trials as Topic/statistics & numerical data , Research Subjects/statistics & numerical data , Stomach Neoplasms , Adolescent , Adult , Aged , Aged, 80 and over , Eligibility Determination , Female , Humans , Male , Middle Aged , Patient Selection , Young Adult
4.
Acad Med ; 97(1): 48-52, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1584029

ABSTRACT

By March 2020, New York City became the early epicenter of the COVID-19 pandemic in the United States. Consequently, Columbia University, with its large portfolio of human subjects research, had to address the challenges of protecting thousands of research participants and research staff from potential exposure to COVID-19 while facilitating essential biomedical research, especially pandemic-related studies. The authors describe, from the perspective of Columbia's research administration leadership, how the University and its primary teaching hospital ramped down-and later ramped up-human subjects research and reflect on lessons learned. As the pandemic unfolded, only studies offering the prospect of direct benefit to subjects were permitted to continue with in-person contact. New in-person participant enrollment ceased, except for COVID-19 prevention or treatment studies. Centralized, frequently updated communication about policies and procedures was disseminated to the Columbia research community. Procedural efficiencies were rapidly developed and implemented for review and oversight of human subjects research and contractual agreements for clinical trials. More frequent institutional review board meetings and 24-hour support markedly reduced turnaround time for COVID-19 studies, without delaying approvals of non-COVID-19 research. Research administration worked closely with relevant principal federal agencies, whose regulatory flexibility facilitated the efficient implementation of COVID-19-related research. Overall, the ramp-down and ramp-up of the majority of human subjects research, with specified priorities and accelerated processes, worked well. Adjustments were made to handle the increase in administrative tasks, the need to respond rapidly to added oversight responsibilities, and the management of the many new COVID-19-related research protocols. Timely, centralized communication, support for staff needs, prioritization, and collaboration were critical to successful research oversight at a large-scale academic setting in the midst of a pandemic. These perspectives may be useful to academic research centers addressing the current and future pandemics.


Subject(s)
COVID-19 , Pandemics , Academic Medical Centers , COVID-19/epidemiology , Ethics Committees, Research , Humans , Pandemics/prevention & control , Research Subjects
6.
Klin Monbl Augenheilkd ; 238(12): 1305-1311, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1442823

ABSTRACT

BACKGROUND: The aim of the study was to assess retinal microcirculation in patients with coronavirus disease 2019 (COVID-19) through the use of optical coherence tomography angiography (OCT-A) and compare the results with those obtained in healthy controls. METHODS: The study enrolled 39 patients who had fully recovered from COVID-19 and 40 healthy controls. OCT-A image acquisitions were obtained using AngioVue software (version 2017.1.0.151) and the RTVue XR Avanti imaging system (Optovue Inc., Fremont, CA, USA). Nonflow area in the superficial capillary plexus (SCP), foveal avascular zone (FAZ) area in the whole retinal vasculature, FAZ perimeter, acircularity index of FAZ, and foveal density were automatically obtained with the FAZ assessment tool. Vessel density (VD) at the SCP and deep capillary plexus were also measured. RESULTS: Compared to the control group, the nonflow area and the FAZ area in the whole retina was greater in the COVID-19 group; however no statistically significant difference was observed (p > 0.05 respectively). As for vessel densities, all superficial parafoveal VD parameters were considerably higher in the COVID-19 group compared to the control group (p < 0.05 respectively). Despite the fact that the vessel densities in the remaining zones were lower in the COVID-19 group, those differences were not statistically significant (p > 0.05 respectively). CONCLUSION: VD at the parafoveal area of the SCP was significantly higher among patients in the late post-recovery period of COVID-19 disease compared to healthy controls. These findings show the impact of COVID-19 on the retinal microvasculature and its possible role as a risk factor for the development of ocular diseases.


Subject(s)
COVID-19 , Fluorescein Angiography , Fovea Centralis , Fundus Oculi , Humans , Microcirculation , Research Subjects , Retinal Vessels/diagnostic imaging , SARS-CoV-2 , Tomography, Optical Coherence
7.
West J Nurs Res ; 43(10): 924-929, 2021 10.
Article in English | MEDLINE | ID: covidwho-1406684

ABSTRACT

Patients with diabetes are experts in the lived experience of self-management, making patient engagement beyond the role of research "subject" imperative for the creation of health care solutions that meaningfully address the problems they identify. We discuss our research team's relationship with our university's College Diabetes Network (CDN), an advocacy and support group for emerging adults with diabetes. Our collaborative research relationship has spanned three years, and multiple research studies with members serving as co-designers, consultants, and co-investigators. We discuss the CDN's role in two particular studies in which CDN members made substantive contributions to study design, instrument adaptation, and interpretation of findings. Key CDN members played a larger role in research activities and facilitated sustained engagement with the larger university CDN chapter. Barriers encountered included navigating research regulatory requirements while engaging CDN members in research and facilitating sustained engagement as CDN membership changes.


Subject(s)
Diabetes Mellitus , Patient Participation , Consultants , Diabetes Mellitus/therapy , Humans , Research Design , Research Subjects
8.
Reprod Sci ; 29(2): 620-626, 2022 02.
Article in English | MEDLINE | ID: covidwho-1345228

ABSTRACT

The Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant) Trial (clinicaltrials.gov no. NCT04173169) was designed to test the hypothesis that 60-day pre-treatment with an oral GnRH antagonist in women with documented endometriosis and planning an IVF cycle will result in a superior live birth rate to placebo. Eight hundred fourteen women are required from 4 national sites. To determine the feasibility of using an electronic medical record (EMR)-based strategy to recruit 204 participants at the Colorado site, we conducted a survey of women within the UCHealth system. Eligible women, identified using relevant ICD-10 codes, were invited to complete a 6-question survey to assess planned utilization of IVF, potential interest in participation, and whether delays in treatment due to COVID-19 would influence their decision to participate. Of 6354 age-eligible women with an endometriosis diagnosis, 421 had a concurrent infertility diagnosis. After eliminating duplicates, 212 were emailed a survey; 76 (36%) responded, 6 of whom reported no endometriosis diagnosis. Of the remaining 70, 29 (41%) were planning fertility treatment; only 19 planned IVF. All 19 expressed interest in participation. COVID-19 delays in treatment were not considered as a factor affecting participation by 8/19; the remaining 11 felt that it would "somewhat" affect their decision. None reported that they would not consider participation because of COVID-19. EMR-based recruitment for an endometriosis clinical trial is feasible although the overall yield of participants is low. Delays in treatment due to COVID-19 did not appear to overly influence potential recruitment.


Subject(s)
COVID-19 , Endometriosis/therapy , Fertility Agents, Female/therapeutic use , Fertilization in Vitro , Health Knowledge, Attitudes, Practice , Hormone Antagonists/therapeutic use , Infertility, Female/therapy , Patient Selection , Research Subjects/psychology , Adolescent , Adult , Choice Behavior , Double-Blind Method , Electronic Health Records , Endometriosis/diagnosis , Endometriosis/physiopathology , Female , Fertility Agents, Female/adverse effects , Gonadotropin-Releasing Hormone/antagonists & inhibitors , Hormone Antagonists/adverse effects , Humans , Infertility, Female/diagnosis , Infertility, Female/physiopathology , Live Birth , Pregnancy , Pregnancy Rate , Treatment Outcome , United States , Young Adult
9.
Narrat Inq Bioeth ; 11(1): 101-105, 2021.
Article in English | MEDLINE | ID: covidwho-1337556

ABSTRACT

In early 2020, clinicians and researchers rushed to understand the SARS-CoV-2 virus and how to go about treating and preventing it. Caring for patients while simultaneously learning about a disease not seen before created challenges on several levels. Much of the spotlight was on the researchers doing this critical work; however, these narratives remind us of the enormous effort and commitment shown by IRB members and research administrators responsible for research infrastructure. Despite the sense of urgency and obligation to plan and conduct clinical research during the pandemic, IRBs guaranteed that researchers still adhered to the core ethical principles that protect the rights and welfare of human subjects so that critical research could continue. Many themes emerge in these stories, including the need for flexibility in processes for both staff and research participants and the perception that IRB members serve as "research gatekeepers." With approaches to clinical research evolving, the SARS-CoV-2 pandemic may be the catalyst needed to make sustainable improvements to our research processes, roles, and goals.


Subject(s)
Biomedical Research/ethics , COVID-19 , Ethics Committees, Research , Pandemics , Ethics, Research , Gatekeeping , Humans , Narration , Research Personnel , Research Subjects , SARS-CoV-2
10.
Narrat Inq Bioeth ; 11(1): 95-99, 2021.
Article in English | MEDLINE | ID: covidwho-1337555

ABSTRACT

This commentary discusses twelve stories in which people who are involved in institutional review board (IRB) administration or serve as IRB members tell the stories of how the COVID-19 pandemic affected their work and lives. Among the aspects of these stories it highlights are the need to focus on the well-being of the institution's employees, and how issues involving protecting vulnerable subjects might relate to current policy debates about underserved communities. The final portion of this commentary focuses in particular on how one might measure success for a program in protecting its research subjects during a pandemic.


Subject(s)
COVID-19 , Ethics Committees, Research , Occupational Health , Pandemics , Research Subjects , Safety , Humans , Narration , Policy , SARS-CoV-2 , Vulnerable Populations
12.
JAMA Netw Open ; 4(7): e2118433, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1330275

ABSTRACT

Importance: During the initial outbreak of the COVID-19 pandemic, cancer clinical trial participation decreased precipitously. Given the continued pandemic-especially the severe wave of new cases and deaths in winter 2020 to 2021-a vital question is whether trial enrollments have remained low or even worsened. Objective: To examine the experience of cancer clinical trial enrollment 1 year after the COVID-19 outbreak. Design, Setting, and Participants: This cohort study examines initial enrollments to treatment trials and cancer control and prevention (CCP) trials conducted by the SWOG Cancer Research Network between January 1, 2016, and February 28, 2021. Participants include patients enrolled in the trials. Exposures: Landmark time points reflecting the onset and the apex, respectively, of the initial COVID-19 wave (March 1 to April 25, 2020) and the winter 2020 to 2021 wave (October 4, 2020, to January 23, 2021). Main Outcomes and Measures: This study used interrupted time-series analysis to examine enrollments over time related to the COVID-19-derived exposure variables using negative-binomial regression. Relative risk (RR) estimates representing weekly enrollment changes compared with expected rates (had the pandemic not occurred) were derived. The numbers of enrollments lost during the pandemic were estimated. Results: Overall, 29 398 patients (mean [SD] age, 60.3 [13.2] years) were enrolled (24 034 before the pandemic and 5364 during the pandemic), with 9198 patients (31.3%) aged 65 years or older, 17 199 female patients (58.6%), 3039 Black patients (10.8%), and 2260 Hispanic patients (7.9%). Most enrollments (19 451 [66.2%]) were to treatment trials. During the initial COVID-19 wave, there was a 9.0% model-estimated weekly reduction in enrollments (RR, 0.91; 95% CI, 0.89-0.93; P < .001), with effects compounding each week. Enrollment recovered thereafter, but decreased again during the winter 2020 to 2021 wave, although by only 2.0% each week (RR, 0.98; 95% CI, 0.97-0.99; P < .001). Overall, during the pandemic, actual enrollments were 77.3% of expected enrollments (5364 of 6913 enrollments; 95% CI, 70.5%-85.0%; P < .001). Actual enrollments were 54.0% of expected enrollments for CCP trials (1421 of 2641 enrollments; 95% CI, 43.0%-67.0%; P < .001) and 91.0% of expected enrollments for treatment trials (3922 of 4304 enrollments; 95% CI, 81.0%-102.0%; P = .12). Conclusions and Relevance: In this cohort study, clinical trial enrollments decreased during the full year of the COVID-19 pandemic. Enrollment reductions were primarily to CCP trials, whereas, remarkably, there was not strong evidence of enrollment reductions to treatment trials. This finding suggests that clinical research rapidly adapted to the circumstances of enrolling and treating patients on protocols during the COVID-19 pandemic.


Subject(s)
COVID-19/epidemiology , Clinical Trials as Topic/statistics & numerical data , Disease Outbreaks , Neoplasms , Research Subjects/statistics & numerical data , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Time Factors
13.
Indoor Air ; 31(6): 1896-1912, 2021 11.
Article in English | MEDLINE | ID: covidwho-1322740

ABSTRACT

The COVID-19 pandemic has highlighted the need to improve understanding of droplet transport during expiratory emissions. While historical emphasis has been placed on violent events such as coughing and sneezing, the recognition of asymptomatic and presymptomatic spread has identified the need to consider other modalities, such as speaking. Accurate prediction of infection risk produced by speaking requires knowledge of both the droplet size distributions that are produced, as well as the expiratory flow fields that transport the droplets into the surroundings. This work demonstrates that the expiratory flow field produced by consonant productions is highly unsteady, exhibiting extremely broad inter- and intra-consonant variability, with mean ejection angles varying from ≈+30° to -30°. Furthermore, implementation of a physical mouth model to quantify the expiratory flow fields for fricative pronunciation of [f] and [θ] demonstrates that flow velocities at the lips are higher than previously predicted, reaching 20-30 m/s, and that the resultant trajectories are unstable. Because both large and small droplet transport are directly influenced by the magnitude and trajectory of the expirated air stream, these findings indicate that prior investigations of the flow dynamics during speech have largely underestimated the fluid penetration distances that can be achieved for particular consonant utterances.


Subject(s)
Aerosols , Air Pollution, Indoor , Mouth/physiology , Speech/physiology , COVID-19 , Humans , Research Subjects , SARS-CoV-2
14.
Appl Physiol Nutr Metab ; 46(9): 1147-1151, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1285092

ABSTRACT

We explored the views of older (≥65 years) past and potential volunteers in regard to participating in physiology research during the COVID-19 pandemic. Using an online questionnaire and focus groups, we found that past volunteers (n = 55) were more likely to take part in both acute (p < 0.05) and chronic (p < 0.05) physiology studies, compared with potential future volunteers (n = 57). Both cohorts demonstrated a positive attitude towards volunteering during the COVID-19 pandemic, although concern was evident. Novelty: Volunteers demonstrated a positive attitude and also concern towards participating in physiology research during COVID-19.


Subject(s)
Biomedical Research , COVID-19/epidemiology , Pandemics , Physiology , Research Subjects/psychology , Volunteers/psychology , Aged , Attitude , Female , Focus Groups , Humans , Male , Motivation , SARS-CoV-2 , Surveys and Questionnaires
16.
J Health Commun ; 25(10): 780-789, 2020 10 02.
Article in English | MEDLINE | ID: covidwho-1236153

ABSTRACT

The COVID-19 pandemic has magnified the importance of clinical trials for finding a safe and effective vaccine to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Although communication about vaccines and vaccine hesitancy were challenges long before COVID-19, the twin facts of a pandemic and an "infodemic" of health information, misinformation, and disinformation have raised new challenges for vaccine-related communication and decision-making. The goal of this commentary is to highlight strategies to improve communication and decision-making for adults considering participation in COVID-19 vaccine clinical trials. First, I present a general conceptual model for clinical trial participation that can be applied to various vaccine and other clinical trial contexts. Next, I introduce the ASK (Assume, Seek, Know) approach for enhancing clinical trial participation: (1) assume that all patients will want to know their options, (2) seek the counsel of stakeholders, and (3) know your numbers. The ideas presented in this commentary are intended to enhance vaccine-specific clinical trial communication, decision-making, and literacy, while dually offering strategies and resources that may help reduce vaccine hesitancy and increase vaccine uptake over time.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Decision Making , Health Communication/methods , Randomized Controlled Trials as Topic , Research Subjects/psychology , Adult , Health Knowledge, Attitudes, Practice , Health Literacy , Humans , Intention , Patient Selection , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/psychology
17.
Clin Trials ; 18(4): 511-513, 2021 08.
Article in English | MEDLINE | ID: covidwho-1195906

ABSTRACT

The proposed triple aim of health care-enhanced patient experience, improved population health, and reduced per capita costs-can be applied to clinical research. A triple aim for clinical research would (1) improve the individual research participant's experience; (2) promote the health of populations; and (3) reduce per capita costs of clinical research. Such an approach is possible by designing trials around the needs of participants rather than sites, embracing digital measures of health, and advancing decentralized studies. Recent studies, including those evaluating therapies for COVID-19, have demonstrated the value of such an approach. Accelerating the adoption of these methods can help fulfill this new triple aim of clinical research.


Subject(s)
Clinical Trials as Topic/methods , Goals , Population Health , Research Subjects , Research Support as Topic , Biomedical Research/economics , Biomedical Research/methods , Biomedical Research/organization & administration , Clinical Trials as Topic/economics , Clinical Trials as Topic/organization & administration , Costs and Cost Analysis , Health Promotion , Humans , Patient Satisfaction , Telemedicine
18.
Hastings Cent Rep ; 50(4): 9-11, 2020 07.
Article in English | MEDLINE | ID: covidwho-635679

ABSTRACT

The Covid-19 crisis has underscored the importance of the collection and analysis of clinical and research data and specimens for ongoing work. The federal government recently completed a related revision of the human subjects research regulations, founded in the traditional principles of research ethics, but in this commentary, we argue that the analysis underpinning this revision overemphasized the importance of informed consent, given the low risks of secondary research. Governing the interests of a community is different from governing the interests of individuals, and here we suggest that, moving forward, the analyses of the risks of secondary research protocols be assessed from the perspective of the former.


Subject(s)
Biomedical Research/ethics , COVID-19 , Informed Consent/ethics , Research Subjects , Ethics Committees, Research , Federal Government , Government Regulation , Human Experimentation/ethics , Humans , Policy Making , Research Design
19.
Trials ; 22(1): 62, 2021 Jan 18.
Article in English | MEDLINE | ID: covidwho-1067257

ABSTRACT

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.


Subject(s)
Academies and Institutes/organization & administration , COVID-19 , Clinical Trials as Topic/organization & administration , Administrative Personnel , Clinical Trials, Phase III as Topic , Communicable Disease Control , Communication , Data Collection , Hospitals, University , Humans , Ireland , Leadership , Patient Dropouts , Patient Selection , Personnel Staffing and Scheduling , Public Policy , Research Personnel , Research Subjects , SARS-CoV-2
20.
Semin Perinatol ; 44(7): 151287, 2020 11.
Article in English | MEDLINE | ID: covidwho-1029495

ABSTRACT

The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected every aspect of medical practice and has all but ceased clinical, translational and basic science research. Pregnant women appear to be similarly affected by the virus as non-pregnant adults. As obstetricians, not only do we have a duty to care for pregnant women and their fetuses, but to continue to conduct research, inclusive of that which would guide us in delivering care during a pandemic. Conducting such research has its challenges. The objective of this chapter is to review the impact of SARS-CoV-2 on ongoing and new pregnancy research during the pandemic, describe the challenges encountered and summarize the key strategies necessary for a successful research environment.


Subject(s)
Biomedical Research , COVID-19 , Clinical Trials as Topic , Obstetrics , Telemedicine , Female , Humans , Patient Selection , Pregnancy , Research Personnel , Research Subjects , SARS-CoV-2 , Telephone , Videoconferencing
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