Expert Panel Recommendations Research Articles

American Society of Regional Anesthesia and Pain Medicine expert panel recommendations on point-of-care ultrasound education and training for regional anesthesiologists and pain physicians—part I: clinical indications

Point-of-care ultrasound (POCUS) is a critical skill for all regional anesthesiologists and pain physicians to help diagnose relevant complications related to routine practice and guide perioperative management. In an effort...

American Society of Regional Anesthesia and Pain Medicine expert panel recommendations on point-of-care ultrasound education and training for regional anesthesiologists and pain physicians—part II: recommendations

Point-of-care ultrasound (POCUS) is a critical skill for all regional anesthesiologists and pain physicians to help diagnose relevant complications related to routine practice and guide perioperative management. In an effort...

Continuing Medical Education Questions: February 2021.

Article Title: The Role of Noninvasive Tests in Clinical Gastroenterology Practices to Identify Patients With Non-Alcoholic Steatohepatitis at High Risk for Adverse Outcomes: Expert Panel Recommendations.

Aducanumab: Appropriate Use Recommendations

Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer’s disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.

Role of Noninvasive Tests in Clinical Gastroenterology Practices to Identify Patients With Nonalcoholic Steatohepatitis at High Risk of Adverse Outcomes: Expert Panel Recommendations.

Nonalcoholic fatty liver disease (NAFLD) is generally considered a silent and potentially reversible condition. The subtype of NAFLD that can be classified as nonalcoholic steatohepatitis (NASH) can progress to advanced fibrosis and cirrhosis. Because of the metabolic nature of the pathogenic mechanism underlying NAFLD and NASH, it is often accompanied by common comorbidities such as obesity, insulin resistance, and type 2 diabetes mellitus. The increase in the prevalence of these comorbidities has resulted in a parallel increase in the prevalence of NAFLD and NASH, globally, nationally, and even in children. In recent years, it has been identified that the stage of fibrosis is the most important predictor of liver outcomes; therefore, identifying patients with NAFLD and NASH with more advanced stages of fibrosis can be essential for optimal management. Several noninvasive tools for diagnosing and staging NAFLD and NASH are available, but simple and straightforward recommendations on the use of these tools are not. Recognizing these unmet needs, hepatologists who are members of the American College of Gastroenterology and the Chronic Liver Disease Foundation created a practical decision tree/algorithm to risk stratify NAFLD/NASH as a resource in gastroenterology/hepatology clinical practices. This review will provide insight into how this algorithm was developed, describe it in detail, and provide recommendations for its use in clinical practice.

Basic oral health goals for Spain 2015/2020

To define the basic oral health goals for Spain 2015 (children)/2020 (adults). The Spanish Society of Epidemiology and Oral Public Health commissioned a six-member Expert Panel, which worked over the period 2006-2007 and reached consensus according to the EuropeAid Evaluation Guidelines. The Panel's work included three meetings and a presentation at the Society's annual conference in 2007. Since each autonomous region/city in Spain has control over its health policy, only basic goals for the country as a whole were defined. The variables used to set goals were caries history and gingival health according to the World Health Organisation criteria, and tooth brushing frequency and health perception according to the European Global Oral Health Indicators Development Project. A total of 16 targets were defined, 8 for children and 8 for adults. For example, the number of permanent decayed, missing and filled teeth should be < 1.0 at 12 years of age by 2015, or the percentage of edentulous persons should be < 15% at 65-74-years by 2020. In order to achieve the proposed goals, the Expert Panel recommends involving all health system personnel in the maintenance and/or development of new oral health programmes and strategies.

PNS176 Is the Door for Rwe in Benefit Assessment in German HTA NOW OPEN?

GSAV, the German law for more safety in drug supply, stipulates that routine clinical practice data may be included in the benefit (re-)assessment of drugs and since 2019 the G-BA may ask for their collection to supplement submitted data. The concepts for generation of routine practice data and their use for the benefit assessment have recently been published by IQWiG. The objective of this study was to critically assess these. We analysed published evidence and engaged in discussions with internal and external experts in the fields of German assessment methodology, RWE and statistics, focusing on the proposed criteria for routine practice data generation and their potential use for conducting treatment comparisons as part of German benefit assessment, comparing to other markets. In A19-43, IQWiG rules out using EMR and claims data for the benefit assessment, due to limited data availability and inconsistent quality. Disease registries are described as the only suitable tool for data collection for benefit assessment. For non-randomised studies, propensity score methods are described as the main acceptable approach to balance treatment groups. In contrast, other HTA bodies (e.g. NICE) allow for more methodological flexibility when generating treatment effect estimates (e.g. multivariate regression analyses). IQWiG concludes that even following the stringent criteria for establishing a registry and guidelines for confounder adjustment, only evidence of ‘low-qualitative certainty’ can be generated. Therefore, our expert panel recommends exploring the use of EMR or claims data, which may fulfil the outlined quality requirements in some cases, in combination with registries. By not making use of the available routine practice data, IQWiG overlooks a data source widely accepted by other HTA bodies. However, the door for RWE in German HTA has now been opened. Other analyses based on propensity score methods, e.g. matched adjusted comparisons may become acceptable in the future.

Cardiovascular impact of COVID-19 with a focus on children: A systematic review.

BACKGROUNDSince the beginning of the pandemic, coronavirus disease-2019 (COVID-19) in children has shown milder cases and a better prognosis than adults. Although the respiratory tract is the primary target for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), cardiovascular involvement is emerging as one of the most significant and life-threatening complications of SARS-CoV-2 infection in adults.AIMTo summarize the current knowledge about the potential cardiovascular involvement in pediatric COVID-19 in order to give a perspective on how to take care of them during the current pandemic emergency. METHODSMultiple searches in MEDLINE, PubMed were performed using the search terms “COVID-19” or “SARS-CoV-2" were used in combination with “myocardial injury” or "arrhythmia" or “cardiovascular involvement” or "heart disease" or "congenital heart disease" or “pulmonary hypertension” or "long QT" or “cardiomyopathies” or “channelopathies” or "Multisystem inflammatory system" or "PMIS" or “MIS-C” or ”Pediatric multisystem inflammatory syndrome" or "myocarditis" or "thromboembolism to identify articles published in English language from January 1st, 2020 until July 31st, 2020. The websites of World Health Organization, Centers for Disease control and Prevention, and the Johns Hopkins Coronavirus Resource Center were reviewed to provide up to date numbers and infection control recommendations. Reference lists from the articles were reviewed to identify additional pertinent articles. Retrieved manuscripts concerning the subject were reviewed by the authors, and the data were extracted using a standardized collection tool. Data were subsequently analyzed with descriptive statistics. For Pediatric multisystemic inflammatory syndrome temporally associated with COVID-19 (PMIS), multiple meta-analyses were conducted to summarize the pooled mean proportion of different cardiovascular variables in this population in pseudo-cohorts of observed patients.RESULTSA total of 193 articles were included. Most publications used in this review were single case reports, small case series, and observational small-sized studies or literature reviews. The meta-analysis of 16 studies with size > 10 patients and with complete data about cardiovascular involvement in children with PMIS showed that PMIS affects mostly previously healthy school-aged children and adolescents presenting with Kawasaki disease-like features and multiple organ failure with a focus on the heart, accounting for most cases of pediatric COVID-19 mortality. They frequently presented cardiogenic shock (53%), ECG alterations (27%), myocardial dysfunction (52%), and coronary artery dilation (15%). Most cases required PICU admission (75%) and inotropic support (57%), with the rare need for extracorporeal membrane oxygenation (4%). Almost all of these children wholly recovered in a few days, although rare deaths have been reported (2%). Out of PMIS cases we identified 10 articles reporting sporadic cases of myocarditis, pulmonary hypertension and cardiac arrythmias in previously healthy children. We also found another 10 studies reporting patients with pre-existing heart diseases. Most cases consisted in children with severe COVID-19 infection with full recovery after intensive care support, but cases of death were also identified. The management of different cardiac conditions are provided based on current guidelines and expert panel recommendations. CONCLUSIONThere is still scarce data about the role of cardiovascular involvement in COVID-19 in children. Based on our review, children (previously healthy or with pre-existing heart disease) with acute COVID-19 requiring hospital admission should undergo a cardiac workup and close cardiovascular monitoring to identify and treat timely life-threatening cardiac complications.

Young Adults with Sickle Cell Disease (SCD) Have Low Interest in Genetic Counseling and Sickle Cell Trait Testing for Sexual Partners

Introduction The 2014 NHLBI Sickle Cell Expert Panel recommends that young adults with sickle cell disease (SCD) be supported to develop a reproductive life plan, but little data about implementing this recommendation exists and reproductive health behaviors or knowledge is not assessed in existing SCD transition readiness forms. Young adults with SCD confront typical age-related reproductive challenges and require additional support due to SCD-related complexities. For men and women, there are questions about the effect of SCD and its treatments on fertility and reproductive lifespan and the problem of genetic risk for SCD in offspring. For men, priapism and erectile dysfunction may be problems, while women face contraception choices and complicated pregnancy care. In our young adult clinic, we assess young adults' reproductive history, intentions and knowledge using a clinical survey and standard intake questions. The purpose of this study was to describe young adult responses to our family planning survey. Methods This is a retrospective analysis of patients who established care at the Johns Hopkins Sickle Cell Center for Adults' Young Adult Clinic (YAC), which serves young adults with SCD &amp;lt;31 years. The survey is administered to all new patients, consists of 10 questions and has a Flesch-Kincaid Grade Level score of 6. A systematic chart review captured respondent demographic data to characterize the responses. Results Fifty patients who established care in the YAC over its first 15 months (April 2019-July 2020) completed the survey. They were 66% female with a median age of 23.5 (IQR 21,25). Most (74%) had sickle cell anemia (SCA); 60% had education beyond high school. Most (78%) were either students (34%) or employed full time (44%). Forty-two percent lived with a parent. Most (68%) were sexually active, and 45% reported contraception use. Condoms were commonly used by both sexes (41%); forty percent of women used depot-medroxyprogesterone acetate (DMPA). Half of women (58%) had a gynecologist. One third of women reported dysmenorrhea. Forty-one percent of men reported priapism. Twenty-four percent of respondents had a history of pregnancy or of impregnating a partner and 14% had children. The median age of parents at the birth of the first child was 21 (IQR 16,22). Survey results are in Table 1. The response rate was 98% for eight questions and 50% for two questions. Few (8%) reported desire to have a child in the next year, and 27% wished to discuss contraception. Among sexually active respondents, 29% knew their partner's sickle cell trait status and 35% of them wanted testing. Few respondents wanted to meet with a genetics counselor (12%) or reported knowledge of preimplantation genetic testing (PGT) (11%). Thirty-eight percent of respondents were interested in learning how to identify if a fetus has SCD. Ninety-two percent of respondents indicated they do not desire pregnancy in the next year, and 38% of them were using contraception - 33% used condoms, 22% used DMPA, and 11% had an intrauterine device (IUD). Those interested in contraception were young (68% under 26), female (77%), and, of those women, most did not have a gynecologist (60%). Most women with dysmenorrhea (63%) were not interested in discussing contraception. Of the 14% of respondents with children, 29% knew their partner's trait status; and of those who did not, 20% wanted testing. Among 10 patients interested in genetic counseling or who knew of PGT, half had more than high school education; most (70%) were women with SCA who had never been pregnant. Among 82% who had not heard of PGT, 17% identified interest in more information. Most (70%) of this group was 22-25 years old, 14% wanted a child in the next year, all were either students (43%) or employed full time (57%); most (57%) had education beyond high school. Conclusions Clinic administration of a family planning survey is feasible. Many young adults transition to adult care and are parents or interested in becoming parents. Ninety-two percent of respondents do not desire pregnancy in the near future but 67% of them are not using reliable birth control. Genetic counseling interest, knowledge of PGT, and knowledge of partner sickle trait status is low. Current transition readiness documents for SCD do not adequately address reproductive health. These results suggest a discordance between the reproductive health priorities of young adults with SCD and providers that should be further examined. Disclosures Stewart: HRSA: Research Funding. Lanzkron:GBT: Research Funding; HRSA: Research Funding; Ironwood: Research Funding; NHLBI: Research Funding; PCORI: Research Funding; Pfizer: Research Funding; Pharmacy Times Continuing Education: Honoraria; Prolong: Research Funding. Pecker:Forma Therapeutics: Consultancy.

Opioid requirement after rotator cuff repair is low with a multimodal approach to pain

Current practices may aim to blunt rather than understand postoperative pain. Perhaps the most common serious complication of arthroscopic rotator cuff repair (ARCR) is persistence of opiate medication intake. Patients still receive upwards of 80 oxycodone 5 mg pills, or 600 morphine milligram equivalents (MMEs), leading more than 20% of opioid-naïve subjects to continue to fill opioid prescriptions beyond 180 days after surgery. Developing evidence-based guidelines for narcotic prescription after ARCR presents an opportunity for orthopedic surgeons to address the opioid epidemic. The purpose of this study was (1) to prospectively determine the requirements for opiate medications after ARCR, and (2) to create an evidence-based guideline for postoperative prescription, in contrast to the anecdotal or expert panel recommendations that currently exist. We further investigated whether a liposomal bupivacaine (LB) interscalene never block (ISNB) would reduce pain and opiate consumption compared with standard bupivacaine ISNB (control) for ARCR. The study enrolled 100 patients who underwent primary ARCR surgery. Patients were provided with postoperative "pain journals" to document their daily pain on a numerical rating scale, satisfaction with pain management using the Likert scale, and track their daily oxycodone 5 mg pill consumption during the 14-day postoperative period. Enrolled patients were further randomized to receiving an LB (experimental) or standard bupivacaine (control) ISNB. A total of 77% of all patients required fewer than 15 pills postoperatively. The LB group consumed an average of 1.7 fewer pills (13.0 MMEs) on postoperative day (POD) 1 (P = .02) and reported statistically lower pain during PODs 1 and 2 (P = .01 and P = .006), as well as cumulatively throughout the study period (P = .03). In addition, LB patients remained opioid-free at a higher rate (44% vs. 15% in controls, P = .03). With a multimodal approach, the majority of patients undergoing ARCR can manage postoperative pain with 15 or fewer oxycodone 5 mg tablets (112.5 MMEs) and maintain a high degree of satisfaction. The addition of an LB ISNB may further reduce the consumption of postoperative narcotics compared with a standard ISNB. This study provides evidence that may be used for surgeon guidelines in the effort to reduce opioid prescriptions after ARCR.

Key indicators for appraising adolescent sexual and reproductive health in South Asia: international expert consensus exercise using the Delphi technique

ABSTRACT Background There is a need for an accurate assessment of the patterns and determinants of sexual and reproductive health in South Asia owing to high fertility rates and high incidence of unplanned pregnancy among adolescents. Health indicator sets, with a wide range of health dimensions, also support in formulating evidence-based policies. For attaining this, indicators should be developed and prioritized based on consensus and relevance. Objective This study aimed to develop a comprehensive list of adolescent sexual and reproductive health (ASRH) key indicators for South Asia through systematic participatory expert consultation exercise using the Delphi technique. Methods Experts were invited to two rounds of an indicator rating exercise and a third round to discuss the results in a broader regional perspective. A list of nine indicator categories, including 41 adolescent health indicators, was rated by the expert panel. Prioritization was based on mean Likert scores while consensus was established using Kendall’s W. Results 24, 16 and six experts participated in the first, second and third round, respectively. Out of the nine indicator categories, demographics, reproductive health, violence, and nutrition were ranked high in relevance by the expert panel. Experts had a strong consensus on the relevance of parental control and connection, and behavioral indicators while there was moderate consensus on the relevance of nutrition, infectious disease, and mortality indicators. Conclusion As far as we know, this is the first study that employs the Delphi technique for prioritizing ASRH indicators for South Asia. Engaging a diverse group of experts, using an online platform, we developed a comprehensive list of key indicators for appraising ASRH relevant to South Asia based on expert panel consensus and recommendations. Our results also highlight that there is a need for developing a region-specific prioritized list of indicators which might assist in identifying regional health needs.

Regional anesthesia training model for resource-limited settings: a prospective single-center observational study with pre–post evaluations

Background and objectivesEducational initiatives are a sustainable means to address provider shortages in resource-limited settings (RLS), yet few regional anesthesia curricula for RLS have been described. We sought to design...

Therapy for Stage IV Non–Small-Cell Lung Cancer Without Driver Alterations: ASCO and OH (CCO) Joint Guideline Update

The aim of this work is to provide evidence-based recommendations updating the 2017 ASCO guideline on systemic therapy for patients with stage IV non-small-cell lung cancer (NSCLC) without driver alterations. A guideline update for patients with stage IV NSCLC with driver alterations will be published separately. The American Society of Clinical Oncology and Ontario Health (Cancer Care Ontario) NSCLC Expert Panel made updated recommendations based on a systematic review of randomized controlled trials from December 2015 to 2019. This guideline update reflects changes in evidence since the previous guideline update. Five randomized controlled trials provide the evidence base. Additional literature suggested by the Expert Panel is discussed. Recommendations apply to patients without driver alterations in epidermal growth factor receptor or ALK. For patients with high programmed death ligand 1 (PD-L1) expression (tumor proportion score [TPS] ≥ 50%) and non-squamous cell carcinoma (non-SCC), the Expert Panel recommends single-agent pembrolizumab. Additional treatment options include pembrolizumab/carboplatin/pemetrexed, atezolizumab/carboplatin/paclitaxel/bevacizumab, or atezolizumab/carboplatin/nab-paclitaxel. For most patients with non-SCC and either negative (0%) or low positive (1% to 49%) PD-L1, the Expert Panel recommends pembrolizumab/carboplatin/pemetrexed. Additional options are atezolizumab/carboplatin/nab-paclitaxel, atezolizumab/carboplatin/paclitaxel/bevacizumab, platinum-based two-drug combination chemotherapy, or non-platinum-based two-drug therapy. Single-agent pembrolizumab is an option for low positive PD-L1. For patients with high PD-L1 expression (TPS ≥ 50%) and SCC, the Expert Panel recommends single-agent pembrolizumab. An additional treatment option is pembrolizumab/carboplatin/(paclitaxel or nab-paclitaxel). For most patients with SCC and either negative (0%) or low positive PD-L1 (TPS 1% to 49%), the Expert Panel recommends pembrolizumab/carboplatin/(paclitaxel or nab-paclitaxel) or chemotherapy. Single-agent pembrolizumab is an option in select cases of low positive PD-L1. Recommendations are conditional on the basis of histology, PD-L1 status, and/or the presence or absence of contraindications. Additional information is available at www.asco.org/lung-cancer-guidelines.

A Narrative Review and Expert Panel Recommendations on Dyslipidaemia Management After Acute Coronary Syndrome in Countries Outside Western Europe and North America.

Patients who have experienced an acute coronary syndrome (ACS) are at very high risk of recurrent atherosclerotic cardiovascular disease (CVD) events. Dyslipidaemia, a major risk factor for CVD, is poorly controlled post ACS in countries outside Western Europe and North America, despite the availability of effective lipid-modifying therapies (LMTs) and guidelines governing their use. Recent guideline updates recommend that low-density lipoprotein cholesterol (LDL-C), the primary target for dyslipidaemia therapy, be reduced by ≥ 50% and to < 1.4 mmol/L (55 mg/dL) in patients at very high risk of CVD, including those with ACS. The high prevalence of CVD risk factors in some regions outside Western Europe and North America confers a higher risk of CVD on patients in these countries. ACS onset is often earlier in these patients, and they may be more challenging to treat. Other barriers to effective dyslipidaemia control include low awareness of the value of intensive lipid lowering in patients with ACS, physician non-adherence to guideline recommendations, and lack of efficacy of currently used LMTs. Lack of appropriate pathways to guide follow-up of patients with ACS post discharge and poor access to intensive medications are important factors limiting dyslipidaemia therapy in many countries. Opportunities exist to improve attainment of LDL-C targets by the use of country-specific treatment algorithms to promote adherence to guideline recommendations, medical education and greater prioritisation by healthcare systems of dyslipidaemia management in very high risk patients. Video Electronic supplementary materialThe online version of this article (10.1007/s12325-020-01302-4) contains supplementary material, which is available to authorized users.

Research Drives More Accessible, Affordable Hearing Care

Approximately 15 percent of U.S. adults report some degree of hearing loss. Untreated hearing loss is a huge issue for health.1,2 It may lead to isolation, and has been associated with serious conditions such as depression,3 anxiety, low self-esteem, dementia,4 reduced mobility, and falls.5 Hearing aids and other assistive devices can significantly improve the quality of life of many people, but only about one in four adults who could benefit from hearing aids has ever used these devices, citing roadblocks such as cost, stigma, perception that they are not effective, and limited access to hearing health care.1 As the lead federal agency supporting research and initiatives to prevent, detect, and treat hearing loss, the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health, has made research on improving access to and affordability of hearing health care a priority over the past decade. In 2009, the NIDCD started a coordinated effort to tackle accessible and affordable hearing health care by forming a working group.6 The working group created a blueprint for research priorities to enhance the affordability and accessibility of hearing health care for adults with mild-to-moderate hearing loss. This launched a focused effort by the institute that has, to date, inspired a dozen funding opportunities leading to NIDCD's support of 40 research projects on the topic. In 2016, the National Academies of Sciences, Engineering, and Medicine (NASEM) published a consensus report, “Hearing Health Care for Adults: Priorities for Improving Access and Affordability.”1 The NIDCD co-sponsored this effort with other federal agencies and the Hearing Loss Association of America. The independent expert panel that conducted the study made recommendations for hearing health care reform, prioritizing the needs of adults with hearing loss. The panelists encouraged agencies, organizations, and professionals to improve access and affordability of services, develop innovative technologies, and better inform consumers about their choices for managing hearing loss. One of the panel's recommendations was for the U.S. Food and Drug Administration (FDA) to create and regulate a new category of over-the-counter (OTC) hearing devices, which could improve access to affordable hearing loss interventions for adults with mild-to-moderate hearing loss. In 2017, the president signed a law that directed the FDA to establish guidelines and quality standards for this new category of OTC hearing aids. A draft of these regulations is underway and expected to be released by August 2020.7 NIDCD-funded research informed the expert panel's recommendations, as well as the policy changes around improving adult hearing health care. For example, preliminary research showed that people with hearing loss are able to independently adjust the settings on their hearing devices in response to changing acoustic environments,8 and when given the ability to control their own hearing aid settings, they are generally more satisfied with the sound of the devices than with the audiologist's fit.9 In 2016, the first randomized, double-blind, placebo-controlled clinical trial comparing an OTC delivery model of hearing aids with traditional fitting by an audiologist found that hearing aid users in both groups reported similar benefits, supporting the viability of a direct-to-consumer service delivery model.10,11 The NIDCD also supports research that improves hearing aid technology for consumers. A small business research grant funded by the NIDCD led to the first self-fitted hearing aid approved by the FDA.12,13 As hearing researchers and clinicians, we are excited to witness the transformation of hearing health care for adults in the United States with mild-to-moderate hearing loss. We applaud the scientists who provided critical evidence leading to positive changes in public policy and in the marketplace. The NIDCD remains committed to improving the landscape of adult hearing health care, and we encourage continued research in this area to fill remaining gaps.

Addressing Cancer Treatment Shortages in Saudi Arabia: Results of a National Survey and Expert Panel Recommendations.

PURPOSECancer treatment shortages are complex and a persistent problem worldwide. Patients with cancer are most vulnerable to drug shortages, which provides opportunities to examine the extent of the challenge(s) facing Saudi Arabia and to provide recommendations toward mitigating the impact of cancer treatment shortages on patient outcomes.MATERIALS AND METHODSA qualitative methodologic approach was conducted in April 2019 using a validated questionnaire and structured panel discussion for data generation.RESULTSOverall, 55 responses were received from practicing oncology health care professionals (26 pharmacists and 29 physicians). The annual average number of treated patients with cancer per institution was 640 (adults [n = 400] and pediatric [n = 240]). All respondents (100%) reported that cancer treatment shortages constitute a current problem in their center, with an average of 5 (range, 1-9) per month. The panelists recognized 2 fundamental points. First, the definition of cancer drug shortages should be standardized and recognized at the national level. Second, the current system must be improved to ensure proper and efficient use of the current resources. On that basis, the panelists developed 9 recommendations for action.CONCLUSIONCancer drug shortage is a significant problem in all health centers in Saudi Arabia. This study presents challenges that should be addressed at the national level and essential consensus recommendations for a coordinated action developed by a panel of experts to tackle the current national problem of cancer treatment shortages. Implementing these recommendations will provide a blueprint for management of national drug shortages in general and cancer treatment shortages in particular.

Constitutional Recognition: a vital human need, not a courtesy

Without constitutional recognition for Indigenous Australians, Australia cannot adequately recognise, respect and protect Indigenous rights to self-determination, culture, sovereignty and development (Bellier and Préaud 2011). The Commonwealth has a long history of disenfranchising, silencing and othering Indigenous Australians and this vision of constitutional recognition is constrained by a number of factors, primarily the need for a referendum. Indigenous Australians are only 3.3 percent of the total Australian population (ABS Census 2016). With this in mind, in accordance with the 2012 Expert Panel recommendation and the 2017 Uluru Statement from the Heart, my opinion is that a successful and consequential referendum relies on a thorough, government-funded but Indigenous-led educational campaign to promote visibility, conversation and learning between Indigenous and non-Indigenous Australians (Newman 2019). Often excluded from writing their own narrative, with ‘substantive constitutional change and structural reform’ (1 Voice Uluru 2019) provides the circumstances vital for providing Indigenous Australians with deserved respect, sovereignty and self-determination as Taylor explains ‘due recognition is not just a courtesy we owe people. It is a vital human need’ (1992).

Practical innovation: Advanced practice nurses in cancer care.

The objectives of this study were to gather emerging practice evidence, through consultation with Advance Practice Nurses (APN), to fill the evidence gaps in the published guidelines, Effective Use of Advanced Practice Nurses in the Delivery of Adult Cancer Services in Ontario, and to provide a set of expert panel recommendations to build a research agenda to promote the collection and publication of Level 1 and 2 evidence. A three-step RAND/UCLA Appropriateness Methodology (RAM) modified Delphi process was used to solicit expert opinion on the use of APNs in adult cancer care in Ontario. Thirty-four (34) case examples of APN use were gathered. The modified Delphi process concluded with the endorsement of 30 APN role statements that were used to develop nine (9) additional recommendations regarding the use of APNs in the delivery of adult cancer care. The recommendations from this study provide direction for future research to close the current evidence gap regarding the role of APNs in cancer care delivery in Canada.

Relevance of Calcium and Vitamin D in Supporting Bone Health: An Expert Panel Recommendation in Indonesia

Osteoporosis is a bone health related condition that weakens the bones, making individuals fragile and prone to breaks. Nutrients such as calcium and vitamin D are essential for bone health. Calcium helps in building and maintaining bone mass while vitamin D aids in the absorption and utilization of calcium. According to WHO, 28.8% men and 32.3% women in Indonesia have osteoporosis, and this is inspite of the international recommendations for the daily intake of calcium and vitamin D intake. This could be attributed to low community awareness on how to prevent and care for osteoporosis. Several high-risk population groups have been identified such as those with osteopenia, undergoing rehabilitation and pregnancy/lactation periods. Therefore, in this review, an expert panel comprising of specialties of dietetics, rehabilitation medicine, orthopaedic, obstetrics & gynaecology, pharmacology, and geriatrics, convened to provide an evidence-based guidance on the prevention and care for osteoporosis. The recommendations are as follows: (i) It is important to know that calcium and vitamin D work synergistically to maintain bone health. (ii) The intake of calcium and vitamin D must start early. (iii) We should be aware that our diet and lifestyle today does not allow us to meet the recommended daily intake of calcium and vitamin D required for optimal bone health. (iv) Supplementation can compensate for the deficits in both calcium and vitamin D intake, thereby strengthening bone health. This study could guide the primary health care team, who plays a critical role in community care, to encourage early bone health awareness and care in Indonesia.

Education Program to Improve the Adherence to Guidelines for Use of Blood Transfusions in Sickle Cell Disease

Background: An expert panel convened by the NHLBI in 2014 provided guidelines and indications for blood transfusions in patients with sickle cell disease (SCD). These recommendations were to help conserve the use of blood transfusions in SCD patients in order to reduce the complications of iron overload, transmission of blood-borne pathogens and development of alloantibodies. In a retrospective review of SCD patients who received blood during inpatient admissions we identified deviations from guideline recommendations including transfusions for pain, and asymptomatic drops in hemoglobin(hgb). A standardized education program was subsequently developed and implemented to improve compliance with NHLBI recommendations for transfusion use in hospitalized patients with SCD. Methods: A standardized education program was developed based on American Society of Hematology (ASH) and NHLBI recommendations. This program included a PowerPoint presentation which was delivered to small groups of hematologists, hospitalists, emergency room and primary care physicians, nurse practioners and medical residents who regularly manage inpatient SCD admissions. A post-test of knowledge was administered and completed by 65 individuals. Additionally, the ASH pocket guide app was placed on physician's smartphones. Following completion of the program, transfusion use and indications were reassessed over the next 6 months. The hospital database was screened for admissions of patients with the diagnosis of SCD (HbSS, HbSβ0, HbSβ+, HbSC) who were billed for a blood transfusion between 8/1/2015 to 8/31/2016. This served as the baseline data. All patients were &gt;18 years of age. Each chart was reviewed individually to assess the clinical setting and reasons for transfusion. The following parameters were documented: age, sex, length of hospital stay (LOS), hgb at time of transfusion, baseline hgb, number of units transfused, documented reason for transfusion, presence of alloantibodies and ferritin level. We defined the infusion of blood as a transfused event which included single or multiple units of blood. We excluded transfusions given for acute bleeding. Following the educational program, this same methodology was used to collect a second cohort of SCD patients admitted to the hospital between 1/2/2019-6/22/2019 wherein the indications and outcomes of blood transfusion were compared with the first, pre-educational cohort. Results: In phase one (pre-education cohort), a total of 87 SCD patients were analyzed and the majority of inpatient transfusions were not indicated by national guidelines with only 34.5% of transfusion events meeting expert panel recommendations. In this phase of our study, we reviewed a second cohort of 53 SCD patients (post-education). A total of 123 units of blood were transfused. 73.5% of patients had HbSS disease, 22.6% had HbSβ0 disease and 3.77% had HbSC disease. The mean age was 32.5 years and 69.8% were female. Compared to management of patients prior to the education program, less blood was administered for the non-guideline indications of acute pain crisis (15% vs 28%) and Hgb drop &gt;2gm (9% vs 21%) (see Figure 1). The mean level of ferritin in the second cohort was 1751 and 7.54% of patients had alloantibodies, compared to the baseline group with ferritin of 2483 and alloantibodies of 17%. The average LOS in the baseline group was 9 days and in the second cohort was 8.4 days with an average LOS for uncomplicated pain or a drop of hemoglobin in the baseline group of 8.9 days and in the second cohort of 6.6 days. The most common indicated guideline reasons for transfusion in both cohorts were for symptomatic anemia and acute chest syndrome. Conclusion: This educational program was able to reduce transfusion use in SCD patients who were hospitalized for vaso-occlusive crises and asymptomatic anemia. There was a trend towards decrease in LOS for patients when they had less transfusions. Face to face education in combination with the use of the readily available ASH pocket app on smartphones are effective tools to increase adherence to national guidelines for transfusion in SCD. Disclosures Cohen: Global Therapeutics: Other: Trial for GBT440.