Healthcare Data Collection & Statistical Tools Discussion

Healthcare Data Collection & Statistical Tools Discussion ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS ON Healthcare Data Collection & Statistical Tools Discussion Shewhart’s Theory for Statistical Process Control (SPC) requires a change in thinking from error detection to error prevention and has a number of benefits in health care. Several of the benefits include patient focus, increased quality awareness, decisions based on data, implementing predictable health care processes, reduced costs, fewer errors resulting in increased patient safety, and improved processes that result in improved health care outcomes and better quality care. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion. However, every process varies. In SPC terminology as it relates to a control chart, a common cause variation does not suggest that a process functions at a desirable or undesirable level, but whether the nature of the variation is stable or predictable within certain limits. A special cause variation is a negative finding, and any changes made in a health care organization should not be made until it identifies and eliminates special causes. A control chart will tell a health care organization if a variation is a common or special cause and how to approach an improvement process. If it is a special cause the health care organization should investigate it and eliminate the variation, not change the process. If there is a common cause variation, the implementation of a process change is what will address the variation. Control charts will reveal whether the change was effective (Joshi et.al, 2014). In this Discussion, you will look at these statistical tools for quality improvement and describe the differences between common cause variation and special cause variation. You will also explain any ethical, legal, or moral obligations that would support your rationale. To prepare: Review the Learning Resources for the week as they relate to Statistical Process Control, common cause, and special cause variation. Read the following situations and determine whether each situation is a common cause variation or a special cause variation: Dispensing the wrong medication to a patient Dispensing the correct medication several hours after it was supposed to be dispensed For both of these examples, apply data-collection and statistical tools to measure and explain your rationale for your determination. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion oversight_on_the_borderline._quality_improvement_and_pragmatic_research..pdf a_meta_ethnography_of_organisa.pdf improving_patient_safety_throu.pdf turning_healthcare_in_to_a_high_reliability_industry._memorial.pdf proposed_ethical_guidelines_for_quality_improvement..pdf Article CLINICAL TRIALS Oversight on the borderline: Quality improvement and pragmatic research Clinical Trials 2015, Vol. 12(5) 457–466 Ó The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1740774515597682 ctj.sagepub.com Jonathan A Finkelstein1, Andrew L Brickman2, Alexander Capron3, Daniel E Ford4, Adrijana Gombosev5, Sarah M Greene6, R Peter Iafrate7, Laura Kolaczkowski8, Sarah C Pallin9, Mark J Pletcher10, Karen L Staman11, Miguel A Vazquez12 and Jeremy Sugarman13 Abstract Pragmatic research that compares interventions to improve the organization and delivery of health care may overlap, in both goals and methods, with quality improvement activities. When activities have attributes of both research and quality improvement, confusion often arises about what ethical oversight is, or should be, required. For routine quality improvement, in which the delivery of health care is modified in minor ways that create only minimal risks, oversight by local clinical or administrative leaders utilizing institutional policies may be sufficient. However, additional consideration should be given to activities that go beyond routine, local quality improvement to first determine whether such non-routine activities constitute research or quality improvement and, in either case, to ensure that independent oversight will occur. This should promote rigor, transparency, and protection of patients’ and clinicians’ rights, well-being, and privacy in all such activities.Walden MMHA 6900 Healthcare Data Collection & Statistical Tools DiscussionWalden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Specifically, we recommend that (1) health care organizations should have systematic policies and processes for designating activities as routine quality improvement, non-routine quality improvement, or quality improvement research and determining what oversight each will receive. (2) Health care organizations should have formal and explicit oversight processes for non-routine quality improvement activities that may include input from institutional quality improvement experts, health services researchers, administrators, clinicians, patient representatives, and those experienced in the ethics review of health care activities. (3) Quality improvement research requires review by an institutional review board; for such review to be effective, institutional review boards should develop particular expertise in assessing quality improvement research. (4) Stakeholders should be included in the review of non-routine quality improvement and quality improvement–related research proposals. Only by doing so will we optimally leverage both pragmatic research on health care delivery and local implementation through quality improvement as complementary activities for improving health. 1 Division of General Pediatrics, Boston Children’s Hospital, Departments of Pediatrics and Population Medicine, Harvard Medical School, Boston, MA, USA 2 Health Choice Network, Miami, FL, USA 3 Gould School of Law and Keck School of Medicine, University of Southern California, Los Angeles, CA, USA 4 Johns Hopkins School of Medicine, Baltimore, MD, USA 5 School of Medicine, University of California, Irvine, Irvine, CA, USA 6 Patient-Centered Outcomes Research Institute, Washington, DC, USA 7 University of Florida, Gainesville, FL, USA 8 Multiple Sclerosis Patient-Powered Research Network, University of Dayton, Dayton, OH, USA 9 Louisiana Public Health Institute, New Orleans, LA, USA 10 University of California, San Francisco, CA, USA 11 CHB Wordsmith, Inc., Raleigh, NC, USA 12 University of Texas Southwestern Medical Center, Dallas, TX, USA 13 Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Corresponding author: Jonathan A Finkelstein, Boston Children’s Hospital, 300 Longwood Ave., Hunnwell 2, Boston, MA 02115, USA. Email:Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion [email protected] 458 Clinical Trials 12(5) Keywords Quality improvement, research, health care operations, pragmatic clinical trials, ethics, stakeholder engagement, patient engagement Introduction Patients and their health care providers face a need for better information on which interventions are most effective in routine practice settings and for more rapid and reliable implementation of those interventions once identified. The former is the realm of pragmatic (or practical) research (creation of new generalizable knowledge about clinical alternatives), while the latter is the purview of quality improvement (QI). Pragmatic clinical research compares therapeutic agents, procedures, behavioral interventions, and diagnostic strategies in normal practice settings. Pragmatic research trials are also used to evaluate systemic interventions to improve the organization and delivery of health care. These and other research activities can overlap, in both goals and methods, with QI. When activities have attributes of both research and QI, health care institutions face uncertainty about what oversight is, or should be, provided and especially about the applicability of the current regulatory framework of human subjects protection. Moreover, while much attention has been focused on patient engagement in both research and QI activities,1 we know little about what patients and other stakeholders believe are reasonable approaches to activities that may have attributes of both. The language that is typically used to differentiate types of ‘‘learning activities,’’ including QI and research, is imprecise. Although federal regulations (45 Code of Federal Regulations (CFR) 46) describe research as an activity intended to create generalizable knowledge, many have noted the limitations of this rather simplistic criterion.2–4 QI, in turn, has been defined as ‘‘… systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings.’’5 Here, for the purpose of discussing ethical oversight, we will categorize activities as ‘‘routine QI,’’‘‘non-routine QI,’’ and ‘‘QI research.’’‘‘Routine QI’’ consists of activities that aim to more reliably deliver intended care processes in a particular health care organization. They include low-risk (from a patient’s or clinician’s perspective) activities to improve care locally by making small changes in rapid cycles (i.e., Plan-Do-Study-Act (PDSA) cycles),6 implementing successful interventions immediately, and testing additional changes until pre-specified goals are met. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion An example would be testing whether use of a checklist for elements of already required screening (e.g., for smoking status) increases reliability of that process. The Centers for Medicare and Medicaid Services (CMS) and accrediting bodies such as The Joint Commission mandate that health care organizations undertake routine QI activities.7,8 While QI may result in new information that might be of interest outside the institution, routine QI activities are not designed to support causal inference or to be widely generalizable to other settings, according to accepted scientific standards. Such routine QI activities are rarely confused with research. At the opposite pole from routine QI are efforts to develop and test new methods for improving health care quality. The latter constitute QI research and have as a primary goal producing generalizable knowledge that rests on accepted scientifically valid inferences or on qualitative research conducted according to recognized methodologies. The greatest problems arise in separating the middle category, non-routine QI, from the other two. Such activities include those that are explicitly designed both to improve care locally and to contribute to knowledge more generally (e.g., by implementation at multiple health care organizations) or that affect care in ways that may confer additional risks (e.g., because of the interventions being used or the sharing of data). Of course, ethical considerations apply regardless of whether a particular activity is considered routine QI, non-routine QI, or QI research. Four principles are commonly articulated as underpinning ethical health care: respect for autonomy, beneficence, non-maleficence, and justice.3,9,10 In addition, a moral argument can be made that activities should be designed to maximize learning (for society) for a given level of burden or risk.3 Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Oversight to ensure adherence to these ethical principles can differ according to the type of activity: research with human subjects is federally regulated in the United States and typically requires oversight by an institutional review board (IRB),11 while mechanisms and policies for QI oversight vary across health systems.12,13 Because of the rise in pragmatic trials that test system-level interventions, as well as the increasing sophistication of some QI activities, it is important to revisit the ethics and regulatory issues for these activities. In particular, in this article, we seek to address two questions: 1. 2. What policies surrounding oversight of QI, routine and non-routine, will help ensure adherence to fundamental ethical principles of health care? Are there special considerations in the oversight of QI research activities that optimally protect patients and other participants yet allow for rapid system learning? Finkelstein et al. Differentiating types of QI-related activities Routine, non-routine, and QI research projects, as defined above, must first be differentiated so that appropriate ethical and regulatory oversight can be applied. Subjecting QI activities to oversight by an IRB can unnecessarily impede local changes in practice aimed at improving care. Conversely, if research activities are erroneously labeled QI, they may escape required IRB oversight. Furthermore, if project leaders design a QI activity with inadequate rigor or measurement in order to avoid having it categorized as ‘‘research’’ so that it is not subject to IRB oversight, it may detract from the quality and usability of the data for any purpose.3,10 We believe that routine QI activities can be recognized as such by local clinical program leaders, without prior independent review of each project. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Institutions should have written policies that delineate the bounds of routine QI so that local leaders can initiate and conduct projects using oversight mechanisms for clinical operations that are already in place. Policies should include the methods of intervention, measurement, and differential implementation (e.g., cluster randomization of or delayed implementation for some clinical units) that are acceptable within an institution without independent review. For activities that do not clearly fit within the scope of routine QI, institutions need a process and criteria that allow independent determination of whether an activity should be considered non-routine QI or QI research. Ogrinc et al.12 have published a framework to differentiate research from QI that considers a project’s intent and methods, and other institutions have developed similar schemas. The Alberta Research Ethics Community Consensus Initiative suggests that projects be screened to determine whether ethics review is needed, according to the purpose (create generalizable knowledge vs other) and the level of risk.14 Given the great degree of variability in the nature of these activities, a single criterion will never distinguish non-routine QI from research trials of care delivery alternatives, nor will a simple ‘‘checklist’’ reliably differentiate them. Instead, discussion and consideration of a number of attributes (Table 1) by those not directly involved in the project may help make this distinction project by project. An example of the continuum of QI activities— routine single-site QI, non-routine QI with concurrent comparison, and randomized research—is presented in Table 2. Oversight of routine QI It is beyond the scope of this article to suggest what constitutes a sufficient or optimal institutional strategy for routine QI as part of health care operations. 459 However, in general, mechanisms in place for oversight of clinical care should suffice for routine QI activities related to that care. Of course, all such activities must be conducted in compliance with governmental regulations for clinical care and use of patient data (Health Insurance Portability and Accountability Act (HIPAA)),15 as well as professional standards. Survey data from hospital executives indicate that important ethical considerations for the conduct of QI include exposing subjects (i.e., patients, health care providers, systems) to no more than minimal risk, focus on assessment and implementation of established practices, and respect for the privacy and confidentiality of subjects.16 While the details of reporting and oversight of clinical operations vary, clinical program leaders are responsible to institutional officials and, often, a board of trustees or directors, for the provision of high-quality, ethical clinical care.Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Although prior independent ethics review of each project is generally not necessary, institutional policies and ongoing activities should be routinely reviewed by organizational leaders (often at a departmental level or by a quality and safety department). For transparency, health care organizations may wish to disclose, through a general notification to all patients when they enter the system, the existence and breadth of routine QI. Patient advisory councils are one way of obtaining local input and guidance on routine QI activities from the consumers of health care services. The considerations for separate oversight and review below are not intended to apply to these generally accepted activities. Oversight of non-routine QI Projects determined to be non-routine QI need independent oversight (although not necessarily by an IRB) to address specific aspects of design, potential risks to patients and clinicians, and need for disclosure about the activities. QI projects frequently use concurrent comparison groups (e.g., implementing a change on one ward and comparing to continuing current practice on another). For example, in QI learning collaboratives,17,18 multiple sites are involved in activities consistent with routine QI, but they also pool their data in order to answer broader questions about implementation. Whether assignment of units is done by willingness to participate, staggered implementation, or by random assignment does not, by itself, make the activity research. However, projects that implement QI interventions concurrently in multiple institutions constitute non-routine QI and independent review is warranted. The body that oversees non-routine QI within an institution has a critical role in determining appropriate disclosure to various stakeholders. For example, while data privacy is covered under HIPAA, there may be 460 Clinical Trials 12(5) Table 1. Factors to consider when assessing and classifying QI and research activities. Factor Probably routine QI Probably non-routine QI Probably QI research Purpose of the activity Primary intent is to improve care in a local clinical delivery system. Results are intended to be locally implemented immediately.Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion May be shared as a QI report. Often seeks to improve care in multiple systems or may have more inherent risks than routine QI. Leaders often intend to share results broadly. May be part of a related research initiative. Tests a particular hypothesis or answers an articulated study question in a way that is primarily intended to produce generalizable knowledge. May also be designed to improve care locally. Project leadership and sponsorship Leaders are from within the clinical unit or system. Sponsorship usually within an institution. Typically changes a process at the level of a clinical system, applied to all patients. Leaders are often from one of the clinical units or systems. Sponsorship may be external or from within an institution. Typically changes a process at the level of clinical systems. May sometimes randomize clusters within or among clinical systems. Leaders and sponsorship commonly are external to the clinical unit under study. Locus of clinical decisions Clinical decisions are made by individual clinicians and patients, although may be influenced by standardized processes, guidelines, or other methods. Clinical decisions are made by individual clinicians and patients, although may be influenced by standardized processes, guidelines, or other methods, which may vary among participating units. Adherence to study protocol determines treatment, although protocols in pragmatic trials may be more flexible than classical randomized controlled trials. Ability of individuals to opt out of intervention Difficult for individuals to opt out of local system-level interventions. Difficult for individuals to opt out of local system-level interventions. Individuals may opt out, if feasible. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Informed consent may be required or waived by a reviewing IRB. Data analysis/ monitoring Collection of data associated with minimal burden on patients. Typically uses displays of data over time, statistical process control, and related QI methods. If evidence emerges that performance is negatively affected, the intervention is immediately stopped. May have additional patient burden for measurement. Analysis primarily uses QI methods, but may use other analytic techniques to assess effects across participating systems. Patient burden for data collection may be substantial, although data collection for pragmatic trials may also be integrated into ongoing care processes. May use statistical analysis of data at specified points to test stated hypothesis. Data and safety monitoring plans may be required. Dissemination of study results Findings are implemented immediately within the participating organization(s) and in other venues for shared QI initiatives. May sometimes be published as a QI report. Dissemination is an expectation of research results through research meetings and peerreviewed journals. Application of findings/ expected actions Improvements are immediately implemented in care processes locally. An expectation exists for continuing tests of change and measurement. Findings are disseminated within the participating organization(s) and in other venues for sharing QI initiatives, but more likely to be more broadly disseminated at professional meetings and through publication. Improvements are immediately implemented in care processes. Walden MMHA 6900 Healthcare Data Collection & Statistical Tools Discussion Typically adopted (with adaptation) by other organizations. Accountability and regulation Oversight is by clinical and institutional leadership under specific policies for routine QI activities. HIPAA and other regulatory rules apply. Stakeholder engagement Input of patient representatives is through institutional channels for patient input in clinical care. Locus of intervention/ randomization Oversight should be by a qualified group within an institution in addition to usual clinical leadership. HIPAA and other regulatory rules apply. Specific requirements for patient notification or consent may be deemed appropriate. Patient input should be sought for prioritization and conduct of major QI activities. May be applied to some individuals and not others. Random assignment may occur at the level of the individual. Typically delayed translation of findings to clinical care. However, the expectation of pragmatic trials is for more immediate dissemination and implementation. Institutional oversight is through an IRB, which operates within federal regulations including the Common Rule and HIPAA. Patient-centered research should include patients as partners in prioritization, conduct, analysis, and reporting. QI: quality improvement; HIPAA: Health Insurance Portability and Accountability Act; IRB: institutional review board. Improvement cycles with comparison: 2 EDs assigned or randomized to intervention or to usual care. 20 EDs convene to i … Get a 10 % discount on an order above $ 100 Use the following coupon code : NURSING10