Research biopsies in patients with gynecologic cancers: patient-reported outcomes, perceptions, and preferences.

BACKGROUND: Despite the growing integration of mandatory biopsies for correlative endpoints within oncology clinical trials, there are sparse data on patient-reported outcomes, perceptions, and preferences. OBJECTIVE: This study aimed to prospectively assess the impact of research biopsies on the quality of life in patients with gynecologic cancer, evaluate patient-reported outcomes, and determine factors associated with patients' willingness to undergo sequential biopsies. STUDY DESIGN: We conducted a prospective study in patients with gynecologic malignancies undergoing research biopsies between 2015 and 2019 at Princess Margaret Cancer Centre (ClinicalTrials.gov Identifier: NCT02334761). Here, we report the results of the paper-based surveys performed before and 1 week after biopsy. Although the questionnaires each assessed the impact of anxiety using a modified version of the Hospital Anxiety and Depression Scale, the postbiopsy questionnaire specifically assessed the likelihood of future biopsies, postbiopsy symptoms, complications, and perceptions. RESULTS: A total of 129 patients were enrolled, of which 91 (70.5%) completed at least 1 questionnaire. These patients had either ovarian (89%; 81 of 91) or endometrial cancer (11%; 10 of 91). Of all biopsies taken, 75% were from the abdomen or pelvis (67 of 89). There was 1 clinician-reported complication, a perihepatic hematoma (1%). Pain during the biopsy and physical discomfort were experienced by 60.3% (41 of 68) and 61.8% (42 of 68), respectively. Embarrassment and loss of dignity were experienced by 13.2% (9 of 68) and 11.8% (8 of 68), respectively. Although the mean Hospital Anxiety and Depression Scale score was in the normal range before and after biopsy, there was a significant decline in the total score after the biopsy (prebiopsy, 5.3 [standard deviation, 4.7] vs postbiopsy, 3.7 [standard deviation, 4.5]; P=.005); 84% of subjects (58 of 69) stated that they would definitely or likely consent to another biopsy. There was no impact on patients' willingness for future biopsies based on Eastern Cooperative Oncology Group status, biopsy site, age, number of cores, and pain during the biopsy; however, subjects who reported feeling physically uncomfortable (odds ratio, 0.14; P=.005), embarrassed (odds ratio, 0.03; P=.004) or experienced loss of dignity (odds ratio, 0.05; P=.01) during the biopsy and those who experienced flu-like symptoms (odds ratio, 0.2; P=.018) or felt feverish (odds ratio, 0.2; P=.035) 1 week after biopsy, were less likely to undergo a sequential biopsy. Similarly, those with higher Hospital Anxiety and Depression Scale scores before biopsy (odds ratio, 0.83; P=.008) and after biopsy (odds ratio, 0.8; P=.003) were less likely to consent for another biopsy. CONCLUSION: Research biopsies were generally well accepted. Most patients (83%) were willing to undergo serial biopsies if necessary. Addressing the potentially modifiable psychosocial aspects of the procedure may improve the experience with research biopsies for patients with gynecologic cancers.

Barriers and facilitators to participating in Alzheimer's disease biomarker research in black and white older adults.

Introduction: The study examined Black and White prospective participants' views of barriers to and facilitators of participation in Alzheimer's disease (AD) biomarker research. Methods: In a mixed-methods study, 399 community-dwelling Black and White older adults (age ≥55) who had never participated in AD research completed a survey about their perceptions of AD biomarker research. Individuals from lower socioeconomic and education backgrounds and Black men were over-sampled to address perspectives of traditionally under-represented groups. A subset of participants (n = 29) completed qualitative interviews. Results: Most participants expressed interest in biomarker research (overall 69%). However, Black participants were comparatively more hesitant than White participants (28.9% vs 15.1%), were more concerned about study risks (28.9% vs 15.1%), and perceived multiple barriers to participating in brain scans. These results persisted even after adjusting for trust and perceived knowledge of AD. Information was a primary barrier (when absent) and incentive (when provided) for AD biomarker research participation. Black older adults desired more information about AD (eg, risk, prevention), general research processes, and specific biomarker procedures. They also desired return of results to make informed decisions about their health, research-sponsored community awareness events, and for researchers to mitigate the burden placed on participants in research (eg, transportation, basic needs). Conclusion: Our findings increase representativeness in the literature by focusing on individuals with no history of AD research experience and those from traditionally underrepresented groups in research. Results suggest that the research community needs to improve information sharing and raising awareness, increase their presence in the communities of underrepresented groups, reduce incidental costs, and provide valuable personal health information to participants to increase interest. Specific recommendations for improving recruitment are addressed. Future studies will assess the implementation of evidence-based, socioculturally sensitive recruitment strategies to increase enrollment of Black older adults into AD biomarker studies.HIGHLIGHTS: Individuals from under-represented groups are interested in Alzheimer's disease (AD) biomarker research.After adjusting for trust and AD knowledge, Black participants were still more hesitant.Information is a barrier (when absent) to and incentive (when given) for biomarker studies.Reducing burden (e.g., transportation) is essential for recruiting Black older adults.

Expanding the Reach of Research: Quantitative Evaluation of a Web-Based Approach for Remote Recruitment of People Who Hear Voices.

BACKGROUND: Similar to other populations with highly stigmatized medical or psychiatric conditions, people who hear voices (ie, experience auditory verbal hallucinations [AVH]) are often difficult to identify and reach for research. Technology-assisted remote research strategies reduce barriers to research recruitment; however, few studies have reported on the efficiency and effectiveness of these approaches. OBJECTIVE: This study introduces and evaluates the efficacy of technology-assisted remote research designed for people who experience AVH. METHODS: Our group developed an integrated, automated and human complementary web-based recruitment and enrollment apparatus that incorporated Google Ads, web-based screening, identification verification, hybrid automation, and interaction with live staff. We examined the efficacy of that apparatus by examining the number of web-based advertisement impressions (ie, number of times the web-based advertisement was viewed); clicks on that advertisement; engagement with web-based research materials; and the extent to which it succeeded in representing a broad sample of individuals with AVH, assessed through the self-reported AVH symptom severity and demographic representativeness (relative to the US population) of the sample recruited. RESULTS: Over an 18-month period, our Google Ads advertisement was viewed 872,496 times and clicked on 11,183 times. A total amount of US $4429.25 was spent on Google Ads, resulting in 772 individuals who experience AVH providing consent to participate in an entirely remote research study (US $0.40 per click on the advertisement and US $5.73 per consented participant) after verifying their phone number, passing a competency screening questionnaire, and providing consent. These participants reported high levels of AVH frequency (666/756, 88.1% daily or more), distress (689/755, 91.3%), and functional interference (697/755, 92.4%). They also represented a broad sample of diversity that mirrored the US population demographics. Approximately one-third (264/756, 34.9%) of the participants had never received treatment for their AVH and, therefore, were unlikely to be identified via traditional clinic-based research recruitment strategies. CONCLUSIONS: Web-based procedures allow for time saving, cost-efficient, and representative recruitment of individuals with AVH and can serve as a model for future studies focusing on hard-to-reach populations.

Children's self reported discomforts as participants in clinical research.

INTRODUCTION: There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts. MATERIALS AND METHODS: Forty-six children (aged 6-18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews. RESULTS: The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures. DISCUSSION: Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way.