Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma.

BACKGROUND: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. METHODS: In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 µg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed. RESULTS: Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups. CONCLUSIONS: Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.).

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults.

BACKGROUND: Black and Latinx adults experience disproportionate asthma-related morbidity and limited specialty care access. The severe acute respiratory syndrome coronavirus 2 pandemic expanded telehealth use. OBJECTIVE: To evaluate visit type (telehealth [TH] vs in-person [IP]) preferences and the impact of visit type on asthma outcomes among Black and Latinx adults with moderate-to-severe asthma. METHODS: For this PREPARE trial ancillary study, visit type preference was surveyed by e-mail or telephone post-trial. Emergency medical record data on visit types and asthma outcomes were available for a subset (March 2020 to April 2021). Characteristics associated with visit type preferences, and relationships between visit type and asthma outcomes (control [Asthma Control Test] and asthma-related quality of life [Asthma Symptom Utility Index]), were tested using multivariable regression. RESULTS: A total of 866 participants consented to be surveyed, with 847 respondents. Among the participants with asthma care experience with both visit types, 42.0% preferred TH for regular checkups, which associated with employment (odds ratio [OR] = 1.61; 95% confidence interval [CI], 1.09-2.39; P = .02), lower asthma medication adherence (OR = 1.06; 95% CI, 1.01-1.11; P = .03), and having more historical emergency department and urgent care asthma visits (OR = 1.10 for each additional visit; 95% CI, 1.02-1.18; P = .02), after adjustment. Emergency medical record data were available for 98 participants (62 TH, 36 IP). Those with TH visits were more likely Latinx, from the Southwest, employed, using inhaled corticosteroid-only controller therapy, with lower body mass index, and lower self-reported asthma medication adherence vs those with IP visits only. Both groups had comparable Asthma Control Test (18.4 vs 18.9, P = .52) and Asthma Symptom Utility Index (0.79 vs 0.84, P = .16) scores after adjustment. CONCLUSION: TH may be similarly efficacious as and often preferred over IP among Black and Latinx adults with moderate-to-severe asthma, especially for regular checkups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02995733.

Caribbean Latinx with moderate-severe asthma bear greater asthma morbidity than other Latinx.

BACKGROUND: Hispanic/Latinx (HL) ethnicity encompasses racially and culturally diverse subgroups. Studies suggest that Puerto Ricans (PR) may bear greater asthma-related morbidity than Mexicans, but these were conducted in children or had limited clinical characterization. OBJECTIVES: This study sought to determine whether disparities in asthma morbidity exist among HL adult subgroups. METHODS: Adults with moderate-severe asthma were recruited from US clinics, including from Puerto Rico, for the Person Empowered Asthma Relief (PREPARE) trial. Considering the shared heritage between PR and other Caribbean HL (Cubans and Dominicans [C&D]), the investigators compared baseline self-reported clinical characteristics between Caribbean HL (CHL) (PR and C&D: n = 457) and other HLs (OHL) (Mexicans, Spaniards, Central/South Americans; n = 141), and between CHL subgroups (C&D [n = 56] and PR [n = 401]). This study compared asthma morbidity measures (self-reported exacerbations requiring systemic corticosteroids, emergency department/urgent care (ED/UC) visits, hospitalizations, health care utilization) through negative binomial regression. RESULTS: CHL compared to OHL were similar in age, body mass index, poverty status, blood eosinophils, and fractional exhaled nitric oxide but were prescribed more asthma controller therapies. Relative to OHL, CHL had significantly increased odds of asthma exacerbations (odds ratio [OR]: 1.84; 95% CI: 1.4-2.4), ED/UC visits (OR: 1.88; 95% CI: 1.4-2.5), hospitalization (OR: 1.98; 95% CI: 1.06-3.7), and health care utilization (OR: 1.91; 95% CI: 1.44-2.53). Of the CHL subgroups, PR had significantly increased odds of asthma exacerbations, ED/UC visits, hospitalizations, and health care utilization compared to OHL, whereas C&D only had increased odds of exacerbations compared to OHL. PR compared to C&D had greater odds of ED/UC and health care utilization. CONCLUSIONS: CHL adults, compared with OHL, adults reported nearly twice the asthma morbidity; these differences are primarily driven by PR. Novel interventions are needed to reduce morbidity in this highly impacted population.

Socioeconomic status associates with worse asthma morbidity among Black and Latinx adults.

BACKGROUND: Asthma disproportionately affects African American/Black (AA/B) and Hispanic/Latinx (H/L) patients and individuals with low socioeconomic status (SES), but the relationship between SES and asthma morbidity within these racial/ethnic groups is inadequately understood. OBJECTIVE: To determine the relationship between SES and asthma morbidity among AA/B and H/L adults with moderate to severe asthma using multidomain SES frameworks and mediation analyses. METHODS: We analyzed enrollment data from the PeRson EmPowered Asthma RElief randomized trial, evaluating inhaled corticosteroid supplementation to rescue therapy. We tested for direct and indirect relationships between SES and asthma morbidity using structural equation models. For SES, we used a latent variable defined by poverty, education, and unemployment. For asthma morbidity, we used self-reported asthma exacerbations in the year before enrollment (corticosteroid bursts, emergency room/urgent care visits, or hospitalizations), and Asthma Control Test scores. We tested for mediation via health literacy, perceived stress, and self-reported discrimination. All models adjusted for age, sex, body mass index, ethnicity, and comorbidities. RESULTS: Among 990 AA/B and H/L adults, low SES (latent variable) was directly associated with hospitalizations (ß = 0.24) and worse Asthma Control Test scores (ß = 0.20). Stress partially mediated the relationship between SES and increased emergency room/urgent care visits and worse asthma control (ß = 0.03 and = 0.05, respectively). Individual SES domains were directly associated with asthma morbidity. Stress mediated indirect associations between low educational attainment and unemployment with worse asthma control (ß = 0.05 and = 0.06, respectively). CONCLUSIONS: Lower SES is directly, and indirectly through stress, associated with asthma morbidity among AA/B and H/L adults. Identification of stressors and relevant management strategies may lessen asthma-related morbidity among these populations.

Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study.

BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).

Patient stakeholder engagement in research: A narrative review to describe foundational principles and best practice activities.

BACKGROUND: Health research is evolving to include patient stakeholders (patients, families and caregivers) as active members of research teams. Frameworks describing the conceptual foundations underlying this engagement and strategies detailing best practice activities to facilitate engagement have been published to guide these efforts. OBJECTIVE: The aims of this narrative review are to identify, quantify and summarize (a) the conceptual foundational principles of patient stakeholder engagement in research and (b) best practice activities to support these efforts. SEARCH STRATEGY, INCLUSION CRITERIA, DATA EXTRACTION AND SYNTHESIS: We accessed a publicly available repository of systematically identified literature related to patient engagement in research. Two reviewers independently screened articles to identify relevant articles and abstracted data. MAIN RESULTS: We identified 990 potentially relevant articles of which 935 (94.4%) were excluded and 55 (5.6%) relevant. The most commonly reported foundational principles were "respect" (n = 25, 45%) and "equitable power between all team members" (n = 21, 38%). Creating "trust between patient stakeholders and researchers" was described in 17 (31%) articles. Twenty-seven (49%) articles emphasized the importance of providing training and education for both patient stakeholder and researchers. Providing financial compensation for patient stakeholders' time and expertise was noted in 19 (35%) articles. Twenty articles (36%) emphasized regular, bidirectional dialogue between patient partners and researchers as important for successful engagement. DISCUSSION AND CONCLUSIONS: Engaging patient stakeholders in research as partners presents an opportunity to design, implement and disseminate patient-centred research. This review creates an overarching foundational framework for authentic and sustainable partnerships between patient stakeholders and researchers.

Patient and Family Advisory Councils for Research: Recruiting and Supporting Members From Diverse and Hard-to-Reach Communities.

OBJECTIVE: To describe strategies to recruit and support members from hard-to-reach groups on research-focused Patient and Family Advisory Councils (PFACs). BACKGROUND: Ensuring diverse representation of members of research PFACs is challenging, and few studies have given attention to addressing this problem. METHODS: A qualitative study was conducted using 8 focus groups and 19 interviews with 80 PFAC members and leaders, hospital leaders, and researchers. RESULTS: Recruitment recommendations were: 1) utilizing existing networks; 2) going out to the community; 3) accessing outpatient clinics; and 4) using social media. Strategies to support inclusion were: 1) culturally appropriate communication methods; 2) building a sense of community between PFAC members; 3) equalizing roles between community members/leaders; 4) having a diverse PFAC leadership team; and 5) setting transparent expectations for PFAC membership. CONCLUSION: Increasing the diversity of research PFACs is a priority, and it is important to determine how best to engage groups that have been traditionally underrepresented.

An Interdisciplinary Clinical Approach for Workplace Violence Prevention and Injury Reduction in the General Hospital Setting: S.A.F.E. Response.

BACKGROUND: Workplace violence is a major public health concern. According to the U.S. Bureau of Labor Statistics, from 2002 to 2013, incidents of serious workplace violence (those requiring days off) were four times more common in health care than in private industry. AIMS: An interprofessional committee developed, implemented, and evaluated a quality improvement project from 2012 to 2016 to reduce workplace violence and prevent staff injury. The initiative termed S.A.F.E. Response stands for Spot a threat, Assess the risk, Formulate a safe response, Evaluate the outcome. METHOD: An institutional review board-approved quality improvement survey was implemented and evaluated. The data were analyzed using descriptive statistics. An interprofessional committee developed and implemented a comprehensive program to prevent injury, which included (a) a mandatory eLearning educational training, (b) a S.A.F.E. Response with standardized interventions for the clinical conditions affecting safety, and (c) a clinical debriefing process. A reduction in nursing staff assault incidence rates was identified as a success. RESULTS: Nursing staff injury rates decreased an average of 40%. CONCLUSIONS: A reduction in nursing staff assault incidence rates was notable. Clinicians equipped with knowledge, skills, and resources can identify and defuse unsafe situations to prevent violence. This clinical approach shifts the focus from crisis intervention to crisis prevention, which reduces injury.

Prospective Evaluation of a Multifaceted Intervention to Improve Outcomes in Intensive Care: The Promoting Respect and Ongoing Safety Through Patient Engagement Communication and Technology Study.

OBJECTIVES: Studies comprehensively assessing interventions to improve team communication and to engage patients and care partners in ICUs are lacking. This study examines the effectiveness of a patient-centered care and engagement program in the medical ICU. DESIGN: Prospective intervention study. SETTING: Medical ICUs at large tertiary care center. PATIENTS: Two thousand one hundred five patient admissions (1,030 before and 1,075 during the intervention) from July 2013 to May 2014 and July 2014 to May 2015. INTERVENTIONS: Structured patient-centered care and engagement training program and web-based technology including ICU safety checklist, tools to develop shared care plan, and messaging platform. Patient and care partner access to online portal to view health information, participate in the care plan, and communicate with providers. MEASUREMENTS AND MAIN RESULTS: Primary outcome was aggregate adverse event rate. Secondary outcomes included patient and care partner satisfaction, care plan concordance, and resource utilization. We included 2,105 patient admissions, (1,030 baseline and 1,075 during intervention periods). The aggregate rate of adverse events fell 29%, from 59.0 per 1,000 patient days (95% CI, 51.8-67.2) to 41.9 per 1,000 patient days (95% CI, 36.3-48.3; p < 0.001), during the intervention period. Satisfaction improved markedly from an overall hospital rating of 71.8 (95% CI, 61.1-82.6) to 93.3 (95% CI, 88.2-98.4; p < 0.001) for patients and from 84.3 (95% CI, 81.3-87.3) to 90.0 (95% CI, 88.1-91.9; p < 0.001) for care partners. No change in care plan concordance or resource utilization. CONCLUSIONS: Implementation of a structured team communication and patient engagement program in the ICU was associated with a reduction in adverse events and improved patient and care partner satisfaction.

Long-term outcomes and life-impacts of necrotizing enterocolitis: A survey of survivors and parents.

Necrotizing enterocolitis (NEC) is a devastating intestinal disease that primarily affects premature infants. Necrotizing enterocolitis is associated with adverse two-year outcomes, yet limited research has evaluated the impact of NEC on long-term complications and quality of life in children older than two years. We conducted a survey to characterize the long-term impact of NEC on physical and mental health, social experiences, and quality of life as self-reported by adult NEC survivors and parents of children who survived NEC. To our knowledge, this is the first study that describes the lived experience of NEC survivors and parents of children affected by NEC to understand their experience years after the original diagnosis. Our survey results describe that NEC survivors and parents of children affected by NEC experience long-term complications that impact their physical and mental health, social experiences, and quality of life.

Socioeconomic impact of COVID-19 and willingness to be vaccinated in African American/Black and Hispanic/Latinx adults.

PURPOSE: To describe the socioeconomic and healthcare-related effects of the COVID-19 pandemic, and willingness to receive a free COVID-19 vaccine, among African American/Black (AA/B) and Hispanic/Latinx (H/L) adults with asthma currently enrolled in a large trial. METHODS: The present analysis is a sub-study of the PeRson EmPowered Asthma RElief (PREPARE) study, a pragmatic study of 1201 AA/B and H/L adults with asthma. A monthly questionnaire was completed by a subset of PREPARE participants (n = 325) during May-August, 2020. The 5-item questionnaire assessed self-reported impact of COVID-19 on respondents' ability to obtain asthma medications, medical care quality, employment, income and ability to pay bills; and willingness to get a free COVID-19 vaccine. Bivariate analysis and multivariate logistic regression were performed to investigate factors associated with vaccine hesitancy. RESULTS: Of 325 survey respondents (25% AA/B, 75% H/L), the majority reported no impact of COVID-19 on medical care or ability to get asthma medications. Approximately half of employed respondents experienced a lower level of employment or job loss, and approximately half reported having difficulty paying bills during the pandemic. Thirty-five percent of respondents reported unwillingness and 31% reported being somewhat likely to receive a free COVID-19 vaccine. AA/B race/ethnicity and poorer reported physical health were associated with a higher likelihood of COVID-19 vaccine hesitancy. CONCLUSION: AA/B and H/L adults with asthma may experience changes in the quality of their asthma care and increased socioeconomic stressors as a result of the COVID-19 pandemic and may be hesitant or unwilling to receive a COVID-19 vaccine.

Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study.

BACKGROUND/OBJECTIVES: In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability. DESIGN: Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries. SETTING: A total of 86 primary care practices within 10 U.S. healthcare systems. PARTICIPANTS: A random subsample of 743 persons aged 75 and older. MEASUREMENTS: The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument. RESULTS: Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference. CONCLUSIONS: STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial.

BACKGROUND: Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Implementation, evaluation, and recommendations for extension of AHRQ Common Formats to capture patient- and carepartner-generated safety data.

OBJECTIVES: The Common Formats, published by the Agency for Healthcare Research and Quality, represent a standard for safety event reporting used by Patient Safety Organizations (PSOs). We evaluated its ability to capture patient-reported safety events. MATERIALS AND METHODS: We formally evaluated gaps between the Common Formats and a safety concern reporting system for use by patients and their carepartners (ie friends/families) at Brigham and Women's Hospital. RESULTS: Overall, we found large gaps between Common Formats (versions 1.2, 2.0) and our patient/carepartner reporting system, with only 22-30% of the data elements matching. DISCUSSION: We recommend extensions to the Common Formats, including concepts that capture greater detail about the submitter and safety categories relevant to unsafe conditions and near misses that patients and carepartners routinely observe. CONCLUSION: Extensions to the Common Formats could enable more complete safety data sets and greater understanding of safety from key stakeholder perspectives, especially patients, and carepartners.

Patient and Family Advisory Councils (PFACs): Identifying Challenges and Solutions to Support Engagement in Research.

OBJECTIVE: The aim was to describe barriers to patient and family advisory council (PFAC) member engagement in research and strategies to support engagement in this context. METHODS: We formed a study team comprising patient advisors, researchers, physicians, and nurses. We then undertook a qualitative study using focus groups and interviews. We invited PFAC members, PFAC leaders, hospital leaders, and researchers from nine academic medical centers that are part of a hospital medicine research network to participate. All participants were asked a standard set of questions exploring the study question. We used content analysis to analyze data. RESULTS: Eighty PFAC members and other stakeholders (45 patient/caregiver members of PFACs, 12 PFAC leaders, 12 hospital leaders, 11 researchers) participated in eight focus and 19 individual interviews. We identified ten barriers to PFAC member engagement in research. Codes were organized into three categories: (1) individual PFAC member reluctance; (2) lack of skills and training; and (3) problems connecting with the right person at the right time. We identified ten strategies to support engagement. These were organized into four categories: (1) creating an environment where the PFAC members are making a genuine and unique contribution; (2) building community between PFAC members and researchers; (3) best practice activities for researchers to facilitate engagement; and (4) tools and training. CONCLUSION: Barriers to engaging PFAC members in research include patients' negative perceptions of research and researchers' lack of training. Building community between PFAC members and researchers is a foundation for partnerships. There are shared training opportunities for PFAC members and researchers to build skills about research and research engagement.

IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons.

Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR's overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.

Background: Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Methods: Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 health care systems across United States. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by health care system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a comanagement model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (nonvertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Results: Trial enrolled 5,451 subjects in 20 months. Intervention and follow-up are ongoing. Conclusions: The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults.

Towards Analytics of the Patient and Family Perspective: A Case Study and Recommendations for Data Capture of Safety and Quality Concerns.

Safety reporting systems are improving our current understanding of safety in hospital settings, although mostly from the clinician perspective. Patient Family Relations (PFR) programs provide the opportunity to capture patient/family concerns in the hospital. Descriptive statistics were completed of PFR concern submissions over a 20 month period, as well as a comparison of structured data fields to those of the AHRQ Common Format. We identified statistically significant differences in rates of concern submissions, methods of submission, and role of submitter across patient populations. Overall, the most frequent concerns submitted to PFR were care/treatment and communication concerns. There was very little overlap of the PFR data elements with those of the AHRQ Common Format (overall rate of mismatch approached 80%). These results emphasize both the unique information that PFR data provides, as well as the need for enhancement and continuity of reporting systems for more effective analysis of safety data.