Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks.

The COVID-19 pandemic strained health-care systems throughout the world. For some, available medical resources could not meet the increased demand and rationing was ultimately required. Hospitals and governments often sought to establish triage committees to assist with allocation decisions. However, for institutions operating under crisis standards of care (during times when standards of care must be substantially lowered in the setting of crisis), relying on these committees for rationing decisions was impractical-circumstances were changing too rapidly, occurring in too many diverse locations within hospitals, and the available information for decision making was notably scarce. Furthermore, a utilitarian approach to decision making based on an analysis of outcomes is problematic due to uncertainty regarding outcomes of different therapeutic options. We propose that triage committees could be involved in providing policies and guidance for clinicians to help ensure equity in the application of rationing under crisis standards of care. An approach guided by egalitarian principles, integrated with utilitarian principles, can support physicians at the bedside when they must ration scarce resources.

National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic: Version 1.

OBJECTIVE: To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. RESULTS: The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus and 13 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is limited in quality. CONCLUSION: These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge.

Vaccine Policy in the United States.

In an era when the success of the US vaccination policies to date is threatened by vaccine hesitancy, it is important for clinicians to have a working understanding of how vaccines are developed and recommended for use in the United States and how federal and state governments are coordinated to ensure a safe and effective vaccine supply. This article discusses the federal agencies involved in vaccine development and recommendation, other organizations involved in vaccine policy, and the role of vaccine-related public health law in promoting universal vaccination.

Augmenting Cost-Effectiveness Analysis for Uncertainty: The Implications for Value Assessment-Rationale and Empirical Support.

DISCLOSURES: This study received unrestricted funding from the Pharmaceutical Research Manufacturers of America. The authors also do consulting, personally or through their employment, with numerous pharmaceutical manufacturers, payers, and other stakeholders with a general interest in this subject matter.

Prostate cancer incidence across stage, NCCN risk groups, and age before and after USPSTF Grade D recommendations against prostate-specific antigen screening in 2012.

BACKGROUND: We sought to determine the extent to which US Preventive Services Task Force (USPSTF) 2012 Grade D recommendations against prostate-specific antigen screening may have impacted recent prostate cancer disease incidence patterns in the United States across stage, National Comprehensive Cancer Network (NCCN) risk groups, and age groups. METHODS: SEER*Stat version 8.3.4 was used to calculate annual prostate cancer incidence rates from 2010 to 2015 for men aged ≥50 years according to American Joint Committee on Cancer stage at diagnosis (localized vs metastatic), NCCN risk group (low vs unfavorable [intermediate or high-risk]), and age group (50-74 years vs ≥75 years). Age-adjusted incidences per 100,000 persons with corresponding year-by-year incidence ratios (IRs) were calculated using the 2000 US Census population. RESULTS: From 2010 to 2015, the incidence (per 100,000 persons) of localized prostate cancer decreased from 195.4 to 131.9 (Ptrend  < .001) and from 189.0 to 123.4 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. The largest relative year-by-year decline occurred between 2011 and 2012 in NCCN low-risk disease (IR, 0.77 [0.75-0.79, P < .0001] and IR 0.68 [0.62-0.74, P < .0001] for men aged 50-74 and ≥75 years, respectively). From 2010-2015, the incidence of metastatic disease increased from 6.2 to 7.1 (Ptrend  < .001) and from 16.8 to 22.6 (Ptrend  < .001) among men aged 50-74 and ≥75 years, respectively. CONCLUSIONS: This report illustrates recent prostate cancer "reverse migration" away from indolent disease and toward more aggressive disease beginning in 2012. The incidence of localized disease declined across age groups from 2012 to 2015, with the greatest relative declines occurring in low-risk disease. Additionally, the incidence of distant metastatic disease increased gradually throughout the study period.

Social Determinants as a Preventive Service: U.S. Preventive Services Task Force Methods Considerations for Research.

The body of research on social determinants of health is rapidly accumulating. The U.S. Preventive Services Task Force is conducting evaluations to consider the inclusion of screening and counseling for social risks as a clinical preventive service. Yet, for many social risks, evidence is still likely needed before the U.S. Preventive Services Task Force can recommend universal screening or counseling. This manuscript offers a brief review of the social determinants of health that may be germane to the U.S. Preventive Services Task Force, the methods the U.S. Preventive Services Task Force uses to evaluate relevant evidence, and current evidence gaps for social risks. Key methods for making clinical preventive service recommendations are applied for considering the integration of social and clinical care. These methods include determining the certainty of the evidence, assessing the net benefit, defining appropriate prevention frameworks, defining health outcomes versus intermediate outcomes, fully assessing the harms, and defining to what populations and care contexts the evidence applies. This road map for research is intended to spark ingenuity and purpose in the next generation of research studies, thereby ensuring that future recommendations to address and prevent social risks in primary care are informed by high-quality evidence. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.

Forming and implementing community advisory boards in low- and middle-income countries: a scoping review.

BACKGROUND: Community advisory boards (CABs) have expanded beyond high-income countries (HICs) and play an increasing role in low- and middle-income country (LMIC) research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. METHODS: We searched five databases (PubMed, Embase, Global Health, Scopus, and Google Scholar) for publications describing or evaluating CABs in LMICs. Two researchers independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. RESULTS: Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies (65) were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa (17), China (8), and Thailand (7) having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs (53/88, 60%) focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. CONCLUSIONS: Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs.

A Toolkit to Improve Diversity in Patient and Family Advisory Councils: A New Method to Advance Health Equity.

The Institute of Medicine (2001) identifies equity as one of six essential components of health-care quality. However, many health-care organizations lack a formal method to deeply understand and evaluate diverse patient and family experiences. Understanding care experiences of patients and families from minority racial and ethnic groups is essential to improving pervasive health disparities and to making health care more equitable. This article describes the creation of a toolkit aimed at strengthening health-care organizations' abilities to advance health equity through patient and family advisory councils (PFACs). This resource, cocreated with representatives from diverse PFACs, identifies and promotes strategies to recruit and retain diverse representation in advisory councils.

Screening and Referral for Childhood Obesity: Adherence to the U.S. Preventive Services Task Force Recommendation.

INTRODUCTION: The U.S. Preventive Services Task Force recommends clinicians screen children aged 6 years or older for obesity and offer or refer children with obesity to intensive weight management programs. This study explores clinician awareness of weight management programs meeting the recommendation, adherence to the recommendation of screening and referral, and associations between provider and practice characteristics and weight management program referrals. METHODS: This cross-sectional study used data from the DocStyles survey 2017, a web-based panel survey, analyzed in 2017. Among 1,023 clinicians who see pediatric patients, this study examined clinician awareness of weight management programs in their communities that met the recommendation, practice of screening for childhood obesity, and referral to weight management programs. Multivariable logistic regression estimated associations between the demographic and practice characteristics of clinicians and weight management program referrals. RESULTS: Only 24.6% of surveyed clinicians were aware of a weight management program that met the U.S. Preventive Services Task Force recommendation in their community; of those aware, 88.9% referred patients to these weight management programs. Most (83.6%) clinicians screened children for obesity in ≥75% of visits. Overall, 53.5% of clinicians provided referrals to weight management programs. Referral was higher among female clinicians and clinicians serving mostly middle-income patients. Providers without teaching hospital privileges had lower odds of referral. CONCLUSIONS: Adherence to clinical recommendations is essential to curbing the childhood obesity epidemic. Only one in four surveyed clinicians were aware of weight management programs in their community meeting U.S. Preventive Services Task Force criteria. Half of clinicians referred pediatric patients with obesity to a weight management program. Results suggest efforts are needed to increase awareness of, and referral to, weight management programs meeting the recommendation.

Key considerations in reimbursement decision-making for multiple sclerosis drugs in Australia.

BACKGROUND: In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. METHODS: The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. RESULTS: A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (n = 11); (2) the validity of the approach to obtain utilities (n = 6); (3) the lack of appropriate/long-term safety data (n = 8); and (4) the time horizon used in the economic models (n = 3). CONCLUSION: A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.

Annual Report to the Nation on the Status of Cancer, part II: Recent changes in prostate cancer trends and disease characteristics.

BACKGROUND: Temporal trends in prostate cancer incidence and death rates have been attributed to changing patterns of screening and improved treatment (mortality only), among other factors. This study evaluated contemporary national-level trends and their relations with prostate-specific antigen (PSA) testing prevalence and explored trends in incidence according to disease characteristics with stage-specific, delay-adjusted rates. METHODS: Joinpoint regression was used to examine changes in delay-adjusted prostate cancer incidence rates from population-based US cancer registries from 2000 to 2014 by age categories, race, and disease characteristics, including stage, PSA, Gleason score, and clinical extension. In addition, the analysis included trends for prostate cancer mortality between 1975 and 2015 by race and the estimation of PSA testing prevalence between 1987 and 2005. The annual percent change was calculated for periods defined by significant trend change points. RESULTS: For all age groups, overall prostate cancer incidence rates declined approximately 6.5% per year from 2007. However, the incidence of distant-stage disease increased from 2010 to 2014. The incidence of disease according to higher PSA levels or Gleason scores at diagnosis did not increase. After years of significant decline (from 1993 to 2013), the overall prostate cancer mortality trend stabilized from 2013 to 2015. CONCLUSIONS: After a decline in PSA test usage, there has been an increased burden of late-stage disease, and the decline in prostate cancer mortality has leveled off. Cancer 2018;124:2801-2814. © 2018 American Cancer Society.

PSA screening, prostate biopsy, and treatment of prostate cancer in the years surrounding the USPSTF recommendation against prostate cancer screening.

BACKGROUND: The 2012 United States Preventive Services Task Force recommendation against screening for prostate cancer has impacted rates of prostate-specific antigen (PSA) screening and appears to be associated with declining prostate cancer incidence. Our objective was to characterize health care utilization that may explain these observed trends. METHODS: MarketScan claims, which capture >30 million privately insured patients in the United States, were queried for all men aged 40-64 years for the years 2008-2014. PSA testing, prostate biopsy, prostate cancer diagnosis, and definitive local treatment were determined using associated International Classification of Diseases, Ninth Revision and Current Procedural Terminology, Fourth Edition codes. RESULTS: There were approximately 6 million qualifying men with a full year of data. PSA testing, prostate biopsy, and prostate cancer detection declined significantly between 2009 and 2014, most notably after 2011. The prostate biopsy rate per 100 patients with a PSA test decreased over the study period from 1.95 (95% confidence interval [CI], 1.92-1.97) to 1.52 (95% CI, 1.50-1.54). Prostate cancer incidence per prostate biopsy increased over the study period from 0.36 (95% CI, 0.35-0.36) to 0.39 (95% CI, 0.39-0.40). Of new prostate cancer diagnoses, the proportion managed with definitive local treatment decreased from 69% (95% CI, 69%-70%) to 54% (95% CI, 53%-55%). Both PSA testing and prostate cancer incidence decreased significantly after 2011 (P < .001). CONCLUSION: In a large cohort of privately insured men, PSA testing, prostate biopsy, prostate cancer incidence, and local definitive treatment for prostate cancer decreased between 2008 and 2014, most notably after 2011. This decrease may be driven by differential referral patterns from primary care providers to urologists. Cancer 2018;124:2733-2739. © 2018 American Cancer Society.

Quality of leadership in multidisciplinary cancer tumor boards: development and evaluation of a leadership assessment instrument (ATLAS).

BACKGROUND: High-quality leadership and chairing skills are vital for good performance in multidisciplinary tumor boards (MTBs), but no instruments currently exist for assessing and improving these skills. OBJECTIVE: To construct and validate a robust instrument for assessment of MTB leading and chairing skills. DESIGN AND SETTING: We developed an observational MTB leadership assessment instrument (ATLAS). ATLAS includes 12 domains that assess the leadership and chairing skills of the MTB chairperson. ATLAS has gone through a rigorous process of refinement and content validation prior to use to assess the MTB lead by two urological surgeons (blinded to each other) in 7 real-live (n = 286 cases) and 10 video-recorded (n = 131 cases) MTBs. OUTCOME MEASURES AND STATISTICAL ANALYSIS: ATLAS domains were analyzed via descriptive statistics. Instrument content was evaluated for validity using the content validation index (CVI). Intraclass correlation coefficients (ICCs) were used to assess inter-observer reliability. RESULTS: Instrument refining resulted in ATLAS including the following 12 domains: time management, communication, encouraging contribution, ability to summarize, ensuring all patients have treatment plan, case prioritization, keeping meeting focused, facilitate discussion, conflict management, leadership, creating good working atmosphere, and recruitment for clinical trials. CVI was acceptable and inter-rater agreement adequate to high for all domains. Agreement was somewhat higher in real-time MTBs compared to video ratings. Concurrent validation evidence was derived via positive and significant correlations between ATLAS and an established validated brief MTB leadership assessment scale. CONCLUSION: ATLAS is an observational assessment instrument that can be reliably used for assessing leadership and chairing skills in cancer MTBs (both live and video-recorded). The ability to assess and feedback on team leader performance provides the ground for promotion of good practice and continuing professional development of tumor board leaders.

Enacting localist health policy in the English NHS: the 'governing assemblage' of Clinical Commissioning Groups.

Objectives The Health and Social Care Act 2012 introduced Clinical Commissioning Groups to take responsibility for commissioning (i.e. planning and purchasing) the majority of services for local populations in the English NHS. Constituted as 'membership organizations', with membership compulsory for all GP practices, Clinical Commissioning Groups are overseen by, and are accountable to, a new arm's-length body, NHS England. This paper critically engages with the content and policy narrative of the 2012 Act and explores this in relation to the reality of local policy enactment. Methods Set against a careful review of the 2012 Act, a case study of a nascent Clinical Commissioning Groups was conducted. The research included observations of Clinical Commissioning Group meetings and events (87 h), and in-depth interviews (16) with clinical commissioners, GPs, and managers. Results The 2012 Act was presented as part of a broader government agenda of decentralization and localism. Clinical Commissioning Group membership organizations were framed as a means of better meeting the needs and preferences of local patients and realizing a desirable increase in localism. The policy delineated the 'governing body' and 'the membership', with the former elected from/by the latter to oversee the organization. 'The membership' was duty bound to be 'good', engaged members and to represent their patients' interests. Fieldwork with Notchcroft Clinical Commissioning Group revealed that Clinical Commissioning Groups' statutory duty to NHS England to 'ensure the continuous improvement' of GP practice members involved performance scrutiny of GP practices. These governance processes were carried out by a varied cast of individuals, many of whom did not fit into the binary categorization of membership and governing body constructed in the policy. A concept, the governing assemblage, was developed to describe the dynamic cast of people involved in shaping the work and direction of the Clinical Commissioning Group, many of whom were unelected and of uncertain status. This was of particular significance in Notchcroft Clinical Commissioning Group because the organization explicitly pursued a governance system based on developing positions of consensus. The governing assemblage concept is valuable in articulating the actual practices of Clinical Commissioning Group governance, how these relate to the normative content of the 2012 Act, and the tensions that emerge. Conclusions The governing assemblage concept provided clarity in discussion of the dynamics of organizational governance in Notchcroft Clinical Commissioning Group, which did not follow the simple template articulated in the 2012 Act. The concept merits application in the study of other Clinical Commissioning Groups and may prove valuable in illuminating governance processes within a range of other health care organizations in different contexts. The governing assemblage holds promise for the analysis of ongoing changes to NHS organization, as well as international health care organizations such as accountable care organizations in the US.

ACOG Committee Opinion No. 729: Importance of Social Determinants of Health and Cultural Awareness in the Delivery of Reproductive Health Care.

Awareness of the broader contexts that influence health supports respectful, patient-centered care that incorporates lived experiences, optimizes health outcomes, improves communication, and can help reduce health and health care inequities. Although there is little doubt that genetics and lifestyle play an important role in shaping the overall health of individuals, interdisciplinary researchers have demonstrated how the conditions in the environment in which people are born, live, work, and age, play equally as important a role in shaping health outcomes. These factors, referred to as social determinants of health, are shaped by historical, social, political, and economic forces and help explain the relationship between environmental conditions and individual health. Recognizing the importance of social determinants of health can help obstetrician-gynecologists and other health care providers better understand patients, effectively communicate about health-related conditions and behavior, and improve health outcomes.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.