Recommendations For Clinical Care Research Articles

Impact of Molecular Tumor Board (MTB) on precision oncology in a community setting

<h3>Objectives:</h3> Many cancer types, including gynecologic malignancies, have seen a surge of treatment and trial opportunities based on molecular profiling. We sought to evaluate the impact of a molecular tumor board (MTB) in a community setting on treatment decisions and outcomes. <h3>Methods:</h3> A systematic program of comphrensive genomic profiling (CGP) was initiated in December 2014. We performed a retrospective analysis of patients with MTB recommendations at a community-based oncology practice January 2015 to December 2018; exclusions were lack of follow-up or death within 60 days of the MTB and/or no metastatic disease. Potentially actionable genomic alterations from CGP (immunohistochemistry, in-situ hybridization, next-generation sequencing) were reviewed bi-weekly by MTB practice experts, pathologists, genetic counselors, and other support staff, and clinical care recommendations were provided. MTB recommendations by category (Figure 1) and number of recommendations followed by the treating physician were collated and analyzed for all cases presented at the MTB. <h3>Results:</h3> During the study period, 4,438 tests were ordered and 837 patients were presented at 87 MTBs Of these, 613/4,438 (14%) were evaluated. The median time between CGP result availability and MTB presentation was 12 days. The most common cancers were lung (23%), breast (19%), and colorectal (17%); others included ovarian, endometrial, bladder, and melanoma. Patients received 837 actionable recommendations: standard therapy (37%), clinical trial (31%), germline testing and genetic counseling (17%), off-label therapy (10%), subspecialty multidisciplinary tumor board review (2%), and advice for classifying tumor of unknown origin (2%). Of these recommendations, 36% to 78% were followed by the treating physician. Clinical trial recommendations were made for immediate enrollment, or for enrollment upon progression after standard of care therapy. Immediate trial recommendation was followed in 93 (56%) and 20 (12%) enrolled in a trial. For progression recommendations, 57 (60%) were followed and 15 (16%) enrolled on a clinical trial. MTB recommendations for standard therapy and off-label therapy were followed by the treating physician in 78% (n=244) and 37% (n=31) of cases, respectively. Germline testing and genetic counseling recommendations were followed in 36% (<i>n</i>=52) of cases. Of those who received testing, 39% (15/43) were positive for a germline mutation. <h3>Conclusions:</h3> The MTB was implemented to provide recommendations on clinical care, increase clinical trial participation, and improve awareness of standard or potential targeted therapies. We found MTB recommendations to be particularly useful in identifying clinical trial candidates. A community oncology-based comprehensive and high-throughput MTB provided useful clinical guidance in various treatment domains within an acceptable timeframe for patients with cancer in a large community setting.

The Role of Tele-Education in Advancing Mental Health Quality of Care: A Content Analysis of Project ECHO Recommendations.

Introduction: Project Extension for Community Healthcare Outcomes (Project ECHO®) is a global-guided practice initiative aimed at building primary care capacity and improving health care quality for underserved populations. This tele-education model brings together primary care providers and subject-matter specialists in online communities of practice to share knowledge, discuss complexities in patient care, and collaborate to reduce health disparities. Methods: Using co-generated clinical care recommendations from ECHO Ontario Mental Health, a mental health focused ECHO program, we explored alignment of recommendations across the Institute of Medicine's (IOM) six domains of health care quality to characterize its impact. A total of 417 recommendations, made for 32 patient cases, were analyzed using a modified directed content analysis method. Each recommendation was coded with one or multiple codes, representing each of the six IOM domains. Key examples of recommendations within each domain are described. Results: An average of 13 recommendations were generated per patient case. The effective domain occurred at least once in each complete set of patient care recommendations. The next highest occurring domain was safe (71.9%), followed by patient-centered (68.8%), efficient (40.6%), equitable (18.8%), and timely (12.5%). Recommendation distribution across the entire data set was effective (97.8%), safe (15.6%), patient-centered (12.0%), efficient (3.6%), equitable (1.9%), and timely (1.4%). Discussion: As the first study to characterize ECHO's impact using health care quality domains, the study highlights ECHO's significant focus on effective, safe, and patient-centered care. These findings can inform ways for ECHO to target quality improvement and measure impact in additional health care quality domains, such as efficient, equitable, and timely.

Clinical-Community Connections: Incorporating Evidence-Based Programs for Improved Patient Outcomes.

Incorporating evidence-based community programs into clinical care recommendations and goals may help bridge the clinic-to-community transition for older adults. Engagement in evidence-based programs can help older adults manage chronic conditions and reduce fall risk through behavior change and self-management following a clinical episode of care. This paper describes evidence-based fall prevention and physical activity programs, provides resources to locate programs, and strategies to match older adults to the right programs.

Practicing Defensive Medicine Benefits No one

Background: More doctors are practising defensive medicine, which may have an impact on patient care. This paper explores the consequences and reasons, for the widespread trend, and recommendations for patient-focused clinical care.&#x0D; Objective: A malpractice suit is the most scarring ordeal that a physician can undergo emotionally and financially. Excessive investigations may be counterproductive. Avoiding certain procedures or patients, for the fear of adverse outcome can be hazardous. There is a need for a better, discerning and judicious system, to minimise the trauma to the largely conscientious and dedicated medical professionals.&#x0D; Discussion&#x0D; How and when the term defensive medicine started, is difficult to trace. However, over the past few decades, it seems to be a well-known practice in industrialised countries. It may have been due to increasing complaints against doctors heralding potential litigation and malpractice suit. Most doctors do not take the privilege of the trust of their patients lightly and respond to it with utmost sincerity.

Early Childhood Caries in Indigenous Communities.

The oral health of Indigenous children of Canada (First Nations, Inuit, and Métis) and the United States (American Indian and Alaska native) is a major child health disparity when compared with the general population of both countries. Early childhood caries (ECC) occurs in Indigenous children at an earlier age, with a higher prevalence, and at much greater severity than in the general population. ECC results in adverse oral health, affecting childhood health and well-being, and may result in high rates of costly surgical treatment under general anesthesia. ECC is an infectious disease that is influenced by multiple factors, but the social determinants of health are particularly important. This policy statement includes recommendations for preventive and clinical oral health care for infants, toddlers, preschool-aged children, and pregnant women by primary health care providers. It also addresses community-based health-promotion initiatives and access to dental care for Indigenous children. This policy statement encourages oral health interventions at early ages in Indigenous children, including referral to dental care for the use of sealants, interim therapeutic restorations, and silver diamine fluoride. Further community-based research on the microbiology, epidemiology, prevention, and management of ECC in Indigenous communities is also needed to reduce the dismally high rate of caries in this population.

DNA-based screening and population health: a points to consider statement for programs and sponsoring organizations from the American College of Medical Genetics and Genomics (ACMG)

DNA-based screening and population health: a points to consider statement for programs and sponsoring organizations from the American College of Medical Genetics and Genomics (ACMG)

European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): Expert Consensus on the Diagnosis, Service Provision, and Care of People with ME/CFS in Europe.

Designed by a group of ME/CFS researchers and health professionals, the European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE) has received funding from the European Cooperation in Science and Technology (COST)—COST action 15111—from 2016 to 2020. The main goal of the Cost Action was to assess the existing knowledge and experience on health care delivery for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in European countries, and to enhance coordinated research and health care provision in this field. We report our findings and make recommendations for clinical diagnosis, health services and care for people with ME/CFS in Europe, as prepared by the group of clinicians and researchers from 22 countries and 55 European health professionals and researchers, who have been informed by people with ME/CFS.

Deep phenotyping in 3q29 deletion syndrome: recommendations for clinical care

PurposeTo understand the consequences of the 3q29 deletion on medical, neurodevelopmental, psychiatric, brain structural, and neurological sequalae by systematic evaluation of affected individuals. To develop evidence-based recommendations using these data for effective clinical care. MethodsThirty-two individuals with the 3q29 deletion were evaluated using a defined phenotyping protocol and standardized data collection instruments. ResultsMedical manifestations were varied and reported across nearly every organ system. The most severe manifestations were congenital heart defects (25%) and the most common were gastrointestinal symptoms (81%). Physical examination revealed a high proportion of musculoskeletal findings (81%). Neurodevelopmental phenotypes represent a significant burden and include intellectual disability (34%), autism spectrum disorder (38%), executive function deficits (46%), and graphomotor weakness (78%). Psychiatric illness manifests across the lifespan with psychosis prodrome (15%), psychosis (20%), anxiety disorders (40%), and attention deficit–hyperactivity disorder (ADHD) (63%). Neuroimaging revealed structural anomalies of the posterior fossa, but on neurological exam study subjects displayed only mild or moderate motor vulnerabilities. ConclusionBy direct evaluation of 3q29 deletion study subjects, we document common features of the syndrome, including a high burden of neurodevelopmental and neuropsychiatric phenotypes. Evidence-based recommendations for evaluation, referral, and management are provided to help guide clinicians in the care of 3q29 deletion patients.

COVID-19 and comorbidities of hepatic diseases in a global perspective.

The worldwide outbreak of coronavirus disease 2019 (COVID-19) has challenged the priorities of healthcare system in terms of different clinical management and infection transmission, particularly those related to hepatic-disease comorbidities. Epidemiological data evidenced that COVID-19 patients with altered liver function because of hepatitis infection and cholestasis have an adverse prognosis and experience worse health outcomes. COVID-19-associated liver injury is correlated with various liver diseases following a severe acute respiratory syndrome-coronavirus type 2 (SARS-CoV-2) infection that can progress during the treatment of COVID-19 patients with or without pre-existing liver disease. SARS-CoV-2 can induce liver injury in a number of ways including direct cytopathic effect of the virus on cholangiocytes/hepatocytes, immune-mediated damage, hypoxia, and sepsis. Indeed, immediate cytopathogenic effects of SARS-CoV-2 via its potential target, the angiotensin-converting enzyme-2 receptor, which is highly expressed in hepatocytes and cholangiocytes, renders the liver as an extra-respiratory organ with increased susceptibility to pathological outcomes. But, underlying COVID-19-linked liver disease pathogenesis with abnormal liver function tests (LFTs) is incompletely understood. Hence, we collated COVID-19-associated liver injuries with increased LFTs at the nexus of pre-existing liver diseases and COVID-19, and defining a plausible pathophysiological triad of COVID-19, hepatocellular damage, and liver disease. This review summarizes recent findings of the exacerbating role of COVID-19 in pre-existing liver disease and vice versa as well as international guidelines of clinical care, management, and treatment recommendations for COVID-19 patients with liver disease.

Research Recommendations to Address Dementia Workforce Development Needs

This policy paper presents workforce development recommendations for research, clinical care and public stakeholders as they plan future research activities to strengthen the workforce to support the healthcare and social needs of persons living with dementia and their families and caregivers. To create these recommendations, the 2020 National Research Summit on Care, Services and Supports for Persons with Dementia and Their Caregivers (2020 Summit) convened a Workforce Development Stakeholder Workgroup. The Stakeholder Workgroup consisted of an interprofessional team of health professionals from academia, professional organizations, and the federal government with expertise in dementia workforce development. The resulting ten workforce development recommendations represent four themes: (1) Accountability by addressing progress towards implementing the 2017 Research Summit on Care, Services, and Supports for Persons with Dementia and their Caregivers (2017 Summit) workforce recommendations; (2) Improving recruitment, retention, and job quality for direct care workers; (3) Creating a tech-savvy and culturally competent workforce; and (4) Developing educational core competencies, domains and milestones. These recommendations will positively impact the ability of persons living with dementia and their caregivers to access person- and family-centred dementia care that promotes independence and quality of life among those navigating their dementia journey.

Establishment of a Molecular Tumor Board (MTB) and Uptake of Recommendations in a Community Setting.

In the precision medicine era, molecular testing in advanced cancer is foundational to patient management. Molecular tumor boards (MTBs) can be effective in processing comprehensive genomic profiling (CGP) results and providing expert recommendations. We assessed an MTB and its role in a community setting. This retrospective analysis included patients with MTB recommendations at a community-based oncology practice January 2015 to December 2018; exclusions were death within 60 days of the MTB and/or no metastatic disease. Potentially actionable genomic alterations from CGP (immunohistochemistry, in-situ hybridization, next-generation sequencing) were reviewed bi-weekly by MTB practice experts, pathologists, genetic counselors, and other support staff, and clinical care recommendations were provided. Subsequent chart reviews determined implementation rates of recommendations. In 613 patients, the most common cancers were lung (23%), breast (19%), and colorectal (17%); others included ovarian, endometrial, bladder, and melanoma. Patients received 837 actionable recommendations: standard therapy (37%), clinical trial (31%), germline testing and genetic counseling (17%), off-label therapy (10%), subspecialty multidisciplinary tumor board review (2%), and advice for classifying tumor of unknown origin (2%). Of these recommendations, 36% to 78% were followed by the treating physician. For clinical trial recommendations (n = 262), 13% of patients enrolled in a clinical trial. The median time between CPG result availability and MTB presentation was 12 days. A community oncology-based comprehensive and high-throughput MTB provided useful clinical guidance in various treatment domains within an acceptable timeframe for patients with cancer in a large community setting.

Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.

Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.

Psychosocial Challenges and Opportunities for Youth With Chronic Health Conditions During the COVID-19 Pandemic.

School closures, altered access to health services, and economic stress during the COVID-19 pandemic have likely had an impact on the mental and physical well-being of youth worldwide, particularly among those with chronic health conditions (CHCs). A number of challenges and opportunities have emerged during the COVID-19 pandemic for youth with CHCs. Challenges include heightened anxiety, disrupted routines, academic and social stresses associated with school closure, increased risk of domestic violence and abuse, and reduced access to physical and psychosocial support. On the other hand, opportunities include reduced academic and social stress, increased time with families, reduced access to substances, easier access to health care using technology, and opportunities to build resilience. This viewpoint paper highlights both challenges and opportunities for youth with CHCs during the pandemic and offers recommendations for further research and clinical care.

Outpatient care for pregnant and puerperal women during the COVID-19 pandemic.

The COVID-19 pandemic remains a rapidly evolving situation, and as new research and data become available, clinical care recommendations should be refined to reflect the most current information.

Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement.

Respiratory illness is the leading cause of mortality in children with cerebral palsy (CP). Although risk factors for developing chronic respiratory illness have been identified, comprehensive clinical care recommendations for the prevention and management of respiratory illness do not currently exist. We invited over 200 clinicians and researchers from multiple disciplines with expertise in the management of respiratory illness in children with CP to develop care recommendations using a modified Delphi method on the basis of the RAND Corporation–University of California Los Angeles Appropriateness Method. These recommendations are intended for use by the wide range of practitioners who care for individuals living with CP. They provide a framework for recognizing multifactorial primary and secondary potentially modifiable risk factors and for providing coordinated multidisciplinary care. We describe the methods used to generate the consensus recommendations, and the overall perspective on assessment, prevention, and treatment of respiratory illness in children with CP.What this paper adds The first consensus statement for preventing and managing respiratory disease in cerebral palsy (CP).Risk factors for respiratory disease in CP should be identified early.Individuals with CP at risk of respiratory disease require regular assessment of risk factors.Effective partnerships between multidisciplinary teams, individuals with CP, and families are essential.Treatment of respiratory disease in individuals with CP must be proactive.

North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper: Plant-based Milks.

Parents and caretakers are increasingly feeding infants and young children plant-based "milk" (PBM) alternatives to cow milk (CM). The US Food and Drug Administration currently defines "milk" and related milk products by the product source and the inherent nutrients provided by bovine milk. Substitution of a milk that does not provide a similar nutritional profile to CM can be deleterious to a child's nutritional status, growth, and development. Milk's contribution to the protein intake of young children is especially important. For almond or rice milk, an 8 oz serving provides only about 2% or 8%, respectively, of the protein equivalent found in a serving of CM. Adverse effects from the misuse of certain plant-based beverages have been well-documented and include failure to gain weight, decreased stature, kwashiorkor, electrolyte disorders, kidney stones, and severe nutrient deficiencies including iron deficiency anemia, rickets, and scurvy. Such adverse nutritional outcomes are largely preventable. It is the position of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) Nutrition Committee, on behalf of the society, that only appropriate commercial infant formulas be used as alternatives to human milk in the first year of life. In young children beyond the first year of life requiring a dairy-free diet, commercial formula may be a preferable alternative to cow's milk, when such formula constitutes a substantial source of otherwise absent or reduced nutrients (eg, protein, calcium, vitamin D) in the child's restricted diet. Consumer education is required to clarify that PBMs do not represent an equivalent source of such nutrients. In this position paper, we provide specific recommendations for clinical care, labelling, and needed research relative to PBMs.

Telemedicine for preoperative assessment during a COVID-19 pandemic: Recommendations for clinical care.

Limiting the spread of the disease is key to controlling the COVID-19 pandemic. This includes identifying people who have been exposed to COVID-19, minimizing patient contact, and enforcing strict hygiene measures. To prevent healthcare systems from becoming overburdened, elective and non-urgent medical procedures and treatments have been postponed, and primary health care has broadened to include virtual appointments via telemedicine. Although telemedicine precludes the physical examination of a patient, it allows collection of a range of information prior to a patient's admission, and may therefore be used in preoperative assessment. This new tool can be used to evaluate the severity and progression of the main disease, other comorbidities, and the urgency of the surgical treatment as well as preferencing anesthetic procedures. It can also be used for effective screening and triaging of patients with suspected or established COVID-19, thereby protecting other patients, clinicians and communities alike.

Therapeutic benefits of blinking exercises in dry eye disease

PurposeDry eye disease (DED) is an important public health concern given its increasing prevalence and impact on patient quality of life. Blinking frequency and completeness are reduced during digital screen exposure, compromising meibum secretion and distribution, causing tear film instability and leading to DED. This study evaluated the effects of blinking exercises on blink pattern and clinical signs and symptoms of DED. MethodsFifty-four participants with dry eye symptoms received instructions to perform a ten-second cycle of blinking exercises every 20 min during waking hours for four weeks. Symptoms were assessed using the 5-item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI); blinking patterns measured with the TearScience LipiView II; and tear film and ocular surface parameters assessed with the Oculus Keratograph 5M. Measures at baseline and on day 28 were compared. ResultsForty-one participants completed the study, reporting an average of 25.6 daily blinking exercise cycles. Improvements were noted in DEQ-5 (from 11 ± 4 to 7 ± 3; p < 0.001), OSDI (36 ± 18 to 22 ± 17; p < 0.001), non-invasive tear film breakup time (6.5 ± 2.4 to 8.1 ± 4.8 s; p < 0.04), the proportion of incomplete blinks (54 ± 36 to 34 ± 29 %; p < 0.001), but not in tear meniscus height or tear film lipid layer thickness. ConclusionBlinking exercises can modify poor blinking patterns and improve dry eye symptomology, with modest changes in objective measures of tear film quality. Incorporating such routines into clinical care recommendations may improve blinking habits and help protect against the impact of digital device use on tear film quality and DED onset and evolution.

The prevalence of type 2 diabetes in people with psychiatric disorders: an umbrella review protocol

BackgroundMany epidemiological studies have investigated the prevalence of type 2 diabetes in individuals with a psychiatric disorder. In an umbrella review, we aim to systematically summarize existing systematic reviews examining the prevalence of type 2 diabetes in people with a psychiatric disorder. When information is available in the identified systematic reviews, comparisons with control groups without a psychiatric disorder will be made. Furthermore, we aim to assess the quality of the included systematic reviews.MethodsThe umbrella review will be based on a comprehensive systematic search of systematic reviews of observational (cross-sectional or longitudinal) studies investigating the prevalence of type 2 diabetes in people with a psychiatric disorder. Four electronic databases (Embase, PsycINFO, PubMed, and the Cochrane Database of Systematic Reviews) will be searched. Retrieved papers will be screened for eligibility by two independent reviewers. Furthermore, the reference lists of all included publications will be screened. Data will be extracted by using an a priori developed data extraction form and two independent reviewers will assess the risk of bias in the included systematic reviews using with the Risk of Bias in Systematic Reviews (ROBIS) tool. A narrative data-synthesis and a subsequent meta-analysis based on the primary studies will be made.DiscussionFor each psychiatric disorder, the data regarding the prevalence of type 2 diabetes will be summarized and discussed. When possible, comparisons with control groups will be reported and discussed. Finally, future implications and recommendations for clinical care will be presented.Systematic review registrationThis protocol was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) on December 9, 2019 (registration number: pending).

Foot Self-Care Experiences Among Patients With Diabetes: A Systematic Review of Qualitative Studies.

The aim of this systematic review was to understand the gaps between the American Diabetes Association clinical recommendations on preventive foot self-care and perceptions of and actions taken by patients with diabetes and diabetic foot ulcers (DFUs). PubMed, the Cumulative Index of Nursing and Allied Health Literature, Cochrane Online Library, Psychological Information Database, and Google Scholar were systematically searched for qualitative research literature published in English from January 1, 2001, to October 21, 2016, using the MeSH terms diabetes mellitus, diabetic foot ulcers, foot care, experiences, and perception to examine the experiences of patients with diabetes regarding foot self-care practices. Publications were screened for inclusion according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and The Standard for Reporting Qualitative Research was used to appraise trustworthiness and publication bias. Publication details (author, year, title, country in which the study was conducted, and the type of publication), study aims, design (study methodology, method of sampling, and analysis method), and participant details were abstracted to Excel sheets for analysis of foot self-care experiences and to determine common themes (foot self-care issues) among patients with diabetes. Of the 14 publications identified, 9 (that included 113 patients with diabetes [95 with or history of DFUs and 18 with no DFUs] and 28 health care professionals [14 podiatrists, 8 physicians, and 6 registered nurses]) met the inclusion criteria for analysis. Research included 4 qualitative descriptive design studies, 2 descriptive phenomenology studies, 1 grounded theory study, 1 interpretive phenomenology study, and 1 exploratory qualitative design study. Four (4) studies were found to lack transparency, and 7 studies did not address trustworthiness. The common themes identified were the high clinical and lifestyle burden of DFUs, poor foot self-care knowledge, perception barriers and resistance, adoption of self-management practices, and discordance between patient and provider impressions and expectations. Several barriers to optimal foot care in persons with diabetes with and without foot ulcers were identified and may be explained and addressed by considering the Health Belief Model. Clinical interventions should be individualized to identify and address patient-specific barriers to optimal foot self-care. Future clinical studies are needed to examine the outcomes of individualized interventions.