Epistemic_Statements  

CORD-19:7cbaa5e3cb5e9d32355628f186dc17dee55b5ca2 JSONTXT 11 Projects

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Id Subject Object Predicate Lexical cue
T1 425-710 Epistemic_statement denotes The Institute of Medicine's groundbreaking report "To Err is Human" characterized the magnitude of the occurrence of medical errors during patient care in the United States, estimating that between 44,000 and 98,000 hospital-based deaths per year could be attributed to medical errors.
T2 1083-1451 Epistemic_statement denotes 3 In the study, authors highlighted that these results place medical errors third on the Center for Disease Control and Prevention's list of leading causes of death in the United Statesdbehind the 611,105 deaths that are associated with heart disease and the 584,881 deaths attributable to cancer, and just above the 149,205 patients who die from respiratory diseases.
T3 1900-2164 Epistemic_statement denotes 6 These figures are unquestionably daunting; however, they do not include either the scores of near misses or latent errors (errors that never reach the patient or result in harm) or the system failures that influence a patient's healthcare experiences negatively.
T4 2165-2451 Epistemic_statement denotes Based on these striking mortality and health care-associated infections data, the fact that the health-care environment is fraught with risks and potential errors that must be identified and deftly managed if patients are to be cared for safely and appropriately seems incontrovertible.
T5 2543-2691 Epistemic_statement denotes As in the case for clinical care, and as noted by several authors in this text, the conduct of clinical research is inherently associated with risk.
T6 2909-3050 Epistemic_statement denotes This intense scrutiny at the protocol level works to improve the safety of subjects relative to the risks associated with the study question.
T7 3064-3334 Epistemic_statement denotes describe additional risks that rarely are considered formally during the review of a clinical research protocol, including the clinical environment in which the research will be conducted, as well as system failures that are inherently associated with clinical medicine.
T8 3335-3581 Epistemic_statement denotes 7 The health-care environmentdwhether an inpatient unit, an ambulatory care clinic, or a community health centerdis a complex system that is influenced by multiple factors that contribute to, or mitigate, risk in the conduct of clinical research.
T9 3695-4058 Epistemic_statement denotes 8 If one applies this definition to the clinical care environment, examples of interdependent elements that one might consider include such factors as the institution's culture (especially with respect to safety), the skill mix and competence of the staff, the availability of state-of-the-art equipment, and the quality of information systems, to name but a few.
T10 4513-4775 Epistemic_statement denotes 6,14e16 Whereas any one of these events could be considered an error resulting from an individual provider's negligence, systems thinking compels us to consider these adverse events as failures in a series of interrelated and/or codependent processes or systems.
T11 4776-4968 Epistemic_statement denotes In truth, in the current complex health-care environment such events almost invariably involve a series of missed opportunities to correct the errordhence they truly represent system failures.
T12 5141-5506 Epistemic_statement denotes Because of the endemic nature of errors and system failures in clinical care, investigators and review bodies must collaborate with the health-care practitioners with whom they entrust their participants' safety to assure that the system/environment in which clinical research is conducted is safe and has the necessary infrastructure in place to support the study.
T13 5507-5795 Epistemic_statement denotes Further, the research team must have strategies in place to monitor the clinical research environment to identify risks and clinical events that could contribute to adverse events and/or protocol deviations and to assure that processes are in place to prevent, mitigate, and manage risks.
T14 5796-5934 Epistemic_statement denotes Clinical research programs must, therefore, embrace a system's approach to managing risk associated with the conduct of clinical research.
T15 5935-6247 Epistemic_statement denotes For the purposes of this chapter, the term "conduct of clinical research" refers both to activities outlined in the research study as well as those intrinsic clinical care activities that are essential to the successful implementation of a study but that may not be explicitly described in the research protocol.
T16 6428-6741 Epistemic_statement denotes These critical clinical care functions often are assumed to be present and functioning at an optimal level to support the investigator's study; however, investigators and/or institutional review boards may lack formal processes to assess the capacity of the clinical environment to support the study under review.
T17 6935-7030 Epistemic_statement denotes In collaboration with the health-care team, the research team should have processes in place to
T18 7031-7456 Epistemic_statement denotes • identify clinical care functions that are critical to the success of the protocol; • identify and assess critical risk points of the clinical care processes that might place participants at undue clinical risk and/or compromise the integrity of the study; • monitor the clinical environment continually for adverse events, errors, near misses, and process failures; • assess systematically and thoroughly errors that occur;
T19 7457-7777 Epistemic_statement denotes • establish an armamentarium of process improvement tools with which to manage process and system issues when they are identified; and • develop robust processes to communicate and learn from untoward events that occur in the clinical care environment in the spirit of organizational learning and continuous improvement.
T20 7778-7922 Epistemic_statement denotes These processes and the tools and techniques described in this chapter can be implemented and managed at a variety of levels of an organization.
T21 7923-8133 Epistemic_statement denotes If the research program resides in a large health-care system, many of these activities can be managed by the hospital's patient safety and clinical quality enterprise, in collaboration with the research teams.
T22 8134-8288 Epistemic_statement denotes However, these processes and tools effectively can be applied on a much smaller scale (i.e., an individual research unit) with the same degree of success.
T23 8289-8532 Epistemic_statement denotes Regardless of where in the organizational structure these functions reside, the findings from these performance measure, risk mitigation, and improvement strategies should be communicated directly to the leadership and across the organization.
T24 8533-8757 Epistemic_statement denotes Nuclear power, aviation, chemical manufacturing, and aerospace are all complex industries in which a single error can result in catastrophic consequences; however, remarkably, these industries are considered incredibly safe.
T25 8902-9183 Epistemic_statement denotes Sutcliffe describes high reliability organizations (HROs) as having a "collective mindfulness" that supports and promotes a culture in which all staff are encouraged to seek out and share all unsafe conditions or problem before the event compromises operations or service delivery.
T26 9584-9899 Epistemic_statement denotes An error or lapse in safety in the aforementioned industries' processes can result in tragic outcomesdmuch like a lapse in proper infection control in the care of a highly immunocompromised patient or a patient with Ebola virus infection can be catastrophic from a personal as well as an organizational perspective.
T27 10035-10200 Epistemic_statement denotes Table 36 .1 provides an overview of each of the principles of high reliability and how the NIH CC leveraged these concepts in the care of acutely ill Ebola patients.
T28 10201-10447 Epistemic_statement denotes A first step in assuring that appropriate clinical care infrastructure is in place to support a planned study is to examine the research protocol to identify the clinical functions that will be required to support the conduct of the study safely.
T29 10448-10680 Epistemic_statement denotes This process begins with the active engagement of the study investigators, the research team, and the patient care staff who identify, objectively and prospectively, steps in the research process that may place participants at risk.
T30 10681-10952 Epistemic_statement denotes Health-care performance improvement tools such as flowcharting, 16e18 failure mode and effects analysis (FMEA), 18e24 and clinical quality performance measures can be applied effectively to the analysis and management of risk in the context of planning clinical research.
T31 11236-11333 Epistemic_statement denotes The NIH CC is a distinctive and complex hospital whose primary mission is the support of science.
T32 11750-11949 Epistemic_statement denotes Of the NIH Clinical Center's approximately 1600 clinical research protocols nearly half are designed to study the natural history and pathogenesis of rare, often genetically determined rare diseases.
T33 12181-12456 Epistemic_statement denotes This unique intersection of clinical care and clinical research mandates that the NIH CC use myriad health-care performance All staff are aware of the potential for risk and harm and are encouraged continually to scan the environment for potential and real threats to safety.
T34 12457-12575 Epistemic_statement denotes • Staff were empowered to ask about, and looking for, the untoward outcomes that could result from our care processes.
T35 13486-13585 Epistemic_statement denotes Leaders and staff need to be constantly aware of how processes and systems affect the organization.
T36 14122-14240 Epistemic_statement denotes Resistance to simplify Staff appreciate that health care is complex, ever-changing and fraught with interdependencies.
T37 14241-14445 Epistemic_statement denotes When faced with challenges, errors, or untoward events HROs seek to understand the "root cause and contributing factors" of these events rather than settle for a more superficial or expedient explanation.
T38 14446-14549 Epistemic_statement denotes And whereas standardization of processes may be useful, HROs understand and actively manage complexity.
T39 14550-14737 Epistemic_statement denotes • Staff were encouraged to resist the risks associated with "painting with broad strokes" when evaluating lapses and failing to dig deeply to find the real source of a particular problem.
T40 14964-15144 Epistemic_statement denotes This principle is based on the assumption that errors and lapse will occur and organizations must actively design processes that allow an organization to "bounce back" from errors.
T41 15145-15295 Epistemic_statement denotes • Every organization must develop strategies to sustain operations and "bounce back" when (not if) an untoward event occurs • The question, "What if?"
T42 15649-15858 Epistemic_statement denotes One example of how performance improvement tools have been used to enhance the conduct of clinical research occurred in our institution as the severe acute respiratory syndrome (SARS) epidemic evolved in 2004.
T43 16137-16303 Epistemic_statement denotes These protocols perhaps positioned the NIH CC somewhat uniquely as one of the few health-care facilities in the world that was actively recruiting patients with SARS.
T44 16495-16623 Epistemic_statement denotes However, several circumstances caused the NIH CC, as an organization, to pause before the decision was made to open recruitment.
T45 16624-16956 Epistemic_statement denotes Because of the nature of the studies conducted at the NIH CC, many of the patients/participants recruited to participate in its clinical research protocols are highly immunocompromised, either as a direct result of their underlying disease or due to the interventions associated with the research studies in which they are enrolled.
T46 16957-17244 Epistemic_statement denotes Further, at the time of the SARS outbreak, the NIH CC's clinical environment was in a buildingd constructed in the 1950sdthat posed significant infrastructural hurdles to providing safe care to patients infected with highly infectious (and in this instance, possibly airborne) pathogens.
T47 17245-17444 Epistemic_statement denotes In this complex clinical context, investigators from the National Institute of Allergy and Infectious Diseases submitted protocols requiring the provision of care for highly infectious SARS patients.
T48 17512-17770 Epistemic_statement denotes As one might have anticipated, several investigators who provide care for patients who have severely compromised immune function were adamantly opposed to admitting patients with SARS or other highly contagious respiratory illnesses electively to the NIH CC.
T49 17771-18011 Epistemic_statement denotes However, because of the clearly urgent public health need, as well as the potential unprecedented scientific opportunities, the leadership of the NIH CC approached the issue not by asking: "Can we safely provide care to patients with SARS?"
T50 18012-18096 Epistemic_statement denotes but rather by asking the question, "How can we care safely for all of our patients?"
T51 18097-18353 Epistemic_statement denotes As the protocols were being reviewed for human subjects' protection, the leadership of the NIH CC set out to identify the critical clinical functions that they felt must be present and operating at optimal levels to admit and care for SARS patients safely.
T52 18929-19168 Epistemic_statement denotes This exercise was eye-opening in that both the clinical care providers and the investigators were astounded by the breadth of hospital functions that required flawless orchestration to assure that the protocols could be implemented safely.
T53 20155-20340 Epistemic_statement denotes The development of a complete listing of the essential clinical processes that need to be in place is a critical first step to prepare for the implementation of a new research protocol.
T54 20341-20410 Epistemic_statement denotes As was the case with the SARS protocol, this process can be daunting.
T55 20411-20587 Epistemic_statement denotes Focusing an organization's finite resources to assure that attention is paid to the most critical and potentially riskiest care processes is a challenge for most organizations.
T56 20588-20736 Epistemic_statement denotes A variety of tools exist to guide the objective prioritization of what may ultimately be a very long list of critical issues that must be addressed.
T57 20976-21306 Epistemic_statement denotes 19,21e28 Historically, FMEA has been used in the engineering environment to assess high-risk processes associated with power generation in the commercial nuclear power industry; in aviation to assess the acceptability of aircraft designs; and in the automotive industry to establish manufacturing requirements for cars and trucks.
T58 22017-22289 Epistemic_statement denotes 19, 20, 22, 23, 27, 28 In a complex care environment, where risk is compounded by the interplay of clinical medicine and clinical research, FMEA is a useful tool to guide risk mitigation by identifying critical risk points in clinical care and clinical research processes.
T59 22686-22931 Epistemic_statement denotes An interdisciplinary team comprised of patient safety professionals, research investigators, nurses, social workers, and hospital leadership used FMEA to evaluate potential risk points throughout the clinical research and patient care processes.
T60 24124-24703 Epistemic_statement denotes Informed by the data from the FMEA, the patient care and research teams collaboratively developed risk mitigation strategies aimed at reducing the likelihood of patient harm or research lapses: a rigorous environmental assessment process was implemented to identify hazards posed by equipment, sharps, and the physical environment; the nurse skill mix as well as staffing plans were evaluated and adjusted based on evidence from the FMEA; and the medical and research teams developed strategies to assure that patients were thoroughly assessed for suicidality prior to discharge.
T61 24704-24784 Epistemic_statement denotes In addition, two positive "unintended consequences" resulted from this analysis:
T62 24785-25098 Epistemic_statement denotes • the process provided an effective forum for focused, deliberate discussions between the research team and clinical care staff regarding protocol requirements that otherwise might not have occurred; and • the care team's "preoccupation with failure" and focus on the culture of patient safety were reinvigorated.
T63 25099-25283 Epistemic_statement denotes FMEA has been, and continues to be, a highly effective tool for identifying, characterizing, and prioritizing risk associated with complex patient care and clinical research processes.
T64 25284-25441 Epistemic_statement denotes Findings from this consensus-driven, objective, and quantitative analysis can be used successfully to leverage organizational change and resource allocation.
T65 25442-25638 Epistemic_statement denotes Using FMEA to identify the clinical risks points associated with the implementation of a clinical care or clinical research process is a critical first step in mitigating patient/participant risk.
T66 25639-25836 Epistemic_statement denotes FMEAs, or other risk assessments, identify process points that are associated with increased risk to the patient/participant, to involved providers, and/or to the scientific integrity of the study.
T67 25837-25994 Epistemic_statement denotes As illustrated in the example above, these risks can be addressed by myriad clinical and organizational interventions that are aimed at reducing those risks.
T68 26310-26723 Epistemic_statement denotes The history of health-care quality improvement and measurement dates to Florence Nightingale's collection of mortality data and infection rates during the Crimean War, as well as to the work of Ernest Codman in establishing standards for hospitals in the early 1900s, including his provocative "end results hypothesis" that led to a Semmelweis-like estrangement from the health-care establishment (see Chapter 1).
T69 27287-27563 Epistemic_statement denotes Clinical research programs, too, should implement processes to assess the performance of the clinical research enterprise systematicallydprimarily to assess for risks to the participants, investigators, and care providers, as well as for threats to the integrity of the study.
T70 27745-27892 Epistemic_statement denotes However, event reporting in clinical research focuses on individual protocols, not on how the system of clinical research is performing as a whole.
T71 27893-28065 Epistemic_statement denotes This "protocolcentric" focus fails to identify clinical care and clinical research system failures that potentially might impact participant safety across multiple studies.
T72 28324-28527 Epistemic_statement denotes Near misses or latent failures are errors that do not result in patient/participant harm; however, these events do have the potential to do harm if the circumstances of the event were somewhat different.
T73 28749-29078 Epistemic_statement denotes Surveillance for errors, adverse events, and latent errors in the clinical care or research setting can be accomplished using a variety of strategies including 1 event reporting systems 2 ; electronic surveillance systems that utilize clinical triggers to identify errors; and 3 analysis of clinical performance measurement data.
T74 29787-30002 Epistemic_statement denotes The NIH CC has found the ORS to be particularly useful as a surveillance tool for identifying trends in latent failures in clinical care and clinical research processes that otherwise would likely not be identified.
T75 30003-30213 Epistemic_statement denotes The following is an example of a potentially harmful near miss or latent failure that could have had a negative impact on clinical research, had the issues not been identified by using data from the NIH CC ORS.
T76 30214-30420 Epistemic_statement denotes On review of data from the ORS, the Pharmacy Department Quality Officer noted a trend in administration events that was occurring associated with a specific investigational drug in a phase I clinical trial.
T77 30421-30558 Epistemic_statement denotes The reports indicated that drug delivery was delayed on several occasions because the infusion pumps had inexplicably suspended infusion.
T78 30559-30856 Epistemic_statement denotes Each time the infusion would stop, the nursing staff would troubleshoot the problem, requiring the infusions to be restarted several times during a single delivery, potentially resulting in a delay of study drug administration, and potentially adversely affecting drug levels and pharmacokinetics.
T79 31980-32290 Epistemic_statement denotes Whereas these incidents do not appear to have caused any harm to the participant or the study, the potential for harm to the participant and the study are obvious, and any future potential adverse events or protocol deviations were averted as a result of identifying this series of events via the NIH CC's ORS.
T80 32554-32724 Epistemic_statement denotes Establishing a nonpunitive "just culture" that encourages the reporting of events, free of reprisal, is essential to maintaining a robust and meaningful reporting system.
T81 32925-33111 Epistemic_statement denotes Finally, organizations should be committed to sharing performance measurement data with the staff to keep them informed and aligned with institutional performance improvement strategies.
T82 33546-33646 Epistemic_statement denotes This technology uses clinical triggers to signal the presence of potential errors or adverse events.
T83 33647-33995 Epistemic_statement denotes Clinical triggers can include high-risk medications, select abnormal laboratory values (e.g., abnormal serum potassium levels, microbiology culture results), treatment interventions such as antidotes (e.g., Naloxone (Narcan), vitamin K), corrective procedures (e.g., chest tube insertions and dialysis) and unplanned intensive care unit admissions.
T84 33996-34338 Epistemic_statement denotes 9,47e52 Electronic event surveillance for clinical care and clinical research errors and latent failures provides a tool that administrative institutional leadership, clinicians, and research investigators can use to identify, mitigate, and report these events in a much timelier manner than traditional, voluntary incident reporting systems.
T85 34728-34903 Epistemic_statement denotes All hospitals and other health-care facilities accredited by the Joint Commission must have systems in place to measure, continually, a proscribed list of clinical activities.
T86 35073-35355 Epistemic_statement denotes 54 Regardless of the type of performance indicators used by an organization to monitor patient care processes, these measures, if well designed and appropriately implemented, provide valuable insight into the health-care organization's management of critical patient care processes.
T87 35427-35608 Epistemic_statement denotes Performance measurement activity in the clinical research setting also should take into consideration important clinical metrics associated with the scientific protocol under study.
T88 35609-35864 Epistemic_statement denotes In addition to national and state benchmarks for clinical performance metrics, clinical researchers should be mindful of the specific processes on which their studies depend and create appropriate performance metrics to track the success of those systems.
T89 35865-35998 Epistemic_statement denotes Data from performance measurement indicators provide investigators with critical information to guide study planning and preparation.
T90 35999-36211 Epistemic_statement denotes For instance, if a clinical research study intervention will be conducted on a highly immunocompromised patient population, the effectiveness of the hospital's infection control processes becomes highly relevant.
T91 36212-36484 Epistemic_statement denotes Quantitative and objective data about the organization's health care-associated infection rates and hand hygiene practices provide valuable information about system and process issues that might need to be addressed prior to recruiting and enrolling patients/participants.
T92 36485-36756 Epistemic_statement denotes Assuring that the clinical care environment in which clinical research participants will receive safe and high-quality care that supports clinical research is a shared responsibility of the health-care organization's leadership, the care providers, and the research team.
T93 36757-37008 Epistemic_statement denotes Basic quality improvement tools such as flowcharting, prospective risk assessment methodologies (e.g., FMEA), and clinical quality and patient safety performance measures provide objective data to guide protocol planning and implementation strategies.
T94 37185-37307 Epistemic_statement denotes In particular, few studies have addressed participants' perceptions of their experiences with clinical research processes.
T95 37421-37578 Epistemic_statement denotes The clinical research community can look to the healthcare industry for guidance in determining how to assess participants' experiences as research subjects.
T96 37579-37979 Epistemic_statement denotes Although the processes of providing patient care in a hospital and the conduct of a clinical research study often differ, investigators and the care teams supporting the research must be mindful that at the center of these processes is a human being interacting with a health-care delivery system whether in a community hospital, a Clinical Translational Science Award unit, or an outpatient setting.
T97 37980-38140 Epistemic_statement denotes How research subjects perceive the clinical research experience provides valuable insights for future improvement of both the clinical and scientific processes.
T98 38251-38562 Epistemic_statement denotes The NIH CC is motivated to understand how patient/ participants perceived the care they receive during their participation in studies conducted at the NIH CC as one method to assure that the needs and expectations of this special group of individuals who volunteer to contribute to scientific discovery are met.
T99 38984-39185 Epistemic_statement denotes The survey was tailored to the unique clinical research environment of the Clinical Center and was designed to include several questions addressing the experience of participating in clinical research.
T100 39186-39311 Epistemic_statement denotes For the past 15 years, the NIH CC used these data to identify opportunities to improve our patient/participants' experiences.
T101 39312-39564 Epistemic_statement denotes Issues such as communication with clinical staff, attention to emotional support, and the participant's understanding about the point at which he or she can cease participation in a study were identified as areas requiring focused review and attention.
T102 40463-40785 Epistemic_statement denotes Irrespective of the approach taken, we believe that researchers and institutions involved in clinical research must collect data from a variety of sources, including the solicitation of perceptions from participants and staff input about their research experiences, to improve the conduct of clinical research continually.
T103 40786-41373 Epistemic_statement denotes Developing clinical research programs that include structured approaches to collecting reliable information about factors that contribute to process failures and adverse events (including careful root cause analyses); mechanisms for assessing trends in process and outcome failures, structured approaches to identifying risk points prior to study implementation (e.g., FMEA); and obtaining participant insights about their perceptions of the clinical research experience will provide the necessary data to allow institutions and investigators to improve the clinical research experience.
T104 41374-41568 Epistemic_statement denotes We believe these approaches to patient safety, clinical quality, and clinical research quality and safety will increase substantially the likelihood of successful completion of clinical studies.