Scenario Analysis: This scenario is professionally challenging because it requires balancing the imperative to advance perioperative medicine through innovation and data collection with the stringent ethical and regulatory obligations to protect patient privacy and ensure informed consent. The rapid pace of translational research can sometimes outstrip clear guidance, creating a grey area where practitioners must exercise significant judgment. Correct Approach Analysis: The best professional practice involves proactively engaging with institutional review boards (IRBs) or equivalent ethics committees and seeking explicit patient consent for the use of their de-identified data in translational research and registry development. This approach ensures that all research activities adhere to established ethical principles, such as respect for autonomy and beneficence, and comply with relevant data protection regulations. By obtaining informed consent, patients are made aware of how their data might be used for future research, allowing them to make an autonomous decision. De-identification further safeguards privacy. This aligns with the core tenets of research ethics and regulatory frameworks designed to protect human subjects. Incorrect Approaches Analysis: One incorrect approach involves proceeding with data collection for a registry and subsequent translational research without prior IRB approval or explicit patient consent, relying solely on the assumption that de-identification is sufficient. This fails to meet the fundamental ethical requirement of respecting patient autonomy and obtaining informed consent for research participation, even if the data is de-identified. It also bypasses the crucial oversight function of an IRB, which is mandated to review research involving human subjects to ensure ethical conduct and regulatory compliance. Another incorrect approach is to only seek IRB approval for the registry itself but not for the specific translational research projects that will subsequently utilize the registry data. While IRB approval for the registry is a necessary first step, it does not automatically grant permission for all future research applications of that data. Each distinct research project, especially those involving novel translational aims, requires its own ethical review to assess its specific risks, benefits, and consent procedures. A third incorrect approach is to assume that existing, broad consent forms for routine clinical care implicitly cover the use of patient data for translational research and registry development. Clinical care consent typically focuses on treatment and immediate care needs, not on the secondary use of data for research purposes. Without specific language addressing research data use and the possibility of contributing to registries, such consent is generally considered insufficient for research ethics and regulatory compliance. Professional Reasoning: Professionals should adopt a proactive and transparent approach. This involves understanding the ethical and regulatory landscape governing research with human data, including informed consent requirements and the role of ethics committees. When initiating projects involving translational research and registries, the first step should always be to consult with the relevant ethics review board. Simultaneously, developing clear, patient-friendly consent processes that explicitly outline the potential use of de-identified data for research and registry contributions is paramount. This systematic approach ensures that innovation in perioperative medicine is pursued responsibly and ethically, fostering trust between patients, researchers, and institutions.

Scenario Analysis: This scenario presents a professional challenge because it requires balancing the need for efficient patient care with the absolute imperative of adhering to established governance frameworks and competency standards. The perioperative team must ensure that all members possess the requisite skills and knowledge, as outlined by the Frontline Global Perioperative Medicine Competency Assessment, to deliver safe and effective care. Failure to do so can lead to patient harm, regulatory sanctions, and damage to professional reputation. The challenge lies in identifying and addressing potential gaps in knowledge or practice without compromising patient safety or team morale. Correct Approach Analysis: The best professional practice involves a proactive and systematic approach to identifying and addressing competency gaps. This begins with a thorough review of the governance framework and the specific requirements of the Frontline Global Perioperative Medicine Competency Assessment. When a potential gap is identified, the immediate and most appropriate action is to implement a targeted educational intervention, such as a focused training session or a mentorship program, designed to address the specific deficit. This approach ensures that the individual’s competency is enhanced in a structured and documented manner, directly aligning with the assessment’s objectives and upholding the principles of continuous professional development and patient safety mandated by best practice guidelines in perioperative medicine. This aligns with the ethical obligation to provide care only within the scope of one’s competence and the regulatory expectation for ongoing professional development. Incorrect Approaches Analysis: One incorrect approach involves delaying any action until a formal performance review or an adverse event occurs. This reactive stance is professionally unacceptable as it prioritizes expediency over patient safety and fails to uphold the proactive governance requirements. It demonstrates a disregard for the established competency framework and creates an unacceptable risk of patient harm. Another inappropriate approach is to assume that the individual’s existing experience is sufficient without verifying it against the specific competencies outlined in the assessment. This assumption bypasses the critical step of objective evaluation and can lead to the deployment of staff who are not adequately prepared for their roles, violating the principle of competence-based practice. Finally, immediately reassigning the individual to less complex tasks without providing an opportunity for skill development or remediation is also professionally deficient. While it might mitigate immediate risk, it fails to address the underlying competency gap and hinders the individual’s professional growth, potentially leading to future issues and not fulfilling the team’s responsibility for developing its members. Professional Reasoning: Professionals should adopt a framework that prioritizes proactive identification and remediation of competency gaps. This involves: 1) Understanding and internalizing the relevant governance frameworks and competency standards. 2) Regularly assessing individual and team performance against these standards, looking for deviations or areas of potential weakness. 3) When a gap is identified, immediately initiating a structured and documented plan for remediation, which may include education, training, or mentorship. 4) Continuously monitoring progress and ensuring that competency is re-established before the individual undertakes tasks where the deficit was identified. This systematic process ensures accountability, promotes continuous improvement, and most importantly, safeguards patient well-being.

Scenario Analysis: This scenario is professionally challenging because it requires balancing the immediate need for diagnostic information with the ethical and regulatory obligations to ensure patient safety, informed consent, and appropriate resource utilization. The perioperative physician must navigate potential biases, the limitations of imaging modalities, and the need for clear communication with the surgical team and the patient. Failure to adhere to established protocols can lead to diagnostic errors, unnecessary patient risk, and regulatory non-compliance. Correct Approach Analysis: The best professional practice involves a systematic, evidence-based approach to imaging selection and interpretation. This begins with a thorough clinical assessment to formulate a differential diagnosis. Based on this, the physician selects the most appropriate imaging modality that offers the highest diagnostic yield with the lowest risk to the patient, considering factors like radiation exposure, contrast agent risks, and availability. Interpretation must be performed by a qualified professional, with findings clearly communicated to the surgical team, including any limitations or uncertainties. This approach aligns with the principles of patient-centered care, evidence-based medicine, and the regulatory requirement for competent medical practice. It ensures that diagnostic decisions are not made in isolation but are integrated into the overall perioperative management plan, minimizing unnecessary interventions and optimizing patient outcomes. Incorrect Approaches Analysis: One incorrect approach involves defaulting to the most advanced or readily available imaging modality without a clear clinical indication or consideration of alternative, less invasive options. This can lead to unnecessary radiation exposure, increased costs, and potential for incidental findings that may cause patient anxiety or lead to further unnecessary investigations. It fails to adhere to the principle of judicious resource utilization and may not be the most effective diagnostic strategy for the specific clinical question. Another incorrect approach is to proceed with imaging based solely on a surgeon’s request without independent clinical assessment or consideration of the diagnostic question being asked. This bypasses the physician’s critical role in diagnostic reasoning and can result in imaging that is not tailored to the patient’s specific presentation, potentially yielding irrelevant information or missing crucial diagnoses. It undermines the collaborative nature of perioperative care and the physician’s responsibility for diagnostic accuracy. A further incorrect approach is to interpret imaging findings in isolation, without considering the patient’s clinical context or communicating potential ambiguities to the surgical team. This can lead to misinterpretations, delayed or incorrect treatment decisions, and a failure to manage patient expectations. It neglects the importance of a multidisciplinary approach to patient care and the ethical imperative of clear and comprehensive communication. Professional Reasoning: Professionals should employ a structured diagnostic reasoning process. This involves gathering comprehensive clinical information, developing a prioritized differential diagnosis, and then selecting the most appropriate diagnostic test based on its diagnostic accuracy, safety profile, cost-effectiveness, and the specific clinical question. Interpretation of results must be contextualized within the patient’s clinical picture, and findings should be communicated clearly and promptly to the relevant members of the healthcare team, including any limitations or areas of uncertainty. This systematic approach ensures that diagnostic decisions are evidence-based, patient-centered, and ethically sound.

This scenario is professionally challenging because it requires balancing immediate patient needs with long-term health outcomes and resource allocation, all within a framework of evidence-based practice and ethical considerations. The perioperative physician must navigate patient complexity, potential for acute exacerbations of chronic conditions, and the need for proactive preventive measures to optimize surgical outcomes and reduce readmissions. Careful judgment is required to prioritize interventions that are both effective and appropriate for the individual patient’s circumstances. The best approach involves a comprehensive pre-operative assessment that integrates evidence-based guidelines for managing acute and chronic conditions with a proactive strategy for preventive care. This includes a thorough review of the patient’s medical history, current medications, and functional status. It necessitates identifying and addressing any acute issues that could compromise surgical safety or recovery, optimizing chronic disease control (e.g., diabetes, hypertension, respiratory conditions) using current best practices, and implementing preventive measures such as vaccinations, smoking cessation counseling, and nutritional optimization. This approach aligns with the principles of patient-centered care, aiming to minimize perioperative morbidity and mortality by ensuring the patient is in the best possible health for surgery and has a smoother recovery. It also reflects a commitment to continuous quality improvement by utilizing evidence to guide clinical decisions and improve patient outcomes. An approach that solely focuses on addressing acute perioperative risks without adequately managing underlying chronic conditions is professionally unacceptable. This failure to optimize chronic disease management can lead to poor surgical outcomes, increased complication rates, and prolonged hospital stays, as the patient’s body is less resilient to surgical stress. Similarly, an approach that neglects preventive care, such as ensuring appropriate vaccinations or addressing modifiable risk factors like smoking, fails to uphold the physician’s ethical duty to promote patient well-being and reduce future health burdens. Focusing only on the immediate surgical procedure without considering the broader health context of the patient represents a fragmented and suboptimal approach to perioperative care. Professionals should employ a systematic decision-making process that begins with a thorough patient assessment, followed by the identification of all relevant acute, chronic, and preventive care needs. This should be followed by an evidence-based evaluation of available management strategies, considering patient preferences and goals. The physician must then prioritize interventions based on their potential impact on surgical outcomes, patient safety, and long-term health, ensuring that all aspects of care are integrated into a cohesive perioperative plan.

Scenario Analysis: This scenario presents a professional challenge related to the integrity and fairness of a competency assessment program. Ensuring that the blueprint accurately reflects the assessment’s learning objectives and that scoring is applied consistently and transparently is crucial for maintaining the credibility of the “Frontline Global Perioperative Medicine Competency Assessment.” Discrepancies in blueprint weighting or scoring can lead to unfair evaluations, potentially impacting patient care if individuals are deemed competent without adequate knowledge or skills. The retake policy also needs to be clearly defined and equitably applied to avoid discouraging candidates or creating an unnecessarily burdensome process. Correct Approach Analysis: The best professional practice involves a thorough and documented review of the assessment blueprint against the stated learning objectives, followed by a transparent communication of any adjustments and the rationale behind them. This approach ensures alignment between what is taught and what is assessed, fostering fairness and validity. The scoring methodology should be clearly defined, consistently applied, and subject to periodic audits to maintain accuracy and impartiality. Retake policies should be clearly articulated, providing candidates with reasonable opportunities to demonstrate competency while upholding assessment standards. This aligns with principles of good governance in professional development and assessment, emphasizing transparency, fairness, and continuous improvement. Incorrect Approaches Analysis: One incorrect approach involves making arbitrary adjustments to the blueprint weighting without a clear rationale or communication to stakeholders. This undermines the validity of the assessment, as the weighting may no longer reflect the importance of specific learning objectives. It also creates an environment of distrust and confusion among candidates. Another incorrect approach is to apply scoring inconsistently, allowing for subjective interpretation or deviation from established rubrics. This compromises the reliability and fairness of the assessment, potentially leading to inaccurate judgments of competency and violating ethical standards of impartial evaluation. A third incorrect approach is to implement a retake policy that is overly restrictive or punitive, without providing adequate support or clear pathways for improvement. This can discourage candidates from pursuing certification and may not effectively identify areas for development, ultimately failing to serve the purpose of a competency assessment. Professional Reasoning: Professionals should approach assessment governance with a commitment to validity, reliability, fairness, and transparency. This involves establishing clear processes for blueprint development and review, consistent scoring mechanisms, and well-defined retake policies. Regular audits and feedback loops are essential for continuous improvement. When discrepancies arise, a systematic and documented approach to resolution, prioritizing stakeholder communication and adherence to established standards, is paramount.

Scenario Analysis: This scenario presents a professional challenge related to ensuring candidates for the Frontline Global Perioperative Medicine Competency Assessment are adequately prepared. The challenge lies in balancing the need for comprehensive preparation with the practical constraints of time and resources, while adhering to the principles of fair assessment and professional development. Misjudging the recommended preparation resources or timeline can lead to either under-prepared candidates who may fail the assessment, or over-burdened candidates who experience undue stress and potentially disengagement. Careful judgment is required to provide guidance that is both effective and realistic. Correct Approach Analysis: The best professional practice involves recommending a structured approach that integrates a variety of evidence-based resources and suggests a phased timeline. This approach typically includes reviewing core perioperative medicine textbooks, engaging with relevant professional guidelines and consensus statements, participating in simulated case studies or workshops, and dedicating specific blocks of time for focused study and revision. The justification for this approach is rooted in the principles of adult learning, which emphasize active engagement, diverse learning modalities, and spaced repetition for optimal knowledge retention and skill development. Furthermore, it aligns with the ethical obligation to ensure candidates are assessed fairly and have a reasonable opportunity to demonstrate competence, by providing them with the tools and time necessary to achieve it. This comprehensive preparation strategy directly supports the assessment’s goal of evaluating frontline perioperative medicine competency. Incorrect Approaches Analysis: Recommending solely relying on a single, introductory-level textbook without supplementary materials is professionally unacceptable. This approach fails to acknowledge the breadth and depth of knowledge required for frontline perioperative medicine, potentially leading to a superficial understanding and inadequate preparation. It also neglects the importance of current professional guidelines and evidence-based practice, which are crucial for safe and effective patient care. Suggesting an extremely condensed, last-minute cramming schedule without prior engagement with the material is also professionally unsound. This method is antithetical to effective learning and retention, increasing the likelihood of candidate anxiety and poor performance. It disregards the cognitive science behind learning, which advocates for consistent, spaced study over intensive, short-term bursts. Such an approach does not provide a realistic or ethical pathway to demonstrating genuine competency. Advocating for candidates to only review past examination papers without understanding the underlying principles is a flawed strategy. While familiarizing oneself with question formats can be beneficial, it does not guarantee comprehension of the subject matter. This approach risks candidates memorizing answers without grasping the ‘why’ behind them, which is essential for applying knowledge in real-world clinical scenarios. It bypasses the development of critical thinking and problem-solving skills vital for perioperative medicine. Professional Reasoning: Professionals should adopt a decision-making process that prioritizes evidence-based guidance and candidate well-being. This involves: 1) Understanding the specific competencies being assessed and the knowledge domains they encompass. 2) Researching and identifying authoritative resources and learning methodologies recognized within the field of perioperative medicine. 3) Considering the typical learning curves and time commitments required for mastering complex medical subjects. 4) Consulting with experienced practitioners and educators to refine recommendations. 5) Communicating clear, actionable, and realistic preparation advice to candidates, emphasizing a balanced approach to study and resource utilization.

Scenario Analysis: This scenario presents a professional challenge due to the inherent tension between patient safety, resource allocation, and the need for timely, evidence-based perioperative care. The introduction of a new, potentially beneficial medication requires a structured yet efficient implementation process. The challenge lies in balancing the urgency of providing optimal care with the necessity of ensuring all staff are adequately trained, potential risks are mitigated, and the medication is integrated seamlessly into existing protocols without compromising patient outcomes or regulatory compliance. Careful judgment is required to navigate these competing demands. Correct Approach Analysis: The best professional practice involves a phased implementation strategy that prioritizes comprehensive staff education and the development of clear, standardized protocols before widespread clinical use. This approach ensures that all perioperative team members understand the medication’s indications, contraindications, dosage, administration, potential side effects, and emergency management procedures. It also allows for the establishment of robust monitoring systems to track patient responses and identify any adverse events early. This aligns with ethical principles of beneficence and non-maleficence, as it seeks to maximize patient benefit while minimizing harm through thorough preparation and risk management. Regulatory frameworks, such as those governing medication safety and professional standards of care, implicitly support such a diligent and systematic approach to introducing new therapeutic agents. Incorrect Approaches Analysis: One incorrect approach involves immediate, widespread adoption of the new medication without adequate staff training or protocol development. This poses a significant risk of medication errors, adverse drug reactions due to improper administration or dosing, and delayed or inappropriate patient management. It fails to uphold the ethical duty of care and directly contravenes regulatory expectations for safe medication practices. Another unacceptable approach is to delay implementation indefinitely due to minor concerns or a lack of immediate perceived urgency, without a structured plan to address those concerns. This can lead to patients not receiving potentially beneficial treatments, which may be considered a failure of the duty to provide optimal care and could be viewed as a breach of professional standards if evidence supports the medication’s efficacy and safety. A further incorrect approach is to rely solely on individual practitioners’ self-directed learning and informal knowledge sharing. This creates a high risk of inconsistent practice, knowledge gaps, and a lack of standardized care. It does not provide the necessary oversight or assurance that all team members possess the required competencies, potentially leading to patient harm and failing to meet regulatory requirements for institutional responsibility in staff education and competency. Professional Reasoning: Professionals should adopt a systematic, evidence-based approach to implementing new treatments. This involves a thorough literature review, consultation with relevant experts, development of clear institutional policies and procedures, comprehensive staff education and competency assessment, and a robust monitoring and evaluation plan. Decision-making should be guided by patient safety, ethical principles, and adherence to all applicable regulatory requirements, ensuring that innovation is pursued responsibly and with due diligence.

Scenario Analysis: This scenario is professionally challenging because it requires the perioperative team to integrate complex foundational biomedical science knowledge with immediate clinical decision-making under time pressure. The patient’s underlying genetic predisposition to malignant hyperthermia, a pharmacogenetic disorder, presents a significant, albeit rare, risk that must be proactively identified and managed to prevent a life-threatening event. Failure to recognize the implications of this genetic history in the context of anesthetic drug selection could lead to catastrophic patient harm. Careful judgment is required to balance the need for effective anesthesia with the imperative to avoid specific triggers. Correct Approach Analysis: The best professional practice involves a thorough pre-operative assessment that specifically queries for a personal or family history of adverse reactions to anesthesia, including malignant hyperthermia. Upon identifying such a history, the perioperative team must then proactively select anesthetic agents and techniques known to be safe for susceptible individuals, such as avoiding volatile anesthetic agents and succinylcholine, and preparing dantrolene. This approach is correct because it directly addresses the identified biomedical risk by applying established clinical guidelines and ethical principles of patient safety and beneficence. It prioritizes harm avoidance based on a known genetic susceptibility, aligning with the duty of care to provide safe and appropriate medical treatment. Incorrect Approaches Analysis: One incorrect approach involves proceeding with standard anesthetic protocols without further investigation, assuming the risk is negligible due to its rarity. This fails to uphold the ethical principle of non-maleficence by not taking reasonable steps to prevent foreseeable harm. It also disregards the foundational biomedical science understanding of pharmacogenetics and the potential for severe adverse reactions in susceptible individuals, representing a failure in clinical vigilance. Another incorrect approach is to acknowledge the history but delay the decision-making process until intraoperatively, perhaps by consulting a specialist only after the patient is already anesthetized. This is professionally unacceptable as it introduces unnecessary risk and delays critical interventions. The ethical failure lies in not acting proactively to mitigate a known risk, potentially exposing the patient to a triggering agent before a safe alternative can be implemented. A further incorrect approach is to dismiss the patient’s or family’s reported history as unreliable or exaggerated without objective verification or a clear rationale based on established medical knowledge. This can lead to a failure to identify a genuine risk, violating the principle of respecting patient autonomy and potentially leading to harm. It also demonstrates a lack of critical appraisal of patient information, which is a fundamental aspect of clinical practice. Professional Reasoning: Professionals should employ a systematic risk assessment framework that begins with a comprehensive patient history, paying close attention to any reported adverse events related to medical procedures or medications. This should be followed by integrating this historical information with current biomedical knowledge, including pharmacogenetics and known disease predispositions. When a potential risk is identified, the decision-making process should prioritize proactive management and the selection of the safest available options, adhering to established clinical guidelines and ethical principles. Open communication with the patient and, where appropriate, consultation with specialists are crucial components of this process to ensure patient safety and optimal care.

This scenario presents a professional challenge rooted in the ethical imperative of informed consent and the practical realities of health systems science, specifically resource allocation and patient advocacy within a complex perioperative environment. The core tension lies between the surgeon’s professional judgment regarding the necessity of a procedure and the patient’s right to make autonomous decisions about their care, even if those decisions are perceived as suboptimal by the clinician. Navigating this requires a delicate balance of communication, empathy, and adherence to ethical principles, all within the constraints of a busy healthcare system. The best approach involves a thorough and patient-centered discussion that prioritizes understanding the patient’s values, concerns, and decision-making capacity. This includes clearly explaining the risks, benefits, and alternatives to the proposed surgery, as well as the potential consequences of non-operative management. Crucially, it requires active listening to the patient’s perspective, addressing their fears, and ensuring they comprehend the information provided. This aligns with the fundamental ethical principle of autonomy, which mandates respecting an individual’s right to self-determination in healthcare decisions. Regulatory frameworks and professional guidelines universally emphasize the importance of informed consent, requiring that patients receive adequate information to make voluntary choices about their treatment. This approach upholds the patient’s dignity and right to participate actively in their care, fostering trust and a collaborative therapeutic relationship. An approach that involves pressuring the patient into surgery, even with the intention of preventing future complications, is ethically unacceptable. This infringes upon the patient’s autonomy and can be construed as coercive, undermining the principle of informed consent. While the surgeon may have a strong clinical rationale, the ultimate decision rests with the patient, provided they have the capacity to make it. Another unacceptable approach is to proceed with surgery without fully exploring the patient’s reservations or ensuring their understanding. This bypasses the informed consent process and violates the patient’s right to be an active participant in their healthcare. It also fails to acknowledge potential underlying factors influencing the patient’s reluctance, such as financial concerns, fear, or personal beliefs, which are critical to address within a health systems science context. Finally, deferring the decision solely to the patient’s family without ensuring the patient’s own understanding and assent, if they have capacity, is also problematic. While family involvement can be supportive, the primary responsibility for informed consent lies with the patient. This approach risks overriding the patient’s wishes and may not accurately reflect their personal values and priorities. Professionals should employ a decision-making process that begins with a comprehensive assessment of the patient’s understanding and values. This involves open-ended questions, active listening, and a clear, jargon-free explanation of medical information. When faced with patient reluctance, the professional should explore the reasons behind it, offering support and addressing any barriers to informed decision-making. If capacity is a concern, a formal assessment should be initiated. The ultimate goal is shared decision-making, where the patient feels empowered and respected in their choices.

The audit findings indicate a persistent disparity in perioperative outcomes between different demographic groups within the hospital’s patient population. This scenario is professionally challenging because it requires the perioperative team to move beyond standard clinical care and actively address systemic issues that contribute to health inequities. It demands a nuanced understanding of population health principles and the ethical imperative to ensure equitable access to and quality of care for all patients, regardless of their background. Careful judgment is required to identify and implement interventions that are both clinically effective and socially responsible, avoiding superficial solutions that fail to address root causes. The best approach involves proactively engaging with community health organizations and patient advocacy groups to understand the social determinants of health impacting perioperative outcomes for underserved populations. This collaborative strategy allows for the co-creation of culturally sensitive care pathways, targeted patient education initiatives, and the identification of barriers to accessing post-operative care, such as transportation or language services. This aligns with the ethical principles of justice and beneficence, aiming to reduce disparities and improve health outcomes for all. Furthermore, it reflects a commitment to population health management by addressing the broader factors influencing patient well-being beyond the immediate clinical encounter. An incorrect approach would be to solely focus on refining existing clinical protocols without investigating the underlying social and economic factors contributing to the observed disparities. This fails to acknowledge the impact of social determinants of health on perioperative outcomes and neglects the ethical obligation to address systemic inequities. Another unacceptable approach is to attribute the disparities solely to patient non-compliance or individual lifestyle choices without considering the environmental and systemic factors that may influence these behaviors. This overlooks the principles of health equity and can lead to stigmatization and further marginalization of vulnerable patient groups. Finally, implementing a one-size-fits-all educational program without tailoring it to the specific needs and cultural contexts of different patient groups is unlikely to be effective and demonstrates a lack of understanding of health literacy and effective patient engagement strategies. Professionals should employ a decision-making framework that begins with data analysis to identify specific disparities. This should be followed by a root cause analysis that considers social determinants of health, patient experiences, and systemic barriers. Subsequently, collaborative solution development with affected communities and relevant stakeholders is crucial. Implementation should be accompanied by ongoing monitoring and evaluation to ensure effectiveness and equity, with a commitment to iterative improvement based on feedback and outcomes data.