Patient engagement in research: lessons learned from CAPTURE ALS, a longitudinal observational ALS study.

Objective: There are compelling ethical and practical reasons for patient engagement in research (PEIR), however, evidence for best practices remains limited. We investigated PEIR as implemented in CAPTURE ALS, a longitudinal observational study, from study inception through the first 2.5 years of operations. Methods: Data were drawn from three engagement initiatives: a community-led letter-writing campaign; consultation with patient and caregiver focus groups; and a study-embedded 'participant partner advisory council' (PPAC). Data were derived retrospectively from study documentation. We used the International Association of Public Participation (IAP2) participation spectrum as a framework for investigation. Results: 2401 letters from community members to the Canadian government affirmed study objectives and advocated for funding. Feedback from focus group consultation influenced study design and supported the study's data-sharing plan. PPAC collaboration shaped all aspects of the study. Contributions included: co-creation of governance documents, input on study protocols and public-facing communication, and development of engagement webinars for study participants and feedback surveys. Effective communication practices fostered collaboration and helped avoid tokenistic engagement. CAPTURE ALS encompassed all IAP2 participation levels. Conclusions: CAPTURE ALS was shaped by meaningful engagement initiatives over the course of the study. Lessons learned included: begin early and embed PEIR within research; build relationships and foster mutual learning; be flexible, open to adaptation, and seek diversity. Primary challenges included funding for early implementation, time needed to maintain relationships, and attrition due to disease progression. All IAP2 participation levels contributed to meaningful PEIR. 'Empowerment' was demonstrated through advocacy.

Twenty-five years of novel drug approvals in rheumatology.

The field of rheumatology has experienced dozens of novel drug approvals in the past two and a half decades, but the regulatory mechanisms underpinning these decisions are not well understood. In the USA, the Food and Drug Administration (FDA) evaluates the safety and efficacy of novel drugs through the New Drug Application (NDA) process. When additional content expertise is required to evaluate scientific or technical matters, the FDA may convene Human Drug Advisory Committees. To better understand the landscape of rheumatology NDAs and the FDA use of advisory committees, we performed a review of all rheumatic disease drug applications from 1996 to 2021 that were granted approval by the FDA. Our review identified 31 NDAs, seven of which utilized an advisory committee. The indications for using advisory committees and their influence on ultimate approvals was not clear. Recommendations to improve transparency and increase public trust in FDA decisions are provided.

Establishment of a Community Advisory Board to Address Postpartum Depression Among Indigenous Women.

In this article, we describe the process of establishing an academically and tribally supported community advisory board (CAB) to guide and inform community-engaged research about postpartum depression (PPD) among Indigenous women. Using a community-based participatory research framework, we created a CAB with stakeholders from the Chickasaw Nation because they are well situated to inform a research agenda about PPD in Indigenous women. We developed CAB roles, goals, and responsibilities; established processes for compensation and recognition; identified and recruited potential members; and conducted meetings to build rapport, brainstorm, receive feedback, and invite discussion of topics related to PPD that have been deemed important by the tribe (October 2021 through June 2022). The CAB defined specific roles, goals, and responsibilities for the academic-community partnership, including assumptions, expectations, and confidentiality. We used a standing agenda item to recognize member achievements. Members of the CAB represented many tribal departments and professional disciplines. We use a CAB framework to evaluate our process and to provide recommendations for future research and policymaking.

Análise situacional da incorporação de tecnologias em hospitais públicos federais no Brasil / Situational analysis of the technology incorporation in the brazilian federal university hospitals / Análisis situacional de la incorporación de tecnologías en hospitalares públicos federales de Brasil

Objetivo: identificar o processo de incorporação de tecnologias na Empresa Brasileira de Serviços Hospitalares, com especial atenção às Comissões de Padronização de Produtos para a Saúde. Métodos: estudo transversal, descritivo, com pesquisa exploratória de campo e análise quanti-qualitativa para um diagnóstico situacional, realizado por meio de questionário eletrônico encaminhado às 36 filiais da Empresa, em todas as regiões do Brasil, de novembro de 2019 a agosto de 2020. Empregou-se a análise quantitativa por meio de estatística descritiva e a qualitativa a partir da análise de conteúdo e de Strengths, Weakness, Opportunities, Threats. Resultados: 44,4% dos hospitais possuem Núcleos de Avaliação de Tecnologias em Saúde, enquanto 91,7% deles dispõem de Comissão de Padronização de Produtos para a Saúde formalmente constituída. As variáveis observadas com maior frequência: ausência de processos documentados, fluxos não definidos e falta de infraestrutura. Conclusão: o processo de incorporação de tecnologias ocorre de maneira desigual. Os dados podem contribuir para que a Empresa Brasileira de Serviços Hospitalares (re)defina estratégias e implemente ações, no sentido de apoiar suas filiais na constituição e implantação dessas instâncias, fundamentais no processo de incorporação de tecnologias em âmbito hospitalar. (AU)

Objective: to identify the process of incorporating technologies at the Brazilian Hospital Services Company, specially to the Commission for the Standardization of Health Products. Methods: this is a cross-sectional and exploratory study, under a descriptive approach with quantitative and qualitative analysis, which sought to perform a situational diagnosis through an electronic research questionnaire sent to the 36 branches, in all regions of Brazil, from November 2019 to August 2020. Using quantitative analysis through of descriptive statistics and qualitative analysis based on content analysis and Strengths, Weakness, Opportunities, Threats. Results: 44.4% of hospitals have Health Technology Assessment Centers, while 91.7% of them have formally constituted a Commission for the Standardization of Health Products. The most frequently observed variables: absence of documented processes, undefined flows and lack of infrastructure. Conclusion: the process of incorporating technologies occurs unevenly. The data can contribute to the Brazilian Hospital Services Company defining strategies and implementing actions, in order to support its branches in the constitution and implantation of these instances, which are fundamental in the process of incorporating technologies in the hospital environment. (AU)

Objectivo: identificar el proceso de incorporación de tecnologias en la Empresa Brasileña de Servicios Hospitalarios, con especial atención a las comisiones de estandarización de productos de salud. Métodos: estudio descriptivo transversal, con investigación de campo exploratoria y análisis cuantitativo y cualitativo para um diagnóstico situacional realizado mediante um cuestionario electrónico enviado a las 36 filiales, em todas las regiones de Brasil, de noviembre de 2019 a agosto de 2020. Usado análisis cuantitativo utilizando estadística descriptiva y la análisis cualitativo basado en análisis de contenido y de la Fortalezas, Debilidades, Oportunidades, Amenazas. Resultados: el 44,4% de los hospitales cuenta con Centros de Evaluación de Tecnologías Sanitarias, mientras que el 91,7% de ellos tiene una Comisión de Estandarización de Productos de Salud formalmente constituída. Las variables observadas con mayor frecuencia: ausencia de procesos documentados, flujos indefinidos y falta de infraestructura. Conclusión: el proceso de incorporación de tecnologías ocurre de manera desigual. Los datos pueden contribuir a que la Empresa Brasileña de Servicios Hospitalarios reinicia estrategias e implemente acciones, a fin de apoyar a sus filiales en la constitución e implantación de estas instancias, fundamentales en el proceso de incorporación de tecnologías en el ámbito hospitalario. (AU)

A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA's Benefit-Risk Framework.

The US FDA Center for Biologics Evaluation and Research (CBER) is responsible for the regulation of biologically derived products. FDA has established Advisory Committees (AC) as vehicles to seek external expert advice on scientific and technical matters related to the development and evaluation of products regulated by the agency. We aimed to identify and evaluate common topics discussed in CBER AC meetings during the regulatory decision-making process for biological products and medical devices. We analyzed the content of 119 CBER-led AC meetings between 2009 and 2021 listed on the FDA AC webpage. We reviewed publicly available meeting materials such as briefing documents, summaries, and transcripts. Using a structured review codebook based on FDA benefit-risk guidance, we identified important considerations within the benefit-risk dimensions discussed at the AC meetings: therapeutic context, benefit, risk and risk management, and benefit-risk trade-off, where evidence and uncertainty are critical parts of the FDA benefit-risk framework. Based on a detailed review of 24 topics discussed in 23 selected AC meetings conducted between 2016 and 2021, the two most frequently discussed considerations were "Uncertainty about assessment of the safety profile" and "Uncertainty about assessment of the benefit based on clinical trial data" (16/24 times each) as defined in our codebook. Most of the reviewed meetings discussed Investigational New Drug or Biologics License Applications of products. This review could help sponsors better plan and design studies by contextualizing how the benefit-risk dimensions were embedded in the AC discussions and the considerations that went into the final AC recommendations.

Addressing the challenges of conducting community-engaged research during COVID-19: Rapid development and evaluation of a COVID-19 Research Patient and Community Advisory Board (PCAB).

Introduction: We created a COVID-19 Research Patient and Community Advisory Board (PCAB) to provide patient and community input into clinical and translational research studies. The purpose of this article is to describe the PCAB creation, implementation, and evaluation. Methods: We identified PCAB members who had participated in previous stakeholder engaged activities at our institution and invited their participation. We created a systematic consultation process where researchers could submit plain language research summaries and questions for the PCAB. A facilitated 1-hour virtual consultation was then held where PCAB members provided feedback. We assessed satisfaction of PCAB members and researchers who received consultations using surveys. We also reviewed video recordings of PCAB consultations and reflections from team meetings to identify key lessons learned. Results: Twenty-seven PCAB members took part in 23 consultation sessions. Twenty-two completed an evaluation survey (81% response rate). Most members agreed or strongly agreed their opinions were valued (86%), it was a productive use of time (86%) and were satisfied (86%). Nineteen researchers completed an evaluation survey (83% response rate). Researchers reported positive experiences of working with the PCAB. Additional insights include limited funding in COVID-19 research for equitable community engagement, deficiencies in researcher communication skills, and a lack of cultural humility incorporated into study activities. Conclusions: PCAB members provided recommendations that maximized the patient-centeredness and health equity focus of COVID-19 research. The detailed description of the process of developing, implementing, and evaluating our PCAB can be used as a template for others wishing to replicate this engagement model.

Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved.

BACKGROUND: The Medical Services Advisory Committee (MSAC) is responsible for the assessment of medical imaging tests proposed for public funding. A number of factors related to the clinical or cost effectiveness of an imaging service may impact on the funding decision. OBJECTIVE: To determine what evidentiary and economic factors impact most on MSAC recommendations for the funding of imaging tests. METHODS: Information was extracted on health technology assessments (HTAs) of medical imaging tests published on the MSAC website, with a funding decision between 2006 to July 2021. Imaging tests with diagnostic, staging or screening indications were eligible. Data were extracted in test-indication pairs and included data on evidence quality, quantity, consistency of findings, cost-effectiveness and financial impact. Multivariate logistic regression analysis was performed with adjustments for clustered data. RESULTS: Overall, 42 imaging test applications to MSAC were included, representing 91 clinical indications. Most were diagnostic tests. The most common evidentiary concerns reported by MSAC were limited evidence (36%), low quality evidence (26%), and applicability of the data (22%). The reference standard for diagnostic accuracy was imperfect or not appropriate in 25% of the indications. In regression analyses, uncertainty about cost-effectiveness of an imaging service predicted most negative funding decisions. CONCLUSIONS: The single biggest contributor to a negative funding decision by MSAC was uncertainty about the cost-effectiveness of the imaging service. This was likely driven by uncertainty regarding the impact on patient health. HTAs that are able to demonstrate the clinical utility of a new imaging service are more likely to publicly funded.

Invisibilidad de género en la gestión de la COVID-19: ¿quién toma las decisiones políticas durante la pandemia? / Gender invisibility in the COVID-19 management: who are the policy decision-makers during the pandemic?

Objetivo: Analizar la composición por sexo de los comités de personas expertas creados para la gestión y la toma de decisiones políticas durante la pandemia de COVID-19 en España. Método: Se realizó una revisión por pares para identificar los comités destinados a la gestión de la COVID-19 en las comunidades autónomas y de ámbito estatal. Se recopilaron el nombre, el número de integrantes, el sexo y las fuentes de información, y se calculó el porcentaje de mujeres. Resultados: En las comunidades autónomas se identificó la composición de 11 comités específicos, con una media de representación de las mujeres del 39,2%, siendo del 42,9% en todo el Estado. El 75% del conjunto de los comités representó a las mujeres por debajo del umbral de paridad. Conclusiones: Existe una significativa infrarrepresentación de las mujeres en los comités para la gestión de la COVID-19, lo que puede limitar la necesaria mirada feminista para la recuperación de la crisis. (AU)

Objective: To analyse the gender composition of the advisory boards created for the management and policy decision-making during the COVID-19 pandemic in Spain. Method: A peer review was carried out to identify the advisory boards involved in the management of COVID-19 in the autonomous regions and in Spain. Name, number of members, sex and sources of information were collected, and the percentage of women was calculated. Results: At the regional level, the composition of eleven advisory boards was identified, with a mean representation of women of 39.2%; 42.9% at the national level. 75% of all boards represented women below the parity threshold. Conclusions: There is a significant under-representation of women in the advisory boards for the COVID-19 management, which may limit a necessary feminist perspective for the crisis recovery. (AU)

Analysis of consumer comments into PBAC decision-making (2014-9).

OBJECTIVES: The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent expert body that recommends new technologies for listing on the Pharmaceutical Benefits Scheme. Its decision-making process is evidence-based and considers a technology's clinical effectiveness, safety, and cost-effectiveness compared with other technologies. Since 2014, the PBAC has formally taken into account input from those impacted by the technology via an online consumer comments portal and has also reported on received comments in the Public Summary Documents (PSDs). Comments are welcomed from those whose health the technology is trying to improve, as well as carers, clinicians, and organizations. Our objective was to analyze and review consumer comments in the PBAC's decision-making process. METHODS: We extracted information about consumer comments from the PBAC PSDs from 2014-9. We conducted simple descriptive analyses. RESULTS: Our findings reveal that two thirds of all submissions did not receive a single consumer comment. Of the remaining third, eight submissions (less than 1 percent) had a substantial number of consumer comments (>500). For these technologies, multiple submissions were required before a recommendation was issued. Submissions spanned multiple therapeutic areas, the therapeutic areas with the most consumer comments were genetic disease, pediatrics, and oncology. CONCLUSIONS: In the light of our review, we have identified limitations to the current consumer comments process, and after an examination of the processes of other comparable health technology assessment agencies, we have identified a number of improvements that could be made to the PBAC's process to increase consumer engagement.

[Gender invisibility in the COVID-19 management: who are the policy decision-makers during the pandemic?] / Invisibilidad de género en la gestión de la COVID-19: ¿quién toma las decisiones políticas durante la pandemia?

OBJECTIVE: To analyse the gender composition of the advisory boards created for the management and policy decision-making during the COVID-19 pandemic in Spain. METHOD: A peer review was carried out to identify the advisory boards involved in the management of COVID-19 in the autonomous regions and in Spain. Name, number of members, sex and sources of information were collected, and the percentage of women was calculated. RESULTS: At the regional level, the composition of eleven advisory boards was identified, with a mean representation of women of 39.2%; 42.9% at the national level. 75% of all boards represented women below the parity threshold. CONCLUSIONS: There is a significant under-representation of women in the advisory boards for the COVID-19 management, which may limit a necessary feminist perspective for the crisis recovery.

Cost-effectiveness of prophylactic hysterectomy in first-degree female relatives with Lynch syndrome of patients diagnosed with colorectal cancer in the United States: a microsimulation study.

BACKGROUND: To evaluate the cost-effectiveness of prophylactic hysterectomy (PH) in women with Lynch syndrome (LS). METHODS: We developed a microsimulation model incorporating the natural history for the development of hyperplasia with and without atypia into endometrial cancer (EC) based on the MISCAN-framework. We simulated women identified as first-degree relatives (FDR) with LS of colorectal cancer patients after universal testing for LS. We estimated costs and benefits of offering this cohort PH, accounting for reduced quality of life after PH and for having EC. Three minimum ages (30/35/40) and three maximum ages (70/75/80) were compared to no PH. RESULTS: In the absence of PH, the estimated number of EC cases was 300 per 1,000 women with LS. Total associated costs for treatment of EC were $5.9 million. Offering PH to FDRs aged 40-80 years was considered optimal. This strategy reduced the number of endometrial cancer cases to 5.4 (-98%), resulting in 516 quality-adjusted life years (QALY) gained and increasing the costs (treatment of endometrial cancer and PH) to $15.0 million (+154%) per 1,000 women. PH from earlier ages was more costly and resulted in fewer QALYs, although this finding was sensitive to disutility for PH. CONCLUSIONS: Offering PH to 40- to 80-year-old women with LS is expected to add 0.5 QALY per person at acceptable costs. Women may decide to have PH at a younger age, depending on their individual disutility for PH and premature menopause.

Management of bias and conflict of interest among occupational exposure limit expert groups.

Our aim was to evaluate policies and procedures for management of conflict of interest (CoI) and other sources of bias, implemented in Occupational Exposure Limit (OEL) expert groups. First, we compiled procedural criteria applicable to OEL-setting, based on literature on CoI and systematic reviews. Second, we identified 58 global OEL-sources and sought the underlying expert groups and operating procedures. We identified eleven active groups, of which five have documented CoI policies. In all five, CoI management is based on declarations of interests (DoIs) and removal of experts from decisions in which they have an interest. Notable differences include publication of DoIs (three of five groups), limitation of DoI to current interests (two groups), quantitative limits for financial interests (none specified to ≥€10,000 per interest), control procedures for undisclosed CoI (one group), and procedures in case of discovery of undisclosed CoI (three groups). Methods to evaluate study quality are described by three groups, while reproducible and comprehensive strategies to identify and select data receive less attention. We conclude that procedures to manage CoI and bias are not broadly implemented, or at least not openly and transparently communicated. This lack of visible procedures is remarkable, considering OEL's impact on health and economy.

The Essential Role of Nurse Practitioners and Midwives on Maternal Mortality Review Committees.

Rates of maternal morbidity and mortality in the United States continue to rise, and three out of every five U.S. pregnancy-related deaths are preventable. A multiprong approach to addressing this public health crisis is needed, including the development and activation of maternal mortality review committees, which can systematically assess maternal deaths and recommend systemic-based interventions and policy changes to reverse this trend. Women's health nurse practitioners and midwives are uniquely positioned to provide insight to maternal mortality review committees, given their holistic approach and person-centered philosophy of care. The Washington State Department of Health developed a robust committee that uses women's health nurse practitioners and midwives in its review and may serve as a model for other state organizations.

Uncertainty tolerance among experts involved in drug reimbursement recommendations: Qualitative evidence from HTA committees in Canada and Poland.

OBJECTIVES: Drug reimbursement decisions often rely on health technology assessment (HTA). Increasingly, new drugs have limited clinical evidence and uncertain clinical benefit. Our goal was to describe how members of drug advisory committees and other stakeholders conceptualize and tolerate uncertainty and how they rationalize uncertainty tolerance. METHODS: Our triangulated parallel design applied two qualitative methods. We interviewed 31 members of drug advisory committees in Canada and Poland about their information needs and included hypothetical scenarios with uncertain clinical benefits. Respondents speculated about their likely reimbursement recommendation. We analyzed written recommendations of the pan Canadian Oncology Drug Review for drugs with uncertain benefit and compared initial recommendations to the responses from patient and clinician groups. RESULTS: Uncertainty tolerance varied among committee members and across jurisdictions. In the scenario analysis, 7 Canadian and 11 Polish respondents leaned against recommending a hypothetical drug with uncertain clinical benefit, whereas 5 Canadian and 5 Polish respondents leaned in favour. Those against rationalized that uncertainty increases potential harm; those in favour rationalized that patients often have no alternatives. The document analysis revealed that patients had higher uncertainty tolerance in general. CONCLUSIONS: Uncertainty tolerance varies among committee members and other stakeholders depending on their backgrounds and on the decision contexts. We argue that policy guidance around uncertainty management could improve the transparency and consistency of recommendations.

Nationwide Circumcision Trends: 2003 to 2016.

PURPOSE: Among some populations access to neonatal circumcision has become increasingly limited despite evidence of its benefits. This study examines national neonatal circumcision trends before and after the 2012 American Academy of Pediatrics recommendation for neonatal circumcision reimbursement. MATERIALS AND METHODS: A retrospective cohort study of boys aged 28 days or less was conducted using data from the Kids' Inpatient Database (2003 to 2016). Boys who underwent neonatal circumcision prior to discharge were compared to boys who did not. Boys with coagulopathies, penile anomalies or a history of prematurity were excluded. RESULTS: An estimated 8,038,289 boys comprised the final cohort. Boys were primarily White (53.7%), privately insured (49.1%) and cared for at large (60.8%) teaching (49.4%) hospitals in metropolitan areas (84.1%). While 55.0% underwent circumcision prior to discharge, neonatal circumcision rates decreased significantly over time (p <0.0001). Black (68.0%) or White (66.0%) boys, boys in the highest income quartile (60.7%) and Midwestern boys (75.0%) were most likely to be circumcised. Neonatal circumcision was significantly more common among privately (64.9%) than publicly (44.6%) insured boys after controlling for demographics, region, hospital characteristics and year (p <0.0001). The odds of circumcision over time were not significantly different in the years before vs after 2012 (p=0.28). CONCLUSIONS: Among approximately 8 million boys sampled over a 13-year period 55.0% underwent neonatal circumcision. The rate of neonatal circumcision varied widely by region, race and socioeconomic status. The finding that boys with public insurance have lower circumcision rates in all years may be related to lack of circumcision access for boys with public insurance.

Influenza vaccination and the evolution of evidence-based recommendations for older adults: A Canadian perspective.

Older adults are at high risk from influenza and its complications, and are therefore an important population for prevention efforts. In Canada, public health efforts targeting influenza are multi-pronged and include vaccination programs as well as surveillance which informs the national surveillance reporting platform FluWatch run by the Public Health Agency of Canada. Recommendations regarding use of vaccines are made nationally by the National Advisory Committee on Immunization (NACI) and by the Comité sur l'immunisation du Québec in Quebec, while vaccination programs are planned and delivered at the provincial/territorial level as opposed to as a harmonized national immunization program. NACI performs rigorous targeted literature reviews to inform their statements, and recommendations also vary by whether they apply on Individual (pertaining to decisions for individual patients) vs. Programmatic (informing policy decisions for implementation of publicly funded vaccination programs) levels. This unique context results in inter-provincial variation in vaccine schedules and funded vaccine products. In this paper, the importance of influenza vaccination for older adults is discussed; to provide insights from the Canadian context, the evolution of NACI evidence reviews and recommendations on influenza vaccination is presented.

Disagreements Between FDA and its Oncologic Drugs Advisory Committee (ODAC).

Cases of discordance between the US Food and Drug Administration (FDA) and its advisory committees are uncommon. Due to the importance of oncology therapies, we sought to identify and discuss instances of disagreement between the regulatory decision made by FDA, and the recommendation made by its Oncologic Drugs Advisory Committee (ODAC) via committee vote. Public databases (Oncologic Drugs Advisory Committee Meeting Materials, Drugs@FDA) as well as publicly available documents from ODAC meetings were reviewed to discern cases of disagreement between the two bodies. This review of public data yielded six (6) instances in which FDA's ultimate regulatory decision went against the recommendation of the ODAC. The six cases are briefly discussed and key drivers for or against an approval decision are outlined. In cases where FDA's decision was less conservative than that of the ODAC, the value of therapies with novel mechanisms of action which provide new options for patients, as well as regulatory precedent were observed as key drivers for regulatory decision-making. In cases where FDA took a more conservative approach than the ODAC, the importance of appropriate clinical trial design, clinically relevant trial endpoints, and the integrity of the data collected were stressed as driving the ultimate regulatory decision.

Reliability and Validity of an Adapted Questionnaire Assessing Occupational Exposures to Hazardous Chemicals among Health Care Workers in Bhutan.

BACKGROUND: Collection of reliable and valid occupational history data is of utmost importance to assess work-related exposures and their health effects. Few standardized questionnaires are available for the collection of occupational history data in low-and-middle income countries. OBJECTIVE: To adapt and test a validated questionnaire developed in the United States by the National Institute of Safety and Health, in order to assess occupational chemical exposures among health care workers in Bhutan. METHODS: The questionnaire was first adapted to suit the Bhutanese context with the advice of an expert review committee. 30 health care workers then completed the questionnaire at baseline and 10-14 days later. Test-retest reliability was assessed by calculating Cohen's κ and percentage agreement. RESULTS: The questionnaire had high test-retest reliability. Cohen's κ ranged from 0.61 to 1.00, and percentage agreement ranged from 86.7% to 100%. Further adaptations included omitting questions on chemicals not available in Bhutan. CONCLUSION: The adapted questionnaire is appropriate for assessing occupational chemical exposures among health care workers in Bhutan.

Development and Retrospective Review of a Pediatric Ethics Consultation Service at a Large Academic Center.

The primary objective was to review pediatric ethics consultations (PECs) at a large academic health center over a nine year period, assessing demographics, ethical issues, and consultant intervention. The secondary objective was to describe the evolution of PECs at our institution. This was a retrospective review of Consultation Summary Sheets compiled for PECs at our Academic Health Center between January 2008 and April 2017. There were 165 PECs reviewed during the study period. Most consult requests came from the inpatient setting, with the Pediatric and Neonatal Intensive Care Units being the highest utilizers. Consultation utilization increased over the study period. The most common patient age was less than one year. Physicians were most likely to request consultation. Patient Best Interest, Withholding/Withdrawing of Life Sustaining Therapy, and Provider Moral Distress were ethical issues most commonly identified by the consultants. Making recommendations was the most common consultant intervention. The ethics consultation process evolved over time from informal provider discussions, to a hospital infant care review committee, to a pediatric only consultation service, to a combined adult/pediatric consultation service, with variable levels of salary support for consultants. Ethics consultation requests are growing at our institution. Similarities in identified ethical issues exist between our findings and existing literature, however meaningful comparisons remains elusive secondary to variability in approaches to investigation and reporting. A combined paid/volunteer/trainee ethics consultation service model appears sustainable and real time ethics consultation is feasible using this approach.