¿Es sustentable la aplicación de las guías de práctica clínica en la práctica clínica del mundo real? / Is the application of clinical practice guidelines sustainable in real-world clinical practice?

Las guías de práctica clínica han contribuido a resolver un problema al sintetizar la evidencia y ponerla al alcance del profesional sanitario, pero su desarrollo e implementación creciente en los últimos años ha dado lugar a nuevos inconvenientes que aún no han sido resueltos. En este artículo editorial, la autora repasa cuestiones no tenidas en cuenta por las guías de práctica clínica, incluso aquellas consideradas de buena calidad de acuerdo a los estándares actuales, y reflexiona en especial sobre el uso del tiempo de los médicos en la consulta, aspecto desatendido que atenta contra la sustentabilidad del modelo actual de cuidado propuesto por estas recomendaciones. (AU)

Clinical practice guidelines have contributed to solving a problem by synthesizing the evidence and making it available to healthcare professionals, but their development and increasing implementation in recent years has given rise to new problems that have not yet been resolved. In this editorial article, the author reviews issues not taken into account by clinical practice guidelines, even those considered to be of good quality according to current standards, and reflects inparticular on the use of physicians' time in the consultation, a neglected aspect that undermines the sustainability of the current care model proposed by these recommendations. (AU)

Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.

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.

Disparities and trends in the participation of minorities, women, and the elderly in breast, colorectal, lung, and prostate cancer clinical trials.

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.

The long term participation trend for the colorectal cancer screening after the 2011 triple disaster in Minamisoma City, Fukushima, Japan.

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.

A scoping review of patient engagement activities during COVID-19: More consultation, less partnership.

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.

The opportunities and challenges of social media in interstitial lung disease: a viewpoint.

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.

Challenging misconceptions about clinical ethics support during COVID-19 and beyond: a legal update and future considerations.

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.

Uptake of fetal aneuploidy screening after the introduction of the non-invasive prenatal test: A national population-based register study.

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.

Patients with Rheumatic Diseases Overlooked during COVID-19 Pandemic: How are They Doing and Behaving?

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.

Participation based intervention with acquired brain injury: Systematic review and meta-analysis.

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.

[COVID-19 and vaccination: a global disruption]. / COVID-19 et vaccination : une dérégulation globale.

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.

TITLE: COVID-19 et vaccination : une dérégulation globale. ABSTRACT: La COVID-19 est une infection pandémique émergente dont l'importante capacité à se propager dans une population dénuée d'immunité n'est plus à prouver. La première réponse des États à la flambée de COVID-19 fut d'imposer un confinement et des mesures barrières, telles que le port du masque et la distanciation sociale. Une des répercussions de cette pandémie, en matière de santé publique, fut la suspension ou le ralentissement brusque des campagnes de vaccination des nourrissons, un peu partout dans le monde. Un des effets indirects de la COVID-19 est donc le risque de peser sur la mortalité mondiale, principalement via une recrudescence de la rougeole et de la poliomyélite, principalement dans les pays en voie de développement. Dans ce chaos potentiel, le seul espoir réside dans le développement rapide d'un vaccin efficace contre le SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2). Cependant, l'acceptation de ce vaccin par la population n'est pas évidente, car outre les nombreuses inconnues qui vont peser inévitablement dans le cas d'un développement très rapide du vaccin, le scepticisme des hésitants vaccinaux va à nouveau se développer.

Accrual Trends for Children's Oncology Group Clinical Trials: A Single Center Experience.

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.

Factors Associated with Lumbar Puncture Participation in Alzheimer's Disease Research.

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.

Trends in participation rates in case-control studies of occupational risk factors 1991-2017.

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.

Patient Engagement, Nursing Theory, and Policy Possibilities.

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.

YouTube as a source of patient information for Coronavirus Disease (COVID-19): A content-quality and audience engagement analysis.

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.