Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 7 de 7
Filter
1.
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
2.
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
3.
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
4.
Nurs Older People ; 33(2): 26-31, 2021 Mar 30.
Article in English | MEDLINE | ID: covidwho-884027

ABSTRACT

Research is important because it underpins evidence-based care. However, people who lack capacity to consent are often excluded from research, due partly to ethical concerns and practical challenges, and partly to a lack of awareness among professionals of the legal framework that supports their inclusion. The COVID-19 pandemic, which has extensively affected care home residents, has reinforced the importance of including older people with cognitive impairment in research. Nurses who care for older people with impaired cognition have an important role in ensuring these people have the opportunity to contribute to and benefit from research. This article discusses some of the challenges associated with the inclusion in research of older people who lack capacity to consent, including the involvement of relatives and friends in decision-making. The article describes the findings of recent research and shares resources with the aim of supporting nurses to ensure that older people in their care who lack capacity can participate in research.


Subject(s)
Informed Consent/legislation & jurisprudence , Mental Competency/legislation & jurisprudence , Nurse-Patient Relations , Research Subjects/psychology , Research/organization & administration , Aged , COVID-19 , Humans , Research Subjects/statistics & numerical data , United Kingdom/epidemiology
5.
J Natl Cancer Inst ; 113(11): 1453-1459, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-787221

ABSTRACT

Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19-related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.


Subject(s)
COVID-19/epidemiology , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/statistics & numerical data , Neoplasms/therapy , Research Subjects/statistics & numerical data , SARS-CoV-2/physiology , COVID-19/virology , Humans , Neoplasms/virology , Research Subjects/psychology , United States/epidemiology
6.
Obesity (Silver Spring) ; 28(12): 2272-2281, 2020 12.
Article in English | MEDLINE | ID: covidwho-731025

ABSTRACT

OBJECTIVE: This study aimed to examine the impact of coronavirus disease 2019 (COVID-19) on current research participants' mental health outcomes, ability to adhere to behavioral intervention recommendations, and desire to participate in research. METHODS: A quantitative/qualitative cross-sectional survey was used among adults currently enrolled in health-related research (N = 250; 85% women; > 50% currently enrolled in behavioral weight loss intervention). RESULTS: COVID-19 was perceived as a severe threat by most (62.3%). Related to COVID-19, 29.6% of participants reported moderate/severe symptoms of anxiety/depression, and 68.4% reported moderate/severe posttraumatic stress disorder (PTSD) symptomatology, with women more likely to demonstrate moderate/severe anxiety/depression (P = 0.047) and PTSD symptomatology (P = 0.028) relative to men. Those with moderate/severe levels of anxiety/depression (P = 0.0154) and distress (P = 0.0330) were more likely to report a decreased desire to participate in research. Among those in behavioral interventions, individuals perceiving COVID-19 as a moderate/severe threat or experiencing moderate/severe depression or PTSD symptomatology were 4 to 19 times more likely to report that COVID-19 affected their ability to adhere to behavioral recommendations. Qualitative analysis identified four themes describing COVID-19's impact on research experiences: transition, remote intervention delivery, ability to adhere to program goals, and research participation interest. CONCLUSIONS: These data suggest that participants engaged in health-related research perceive COVID-19 as a significant threat, affecting mental health, desire to participate in research, and ability to adhere to intervention recommendations.


Subject(s)
Anxiety/psychology , COVID-19/psychology , Research Subjects/psychology , Stress Disorders, Post-Traumatic/psychology , Stress, Psychological/psychology , Adult , COVID-19/epidemiology , Cross-Sectional Studies , Depression/psychology , Female , Humans , Male , Mental Health , Middle Aged , Outcome Assessment, Health Care , SARS-CoV-2 , Surveys and Questionnaires
7.
J Am Geriatr Soc ; 68(6): E14-E18, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-96623

ABSTRACT

BACKGROUND/OBJECTIVES: The COVID-19 pandemic has massively disrupted essential clinical research. Many regulatory organizations have rightfully advocated to temporarily halt enrollment and curtail all face-to-face interactions. Views and opinions of patients and their caregivers are seldom considered while making such decisions. The objective was to study older participants' and their caregivers' perspectives to participate in ongoing clinical research during the COVID-19 pandemic. DESIGN: Cross-sectional. SETTING: VISN-16/Geriatric Research, Education and Clinical Center (GRECC), Department of Veterans Affairs. PARTICIPANTS: Older participants and their caregivers (N = 51) enrolled in ongoing clinical research studies. MEASUREMENTS: Questions about perceptions of safety to attend research visit, the level of panic among the general public, and medical center's preparedness in handling the pandemic. Other questions identified the source of pandemic information and the preference of a phone or in-person visit. RESULTS: Mean age was 69.3 (±9.4) years, 53% were male, 39% were caregivers, and 65% were Caucasian. Majority (78%) of the participants felt safe/very safe attending the scheduled research appointment; 63% felt that the extra screening made them feel safe/very safe; 82% felt that the medical center was prepared/very prepared for the pandemic. Participants split evenly on their preference for phone versus in-person visits. Family members and television news media were the commonly used sources of pandemic information irrespective of their education. Perceptions were influenced by gender and source of information, not by age or education. Females perceived higher level of panic compared to males (P = .02). Those relying on news media felt safer compared to those that relied on family members (P = .008). CONCLUSION: Even though informants felt that the medical center was prepared to handle the pandemic, only half the participants preferred the in-person visit. Pandemic information was obtained from family members or the television news media. Knowing patients' perspectives may help researchers be better prepared for future pandemics. J Am Geriatr Soc 68:E14-E18, 2020.


Subject(s)
Biomedical Research , Caregivers/psychology , Coronavirus Infections/psychology , Pneumonia, Viral/psychology , Research Subjects/psychology , Aged , Betacoronavirus , COVID-19 , Cross-Sectional Studies , Female , Humans , Male , Pandemics , Patient Safety , SARS-CoV-2
SELECTION OF CITATIONS
SEARCH DETAIL