BACKGROUND: A better understanding of SARS-CoV-2 infection risk among Hispanic and Latino populations and in low-resource settings in the United States is needed to inform control efforts and strategies to improve health equity. Puerto Rico has a high poverty rate and other population characteristics associated with increased vulnerability to COVID-19, and there are limited data to date to determine community incidence.
OBJECTIVE: This study describes the protocol and baseline seroprevalence of SARS-CoV-2 in a prospective community-based cohort study (COPA COVID-19 [COCOVID] study) to investigate SARS-CoV-2 infection incidence and morbidity in Ponce, Puerto Rico.
METHODS: In June 2020, we implemented the COCOVID study within the Communities Organized to Prevent Arboviruses project platform among residents of 15 communities in Ponce, Puerto Rico, aged 1 year or older. Weekly, participants answered questionnaires on acute symptoms and preventive behaviors and provided anterior nasal swab samples for SARS-CoV-2 polymerase chain reaction testing; additional anterior nasal swabs were collected for expedited polymerase chain reaction testing from participants that reported 1 or more COVID-19-like symptoms. At enrollment and every 6 months during follow-up, participants answered more comprehensive questionnaires and provided venous blood samples for multiantigen SARS-CoV-2 immunoglobulin G antibody testing (an indicator of seroprevalence). Weekly follow-up activities concluded in April 2022 and 6-month follow-up visits concluded in August 2022. Primary study outcome measures include SARS-CoV-2 infection incidence and seroprevalence, relative risk of SARS-CoV-2 infection by participant characteristics, SARS-CoV-2 household attack rate, and COVID-19 illness characteristics and outcomes. In this study, we describe the characteristics of COCOVID participants overall and by SARS-CoV-2 seroprevalence status at baseline.
RESULTS: We enrolled a total of 1030 participants from 388 households. Relative to the general populations of Ponce and Puerto Rico, our cohort overrepresented middle-income households, employed and middle-aged adults, and older children (P<.001). Almost all participants (1021/1025, 99.61%) identified as Latino/a, 17.07% (175/1025) had annual household incomes less than US $10,000, and 45.66% (463/1014) reported 1 or more chronic medical conditions. Baseline SARS-CoV-2 seroprevalence was low (16/1030, 1.55%) overall and increased significantly with later study enrollment time (P=.003).
CONCLUSIONS: The COCOVID study will provide a valuable opportunity to better estimate the burden of SARS-CoV-2 and associated risk factors in a primarily Hispanic or Latino population, assess the limitations of surveillance, and inform mitigation measures in Puerto Rico and other similar populations.
UNASSIGNED: RR1-10.2196/53837.

BACKGROUND: The high prevalence of adverse events (AEs) globally in health care delivery has led to the establishment of many guidelines to enhance patient safety. However, patient safety is a relatively nascent concept in low- and middle-income countries (LMICs) where health systems are already overburdened and underresourced. This is why it is imperative to study the nuances of patient safety from a local perspective to advocate for the judicious use of scarce public health resources.
OBJECTIVE: This study aims to assess the status of patient safety in a health care system within a low-resource setting, using a multipronged, multimethod approach of standardized methodologies adapted to the local setting.
METHODS: We propose purposive sampling to include a representative mix of public and private, rural and urban, and tertiary and secondary care hospitals, preferably those ascribed to the same hospital quality standards. Six different approaches will be considered at these hospitals including (1) focus group discussions on the status quo of patient safety, (2) Hospital Survey on Patient Safety Culture, (3) Hospital Consumer Assessment of Healthcare Providers and Systems, (4) estimation of incidence of AEs identified by patients, (5) estimation of incidence of AEs via medical record review, and (6) assessment against the World Health Organization\'s Patient Safety Friendly Hospital Framework via thorough reviews of existing hospital protocols and in-person surveys of the facility.
RESULTS: The abovementioned studies collectively are expected to yield significant quantifiable information on patient safety conditions in a wide range of hospitals operating within LMICs.
CONCLUSIONS: A multidimensional approach is imperative to holistically assess the patient safety situation, especially in LMICs. Our low-budget, non-resource-intensive research proposal can serve as a benchmark to conduct similar studies in other health care settings within LMICs.
UNASSIGNED: PRR1-10.2196/50532.

BACKGROUND: User engagement is crucial for digital therapeutics (DTx) effectiveness; due to variations in the conceptualization of engagement and intervention design, assessment and retention of engagement remain challenging.
OBJECTIVE: We investigated the influence of the perceived acceptability of experimental intervention components and satisfaction with core intervention components in DTx on user engagement, while also identifying potential barriers and facilitators to user engagement.
METHODS: We conducted a mixed methods study with a 2 × 2 factorial design, involving 12 outpatients with atopic dermatitis. Participants were randomized into 4 experimental groups based on push notification (\"basic\" or \"advanced\") and human coach (\"on\" or \"off\") experimental intervention components. All participants engaged in self-monitoring and learning courses as core intervention components within an app-based intervention over 8 weeks. Data were collected through in-app behavioral data, physician- and self-reported questionnaires, and semistructured interviews assessed at baseline, 4 weeks, and 8 weeks. Descriptive statistics and thematic analysis were used to evaluate user engagement, perceived acceptability of experimental intervention components (ie, push notification and human coach), satisfaction with core intervention components (ie, self-monitoring and learning courses), and intervention effectiveness through clinical outcomes.
RESULTS: The primary outcome indicated that group 4, provided with \"advanced-level push notifications\" and a \"human coach,\" showed higher completion rates for self-monitoring forms and learning courses compared to the predetermined threshold of clinical significance. Qualitative data analysis revealed three key themes: (1) perceived acceptability of the experimental intervention components, (2) satisfaction with the core intervention components, and (3) suggestions for improvement in the overall intervention program. Regarding clinical outcomes, the Perceived Stress Scale and Dermatology Life Quality Index scores presented the highest improvement in group 4.
CONCLUSIONS: These findings will help refine the intervention and inform the design of a subsequent randomized trial to test its effectiveness. Furthermore, this design may serve as a model for broadly examining and optimizing overall engagement in DTx and for future investigation into the complex relationship between engagement and clinical outcomes.
BACKGROUND: Clinical Research Information Service KCT0007675; http://tinyurl.com/2m8rjrmv.

Emerging adulthood has been characterized as a developmental period of insecurities and instabilities, especially among sexual minorities (i.e., queer people). This brief report proposes the utility of life calendaring as a tool to examine how queer emerging adults make sense of their security. First, this paper reviews the basic principles of human security as an approach to human development among emerging adults and explains how sexuality influences their sense of security in their present and projected lives. Second, this report explains the methodological features of life-calendaring as a qualitative research strategy and describes the process of an ongoing life-calendaring-aided interview research project that examines human security among queer emerging adult men. Finally, this article presents key insights from three life calendaring exemplars to demonstrate queering human security in emerging adulthood.

OBJECTIVE: Evidence-based research (EBR) is the systematic and transparent use of prior research to inform a new study so that it answers questions that matter in a valid, efficient, and accessible manner. This study surveyed experts about existing (e.g., citation analysis) and new methods for monitoring EBR and collected ideas about implementing these methods.
METHODS: We conducted a cross-sectional study via an online survey between November 2022 and March 2023. Participants were experts from the fields of evidence synthesis and research methodology in health research. Open-ended questions were coded by recurring themes; descriptive statistics were used for quantitative questions.
RESULTS: Twenty-eight expert participants suggested that citation analysis should be supplemented with content evaluation (not just what is cited but also in which context), content expert involvement, and assessment of the quality of cited systematic reviews. They also suggested that citation analysis could be facilitated with automation tools. They emphasized that EBR monitoring should be conducted by ethics committees and funding bodies before the research starts. Challenges identified for EBR implementation monitoring were resource constraints and clarity on responsibility for EBR monitoring.
CONCLUSIONS: Ideas proposed in this study for monitoring the implementation of EBR can be used to refine methods and define responsibility but should be further explored in terms of feasibility and acceptability. Different methods may be needed to determine if the use of EBR is improving over time.

Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.

OBJECTIVE: To apply videoconferencing as a new verification method prior to enrollment for an online survey-based study.
METHODS: A prospective-observational, mixed methods, three group, repeated measures study involved recruiting a population-based sample of breastfeeding mothers and infants (N = 81). Twenty-seven mothers were recruited for each group: mothers returning to work outside of the home, mothers returning to work from home and mothers staying home with their infants full-time.
METHODS: Data were collected at four time points, infant age 4, 12, 20 and 24 weeks, via online survey. Participating mothers received a $10 gift card for completing each survey. Social media, word of mouth and brochures promoted United States-based recruitment nationwide. A publicly available direct link to the survey was initially provided to interested mothers. After the suspicion of online fraud, videoconferencing was instituted for self-referrals and phone calls for professional referrals.
RESULTS: The survey was invaded by response fraud 3 weeks after the initial survey deployment. Out of 109 respondents who visited the survey site during that timeframe, only eight mothers (10%) were eligible (22 June 2022 to 14 July 2022). After recruitment modification, 313 individuals emailed the study team with 65 self-referred mothers (80%) enrolled in the study via videoconferencing while eight mothers (10%) had a professional referral and enrolled via phone call (23 August 2022 to 30 March 2023).
CONCLUSIONS: Providing a direct survey link, even with CAPTCHA-protection, evoked fraudulent responses. Videoconferencing is an emerging verification method that can be readily applied to the enrollment of breastfeeding dyads for an online study.
CONCLUSIONS: The emergence of fraudulent respondents and internet bots threatens data quality. This study addressed the strategy of videoconferencing as a new verification method for recruitment and enrollment of breastfeeding dyads. This knowledge can be applied by researchers to secure sample validity and data integrity.

People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the presentation of information using multimedia which included generic and trial-specific content. Our aim was to embed \'Studies Within A Trial\' (SWATs) across multiple ongoing trials to test whether multimedia presentation of patient information led to better rates of recruitment.
Five trials included a SWAT and randomised their participants to receive a multimedia presentation alongside standard information, or standard written information alone. We collected data on trial recruitment, acceptance and retention and analysed the pooled results using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised following an invitation to take part.
Five SWATs provided data on the primary outcome of proportion of participants randomised. Multimedia alongside written information results in little or no difference in recruitment rates (pooled odds ratio = 0.96, 95% CI: 0.79 to 1.17, p-value = 0.671, I2 = 0%). There was no effect on any other outcomes.
Multimedia alongside written information did not improve trial recruitment rates.
ISRCTN71952900, ISRCTN 06710391, ISRCTN 17160087, ISRCTN05926847, ISRCTN62869767.

OBJECTIVE: A measurement tool to assess systematic reviews 2 (AMSTAR 2) was originally developed for systematic reviews (SRs) of health-care interventions. The aim of this study was to assess the applicability of AMSTAR 2 to SRs of non-intervention studies.
METHODS: This was a meta-research study. We used 20 SRs for each of the following four types of SRs: Diagnostic Test Accuracy reviews, Etiology and/or Risk reviews, Prevalence and/or Incidence reviews, and Prognostic reviews (80 in total). Three authors applied AMSTAR 2 independently to each included SRs. Then, the authors assessed the applicability of each item to that SR type and any SR type.
RESULTS: Researchers unanimously indicated that 7 of 16 AMSTAR 2 items were applicable for all four specific SR types and any SR type (items 2, 5, 6, 7, 10, 14 and 16), but 8 of 16 items for any SR type. These items could cover generic SR methods that do not depend on a specific SR type.
CONCLUSIONS: AMSTAR 2 is only partially applicable for non-intervention SRs. There is a need to adapt/extend AMSTAR 2 for SRs of non-intervention studies. Our study can help to further define generic methodological aspects shared across SR types and methodological expectations for non-intervention SRs.

When reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards - IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants\' time, researchers\' time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews.
We conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey.
We collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky).
We discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews.