Name: a novel method for involving women of color at high risk for preterm birth in research priority setting
Uploaded: 2018-01-12T12:30:00.000+00:00
Duration: 14 min 43 s
Description: Watch this Scientific Journal Video about A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting at JoVE.com

This research was supported by the UCSF California Preterm Birth Initiative. The authors wish to thank Brittany Edwards, Lisa Edwards and Olga Nunez for their assistance and the participants for sharing their experiences and views.

<ol>
	<li>Mullins, C. D., Abdulhalim, A. M., Lavallee, D. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Continuous+patient+engagement+in+comparative+effectiveness+research.">Continuous patient engagement in comparative effectiveness research.</a> JAMA. 307 (15), 1587-1588 (2012).</li><li>Belone, L., Lucero, J. E., Duran, B., Tafoya, G., Baker, E. A., Chan, D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Community-based+participatory+research+conceptual+model:+Community+partner+consultation+and+face+Validity.">Community-based participatory research conceptual model: Community partner consultation and face Validity.</a> Qual Health Res. 26 (1), 117-135 (2016).</li><li>Viswanathan, M., Ammerman, A., Eng, E., Gartlehner, G., Lohr, K. N., Griffith, D., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Community-based+participatory+research:+Assessing+the+evidence.">Community-based participatory research: Assessing the evidence.</a> Evid Rep Technol Assess (Summ). (99), 1-8 (2004).</li><li>Selby, J. V., Forsythe, L., Sox, H. C. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Stakeholder-Driven+Comparative+Effectiveness+Research:+An+Update+From+PCORI.">Stakeholder-Driven Comparative Effectiveness Research: An Update From PCORI.</a> JAMA. 314 (21), 2235-2236 (2015).</li><li>Reay, H., Arulkumaran, N., Brett, S. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Priorities+for+future+intensive+care+research+in+the+UK:+results+of+a+James+Lind+Alliance+Priority+Setting+Partnership.">Priorities for future intensive care research in the UK: results of a James Lind Alliance Priority Setting Partnership.</a> J Intens Care Soc. 15 (4), 288-296 (2014).</li><li>Wald, H. L., Leykum, L. K., Mattison, M. L., Vasilevskis, E. E., Meltzer, D. O. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+patient-centered+research+agenda+for+the+care+of+the+acutely+ill+older+patient.">A patient-centered research agenda for the care of the acutely ill older patient.</a> J Hosp Med. May. 10 (5), 318-327 (2015).</li><li>Reverby, S. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Listening+to+narratives+from+the+Tuskegee+syphilis+study.">Listening to narratives from the Tuskegee syphilis study.</a> Lancet. 377 (9778), 1646-1647 (2011).</li><li>Ocloo, J., Matthews, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=From+tokenism+to+empowerment:+progressing+patient+and+public+involvement+in+healthcare+improvement.">From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.</a> BMJ Qual Saf. 25, 626-632 (2016).</li><li>Behrman, R. E., Butler, A. S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Preterm Birth: Causes, Consequences, and Prevention. , (2007).</li><li>MacDorman, M. F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Race+and+ethnic+disparities+in+fetal+mortality,+preterm+birth,+and+infant+mortality+in+the+United+States:+an+overview.">Race and ethnic disparities in fetal mortality, preterm birth, and infant mortality in the United States: an overview.</a> Semin Perinatol. 35 (4), 200-208 (2011).</li><li>Braveman, P. A., Heck, K., Egerter, S., Marchi, K. S., Dominguez, T. P., Cubbin, C., Fingar, K., Pearson, J. A., Curtis, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+role+of+socioeconomic+factors+in+Black-White+disparities+in+preterm+birth.">The role of socioeconomic factors in Black-White disparities in preterm birth.</a> Am J Public Health. Apr. 105 (4), 694-702 (2015).</li><li>Tucker Edmonds, B., Mogul, M., Shea, J. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Understanding+low-income+African+American+women's+expectations,+preferences,+and+priorities+in+prenatal+care.">Understanding low-income African American women's expectations, preferences, and priorities in prenatal care.</a> Fam Comm Health. 38 (2), 149-157 (2015).</li><li>Duley, L., Uhm, S., Oliver, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Top+15+UK+research+priorities+for+preterm+birth.">Top 15 UK research priorities for preterm birth.</a> Lancet. 383 (9934), 2041-2042 (2014).</li><li>Ulm, S., Crowe, S., Dowling, I., Oliver, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+process+and+outcomes+of+setting+research+priorities+about+preterm+birth+-+a+collaborative+partnership.">The process and outcomes of setting research priorities about preterm birth - a collaborative partnership.</a> Infant. 10 (6), 178-181 (2014).</li><li>Braun, V., Clarke, V. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Using+thematic+analysis+in+psychology.">Using thematic analysis in psychology.</a> Qualitative Research in Psychology. 3 (2), 77-101 (2006).</li><li>Frank, L., Forsythe, L., Ellis, L., Schrandt, S., Sheridan, S., Gerson, J., Konopka, K., Daugherty, S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Conceptual+and+practical+foundations+of+patient+engagement+in+research+at+the+patient-centered+outcomes+research+institute.">Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute.</a> Qual Life Res. 24 (5), 1033-1041 (2015).</li></ol>

The authors have nothing to disclose.

The RPAC protocol was specifically developed to guide initial, exploratory research priority setting involvement with under-represented minority individuals who are at high risk for health problems and who face disproportionate burden of disease. It was first trialed with women at high socio-demographic risk for preterm birth to generate a prioritized list of researchable questions and topics about pregnancy, birth and neonatal care and treatment. The prioritized lists resulting from RPAC can then be included in research priority setting by funders and researchers. The RPAC follows the principles of national-level patient engagement rubrics, such as the Patient Centered Outcome Research Institute9,21 in the US and the UK JLA Priority Setting Partnership.10 The RPAC uses elements of the Priority Setting Partnership prioritization protocol, but differs from the Priority Setting Partnership protocol in significant ways. First, the RPAC focuses solely on members of communities affected by a health condition and does not include front-line clinicians whose voices might be privileged in the discussion (even unconsciously by the participants themselves). Second, the RPAC protocol is designed to generate the initial question list de novo from within the group, rather than from prior research literature or surveys. Third, the RPAC is designed to probe more deeply the priorities, experiences and context in which those priorities develop, of a small number of individuals with expertise in the condition by virtue of their individual and community experience, whereas the Priority Setting Partnership protocol is designed to engage a large number of individuals and organizational representatives with broad knowledge of the condition and its impact on patients and families in the research priority setting process. However, the use of RPAC and the JLA Priority Setting Partnerships are not mutually exclusive and RPAC could naturally lead to the formation of a JLA-style Priority Setting Partnership or, conversely JLA Priority Setting Partnership work might lead to use of RPAC for deeper involvement of specific communities affected by a health condition. Once research priorities have been established with patient and public involvement by one or both of these methods, community based participatory research methods can be used to co-design and carry out specific research projects.3,4
The representative results described in this paper illustrate the power of the RPAC protocol to rapidly and deeply engage with women at high socio-demographic risk for preterm birth in identifying the specific research questions and broader research topics of greatest importance to them and their community. These women had no prior research experience and had no prior relationship with the facilitators or their organization. None of them worked in a clinical setting or had any scientific training. Yet, by the end of the first two-hour session, they had generated over 135 unique, researchable questions based on their own experience of care and unanswered health questions as well as from their general curiosity about maternal and infant health that was awakened in the group discussion with other women like themselves. Moreover, as part of the two-session protocol, participants engaged in deep discussion about their own health and healthcare experiences during pregnancy, childbirth and parenting. These data provided a rich substrate for further qualitative analysis of these experiences, with a particular focus on patient-provider and patient-health system interactions.
The RPAC protocol is new and there are a number of issues to consider in evaluating whether or not it is appropriate for other investigations. First, having a clear intention and plan for how the research priorities will inform research strategy and funding decisions is essential, as failure to do so will compromise credibility focus group sessions between the researchers and community. Second, having a CBO partner who is trusted and well-integrated into the community of interest is also essential for success. Third, researchers should be prepared to engage in discussion with the CBO and with RPAC participants about personal and historical misconduct in research because this may arise when the topic of research is raised with communities of color.12 The RPAC protocol has been used thus far only with African-American and Latina women in California at high socio-demographic risk for preterm birth. Therefore, the generalizability of the method requires further evaluation. Nonetheless, it is a promising approach for exploratory research priority setting involvement with under-represented minority individuals who are at high risk for and are disproportionately affected by other health problems.
Partnership with a trusted CBO and skilled facilitation are essential to quickly building and transferring trust among the participants so that they feel comfortable to speak freely and to generate rich data. As with all facilitated group activities, the quality of the output is greatly dependent on the skills of the facilitator to engage the participants in the topic and with each other. Because of the focus on health research, at least one of the facilitators should have a strong working knowledge of clinical care and of the research evidence for the specific health condition under discussion. This is important so that the facilitator can provide example questions if necessary to stimulate discussion or steer the conversation to explore other aspect of the health condition that are not spontaneously brought forth by the participants. At the same time, the facilitators must refrain from providing answers to any research questions posed by the participants or from engaging in any teaching or counseling during this session. Such actions can quickly stifle participants from developing further questions or exploring uncertainties and is to be avoided at all costs. Facilitators should work with the CBO partner to offer participants health information or research evidence after the completion of session 2.
Several important outcomes emerged from the use of RPAC with women at high social-demographic risk for preterm birth. First, the research priority lists generated from the RPAC work in San Francisco, Oakland and Fresno California were included in request for proposals issued by PTBi-CA. Second, some of the women who participated in RPAC applied to and were selected for the PTBi-CA Community Advisory Board and participated in proposal review and recommendation for funding of proposals submitted in response to the request for proposals. This input has been invaluable for the PTBi-CA, ensuring that the commissioned research addresses questions of importance to science and to the community the science is intended to benefit (see brief video example: https://www.youtube.com/watch?v=df1qRu4wzJo).
In summary, the RPAC protocol is a useful method for generating rapid, in-depth knowledge of the research priorities of women at high socio-demographic risk for preterm birth. The RPAC protocol provides a strong foundation for ongoing patient and public involvement in research and can lead to meaningful partnership in research funding decisions to better address the epidemic of preterm birth. The protocol may be further customized for use with underserved minority individuals from communities affected by other health condition to achieve meaningful involvement in decisions about research foci and funding to address those health conditions.

Patient and public involvement in healthcare research improves relevance and credibility of results, increases enrollment and retention, and accelerates translation into clinical practice.1 Although the terms are often used interchangeably, engagement, participation, and involvement represent three different levels of contact between researchers and individual patients or the general public. Engagement is the lowest level and includes activities of researchers and institutions to share information and knowledge about research with patients and the public. Participation is the activity of study subjects taking part in research studies. Involvement is the highest level of contact, where patients, members of affected communities or of the general public are actively involved in shaping research projects from design to dissemination, including as co-researchers.2,3 The partnership between community members or representatives and researchers or academic institutions in co-development of research questions and co-ownership of research projects is commonly known as community based participatory research.4 These methods have been effective in increasing the level of involvement of patients and the public in research as well as the relevance of research findings to affected communities.5 More recently, research funders have begun to recognize the importance of patient and public involvement in strategic research agenda setting and to seek the engagement/involvement of patients and the public in defining areas of focus for research funding and in prioritizing what research to fund. Patient and public involvement in research priority setting represents the highest level of involvement, and is upstream from community based participatory research. Patient and public involvement in research priority setting is essential for research funding strategy development so that requests for proposals and funding decisions reflect topics of greatest interest to the public as well as to the research community.6 There is a clear and growing international expectation that high quality research be conducted in partnership with patients and communities and not on them solely as research subjects.
Methods for patient and public involvement in research priority setting are relatively new and evolving. Thus far, major funders tend to solicit involvement of representatives from patient advocacy organizations with experience of patient and public involvement rather than directly from members of affected communities or the general public. The involvement of patients or patient representatives is usually as part of larger stakeholder groups that may include frontline healthcare professionals and industry through online survey methods and focus groups with predominantly professional stakeholders7,8,9, or &#39;town hall&#39; style meetings.9
The most well-established method for research patient and public involvement is the James Lind Alliance (JLA) Priority Setting Partnerships method. Established in 2004, the JLA Priority Setting Partnership method10 is a structured approach, bringing patients, their caregivers and clinician groups together to identify treatment uncertainties (i.e., questions about treatments which cannot be answered by existing research) which are important to all groups. The goals of the Priority Setting Partnerships are to reach consensus on the priority uncertainties and to produce a final list (often a &#34;top 10&#34;) of jointly agreed research priorities, and then to publicize the priorities widely to influence researchers and research funders to address them. The JLA Priority Setting Partnership method has been effectively used for a wide range of conditions. The JLA Guidebook10 provides a detailed step-by-step protocol for establishing and conducting Priority Setting Partnerships for any health topic. It consists of a multi-phase approach, beginning with an extensive literature review and online or postal surveys with a wide range of stakeholders to generate a comprehensive list of uncertainties on a particular health topic. Then, if needed, survey consensus methods, such as modified Delphi techniques, wherein repeated rounds of ranking (usually by questionnaires) and reporting back group results are used to achieve consensus and narrow the uncertainty list to a manageable number. The list is then presented to mixed stakeholder focus groups who use group consensus methods, such as Nominal Group technique, to rank the most important research topics and produce a prioritized list.7,8
Notably absent from the published literature on patient and public involvement in research priority setting is the involvement of patients and members of the public from under-represented minority groups. This exacerbates the disparities in patient and public involvement by under-represented minority populations in healthcare research overall,11 and perhaps perpetuates the mistrust resulting from historical misconduct of research, particularly with communities of color.12 Moreover, there has been very little focus on methods to specifically engage individuals from under-represented minority groups in research priority setting.11,13 This is a critical omission because without evidence of the effectiveness of the methods in successfully involving individuals from under-represented minority groups in research prioritization, there may be unintended consequences, such as privileging views of certain stakeholders leading to further disengagement of those minority groups. For example, the JLA Priority Setting Partnership 10 method does not specifically address the challenge of ensuring involvement of under-represented minority groups and there are several phases of the process where their views may be given lesser priority than other stakeholders. First, reliance on the literature and traditional stakeholder representative groups for the first level generation of uncertainties privileges the research that has been conducted based on priorities of the research community and established organizations, which do not represent well the uncertainties and questions of under-represented minority groups. Second, even with skilled facilitators and well-tested methods, holding consensus groups with under-represented minority individuals and healthcare professionals together might unintentionally privilege the voices and views of the professionals. Therefore, new methods are needed that focus on and develop capacity for under-represented minority groups to be involved in research priority setting, especially when they are disproportionately affected by serious health conditions.
One such health condition is preterm birth, defined as birth before completion of 37 weeks of gestation. Preterm birth is a complex condition with both medical and socio-demographic risk factors that is associated with numerous adverse maternal and infant outcomes, affecting the lives of children and families and costing many billions to society.14 African-American race, low socioeconomic status and limited education are among the strong, but largely unexplained risk factors for preterm birth.14,15,16,17 Until recently, there has been very little research on the experiences and views of women at high socio-demographic risk for preterm birth14 and preterm birth research priority setting in the United States has had no direct patient and public involvement. The first patient and public involvement in preterm birth research priority setting was reported in 2014 the United Kingdom (UK).18,19 Although groundbreaking for the field, the UK preterm birth Priority Setting Partnership16 did not include women at high socio-demographic risk for preterm birth, such as those at-risk due to social determinants of health or health disparities. Since these groups bear a disproportionate burden of disease, it is imperative that their view be included in research priority setting.
The UCSF California Preterm Birth Initiative (PTBi-CA) is a multi-year, philanthropically-funded research initiative to reduce the burden of the unchecked preterm birth epidemic in high-disparity regions of California (www.pretermbirth.ucsf.edu). PTBi-CA brings together researchers from across numerous specialties and disciplines, public health agencies and community leaders to work in direct partnership with women and families most affected by the epidemic. Women who have had a preterm birth and those who are at high socio-demographic risk for preterm birth and the frontline clinical and social care providers who work with these women and their families are involved at all stages of the research process &#8212; from developing the research priorities, designing research protocols, conducting studies, disseminating results and translation of findings to practice and policy.
Given the limited methods to specifically involve under-represented minority groups in research priority setting, and because it was not known if women of color at high socio-demographic risk for preterm birth would be interested or willing to engage in the research priority setting process, the established JLA Priority Setting Partnership method was not appropriate as a first step in patient and public involvement for this population and topic. This paper describes the protocol for a new method to initiate patient and public involvement, Research Prioritization by Affected Communities (RPAC), and describes its use with women at high socio-demographic risk for preterm birth. The goal of RPAC is to directly involve individuals from under-represented minority groups, in this case women of color, in identifying and prioritizing their unanswered questions about their health condition, in this case pregnancy, birth and neonatal care and treatment. The RPAC method enables discovery of the researchable unanswered research questions of greatest priority to the affected communities so that they can be included in research priority setting by funders and researchers. The UCSF PTBi-CA incorporated the research priorities of women at high socio-demographic risk for preterm birth in their request for proposals and included women who participated in the RPAC process in proposal review and funding decisions (see brief video example: https://www.youtube.com/watch?v=df1qRu4wzJo). The RPAC protocol can lead to meaningful partnership of individuals from communities affected by a health condition in decisions about research foci and funding.

<table><tbody><tr><td>&lt;strong&gt;Session 1: Room arrangement and supplies&lt;/strong&gt;</td><td></td><td></td><td></td></tr><tr><td>Room arrangement: Arrange tables and seating in a U-shape facing a large whiteboard or smooth wall (10 to 12 feet in length ideal) on which self-adhesive flip chart paper can be mounted and written on. If easels are used, have a minimum of 2, ideally 3)</td><td></td><td></td><td></td></tr><tr><td>Self-adhesive flip chart paper (at least 110 sheets)</td><td></td><td></td><td></td></tr><tr><td>Markers and pens</td><td></td><td></td><td></td></tr><tr><td>Pens and note-taking pads for all participants</td><td></td><td></td><td></td></tr><tr><td>Audio recorder</td><td></td><td></td><td></td></tr><tr><td>Name tags</td><td></td><td></td><td></td></tr><tr><td>Required forms (e.g., photo consents, reimbursement forms)</td><td></td><td></td><td></td></tr><tr><td>Options (but strongly recommended): Refreshments, gift cards or gifts to acknowledge participant time and contribution to the project</td><td></td><td></td><td></td></tr><tr><td>&lt;strong&gt;Session 2: Room arrangement and supplies&lt;/strong&gt;</td><td></td><td></td><td></td></tr><tr><td>Room arrangement: Arrange tables and seating in a U-shape facing a large whiteboard or smooth wall (10 to 12 feet in length ideal) on which self-adhesive flip chart paper can be mounted and written on. If easels are used, have a minimum of 3, ideally 4)</td><td></td><td></td><td></td></tr><tr><td>Individual research questions (from Session 1 analysis) printed in large font on self-stick* half-sheets of 8.5 x 11 paper *If not available, also need tape or spray adhesive</td><td></td><td></td><td></td></tr><tr><td>Blank half-sheets (in a different color paper) for new questions generated in session 2</td><td></td><td></td><td></td></tr><tr><td>Research topics (from Session 1 analysis) printed in bold large font on self-stick* half-sheets of 8.5 x 11 paper *If not available, also need tape or spray adhesive</td><td></td><td></td><td></td></tr><tr><td>Blank half-sheets (in a different color paper) for new topics generated in session 2</td><td></td><td></td><td></td></tr><tr><td>Post-it flip chart paper (at least 15 sheets)</td><td></td><td></td><td></td></tr><tr><td>Markers and pens</td><td></td><td></td><td></td></tr><tr><td>Sticker dots in different colors or patterns &amp;mdash; each participant will need 20 sticker dots in a different color or pattern (15 dots for round 1 and 5 dots for round 2 of the prioritization exercise)</td><td></td><td></td><td></td></tr><tr><td>Paper copies for all participants and facilitators with the research questions organized by topic</td><td></td><td></td><td></td></tr><tr><td>Audio recorder</td><td></td><td></td><td></td></tr><tr><td>Name tags</td><td></td><td></td><td></td></tr><tr><td>Required forms (e.g., photo consents, reimbursement forms)</td><td></td><td></td><td></td></tr><tr><td>Options (but strongly recommended): Refreshments, gift cards or gifts to acknowledge participant time and contribution to the project</td><td></td><td></td><td></td></tr></tbody></table>

a novel method for involving women of color at high risk for preterm birth in research priority setting

Involvement of patients and the public is now recognized to be essential for the good conduct of research. Patient and public involvement in research priority setting and funding decisions is only beginning to be recognized as important, and methods for doing so are nascent. This protocol describes the Research Prioritization by Affected Communities (RPAC) protocol and findings from its use with women at high socio-demographic risk for preterm birth. The goal was to directly involve these women in identifying and prioritizing their unanswered questions about pregnancy, birth and neonatal care, and treatment so that their views could be included in research priority setting by funders and researchers. The RPAC protocol may be used to meaningfully involve under-represented groups at high-risk for specific health problems, or those who face disproportionate burden of disease, in research strategy and funding priority setting.

The following results were derived from an ongoing project to involve women at high sociodemographic risk for preterm birth in the research strategy and funding priorities for the PTBI-CA in San Francisco, Oakland and Fresno, California. The representative results are from two CBOs serving women in San Francisco, CA: the Homeless Prenatal Program (HPP) and the Black Infant Health Program (BIH). The organizations either directly deliver or host a variety of services including prenatal, childbirth preparation and post-partum classes. Additional free services include case management, individualized life and goal planning, public health nurse consultation, referral services for medical, social, economic and mental health services and transportation. Staff at each organization invited clients who were pregnant or who had young preterm children to participate in the project.
There were 14 participants in total, 6 from HPP and 8 from BIH, ranging in age from 20 to 42. Of the participants&#39; total of 44 children (range 1 to 5 each), 21% (n=9) were born preterm. Participants self-identified as African-American (n=12), Latina (n=1), or Asian/Pacific Islander (n=1). Three of the women were pregnant at the time of the focus groups, 2 in the HPP groups and 1 in the BIH groups. Participants were compensated for their time. There was no attrition during the study period.
After removing questions posed by participants that had strong evidence from systematic reviews or national guidelines as well as duplicate questions between the two groups, a combined list of 135 unique research questions had been generated from the session 1 activities at the two sites. Using thematic analysis, the questions were grouped under 11 overarching research topic themes. These questions and topics were presented to each of the groups in session 2 and the top 10 (HPP) and top 15 (BIH) research questions were agreed by group consensus. Figure 1 shows the participants performing the dot voting to indicate their round 2 top priority research questions. The results from both groups were again examined together and duplicates removed, resulting in the final list of the combined top 10 specific research questions (Table 1) and top 9 research topics (Table 2).
During the course of the two-session protocol, participants spoke intimately about their own health and healthcare experiences. Participants reported that hearing other women tell their stories prompted them to share more about themselves. During each of the sessions there was discussion among participants about the impact of the women&#39;s healthcare experiences personally and on their community. These data were recorded and transcribed as part of the sessions and later subjected to qualitative analysis, adding context, meaning and, on occasion, suggestions for further research on the research priority topics identified as important by the women (data not shown). In the debriefing discussions at the close of session 2 at each site, all of the women reported that participation was a positive learning experience and all expressed interest in continued involvement with researchers.
<img alt="Figure 1" class="xfigimg" src="/files/ftp_upload/56220/56220fig1.jpg" /> 
Figure 1. Participants in Session 2 performing the dot voting to indicate their round 2 top priority research questions. <a href="https://cloudflare.jove.com/files/ftp_upload/56220/56220fig1large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>How does a mother&#8217;s stress affect the baby?</td>
		</tr>
		<tr>
			<td>What are the most effective ways to improve patient-provider communication, particularly when patients perceive insensitive and rude comments from health care workers?</td>
		</tr>
		<tr>
			<td>What is the most effective care for pregnancy and high-risk pregnancy? For example, if African American women are at higher risk, why isn&#8217;t there specialized care to improve outcomes?</td>
		</tr>
		<tr>
			<td>What causes Sudden Infant Death Syndrome?</td>
		</tr>
		<tr>
			<td>Does the type of insurance you have determine the type of care that you get, or the quality of your care and is care different based on insurance status or race?</td>
		</tr>
		<tr>
			<td>What could make hospital visits and in-hospital stays easier for families and what supports are most helpful for moms with children at home?</td>
		</tr>
		<tr>
			<td>What medicines are safe to take during pregnancy?</td>
		</tr>
		<tr>
			<td>How do birth plans help and how can the health care team better follow a woman&#8217;s birth plan?</td>
		</tr>
		<tr>
			<td>How do health care providers decide to involve Child Protective Services during pregnancy care when abuse and neglect are not clearly present?</td>
		</tr>
		<tr>
			<td>Could experienced moms be used more effectively for breastfeeding support?</td>
		</tr>
	</tbody>
</table>
Table 1. Top 10 specific research questions of women at high sociodemographic risk for preterm birth
<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Priority</td>
			<td colspan="4">Research topic</td>
		</tr>
		<tr>
			<td>1</td>
			<td colspan="4">Stress during pregnancy and its impact on women and infants</td>
		</tr>
		<tr>
			<td>2</td>
			<td colspan="4">Standards for monitoring and care of women with high risk pregnancies</td>
		</tr>
		<tr>
			<td>3</td>
			<td colspan="4">Impact of employment and insurance coverage on care and outcomes</td>
		</tr>
		<tr>
			<td>4</td>
			<td colspan="4">Safety of drugs and substances during pregnancy and for newborns</td>
		</tr>
		<tr>
			<td>5</td>
			<td colspan="4">Provider-patient communications and decision-making</td>
		</tr>
		<tr>
			<td>6</td>
			<td colspan="4">Breastfeeding support</td>
		</tr>
		<tr>
			<td>7</td>
			<td colspan="4">Standards for referral of women and families to social services</td>
		</tr>
		<tr>
			<td>8</td>
			<td colspan="4">Causes and prevention of Sudden Infant Death Syndrome</td>
		</tr>
		<tr>
			<td>9</td>
			<td colspan="4">Support for mothers and babies at home</td>
		</tr>
	</tbody>
</table>
Table 2. Priority research topics for women at high sociodemographic risk for preterm birth

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A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

This manuscript describes the Research Prioritization by Affected Communities (RPAC) protocol and findings from its use with women at risk for preterm birth. Using the protocol, women identified and prioritized their unanswered questions about pregnancy, birth and neonatal care aimed at influencing research priority setting by funders and researchers.

Involvement of patients and the public is now recognized to be essential for the good conduct of research. Patient and public involvement in research ...

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The Nursing Process I

SCIENTISTS IN ACTION

11.7K Views.  University of California, San Francisco. Dit manuscript beschrijft de prioritering van het onderzoek door getroffen gemeenschappen (RPAC) protocol en bevindingen van het gebruik ervan met vrouwen in gevaar voor vroeggeboorte. Met behulp van het protocol, vrouwen geïdentificeerd en geprioriteerd hun onbeantwoorde vragen over zwangerschap, geboorte en neonatale zorg gericht op het vaststellen van de prioriteiten van onderzoek te beïnvloeden door financiers en onderzoekers.

Video: A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale

There has been a long-standing interest in the assessment of the neurobehavioral integrity of the newborn infant. The NICU Network Neurobehavioral Scale (NNNS) was developed as an assessment for the at-risk infant. These are infants who are at increased risk for poor developmental outcome because of insults during prenatal development, such as substance exposure or prematurity or factors such as poverty, poor nutrition or lack of prenatal care that can have adverse effects on the intrauterine environment and affect the developing fetus. The NNNS assesses the full range of infant neurobehavioral performance including neurological integrity, behavioral functioning, and signs of stress/abstinence. The NNNS is a noninvasive neonatal assessment tool with demonstrated validity as a predictor, not only of medical outcomes such as cerebral palsy diagnosis, neurological abnormalities, and diseases with risks to the brain, but also of developmental outcomes such as mental and motor functioning, behavior problems, school readiness, and IQ. The NNNS can identify infants at high risk for abnormal developmental outcome and is an important clinical tool that enables medical researchers and health practitioners to identify these infants and develop intervention programs to optimize the development of these infants as early as possible. The video shows the NNNS procedures, shows examples of normal and abnormal performance and the various clinical populations in which the exam can be used.

The NICU Network Neurobehavioral Scale (NNNS) was developed as an assessment for the at-risk infant. The purpose of this article is to describe the NNNS, provide video examples of the NNNS procedures and discuss the ways in which the exam has been used.

There has been a long-standing interest in the assessment of the neurobehavioral integrity of the newborn infant.  The NICU Network Neurobehavioral Scale ...

Preterm EEG: A Multimodal Neurophysiological Protocol

Since its introduction in early 1950s, electroencephalography (EEG) has been widely used in the neonatal intensive care units (NICU) for assessment and monitoring of brain function in preterm and term babies. Most common indications are the diagnosis of epileptic seizures, assessment of brain maturity, and recovery from hypoxic-ischemic events. EEG recording techniques and the understanding of neonatal EEG signals have dramatically improved, but these advances have been slow to penetrate through the clinical traditions. The aim of this presentation is to bring theory and practice of advanced EEG recording available for neonatal units. 
In the theoretical part, we will present animations to illustrate how a preterm brain gives rise to spontaneous and evoked EEG activities, both of which are unique to this developmental phase, as well as crucial for a proper brain maturation. Recent animal work has shown that the structural brain development is clearly reflected in early EEG activity. Most important structures in this regard are the growing long range connections and the transient cortical structure, subplate. Sensory stimuli in a preterm baby will generate responses that are seen at a single trial level, and they have underpinnings in the subplate-cortex interaction. This brings neonatal EEG readily into a multimodal study, where EEG is not only recording cortical function, but it also tests subplate function via different sensory modalities. Finally, introduction of clinically suitable dense array EEG caps, as well as amplifiers capable of recording low frequencies, have disclosed multitude of brain activities that have as yet been overlooked.
In the practical part of this video, we show how a multimodal, dense array EEG study is performed in neonatal intensive care unit from a preterm baby in the incubator. The video demonstrates preparation of the baby and incubator, application of the EEG cap, and performance of the sensory stimulations.

This video explains the background theory of the neonatal EEG activity and the sensory responses, followed by a live demonstration of their recording in neonatal intensive care unit.

Since its introduction in early 1950s, electroencephalography (EEG) has been widely used in the neonatal intensive care units (NICU) for assessment and ...

Neuroscience

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Biomarkers are directly-measured biological indicators of disease, health, exposures, or other biological information. In population and social sciences, biomarkers need to be easy to obtain, transport, and analyze. Dried Blood Spots meet this need, and can be collected in the field with high response rates. These elements are particularly important in longitudinal study designs including interventions where attrition is critical to avoid, and high response rates improve the interpretation of results. Dried Blood Spot sample collection is simple, quick, relatively painless, less invasive then venipuncture, and requires minimal field storage requirements (i.e.&#160;samples do not need to be immediately frozen and can be stored for a long period of time in a stable freezer environment before assay). The samples can be analyzed for a variety of different analytes, including cholesterol, C-reactive protein, glycosylated hemoglobin, numerous cytokines, and other analytes, as well as provide genetic material. DBS collection is depicted as employed in several recent studies.

Biomarkers are directly-measured biological indicators of disease or health. In population and social sciences, biomarkers need to be easy to obtain, transport, and analyze. Dried Blood Spot (DBS) collection meets this need, can be collected in the field with high response rates&#160;and analyzed for a variety of biomarkers.

Biomarkers are directly-measured biological indicators of disease, health, exposures, or other biological information. In population and social sciences, ...

Medicine

Isolation of Leukocytes from the Human Maternal-fetal Interface

Pregnancy is characterized by the infiltration of leukocytes in the reproductive tissues and at the maternal-fetal interface (decidua basalis and decidua parietalis). This interface is the anatomical site of contact between maternal and fetal tissues; therefore, it is an immunological site of action during pregnancy. Infiltrating leukocytes at the maternal-fetal interface play a central role in implantation, pregnancy maintenance, and timing of delivery. Therefore, phenotypic and functional characterizations of these leukocytes will provide insight into the mechanisms that lead to&#160;pregnancy disorders. Several protocols have been described in order to isolate infiltrating leukocytes from the decidua basalis and decidua parietalis; however, the lack of consistency in the reagents, enzymes, and times of incubation makes it difficult to compare these results. Described herein is&#160;a novel approach that combines the use of gentle mechanical and enzymatic dissociation techniques to preserve the viability and integrity of extracellular and intracellular markers in leukocytes isolated from the human tissues at the maternal-fetal interface. Aside from immunophenotyping, cell culture, and cell sorting, the future applications of this protocol are numerous and varied. Following this protocol, the isolated leukocytes can be used to determine DNA methylation, expression of target genes, in vitro leukocyte functionality (i.e., phagocytosis, cytotoxicity, T-cell proliferation, and plasticity, etc.), and the production of reactive oxygen species at the maternal-fetal interface. Additionally, using the described protocol, this laboratory has been able to describe new and rare leukocytes at the maternal-fetal interface.

Described herein is a protocol to isolate and further study the infiltrating leukocytes of the decidua basalis and decidua parietalis - the human maternal-fetal interface. This protocol maintains the integrity of cell surface markers and yields enough viable cells for downstream applications as proven by flow cytometry analysis.

Pregnancy is characterized by the infiltration of leukocytes in the reproductive tissues and at the maternal-fetal interface (decidua basalis and decidua ...

Immunology and Infection

Pipeline for Analyzing Behavioral Responses to External Cues in MRI Environments

Profiling Maternal Behavior Responses During Whole-Brain Imaging

Recent advancements in whole-brain imaging tools have enabled neuroscientists to investigate how coordinated brain activity processes external cues, influencing internal state changes and eliciting behavioral responses. For example, functional magnetic resonance imaging (fMRI) is a noninvasive technique that allows for the measurement of whole-brain activity in awake, behaving mice using the blood oxygenation-level-dependent (BOLD) response. However, to fully understand BOLD responses evoked by external stimuli, it is crucial that experimenters also assess behavioral responses during scans. The MRI environment poses challenges to this goal, rendering commonly employed methods of behavioral monitoring incompatible. These challenges include (1) a restricted field of view and (2) the limited availability of equipment without ferromagnetic components. Presented here is a behavioral video analysis pipeline that overcomes these limitations by extracting valuable information from videos acquired within these environmental constraints, enabling the evaluation of behavior during the acquisition of whole-brain neural data. Employing methods such as optical flow estimation and dimensionality reduction, robust differences can be detected in behavioral responses to stimuli presented during fMRI scans. For example, representative results suggest that mouse pup vocalizations, but not pure tones, evoke significantly different behavioral responses in maternal versus virgin female mice. Moving forward, this behavioral analysis pipeline, initially tailored to overcome challenges in fMRI experiments, can be extended to various neural recording methods, providing versatile behavioral monitoring in constrained environments. The coordinated evaluation of behavioral and neural responses will offer a more comprehensive understanding of how the perception of stimuli leads to the coordination of complex behavioral outputs.

Presented here is a video analysis pipeline that overcomes challenges in behavioral monitoring within MRI environments, allowing for the detection of uninstructed behavioral responses to external cues. This analysis will facilitate a more comprehensive understanding of evoked internal state changes and brain-wide activity.

Recent advancements in whole-brain imaging tools have enabled neuroscientists to investigate how coordinated brain activity processes external cues, ...

Transcutaneous Microcirculatory Imaging in Preterm Neonates

Microcirculatory imaging (MI) is a relatively new research tool mainly used in the intensive care setting. MI provides a clear view of the smallest capillaries, arterioles and venules. The magnifying effect visualizes the flow pattern of erythrocytes through these vessels.
It's non-invasive character makes it suitable to apply in (preterm) neonates, even in cardiorespiratory unstable patients. In adults and children, MI is mainly performed sublingually, but this is not possible in preterm infants as these cannot cooperate and the size of the probe is problematic. In preterm infants, MI is therefore performed transcutaneously. Their thin skin makes it possible to obtain high quality images of peripheral microcirculation. 
In this manuscript we will demonstrate the method of transcutaneous MI in preterm infants. We will focus on the different techniques and provide tips to optimize image quality. The highlights of software settings, safety and offline analysis are also addressed.

Microcirculatory imaging (MI) is used to monitor peripheral perfusion in critically ill or preterm neonates. This manuscript and video demonstrates the optimal approach for obtaining high-quality images.

Microcirculatory imaging (MI) is a relatively new research tool mainly used in the intensive care setting. MI provides a clear view of the smallest ...

The 4-vessel Sampling Approach to Integrative Studies of Human Placental Physiology In Vivo

The human placenta is highly inaccessible for research while still in utero. The current understanding of human placental physiology in vivo is therefore largely based on animal studies, despite the high diversity among species in placental anatomy, hemodynamics and duration of the pregnancy. The vast majority of human placenta studies are ex vivo perfusion studies or in vitro trophoblast studies. Although in vitro studies and animal models are essential, extrapolation of the results from such studies to the human placenta in vivo is uncertain. We aimed to study human placenta physiology in vivo at term, and present a detailed protocol of the method. Exploiting the intraabdominal access to the uterine vein just before the uterine incision during planned cesarean section, we collect blood samples from the incoming and outgoing vessels on the maternal and fetal sides of the placenta. When combining concentration measurements from blood samples with volume blood flow measurements, we are able to quantify placental and fetal uptake and release of any compound. Furthermore, placental tissue samples from the same mother-fetus pairs can provide measurements of transporter density and activity and other aspects of placental functions in vivo. Through this integrative use of the 4-vessel sampling method we are able to test some of the current concepts of placental nutrient transfer and metabolism in vivo, both in normal and pathological pregnancies. Furthermore, this method enables the identification of substances secreted by the placenta to the maternal circulation, which could be an important contribution to the search for biomarkers of placenta dysfunction.

The 4-vessel Sampling Approach to Integrative Studies of Human Placental Physiology In Vivo

We present a detailed method to study human placental physiology in vivo at term. The method combines blood sampling from the incoming and outgoing vessels on the maternal and fetal sides of the placenta with ultrasound measurements of volume blood flow and placental tissue sampling.

The human placenta is highly inaccessible for research while still in utero. The current understanding of human placental physiology in vivo is therefore ...

Visualizing Uterine Contractions by EMMI for Improved Labor Management

Electromyometrial Imaging of Uterine Contractions in Pregnant Women

During normal pregnancy, the uterine smooth muscle, the myometrium, begins to have weak, uncoordinated contractions at late gestation to help the cervix remodel. In labor, the myometrium has strong, coordinated contractions to deliver the fetus. Various methods have been developed to monitor uterine contraction patterns to predict labor onset. However, the current techniques have limited spatial coverage and specificity. We developed electromyometrial imaging (EMMI) to noninvasively map uterine electrical activity onto the three-dimensional uterine surface during contractions. The first step in EMMI is to use T1-weighted magnetic resonance imaging to acquire the subject-specific body-uterus geometry. Next, up to 192 pin-type electrodes placed on the body surface are used to collect electrical recordings from the myometrium. Finally, the EMMI data processing pipeline is performed to combine the body-uterus geometry with body surface electrical data to reconstruct and image uterine electrical activities on the uterine surface. EMMI can safely and noninvasively image, identify, and measure early activation regions and propagation patterns across the entire uterus in three dimensions.

Author Spotlight: Advancing Labor Management Through Electromyometrial Imaging for Understanding Uterine Contractions 

We present a protocol for conducting electromyometrial imaging (EMMI), including the following procedures: multiple electromyography electrode sensor recordings from the body surface, magnetic resonance imaging, and uterine electrical signal reconstruction.

During normal pregnancy, the uterine smooth muscle, the myometrium, begins to have weak, uncoordinated contractions at late gestation to help the cervix ...

Bioengineering

Clinical Practice Protocol of Creative Music Therapy for Preterm Infants and Their Parents in the Neonatal Intensive Care Unit

Creative music therapy for preterm infants and their parents (CMT) has emerged as a promising family-integrated early intervention involving communicative musicality to improve infant development, parental well-being, and bonding. It aims at relaxing and nurturing the infant as well as promoting safety and social interaction for the parent-infant dyad. A music therapist specially trained in CMT hums or sings in an infant-directed, improvised, lullaby style continually adjusting to the individual needs, expressions, and breathing pattern of the preterm infant. Based on the principles of family-integrated care, the family is incorporated individually in the therapeutic process, namely by delivering CMT during kangaroo care (KC) and by motivating and facilitating parental vocal interaction with their infant to strengthen the parent-infant bonding. CMT aims at relaxing, stimulating, and coregulating premature infants at a time when many other interventions are still risky and can overwhelm the vulnerable patient group. CMT may be advantageous not by educating and teaching parents, but rather by uncovering the intuitive capacities of parenting that are often overshadowed by the traumatic experience of preterm birth. However, CMT can only be provided when the infants are clinically stable. CMT with parental integration is feasible when parents are available and receptive to participate. This paper presents a detailed protocol on how to use CMT to empower preterm infants and their families.

Creative music therapy for preterm infants and their parents has emerged as a promising family-integrated early intervention. We present a detailed protocol on how to use vocal interaction, humming, or singing to empower preterm infants and their families.

Creative music therapy for preterm infants and their parents (CMT) has emerged as a promising family-integrated early intervention involving communicative ...

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

A protocol for involving individuals presenting with developmental language disorder (DLD) (iDLD) and their parents/carers (iDLDPC) in a research priority setting exercise is presented.
iDLD have difficulties with communication skills, such as understanding language, word-finding and discourse. Such difficulties mean existing research priority setting protocols are difficult for iDLD to access, since they require sophisticated communication skills. Thus, a novel protocol for involving iDLD in these exercises is warranted. The same protocol is recommended for use with iDLDPC, to ensure accessibility.
The protocol is presented in 4 steps. Step 1 describes a program of activities delivered by trained, specialist DLD speech and language therapists (SLTs) that prepares iDLD/iDLDPC for involvement. Step 2 outlines an approach to elicit iDLD/iDLDPC&#8217;s opinions on research priorities. Steps 3 and 4 describe methods to analyze and integrate this data at multiple stages of the research priority setting process.
9 trained specialist DLD SLTs delivered steps 1 and 2. 17 iDLDs and 25 iDLDPCs consented to involvement. Opinions from all participants were elicited, and this data was used to influence the process and output of the exercise.
An advantage of this protocol is its accommodation of the heterogeneity in support needs of iDLD/iDLDPC, through a menu of options, whilst also providing a structured framework. Due to the novelty of the protocol, the methods for data integration were developed by the research group. These are potential limitations of the protocol, and may bring the reliability and validity under scrutiny, which are yet to be tested.
This protocol enables meaningful involvement of iDLD/iDLDPC in&#160;research priority setting and could be utilized for people with other kinds of speech, language or communication needs. Further research should evaluate the effectiveness of the protocol and whether it can be adapted for involvement of such populations in other research studies.

A protocol to enable individuals with developmental language disorder (DLD) and their parents/carers to meaningfully participate in a research priority setting exercise is established. The protocol includes a defined program of activities for data collection, and methods to incorporate this data into the broader research priority setting process.

A protocol for involving individuals presenting with developmental language disorder (DLD) (iDLD) and their parents/carers (iDLDPC) in a research priority ...

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

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