Measuring the Impact of Patient Engagement in Health Research: An Exploratory Study Using Multiple Survey Tools.

Background: Studies report various ways in which patients are involved in research design and conduct. Limited studies explore the influence of patient engagement (PE) at each research stage in qualitative research from the perspectives of all stakeholders. Methods: We established two small research groups, a Patient Researcher-Led Group and an Academic Researcher-Led Group. We recruited patient research partners (PRP; n = 5), researchers (n = 5), and clinicians (n = 4) to design and conduct qualitative research aimed at identifying candidate attributes related to patient preferences for tapering biologic treatments in inflammatory bowel disease. We administered surveys before starting, two months into, and post-project work. The surveys contained items from three PE evaluation tools. We assessed the two groups regarding the influence and impact each stakeholder had during the different research stages. Results: PRPs had a moderate or a great deal of influence on the critical research activities across the research stages. They indicated moderate/very/extremely meaningful engagement and agreed/strongly agreed impact of PE. PRPs helped operationalize the research question; design the study and approach; develop study materials; recruit participants; and collect and interpret the data. Conclusion: The three tools together provide deeper insight into the influence of PE at each research stage. Lessons learnt from this study suggest that PE can impact many aspects of research including the design, process, and approach in the context of qualitative research, increasing the patient-centeredness of the study. More comprehensive validated tools are required that work with a more diverse subject pool and in other contexts.

Studying How Patient Engagement Influences Research: A Mixed Methods Study.

BACKGROUND: There is evidence supporting the value of patient engagement (PE) in research to patients and researchers. However, there is little research evidence on the influence of PE throughout the entire research process as well as the outcomes of research engagement. The purpose of our study is to add to this evidence. METHODS: We used a convergent mixed method design to guide the integration of our survey data and observation data to assess the influence of PE in two groups, comprising patient research partners (PRPs), clinicians, and researchers. A PRP led one group (PLG) and an academic researcher led the other (RLG). Both groups were given the same research question and tasked to design and conduct an inflammatory bowel disease (IBD)-related patient preference study. We administered validated evaluation tools at three points and observed PE in the two groups conducting the IBD study. RESULTS: PRPs in both groups took on many operational roles and influenced all stages of the IBD-related qualitative study: launch, design, implementation, and knowledge translation. PRPs provided more clarity on the study design, target population, inclusion-exclusion criteria, data collection approach, and the results. PRPs helped operationalize the project question, develop study material and data collection instruments, collect data, and present the data in a relevant and understandable manner to the patient community. The synergy of collaborative partnership resulted in two projects that were patient-centered, meaningful, understandable, legitimate, rigorous, adaptable, feasible, ethical and transparent, timely, and sustainable. CONCLUSION: Collaborative and meaningful engagement of patients and researchers can influence all stages of qualitative research including design and approach, and outputs.

Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial.

Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. Patients & methods: This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. Data analysis: Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. Discussion/conclusion: Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC. Clinical Trial Registration: NCT04930159 (ClinicalTrials.gov).

Patient adherence to patient-reported outcome measure (PROM) completion in clinical care: current understanding and future recommendations.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly being used as an assessment and monitoring tool in clinical practice. However, patient adherence to PROMs completions are typically not well documented or explained in published studies and reports. Through a collaboration between the International Society for Quality-of-Life Research (ISOQOL) Patient Engagement and QOL in Clinical Practice Special Interest Groups (SIGs) case studies were collated as a platform to explore how adherence can be evaluated and understood. Case studies were drawn from across a range of clinically and methodologically diverse PROMs activities. RESULTS: The case studies identified that the influences on PROMs adherence vary. Key drivers include PROMs administeration methods within a service and wider system, patient capacity to engage and clinician engagement with PROMs information. It was identified that it is important to  evaluate  PROMs integration and adherence from multiple perspectives. CONCLUSION: PROM completion rates are an important indicator of patient adherence. Future research prioritizing an understanding of PROMs completion rates by patients is needed.

Exploring the outcomes of research engagement using the observation method in an online setting.

OBJECTIVE: The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research. DESIGN: We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis. SETTING: The study was conducted online. PARTICIPANTS: Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study. MAIN OUTCOME MEASURES: Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE. RESULTS: Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups. CONCLUSIONS: Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

Factors associated with lung cancer risk factor documentation.

Objectives: To identify factors associated with the minimum necessary information to determine an individual's eligibility for lung cancer screening (ie, sufficient risk factor documentation) and to characterize clinic-level variability in documentation. Study Design: Cross-sectional observational study using electronic health record data from an academic health system in 2019. Methods: We calculated the relative risk of sufficient lung cancer risk factor documentation by patient-, provider-, and system-level variables using Poisson regression models, clustering by clinic. We compared unadjusted, risk-adjusted, and reliability-adjusted proportions of patients with sufficient smoking documentation across 31 clinics using logistic regression models and 2-level hierarchical logit models to estimate reliability-adjusted proportions across clinics. Results: Among 20,632 individuals, 60% had sufficient risk factor documentation to determine screening eligibility. Patient-level factors inversely associated with risk factor documentation included Black race (relative risk [RR], 0.70; 95% CI, 0.60-0.81), non-English preferred language (RR, 0.60; 95% CI, 0.49-0.74), Medicaid insurance (RR, 0.64; 95% CI, 0.57-0.71), and nonactivated patient portal (RR, 0.85; 95% CI, 0.80-0.90). Documentation varied across clinics. The reliability-adjusted intraclass correlation coefficient decreased from 11.0% (95% CI, 6.9%-17.1%) to 5.3% (95% CI, 3.2%-8.6%), adjusting for covariates. Conclusions: We found a low rate of sufficient lung cancer risk factor documentation and associations of risk factor documentation based on patient-level factors such as race, insurance status, language, and patient portal activation. Risk factor documentation rates varied across clinics, and only approximately half the variation was explained by factors in our analysis.

Optimizing PROM Implementation in Orthopedic Clinics for Longitudinal Outcome Monitoring: Lessons from a Multisite Study.

BACKGROUND: Systematic patient-reported outcome measure (PROM) collection is challenging for clinics, particularly when patients are not in the office. The Arthritis care through Shared Knowledge (ASK) study deployed multimodal approaches to collect PROMs using a clinical microsystem framework. CONCEPTUAL MODEL: Informed by the clinical microsystem model, the authors coached 12 orthopedic practices to implement shared processes to support best practices for PROM collection and use. Orthopedic sites collected PROMs from new patients before the first office visit; patients completed the PROM from home via an online assessment in a personalized e-mail. Site staff placed follow-up phone reminders. At 6 and 12 months after the visit, PROMs were collected from home, prompted by an e-mail or phone call. PERFORMANCE OUTCOMES: Of the 25,043 new patients identified by clinical sites during the study enrollment, approximately 60% completed a pre-visit PROM-36.6% completed the online PROM after receiving a single automated e-mail, and an additional 31.1% completed the PROM after receiving a text, an e-mail, or a phone call from the staff. The remaining 32.2% of PROMs were collected on arrival at the office. Of patients completing PROMs, 11,140 were eligible to participate in longitudinal collection, and 51.3% consented. Of these, approximately 84% completed a 6-month survey, more than 83% completed a 12-month survey, and more than 91% completed either a 6-month PROM, a 12-month PROM, or both. LEARNING: This study illustrates that a multimodal approach to PROM collection using a clinical microsystem approach sustainably supports PROM completion rates. Further efforts are needed to define strategies to engage all patients in understanding and reporting PROMs to inform their care.

Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations.

Background/Objective: The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. Methods: We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai'i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains. Results: We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%). Conclusions: Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.

Health system use and outcomes of urgently triaged callers to a nurse-managed telephone service for provincial health information after initiation of supplemental virtual physician assessment: a descriptive study.

BACKGROUND: British Columbia's 8-1-1 telephone service connects callers with nurses for health care advice. As of Nov. 16, 2020, callers advised by a registered nurse to obtain in-person medical care can be subsequently referred to virtual physicians. We sought to determine health system use and outcomes of 8-1-1 callers urgently triaged by a nurse and subsequently assessed by a virtual physician. METHODS: We identified callers referred to a virtual physician between Nov. 16, 2020, and Apr. 30, 2021. After assessment, virtual physicians assigned callers to 1 of 5 triage dispositions (i.e., go to emergency department [ED] now, see primary care provider within 24 hours, schedule an appointment with a health care provider, try home treatment, other). We linked relevant administrative databases to ascertain subsequent health care use and outcomes. RESULTS: We identified 5937 encounters with virtual physicians involving 5886 8-1-1 callers. Virtual physicians advised 1546 callers (26.0%) to go to the ED immediately, of whom 971 (62.8%) had 1 or more ED visits within 24 hours. Virtual physicians advised 556 (9.4%) callers to seek primary care within 24 hours, of whom 132 (23.7%) had primary care billings within 24 hours. Virtual physicians advised 1773 (29.9%) callers to schedule an appointment with a health care provider, of whom 812 (45.8%) had primary care billings within 7 days. Virtual physicians advised 1834 (30.9%) callers to try a home treatment, of whom 892 (48.6%) had no health system encounters over the next 7 days. Eight (0.1%) callers died within 7 days of assessment with a virtual physician, 5 of whom were advised to go to the ED immediately. Fifty-four (2.9%) callers with a "try home treatment" disposition were admitted to hospital within 7 days of a virtual physician assessment, and no callers who were advised home treatment died. INTERPRETATION: This Canadian study evaluated health service use and outcomes arising from the addition of virtual physicians to a provincial health information telephone service. Our findings suggest that supplementation of this service with an assessment from a virtual physician safely reduces the overall proportion of callers advised to seek urgent in-person visits.

Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort.

OBJECTIVE: To compare secondary patient reported outcomes of perceptions of treatment success and function for patients treated for appendicitis with appendectomy vs. antibiotics at 30 days. SUMMARY BACKGROUND DATA: The Comparison of Outcomes of antibiotic Drugs and Appendectomy trial found antibiotics noninferior to appendectomy based on 30-day health status. To address questions about outcomes among participants with lower socioeconomic status, we explored the relationship of sociodemographic and clinical factors and outcomes. METHODS: We focused on 4 patient reported outcomes at 30 days: high decisional regret, dissatisfaction with treatment, problems performing usual activities, and missing >10 days of work. The randomized (RCT) and observational cohorts were pooled for exploration of baseline factors. The RCT cohort alone was used for comparison of treatments. Logistic regression was used to assess associations. RESULTS: The pooled cohort contained 2062 participants; 1552 from the RCT. Overall, regret and dissatisfaction were low whereas problems with usual activities and prolonged missed work occurred more frequently. In the RCT, those assigned to antibiotics had more regret (Odd ratios (OR) 2.97, 95% Confidence intervals (CI) 2.05-4.31) and dissatisfaction (OR 1.98, 95%CI 1.25-3.12), and reported less missed work (OR 0.39, 95%CI 0.27-0.56). Factors associated with function outcomes included sociodemographic and clinical variables for both treatment arms. Fewer factors were associated with dissatisfaction and regret. CONCLUSIONS: Overall, participants reported high satisfaction, low regret, and were frequently able to resume usual activities and return to work. When comparing treatments for appendicitis, no single measure defines success or failure for all people. The reported data may inform discussions regarding the most appropriate treatment for individuals. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02800785.

Patient-centred outcomes of imaging tests: recommendations for patients, clinicians and researchers.

BACKGROUND: Imaging tests are one of the most frequently used diagnostic modalities in healthcare, but the benefits of their direct impacts on clinical decision-making have been countered by concerns that they can be overused. Assessing the relative value of imaging tests has largely focused on measures of test accuracy, which overlooks more comprehensive benefits and risks of imaging tests, particularly their impact on patient-centred outcomes (PCOs). We present the findings of the Patient Reported Outcomes of Diagnostics (PROD) research study in response to a methodological gap in the area of diagnostic test comparative effectiveness research. METHODS: Over a 3-year period, the PROD Study engaged with multiple stakeholders to identify existing conceptual models related to PCOs for imaging testing, conducted primary research and evidence synthesis, and developed consensus recommendations to describe and categorise PCOs related to imaging testing. RESULTS: The PROD framework categorises PCOs from imaging studies within four main domains: information or knowledge yielded, physical impact, emotional outcomes and test burden. PCOs interact with each other and influence effects across domains, and can be modified by factors related to the patient, clinical situation, healthcare team and the testing environment. CONCLUSIONS: Using PCOs to inform healthcare decision-making will require ways of collating and presenting information on PCOs in ways that can inform patient-provider decision-making, and developing methods to determine the relative importance of outcomes (including test accuracy) to one another.

One report, multiple aims: orthopedic surgeons vary how they use patient-reported outcomes with patients.

PURPOSE: We conducted semi-structured qualitative interviews with surgeons to assess their goals for incorporating a patient-reported outcome measure (PROM)-based shared decision report into discussions around surgical and non-surgical treatment options for osteoarthritis of the knee and hip. METHODS: Surgeons actively enrolling patients into a study incorporating a standardized PROM-based shared decision report were invited to participate in a semi-structured interview lasting 30 min. Open-ended questions explored how the surgeon used report content, features that were helpful, confusing, or could be improved, and how use of the report fit into the surgeon's workflow. We used a conventional content analysis approach. RESULTS: Of the 16 eligible surgeons, 11 agreed to participate with 9 completing the interview and 2 withdrawing due to work demands. We identified 8 themes related to PROM-based report use: Acceptability, Patient Characteristics, Communication Goals, Useful Content, Not Useful Content, Challenges, Training Needs, and Recommended Improvements. Additional sub-themes emerged for Communication Goals (7) and Challenges (8). All surgeons shared positive feedback about using the report as part of clinical care. Whereas surgeons described the use of the report to achieve different goals, the most common uses related to setting expectations for post-surgical outcomes (89%) and educating patients (100%). CONCLUSION: Surgeons tailor their use of a PROM-based report with individual patients to achieve a range of aims. This study suggests multiple opportunities to further our understanding of the ways PROMs can be used in clinical practice. The way PROM information is visually displayed and multi-component reports are assembled can facilitate diverse aims.

Creating a provincial post COVID-19 interdisciplinary clinical care network as a learning health system during the pandemic: Integrating clinical care and research.

Introduction: Coronavirus Disease-2019 (COVID-19) affects multiple organ systems in the acute phase and also has long-term sequelae. Research on the long-term impacts of COVID-19 is limited. The Post COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN), conceived in July 2020, is a provincially funded resource that is modelled as a Learning Health System (LHS), focused on those people with persistent symptoms post COVID-19 infection. Methods: The PC-ICCN emerged through collaboration among over 60 clinical specialists, researchers, patients, and health administrators. At the core of the network are the post COVID-19 Recovery Clinics (PCRCs), which provide direct patient care that includes standardized testing and education at regular follow-up intervals for a minimum of 12 months post enrolment. The PC-ICCN patient registry captures data on all COVID-19 patients with confirmed infection, by laboratory testing or epi-linkage, who have been referred to one of five post COVID-19 Recovery Clinics at the time of referral, with data stored in a fully encrypted Oracle-based provincial database. The PC-ICCN has centralized administrative and operational oversight, multi-stakeholder governance, purpose built data collection supported through clinical operations geographically dispersed across the province, and research operations including data analytics. Results: To date, 5364 patients have been referred, with an increasing number and capacity of these clinics, and 2354 people have had at least one clinic visit. Since inception, the PC-ICCN has received over 30 research proposal requests. This is aligned with the goal of creating infrastructure to support a wide variety of research to improve care and outcomes for patients experiencing long-term symptoms following COVID-19 infection. Conclusions: The PC-ICCN is a first-in-kind initiative in British Columbia to enhance knowledge and understanding of the sequelae of COVID-19 infection over time. This provincial initiative serves as a model for other national and international endeavors to enable care as research and research as care.

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785.

Paving the Way for Electronic Patient-Centered Measurement in Team-Based Primary Care: Integrated Knowledge Translation Approach.

BACKGROUND: Patient-centered measurement (PCM) aims to improve the overall quality of care through the collection and sharing of patient values, outcomes, and perspectives. However, the use of PCM in care team decisions remains limited. Integrated knowledge translation (IKT) offers a collaborative, adaptive approach to explore best practices for incorporating PCM into primary care practices by involving knowledge users, including patients and providers, in the exploratory process. OBJECTIVE: This study aims to test the feasibility of using patient-generated data in team-based care; describe the use of these data for team-based mental health care; and summarize patient and provider care experiences with PCM. METHODS: We conducted a multi-method exploratory study in a rural team-based primary care clinic using IKT to co-design, implement, and evaluate the use of PCM in team-based mental health care. Care pathways, workflows, and quality improvement activities were adjusted iteratively to improve integration efforts. Patient and provider experiences were evaluated using individual interviews relating to the use of PCM and patient portals in practice. All meeting notes, interview summaries, and emails were analyzed to create a narrative evaluation. RESULTS: During co-design, a care workflow was developed to incorporate electronically collected patient-generated data from the patient portal into the electronic medical record, and customized educational tools and resources were added. During implementation, care pathways and patient workflows for PCM were developed. Patients found portal use easy, educational, and validating, but data entries were not used during care visits. Providers saw the portal as extra work, and the lack of portal and electronic medical record integration was a major barrier. The IKT approach was invaluable for addressing workflow changes and understanding the ongoing barriers to PCM use and quality improvement. CONCLUSIONS: Although the culture toward using PCM is changing, the use of PCM during care has not been successful. Patients felt validated and supported through portal use and could be empowered to bring these data to their visits. Training, modeling, and adaptable PCM methods are required before PCM can be integrated into routine care.

Patient Factors Associated With Appendectomy Within 30 Days of Initiating Antibiotic Treatment for Appendicitis.

IMPORTANCE: Use of antibiotics for the treatment of appendicitis is safe and has been found to be noninferior to appendectomy based on self-reported health status at 30 days. Identifying patient characteristics associated with a greater likelihood of appendectomy within 30 days in those who initiate antibiotics could support more individualized decision-making. OBJECTIVE: To assess patient factors associated with undergoing appendectomy within 30 days of initiating antibiotics for appendicitis. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study using data from the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial, characteristics among patients who initiated antibiotics were compared between those who did and did not undergo appendectomy within 30 days. The study was conducted at 25 US medical centers; participants were enrolled between May 3, 2016, and February 5, 2020. A total of 1552 participants with acute appendicitis were randomized to antibiotics (776 participants) or appendectomy (776 participants). Data were analyzed from September 2020 to July 2021. EXPOSURES: Appendectomy vs antibiotics. MAIN OUTCOMES AND MEASURES: Conditional logistic regression models were fit to estimate associations between specific patient factors and the odds of undergoing appendectomy within 30 days after initiating antibiotics. A sensitivity analysis was performed excluding participants who underwent appendectomy within 30 days for nonclinical reasons. RESULTS: Of 776 participants initiating antibiotics (mean [SD] age, 38.3 [13.4] years; 286 [37%] women and 490 [63%] men), 735 participants had 30-day outcomes, including 154 participants (21%) who underwent appendectomy within 30 days. After adjustment for other factors, female sex (odds ratio [OR], 1.53; 95% CI, 1.01-2.31), radiographic finding of wider appendiceal diameter (OR per 1-mm increase, 1.09; 95% CI, 1.00-1.18), and presence of appendicolith (OR, 1.99; 95% CI, 1.28-3.10) were associated with increased odds of undergoing appendectomy within 30 days. Characteristics that are often associated with increased risk of complications (eg, advanced age, comorbid conditions) and those clinicians often use to describe appendicitis severity (eg, fever: OR, 1.28; 95% CI, 0.82-1.98) were not associated with odds of 30-day appendectomy. The sensitivity analysis limited to appendectomies performed for clinical reasons provided similar results regarding appendicolith (adjusted OR, 2.41; 95% CI, 1.49-3.91). CONCLUSIONS AND RELEVANCE: This cohort study found that presence of an appendicolith was associated with a nearly 2-fold increased risk of undergoing appendectomy within 30 days of initiating antibiotics. Clinical characteristics often used to describe severity of appendicitis were not associated with odds of 30-day appendectomy. This information may help guide more individualized decision-making for people with appendicitis.

Augmenting systems-level implementation of patient-reported outcomes for depression care through the use of structured analysis and design technique.

Background: Health systems increasingly need to implement complex practice changes such as the routine capture of patient-reported outcome (PRO) measures. Yet, health systems have met challenges when trying to bring practice change to scale across systems at large. While implementation science can guide the evaluation of implementation determinants, teams first need tools to systematically understand and compare workflow activities across practice sites. Structured analysis and design technique (SADT), a system engineering method of workflow modeling, may offer an opportunity to enhance the scalability of implementation evaluation for complex practice change like PROs. Method: We utilized SADT to identify the core workflow activities needed to implement PROs across diverse settings and goals for use, establishing a generalizable PRO workflow diagram. We then used the PRO workflow diagram to guide implementation monitoring and evaluation for a 1-year pilot implementation of the electronic Patient Health Questionnaire-9 (ePHQ). The pilot occurred across multiple clinical settings and for two clinical use cases: depression screening and depression management. Results: SADT identified five activities central to the use of PROs in clinical care: deploying PRO measures, collecting PRO data, tracking PRO completion, reviewing PRO results, and documenting PRO data for future use. During the 1-year pilot, 8,596 patients received the ePHQ for depression screening via the patient portal, of which 1,719 (21%) submitted the ePHQ; 367 patients received the ePHQ for depression management, of which 174 (47%) submitted the ePHQ. We present three case examples of how the SADT PRO workflow diagram augmented implementation monitoring, tailoring, and evaluation activities. Conclusions: Use of a generalizable PRO workflow diagram aided the ability to systematically assess barriers and facilitators to fidelity and identify needed adaptations. The use of SADT offers an opportunity to align systems science and implementation science approaches, augmenting the capacity for health systems to advance system-level implementation. Plain Language Summary: Health systems increasingly need to implement complex practice changes such as the routine capture of patient-reported outcome (PRO) measures. Yet these system-level changes can be challenging to manage given the variability in practice sites and implementation context across the system at large. We utilized a systems engineering method-structured analysis and design technique-to develop a generalizable diagram of PRO workflow that captures five common workflow activities: deploying PRO measures, collecting PRO data, tracking PRO completion, reviewing PRO results, and documenting PRO data for future use. Next, we used the PRO workflow diagram to guide our implementation of PROs for depression care in multiple clinics. Our experience showed that use of a standard workflow diagram supported our implementation evaluation activities in a systematic way. The use of structured analysis and design technique may enhance future implementation efforts in complex health settings.

What's in a Number? Assessing the Burden of Diverticular Disease.

MINI-ABSTRACT: In this prospective observational cohort of patients with a history of diverticulitis, we assessed the correlation between the diverticulitis quality of life survey (DVQOL) and other patient-reported expressions of disease measures including work and activity impairment, and contentment with gastrointestinal-related health. Then, we assessed whether the DVQOL is better correlated with these measures than diverticulitis episode count. Our study results showed that the DVQOL has a stronger correlation with other disease measures than diverticulitis episode count, and our findings support the broader use of the DVQOL in assessing the burden of diverticulitis and monitoring response to management.

Advancing digital patient-centered measurement methods for team-based care.

Objectives: To conceptualize new methods for integrating patient-centered measurement into team-based care. Methods: A standalone portal was introduced into a rural clinic to support conceptualization of new methods for integration of patient-centered measurement in team-based care. The portal housed mental health-related online resources, three patient-reported measures and a self-action plan. Six providers and four patients used the portal for four months. Our data collection techniques included clinic discussions, one-on-one interviews, workflow diagrams and data generated through the portal. Analysis was supported through coding interview transcripts, looking across multiple sources of research data and research team discussions. Results: Our research team conceptualized five team-based patient-centered measurement methods through this study. Patient-centered measurement Team Mapping offfers a technique to provide greater clarity of care-team roles and responsibilities in data collected through patient-centered measurement. Longitudinal Care Alignment can guide the care-team on incorporating patient-centered measurement into ongoing provider-patient interactions. Digital Tool Exploration can be used to evaluate a team's readiness toward digital tool adoption, and the impact of these tools. Team-based quality improvement serves as a framework for engaging teams in patient-centered quality improvement. Shared learning is a method that promotes patientprovider interactions that validate patient's perspectives of their care. Conclusion: The portal illuminated new methods for the integration of patient-centered measurement in team-based care. The first three proposed patient-centered measurement methods provides ways to assess how a clinic can incorporate patient-centered measurement methods into team-based care. The latter two methods focus on the aim of patient-generated data in which patient's values and perspectives are represented and quality of patient-centered care can be evaluated. Further testing is needed to assess the utility of these patient-centered measurement methods across different clinical settings and domains.