Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

The Impact of the COVID-19 Pandemic on Surgical Management of Breast Cancer: Global Trends and Future Perspectives.

INTRODUCTION: The rapid spread of COVID-19 across the globe is forcing surgical oncologists to change their daily practice. We sought to evaluate how breast surgeons are adapting their surgical activity to limit viral spread and spare hospital resources. METHODS: A panel of 12 breast surgeons from the most affected regions of the world convened a virtual meeting on April 7, 2020, to discuss the changes in their local surgical practice during the COVID-19 pandemic. Similarly, a Web-based poll based was created to evaluate changes in surgical practice among breast surgeons from several countries. RESULTS: The virtual meeting showed that distinct countries and regions were experiencing different phases of the pandemic. Surgical priority was given to patients with aggressive disease not candidate for primary systemic therapy, those with progressive disease under neoadjuvant systemic therapy, and patients who have finished neoadjuvant therapy. One hundred breast surgeons filled out the poll. The trend showed reductions in operating room schedules, indications for surgery, and consultations, with an increasingly restrictive approach to elective surgery with worsening of the pandemic. CONCLUSION: The COVID-19 emergency should not compromise treatment of a potentially lethal disease such as breast cancer. Our results reveal that physicians are instinctively reluctant to abandon conventional standards of care when possible. However, as the situation deteriorates, alternative strategies of de-escalation are being adopted. IMPLICATIONS FOR PRACTICE: This study aimed to characterize how the COVID-19 pandemic is affecting breast cancer surgery and which strategies are being adopted to cope with the situation.

EAES Recommendations for Recovery Plan in Minimally Invasive Surgery Amid COVID-19 Pandemic.

BACKGROUND: COVID-19 pandemic presented an unexpected challenge for the surgical community in general and Minimally Invasive Surgery (MIS) specialists in particular. This document aims to summarize recent evidence and experts' opinion and formulate recommendations to guide the surgical community on how to best organize the recovery plan for surgical activity across different sub-specialities after the COVID-19 pandemic. METHODS: Recommendations were developed through a Delphi process for establishment of expert consensus. Domain topics were formulated and subsequently subdivided into questions pertinent to different surgical specialities following the COVID-19 crisis. Sixty-five experts from 24 countries, representing the entire EAES board, were invited. Fifty clinicians and six engineers accepted the invitation and drafted statements based on specific key questions. Anonymous voting on the statements was performed until consensus was achieved, defined by at least 70% agreement. RESULTS: A total of 92 consensus statements were formulated with regard to safe resumption of surgery across eight domains, addressing general surgery, upper GI, lower GI, bariatrics, endocrine, HPB, abdominal wall and technology/research. The statements addressed elective and emergency services across all subspecialties with specific attention to the role of MIS during the recovery plan. Eighty-four of the statements were approved during the first round of Delphi voting (91.3%) and another 8 during the following round after substantial modification, resulting in a 100% consensus. CONCLUSION: The recommendations formulated by the EAES board establish a framework for resumption of surgery following COVID-19 pandemic with particular focus on the role of MIS across surgical specialities. The statements have the potential for wide application in the clinical setting, education activities and research work across different healthcare systems.

Withdrawal of intensive care during times of severe scarcity: Triage during a pandemic only upon arrival or with the inclusion of patients who are already under treatment?

Many countries have adopted new triage recommendations for use in the event that intensive care beds become scarce during the COVID-19 pandemic. In addition to establishing the exact criteria regarding whether treatment for a newly arriving patient shows a sufficient likelihood of success, it is also necessary to ask whether patients already undergoing treatment whose prospects are low should be moved into palliative care if new patients with better prospects arrive. This question has led to divergent ethical guidelines. This paper explores the distinction between withholding and withdrawing medical treatment during times of scarcity. As a first central point, the paper argues that a revival of the ethical distinction between doing and allowing would have a revisionary impact on cases of voluntary treatment withdrawal. A second systematic focus lies in the concern that withdrawal due to scarcity might be considered a physical transgression and therefore more problematic than not treating someone in the first place. In light of the persistent disagreement, especially concerning the second issue, the paper concludes with two pragmatic proposals for how to handle the ethical uncertainty: (1) triage protocols should explicitly require that intensive care attempts are designed as time-limited trials based on specified treatment goals, and this intent should be documented very clearly at the beginning of each treatment; and (2) lower survival prospects can be accepted for treatments that have already begun, compared with the respective triage rules for the initial access of patients to intensive care.

Crisis standards of care in a pandemic: navigating the ethical, clinical, psychological and policy-making maelstrom.

The COVID-19 pandemic has caused clinicians at the frontlines to confront difficult decisions regarding resource allocation, treatment options and ultimately the life-saving measures that must be taken at the point of care. This article addresses the importance of enacting crisis standards of care (CSC) as a policy mechanism to facilitate the shift to population-based medicine. In times of emergencies and crises such as this pandemic, the enactment of CSC enables concrete decisions to be made by governments relating to supply chains, resource allocation and provision of care to maximize societal benefit. This shift from an individual to a population-based societal focus has profound consequences on how clinical decisions are made at the point of care. Failing to enact CSC may have psychological impacts for healthcare providers particularly related to moral distress, through an inability to fully enact individual beliefs (individually focused clinical decisions) which form their moral compass.

Dutifully Defying Death: A Right to Life-saving Emergency Treatment.

Article 12 of the International Covenant on Economic, Social and Cultural Rights provides for the right to health. Two questions are considered in this article. Does this right entail a more specific right to life-saving emergency treatment? And if so, should the latter right become justiciable in the domestic courts? Two propositions will be made in this article. First, the right to life-saving emergency treatment is a necessary component of the right to health. Second, the conventional arguments against the justiciability of socio-economic rights do not apply to the right to life-saving emergency treatment. Such a right should be justiciable at the domestic level.

Triage tool for the rationing of blood for massively bleeding patients during a severe national blood shortage: guidance from the National Blood Transfusion Committee.

The emerging COVID-19 pandemic has overwhelmed healthcare resources worldwide, and for transfusion services this could potentially result in rapid imbalance between supply and demand due to a severe shortage of blood donors. This may result in insufficient blood components to meet every patient's needs resulting in difficult decisions about which patients with major bleeding do and do not receive active transfusion support. This document, which was prepared on behalf of the National Blood Transfusion Committee in England, provides a framework and triage tool to guide the allocation of blood for patients with massive haemorrhage during severe blood shortage. Its goal is to provide blood transfusions in an ethical, fair, and transparent way to ensure that the greatest number of life years are saved. It is based on an evidence- and ethics-based Canadian framework, and would become operational where demand for blood greatly exceeds supply, and where all measures to manage supply and demand have been exhausted. The guidance complements existing national shortage plans for red cells and platelets.

Adult ICU Triage During the Coronavirus Disease 2019 Pandemic: Who Will Live and Who Will Die? Recommendations to Improve Survival.

OBJECTIVES: Coronavirus disease 2019 patients are currently overwhelming the world's healthcare systems. This article provides practical guidance to front-line physicians forced to make critical rationing decisions. DATA SOURCES: PubMed and Medline search for scientific literature, reviews, and guidance documents related to epidemic ICU triage including from professional bodies. STUDY SELECTION: Clinical studies, reviews, and guidelines were selected and reviewed by all authors and discussed by internet conference and email. DATA EXTRACTION: References and data were based on relevance and author consensus. DATA SYNTHESIS: We review key challenges of resource-driven triage and data from affected ICUs. We recommend that once available resources are maximally extended, triage is justified utilizing a strategy that provides the greatest good for the greatest number of patients. A triage algorithm based on clinical estimations of the incremental survival benefit (saving the most life-years) provided by ICU care is proposed. "First come, first served" is used to choose between individuals with equal priorities and benefits. The algorithm provides practical guidance, is easy to follow, rapidly implementable and flexible. It has four prioritization categories: performance score, ASA score, number of organ failures, and predicted survival. Individual units can readily adapt the algorithm to meet local requirements for the evolving pandemic. Although the algorithm improves consistency and provides practical and psychologic support to those performing triage, the final decision remains a clinical one. Depending on country and operational circumstances, triage decisions may be made by a triage team or individual doctors. However, an experienced critical care specialist physician should be ultimately responsible for the triage decision. Cautious discharge criteria are proposed acknowledging the difficulties to facilitate the admission of queuing patients. CONCLUSIONS: Individual institutions may use this guidance to develop prospective protocols that assist the implementation of triage decisions to ensure fairness, enhance consistency, and decrease provider moral distress.

Equity and efficiency of health care resource allocation in Jiangsu Province, China.

BACKGROUND: Jiangsu was one of the first four pilot provinces to engage in comprehensive health care reform in China, which has been on-going for the past 5 years. This study aims to evaluate the equity, efficiency and productivity of health care resource allocation in Jiangsu Province using the most recent data, analyse the causes of deficiencies, and discuss measures to solve these problems. METHODS: Data were extracted from the Jiangsu Health/Family Planning Statistical Yearbook (2015-2019) and Jiangsu Statistical Yearbook (2015-2019). The Gini coefficient (G), Theil index (T) and health resource density index (HRDI) were chosen to study the fairness of health resource allocation in Jiangsu Province. Data envelopment analysis (DEA) and the Malmquist productivity index (MPI) were used to analyse the efficiency and productivity of this allocation. RESULTS: From 2014 to 2018, the total amount of health resources in Jiangsu Province increased. The G of primary resource allocation by population remained below 0.15, and that by geographical area was between 0.14 and 0.28; additionally, the G of health financial resources was below 0.26, and that by geographical area was above 0.39. T was consistent with the results for G and Lorenz curves. The HRDI shows that the allocated amounts of health care resources were the highest in southern Jiangsu, except for the number of health institutions. The average value of TE was above 0.93, and the DEA results were invalid for only two cities. From 2014 to 2018, the mean TFPC in Jiangsu was less than 1, and the values exceeded 1 for only five cities. CONCLUSION: The equity of basic medical resources was better than that of financial resources, and the equity of geographical allocation was better than that of population allocation. The overall efficiency of health care resource allocation was high; however, the total factor productivity of the whole province has declined due to technological regression. Jiangsu Province needs to further optimize the allocation and increase the utilization efficiency of health care resources.

'The problem is small enough, the problem is big enough': a qualitative study of health technology assessment and public policy on drug funding decisions for children.

BACKGROUND: Public policy approaches to funding paediatric medicines in developed public health systems remain understudied. Current approaches to HTA present a variety of conceptual, methodological and practical problems in the context of child health. This study explores the technical and sociopolitical determinants of public funding decisions on paediatric drugs, through the analysis of interviews with stakeholders involved in or impacted by HTA for child health technologies at the provincial and national levels in Canada. METHODS: We undertook in-depth interviews with a purposive sample (n = 22) of stakeholders involved with or affected by drug funding decisions for children at the provincial (Ontario) and national levels in Canada. Grounded theory methods were employed to guide data collection and analysis. Theory on 'technology-as-policy' and the sociopolitics of health technologies served as sensitizing concepts for inductive data coding and analysis. Emergent themes informed the development of conceptual and practical insights on social values and system dynamics related to child HTA, of relevance to public policymaking on the coverage of health technologies for children in Canada. RESULTS: Participant reflection on the normative and systems dimensions of drug funding for children formed two broad categories: HTA paradigms and sociopolitical context. Our analysis revealed notable differences of context and substance related to child health technology production, evaluation and use. These differences spanned the major phases of HTA (from assembly to assessment to integration) and the surrounding sociopolitical milieu (from markets to governance to politics). Careful analysis of these differences sets in relief a number of substantive and procedural shortcomings of current HTA paradigms in respect of child health. Our findings suggest a need to rethink how HTA is structured and operationalized for child health technologies. CONCLUSIONS: Current approaches to health technology assessment are not well calibrated to the realities of child health and illness. Our study presents a nuanced and contextually grounded analysis of concepts instrumental to drug funding decisions for children. The insights generated are directly applicable to the Canadian and Ontario contexts, but also yield fundamental knowledge about HTA for children that are germane to drug policy in other health systems.

Management of patients with magnetically controlled growth rods amidst the global COVID-19 pandemic.

INTRODUCTION: At the time of writing, we are all coping with the global COVID-19 pandemic. Amongst other things, this has had a significant impact on postponing virtually all routine clinic visits and elective surgeries. Concurrently, the Magnetic Expansion Control (MAGEC) rod has been issued with a number of field safety notices and UK regulator medical device alerts. METHODS: This document serves to provide an overview of the current situation regarding the use of MAGEC rods, primarily in the UK, and the impact that the pandemic has had on the management of patients with these rods. RESULTS AND CONCLUSION: The care of each patient must of course be determined on an individual basis; however, the experience of the authors is that a short delay in scheduled distractions and clinic visits will not adversely impact patient treatment. The authors caution against a gap in distractions of longer than 6 months and emphasise the importance of continued remote patient monitoring to identify those who may need to be seen more urgently.

Plastic Surgery and the COVID-19 Pandemic: A Review of Clinical Guidelines.

BACKGROUND: A novel coronavirus disease (COVID-19) was first reported in December 2019 in China and was soon declared a pandemic by the World Health Organization. Many elective and nonessential surgeries were postponed worldwide in an effort to minimize spread of disease, as well as to conserve resources. Our goal with this article is to review current practice guidelines in setting of the COVID-19 pandemic, based on available data and literature. METHODS: Websites pertaining to surgical and medical societies, and government agencies were reviewed, along with recently published literature to identify recommendations related to COVID-19 and plastic surgery procedures. RESULTS: Clinical practice modifications are recommended during the pandemic in outpatient and perioperative settings. Use of personal protective equipment is critical for aerosol-generating procedures, such as surgery in the head and neck area. Care for trauma and malignancy should continue during the pandemic; however, definitive reconstruction could be delayed for select cases. Specific recommendations were made for surgical treatment of cancer, trauma, and semiurgent reconstructive procedures based on available data and literature. CONCLUSIONS: The risk and benefit of each reconstructive procedure should be carefully analyzed in relation to necessary patient care, minimized COVID-19 spread, protection of health care personnel, and utilization of resources. Recommendations in this article should be taken in the context of each institute's resources and prevalance of COVID-19 in the region. It should be emphasized that the guidelines provided are a snapshot of current practices and are subject to change as the pandemic continues to evolve.

The Epidemiology of COVID-19: A Review.

COVID-19 is a new lethal disease with limited information on its transmissibility, the severity of its sequelae, its clinical manifestations, and epidemiology. This commentary analyzed the global epidemiology of COVID-19 among the vulnerable population. The analysis revealed that most pediatric COVID-19 cases are not severe, but related severe illness still occurs in children. All ages of children are susceptible to COVID-19, and no significant gender difference exists. COVID-19 infection during pregnancy produced fatal outcomes for mothers, but less risky for the baby. The hot spot clusters for COVID-19 are the prisons/jails, nursing/group homes, and long-term facilities where most of the vulnerable populations reside. Ethnic minority groups in the USA and UK are disproportionately exposed to COVID-19 infection and death than Caucasians. The difference may be because ethnic minorities are exposed to higher risks at work and the long-standing structural economic and health disparities in the two countries. There are now changes in guidelines on who is qualified to receive ventilators in dire situations in many countries around the world if the healthcare system is overwhelmed.

Evaluation of endoscopy requests in the resumption of activity during the SARS-CoV-2 pandemic: denial of nonindicated requests and prioritization of accepted requests.

INTRODUCTION: the global SARS-CoV-2 pandemic forced the closure of endoscopy units. Before resuming endoscopic activity, we designed a protocol to evaluate gastroscopies and colonoscopies cancelled during the pandemic, denying inappropriate requests and prioritizing appropriate ones. METHODS: two types of inappropriate request were established: a) COVID-19 context, people aged ≤ 50 years without alarm symptoms and a low probability of relevant endoscopic findings; and b) inappropriate context, requests not in line with clinical guidelines or protocols. Denials were filed in the medical record. Appropriate requests were classified into priority, conventional and follow-up. Requests denied by specialty were compared and the findings of priority requests were evaluated. RESULTS: between March 16th and June 30th 2020, 1,658 requests (44 % gastroscopies and 56 % colonoscopies) were evaluated, of which 1,164 (70 %) were considered as appropriate (priority 8.5 %, conventional 48 %, follow-up 43 % and non-evaluable 0.5 %) and 494 (30 %) as inappropriate (20 % COVID-19 context, 80 % inappropriate context). The reasons for denial of gastroscopy were follow-up of lesions (33 %), insufficiently studied symptoms (20 %) and relapsing symptoms after a previous gastroscopy (18 %). The reasons for denial of colonoscopies were post-polypectomy surveillance (25 %), colorectal cancer after surgery (21 %) and a family history of cancer (13 %). There were significant differences in denied requests according to specialty: General Surgery (52 %), Hematology (37 %) and Primary Care (29 %); 31 % of priority cases showed relevant findings. CONCLUSIONS: according to our study, 24 % of endoscopies were discordant with scientific recommendations. Therefore, their denial and the prioritization of appropriate ones optimize the use of resources.

Rationing of nursing care, a deviation from holistic nursing: A systematic review.

BACKGROUND: Rationing of care in nursing is nurses' inability to complete all care activities for patients because of scarcity in time and resource. Literature suggests that rationing of care is closely related to patient safety and quality of care. The phenomena have been defined and studied from varied perspectives and contexts. A systematic review of studies related to the concept was aimed at identifying and synthesizing the finding. METHODS: The review followed Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines, and literature searches were conducted in MEDLINE, CINAHL, PsycInfo, Web of Science and EMBASE databases. Fifty-seven quantitative studies were included in the review. FINDINGS: The review observed that nursing activities addressing the emotional, educational, mobility and hygiene needs of the patients were commonly rationed. Antecedents of rationing included resource inadequacy and organizational work environment. Rationing influenced patient satisfaction, mortality and a number of adverse events and was associated with decreased job satisfaction, increased intention to leave and high turnover among nurses. DISCUSSIONS: This review concludes that rationing in nursing is ubiquitous, embedded in the work environment and poses a threat to the professional health and philosophical base of nursing in addition to having serious implications on patients' safety. Strategies to reframe and reconsider organizational traits, and open discussion with other healthcare stakeholders can reduce rationing of nursing care. The review suggests future researchers adopt different methodological layout to study rationing.

Liver Transplantation in France.

In France, the main indications for liver transplantation are hepatocellular carcinoma (HCC) and alcoholic cirrhosis. The number of candidates for decompensated hepatitis C virus-related cirrhosis has markedly decreased since the advent of direct-acting antiviral agents. Nonalcoholic steatohepatitis represents a lower proportion of candidates as compared with the United States. The main source of donors is donation after brain death, but the program of transplantation using donation after circulatory death is growing with excellent results. The deceased donation rate was 28.8 per million people in 2017, which has increased over the last few years. Adult-to-adult living donor liver transplantation has been almost completely abandoned. Donors are allocated on a national basis, and there is no longer local or regional priority. In patients with decompensated cirrhosis, prioritization is based on the Model for End-Stage Liver Disease (MELD) score. The distance between the donor and the recipient is taken into account according to an original gravity model. In patients with HCC, prioritization depends on the alfa-fetoprotein (AFP) score, the MELD score, and waiting time. Only patients with HCC tumor-node-metastasis ≥2 and AFP score ≤2 are eligible for the HCC score. A list of MELD exceptions, consisting of uncommon complications where mortality risk is not adequately predicted by the MELD score and conditions other than cirrhosis, has been established. MELD exceptions must be individually validated by a college of experts mandated by the French Regulatory Agency of Transplantation (Agence de la Biomédecine). The most common MELD exception is refractory ascites with a low MELD score. A major challenge is to reduce the rate of refusal of donation through information campaigns.

Current Status of Simultaneous Liver-Kidney Transplantation in the United States.

On August 10, 2017, a formal policy was enacted in the United States that defined listing criteria for simultaneous liver-kidney transplantation and priority for patients who received a liver transplantation (LT) and subsequently developed significant kidney disease after LT. This article reviews and summarizes the rationale for such policies, the policies themselves, and the potential impact on LT candidates.

Defining the Value of Health Technologies in Latin America: Developments in Value Frameworks to Inform the Allocation of Healthcare Resources.

OBJECTIVES: The recent development of value frameworks to inform healthcare resource allocation responds to a demand to make the decision-making process more inclusive and explicit. The objectives of the 2018 Latin American (LAtam) Health Technology Assessment International (HTAi) Policy Forum were to explore the current international experiences and to discuss the potential application of value frameworks in Latin America. METHODS: A background paper, presentations, and group discussions of Policy Forum members (43 participants, 12 LAtam countries represented) at the 2018 HTAi Policy Forum meeting informed this paper. RESULTS: Participants agreed that HTA and decision making based on more comprehensive and inclusive value frameworks could improve health system effectiveness, efficiency, sustainability, and equity; promote transparency in the decision process; sustain a more comprehensive assessment of technologies; and facilitate stakeholder participation as well as accountability of decisions. Criteria that were identified as essential to be included in a value framework for LAtam were burden of illness and severity of the disease, effectiveness and safety of the technology, quality of the evidence, cost-effectiveness, and budget impact. Potential challenges identified for the application of value frameworks in LAtam, included scarcity of human resources and delays in the assessment process. CONCLUSIONS: Forum participants agreed that the next steps should be to identify appropriate processes and methodologies, adapted to the context of each country, regarding the application of value frameworks to improve the link between HTA and decision making.

Perceptions of nursing workloads and contributing factors, and their impact on implicit care rationing: A Queensland, Australia study.

AIMS: To explore nurses' perceptions of factors affecting workloads and their impact on patient care. BACKGROUND: Fiscal restraints and unpredictable patient illness trajectories challenge the provision of care. Cost containment affects the number of staff employed and the skill-mix for care provision. While organisations may acknowledge explicit rationing of care, implicit rationing takes place at the point of service as nurses are forced to make decisions about what care they can provide. METHOD: A self-report cross sectional study was conducted using an on-line survey with 2,397 nurses in Queensland, Australia. RESULTS: Twenty to forty per cent reported being unable to provide care in the time available; having insufficient staff; and an inadequate skill-mix. The respondents reported workload and skill-mix issues leading to implicit care rationing. Over 60% believed that the processes to address workload issues were inadequate. CONCLUSIONS: Institutional influences on staffing levels and skill-mix are resulting in implicit care rationing. IMPLICATIONS FOR NURSE MANAGERS: Adequate staffing should be based on patient acuity and the skill-mix required for safe care. Managers should be more assertive about adequate clinical workloads, involve staff in decision-making, and adopt a systematic planning approach. Failure to do so results in implicit care rationing impacting on patient safety.