This project was sponsored through internal funding provided by the PRIS-M QUERI at the Richard L. Roudebush VA Medical Center in Indianapolis, Indiana Veterans Health Administration (QUE 15-280). The funding body had no role in the design of the study, the collection, analysis, and interpretation of data, or the writing of the manuscript. The authors retain sole responsibility for the content of this study. The PRIUS method is in the public domain and freely available for anyone to use.

This study was approved by the Indiana University Institutional Review Board (Protocol #1602800879). With this approval, the reviewing body included a waiver for the need for informed consent, as it was deemed that participation was entirely voluntary, there was minimal risk of harm, and the study involved no procedures for which written consent was normally required outside of the research context.
1. Participant-Reported Implementation Update and Score (PRIUS)
<ol>
	<li>Ask participant PRIUS prompt #1.
	<ol>
		<li>At a mutually agreed-upon time, meet the participant over a videoconferencing application like Zoom.</li>
		<li>Pose the first verbal prompt to the participant: &#34;What are some things that happened over the past two weeks (or since the last time we spoke) that seem relevant from your perspective to the implementation of this project&#34;?</li>
	</ol>
	</li>
	<li>Capture qualitative responses to prompt #1.
	<ol>
		<li>Using a spreadsheet template like the one pictured below in Table 1, capture the first implementation-related development that the participant reports in the first row under the first column labeled &#34;Update.&#34; It is not necessary to capture each development verbatim; a bullet-style summary is sufficient.</li>
		<li>Repeat as needed for each additional development reported by the participant during the same session.</li>
	</ol>
	</li>
</ol>
Table 1. A blank 4-column PRIUS template. <a href="https://www.jove.com/files/ftp_upload/61738/Table 1_Miech_PRIUS.docx" target="_blank">Please click here to download this Table.</a>
<ol start="3">
	<li>Ask participant PRIUS prompt #2.
	<ol>
		<li>For each reported development, pose the second verbal prompt: &#34;From your perspective, what would you say the impact of that development has had on the implementation of the project? Do you think it has has a strong, moderate or weak impact, and is the direction of that impact positive or negative?&#34;</li>
	</ol>
	</li>
	<li>Capture scored responses to prompt #2.
	<ol>
		<li>Based on the response from the participant, score each development on the template on a 7-point scale ranging from +3 to -3, with zero as the middle value. Next to each development entered into the spreadsheet in Step 1.2, enter the score in the column labeled &#34;Score.&#34; Positive scores indicate positive influence on the implementation process; negative scores indicate negative influence; and zero indicates no discernible influence one way or the other. In terms of magnitude, 3 indicates a strong influence, 2 a moderate influence and 1 a weak influence. For example, a PRIUS update with a &#34;-2&#34; score would indicated that that the development was perceived to have a moderate negative impact on implementation of the project.</li>
	</ol>
	</li>
	<li>Ask participant PRIUS prompt #3.
	<ol>
		<li>For each development reported and scored, ask the participant to provide a brief rationale for each score with the third verbal prompt: &#34;Why do you think it has had that impact?&#34; (i.e., strong/moderate/weak as well as positive/negative). For example, ask a participant to explain why they thought a particular development had a &#34;weak negative&#34; impact (i.e., a &#34;-1&#34;) on implementation progress.</li>
	</ol>
	</li>
	<li>Capture qualitative responses to prompt #3.
	<ol>
		<li>Capture each rationale that the participant reports. Enter it in the third column of the spreadsheet entitled &#34;Rationale&#34; for each score captured in Step 1.4. As before, a short text summary is sufficient.</li>
	</ol>
	</li>
	<li>Note any additional information.
	<ol>
		<li>Capture any additional information in the optional fourth column of the spreadsheet labeled &#34;Comments&#34; as desired. This might include observed nonverbal cues like facial expressions, body language, and tone of voice and/or additional relevant details.</li>
	</ol>
	</li>
	<li>Check in with participant on a recurring basis.
	<ol>
		<li>Meet again with participant every two weeks and repeat steps 1.1 through 1.7.</li>
	</ol>
	</li>
</ol>

<ol>
	<li>Curran, G. M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Implementation+science+made+too+simple:+a+teaching+tool.">Implementation science made too simple: a teaching tool.</a> Implementation Science Communications. 1 (27), 1-3 (2020).</li><li>Powell, B. J., 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=A+refined+compilation+of+implementation+strategies:+results+from+the+Expert+Recommendations+for+Implementing+Change+(ERIC)+project.">A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project.</a> Implementation Science. 10 (21), 1-14 (2015).</li><li>Beebe, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Rapid Assessment Process: An Introduction. , (2001).</li><li>McNall, M., Foster-Fishman, P. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Methods+of+rapid+evaluation,+assessment,+and+appraisal.">Methods of rapid evaluation, assessment, and appraisal.</a> American Journal of Evaluation. 28 (2), 151-168 (2007).</li><li>Green, C. A., 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=Approaches+to+mixed+methods+dissemination+and+implementation+research:+methods,+strengths,+caveats,+and+opportunities.">Approaches to mixed methods dissemination and implementation research: methods, strengths, caveats, and opportunities.</a> Administration and Policy in Mental Health. 42 (5), 508-523 (2015).</li><li>Averill, J. B. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Matrix+analysis+as+a+complementary+analytic+strategy+in+qualitative+inquiry.">Matrix analysis as a complementary analytic strategy in qualitative inquiry.</a> Qualitative Health Research. 12 (6), 855-866 (2002).</li><li>Nadin, S., Cassell, C., Cassell, C., Symon, G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Using+data+matrices.">Using data matrices.</a> Essential Guide to Qualitative Research Methods in Organizational Research. , 271-287 (2004).</li><li>Kahneman, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=.">.</a> Thinking Fast and Slow. , (2013).</li><li>Rabin, B. A., 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=Systematic,+multimethod+assessment+of+adaptations+across+four+diverse+health+systems+interventions.">Systematic, multimethod assessment of adaptations across four diverse health systems interventions.</a> Frontiers in Public Health. 6 (102), 1-11 (2018).</li><li>Finley, E. P., 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=Periodic+reflections:+a+method+of+guided+discussions+for+documenting+implementation+phenomena.">Periodic reflections: a method of guided discussions for documenting implementation phenomena.</a> BMC Medical Research Methodology. 18 (1), 153 (2018).</li><li>Damschroder, L. J., 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=Fostering+implementation+of+health+services+research+findings+into+practice:+a+consolidated+framework+for+advancing+implementation+science.">Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.</a> Implementation Science. 4 (1), (2009).</li><li>Miech, E. J., 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=The+prospectively-reported+implementation+update+and+score+(PRIUS):+a+new+method+for+capturing+implementation-related+developments+over+time.">The prospectively-reported implementation update and score (PRIUS): a new method for capturing implementation-related developments over time.</a> BMC Health Services Research. 19 (1), 124 (2019).</li><li>Rattray, N. A., 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=Evaluating+the+feasibility+of+implementing+a+Telesleep+pilot+program+using+two-tiered+external+facilitation.">Evaluating the feasibility of implementing a Telesleep pilot program using two-tiered external facilitation.</a> BMC Health Services Research. 20 (1), 357 (2020).</li></ol>

The authors have nothing to disclose.

No special software is required to use the PRIUS method. PRIUS sessions can be administered by researchers, research assistants, and/or other research team members who have been appropriately trained.
Alternative settings for conducting PRIUS sessions include in-person check-ins or over the telephone. The recommended timeframe for checking in with participants is every two weeks; this frequency can be modified if necessary to more closely align with needs of specific projects.
The first PRIUS prompt (&#34;What are some things that happened over the past two weeks (or since the last time we spoke) that seem relevant from your perspective to the implementation of this project&#34;?) bounds participant responses in three specific ways: it provides a specific reporting timeframe; it engages others by explicitly valuing their individual perspectives on implementation; and it focuses attention on only the most notable (i.e., relevant) implementation developments. In practice, participants typically report two or three developments during a check-in session.
The rationale behind the second prompt (i.e., &#34;From your perspective, what would you say the impact of that development has had on the implementation of the project?&#34;) is to draw upon the experience and perspectives of individual participants at the same time that they report each development to sort those developments into discrete categories of perceived impact. These numerical scores provide an additional factor with seven different possible values that link directly to the qualitative data reported in the developments and provide another source of data for the implementation support team to use when sorting, analyzing, and reporting on implementation progress in Data Analysis.
The third prompt (i.e., &#34;Why do you think it has had that impact?&#34;) explicitly invites participants to explain the reason behind their score. In many cases, this may be the first time that individual participants working extremely busy schedules have had an opportunity to step back and reflect on the meaning and influence of specific implementation-related developments.
The fourth column in the PRIUS template (i.e., &#34;Comments&#34;) affords researchers the option to capture any important contextual details related to the reporting of specific implementation developments.
As with any research method, project teams planning to use the PRIUS method in a formal research setting should obtain Institutional Review Board approval or exemption as required by the responsible institution.
It is highly recommended that teams planning to use the PRIUS method schedule a dedicated training session for team members. Suggested length is 1-2 hours. During the training, describe and explain each step of the PRIUS method&#160;and watch the video accompanying this article. Pair up team members and have them practice administering PRIUS check-ins with one another in a simulated session, where each member of the pair takes turns being the person administering the PRIUS.
As individual PRIUS sessions are completed, project teams should integrate the PRIUS data on a rolling basis into a unified database in a secure online location that team members can access. A six-column spreadsheet is sufficient for this purpose, where the two additional columns capture the date and respondent for each entry. It is also a recommended practice to make a backup copy of the master PRIUS spreadsheet at regular intervals in case the original is damaged or corrupted.
The project team should conduct reviews of the ever-expanding PRIUS dataset on a periodic basis (e.g., once a month) to examine how recent entries compare with earlier entries, assess implementation-related trends and patterns, identify perceived strengths and weaknesses of&#160;implementation to date, and develop specific recommendations for implementation leaders about emergent opportunities to support and sustain implementation progress.
When preparing to conduct the PRIUS, the research team should determine the timeframe over which the PRIUS check-in sessions will occur, including start and end dates. A sample timeframe, for example, might involve administering the PRIUS method for a 3-month period, with individual PRIUS check-in sessions taking place roughly once every two weeks; in this example, the average participant would complete a total of five or six PRIUS check-in sessions.
It is also recommended that the research team send a general announcement to potential participants in advance to notify them that they may receive an invitation to participate in brief 5-minute check-ins to learn more about their perspectives on how implementation is faring. This message ideally would be sent through regular and established communication channels, such as email messages and/or announcements at regular staff meetings. The research team may wish to highlight the following points in the message:
1. participation is voluntary;
2. no preparation is necessary in advance of a PRIUS check-in;
3. the 5-minute check-ins will occur in a spoken conversation (e.g., over the phone, in person or over a videoconferencing application like Zoom) at a time convenient for the participant;
4. comments can be anonymous if desired;
5. the purpose of the check-ins is to develop on overall picture of how implementation is going throughout the organization - including the identification of problems and challenges - in order to improve the implementation process.
An important decision for the research team to consider at this juncture is whom to invite to participate in the PRIUS check-in sessions. This group of participants should represent a diverse sample of individuals affected by implementation; it is neither necessary nor advisable to invite all participants. The research team may wish to invite both individuals who are thought to be supportive of the program as well as those who are thought to be critical or skeptical. The overall number of participants to invite should be dictated by the number of implementation core support team members available to administer the PRIUS check-ins, with each implementation core member assigned 1-3 individual participants. Keep in mind that anyone not extended an initial invitation can be added at a later point in time if desired.
After a group of participants has been identified, it is time for the implementation core team to pair particular members of the implementation core team with specific participants. It is suggested that the same implementation core members conduct the PRIUS check-in session with the same participants over the longer timeframe in order to allow rapport and trust to develop within the dyads.
Before the first PRIUS session, implementation core members may find it helpful to conduct individual outreach to the participants with whom they have been paired for the PRIUS check-in sessions. Ideally, this outreach would take place informally and&#160;allow for a two-way conversation about the purpose and structure of the PRIUS check-ins. This individual outreach could emphasize in particular that the PRIUS is voluntary, that no preparation is necessary in advance of a session, and that the 5-minute check-ins occur at a time convenient for the participant. If the participant agrees, and if the IRB requirements (if any) for administering the PRIUS method have been satisfied, the first PRIUS check-in session should be conducted with that individual as soon as feasible.
It is highly recommended that any implementation core team using the PRIUS method also develop communication channels that link the implementation core with the intervention team responsible for implementing the new clinical program, especially if (as is often the case) these constitute two separate groups. These communication channels could consist of recurring meetings, shared online folders and/or email distribution lists. Regular exchange of information can facilitate a close working relationship across the evaluation and intervention teams, essential in order for PRIUS-related analysis and insights to inform mid-course adjustments to ongoing implementation.
The format of the PRIUS is easily sortable to facilitate data analysis. Researchers can review, sift and search the growing body of PRIUS entries at any time on an ongoing, iterative basis, and can conduct longitudinal analyses in at least two ways: comparing PRIUS updates scored with similar values at two different timepoints (e.g., comparing all updates scored with &#34;-2&#34; or &#34;-3&#34; in March 2020 with &#34;-2&#34; or &#34;-3&#34; entries in June 2020); and comparing how scores change over time for the same kind of entry (e.g., perspectives on the quality and adequacy of the professional development provided for the program).
When discrepancies in scores are observed across respondents for similar items, implementation core members can flag those implementation-related developments for further scrutiny and discussion in order to assess if the underlying source of the differences is due to a relatively minor semantic issue or if it reflects a deeper polarization of perspectives. If the latter, the research team may opt to bring these discrepancies to the attention of the team responsible for implementing the new clinical intervention for further discussion and possible corrective action.
In terms of limitations, a business case analysis has not yet been conducted on the PRIUS, as cost and time data have not yet been formally collected. PRIUS methods may be better suited for small- and modest-sized interventions, where they could prove more feasible for capturing prospective data from participants on an ongoing basis.
Overall, the PRIUS method addresses an outstanding need in healthcare research for an efficient and structured method to capture data on the status and progress of implementation interventions. If the successful implementation of a novel clinical initiative (i.e., &#34;the new thing&#34;) hinges on an effective implementation intervention (i.e., the set of parallel activities encouraging staff to &#34;do the new thing&#34;), then the PRIUS method offers a novel and straightforward way to capture valuable implementation-related data that might otherwise prove fleeting.

&#34;Implementation&#34; of new initiatives in healthcare settings typically encompasses two distinct components: a &#34;clinical intervention&#34; plus accompanying &#34;implementation strategies&#34; that support putting the clinical intervention into day-to-day practice. A simple analogy to explain the difference is that a clinical intervention represents &#34;the new thing&#34; to be put into practice, whereas an implementation strategy encourages people to &#34;do the new thing1.&#34; A novel clinical intervention, for example, might consist of a new medication, a new protocol, a new device, or a new program. As clinical interventions are not self-implementing, however, they nearly always require effective implementation strategies in order to succeed. Implementation strategies set out to engage healthcare providers, staff and patients in ways that increase the likelihood of participants adopting the new initiative, a process that often involves behavior change and new ways of thinking2. One of the long-standing challenges in studying implementation is that it can be extremely difficult to collect data about the current status of implementation related to either of these two components, including participants&#39; own perspectives on implementation progress. This protocol describes a novel method for collecting and analyzing data related to ongoing implementation called the Participant-Reported Implementation Update and Score, or PRIUS. The PRIUS method allows healthcare researchers to capture qualitative and quantitative data efficiently and systematically related to how implementation unfolds over time and how it appears from the vantage points of multiple participants.
The PRIUS occupies a unique niche within the larger family of methods used to study healthcare implementation. Other approaches that predate the PRIUS include Rapid Evaluation and Assessment Methods (REAM), which provides a way for researchers to collect and analyze data on an accelerated timetable yet maintain rigor3,4,5, as well as matrix displays, where researchers integrate large amounts of data into rows and columns that they can then sort and sift to support ongoing analyses6,7. A limitation of these methods, though, is that they can place substantial time and resource demands on researchers, and hence have been primarily used retrospectively to analyze prior implementation.
The use of prospective and longitudinal approaches for collecting implementation-related information can help retain accuracy in data collection, minimizing the possibility of hindsight bias (i.e., when the ultimate success or failure of an initiative influences reporting of earlier events) and recall bias (i.e., when participants do not remember prior events accurately)8. Other prospective and longitudinal approaches exist in implementation but with different aims than the PRIUS. For example, a systemic method has been developed to describe and track local adaptations to implementation as they occur over time using a 10-item spreadsheet9. Another approach known as &#34;Periodic Reflections&#34; provides a structured way for implementation core members to conduct monthly or bimonthly 30-60 minute telephone discussions with implementation team members in to document ongoing implementation phenomena10.
The PRIUS, by contrast, is distinct from these other prospective methods in that it has been designed explicitly to address the need for (a) a brief and systematic method to collect data on the status and progress of implementation interventions as it happens (b) from the perspectives of front-line participants themselves. In the span of a 5-10 minute verbal check-in, the PRIUS both captures implementation developments deemed noteworthy by individual participants as well as their subjective input (in the form of scores assigned on a +2 to -2 scale) about the perceived implications of those developments for ongoing implementation. The PRIUS approach, moreover, integrates qualitative and numerical information from participants for each implementation-related update, generating linked data that can be easily categorized, sorted and sifted to identify major themes as well as trends and patterns over time. The PRIUS method is succinct and organized around three simple verbal prompts: (1) &#34;What are some things that happened over the past two weeks (or since the last time we spoke) that seem relevant from your perspective to the implementation of this project?&#34;; (2) &#34;What impact do you think each of these developments has had on implementation progress?&#34;; and (3) &#34;Why?&#34;
The conceptual framework for the PRIUS is the Consolidated Framework for Implementation Research (CFIR)11, which provides an overall typology for understanding implementation in health services settings. The CFIR framework is both theory-based and evidence-based, and represents the accumulated result of over 50 years of research on implementation and diffusion. The CFIR framework encompasses five interrelated domains: intervention characteristics, outer setting, inner setting, individuals involved, and implementation process. The PRIUS method focuses especially on the intersection of the last three domains, asking individuals about their own perspectives related to the implementation process actively underway in the inner setting.
The PRIUS method is in the public domain and freely available for anyone to use. The protocol presented here further develops the PRIUS approach presented in an earlier publication12 and focuses exclusively on how to conduct the PRIUS with a single participant.

the participant-reported implementation update and score (prius): a novel method for capturing implementation-related data over time

"Implementation" of new initiatives in healthcare settings typically encompasses two distinct components: a "clinical intervention" plus accompanying "implementation strategies" that support putting the clinical intervention into day-to-day practice. A novel clinical intervention, for example, might consist of a new medication, a new protocol, a new device, or a new program. As clinical interventions are not self-implementing, however, they nearly always require effective implementation strategies in order to succeed. Implementation strategies set out to engage healthcare providers, staff and patients in ways that increase the likelihood of the new initiative being successfully adopted, a process that often involves behavior change and new ways of thinking by participants. One of the challenges in studying implementation is that it can be difficult to collect data about the status and progress of implementation, including participants' own perspectives and experiences concerning implementation to date. This protocol describes a novel method for collecting and analyzing data related to ongoing implementation called the Participant-Reported Implementation Update and Score, or PRIUS. The PRIUS method allows for the efficient and systematic capture of qualitative and quantitative data that can provide a detailed and nuanced account of implementation over time and from multiple viewpoints. This longitudinal method can enable researchers, as well as implementation leaders and organizational stakeholders, to monitor implementation progress more closely, conduct formative evaluation, identify improvement opportunities, and gauge the effect of any implementation changes on a rolling basis.

As reported in an earlier publication12, twelve staff members at a single VA medical center in the midwestern United States participated in PRIUS sessions related to a quality improvement (QI) project over a 6-month period in 2016. This project resulted in a total of over 190 different PRIUS items. The typical PRIUS session yielded three or four items (or &#34;rows&#34; in the PRIUS template). New PRIUS updates were discussed during regular implementation support team meetings, with PRIUS-based findings and insights shared with the leaders of the QI project.
<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td colspan="3">PRIUS Updates (n=190)</td>
		</tr>
		<tr>
			<td>Score</td>
			<td>Frequency (%)</td>
			<td>Major Descriptive Themes</td>
		</tr>
		<tr>
			<td>3</td>
			<td>49 (26)</td>
			<td>Positive experiences during general professional development and training events at beginning of TeleSleep project; positive interactions with vendor (ResMED); implementation of new electronic tools (e.g., TeleSleep template and tracking spreadsheet) very helpful</td>
		</tr>
		<tr>
			<td>2</td>
			<td>28 (15)</td>
			<td>Positive interactions between individuals from different clinical areas</td>
		</tr>
		<tr>
			<td>1</td>
			<td>15 (8)</td>
			<td>Small, incremental changes (e.g., enrolling an additional patient)</td>
		</tr>
		<tr>
			<td>0</td>
			<td>26 (14)</td>
			<td>Potential opportunities representing a change from status quo (e.g., Telehealth not reviewing TeleSleep data during Telehealth meetings; possibility for additional funds to become available in future to TeleSleep)</td>
		</tr>
		<tr>
			<td>-1</td>
			<td>16 (8)</td>
			<td>Perceived lack of interest by frontline clinical staff in starting TeleSleep program</td>
		</tr>
		<tr>
			<td>-2</td>
			<td>33 (17)</td>
			<td>Negative interactions between individuals from different clinical areas; slow patient enrollment in TeleSleep between February-April 2016; perceived need for additional training to meet PAP needs of patients</td>
		</tr>
		<tr>
			<td>-3</td>
			<td>23 (12)</td>
			<td>TeleSleep workload heavier than originally anticipated; distrust and hostility among individuals from different clinical areas</td>
		</tr>
	</tbody>
</table>
Table 2. Summary of PRIUS entries from a QI project by score and major descriptive themes.&#160;(adapted from Miech et al., 2019).12
Table 2 above shows a summary of 190 PRIUS entries from the QI project by score and major descriptive themes. The most frequent score applied by participants to PRIUS entries in this project was +3, the highest possible score on the 7-point scale of +3 to -3. Entries scored with a +3 included initial professional development and training events, interactions with the outside vendor and the implementation of new electronic tools. The next most frequent score was -2, the second-lowest possible score. Entries scored with a -2 included interactions between individuals from different clinical areas, slow initial patient enrollment, and the need for follow-up training for staff in order to meet the PAP needs of patients.
Longitudinal analysis of this same PRIUS dataset demonstrated major changes in program-related components over time: for example, PRIUS items related to professional development changed from a strong positive score (i.e., +3) in February to a moderate negative score (-2) by April.
Analysis of PRIUS data led directly to changes in the implementation intervention. During a formally scheduled meeting to review the PRIUS data, the implementation core support team shared with the clinical intervention leader that participants from different clinical areas had disparate and conflicting perspectives on project implementation. Subsequent discussion about this finding led to the realization that key frontline staff from two areas implementing the QI project had not been able to attend project meetings because of conflicting clinical duties, while managers and service chiefs in those same two clinical areas had been regular attendees. Key frontline staff across these two areas, furthermore, neither knew each other nor understood what happened when patients enrolled in the QI program transferred from one service to the other.
The following month, patient enrollment in the QI project nearly came to a halt, with only 5 patients enrolled when the original target had been 30. As a direct result of the earlier PRIUS discussion, the QI intervention leader and the implementation core support team decided to provide an &#34;appreciation&#34; lunch for all interested frontline staff in the two clinical areas. As part of this voluntary event, the clinical intervention leader thanked front-line staff personally for their participation in the program and shared data demonstrating the efficacy of the QI project to date in terms of improving patient outcomes. The appreciation lunch was well-attended and positively received, with frontline staff from the two services engaging in personal conversations for the first time.
Program recruitment improved dramatically after this lunch; within a month enrollment had to be temporarily suspended so staff could catch up with the influx of new patients. PRIUS updates collected after the event clearly singled out this lunch as an inflection point for implementation. Independent of one another, several individuals reported in their PRIUS updates that it was only after this event that they understood the overall project, knew about the positive impact they were having on patients through the program, and appreciated the perspectives of other frontline staff from different clinical areas13. As intended, the PRIUS made the leader of the clinical intervention aware of an implementation issue that otherwise would have remained undetected, helped inform the development of a course correction, and provided a way to evaluate the effect of that change on ongoing implementation.

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The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

This protocol describes a novel method for collecting and analyzing data related to ongoing implementation called the Participant-Reported Implementation Update and Score (PRIUS). The PRIUS method allows for the efficient and systematic capture of data over time and from multiple viewpoints in healthcare settings.

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

"Implementation" of new initiatives in healthcare settings typically encompasses two distinct components: a "clinical intervention" plus accompanying ...

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1.2K Views.  Richard L. Roudebush VA Medical Center. De PRIUS-methode gaat expliciet in op de behoefte aan een korte en systematische methode voor het verzamelen van doorlopende gegevens over de status en voortgang van de implementatie vanuit het perspectief van de deelnemers zelf. Als hoofdonderzoeker van een project dat deze methode gebruikt, kan ik bevestigen dat het echt het perspectief geeft van veel verschillende soorten mensen in de loop van de tijd over hoe het implementatieproces zich ontvouwt. Deze techniek voorziet in een uitstekende...

Video: The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

Development of a Virtual Reality Assessment of Everyday Living Skills

Cognitive impairments affect the majority of patients with schizophrenia and these impairments predict poor long term psychosocial outcomes.&#160; Treatment studies aimed at cognitive impairment in patients with schizophrenia not only require demonstration of improvements on cognitive tests, but also evidence that any cognitive changes lead to clinically meaningful improvements.&#160; Measures of &#8220;functional capacity&#8221; index the extent to which individuals have the potential to perform skills required for real world functioning. &#160;Current data do not support the recommendation of any single instrument for measurement of functional capacity.&#160; The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a novel, interactive gaming based measure of functional capacity that uses a realistic simulated environment to recreate routine activities of daily living. Studies are currently underway to evaluate and establish the VRFCAT&#8217;s sensitivity, reliability, validity, and practicality.&#160;This new measure of functional capacity is practical, relevant, easy to use, and has several features that improve validity and sensitivity of measurement of function in clinical trials of patients with CNS disorders.

A challenge for proving treatment efficacy for cognitive impairments in schizophrenia is finding the optimizing measurement of skills related to everyday functioning.&#160; The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is an interactive gaming based computerized measure aimed at skills associated with everyday functioning, including baseline impairments and treatment related changes.

Cognitive impairments affect the majority of patients with schizophrenia and these impairments predict poor long term psychosocial outcomes.&#160; ...

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

An end-to-end suite of technologies has been established for the unobtrusive and continuous monitoring of health and activity changes occurring in the daily life of older adults over extended periods of time. The technology is aggregated into a system that incorporates the principles of being minimally obtrusive, while generating secure, privacy protected, continuous objective data in real-world (home-based) settings for months to years. The system includes passive infrared presence sensors placed throughout the home, door contact sensors installed on exterior doors, connected physiological monitoring devices (such as scales), medication boxes, and wearable actigraphs. Driving sensors are also installed in participants' cars and computer (PC, tablet or smartphone) use is tracked. Data is annotated via frequent online self-report options that provide vital information with regard to the data that is difficult to infer via sensors such as internal states (e.g., pain, mood, loneliness), as well as data referent to activity pattern interpretation (e.g., visitors, rearranged furniture). Algorithms have been developed using the data obtained to identify functional domains key to health or disease activity monitoring, including mobility (e.g., room transitions, steps, gait speed), physiologic function (e.g., weight, body mass index, pulse), sleep behaviors (e.g., sleep time, trips to the bathroom at night), medication adherence (e.g., missed doses), social engagement (e.g., time spent out of home, time couples spend together), and cognitive function (e.g., time on computer, mouse movements, characteristics of online form completion, driving ability). Change detection of these functions provides a sensitive marker for the application in health surveillance of acute illnesses (e.g., viral epidemic) to the early detection of prodromal dementia syndromes. The system is particularly suitable for monitoring the efficacy of clinical interventions in natural history studies of geriatric syndromes and in clinical trials.

Unobtrusive sensors and pervasive computing technology incorporated into the daily home life of older adults enables meaningful health and activity changes to be recorded continuously for months to years, providing ecologically valid, high frequency, multi-domain data for research or clinical use.

An end-to-end suite of technologies has been established for the unobtrusive and continuous monitoring of health and activity changes occurring in the ...

Use of a Video Scoring Anchor for Rapid Serial Assessment of Social Communication in Toddlers

Reciprocal social behavior (RSB), an early-emerging capacity to engage in social contingency&#8212;which is foundational for both social learning and social competency&#8212;is hypothesized to be disrupted in autism spectrum disorder (ASD). The ability to quantify the full range of RSB during the toddler period, when core symptoms of ASD often arise, is pivotal for evaluating early risk for ASD, characterizing social development, and tracking response to early interventions. However, important parameters of variation in RSB&#8212;especially prior to the development of verbal language&#8212;can be nuanced and difficult to characterize using questionnaire-based methods. To address this challenge, we developed a system for measuring quantitative variation in RSB in toddlers (ages 18 - 30 months) that incorporated not only standard questionnaire data from caregivers but also a novel set of video-referenced items, through which a respondent compares the behavior of a subject to that observed in a short video of a young child manifesting a highly competent level of social communication. Testing of this measure in a general population sample of twins confirmed that both the video-referenced items and the RSB Total Score (video-referenced items plus non-video-referenced items) displayed unimodal, continuous distributions, strong internal consistency, marked preservation of individual differences, and extremely high heritability. In addition, video-referenced items were particularly sensitive to quantifying incremental changes in social communication, a major element of RSB, over the course of early childhood development. Scores on the vrRSB clearly differentiated children with and without ASD and these data comprise an initial validation of this promising method for quantifying early RSB&#8212;cross-sectionally, over time, and as a function of early intervention.

Here we present a protocol for administration of the video-referenced rating of reciprocal social behavior (vrRSB) using a paper or online version. This survey quantifies RSB, a prerequisite for social competence, in toddlers through &#34;video-referenced&#34; items whereby a subject is compared to a reference child shown in a three-minute video.

Reciprocal social behavior (RSB), an early-emerging capacity to engage in social contingency&#8212;which is foundational for both social learning and ...

Visualization of Intensity Levels to Reduce the Gap Between Self-Reported and Directly Measured Physical Activity

Physical activity (PA) assessment needs tools that are inexpensive and easy to administer. Common questionnaires inquire time spent in light, moderate, and vigorous PA. However, inaccuracies may occur due to individually different understanding of PA intensity levels. Alternatively used direct measures (e.g., accelerometers) are susceptible to reactivity bias and may lack the ability to capture certain activities. Compared to accelerometer measurement, respondents report more time spent in higher-intensity PA. A video that visualizes PA intensity levels might help to overcome this problem. This report describes the design of a randomized controlled trial as a methodology to investigate the effect of a video on the difference between self-reported and directly measured PA. It is hypothesized that the video reduces the mean difference between the two measures. Individuals from the general population are recruited. Hip-worn accelerometers are used to collect directly measured PA data on seven consecutive days. Afterwards, participants are randomly allocated to the experimental and the control group. The experimental group receives a video demonstration on PA intensity levels and subsequent PA assessment via self-administered computer-assisted questionnaire. The control group receives PA assessment only. Thereafter, the data are processed to compare the difference between self-reported and accelerometer-based moderate-to-vigorous physical activity (MVPA) between the study groups using a two-sample t-test. This methodology is appropriate for investigating the effect of any existing or self-produced video on the difference between the two measurement methods. It can be used not only for persons from the general population, but for a variety of other populations and contexts as accurate measures are needed to evaluate PA levels.

This protocol describes a randomized controlled trial as a method to test the effect of a video demonstration on the intra-individual difference between self-reported and accelerometer-based moderate-to-vigorous physical activity.

Physical activity (PA) assessment needs tools that are inexpensive and easy to administer. Common questionnaires inquire time spent in light, moderate, ...

Using Continuous Data Tracking Technology to Study Exercise Adherence in Pulmonary Rehabilitation

Pulmonary rehabilitation (PR) is an important component in the management of respiratory diseases. The effectiveness of PR is dependent upon adherence to exercise training recommendations. The study of exercise adherence is thus a key step towards the optimization of PR programs. To date, mostly indirect measures, such as rates of participation, completion, and attendance, have been used to determine adherence to PR. The purpose of the present protocol is to describe how continuous data tracking technology can be used to measure adherence to a prescribed aerobic training intensity on a second-by-second basis.
In our investigations, adherence has been defined as the percent time spent within a specified target heart rate range. As such, using a combination of hardware and software, heart rate is measured, tracked, and recorded during cycling second-by-second for each participant, for each exercise session. Using statistical software, the data is subsequently extracted and analyzed. The same protocol can be applied to determine adherence to other measures of exercise intensity, such as time spent at a specified wattage, level, or speed on the cycle ergometer. Furthermore, the hardware and software is also available to measure adherence to other modes of training, such as the treadmill, elliptical, stepper, and arm ergometer. The present protocol, therefore, has a vast applicability to directly measure adherence to aerobic exercise.

Pulmonary rehabilitation is widely recognized in the management of respiratory diseases. A key component to successful pulmonary rehabilitation is adherence to the recommended exercise training. The purpose of the present protocol is to describe how continuous data tracking technology can be used to precisely measure adherence to a prescribed aerobic training intensity.

Pulmonary rehabilitation (PR) is an important component in the management of respiratory diseases. The effectiveness of PR is dependent upon adherence to ...

Medicine

Visualizing Field Data Collection Procedures of Exposure and Biomarker Assessments for the Household Air Pollution Intervention Network Trial in India

Here, we present a visual representation of standard procedures to collect population-level data on personal exposures to household air pollution (HAP) from two different study sites in a resource-constrained setting of Tamil Nadu, India. Particulate matter PM2.5 (particles smaller than 2.5 microns in aerodynamic diameter), carbon monoxide (CO), and black carbon (BC) were measured in pregnant mothers (M), other adult women (OAW), and children (C) at various times over a 4 year period. In addition, stove usage monitoring (SUMs) with data-logging thermometers and ambient measurements of air pollution were carried out. Furthermore, the feasibility of collecting biological samples (urine and dried blood spots [DBSs]) from study participants at the field sites was successfully demonstrated. Based on findings from this and earlier studies, the methods used here have enhanced the data quality and avoided issues with household air pollution and biological sample collection in resource-constrained situations. The procedures established may be a valuable educational tool and resource for researchers conducting similar air pollution and health studies in India and other low- and middle-income countries (LMICs).

We detail the consistent, high-quality procedures used throughout air and biological sampling processes at Indian field sites during a large randomized controlled trial. Insights gathered from the oversight of applications of innovative technologies, adapted for exposure assessment in rural regions, enable better field data collection practices with more reliable outcomes.

Here, we present a visual representation of standard procedures to collect population-level data on personal exposures to household air pollution (HAP) ...

Environment

Iterative Development of an Innovative Smartphone-Based Dietary Assessment Tool: Traqq

To collect dietary intake data in a fast and reliable manner, a flexible and innovative smartphone application (app) called Traqq was developed (iOS/Android). This app can be used as a food record and&#160;24-h recall (or shorter recall periods). Different sampling schemes can be created on either prespecified or random days/times within a predetermined period for both methods, with&#160;push notifications to urge the participants to register their food intake. In case of non-response, notifications are automatically rescheduled to ensure complete data collection. For use as a food record, respondents can access the app and log their food intake throughout the day. Food records close automatically at the end of the day; recalls close after submission of the consumed items. The recall as well as the food record module provide access to an extensive food list based on the Dutch food composition database (FCDB), which can be accustomed to fit different research purposes. When selecting a food item, respondents are simultaneously prompted to insert portion size, i.e., in household measures (e.g., cups, spoons, glasses), standard portion sizes (e.g., small, medium, large), or weight in grams, and eating occasion/time of consumption. Portion size options can be adjusted, e.g., only entry in grams in case of a weighed food record or time of consumption instead of eating occasion). The app also includes a My Dishes function, which allows the respondent to create their own recipes or product combinations (e.g., a daily breakfast) and only report the total quantity consumed. Subsequently, the app accounts for yield and retention factors. The data are stored on a secure server. If desired, additional questions, i.e., in general or those related to specific food items or eating occasions can be incorporated. This paper describes the development of the system (app and backend), including expert evaluations and usability testing.

This article describes the protocol for the development of an innovative smartphone-based dietary assessment application Traqq, including expert evaluations and usability testing.

To collect dietary intake data in a fast and reliable manner, a flexible and innovative smartphone application (app) called Traqq was developed ...

Povidone Iodine Rectal Preparation at Time of Prostate Needle Biopsy is a Simple and Reproducible Means to Reduce Risk of Procedural Infection

Single institution and population-based studies highlight that infectious complications following transrectal ultrasound guided prostate needle biopsy (TRUS PNB) are increasing. Such infections are largely attributable to quinolone resistant microorganisms which colonize the rectal vault and are translocated into the bloodstream during the biopsy procedure. A povidone iodine rectal preparation (PIRP) at time of biopsy is a simple, reproducible method to reduce rectal microorganism colony counts and therefore resultant infections following TRUS PNB.
All patients are administered three days of oral antibiotic therapy prior to biopsy. The PIRP technique involves initially positioning the patient in the standard manner for a TRUS PNB. Following digital rectal examination, 15 ml&#160;of a 10% solution of commercially available povidone iodine is mixed with 5 ml&#160;of 1% lidocaine jelly to create slurry. A 4 cm x 4 cm sterile gauze is soaked in this slurry and then inserted into the rectal vault for 2 min after which it is removed. Thereafter, a disposable cotton gynecologic swab is used to paint both the perianal area and the rectal vault to a distance of 3 cm from the anus. The povidone iodine solution is then allowed to dry for 2 - 3 min prior to proceeding with standard transrectal ultrasonography and subsequent biopsy.
This PIRP technique has been in practice at our institution since March of 2012 with an associated reduction of post-biopsy infections from 4.3% to 0.6% (p = 0.02). The principal advantage of this prophylaxis regimen is its simplicity and reproducibility with use of an easily available, inexpensive agent to reduce infections. Furthermore, the technique avoids exposing patients to additional systemic antibiotics with potential further propagation of multi-drug resistant organisms. Usage of PIRP at TRUS PNB, however, is not applicable for patients with iodine or shellfish allergies.

Here, we present a protocol for use at the time of transrectal ultrasound guided prostate needle biopsy (TRUS PNB) that is a simple and cost-effective means to reduce infections following the procedure.

Single institution and population-based studies highlight that infectious complications following transrectal ultrasound guided prostate needle biopsy ...

Setup of Consumer Wearable Devices for Exposure and Health Monitoring in Population Studies

Wearable sensors, which are often embedded in commercial smartwatches, allow for continuous and non-invasive health measurements and exposure assessments in clinical studies. Nevertheless, the real-life application of these technologies in studies involving a large number of participants for a significant observation period may be hindered by several practical challenges. 
In this study, we present a modified protocol from a previous intervention study for the mitigation of health effects from desert dust storms. The study involved two distinct population groups: asthmatic children aged 6-11 years and elderly patients with atrial fibrillation (AF). Both groups were equipped with a smartwatch for the assessment of physical activity (using a heart rate monitor, pedometer, and accelerometer) and location (using GPS signals to locate individuals in indoor "at home" or outdoor microenvironments). The participants were required to wear the smartwatch equipped with a data collection application on a daily basis, and data were transmitted via a wireless network to a centrally administered data collection platform for the near real-time assessment of compliance. 
Over a period of 26 months, more than 250 children and 50 patients with AF participated in the aforementioned study. The main technical challenges identified included restricting access to standard smartwatch features, such as gaming, internet browser, camera, and audio recording applications, technical issues, such as loss of GPS signal, especially in indoor environments, and the internal smartwatch settings interfering with the data collection application.
The aim of this protocol is to demonstrate how the use of publicly available application lockers and device automation applications made it possible to address most of these challenges in a simple and cost-effective way. In addition, the inclusion of a Wi-Fi received signal strength indicator significantly improved indoor localization and largely minimized GPS signal misclassification. The implementation of these protocols during the roll-out of this intervention study in the spring of 2020 led to significantly improved results in terms of data completeness and data quality.

Commercial smartwatches equipped with wearable sensors are increasingly being used in population studies. However, their utility is often constrained by their limited battery duration, memory capacity, and data quality. This report provides examples of cost-effective solutions to real-life technical challenges encountered during studies involving asthmatic children and elderly cardiac patients.

Wearable sensors, which are often embedded in commercial smartwatches, allow for continuous and non-invasive health measurements and exposure assessments ...

Bioengineering

Training Novices in POCUS for Vascular Cannulation Using Simulation Models

Using Simulation Models to Train Clinicians in the Use of Point-of-Care Ultrasound

The use of point-of-care ultrasound (POCUS) has shown to be a beneficial non-invasive vascular access assessment method by clinicians, which can provide critical elements of visual and measurable information that proves to be useful in the context of vascular access cannulation, in combination with the practical skill of the clinician performing the cannulation. However, the use of POCUS in this context is to practically train and enable individuals who are novices in using this technique to become proficient in performing this task subsequently on patients in a careful and successful way. The simulation of these vascular conditions may be useful to help healthcare professionals learn, understand, apply, and establish such practical skills for vascular cannulation safely to achieve the desired outcomes. This project intended, through the attendance of a half-day workshop, to establish skills to use POCUS in connection with simulation models and perform specific tasks to enable clinicians to use this method in their clinical practice for vascular access cannulation in patients. A mixed-methods longitudinal study design was used to evaluate the effect of a point-of-care ultrasound workshop for peripheral intravenous cannula insertion, including specific tasks for the participants to be performed on simulation models. A total of 81 individuals participated in 11 half-day workshops through 2021 and 2022. Offering a workshop that uses simulation models in combination with various POCUS devices is useful in establishing this newly learned skill in clinicians, such as measurements of depth, caliper, and direction of a vein with POCUS prior to cannulation providing essential anatomical facts to the operator, which increases the likelihood of first-time success in cannulation.

Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training

The present protocol describes an ideal solution to train novices in the use of point-of-care ultrasound devices for the practical clinical skill of visually assessing distinct individual anatomical vascular conditions prior to and during an intended venous vascular cannulation using point-of-care ultrasound in a patient.

The use of point-of-care ultrasound (POCUS) has shown to be a beneficial non-invasive vascular access assessment method by clinicians, which can provide ...

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

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