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Background: This study was done to determine the representation of minorities, women, and the elderly in National Cancer Institute (NCI) clinical trials., Methods: This is an analysis in the NCI Clinical Data Update System. Patients were evaluated in breast, colorectal, lung, and prostate cancer trials from 2000 to 2019. Representation in a trial was determined by race/ethnicity, sex, and age. Secondarily, the change in trial participation by multivariable analysis by comparing years 2000 through 2004 to 2015 through 2019 was evaluated., Results: The cohort included 242,720 participants: 197,320 Non-Hispanic White (81.3%), 21,190 Black (8.7%), 11,587 Hispanic (4.8%), and 6880 Asian/Pacific Islander (2.8%). Black and Hispanic patients were underrepresented for colorectal (odds ratio [OR], 0.58; 95% confidence interval [CI], 0.50-0.67; P < .001 and OR, 0.74; 95% CI, 0.64-0.87; P < .001, respectively), lung (OR, 0.83; 95% CI, 0.76-0.91; P < .001 and 0.66; 95% CI, 0.57-0.77; P < .001, respectively), and prostate cancer trials (OR, 0.85; 95% CI, 0.79-0.92; P < .001 and OR, 0.58; 95% CI, 0.51-0.66; P < .001) between 2015 and 2019. The odds of participation in 2015 to 2019 increased among Black patients in breast (OR, 2.19; 95% CI, 2.07-%2.32; P < .001), lung (OR, 1.54; 95% CI, 1.38-1.73; P < .001), and prostate cancer trials (OR, 1.14; 95% CI, 1.04-1.26; P < .001). The odds of participation in a trial among Hispanic patients increased for breast (OR, 3.32; 95% CI, 3.09-3.56; P < .001), colorectal (OR, 2.46; 95% CI, 2.04-2.96; P < .001), lung (OR, 3.88; 95% CI, 3.20-4.69; P < .001), and prostate cancer (OR, 1.70; 95% CI, 1.42-2.04; P = .005)., Conclusions: This study identified that Black and Hispanic patients remain underrepresented in trials, but in recent years, participation has increased. These findings indicate that minority participation has increased over time, but further efforts are needed., (© 2021 American Cancer Society.)

Background: Use of patient-reported outcomes (PROs) and patient and public engagement are critical ingredients of pragmatic trials, which are intended to be patient centered. Engagement of patients and members of the public in selecting the primary trial outcome and determining the target difference can better ensure that the trial is designed to inform the decisions of those who ultimately stand to benefit. However, to the best of our knowledge, the use and reporting of PROs and patient and public engagement in pragmatic trials have not been described. The objectives of this study were to review a sample of pragmatic trials to describe (1) the prevalence of reporting patient and public engagement; (2) the prevalence and types of PROs used; (3) how its use varies across trial characteristics; and (4) how sample sizes and target differences are determined for trials with primary PROs., Methods and Findings: This was a methodological review of primary reports of pragmatic trials. We used a published electronic search filter in MEDLINE to identify pragmatic trials, published in English between January 1, 2014 and April 3, 2019; we identified the subset that were registered in ClinicalTrials.gov and explicitly labeled as pragmatic. Trial descriptors were downloaded from ClinicalTrials.gov; information about PROs and sample size calculations were extracted from the manuscript. Chi-squared, Cochran-Armitage, and Wilcoxon rank sum tests were used to examine associations between trial characteristics and use of PROs. Among 4,337 identified primary trial reports, 1,988 were registered in CT.gov, of which 415 were explicitly labeled as pragmatic. Use of patient and public engagement was identified in 39 (9.4%). PROs were measured in 235 (56.6%): 144 (34.7%) used PROs as primary outcomes and 91 (21.9%) as only secondary outcomes. Primary PROs were symptoms (64; 44%), health behaviors (36; 25.0%), quality of life (17; 11.8%), functional status (16; 11.1%), and patient experience (10; 6.9%). Trial characteristics with lower prevalence of use of PROs included being conducted exclusively in children or adults over age 65 years, cluster randomization, recruitment in low- and middle-income countries, and primary purpose of prevention; trials conducted in Europe had the highest prevalence of PROs. For the 144 trials with a primary PRO, 117 (81.3%) reported a sample size calculation for that outcome; of these, 71 (60.7%) justified the choice of target difference, most commonly, using estimates from pilot studies (31; 26.5%), standardized effect sizes (20; 17.1%), or evidence reviews (16; 13.7%); patient or stakeholder opinions were used to justify the target difference in 8 (6.8%). Limitations of this study are the need for trials to be registered in ClinicalTrials.gov, which may have reduced generalizability, and extracting information only from the primary trial report., Conclusions: In this study, we observed that pragmatic trials rarely report patient and public engagement and do not commonly use PROs as primary outcomes. When provided, target differences are often not justified and rarely informed by patients and stakeholders. Research funders, scientific journals, and institutions should support trialists to incorporate patient engagement to fulfill the mandate of pragmatic trials to be patient centered., Competing Interests: The authors have declared that no competing interests exist.

Colorectal cancer (CRC) screening is a well-established cancer screening method, and its effectiveness depends on maintaining a high participation rate in the target population. In this study, we analyzed the trends in CRC screening participation rates over 10 years in Minamisoma City, where residents were forced to evacuate after the 2011 triple disaster in Fukushima, Japan. The immunochemical fecal occult blood test is provided as municipal CRC screening. We calculated the annual CRC screening participation rate and analyzed the factors associated with participation in screening. Overall, 4069 (12.3%) and 3839 (11.7%) persons participated in CRC screening in 2009 and 2010, respectively; however, the number decreased significantly to 1090 (3.4%) in 2011 when the earthquake occurred. Over the following 3 years, the rate gradually recovered. Multivariable logistic analysis showed that age < 65 years, living alone, and evacuation were significant associated factors for non-participation after 2011 (p < 0.05). In conclusion, the CRC screening participation rate decreased significantly during the Great East Japan Earthquake but recovered over the next 3 years. Further analysis of factors preventing CRC screening participation and research on the long-term effects of its post-disaster decline are important to consider in assessing the need for intervention in post-disaster cancer screening., (© 2021. The Author(s).)

Background: The COVID-19 pandemic has had a devastating impact on healthcare systems and care delivery, changing the context for patient and family engagement activities. Given the critical contribution of such activities in achieving health system quality goals, we undertook to address the question: What is known about work that has been done on patient engagement activities during the pandemic?, Objective: To examine peer-reviewed and grey literature to identify the range of patient engagement activities, broadly defined (inclusive of engagement to support clinical care to partnerships in decision-making), occurring within health systems internationally during the first six months of the COVID-19 pandemic, as well as key barriers and facilitators for sustaining patient engagement activities during the pandemic., Methods: The following databases were searched: Medline, Embase and LitCOVID; a search for grey literature focused on the websites of professional organizations. Articles were required to be specific to COVID-19, describe patient engagement activities, involve a healthcare organization and be published from March 2020 to September 2020. Data were extracted and managed using Microsoft Excel. A content analysis of findings was conducted., Results: Twenty-nine articles were included. Few examples of more genuine partnership with patients were identified (such as co-design and organizational level decision making); most activities related to clinical level interactions (e.g. virtual consultations, remote appointments, family visits using technology and community outreach). Technology was leveraged in almost all reported studies to interact or connect with patients and families. Five main descriptive categories were identified: (1) Engagement through Virtual Care; (2) Engagement through Other Technology; (3) Engagement for Service Improvements/ Recommendations; (4) Factors Impacting Patient Engagement; and (5) Lessons Learned though Patient Engagement., Conclusions: Evidence of how healthcare systems and organizations stayed connected to patients and families during the pandemic was identified; the majority of activities involved direct care consultations via technology. Since this review was conducted over the first six months of the pandemic, more work is needed to unpack the spectrum of patient engagement activities, including how they may evolve over time and to explore the barriers and facilitators for sustaining activities during major disruptions like pandemics., Competing Interests: The authors have declared that no competing interests exist.

Social media is an increasingly popular source of health information, and the rarity and complexity of interstitial lung disease (ILD) may particularly draw patients with ILD to social media for information and support. The objective of this viewpoint is to provide an overview of social media, explore the benefits and limitations of ILD-related social media use, and discuss future development of healthcare information on social media. We describe the value of integrating social media into the practice of ILD health professionals, including its role in information dissemination, patient engagement, knowledge generation, and formation of health policy. We also describe major challenges to expanded social media use in ILD, including limited access for some individuals and populations, abundance of misinformation, and concerns about patient privacy. Finally, for healthcare professionals looking to join social media, we provide practical guidance and considerations to optimize the potential benefits and minimize the potential pitfalls of social media., (© 2021. The Author(s).)

Background: People with rheumatic disease may be at higher risk for more severe course with COVID- 19, and the adverse effects of drugs used to treat rheumatic diseases is a major concern., Objective: We conducted this survey to learn about the real impact of COVID-19 pandemic on patients with rheumatic diseases., Methods: Participants were asked to complete a questionnaire using a telephonic interview conducted by two rheumatologists. Rheumatic disease characteristics, knowledge and attitude toward COVID-19, and impacts of pandemic on rheumatology care and patient's compliance were assessed., Results: We included 307 patients in the survey, and rheumatoid arthris was the main rheumatic disease. Patients had mostly moderate level of knowledge about COVID-19, and patients with higher level of education were more likely to have better knowledge. Participants respected mainly recommended preventive measures. The pandemic and sanitary containment impacted strongly the rheumatology care. Over quarter of patients noted worsening of their rheumatic disease, two-thirds reported postponed or canceled medical apointments and more than three quarters postponed their laboratory tests. Patients with higher disease activity were more likely to have lack of follow-up. Medication change was noted in more than third of cases. It was mostly stopped, and DMARDs were mainly affected. Patients living in rural areas and who had canceled, or postponed their appointments were more likely to change their treatment., Conclusion: Our data are useful to better manage rheumatic patients. Physicians are encouraged to renew contact with their patients to insure medication compliance., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

The pace of change and, indeed, the sheer number of clinical ethics committees (not to be confused with research ethics committees) has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children NHS Foundation Trust v MX, FX and X ([2020] EWHC 1958 (Fam), [21]-[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK., Competing Interests: Competing interests: JB and DA are members of the GOSH Bioethics team., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The introduction of the non-invasive prenatal test (NIPT) has shifted the prenatal screening landscape. Countries are exploring ways to integrate NIPT in their national prenatal screening programs, either as a first- or second-tier test. This study aimed to describe how the uptake of fetal aneuploidy screening changed after the introduction of NIPT as a second-tier and as a first-tier test within the national prenatal screening program of the Netherlands., Material and Methods: A population-based register study in the Netherlands, recording uptake of fetal aneuploidy screening. Data from all pregnant women choosing to have the first-trimester combined test (FCT) or first-tier NIPT between January 2007 and March 2019 were retrospectively collected using national registration systems. Uptake percentages for fetal aneuploidy screening (FCT and NIPT) were calculated and stratified by region and maternal age. Statistical significance was determined using trend analysis and chi-squared tests., Results: Between 2007 and 2013 FCT uptake increased from 14.8% to 29.5% (P = .004). In April 2014 NIPT was introduced as a second-tier test for high-risk women after FCT (TRIDENT-1 study). FCT uptake rose from 29.5% in 2013 to 34.2% in 2015 (P < .0001). After the introduction of NIPT as a first-tier test for all women in April 2017 (TRIDENT-2 study), FCT uptake declined significantly from 35.8% in 2016 to 2.6% in 2018 (P < .0001). NIPT uptake increased to 43.4% in 2018. Regionally, NIPT uptake ranged from 31.8% to 67.9%. Total uptake (FCT and NIPT) between 2007 and 2018 increased significantly from 14.8% to 45.9% (P < .0001). However, total uptake stabilized at 46% for both years of TRIDENT-2 (April 2017-March 2019)., Conclusions: An increase in total fetal aneuploidy screening uptake up to 45.9% was observed after the introduction of NIPT. Uptake appears to have stabilized within a year after introducing first-tier NIPT., (© 2021 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Coronavirus disease (COVID)-19 is an emerging pandemic infection whose significant ability to spread in a naïve population is well established. The first response of states to the COVID-19 outbreak was to impose lock-down and social barrier measures, such as wearing a surgical mask or social distancing. One of the consequences of this pandemic in terms of public health was the suspension or slowdown of infant vaccination campaigns, in almost all countries. The indirect effects of COVID-19 may therefore weigh on mortality from measles and polio in developing countries. In this pandemic chaos, the only hope lies in the rapid development of an effective vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). However, acceptance of this vaccine has not yet been won, as beyond the many unknowns that will inevitably weigh around such rapid development, skepticism among vaccine hesitants is growing., (© 2020 médecine/sciences – Inserm.)

Objectives: The objective of the study was to assess female representation in primary studies underpinning recommendations from clinical guidelines and systematic reviews for sepsis treatment in adults., Study Design and Setting: We conducted a bibliometric study. We removed studies pertaining to sex-specific diseases and included quasirandomized, randomized clinical trials (RCTs), and observational studies. We analyzed the female participation-to-prevalence ratio (PPR)., Results: We included 277 studies published between 1973 and 2017. For the 246 studies for which sex data were available, the share of female participation was 40%. Females overall were under-represented relative to their share of the sepsis population (PPR 0.78). Disaggregated results were reported by sex in 57 studies. In univariate analyses, non-intensive care unit setting and consideration of other social health determinants were significantly associated with greater female participation (P < 0.001 and P = 0.023, respectively). In regression models, studies published in 1996 or later were likely to report sex, while RCTs were unlikely to do so (P = 0.019 and P < 0.001, respectively)., Conclusion: Our study points to female underenrollment in sepsis studies. Primary studies underpinning recommendations for sepsis have poorly reported their findings by sex., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Children's Oncology Group (COG) has been highly successful in improving childhood cancer survival through well-designed multi-institutional clinical trials. However, our center has recognized a decline in the number of enrollments on COG therapeutic clinical trials over recent years. Our single center, retrospective analysis evaluated in detail the patient enrollment rates, annual number of available clinical trials and reason for nonenrollment over the last decade. We found a 61% decrease in enrollment for phase II to III trials of newly diagnosed patients at our center (2011-2018) along a 29% decrease in the number of open COG studies annually. The primary reason for nonenrollment was unavailability of a suitable trial (76%). We also recognized a decrease in number of adolescent and young adult enrollment particularly in the last 8 years (2010-2018); however, the enrollment rate for adolescent and young adults was not substantially different than enrollment of children. The reasons for reduced enrollments are most likely multifactorial and complex. It is imperative that we continue to develop novel clinical studies using a portfolio of federal, investigator-initiated, and industry trials for pediatric oncology patients to continue to advance outcomes, study survivorship, and improve quality of life for these patients.

Objective: Declining participation has been observed in previous epidemiological studies, could occupational risk factor epidemiology be particularly vulnerable to this trend? The objective of this study was to assess trends of participation rates in occupational case-control studies., Methods: Five prominent occupational and epidemiological journals were pre-selected and all articles published between 1991 and 2017 were screened for case-control studies of occupational risk factors for chronic disease outcomes. The primary independent variable was median year of data collection, while the primary outcome variable was reported participation rate. We conducted linear regression, adjusting for study characteristics that included study gender mix, location of recruitment, disease outcome, and data collection method., Results: A total of 180 studies published in the five journals were included in the final analysis. The mean participation was higher for cases (78.9%) than for controls (71.5%). In linear regression, a significant trend of decreasing participation was observed for both cases with a percent change of -0.50 per year (95% CI -0.75 to -0.25) for cases and a percent change of -0.95 per year (95% CI -1.23 to -0.67) for controls. After adjustment for study gender mix, location, disease outcome, and data collection method, the trend remained statistically significant for both case and control groups., Conclusion: Declining participation rates in case-control studies of occupational risk factors may reflect an overall decline of participation in population-based samples. Lower participation rates introduce the potential for bias and may deter future population-based studies of occupational risk factors., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

YouTube is the second most popular website in the world and is increasingly being used as a platform for disseminating health information. Our aim was to evaluate the content-quality and audience engagement of YouTube videos pertaining to the SARS (severe acute respiratory syndrome)-CoV-2 virus which causes the Coronavirus Disease 2019 (COVID-19), during the early phase of the pandemic. We chose the first 30 videos for seven different search phrases: "2019 nCoV," "SARS CoV-2," "COVID-19 virus," "coronavirus treatment," "coronavirus explained," "what is the coronavirus" and "coronavirus information." Video contents were evaluated by two independent medical students with more than 5 years of experience using the DISCERN instrument. Qualitative data, quantitative data and upload source for each video was noted for a quality and audience engagement analysis. Out of the total 210 videos, 137 met our inclusion criteria and were evaluated. The mean DISCERN score was 31.33 out of 75 possible points, which indicates that the quality of YouTube videos on COVID-19 is currently poor. There was excellent reliability between the two raters (intraclass correlation coefficient = 0.96). 55% of the videos discussed prevention, 49% discussed symptoms and 46% discussed the spread of the virus. Most of the videos were uploaded by news channels (50%) and education channels (40%). The quality of YouTube videos on SARS-CoV-2 and COVID-19 is poor, however, we have listed the top-quality videos in our article as they may be effective tools for patient education during the pandemic., (© 2020 John Wiley & Sons, Ltd.)

It is important to continually carve out ways to connect with persons in practice and ensure that polices and processes directing practice are aligned with the values and beliefs of nurses and those they serve. In this paper, patient engagement is discussed in light of nursing theoretical principles and concepts, specifically Parse's (2014) humanbecoming paradigm. In addition, policy connections will be outlined to show how nurses may participate in patient engagement in unique ways.

Cervical cancer screening is considered one of the most significant public health interventions that can reduce not only the incidence, but also the mortality of the disease. One of the most important factors for screening effectiveness is coverage defined as the number of women tested within a recommended interval. In the first years of the cervical screening, the participation rate in National Screening Program in Romania was 14.2% with slight difference in different region of the country. In the northeastern part of the country, in the first four years of the program, the rate was 16.9% with an alarmingly continuous decrease. Thus, increasing the rate of uptake of cervical screening is essential. The policy-makers should take new measures to increase women's participation in this screening program. The objective of this paper was to review situation of the screening program and to identify gaps and needs in the system and to bring or suggest solution., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Background: Pragmatic use of the anti-fibrotic medications pirfenidone and nintedanib for idiopathic pulmonary fibrosis (IPF) in the United States (US) has not been studied and may be different from international settings due to structural differences between health care systems. This study examined the relationship between patient- and site-level characteristics and anti-fibrotic (a) use and (b) selection., Methods: Data from the Pulmonary Fibrosis Foundation Patient Registry was used to perform univariable and multivariable regressions with generalized linear mixed models. A random effects model examined registry site variation., Results: 703 of 1218 (57.7%) patients were taking a single anti-fibrotic of which 312 (44.4%) were taking nintedanib and 391 (55.6%) were taking pirfenidone. Up to 25% of patients using an anti-fibrotic may have been excluded from clinical trial participation due to having too severe disease as measured by diffusion limitation for carbon monoxide. Age (OR = 0.974, p = 0.0086) and diffusion capacity of the lungs for carbon monoxide (per 10% increase in percent-predicted; OR = 0.896, p = 0.0007) was negatively associated with anti-fibrotic use while time (in log of days) since diagnosis (OR = 1.138, p < 0.0001), recent patient clinical trial participation (OR = 1.569, p = 0.0433) and oxygen use (OR = 1.604, p = 0.0027) was positively associated with anti-fibrotic use. Time (log of days) since diagnosis (OR = 1.075, p = 0.0477), history of coronary artery disease (OR = 1.796, p = 0.0030), presence of pulmonary hypertension (OR = 2.139, p = 0.0376), patient clinical trial participation in the prior 12 months (OR = 2.485, p = 0.0002), diffusion capacity of the lungs for carbon monoxide (per 10% increase in percent-predicted; OR = 1.138, p = 0.0184), anticoagulant use (OR = 2.507, p = 0.0028), and enrollment at a registry site in the Midwest region (OR = 1.600, p = 0.0446) were associated with pirfenidone use. Anti-fibrotic use varied by registry site. Rates of discontinuation were modest and nearly identical for the two medications with side effects being the most common reason given for discontinuation. Twenty-three percent (23%, 274) of persons with IPF were using or had recently used an immunomodulatory agent., Conclusions: This analysis provides a detailed characterization of IPF treatment patterns in the US; many users of anti-fibrotic medications may not have qualified for inclusion in clinical trials. More research is needed to understand variations in medical decision-making for use and selection of anti-fibrotic medication.

Purpose: Clinical trial enrollment is low among adolescents and young adults (AYAs) with cancer and may contribute to inferior survival gains in recent years in this population compared with other age groups. We investigated clinical trial participation among AYA women with cancer, and examined whether patients discussed clinical trial participation with their doctor and reasons for nonparticipation. Methods: Women with a diagnosis of breast cancer, thyroid cancer, melanoma, lymphoma, or gynecologic cancer at ages 15-39 years during 2004-2016 were identified from the North Carolina Central Cancer Registry and the Kaiser Permanente Southern California health system. During 2018-2019, a total of 1264 eligible women completed an online survey (response = 13%), which examined survivorship issues among AYAs. Results: Overall, 5% of participants reported that they had participated in a clinical trial. Most women reported that they had not discussed clinical trial participation with a medical provider (76%) and that they did not know whether a relevant trial was available for their cancer (73%). Among those who knew that a trial was available but did not participate, the most commonly reported reasons for nonparticipation included concerns about side effects of the treatment in the trial and concerns that the treatment had not been sufficiently tested. Conclusion: Only a small proportion of AYA women with cancer in our cohort reported discussing a clinical trial with a provider or knowing whether a relevant trial was available. Our findings point to opportunities to improve patient/provider communication to increase clinical trial enrollment among AYAs with cancer.

Background The number of global clinical trials is increasing. Recruitment rate in clinical trials is a challenging task that affects sample size, power of the study, and adequate representation of the targeted population. An understanding of the worries and reasons why patients may refrain from participation in trials may lead to improved enrollment rates. Objectives To assess the rate of patients who are willing to participate in clinical trials, and aspects that might have an impact on the patients' willingness to participate. Setting Government tertiary hospital in Jordan. Methods This is a cross-sectional study. Patients were interviewed by pharmacists in different clinics in a tertiary hospital and information was collected using a data collection sheet. Main outcome measure Factors that might predict the inclination of a patient to participate in clinical trials, and the rate of willingness to participation in randomized controlled trials in cancer patients compared to non-cancer patients. Results A total of 1193 participants were enrolled in the study, one hundred and thirty-five participants (11.3%) had cancer and 80% of the participants had at least one chronic medical condition. Majority of patients (n = 882, 73.9%) believed that trials were safe and 1106 (92.7%) patients thought they were important. Age, education level, income, having cancer or any chronic medical condition, and degree of control of chronic diseases were statistically significant predictors of the willingness of patients to participate in trials. Patients with cancer had a higher rate of acceptance to participation in randomized controlled trials compared to non-cancer patients, 80.0% versus 62.4%, p value < 0.001. Conclusion In general, almost two-thirds of patients were willing to participate in clinical trials, with a higher rate in cancer patients. Factors such as education level, income, and extent of control of medical conditions that might refrain patients from enrollment in trials will lower recruitment rate and must be addressed and taken into consideration before launching clinical trials.

Small, well prepared, culturally competent, and embedded health engagement teams (EHET) tailored to work within a partner health system, rather than outside of it, will achieve greater mutual benefit, desired military objectives, and better health outcomes for the United States Department of Defence and its partners. EHETs have significant advantages over traditional methods of choice for health security cooperation and humanitarian assistance missions. These advantages include enhanced capability and capacity building, greater trust through intentional cultural expertise, a ready platform for enduring relationships, enhanced host nation legitimacy, and flexibility to target specific issues with greater fidelity. We must first define a prototype EHET, compare the concept against prior units that have executed health engagement, and test it prospectively in employment. The U.S. military and the civilian business world each have extensive experience in employing small teams that the health community can emulate. The ideal EHET should have the following nine characteristics: 12 people or fewer, skillsets for the tasks, global health knowledge, be multidisciplinary, a balance of experience, local language capability, geopolitical and cultural competence, targeted preparation for specific security and health objectives, and joint representation. This paper will explore these components of the prototype EHET as it will be tested in our research project., (© Association of Military Surgeons of the United States 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Continued long-term rehabilitation programs with acquired brain injury are important for their participation in meaningful daily activities., Objective: This paper investigated the participation-based interventions on outcomes in patients with acquired brain injury., Methods: A systematic review and meta-analysis search for randomized control trials published between 1998 and 2019 using PubMed, CINAHL, and MEDLINE was performed. Nine studies were selected and analyzed for systematic review. Five studies analyzed the effectiveness of participation-based intervention using meta-analysis and assessed the level of evidence of qualitative studies., Results: A total of 843 publications were searched. Nine studies met the inclusion criteria and were of high quality. The effective score for improving participation following participation-based interventions in persons with acquired brain injury was 0.32 and significant in this study (p < 0.05)., Conclusions: The findings of this systematic review and meta-analysis suggest that, in persons with acquired brain injury, participation-based interventions are essential for community living.

Digital culture gives the patient an ever greater role in managing their own health, which should be a normal place and time of sharing, based on general principles of democracy. The risk is that life itself becomes pertinent to medicine, as it is objectified in medical terms through increasingly advanced and intrusive digital technologies, and that these end up transforming people into datasets, "datomi". Therefore, strategies and tools must be developed for a "true" participation in the culture of health/disease, which does not mean the exploitation of people transformed into data profiling or direct management by citizens, but a concrete exercise in listening and sharing values, meaning, interests and objectives.

Background: Despite cardiac rehabilitation (CR) being shown to improve health outcomes among patients with heart disease, its use has been suboptimal. In response, the Million Hearts Cardiac Rehabilitation Collaborative developed a road map to improve CR use, including increasing participation rates to ≥70% by 2022. This observational study provides current estimates to measure progress and identifies the populations and regions most at risk for CR service underutilization., Methods and Results: We identified Medicare fee-for-service beneficiaries who were CR eligible in 2016, and assessed CR participation (≥1 CR session attended), timely initiation (participation within 21 days of event), and completion (≥36 sessions attended) through 2017. Measures were assessed overall, by beneficiary characteristics and geography, and by primary CR-qualifying event type (acute myocardial infarction hospitalization; coronary artery bypass surgery; heart valve repair/replacement; percutaneous coronary intervention; or heart/heart-lung transplant). Among 366 103 CR-eligible beneficiaries, 89 327 (24.4%) participated in CR, of whom 24.3% initiated within 21 days and 26.9% completed CR. Eligibility was highest in the East South Central Census Division (14.8 per 1000). Participation decreased with increasing age, was lower among women (18.9%) compared with men (28.6%; adjusted prevalence ratio: 0.91 [95% CI, 0.90-0.93]) was lower among Hispanics (13.2%) and non-Hispanic blacks (13.6%) compared with non-Hispanic whites (25.8%; adjusted prevalence ratio: 0.63 [0.61-0.66] and 0.70 [0.67-0.72], respectively), and varied by hospital referral region and Census Division (range: 18.6% [East South Central] to 39.1% [West North Central]) and by qualifying event type (range: 7.1% [acute myocardial infarction without procedure] to 55.3% [coronary artery bypass surgery only]). Timely initiation varied by geography and qualifying event type; completion varied by geography., Conclusions: Only 1 in 4 CR-eligible Medicare beneficiaries participated in CR and marked disparities were observed. Reinforcement of current effective strategies and development of new strategies will be critical to address the noted disparities and achieve the 70% participation goal.

Background: Cerebrospinal fluid (CSF) provides insight into the spectrum of Alzheimer's disease (AD) pathology. While lumbar punctures (LPs) for CSF collection are generally considered safe procedures, many participants remain hesitant to participate in research involving LPs., Objective: To explore factors associated with participant willingness to undergo a research LP at baseline and follow-up research study visit., Methods: We analyzed data from 700 participants with varying cognition (unimpaired, mild cognitive impairment, and dementia) in the Wisconsin Alzheimer's Disease Research Center. We evaluated the relationship of demographic variables (age, sex, race, ethnicity, and years of education) and clinical variables (waist-to-hip ratio, body mass index, AD parental history, cognitive diagnosis) on decision to undergo baseline LP1. We evaluated the relationship of prior LP1 experience (procedure success and adverse events) with the decision to undergo follow-up LP2. The strongest predictors were incorporated into regression models., Results: Over half of eligible participants opted into both baseline and follow-up LP. Participants who underwent LP1 had higher mean education than those who declined (p = 0.020). White participants were more likely to choose to undergo LP1 (p < 0.001); 33% of African American participants opted in compared to 65% of white participants. Controlling for age, education, and AD parental history, race was the only significant predictor for LP1 participation. Controlling for LP1 mild adverse events, successful LP1 predicted LP2 participation., Conclusion: Race was the most important predictor of baseline LP participation, and successful prior LP was the most important predictor of follow-up LP participation.

Competing Interests: Competing interests: Mikie Mork is an employee of Alberta Health Services. No other competing interests were declared.

Objectives: Patient and public involvement (PPI) is a relatively new practice whereby researchers involve patients and the public in the conduct of their research. The Sheffield Motor Neurone Disorders Research Advisory Group (SMNDRAG) is one of the first groups to specialise in motor neuron disease (MND). Its members include people living with MND, carers, relatives, volunteers, clinicians, and scientists. Our aim was to explore the experiences of those who participate in, organise and work with the SMNDRAG. Methods: We conducted 13 semi-structured interviews: 10 with members of the SMNDRAG and three with researchers who have worked with the group. We used thematic analysis to identify ways in which the group influenced research and the barriers and enablers to PPI. Results: A number of motivations for participating in the SMNDRAG were reported but the majority were altruistic. The SMNDRAG offered individuals psychosocial and intellectual benefits. The SMNDRAG has overcome a number of practical and psychological barriers to developing a successful and effective collaborative partnership resulting in a positive impact on research and researchers at each stage of the research process. For example, the group identified research priorities which ensured that research was patient-focused. However, several barriers remain, including the lack of diversity within the group and the perception that PPI participation requires a "certain type of person." Conclusions: PPI can make a valuable contribution to all aspects of research and can have a positive impact on those involved. We recommend ways in which PPI can and should be incorporated into research.

Aims: Patients may experience unfair reception when in contact with psychiatric services. The aims are to illuminate these perceptions, and the extent of inpatients' involvement in their care, and if degree of involvement depends on compulsory or voluntary care. Furthermore, we sought to determine if an educational intervention for staff members, including systematic listening and offering the inpatients involvement using microdecisions, affects the inpatients' experiences and the use of coercion. Materials and methods: We used a naturalistic setting case control design in two psychiatric wards for one year, including all inpatients ( n  = 685) of which 458 took part of the microdecision intervention. Structured direct interviews were carried out with inpatients based on the Discrimination and Stigma Scale (DISC), Dyadic OPTION, and CollaboRATE instruments before ( n  = 19) and after ( n  = 46) the intervention. Frequencies of coercive measures before and after the intervention were compared ( n  = 685). Results: Respondents subjected to the intervention experienced less discrimination related to psychiatric care compared to responders not subjected. Tendencies of improvements post intervention were found for some aspects of involvement, as attention to concerns and possibilities to ask questions. A decrease in the use of coercive measures at three and six months after the start of the intervention was observed. Conclusion: Results suggest that the intervention could decrease the inpatients' experiences of discrimination during psychiatric care as well as the use of coercion in the service. The Dyadic OPTION instrument showed a mixed picture with results implying improvements in some areas and impairments in others.

Background: Many health care organizations around the world have implemented health information technologies (ITs) to enhance health service efficiency, effectiveness, and safety. Studies have demonstrated that promising outcomes of health IT initiatives can be obtained when patients and family members participate and engage in the adoption, use, and evaluation of these technologies. Despite knowing this, there is a lack of health care organizations using patient and family engagement strategies to enhance the use and adoption of health ITs, specifically., Objective: This study aimed to answer the following three research questions (RQs): (1) what current frameworks or theories have been used to guide patient and family engagement in health IT adoption, use, implementation, selection, and evaluation?, (2) what studies have been done on patient and family engagement strategies in health IT adoption, use, implementation, selection, and evaluation?, and (3) what patient and family engagement frameworks, studies, or resources identified in the literature can be applied to health IT adoption, use, implementation, selection, and evaluation?, Methods: This scoping review used a five-step framework developed by Arksey and O'Malley and adapted by Levac et al. These steps include the following: (1) identifying the RQ, (2) identifying relevant studies, (3) selecting studies, (4) charting relevant data, and (5) summarizing and reporting the result. Retrieved academic and grey literature records were evaluated using a literature review software based on inclusion and exclusion criteria by two independent reviewers. If consensus was not achieved, two reviewers would resolve conflicts by discussion. Research findings and strategies were extracted from the studies and summarized in data tables., Results: A total of 35 academic articles and 23 gray literature documents met the inclusion criteria. In total, 20 of the 35 included studies have been published since 2017. Frameworks found include the patient engagement framework developed by Healthcare Information and Management Systems Society and the patient and family engagement framework proposed by Carman et al. Effective strategies include providing patients with clear expectations and responsibilities and providing reimbursement for time and travel. The gray literature sources outlined key considerations for planning and supporting engagement initiatives such as providing patients with professional development opportunities, and embedding patients in existing governance structures., Conclusions: Several studies have reported their findings regarding successful strategies to engage patients and family members in health IT initiatives and the positive impact that can emerge when patients and family members are engaged in such initiatives in an effective manner. Currently, no framework has consolidated all of the key strategies and considerations that were found in this review to guide health care organizations when engaging patients and family members in a health IT-specific project or initiative. Further research to evaluate and validate the existing strategies would be of value., (©Kevin Leung, Drew Lu-McLean, Craig Kuziemsky, Richard G Booth, Sarah Collins Rossetti, Elizabeth Borycki, Gillian Strudwick. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.10.2019.)

Objectives: The Royal College of Physician's (RCP) Future Hospital Programme (FHP) set out a blueprint for a radical new model of care that put patient experience centre stage. This paper reports on the results of an independent evaluation of the FHP and focuses on the role public patient involvement (PPI) played in these projects. The paper explores the perceptions and experiences of those involved in the FHP of how PPI was operationalised in this context, and develops an 'ex-post' programme theory of PPI in the FHP. We conclude by assessing the benefits and challenges of this work., Setting: Secondary care. The FHP consisted of eight clinician-led healthcare improvement hospital development sites with two phases., Participants: Development site clinical teams, patient representatives, the RCP's Patient and Carer Network, members of the FHP team, and fellows and members of the RCP., Design/methods: We conducted an independent evaluation of the FHP using FHP documentation and data collected specifically for the evaluation: qualitative interviews, focus groups and a web-based survey., Results: The PPI initiatives set out to develop more patient-centred care and improve the patient experience. The mechanisms designed to meet these goals were (1) a programme of PPI in the development site's projects, (2) a better understanding of patient experience and (3) evaluation of patient experience., Conclusion: This evaluation of the FHP identifies some key elements that need to be considered when attempting to more closely integrate PPI and co-production in service re-design. The structure of FHP over two phases enabled learning from phase I to be incorporated into phase II. Having the PPI representatives closely involved, developing communities of practice, and the oversight and measuring activities acted as 'disciplinary structures' that contributed to embedding PPI in the FHP and kept the patient experience at the forefront of the improvement initiatives., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

The digital age is beginning to impact the healthcare system. Smartphones and other devices based on cellular technology have made access to information ubiquitous among consumers throughout the world. There has been a shift from devices that collect data to systems for those medical conditions, such as atrial fibrillation. This changes the focus from health literacy to digital health literacy and the information-communication between the healthcare professional and the individual. Moving from health literacy to digital health literacy, therefore also means shifting from patients to persons and from managing health to empowering people to live a healthier life. Digital solutions will uncover an even greater tool, the engaged patient., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: there is little research on how people with dementia are involved in treatment decisions at diagnosis., Objective: to measure shared decision making when starting cholinesterase inhibitors, investigate associations with contextual factors and explore satisfaction and experience of the diagnostic meeting., Setting: nine UK memory clinics in two geographical locations., Subjects: 74 people receiving dementia diagnoses (with 69 companions) and 21 doctors., Methods: we video-recorded 74 memory clinic consultations and rated doctor-shared decision making behaviours using the Observing Patient Involvement in Decision Making scale (OPTION-5 scale). Patients and companions rated their satisfaction and experience. Mixed-effects regressions investigated involvement and (i) number people present, meeting length, capacity, cognitive functioning, diagnosis; and (ii) patient/companion satisfaction and consultation experience., Results: mean consultation time was 26.7 min. Mean OPTION-5 score was 22.5/100 (Standard Deviation = 17.3). Doctors involved patients in decisions more often when patients had mixed dementia (β = 10.13, 95% confidence interval 1.25-19.0, P = 0.025) and in shorter meetings (β = -0.51, 95% CI -0.87 to -0.15, P = 0.006). Patient and companion satisfaction were high and not associated with whether doctors invited patient involvement. Half of patients and one-third companions were uncertain about the meeting outcome, experienced communication barriers and negative emotions., Conclusions: consultations scored low on shared decision making, but were comparable to other settings and were not lower with more cognitively impaired patients. Negative patient and companion experiences reflect the importance of supporting healthcare providers to address patient and companion emotions and need for information., (© The Author(s) 2019. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: Many clinical practices and health systems are increasingly interested in adopting structures for consumer engagement to inform organizational policies and programs. These structures can include patient and family advisory committees, patient representation on an organization's board of directors, or inclusion of patients and family members in quality improvement activities. However, to date only limited information has been available on the uptake of patient engagement strategies and structures, and none specific to geriatrics. We surveyed American Geriatrics Society (AGS) members to ascertain how and when consumer engagement is occurring in the clinical settings where AGS members provide care, and to identify opportunities to improve engagement., Design: Descriptive survey., Participants: A total of 20% (829) of eligible AGS members responded to this section of the survey., Measurements: Respondents' primary work site, methods and staffing of patient and family engagement, barriers to engagement, and strategies to improve engagement., Results: The most common methods of engagement were through advisory committees (28%), quality improvement and program evaluations (27%), and focus groups (21%). However, more than one-third of respondents (35%) said they were not sure whether their clinical setting had any structures or strategies in place for consumer engagement. Respondents identified barriers to engagement as well as the tools and information that would help improve engagement., Conclusion: The survey findings provide insight into what patient engagement looks like in the hospitals, health systems, and other clinical settings where geriatrics health professionals work. Making structures for patient and family engagement more widespread in geriatric practice settings will require addressing the barriers identified by survey respondents including the need for funding and staff time, transportation, and training and supports for participating patients and caregivers. J Am Geriatr Soc 67:1791-1794, 2019., (© 2019 The American Geriatrics Society.)

Background: Internationally, there is a drive to involve patients and the public in health research, due to recognition that patient and public involvement (PPI) may increase the impact and relevance of health research. This scoping review describes the extent and nature of PPI in dementia research in the European Union (EU) and summarises: (i) how PPI is carried out; and (ii) the impact of PPI on people living with dementia and the public, researchers, and the research process., Methods: Relevant studies were identified by searches in electronic reference databases and then filtered by two reviewers independently. Eligibility criteria for included studies were: (i) people living with dementia and/or care partners; (ii) PPI activity in dementia research conducted in the European Union (EU); and (iii) published between 2000 and 2018. An adapted version of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2 SF) was used to collate the data. There was no language restriction other than the abstract needed to be available in English., Results: We found 19 studies from the UK and one from the Netherlands meeting inclusion criteria. No studies from other EU countries met inclusion criteria. Studies reported various methods of PPI including workshops, drop-in sessions, meetings, consensus conference, reader consultation and participatory approach. The reported aims of PPI included identifying and prioritising research questions (n = 4), research design (n = 5), undertaking and managing research (n = 8), and data analysis and interpretation (n = 3). All PPI related to design and implementation of non-pharmacological studies. One study described two pharmacological studies as case studies incorporating PPI. Seventeen studies reported anecdotal impacts of PPI., Conclusions: Further development of PPI in dementia research in the EU and in pharmacological dementia research is required. Given the wide range of objectives of PPI in dementia research, PPI methods should be flexible and appropriate for the research context. Researchers should also formally evaluate and report the impacts of PPI for researchers, patients and the general public using good quality research designs to foster development of the field and enable the benefits and challenges of PPI to be better understood., Trial Registration: PROSPERO 2017: CRD42017053260 .

Resources are needed to assist patients in understanding their diagnoses and considering treatment options. This commentary focuses on improving the language used to communicate disease and treatment information so that patients can make informed decisions., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article.

Background: Substance use can reduce care engagement for individuals with HIV. However, little is known as to whether heavy drinkers differ from drug users. This study compares heavy drinkers, drug users, and those drinking heavily and using drugs on their HIV care engagement., Methods: HIV-infected adult inpatients (n = 801; 67% male; 78% Black) from 11 urban hospitals across the United States participated in a multisite clinical trial to improve patient engagement in HIV care and virologic outcomes. All participants drank heavily and/or used drugs, and had poorly controlled HIV. Participants reported care history at baseline. We compared heavy drinkers, drug users, and those both drinking heavily and using drugs (reference group) on their engagement in care., Results: Heavy drinkers reported lowest rates of lifetime HIV care, AOR = 0.59 (95% CI = 0.36, 0.97). Groups did not differ in recent care, prescription of HIV medication, medical mistrust, or patient-provider relationship. Drug users evidenced the best medication adherence, AOR = 2.38 (95% CI = 1.33, 4.23). Exploratory analyses indicated that drinkers had lower initial care engagement, but that it increased more rapidly with duration of known HIV infection, with similar rates of recent care. Drinkers had the lowest CD4 counts (B=-0.28, p < 0.0001), but no difference in viral load., Conclusions: Heavy drinkers were least likely to have ever been in HIV care. More research is needed to determine why heavy drinkers evidence the lowest initial care engagement and current CD4 counts, and whether drinking intervention early in infection may increase HIV care engagement., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Healthcare personnel are responsible for providing patient-centered care regardless of their patients' language skills, but language barriers is identified as the main hindrances providing effective, equitable and safe care to patients with limited proficiency in a country's majority language. This study is a national multisite cross-sectional survey aiming to investigate communication over language barriers in pediatric oncology care. Material and Methods: A survey using the Communication over Language Barriers questionnaire (CoLB-q) distributed to medical doctors, registered nurses and nursing assistants at six pediatric oncology centers in Sweden (response rate 90%) using descriptive statistical analyses. Results: Professional interpreters on site were the most common solution when using an interpreter, although relatives or even children were used. The use of professional interpreters on site differed among the professions and in different clinical situations, such as medical encounter, education or procedure preparation. All professions reported that the use of professional interpreters greatly increased care relationships, patient safety and patient involvement in care. Conclusions: Healthcare personnel seem to believe that professional interpreters are crucial when caring for patients and family members who do not speak the majority language, but there is an obvious discrepancy between this belief and their use of professional interpreters.

Background: Cancer survival rates in adolescents and young adults (AYAs) have shown slow improvements in comparison with other age groups, and this may be due to lower participation in clinical trials. Little evidence has been provided regarding how nonmetropolitan residence may influence clinical trial enrollment for AYAs with cancer. This study sought to determine whether AYAs from nonmetropolitan areas have lower rates of clinical trial enrollment than their urban counterparts and to examine factors associated with enrollment variation., Methods: Data from the National Cancer Institute's 2006 and 2013 Surveillance, Epidemiology, and End Results Patterns of Care AYA cohorts were analyzed. Patients with acute lymphoblastic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, and sarcoma were included (n = 3155). Urban influence codes were used to measure the rurality of the county of residence at diagnosis, which was categorized as large metropolitan, small metropolitan, or nonmetropolitan. Logistic regression compared trial participants and nonparticipants while adjusting for patient and provider factors., Results: Compared with AYAs from large metropolitan counties, AYAs from small metropolitan (odds ratio [OR], 2.04; 95% confidence interval [CI], 1.57-2.64) or nonmetropolitan counties (OR, 1.86; 95% CI, 1.23-2.81) experienced greater trial enrollment. AYAs treated at a hospital with a residency program (OR, 2.27; 95% CI, 1.63-3.16) or by a pediatric oncologist (OR, 4.02; 95% CI, 3.03-5.32) were associated with greater enrollment. There was a significant interaction between rurality and hospital size, which had the greatest impact on nonmetropolitan enrollment., Conclusions: Clinical trial enrollment was higher among AYAs from nonmetropolitan counties than those from metropolitan counties, predominantly when they were treated at large hospitals., (© 2019 American Cancer Society.)

Reality is defined as a real event, a real thing, or state of affairs. Reality exists in the places where we live our daily lives, in the relationships we have with others, and in our experiences, circumstances, and situations that occur across the lifespan. As the everydayness of our lives becomes increasingly digitized, data generated from the reality that exists outside of our healthcare encounters holds much promise to fill recognized gaps in real-world evidence (RWE). In the past decade, many factors have converged to uniquely position person-generated data for use in health care delivery, payment reform, product development, and regulatory decision making. Yet, real-world data will fall short of its promise to fill gaps in RWE if what we learn does not reflect the real lives of real people from across the spectrum of social, economic, and cultural experiences., (© 2019 The Author Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Background: Individuals with CF and their parents cite safety concerns as barriers to participating in clinical studies. We assessed whether a brochure/infographic describing patient safety monitoring processes could reduce knowledge and attitude barriers regarding safety monitoring. We also identified factors associated with likely participation in future CF studies., Methods: Respondents from three CF centers in the U.S. were randomly assigned to receive the safety monitoring brochure/infographic or an unrelated brochure. Fifty parents of children with CF <16, 50 adolescents with CF 16-21, and 50 adults with CF ≥22 years old were recruited to complete the study survey. Factors associated with survey responses and with reported likelihood of participating in future studies were assessed., Results: Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 95 1.01-5.28), but not in drug studies. Non-Hispanic respondents reported greater likelihood of participating in a future drug study than Hispanic respondents (aOR 3.18, CI 95 1.30-7.74). Adults with CF (aOR 2.62, CI 95 1.05-6.51) and parents (aOR 4.49, CI 95 1.66-12.15) were more likely than adolescents to report they would ask their care team about clinical trials. Confidence in safety monitoring was associated with reported likelihood of future participation in drug studies., Conclusions: Potential future participation in CF drug and/or non-drug studies was associated with respondent age and ethnicity, receiving the safety monitoring brochure/infographic, and confidence in safety monitoring. Our findings underscore the need for education about safety monitoring, with targeted approaches for the Hispanic CF population and adolescents., (Copyright © 2019 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.)

This article presents the author's opinion on the past and present state of the Patient Engagement movement and discusses ways in which the movement will need to change and evolve if it is to become viable and standard practice in drug development. For most of the past decade, drug development sponsors-both government-funded and industry-funded research-have been aspirational in their support of Patient Engagement initiatives. New frameworks and guidelines have been proposed and developed, and a wide variety of initiatives have been planned and piloted. Many factors have facilitated a tentative and experimental posture-these include internal resistance to modifying legacy practices and processes; insufficient funding and staff to implement and manage initiatives; lack of clarity from regulatory and health authorities; and uncertainty around expected impact and return on investment. Recently, research sponsors have begun restructuring their Patient Engagement capabilities and they have been seeking more concrete return on engagement measures. These developments signal that the Patient Engagement movement has entered a new phase, becoming more rigorous as it seeks to balance ethical and moral obligations with scientific and business imperatives.

The research into patient involvement is seldom concerned with the significance of cultural and structural factors. In this discussion paper, we illustrate our considerations on some of the challenges in implementing the ideal of patient involvement by showing how such factors take part in shaping the ways in which the intentions to involve patients are converted to practical interventions. The aim was to contribute to the approach dealing with contextual and structural factors of significance for patient involvement. With the idea of "institutional logics," borrowed from the Danish scholar, Erik Riiskjaer, we first demonstrate, with examples from our own research, how patient involvement is interpreted differently within the different logics. Then, we show how the different interpretations of patient involvement meet and conflict in mutual competition as the ideals are sought to be converted to practical interventions. At last, we argue that an adequate theoretical model for the development in the future health care system should be expanded with a "patient logic.", (© 2018 John Wiley & Sons Ltd.)

Objective: To describe opportunities for pharmacists to use mobile messaging and real-time monitoring to engage with patients taking long-term medications., Summary: The proliferation of mobile phone use across the United States has been met with increased application of these devices by the medical community. However, beyond simple text messages and app-based functions, use of these devices by pharmacies and pharmacists has not been leveraged to improve patient outcomes, such as medication adherence. Resources now exist that can facilitate more advanced mobile communication between patients and pharmacists, which can be managed and informed by data available in most pharmacies. Such tailored messaging can be personalized further by being reactive to patient behavior using real-time medication use monitoring tools, facilitating low-cost, high-reach interventions for patients in need of ongoing guidance., Conclusion: Mechanisms now exist for pharmacies to engage patients more proactively with their prescribed therapy using mobile communication and devices. By facilitating such engagement, pharmacists can remain connected with patients throughout their care, better interpret their needs, navigate adherence-related issues, and more holistically counsel patients based on observed behaviors. Community pharmacy leadership should pursue the use of these advanced mobile messaging techniques as another tool in their arsenal to improve patient outcomes., (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)