Computerized Decision Support System Improves Fluid Resuscitation Outcomes Following Severe Burns: An Original Study

DTIC Science & Technology

2011-01-01

clinical decision- making paradigms, coupled with regula- tory and technical limitations, is just one of the hurdles that has kept advanced information...responses to assist care personnel during the resuscitation phase. CDSSs have been successfully used in the clinical setting for several years (23–24...because of clinical complications, death, or other factors were excluded. The control cohort included only patients who sur- vived for the initial 24

A pilot study of distributed knowledge management and clinical decision support in the cloud.

PubMed

Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

2013-09-01

Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable path toward achieving better support of clinical decision-making across the widest range of health care providers. Published by Elsevier B.V.

Evaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.

PubMed

Akbas, Neval; Schryver, Patricia G; Algeciras-Schimnich, Alicia; Baumann, Nikola A; Block, Darci R; Budd, Jeffrey R; Gaston, S J Stephen; Klee, George G

2014-11-01

We evaluated the analytical performance of 24 immunoassays using the Beckman Coulter DxI 800 immunoassay systems at Mayo Clinic, Rochester, MN for trueness, precision, detection limits, linearity, and consistency (across instruments and reagent lots). Clinically oriented performance goals were defined using the following methods: trueness-published desirable accuracy limits, precision-published desirable biologic variation; detection limits - 0.1 percentile of patient test values, linearity - 50% of total error, and consistency-percentage test values crossing key decision points. Local data were collected for precision, linearity, and consistency. Data were provided by Beckman Coulter, Inc. for trueness and detection limits. All evaluated assays except total thyroxine were within the proposed goals for trueness. Most of the assays met the proposed goals for precision (86% of intra-assay results and 75% of inter-assay results). Five assays had more than 15% of the test results below the minimum detection limits. Carcinoembryonic antigen, total thyroxine and free triiodothyronine exceeded the proposed goals of ±6.3%, ±5% and ±5.7% for dilution linearity. All evaluated assays were within the proposed goals for instrument consistency. Lot-to-lot consistency results for cortisol, ferritin and total thyroxine exceeded the proposed goals of 3.3%, 11.4% and 7% at one medical decision level, while vitamin B12 exceeded the proposed goals of 5.2% and 3.8% at two decision levels. The Beckman Coulter DxI 800 immunoassay system meets most of these proposed goals, even though these clinically focused performance goals represent relatively stringent limits. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Conceptual framework of knowledge management for ethical decision-making support in neonatal intensive care.

PubMed

Frize, Monique; Yang, Lan; Walker, Robin C; O'Connor, Annette M

2005-06-01

This research is built on the belief that artificial intelligence estimations need to be integrated into clinical social context to create value for health-care decisions. In sophisticated neonatal intensive care units (NICUs), decisions to continue or discontinue aggressive treatment are an integral part of clinical practice. High-quality evidence supports clinical decision-making, and a decision-aid tool based on specific outcome information for individual NICU patients will provide significant support for parents and caregivers in making difficult "ethical" treatment decisions. In our approach, information on a newborn patient's likely outcomes is integrated with the physician's interpretation and parents' perspectives into codified knowledge. Context-sensitive content adaptation delivers personalized and customized information to a variety of users, from physicians to parents. The system provides structuralized knowledge translation and exchange between all participants in the decision, facilitating collaborative decision-making that involves parents at every stage on whether to initiate, continue, limit, or terminate intensive care for their infant.

Bringing a humanistic approach to cancer clinical trials

PubMed Central

Arai, Roberto Jun; Longo, Elaine Santana; Sponton, Maria Helena; Del Pilar Estevez Diz, Maria

2017-01-01

In this article, we describe some practical aspects that promote the humanisation of clinical research. Actions are not limited to improving the communication skills of medical staff but also include maintenance of care continuity, accessible written information, and application of theoretic models such as shared decision-making and management of stress in decision-making under uncertainty. We believe that a comprehensive strategy will increase patients’ motivation to participate in and adhere to clinical research. PMID:28596804

Decision-Making Difficulties Experienced by Adults with Autism Spectrum Conditions

ERIC Educational Resources Information Center

Luke, Lydia; Clare, Isabel C. H.; Ring, Howard; Redley, Marcus; Watson, Peter

2012-01-01

Autobiographical and clinical accounts, as well as a limited neuropsychological research literature, suggest that, in some situations, men and women with autism spectrum conditions (ASCs) may have difficulty making decisions. Little is known, however, about how people with ASCs experience decision-making or how they might best be supported to make…

[Shared decision-making in acute psychiatric medicine : Contraindication or a challenge?

PubMed

Heres, S; Hamann, J

2017-09-01

The concept of shared decision-making (SDM) has existed since the 1990s in multiple fields of somatic medicine but has only been poorly applied in psychiatric clinical routine despite broad acceptance and promising outcomes in clinical studies on its positive effects. The concept itself and its practicability in mental health are carefully assessed and strategies for its future implementation in psychiatric medicine are presented in this article. Ongoing clinical studies probing some of those strategies are further outlined. On top of the ubiquitous shortage of time in clinical routine, psychiatrists report their concern about patients' limited abilities in sharing decisions and their own fear of potentially harmful decisions resulting from a shared process. Misinterpretation of shared decision-making restricting the health care professional to rather an informed choice scenario and their own adhesion to the traditional paternalistic decision-making approach further add to SDM's underutilization. Those hurdles could be overcome by communication skill workshops for all mental health care professionals, including nursing personnels, psychologists, social workers and physicians, as well as the use of decision aids and training courses for patients to motivate and empower them in sharing decisions with the medical staff. By this, the patient-centered treatment approach demanded by guidelines, carers and users could be further facilitated in psychiatric clinical routine.

[Treatment regulations and treatment limits: factors influencing clinical decision-making].

PubMed

Baberg, H T; Kielstein, R; de Zeeuw, J; Sass, H-M

2002-08-02

Providing or withholding of treatment is based on a variety of factors. We sought for criteria in clinical decision making and reviewed attitudes towards clinical intuition and the patient's will. 503 physicians (25.6 % females; mean age 36.3) in 49 departments at nine hospitals of the universities Bochum and Magdeburg filled in a validated questionnaire. The most important factors in the decision to carry out a therapy were "international standards" and "own experience". The decision to omit a therapy was mainly influenced by the "patient's wish". Physicians with a higher status judged their own experience higher than young physicians, who considered the experience of colleagues more important. "Severe accompanying illnesses" and "multimorbidity" were the most frequently named reasons to withdraw a therapy. Intuitive decision-making was rare, especially in young physicians, although these decisions were seldom risky and often successful. A patient's will plays a prominent role in clinical decision making, especially in decisions to withdraw or to withhold treatment. Cost containment and research interest have been called less important, a remarkable response from research-based university hospitals. Also remarkable is the recognition and importance of clinical intuition in situations of complex or missing information. This important aspect is rarely discussed in the literature or in medical education. The widely voiced concern that priorities in clinical care are guided by scientific interest, financial or technical possibilities could not be confirmed.

The utility of clinical decision tools for diagnosing osteoporosis in postmenopausal women with rheumatoid arthritis

PubMed Central

Brand, Caroline; Lowe, Adrian; Hall, Stephen

2008-01-01

Background Patients with rheumatoid arthritis have a higher risk of low bone mineral density than normal age matched populations. There is limited evidence to support cost effectiveness of population screening in rheumatoid arthritis and case finding strategies have been proposed as a means to increase cost effectiveness of diagnostic screening for osteoporosis. This study aimed to assess the performance attributes of generic and rheumatoid arthritis specific clinical decision tools for diagnosing osteoporosis in a postmenopausal population with rheumatoid arthritis who attend ambulatory specialist rheumatology clinics. Methods A cross-sectional study of 127 ambulatory post-menopausal women with rheumatoid arthritis was performed. Patients currently receiving or who had previously received bone active therapy were excluded. Eligible women underwent clinical assessment and dual-energy-xray absorptiometry (DXA) bone mineral density assessment. Clinical decision tools, including those specific for rheumatoid arthritis, were compared to seven generic post-menopausal tools to predict osteoporosis (defined as T score < -2.5). Sensitivity, specificity, positive predictive and negative predictive values and area under the curve were assessed. The diagnostic attributes of the clinical decision tools were compared by examination of the area under the receiver-operator-curve. Results One hundred and twenty seven women participated. The median age was 62 (IQR 56–71) years. Median disease duration was 108 (60–168) months. Seventy two (57%) women had no record of a previous DXA examination. Eighty (63%) women had T scores at femoral neck or lumbar spine less than -1. The area under the ROC curve for clinical decision tool prediction of T score <-2.5 varied between 0.63 and 0.76. The rheumatoid arthritis specific decision tools did not perform better than generic tools, however, the National Osteoporosis Foundation score could potentially reduce the number of unnecessary DXA tests by approximately 45% in this population. Conclusion There was limited utility of clinical decision tools for predicting osteoporosis in this patient population. Fracture prediction tools that include risk factors independent of BMD are needed. PMID:18230132

Clinical decision guidelines for NHS cosmetic surgery: analysis of current limitations and recommendations for future development.

PubMed

Cook, S A; Rosser, R; Meah, S; James, M I; Salmon, P

2003-07-01

Because of increasing demand for publicly funded elective cosmetic surgery, clinical decision guidelines have been developed to select those patients who should receive it. The aims of this study were to identify: the main characteristics of such guidelines; whether and how they influence clinical decision making; and ways in which they should be improved. UK health authorities were asked for their current guidelines for elective cosmetic surgery and, in a single plastic surgery unit, we examined the impact of its guidelines by observing consultations and interviewing surgeons and managers. Of 115 authorities approached, 32 reported using guidelines and provided sufficient information for analysis. Guidelines mostly concerned arbitrary sets of cosmetic procedures and lacked reference to an evidence base. They allowed surgery for specified anatomical, functional or symptomatic reasons, but these indications varied between guidelines. Most guidelines also permitted surgery 'exceptionally' for psychological reasons. The guidelines that were studied in detail did not appreciably influence surgeons' decisions, which reflected criteria that were not cited in the guidelines, including cost of the procedure and whether patients sought restoration or improvement of their appearance. Decision guidelines in this area have several limitations. Future guidelines should: include all cosmetic procedures; be informed by a broad range of evidence; and, arguably, include several nonclinical criteria that currently inform surgeons' decision-making.

Evaluating Diagnostic Point-of-Care Tests in Resource-Limited Settings

PubMed Central

Drain, Paul K; Hyle, Emily P; Noubary, Farzad; Freedberg, Kenneth A; Wilson, Douglas; Bishai, William; Rodriguez, William; Bassett, Ingrid V

2014-01-01

Diagnostic point-of-care (POC) testing is intended to minimize the time to obtain a test result, thereby allowing clinicians and patients to make an expeditious clinical decision. As POC tests expand into resource-limited settings (RLS), the benefits must outweigh the costs. To optimize POC testing in RLS, diagnostic POC tests need rigorous evaluations focused on relevant clinical outcomes and operational costs, which differ from evaluations of conventional diagnostic tests. Here, we reviewed published studies on POC testing in RLS, and found no clearly defined metric for the clinical utility of POC testing. Therefore, we propose a framework for evaluating POC tests, and suggest and define the term “test efficacy” to describe a diagnostic test’s capacity to support a clinical decision within its operational context. We also proposed revised criteria for an ideal diagnostic POC test in resource-limited settings. Through systematic evaluations, comparisons between centralized diagnostic testing and novel POC technologies can be more formalized, and health officials can better determine which POC technologies represent valuable additions to their clinical programs. PMID:24332389

Estimation of metabolic factors related to insulin resistance and metabolic syndrome in young people.

PubMed

Płaczkowska, Sylwia; Pawlik-Sobecka, Lilla; Kokot, Izabela; Piwowar, Agnieszka

2018-05-09

Civilizational developments occurring during recent decades have resulted in an increased incidence of a variety of metabolic disorders related to insulin resistance in younger people. The determination of decision limits for insulin resistance indices, especially among young people, is a significant challenge in clinical practice. The aim of this study was the estimation of metabolic factors related to their relationship to insulin resistance and metabolic syndrome (MS) features in young, apparently healthy people. Moreover, we evaluated the optimal decision limits for patients with MS identification for HOMA1-IR, HOMA2-IR, HOMA2 obtained from C-peptide concentrations. 349 apparently healthy people aged 18-31 (260 women and 89 men), were enrolled in this study. The present analysis of metabolic, anthropometric and clinical parameters observed them in clusters covering the criteria of MS recognition, but MS in this group was only partially related to insulin resistance. The HOMA1-IR decision limit estimation is likely to became be useful in the prognostication of metabolic disturbances in young, apparently healthy people. A measure of insulin resistance that can provide a reliable early prediction of MS is likely to provide an opportunity for instigating preventive measures of significant clinical utility.

Implementation of workflow engine technology to deliver basic clinical decision support functionality.

PubMed

Huser, Vojtech; Rasmussen, Luke V; Oberg, Ryan; Starren, Justin B

2011-04-10

Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform.

Informed decision making before initiating screening mammography: does it occur and does it make a difference?

PubMed

Nekhlyudov, Larissa; Li, Rong; Fletcher, Suzanne W

2008-12-01

Informed decision making regarding screening mammography is recommended for women under age 50. To what extent it occurs in clinical settings is unclear. Using a mailed instrument, we surveyed women aged 40-44 prior to their first screening mammogram. All women were members of a large health maintenance organization and received care at a large medical practice in the Greater Boston area. The survey measured informed decision making, decisional conflict, satisfaction, and screening mammography knowledge and intentions to undergo screening. Ninety-six women responded to the survey (response rate 47%). Overall, women reported limited informed decision making regarding screening mammography, both with respect to information exchange and involvement in the decision process. Less than half (47%) reported discussing the benefits of screening; 23% the uncertainties; and only 7% the harms. About 30% reported discussing the nature of the decision or clinical issue; and 29% reported their provider elicited their preferred role in the decision; 38% their preferences; and 24% their understanding of the information. Women who were uninformed had higher decisional conflict (2.37 vs. 1.83, P=0.005) about screening mammography and were more likely to be dissatisfied with the information and involvement. Women's screening mammography knowledge was limited in most areas; however being presented with information did not diminish their intentions to undergo screening. Informed decision making before initiating screening mammography is limited in this setting. There appears to be little indication that information about the benefits and harms decreases women's intentions to undergo screening. Methods to communicate information to women before initiating screening mammography are needed.

Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE).

PubMed

Hammerer-Lercher, Angelika; Collinson, Paul; van Dieijen-Visser, Marja P; Pulkki, Kari; Suvisaari, Janne; Ravkilde, Jan; Stavljenic-Rukavina, Ana; Baum, Hannsjörg; Laitinen, Päivi

2013-06-01

Natriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe. Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing. There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006. The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

[Decisions on limiting treatment in critically-ill neonates: a multicenter study].

PubMed

2002-12-01

Backgrounds Some patients with a poor prognosis cause serious doubts about the real benefit of life-sustaining treatment. In some cases the possibility of limiting those treatments is raised. Such end-of-life decisions provoke ethical dilemmas and questions about procedure.ObjectivesTwo determine the frequency of end-of-life decisions in neonates, patient characteristics, and the criteria used by those taking decisions.Patients and methodsWe performed a multicenter, descriptive, prospective study. Neonates from 15 neonatal intensive care units who died during their stay in the hospital between 1999 and 2000, as well as those in whom end-of-life decisions were taken, were included. End-of-life decisions were defined as clinical decisions to withhold or withdraw life-sustaining treatment.ResultsA total of 330 patients were included. End-of-life decisions were taken in 171 (52 %); of these, 169 (98.8 %) died. The remaining 159 patients (48.2 %) died without treatment limitation. The main disorders involving end-of-life decisions were congenital malformation (47 %), neurologic disorders secondary to perinatal asphyxia and intracranial hemorrhage-periventricular leukomalacia (37 %). Of the 171 neonates, treatment was withheld in 80 and vital support was withdrawn in 91. The most frequently withdrawn life-sustaining treatment was mechanical ventilation (68 %). The criteria most commonly used in end-of-life decisions were poor vital prognosis (79.5 %), and current and future quality of life (37 % and 48 % respectively). The patient's external factors such as unfavorable family environment or possible negative consequences for familial equilibrium were a factor in 5 % of decisions.ConclusionsThe present study, the first of this type performed in Spain, reveals little-known aspects about the clinical practice of withholding and/or withdrawing life-sustaining treatment in critically ill neonates. End-of-life decisions were frequent (52 %) and were followed by death in most of the patients (98,8 %). The main criteria in decision-making were poor vital prognosis and the patient's current and future quality of life.

Applicability of randomized trials in radiation oncology to standard clinical practice.

PubMed

Apisarnthanarax, Smith; Swisher-McClure, Samuel; Chiu, Wing K; Kimple, Randall J; Harris, Stephen L; Morris, David E; Tepper, Joel E

2013-08-15

Randomized controlled trials (RCTs) are commonly used to inform clinical practice; however, it is unclear how generalizable RCT data are to patients in routine clinical practice. The authors of this report assessed the availability and applicability of randomized evidence guiding medical decisions in a cohort of patients who were evaluated for consideration of definitive management in a radiation oncology clinic. The medical records of consecutive, new patient consultations between January and March 2007 were reviewed. Patient medical decisions were classified as those with (Group 1) or without (Group 2) available, relevant level I evidence (phase 3 RCT) supporting recommended treatments. Group 1 medical decisions were further divided into 3 groups based on the extent of fulfilling eligibility criteria for each RCT: Group 1A included decisions that fulfilled all eligibility criteria; Group 1B, decisions that did not fulfill at least 1 minor eligibility criteria; or Group 1C, decisions that did not fulfill at least 1 major eligibility criteria. Patient and clinical characteristics were tested for correlations with the availability of evidence. Of the 393 evaluable patients, malignancies of the breast (30%), head and neck (18%), and genitourinary system (14%) were the most common presenting primary disease sites. Forty-seven percent of all medical decisions (n = 451) were made without available (36%) or applicable (11%) randomized evidence to inform clinical decision making. Primary tumor diagnosis was significantly associated with the availability of evidence (P < .0001). A significant proportion of medical decisions in an academic radiation oncology clinic were made without available or applicable level I evidence, underscoring the limitations of relying solely on RCTs for the development of evidence-based health care. Copyright © 2013 American Cancer Society.

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PubMed

Hollen, Patricia J; Gralla, Richard J; Jones, Randy A; Thomas, Christopher Y; Brenin, David R; Weiss, Geoffrey R; Schroen, Anneke T; Petroni, Gina R

2013-03-01

Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

Clinical errors that can occur in the treatment decision-making process in psychotherapy.

PubMed

Park, Jake; Goode, Jonathan; Tompkins, Kelley A; Swift, Joshua K

2016-09-01

Clinical errors occur in the psychotherapy decision-making process whenever a less-than-optimal treatment or approach is chosen when working with clients. A less-than-optimal approach may be one that a client is unwilling to try or fully invest in based on his/her expectations and preferences, or one that may have little chance of success based on contraindications and/or limited research support. The doctor knows best and the independent choice models are two decision-making models that are frequently used within psychology, but both are associated with an increased likelihood of errors in the treatment decision-making process. In particular, these models fail to integrate all three components of the definition of evidence-based practice in psychology (American Psychological Association, 2006). In this article we describe both models and provide examples of clinical errors that can occur in each. We then introduce the shared decision-making model as an alternative that is less prone to clinical errors. PsycINFO Database Record (c) 2016 APA, all rights reserved

A medical informatics perspective on clinical decision support systems. Findings from the yearbook 2013 section on decision support.

PubMed

Bouaud, J; Lamy, J-B

2013-01-01

To summarize excellent research and to select best papers published in 2012 in the field of computer-based decision support in healthcare. A bibliographic search focused on clinical decision support systems (CDSSs) and computer provider order entry was performed, followed by a double-blind literature review. The review process yielded six papers, illustrating various aspects of clinical decision support. The first paper is a systematic review of CDSS intervention trials in real settings, and considers different types of possible outcomes. It emphasizes the heterogeneity of studies and confirms that CDSSs can improve process measures but that evidence lacks for other types of outcomes, especially clinical or economic. Four other papers tackle the safety of drug prescribing and show that CDSSs can be efficient in reducing prescription errors. The sixth paper exemplifies the growing role of ontological resources which can be used for several applications including decision support. CDSS research has to be continuously developed and assessed. The wide variety of systems and of interventions limits the understanding of factors of success of CDSS implementations. A standardization in the characterization of CDSSs and of intervention trial reporting will help to overcome this obstacle.

Medical decision and patient's preference: 'much ethics' and more trust always needed.

PubMed

Anyfantakis, Dimitrios; Symvoulakis, Emmanouil K

2011-01-01

There is much discussion on medical ethics literature regarding the importance of the patients' right for self-determination. We discuss some of the limitations of patient's autonomy with the aim to draw attention to the ethical complexity of medical decision making in the everyday clinical practice.

Implementation of workflow engine technology to deliver basic clinical decision support functionality

PubMed Central

2011-01-01

Background Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. Results We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. Conclusions We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform. PMID:21477364

Cancer patient decision making related to clinical trial participation: an integrative review with implications for patients' relational autonomy.

PubMed

Bell, Jennifer A H; Balneaves, Lynda G

2015-04-01

Oncology clinical trials are necessary for the improvement of patient care as they have the ability to confirm the efficacy and safety of novel cancer treatments and in so doing, contribute to a solid evidence base on which practitioners and patients can make informed treatment decisions. However, only 3-5 % of adult cancer patients enroll in clinical trials. Lack of participation compromises the success of clinical trials and squanders an opportunity for improving patient outcomes. This literature review summarizes the factors and contexts that influence cancer patient decision making related to clinical trial participation. An integrative review was undertaken within PubMed, CINAHL, and EMBASE databases for articles written between 1995 and 2012 and archived under relevant keywords. Articles selected were data-based, written in English, and limited to adult cancer patients. In the 51 articles reviewed, three main types of factors were identified that influence cancer patients' decision making about participation in clinical trials: personal, social, and system factors. Subthemes included patients' trust in their physician and the research process, undue influence within the patient-physician relationship, and systemic social inequalities. How these factors interact and influence patients' decision-making process and relational autonomy, however, is insufficiently understood. Future research is needed to further elucidate the sociopolitical barriers and facilitators of clinical trial participation and to enhance ethical practice within clinical trial enrolment. This research will inform targeted education and support interventions to foster patients' relational autonomy in the decision-making process and potentially improve clinical trial participation rates.

Clinical decision-making and therapeutic approaches in osteopathy - a qualitative grounded theory study.

PubMed

Thomson, Oliver P; Petty, Nicola J; Moore, Ann P

2014-02-01

There is limited understanding of how osteopaths make decisions in relation to clinical practice. The aim of this research was to construct an explanatory theory of the clinical decision-making and therapeutic approaches of experienced osteopaths in the UK. Twelve UK registered osteopaths participated in this constructivist grounded theory qualitative study. Purposive and theoretical sampling was used to select participants. Data was collected using semi-structured interviews which were audio-recorded and transcribed. As the study approached theoretical sufficiency, participants were observed and video-recorded during a patient appointment, which was followed by a video-prompted interview. Constant comparative analysis was used to analyse and code data. Data analysis resulted in the construction of three qualitatively different therapeutic approaches which characterised participants and their clinical practice, termed; Treater, Communicator and Educator. Participants' therapeutic approach influenced their approach to clinical decision-making, the level of patient involvement, their interaction with patients, and therapeutic goals. Participants' overall conception of practice lay on a continuum ranging from technical rationality to professional artistry, and contributed to their therapeutic approach. A range of factors were identified which influenced participants' conception of practice. The findings indicate that there is variation in osteopaths' therapeutic approaches to practice and clinical decision-making, which are influenced by their overall conception of practice. This study provides the first explanatory theory of the clinical decision-making and therapeutic approaches of osteopaths. Copyright © 2013 Elsevier Ltd. All rights reserved.

Design, implementation, use, and preliminary evaluation of SEBASTIAN, a standards-based Web service for clinical decision support.

PubMed

Kawamoto, Kensaku; Lobach, David F

2005-01-01

Despite their demonstrated ability to improve care quality, clinical decision support systems are not widely used. In part, this limited use is due to the difficulty of sharing medical knowledge in a machine-executable format. To address this problem, we developed a decision support Web service known as SEBASTIAN. In SEBASTIAN, individual knowledge modules define the data requirements for assessing a patient, the conclusions that can be drawn using that data, and instructions on how to generate those conclusions. Using standards-based XML messages transmitted over HTTP, client decision support applications provide patient data to SEBASTIAN and receive patient-specific assessments and recommendations. SEBASTIAN has been used to implement four distinct decision support systems; an architectural overview is provided for one of these systems. Preliminary assessments indicate that SEBASTIAN fulfills all original design objectives, including the re-use of executable medical knowledge across diverse applications and care settings, the straightforward authoring of knowledge modules, and use of the framework to implement decision support applications with significant clinical utility.

Echocardiography for Intraoperative Decision Making in Mitral Valve Surgery-A Pilot Simulation-Based Training Module.

PubMed

Morais, Rex Joseph; Ashokka, Balakrishnan; Paranjothy, Suresh; Siau, Chiang; Ti, Lian Kah

2017-10-01

Echocardiographic assessment of the repaired or replaced mitral valve intraoperatively involves making a high-impact joint decision with the surgeon, in a time-sensitive manner, in a dynamic clinical situation. These decisions have to take into account the degree of imperfection if any, the likelihood of obtaining a better result, the underlying condition of the patient, and the impact of a longer cardiopulmonary bypass period if the decision is made to reintervene. Traditional echocardiography teaching is limited in its ability to provide this training. The authors report the development and implementation of a training module simulating the dynamic clinical environment of a mitral valve surgery in progress and the critical echo-based intraoperative decision making involved in the assessment of the acceptability of the surgical result. Copyright © 2017 Elsevier Inc. All rights reserved.

Shared Decision Making at the Limit of Viability: A Blueprint for Physician Action

PubMed Central

2016-01-01

Objective To document interactions during the antenatal consultation between parents and neonatologist that parents linked to their satisfaction with their participation in shared decision making for their infant at risk of being born at the limit of viability. Methods This multiple-case ethnomethodological qualitative research study, included mothers admitted for a threatened premature delivery between 200/7 and 266/7 weeks gestation, the father, and the staff neonatologist conducting the clinical antenatal consultation. Content analysis of an audiotaped post-antenatal consultation interview with parents obtained their satisfaction scores as well as their comments on physician actions that facilitated their desired participation. Results Five cases, each called a “system—infant at risk”, included 10 parents and 6 neonatologists. From the interviews emerged a blueprint for action by physicians, including communication strategies that parents say facilitated their participation in decision making; such as building trustworthy physician-parent relationships, providing "balanced" information, offering choices, and allowing time to think. Conclusion Parent descriptions indicate that the opportunity to participate to their satisfaction in the clinical antenatal consultation depends on how the physician interacts with them. Practice implications The parent-identified communication strategies facilitate shared decision making regarding treatment in the best interest of the infant at risk to be born at the limit of viability. PMID:27893823

Implementation of Patient Decision Support Interventions in Primary Care: The Role of Relational Coordination.

PubMed

Tietbohl, Caroline K; Rendle, Katharine A S; Halley, Meghan C; May, Suepattra G; Lin, Grace A; Frosch, Dominick L

2015-11-01

The benefits of patient decision support interventions (DESIs) have been well documented. However, DESIs remain difficult to incorporate into clinical practice. Relational coordination (RC) has been shown to improve performance and quality of care in health care settings. This study aims to demonstrate how applying RC theory to DESI implementation could elucidate underlying issues limiting widespread uptake. Five primary care clinics in Northern California participated in a DESI implementation project. We used a deductive thematic approach guided by behaviors outlined in RC theory to analyze qualitative data collected from ethnographic field notes documenting the implementation process and focus groups with health care professionals. We then systematically compared the qualitative findings with quantitative DESI distribution data. Based on DESI distribution rates, clinics were placed into 3 performance categories: high, middle, and low. Qualitative data illustrated how each clinic's performance related to RC behaviors. Consistent with RC theory, the high-performing clinic exhibited frequent, timely, and accurate communication and positive working relationships. The 3 middle-performing clinics exhibited high-quality communication within physician-staff teams but limited communication regarding DESI implementation across the clinic. The lowest-performing clinic was characterized by contentious relationships and inadequate communication. Limitations of the study include nonrandom selection of clinics and limited geographic diversity. In addition, ethnographic data collected documented only DESI implementation practices and not larger staff interactions contributing to RC. These findings suggest that a high level of RC within clinical settings may be a key component and facilitator of successful DESI implementation. Future attempts to integrate DESIs into clinical practice should consider incorporating interventions designed to increase positive RC behaviors as a potential means to improve uptake. © The Author(s) 2015.

Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Ledford, Christy J. W.; Womack, Jasmyne J.; Rider, Heather A.; Seehusen, Angela B.; Conner, Stephen J.; Lauters, Rebecca A.; Hodge, Joshua A.

2018-01-01

Background: As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing…

Medical Decision and Patient's Preference: 'Much Ethics' and More Trust Always Needed

PubMed Central

Anyfantakis, Dimitrios; Symvoulakis, Emmanouil K

2011-01-01

There is much discussion on medical ethics literature regarding the importance of the patients' right for self-determination. We discuss some of the limitations of patient's autonomy with the aim to draw attention to the ethical complexity of medical decision making in the everyday clinical practice. PMID:21647328

Assessment of Competence in Clinical Reasoning and Decision-Making under Uncertainty: The Script Concordance Test Method

ERIC Educational Resources Information Center

Ramaekers, Stephan; Kremer, Wim; Pilot, Albert; van Beukelen, Peter; van Keulen, Hanno

2010-01-01

Real-life, complex problems often require that decisions are made despite limited information or insufficient time to explore all relevant aspects. Incorporating authentic uncertainties into an assessment, however, poses problems in establishing results and analysing their methodological qualities. This study aims at developing a test on clinical…

Reference intervals: current status, recent developments and future considerations.

PubMed

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term 'RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. 
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

Reference intervals: current status, recent developments and future considerations

PubMed Central

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. PMID:26981015

Evidence-based medicine, clinical practice guidelines, and common sense in the management of osteoporosis.

PubMed

Lewiecki, E Michael; Binkley, Neil

2009-01-01

To evaluate the benefits and limitations of randomized controlled trials (RCTs), clinical practice guidelines (CPGs), and clinical judgment in the management of osteoporosis. A review was conducted of the English-language literature on the origins and applications of RCTs, CPGs, evidence-based medicine, and clinical judgment in the management of osteoporosis. Evidence-based medicine is use of the currently available best evidence in making clinical decisions for individual patients. CPGs are recommendations for making clinical decisions based on research evidence, sometimes with consideration of expert opinion, health care policy, and costs of care. The highest levels of medical evidence are usually thought to be RCTs and meta-analyses of high-quality RCTs. Although it is desirable and appropriate for clinicians to consider research evidence from RCTs and recommendations presented in CPGs in making clinical decisions, other factors-such as patient preference, comorbidities, affordability, and availability of care-are important for the actual implementation of evidence-based medicine. Decisions about who to treat, which drug to use, how best to monitor, and how long to treat require clinical skills in addition to knowledge of medical research. The necessity of integrating common sense and clinical judgment is highlighted by the fact that many patients treated for osteoporosis in clinical practice would not qualify for participation in the pivotal clinical trials that demonstrated efficacy and safety of the drugs used to treat them.

Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-03-20

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2013 Elsevier B.V. All rights reserved.

Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

PubMed

Hyltoft Petersen, Per; Klee, George G

2014-05-15

Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2014. Published by Elsevier B.V.

Health Technology Assessment and Private Payers' Coverage of Personalized Medicine

PubMed Central

Trosman, Julia R.; Van Bebber, Stephanie L.; Phillips, Kathryn A.

2011-01-01

Purpose: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice. Study Design: Literature review and semistructured interviews. Methods: We reviewed seven HTA organizations used by private payers in decision making and explored how HTA is used by major US private payers (n = 11) for coverage of personalized medicine. Results: All payers used HTA in coverage decisions, but the number of HTA organizations used by an individual payer ranged from one (n = 1) to all seven (n = 1), with the majority of payers (n = 8) using three or more. Payers relied more extensively on HTAs for reviews of personalized medicine (64%) than for other technologies. Most payers (82%) equally valued expertise of reviewers and rigor of evaluation as HTA strengths, whereas genomic-specific methodology was less important. Key reported shortcomings were limited availability of reviews (73%) and limited inclusion of nonclinical factors (91%), such as cost-effectiveness or adoption of technology in clinical practice. Conclusion: Payers use a range of HTAs in their coverage decisions related to personalized medicine, but the current state of HTA to comprehensively guide those decisions is limited. HTA organizations should address current gaps to improve their relevance to payers and clinicians. Current HTA shortcomings may also inform the national HTA agenda. PMID:21886515

Use of Decision Models in the Development of Evidence-Based Clinical Preventive Services Recommendations: Methods of the U.S. Preventive Services Task Force.

PubMed

Owens, Douglas K; Whitlock, Evelyn P; Henderson, Jillian; Pignone, Michael P; Krist, Alex H; Bibbins-Domingo, Kirsten; Curry, Susan J; Davidson, Karina W; Ebell, Mark; Gillman, Matthew W; Grossman, David C; Kemper, Alex R; Kurth, Ann E; Maciosek, Michael; Siu, Albert L; LeFevre, Michael L

2016-10-04

The U.S. Preventive Services Task Force (USPSTF) develops evidence-based recommendations about preventive care based on comprehensive systematic reviews of the best available evidence. Decision models provide a complementary, quantitative approach to support the USPSTF as it deliberates about the evidence and develops recommendations for clinical and policy use. This article describes the rationale for using modeling, an approach to selecting topics for modeling, and how modeling may inform recommendations about clinical preventive services. Decision modeling is useful when clinical questions remain about how to target an empirically established clinical preventive service at the individual or program level or when complex determinations of magnitude of net benefit, overall or among important subpopulations, are required. Before deciding whether to use decision modeling, the USPSTF assesses whether the benefits and harms of the preventive service have been established empirically, assesses whether there are key issues about applicability or implementation that modeling could address, and then defines the decision problem and key questions to address through modeling. Decision analyses conducted for the USPSTF are expected to follow best practices for modeling. For chosen topics, the USPSTF assesses the strengths and limitations of the systematically reviewed evidence and the modeling analyses and integrates the results of each to make preventive service recommendations.

External validation and clinical utility of a prediction model for 6-month mortality in patients undergoing hemodialysis for end-stage kidney disease.

PubMed

Forzley, Brian; Er, Lee; Chiu, Helen Hl; Djurdjev, Ognjenka; Martinusen, Dan; Carson, Rachel C; Hargrove, Gaylene; Levin, Adeera; Karim, Mohamud

2018-02-01

End-stage kidney disease is associated with poor prognosis. Health care professionals must be prepared to address end-of-life issues and identify those at high risk for dying. A 6-month mortality prediction model for patients on dialysis derived in the United States is used but has not been externally validated. We aimed to assess the external validity and clinical utility in an independent cohort in Canada. We examined the performance of the published 6-month mortality prediction model, using discrimination, calibration, and decision curve analyses. Data were derived from a cohort of 374 prevalent dialysis patients in two regions of British Columbia, Canada, which included serum albumin, age, peripheral vascular disease, dementia, and answers to the "the surprise question" ("Would I be surprised if this patient died within the next year?"). The observed mortality in the validation cohort was 11.5% at 6 months. The prediction model had reasonable discrimination (c-stat = 0.70) but poor calibration (calibration-in-the-large = -0.53 (95% confidence interval: -0.88, -0.18); calibration slope = 0.57 (95% confidence interval: 0.31, 0.83)) in our data. Decision curve analysis showed the model only has added value in guiding clinical decision in a small range of threshold probabilities: 8%-20%. Despite reasonable discrimination, the prediction model has poor calibration in this external study cohort; thus, it may have limited clinical utility in settings outside of where it was derived. Decision curve analysis clarifies limitations in clinical utility not apparent by receiver operating characteristic curve analysis. This study highlights the importance of external validation of prediction models prior to routine use in clinical practice.

Withholding or withdrawing of life-sustaining therapy in older adults (≥ 80 years) admitted to the intensive care unit.

PubMed

Guidet, Bertrand; Flaatten, Hans; Boumendil, Ariane; Morandi, Alessandro; Andersen, Finn H; Artigas, Antonio; Bertolini, Guido; Cecconi, Maurizio; Christensen, Steffen; Faraldi, Loredana; Fjølner, Jesper; Jung, Christian; Marsh, Brian; Moreno, Rui; Oeyen, Sandra; Öhman, Christina Agwald; Pinto, Bernardo Bollen; Soliman, Ivo W; Szczeklik, Wojciech; Valentin, Andreas; Watson, Ximena; Zafeiridis, Tilemachos; De Lange, Dylan W

2018-05-17

To document and analyse the decision to withhold or withdraw life-sustaining treatment (LST) in a population of very old patients admitted to the ICU. This prospective study included intensive care patients aged ≥ 80 years in 309 ICUs from 21 European countries with 30-day mortality follow-up. LST limitation was identified in 1356/5021 (27.2%) of patients: 15% had a withholding decision and 12.2% a withdrawal decision (including those with a previous withholding decision). Patients with LST limitation were older, more frail, more severely ill and less frequently electively admitted. Patients with withdrawal of LST were more frequently male and had a longer ICU length of stay. The ICU and 30-day mortality were, respectively, 29.1 and 53.1% in the withholding group and 82.2% and 93.1% in the withdrawal group. LST was less frequently limited in eastern and southern European countries than in northern Europe. The patient-independent factors associated with LST limitation were: acute ICU admission (OR 5.77, 95% CI 4.32-7.7), Clinical Frailty Scale (CFS) score (OR 2.08, 95% CI 1.78-2.42), increased age (each 5 years of increase in age had a OR of 1.22 (95% CI 1.12-1.34) and SOFA score [OR of 1.07 (95% CI 1.05-1.09 per point)]. The frequency of LST limitation was higher in countries with high GDP and was lower in religious countries. The most important patient variables associated with the instigation of LST limitation were acute admission, frailty, age, admission SOFA score and country. ClinicalTrials.gov (ID: NTC03134807).

Progress in evidence-based medicine: a quarter century on.

PubMed

Djulbegovic, Benjamin; Guyatt, Gordon H

2017-07-22

In response to limitations in the understanding and use of published evidence, evidence-based medicine (EBM) began as a movement in the early 1990s. EBM's initial focus was on educating clinicians in the understanding and use of published literature to optimise clinical care, including the science of systematic reviews. EBM progressed to recognise limitations of evidence alone, and has increasingly stressed the need to combine critical appraisal of the evidence with patient's values and preferences through shared decision making. In another progress, EBM incorporated and further developed the science of producing trustworthy clinical practice guidelines pioneered by investigators in the 1980s. EBM's enduring contributions to clinical medicine include placing the practice of medicine on a solid scientific basis, the development of more sophisticated hierarchies of evidence, the recognition of the crucial role of patient values and preferences in clinical decision making, and the development of the methodology for generating trustworthy recommendations. Copyright © 2017 Elsevier Ltd. All rights reserved.

Multimorbidity, service organization and clinical decision making in primary care: a qualitative study.

PubMed

Bower, Peter; Macdonald, Wendy; Harkness, Elaine; Gask, Linda; Kendrick, Tony; Valderas, Jose M; Dickens, Chris; Blakeman, Tom; Sibbald, Bonnie

2011-10-01

Primary care professionals often manage patients with multiple long-term health conditions, but managing multimorbidity is challenging given time and resource constraints and interactions between conditions. To explore GP and nurse perceptions of multimorbidity and the influence on service organization and clinical decision making. A qualitative interview study with primary care professionals in practices in Greater Manchester, U.K. Interviews were conducted with 15 GPs and 10 practice nurses. Primary care professionals identified tensions between delivering care to meet quality targets and fulfilling the patient's agenda, tensions which are exacerbated in multimorbidity. They were aware of the inconvenience suffered by patients through attendance at multiple clinic appointments when care was structured around individual conditions. They reported difficulties managing patients with multimorbidity in limited consultation time, which led to adoption of an 'additive-sequential' decision-making model which dealt with problems in priority order until consultation resources were exhausted, when further management was deferred. Other challenges included the need for patients to co-ordinate their care, the difficulties of self-management support in multimorbidity and problems of making sense of the relationships between physical and mental health. Doctor and nurse accounts included limited consideration of multimorbidity in terms of the interactions between conditions or synergies between management of different conditions. Primary care professionals identify a number of challenges in care for multimorbidity and adopt a particular model of decision making to deliver care for multiple individual conditions. However, they did not describe specific decision making around managing multimorbidity per se.

Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013.

PubMed

Pauwels, Kim; Huys, Isabelle; De Nys, Katelijne; Casteels, Minne; Simoens, Steven

2015-01-01

Price setting and reimbursement decisions regarding drugs are competence of individual member states in Europe. These decisions involve important trade-offs between social, ethical, clinical and economic criteria. The aim of this study was to investigate the relative importance of criteria for reimbursement of oncology drugs in Belgium. Reimbursement dossiers on oncology drugs for which reimbursement was applied between 2002 and 2013 were consulted. Multivariate logistic regression was performed. Results showed that clinical evidence and presence of alternative treatments have a significant impact on the reimbursement decisions. Evidence-based medicine still plays a role in Belgian reimbursement decision-making. In order to allow transition towards value-based medicine and avoid spending money on products with limited incremental benefit, therapeutic need at patient level need to be taken into account.

A study of diverse clinical decision support rule authoring environments and requirements for integration

PubMed Central

2012-01-01

Background Efficient rule authoring tools are critical to allow clinical Knowledge Engineers (KEs), Software Engineers (SEs), and Subject Matter Experts (SMEs) to convert medical knowledge into machine executable clinical decision support rules. The goal of this analysis was to identify the critical success factors and challenges of a fully functioning Rule Authoring Environment (RAE) in order to define requirements for a scalable, comprehensive tool to manage enterprise level rules. Methods The authors evaluated RAEs in active use across Partners Healthcare, including enterprise wide, ambulatory only, and system specific tools, with a focus on rule editors for reminder and medication rules. We conducted meetings with users of these RAEs to discuss their general experience and perceived advantages and limitations of these tools. Results While the overall rule authoring process is similar across the 10 separate RAEs, the system capabilities and architecture vary widely. Most current RAEs limit the ability of the clinical decision support (CDS) interventions to be standardized, sharable, interoperable, and extensible. No existing system meets all requirements defined by knowledge management users. Conclusions A successful, scalable, integrated rule authoring environment will need to support a number of key requirements and functions in the areas of knowledge representation, metadata, terminology, authoring collaboration, user interface, integration with electronic health record (EHR) systems, testing, and reporting. PMID:23145874

Exploring Decision-Making of HIV-Infected Hispanics and African Americans Participating in Clinical Trials

PubMed Central

Rivera-Goba, Migdalia V.; Dominguez, Dinora C.; Stoll, Pamela; Grady, Christine; Ramos, Catalina; Mican, JoAnn M.

2011-01-01

Underrepresentation of HIV-infected Hispanics and African Americans in clinical trials seriously limits our understanding of the benefits and risks of treatment in these populations. This qualitative study examined factors that racial/ethnic minority patients consider when making decisions regarding research participation. Thirty-five HIV-infected Hispanic and African American patients enrolled in clinical research protocols at the National Institutes of Health were recruited to participate in focus groups and in-depth interviews. The sample of mostly men (n = 22), had a mean age of 45, nearly equal representation of race/ethnicity, and diagnosed 2 to 22 years ago. Baseline questionnaires included demographics and measures of social support and acculturation. Interviewers had similar racial/ethnic, cultural, and linguistic backgrounds as the participants. Four major themes around participants’ decisions to enroll in clinical trials emerged: Enhancers, Barriers, Beliefs, and Psychosocial Context. Results may help researchers develop strategies to facilitate inclusion of HIV-infected Hispanics and African Americans into clinical trials. PMID:21256054

The utility of observational studies in clinical decision making: lessons learned from statin trials.

PubMed

Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

2010-05-01

Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

The role (or not) of economic evaluation at the micro level: can Bourdieu's theory provide a way forward for clinical decision-making?

PubMed

Lessard, Chantale; Contandriopoulos, André-Pierre; Beaulieu, Marie-Dominique

2010-06-01

Despite increasing interest in health economic evaluation, investigations have shown limited use by micro (clinical) level decision-makers. A considerable amount of health decisions take place daily at the point of the clinical encounter; especially in primary care. Since every decision has an opportunity cost, ignoring economic information in family physicians' (FPs) decision-making may have a broad impact on health care efficiency. Knowledge translation of economic evaluation is often based on taken-for-granted assumptions about actors' interests and interactions, neglecting much of the complexity of social reality. Health economics literature frequently assumes a rational and linear decision-making process. Clinical decision-making is in fact a complex social, dynamic, multifaceted process, involving relationships and contextual embeddedness. FPs are embedded in complex social networks that have a significant impact on skills, attitudes, knowledge, practices, and on the information being used. Because of their socially constructed nature, understanding preferences, professional culture, practices, and knowledge translation requires serious attention to social reality. There has been little exploration by health economists of whether the problem may be more fundamental and reside in a misunderstanding of the process of decision-making. There is a need to enhance our understanding of the role of economic evaluation in decision-making from a disciplinary perspective different than health economics. This paper argues for a different conceptualization of the role of economic evaluation in FPs' decision-making, and proposes Bourdieu's sociological theory as a research framework. Bourdieu's theory of practice illustrates how the context-sensitive nature of practice must be understood as a socially constituted practical knowledge. The proposed approach could substantially contribute to a more complex understanding of the role of economic evaluation in FPs' decision-making. Copyright 2010 Elsevier Ltd. All rights reserved.

The laboratory diagnosis of testosterone deficiency.

PubMed

Paduch, Darius A; Brannigan, Robert E; Fuchs, Eugene F; Kim, Edward D; Marmar, Joel L; Sandlow, Jay I

2014-05-01

The evaluation and treatment of hypogonadal men has become an important part of urologic practice. Fatigue, loss of libido, and erectile dysfunction are commonly reported, but nonspecific symptoms and laboratory verification of low testosterone (T) are an important part of evaluation in addition to a detailed history and physical examination. Significant intraindividual fluctuations in serum T levels, biologic variation of T action on end organs, the wide range of T levels in human serum samples, and technical limitations of currently available assays have led to poor reliability of T measurements in the clinical laboratory setting. There is no universally accepted threshold of T concentration that distinguishes eugonadal from hypogonadal men; thus, laboratory results have to be interpreted in the appropriate clinical setting. This review focuses on clinical, biological, and technological challenges that affect serum T measurements to educate clinicians regarding technological advances and limitations of the currently available laboratory methods to diagnose hypogonadism. A collaborative effort led by the American Urological Association between practicing clinicians, patient advocacy groups, government regulatory agencies, industry, and professional societies is underway to provide optimized assay platforms and evidence-based normal assay ranges to guide clinical decision making. Until such standardization is commonplace in clinical laboratories, the decision to treat should be based on the presence of signs and symptoms in addition to serum T measurements. Rigid interpretation of T ranges should not dictate clinical decision making or define coverage of treatment by third party payers. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical and regulatory considerations in pharmacogenetic testing.

PubMed

Schuck, Robert N; Marek, Elizabeth; Rogers, Hobart; Pacanowski, Michael

2016-12-01

Both regulatory science and clinical practice rely on best available scientific data to guide decision-making. However, changes in clinical practice may be driven by numerous other factors such as cost. In this review, we reexamine noteworthy examples where pharmacogenetic testing information was added to drug labeling to explore how the available evidence, potential public health impact, and predictive utility of each pharmacogenetic biomarker impacts clinical uptake. Advances in the field of pharmacogenetics have led to new discoveries about the genetic basis for variability in drug response. The Food and Drug Administration recognizes the value of pharmacogenetic testing strategies and has been proactive about incorporating pharmacogenetic information into the labeling of both new drugs and drugs already on the market. Although some examples have readily translated to routine clinical practice, clinical uptake of genetic testing for many drugs has been limited. Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmacogenetic testing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

What is a medical decision? A taxonomy based on physician statements in hospital encounters: a qualitative study.

PubMed

Ofstad, Eirik H; Frich, Jan C; Schei, Edvin; Frankel, Richard M; Gulbrandsen, Pål

2016-02-11

The medical literature lacks a comprehensive taxonomy of decisions made by physicians in medical encounters. Such a taxonomy might be useful in understanding the physician-centred, patient-centred and shared decision-making in clinical settings. We aimed to identify and classify all decisions emerging in conversations between patients and physicians. Qualitative study of video recorded patient-physician encounters. 380 patients in consultations with 59 physicians from 17 clinical specialties and three different settings (emergency room, ward round, outpatient clinic) in a Norwegian teaching hospital. A randomised sample of 30 encounters from internal medicine was used to identify and classify decisions, a maximum variation sample of 20 encounters was used for reliability assessments, and the remaining encounters were analysed to test for applicability across specialties. On the basis of physician statements in our material, we developed a taxonomy of clinical decisions--the Decision Identification and Classification Taxonomy for Use in Medicine (DICTUM). We categorised decisions into 10 mutually exclusive categories: gathering additional information, evaluating test results, defining problem, drug-related, therapeutic procedure-related, legal and insurance-related, contact-related, advice and precaution, treatment goal, and deferment. Four-coder inter-rater reliability using Krippendorff's α was 0.79. DICTUM represents a precise, detailed and comprehensive taxonomy of medical decisions communicated within patient-physician encounters. Compared to previous normative frameworks, the taxonomy is descriptive, substantially broader and offers new categories to the variety of clinical decisions. The taxonomy could prove helpful in studies on the quality of medical work, use of time and resources, and understanding of why, when and how patients are or are not involved in decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

27 The DiPEP (Diagnosis of PE in Pregnancy) study: can clinical assessment, d-dimer or chest x-ray be used to select pregnant or postpartum women with suspected PE for diagnostic imaging?

PubMed

Goodacre, Steve; Horspool, Kimberley; Nelson-Piercy, Catherine; Knight, Marian; Shephard, Neil; Lecky, Fiona; Thomas, Steven; Hunt, Beverley; Fuller, Gordon

2017-12-01

To determine whether clinical features (in the form of a clinical decision rule) or d-dimer can be used to select pregnant or postpartum women with suspected PE for diagnostic imaging. Observational cohort study augmented with additional cases. Consultant-led maternity units participating in the UK Obstetric Surveillance System (UKOSS) and emergency departments and maternity units at eleven prospectively recruiting sites. 198 pregnant or postpartum women with diagnosed PE identified through UKOSS and 324 pregnant or postpartum women with suspected PE from prospectively recruiting sites. Data were collected relating to clinical features, elements of clinical decision rules, d-dimer measurements, diagnostic imaging, treatment for PE and adverse outcomes. Women were classified as having or not having PE on the basis of diagnostic imaging, treatment and subsequent adverse outcomes. Primary analysis was limited to women with conclusive diagnostic imaging. Secondary analyses included women with clinically diagnosed or ruled out PE. The primary analysis included 181 women with PE and 259 without. Most clinical features showed no association with PE. The only exceptions were number of previous pregnancies over 24 weeks (p=0.017), no varicose veins (p=0.045), no recent long haul travel (p=0.006), recent surgery including caesarean section (p=0.001), increased temperature (p=0.003), low oxygen saturation (p<0.001), PE-related chest x-ray abnormality (p=0.01) and other chest x-ray abnormality (p=0.001).Clinical decision rules had areas under the receiver-operator characteristic curve ranging from 0.577 to 0.732. No clinically useful threshold for decision-making was identified for any rule. The sensitivities and specificities of d-dimer were 88.4% and 8.8% using the standard laboratory threshold and 69.8% and 32.8% using a pregnancy-specific threshold. Clinical decision rules, d-dimer and chest x-ray should not be used to select pregnant or postpartum women with suspected PE for diagnostic imaging. © 2017, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

Optimization of the decision-making process for the selection of therapeutics to undergo clinical testing for spinal cord injury in the North American Clinical Trials Network.

PubMed

Guest, James; Harrop, James S; Aarabi, Bizhan; Grossman, Robert G; Fawcett, James W; Fehlings, Michael G; Tator, Charles H

2012-09-01

The North American Clinical Trials Network (NACTN) includes 9 clinical centers funded by the US Department of Defense and the Christopher Reeve Paralysis Foundation. Its purpose is to accelerate clinical testing of promising therapeutics in spinal cord injury (SCI) through the development of a robust interactive infrastructure. This structure includes key committees that serve to provide longitudinal guidance to the Network. These committees include the Executive, Data Management, and Neurological Outcome Assessments Committees, and the Therapeutic Selection Committee (TSC), which is the subject of this manuscript. The NACTN brings unique elements to the SCI field. The Network's stability is not restricted to a single clinical trial. Network members have diverse expertise and include experts in clinical care, clinical trial design and methodology, pharmacology, preclinical and clinical research, and advanced rehabilitation techniques. Frequent systematic communication is assigned a high value, as is democratic process, fairness and efficiency of decision making, and resource allocation. This article focuses on how decision making occurs within the TSC to rank alternative therapeutics according to 2 main variables: quality of the preclinical data set, and fit with the Network's aims and capabilities. This selection process is important because if the Network's resources are committed to a therapeutic, alternatives cannot be pursued. A proposed methodology includes a multicriteria decision analysis that uses a Multi-Attribute Global Inference of Quality matrix to quantify the process. To rank therapeutics, the TSC uses a series of consensus steps designed to reduce individual and group bias and limit subjectivity. Given the difficulties encountered by industry in completing clinical trials in SCI, stable collaborative not-for-profit consortia, such as the NACTN, may be essential to clinical progress in SCI. The evolution of the NACTN also offers substantial opportunity to refine decision making and group dynamics. Making the best possible decisions concerning therapeutics selection for trial testing is a cornerstone of the Network's function.

A computerized clinical decision support system as a means of implementing depression guidelines.

PubMed

Trivedi, Madhukar H; Kern, Janet K; Grannemann, Bruce D; Altshuler, Kenneth Z; Sunderajan, Prabha

2004-08-01

The authors describe the history and current use of computerized systems for implementing treatment guidelines in general medicine as well as the development, testing, and early use of a computerized decision support system for depression treatment among "real-world" clinical settings in Texas. In 1999 health care experts from Europe and the United States met to confront the well-documented challenges of implementing treatment guidelines and to identify strategies for improvement. They suggested the integration of guidelines into computer systems that is incorporated into clinical workflow. Several studies have demonstrated improvements in physicians' adherence to guidelines when such guidelines are provided in a computerized format. Although computerized decision support systems are being used in many areas of medicine and have demonstrated improved patient outcomes, their use in psychiatric illness is limited. The authors designed and developed a computerized decision support system for the treatment of major depressive disorder by using evidence-based guidelines, transferring the knowledge gained from the Texas Medication Algorithm Project (TMAP). This computerized decision support system (CompTMAP) provides support in diagnosis, treatment, follow-up, and preventive care and can be incorporated into the clinical setting. CompTMAP has gone through extensive testing to ensure accuracy and reliability. Physician surveys have indicated a positive response to CompTMAP, although the sample was insufficient for statistical testing. CompTMAP is part of a new era of comprehensive computerized decision support systems that take advantage of advances in automation and provide more complete clinical support to physicians in clinical practice.

The role of decision analytic modeling in the health economic assessment of spinal intervention.

PubMed

Edwards, Natalie C; Skelly, Andrea C; Ziewacz, John E; Cahill, Kevin; McGirt, Matthew J

2014-10-15

Narrative review. To review the common tenets, strengths, and weaknesses of decision modeling for health economic assessment and to review the use of decision modeling in the spine literature to date. For the majority of spinal interventions, well-designed prospective, randomized, pragmatic cost-effectiveness studies that address the specific decision-in-need are lacking. Decision analytic modeling allows for the estimation of cost-effectiveness based on data available to date. Given the rising demands for proven value in spine care, the use of decision analytic modeling is rapidly increasing by clinicians and policy makers. This narrative review discusses the general components of decision analytic models, how decision analytic models are populated and the trade-offs entailed, makes recommendations for how users of spine intervention decision models might go about appraising the models, and presents an overview of published spine economic models. A proper, integrated, clinical, and economic critical appraisal is necessary in the evaluation of the strength of evidence provided by a modeling evaluation. As is the case with clinical research, all options for collecting health economic or value data are not without their limitations and flaws. There is substantial heterogeneity across the 20 spine intervention health economic modeling studies summarized with respect to study design, models used, reporting, and general quality. There is sparse evidence for populating spine intervention models. Results mostly showed that interventions were cost-effective based on $100,000/quality-adjusted life-year threshold. Spine care providers, as partners with their health economic colleagues, have unique clinical expertise and perspectives that are critical to interpret the strengths and weaknesses of health economic models. Health economic models must be critically appraised for both clinical validity and economic quality before altering health care policy, payment strategies, or patient care decisions. 4.

The value of decision tree analysis in planning anaesthetic care in obstetrics.

PubMed

Bamber, J H; Evans, S A

2016-08-01

The use of decision tree analysis is discussed in the context of the anaesthetic and obstetric management of a young pregnant woman with joint hypermobility syndrome with a history of insensitivity to local anaesthesia and a previous difficult intubation due to a tongue tumour. The multidisciplinary clinical decision process resulted in the woman being delivered without complication by elective caesarean section under general anaesthesia after an awake fibreoptic intubation. The decision process used is reviewed and compared retrospectively to a decision tree analytical approach. The benefits and limitations of using decision tree analysis are reviewed and its application in obstetric anaesthesia is discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Gatekeepers for Pragmatic Clinical Trials

PubMed Central

Whicher, Danielle M.; Miller, Jennifer E.; Dunham, Kelly M.; Joffe, Steven

2015-01-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g., clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the United States clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This manuscript provides a framework to help guide gatekeepers’ decision-making related to the use of resources for pragmatic clinical trials. These include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers’ decisions, including protection from harm and maximization of benefits, (2) advancement of organizational mission and values, and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers’ actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding the use of limited and valuable resources. PMID:26374683

Description and status update on GELLO: a proposed standardized object-oriented expression language for clinical decision support.

PubMed

Sordo, Margarita; Boxwala, Aziz A; Ogunyemi, Omolola; Greenes, Robert A

2004-01-01

A major obstacle to sharing computable clinical knowledge is the lack of a common language for specifying expressions and criteria. Such a language could be used to specify decision criteria, formulae, and constraints on data and action. Al-though the Arden Syntax addresses this problem for clinical rules, its generalization to HL7's object-oriented data model is limited. The GELLO Expression language is an object-oriented language used for expressing logical conditions and computations in the GLIF3 (GuideLine Interchange Format, v. 3) guideline modeling language. It has been further developed under the auspices of the HL7 Clinical Decision Support Technical Committee, as a proposed HL7 standard., GELLO is based on the Object Constraint Language (OCL), because it is vendor-independent, object-oriented, and side-effect-free. GELLO expects an object-oriented data model. Although choice of model is arbitrary, standardization is facilitated by ensuring that the data model is compatible with the HL7 Reference Information Model (RIM).

Medical sieve: a cognitive assistant for radiologists and cardiologists

NASA Astrophysics Data System (ADS)

Syeda-Mahmood, T.; Walach, E.; Beymer, D.; Gilboa-Solomon, F.; Moradi, M.; Kisilev, P.; Kakrania, D.; Compas, C.; Wang, H.; Negahdar, R.; Cao, Y.; Baldwin, T.; Guo, Y.; Gur, Y.; Rajan, D.; Zlotnick, A.; Rabinovici-Cohen, S.; Ben-Ari, R.; Guy, Amit; Prasanna, P.; Morey, J.; Boyko, O.; Hashoul, S.

2016-03-01

Radiologists and cardiologists today have to view large amounts of imaging data relatively quickly leading to eye fatigue. Further, they have only limited access to clinical information relying mostly on their visual interpretation of imaging studies for their diagnostic decisions. In this paper, we present Medical Sieve, an automated cognitive assistant for radiologists and cardiologists designed to help in their clinical decision-making. The sieve is a clinical informatics system that collects clinical, textual and imaging data of patients from electronic health records systems. It then analyzes multimodal content to detect anomalies if any, and summarizes the patient record collecting all relevant information pertinent to a chief complaint. The results of anomaly detection are then fed into a reasoning engine which uses evidence from both patient-independent clinical knowledge and large-scale patient-driven similar patient statistics to arrive at potential differential diagnosis to help in clinical decision making. In compactly summarizing all relevant information to the clinician per chief complaint, the system still retains links to the raw data for detailed review providing holistic summaries of patient conditions. Results of clinical studies in the domains of cardiology and breast radiology have already shown the promise of the system in differential diagnosis and imaging studies summarization.

Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials.

PubMed

Phillips, Patrick P J; Mendel, Carl M; Burger, Divan A; Crook, Angela M; Crook, Angela; Nunn, Andrew J; Dawson, Rodney; Diacon, Andreas H; Gillespie, Stephen H

2016-02-04

Despite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological markers measured during treatment and long-term clinical outcomes is critical to evaluate their usefulness for decision-making for both individual patient care and for advancing novel regimens into time-consuming and expensive pivotal phase III trials. Using data from the randomized controlled phase III trial REMoxTB, we evaluated sputum-based markers of speed of clearance of bacilli: time to smear negative status; time to culture negative status on LJ or in MGIT; daily rate of change of log10(TTP) to day 56; and smear or culture results at weeks 6, 8 or 12; as individual- and trial-level surrogate endpoints for long-term clinical outcome. Time to culture negative status on LJ or in MGIT, time to smear negative status and daily rate of change in log10(TTP) were each independent predictors of clinical outcome, adjusted for treatment (p <0.001). However, discrimination between low and high risk patients, as measured by the c-statistic, was modest and not much higher than the reference model adjusted for BMI, history of smoking, HIV status, cavitation, gender and MGIT TTP. Culture conversion during treatment for tuberculosis, however measured, has only a limited role in decision-making for advancing regimens into phase III trials or in predicting the outcome of treatment for individual patients. REMoxTB ClinicalTrials.gov number: NCT00864383.

American College of Emergency Physicians Ethics Manual.

PubMed

1991-10-01

Ethical concerns are a major part of the clinical practice of emergency medicine. The emergency physician must make hard choices, not only with regard to the scientific/technical aspects but also with regard to the moral aspects of caring for emergency patients. By the nature of the specialty, emergency physicians face ethical dilemmas often requiring prompt decisions with limited information. This manual identifies important moral principles and values in emergency medicine. The underlying assumption is that a knowledge of moral principles and ethical values helps the emergency physician make responsible moral choices. Neither the scientific nor the moral aspects of clinical decision making can be reduced to simple formulas. Nevertheless, decisions must be made. Emergency physicians should, therefore, be cognizant of the ethical principles that are important for emergency medicine, understand the process of ethical reasoning, and be capable of making rational moral decisions based on a stable framework of values.

How are evidence and knowledge used in orthopaedic decision-making? Three comparative case studies of different approaches to implementation of clinical guidance in practice.

PubMed

Grove, Amy; Clarke, Aileen; Currie, Graeme

2018-05-31

The uptake and use of clinical guidelines is often insufficient to change clinical behaviour and reduce variation in practice. As a consequence of diverse organisational contexts, the simple provision of guidelines cannot ensure fidelity or guarantee their use when making decisions. Implementation research in surgery has focused on understanding what evidence exists for clinical practice decisions but limits understanding to the technical, educational and accessibility issues. This research aims to identify where, when and how evidence and knowledge are used in orthopaedic decision-making and how variation in these factors contributes to different approaches to implementation of clinical guidance in practice. We used in-depth case studies to examine guideline implementation in real-life surgical practice. We conducted comparative case studies in three English National Health Service hospitals over a 12-month period. Each in-depth case study consisted of a mix of qualitative methods including interviews, observations and document analysis. Data included field notes from observations of day-to-day practice, 64 interviews with NHS surgeons and staff and the collection of 121 supplementary documents. Case studies identified 17 sources of knowledge and evidence which influenced clinical decisions in elective orthopaedic surgery. A comparative analysis across cases revealed that each hospital had distinct approaches to decision-making. Decision-making is described as occurring as a result of how 17 types of knowledge and evidence were privileged and of how they interacted and changed in context. Guideline implementation was contingent and mediated through four distinct contextual levels. Implementation could be assessed for individual surgeons, groups of surgeons or the organisation as a whole, but it could also differ between these levels. Differences in how evidence and knowledge were used contributed to variations in practice from guidelines. A range of complex and competing sources of evidence and knowledge exists which influence the working practices of healthcare professionals. The dynamic selection, combination and use of each type of knowledge and evidence influence the implementation and use of clinical guidance in practice. Clinical guidelines are a fundamental part of practice, but represent only one type of evidence influencing clinical decisions. In the orthopaedic speciality, other distinct sources of evidence and knowledge are selected and used which impact on how guidelines are implemented. New approaches to guideline implementation need to appreciate and incorporate this diverse range of knowledge and evidence which influences clinical decisions and to take account of the changing contexts in which decisions are made.

Is risk assessment the new clinical model in public mental health?

PubMed

Holmes, Alex

2013-12-01

Australian public mental health services have seen a rapid adoption of risk assessment into clinical practice over the past decade. It is timely to review the role of risk assessment in clinical practice, evidence for its validity and to explore its role in clinical decision-making. There is little evidence to support the current form of risk assessment used in public mental health. The continued focus in risk may lead public psychiatrists into a bind where their specialist role is defined by a capacity that they do not fully possess. Further work is required to find ways of demonstrating our attention to the possibility of adverse outcomes whilst maintaining our skills and capacity to manage mental illness with complexity and balance within the limitations of rational decision-making.

Use of large healthcare databases for rheumatology clinical research.

PubMed

Desai, Rishi J; Solomon, Daniel H

2017-03-01

Large healthcare databases, which contain data collected during routinely delivered healthcare to patients, can serve as a valuable resource for generating actionable evidence to assist medical and healthcare policy decision-making. In this review, we summarize use of large healthcare databases in rheumatology clinical research. Large healthcare data are critical to evaluate medication safety and effectiveness in patients with rheumatologic conditions. Three major sources of large healthcare data are: first, electronic medical records, second, health insurance claims, and third, patient registries. Each of these sources offers unique advantages, but also has some inherent limitations. To address some of these limitations and maximize the utility of these data sources for evidence generation, recent efforts have focused on linking different data sources. Innovations such as randomized registry trials, which aim to facilitate design of low-cost randomized controlled trials built on existing infrastructure provided by large healthcare databases, are likely to make clinical research more efficient in coming years. Harnessing the power of information contained in large healthcare databases, while paying close attention to their inherent limitations, is critical to generate a rigorous evidence-base for medical decision-making and ultimately enhancing patient care.

Patients’ perceptions of gene expression profiling in breast cancer treatment decisions

PubMed Central

Bombard, Y.; Rozmovits, L.; Trudeau, M.E.; Leighl, N.B.; Deal, K.; Marshall, D.A.

2014-01-01

Introduction Determining the likely benefit of adjuvant chemotherapy for early-stage breast cancer patients depends on estimating baseline recurrence risk. Gene expression profile (gep) testing of tumours informs risk prediction, but evidence of its clinical utility is limited. We explored patient perceptions of gep testing and the impact of those perceptions on chemotherapy decisions. Methods We conducted one focus group (n = 4) and individual interviews (n = 24) with patients who used gep testing, recruited through clinics at two hospitals in Ontario. Data were analyzed using content analysis and constant comparison techniques. Results Patients’ understanding of gep testing was variable, and misapprehensions were common. Patients valued the test because it provided them with certainty amidst confusion, with options and a sense of empowerment, and with personalized, authoritative information. They commonly believed that the test was better and fundamentally different from other clinical tests, attributing to it unique power and truth-value. This kind of “magical thinking” was derived from an amplified perception of the test’s validity and patients’ need for reassurance about their treatment choices. Despite misperceptions or magical thinking, gep was widely considered to be the deciding factor in treatment decisions. Conclusions Patients tend to overestimate the truth-value of gep testing based on misperceptions of its validity. Our results identify a need to better support patient understanding of the test and its limitations. Findings illustrate the deep emotional investment patients make in gep test results and the impact of that investment on their treatment decisions. PMID:24764705

8th edition AJCC/UICC staging of cancers of the esophagus and esophagogastric junction: application to clinical practice.

PubMed

Rice, Thomas W; Patil, Deepa T; Blackstone, Eugene H

2017-03-01

The 8th edition of the American Joint Committee on Cancer (AJCC) staging of epithelial cancers of the esophagus and esophagogastric junction (EGJ) presents separate classifications for clinical (cTNM), pathologic (pTNM), and postneoadjuvant (ypTNM) stage groups. Histopathologic cell type markedly affects survival of clinically and pathologically staged patients, requiring separate groupings for each cell type, but ypTNM groupings are identical for both cell types. Clinical categories, typically obtained by imaging with minimal histologic information, are limited by resolution of each method. Strengths and shortcomings of clinical staging methods should be recognized. Complementary cytology or histopathology findings may augment imaging and aid initial treatment decision-making. However, prognostication using clinical stage groups remains coarse and inaccurate compared with pTNM. Pathologic staging is losing its relevance for advanced-stage cancer as neoadjuvant therapy replaces esophagectomy alone. However, it remains relevant for early-stage cancers and as a staging and survival reference point. Although pathologic stage could facilitate decision-making, its use to direct postoperative adjuvant therapy awaits more effective treatment. Prognostication using pathologic stage groups is the most refined of all classifications. Postneoadjuvant staging (ypTNM) is introduced by the AJCC but not adopted by the Union for International Cancer Control (UICC). Drivers of this addition include absence of equivalent pathologic (pTNM) categories for categories peculiar to the postneoadjuvant state (ypT0N0-3M0 and ypTisN0-3M0), dissimilar stage group compositions, and markedly different survival profiles. Thus, prognostication is specific for patients undergoing neoadjuvant therapy. The role of ypTNM classification in additional treatment decision-making is currently limited. Precision cancer care advances are necessary for this information to be clinically useful.

Cost-effectiveness analyses and their role in improving healthcare strategies.

PubMed

Rodriguez, Maria I; Caughey, Aaron B

2013-12-01

In this era of healthcare reform, attention is focused on increasing the quality of care and access to services, while simultaneously reducing the cost. Economic evaluations can play an important role in translating research to evidence-based practice and policy. Cost-effectiveness analysis (CEA) and its utility for clinical and policy decision making among U.S. obstetricians and gynecologists is reviewed. Three case examples demonstrating the value of this methodology in decision making are considered. A discussion of the methodologic principles of CEA, the advantages, and the limitations of the methodology are presented. CEA can play an important role in evidence-based decision making, with value for clinicians and policy makers alike. These studies are of particular interest in the field of obstetrics and gynecology, in which uncertainty from epidemiologic or clinical trials exists, or multiple perspectives need to be considered (maternal, neonatal, and societal). As with all research, it is essential that economic evaluations are conducted according to established methodologic standards. Interpretation and application of results should occur with a clear understanding of both the value and the limitations of economic evaluations.

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial.

PubMed

LeBlanc, Annie; Ruud, Kari L; Branda, Megan E; Tiedje, Kristina; Boehmer, Kasey R; Pencille, Laurie J; Van Houten, Holly; Matthews, Marc; Shah, Nilay D; May, Carl R; Yawn, Barbara P; Montori, Victor M

2012-05-28

Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. NCT00388050.

Observational Research Opportunities and Limitations

PubMed Central

Boyko, Edward J.

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principle engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. PMID:24055326

Observational research--opportunities and limitations.

PubMed

Boyko, Edward J

2013-01-01

Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principal engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. © 2013.

Quality specifications for the extra-analytical phase of laboratory testing: Reference intervals and decision limits.

PubMed

Ceriotti, Ferruccio

2017-07-01

Reference intervals and decision limits are a critical part of the clinical laboratory report. The evaluation of their correct use represents a tool to verify the post analytical quality. Four elements are identified as indicators. 1. The use of decision limits for lipids and glycated hemoglobin. 2. The use, whenever possible, of common reference values. 3. The presence of gender-related reference intervals for at least the following common serum measurands (besides obviously the fertility relate hormones): alkaline phosphatase (ALP), alanine aminotransferase (ALT), creatine kinase (CK), creatinine, gamma-glutamyl transferase (GGT), IgM, ferritin, iron, transferrin, urate, red blood cells (RBC), hemoglobin (Hb) and hematocrit (Hct). 4. The presence of age-related reference intervals. The problem of specific reference intervals for elderly people is discussed, but their use is not recommended; on the contrary it is necessary the presence of pediatric age-related reference intervals at least for the following common serum measurands: ALP, amylase, creatinine, inorganic phosphate, lactate dehydrogenase, aspartate aminotransferase, urate, insulin like growth factor 1, white blood cells, RBC, Hb, Hct, alfa-fetoprotein and fertility related hormones. The lack of such reference intervals may imply significant risks for the patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Clinical judgment, moral anxiety, and the limits of psychiatry.

PubMed

Murray, Bradley

2017-12-01

It is common for clinicians working in psychiatry and related clinical disciplines to be called on to make diagnostic clinical judgments concerning moral anxiety, which is a kind of anxiety that is closely bound up with decisions individuals face as moral agents. To make such a judgment, it is necessary to make a moral judgment. Although it has been common to acknowledge that there are ways in which moral and clinical judgment interact, this type of interaction has remained unacknowledged. This raises questions as to the nature and limits of psychiatry-particularly concerning the extent to which psychiatric discourse ought to incorporate moral discourse, and the role of the clinician as an expert in identifying problematic anxiety.

The Use of Intuition in Homeopathic Clinical Decision Making: An Interpretative Phenomenological Study

PubMed Central

Brien, Sarah; Dibb, Bridget; Burch, Alex

2011-01-01

While intuition plays a role in clinical decision making within conventional medicine, little is understood about its use in complementary and alternative medicine (CAM). The aim of this qualitative study was to investigate intuition from the perspective of homeopathic practitioners; its' manifestation, how it was recognized, its origins and when it was used within daily clinical practice. Semi-structured interviews were carried out with clinically experienced non-National Health Service (NHS) UK homeopathic practitioners. Interpretative phenomenological analysis was used to analyze the data. Homeopaths reported many similarities with conventional medical practitioner regarding the nature, perceived origin and manifestation of their intuitions in clinical practice. Intuition was used in two key aspects of the consultation: (i) to enhance the practitioner-patient relationship, these were generally trusted; and (ii) intuitions relating to the prescribing decision. Homeopaths were cautious about these latter intuitions, testing any intuitive thoughts through deductive reasoning before accepting them. Their reluctance is not surprising given the consequences for patient care, but we propose this also reflects homeopaths' sensitivity to the academic and medical mistrust of both homeopathy and intuition. This study is the first to explore the use of intuition in decision making in any form of complementary medicine. The similarities with conventional practitioners may provide confidence in validating intuition as a legitimate part of the decision making process for these specific practitioners. Further work is needed to elucidate if these findings reflect intuitive use in clinical practice of other CAM practitioners in both private and NHS (i.e., time limited) settings. PMID:19773389

Surrogates and extra-familial interests.

PubMed

Baergen, Ralph; Woodhouse, William

2013-01-01

A case is presented in which the therapeutic interests of the patient conflict with the safety of a community, and in which the surrogate decision maker has very limited knowledge of or concern for the patient's preferences. The substituted judgment and best interest (or rational patient) standards for surrogate decision making are problematic in this case. It is argued that the interests of even those outside the family ought to be taken seriously when making decisions about such cases, and it is proposed that clinical ethics committees could play a new role here. This case also illustrates the difficulties of making decisions regarding the treatment of a very unlikable patient.

Bayesian imperfect information analysis for clinical recurrent data

PubMed Central

Chang, Chih-Kuang; Chang, Chi-Chang

2015-01-01

In medical research, clinical practice must often be undertaken with imperfect information from limited resources. This study applied Bayesian imperfect information-value analysis to realistic situations to produce likelihood functions and posterior distributions, to a clinical decision-making problem for recurrent events. In this study, three kinds of failure models are considered, and our methods illustrated with an analysis of imperfect information from a trial of immunotherapy in the treatment of chronic granulomatous disease. In addition, we present evidence toward a better understanding of the differing behaviors along with concomitant variables. Based on the results of simulations, the imperfect information value of the concomitant variables was evaluated and different realistic situations were compared to see which could yield more accurate results for medical decision-making. PMID:25565853

Designing Colorectal Cancer Screening Decision Support: A Cognitive Engineering Enterprise.

PubMed

Militello, Laura G; Saleem, Jason J; Borders, Morgan R; Sushereba, Christen E; Haverkamp, Donald; Wolf, Steven P; Doebbeling, Bradley N

2016-03-01

Adoption of clinical decision support has been limited. Important barriers include an emphasis on algorithmic approaches to decision support that do not align well with clinical work flow and human decision strategies, and the expense and challenge of developing, implementing, and refining decision support features in existing electronic health records (EHRs). We applied decision-centered design to create a modular software application to support physicians in managing and tracking colorectal cancer screening. Using decision-centered design facilitates a thorough understanding of cognitive support requirements from an end user perspective as a foundation for design. In this project, we used an iterative design process, including ethnographic observation and cognitive task analysis, to move from an initial design concept to a working modular software application called the Screening & Surveillance App. The beta version is tailored to work with the Veterans Health Administration's EHR Computerized Patient Record System (CPRS). Primary care providers using the beta version Screening & Surveillance App more accurately answered questions about patients and found relevant information more quickly compared to those using CPRS alone. Primary care providers also reported reduced mental effort and rated the Screening & Surveillance App positively for usability.

Designing Colorectal Cancer Screening Decision Support: A Cognitive Engineering Enterprise

PubMed Central

Militello, Laura G.; Saleem, Jason J.; Borders, Morgan R.; Sushereba, Christen E.; Haverkamp, Donald; Wolf, Steven P.; Doebbeling, Bradley N.

2016-01-01

Adoption of clinical decision support has been limited. Important barriers include an emphasis on algorithmic approaches to decision support that do not align well with clinical work flow and human decision strategies, and the expense and challenge of developing, implementing, and refining decision support features in existing electronic health records (EHRs). We applied decision-centered design to create a modular software application to support physicians in managing and tracking colorectal cancer screening. Using decision-centered design facilitates a thorough understanding of cognitive support requirements from an end user perspective as a foundation for design. In this project, we used an iterative design process, including ethnographic observation and cognitive task analysis, to move from an initial design concept to a working modular software application called the Screening & Surveillance App. The beta version is tailored to work with the Veterans Health Administration’s EHR Computerized Patient Record System (CPRS). Primary care providers using the beta version Screening & Surveillance App more accurately answered questions about patients and found relevant information more quickly compared to those using CPRS alone. Primary care providers also reported reduced mental effort and rated the Screening & Surveillance App positively for usability. PMID:26973441

Relational autonomy: moving beyond the limits of isolated individualism.

PubMed

Walter, Jennifer K; Ross, Lainie Friedman

2014-02-01

Although clinicians may value respecting a patient's or surrogate's autonomy in decision-making, it is not always clear how to proceed in clinical practice. The confusion results, in part, from which conception of autonomy is used to guide ethical practice. Reliance on an individualistic conception such as the "in-control agent" model prioritizes self-sufficiency in decision-making and highlights a decision-maker's capacity to have reason transcend one's emotional experience. An alternative model of autonomy, relational autonomy, highlights the social context within which all individuals exist and acknowledges the emotional and embodied aspects of decision-makers. These 2 conceptions of autonomy lead to different interpretations of several aspects of ethical decision-making. The in-control agent model believes patients or surrogates should avoid both the influence of others and emotional persuasion in decision-making. As a result, providers have a limited role to play and are expected to provide medical expertise but not interfere with the individual's decision-making process. In contrast, a relational autonomy approach acknowledges the central role of others in decision-making, including clinicians, who have a responsibility to engage patients' and surrogates' emotional experiences and offer clear guidance when patients are confronting serious illness. In the pediatric setting, in which decision-making is complicated by having a surrogate decision-maker in addition to a patient, these conceptions of autonomy also may influence expectations about the role that adolescents can play in decision-making.

Evidence-based periodontal therapy: An overview

PubMed Central

Vijayalakshmi, R.; Anitha, V.; Ramakrishnan, T.; Sudhakar, Uma

2008-01-01

Dentists need to make clinical decisions based on limited scientific evidence. In clinical practice, a clinician must weigh a myriad of evidences every day. The goal of evidence-based dentistry is to help practitioners provide their patients with optimal care. This is achieved by integrating sound research evidence with personal clinical expertise and patient values to determine the best course of treatment. Periodontology has a rich background of research and scholarship. Therefore, efficient use of this wealth of research data needs to be a part of periodontal practice. Evidence-based periodontology aims to facilitate such an approach and it offers a bridge from science to clinical practice. The clinician must integrate the evidence with patient preference, scientific knowledge, and personal experience. Most important, it allows us to care for our patients. Therefore, evidence-based periodontology is a tool to support decision-making and integrating the best evidence available with clinical practice. PMID:20142947

A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems.

PubMed

Phansalkar, Shobha; Edworthy, Judy; Hellier, Elizabeth; Seger, Diane L; Schedlbauer, Angela; Avery, Anthony J; Bates, David W

2010-01-01

The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design.

Predicting adverse hemodynamic events in critically ill patients.

PubMed

Yoon, Joo H; Pinsky, Michael R

2018-06-01

The art of predicting future hemodynamic instability in the critically ill has rapidly become a science with the advent of advanced analytical processed based on computer-driven machine learning techniques. How these methods have progressed beyond severity scoring systems to interface with decision-support is summarized. Data mining of large multidimensional clinical time-series databases using a variety of machine learning tools has led to our ability to identify alert artifact and filter it from bedside alarms, display real-time risk stratification at the bedside to aid in clinical decision-making and predict the subsequent development of cardiorespiratory insufficiency hours before these events occur. This fast evolving filed is primarily limited by linkage of high-quality granular to physiologic rationale across heterogeneous clinical care domains. Using advanced analytic tools to glean knowledge from clinical data streams is rapidly becoming a reality whose clinical impact potential is great.

Sideline coverage: when to get radiographs? A review of clinical decision tools.

PubMed

Gould, Sara J; Cardone, Dennis A; Munyak, John; Underwood, Philipp J; Gould, Stephen A

2014-05-01

Sidelines coverage presents unique challenges in the evaluation of injured athletes. Health care providers may be confronted with the question of when to obtain radiographs following an injury. Given that most sidelines coverage occurs outside the elite level, radiographs are not readily available at the time of injury, and the decision of when to send a player for radiographs must be made based on physical examination. Clinical tools have been developed to aid in identifying injuries that are likely to result in radiographically important fractures or dislocations. A search for the keywords x-ray and decision rule along with the anatomic locations shoulder, elbow, wrist, knee, and ankle was performed using the PubMed database. No limits were set regarding year of publication. We selected meta-analyses, randomized controlled trials, and survey results. Our selection focused on the largest, most well-studied published reports. We also attempted to include studies that reported the application of the rules to the field of sports medicine. Retrospective literature review. Level 4. The Ottawa Foot and Ankle Rules have been validated and implemented and are appropriate for use in both pediatric and adult populations. The Ottawa Knee Rules have been widely studied, validated, and accepted for evaluation of knee injuries. There are promising studies of decision rules for clinically important fractures of the wrist, but these studies have not been validated. The elbow has been evaluated with good outcomes via the elbow extension test, which has been validated in both single and multicenter studies. Currently, there are no reliable clinical decision tools for traumatic sports injuries to the shoulder to aid in the decision of when to obtain radiographs. Clinical decision tools have been developed to aid in the diagnosis and management of injuries commonly sustained during sporting events. Tools that have been appropriately validated in populations outside the initial study population can assist sports medicine physicians in the decision of when to get radiographs from the sidelines.

Using evidence-based algorithms to improve clinical decision making: the case of a first-time anterior shoulder dislocation.

PubMed

Federer, Andrew E; Taylor, Dean C; Mather, Richard C

2013-09-01

Decision making in health care has evolved substantially over the last century. Up until the late 1970s, medical decision making was predominantly intuitive and anecdotal. It was based on trial and error and involved high levels of problem solving. The 1980s gave way to empirical medicine, which was evidence based probabilistic, and involved pattern recognition and less problem solving. Although this represented a major advance in the quality of medical decision making, limitations existed. The advantages of the gold standard of the randomized controlled clinical trial (RCT) are well-known and this technique is irreplaceable in its ability to answer critical clinical questions. However, the RCT does have drawbacks. RCTs are expensive and can only capture a snapshot in time. As treatments change and new technologies emerge, new expensive clinical trials must be undertaken to reevaluate them. Furthermore, in order to best evaluate a single intervention, other factors must be controlled. In addition, the study population may not match that of another organization or provider. Although evidence-based medicine has provided powerful data for clinicians, effectively and efficiently tailoring it to the individual has not yet evolved. We are now in a period of transition from this evidence-based era to one dominated by the personalization and customization of care. It will be fueled by policy decisions to shift financial responsibility to the patient, creating a powerful and sophisticated consumer, unlike any patient we have known before. The challenge will be to apply medical evidence and personal preferences to medical decisions and deliver it efficiently in the increasingly busy clinical setting. In this article, we provide a robust review of the concepts of customized care and some of techniques to deliver it. We will illustrate this through a personalized decision model for the treatment decision after a first-time anterior shoulder dislocation.

Limitations in conduct and reporting of cochrane reviews rarely inhibit the determination of the validity of evidence for clinical decision-making.

PubMed

Alper, Brian S; Fedorowicz, Zbys; van Zuuren, Esther J

2015-08-01

To determine how often clinical conclusions derived from Cochrane Reviews have uncertain validity due to review conduct and reporting deficiencies. We evaluated 5142 clinical conclusions in DynaMed (an evidence-based point-of-care clinical reference) based on 4743 Cochrane Reviews. Clinical conclusions with level 2 evidence due to shortcomings in the review's conduct or reporting (rather than deficiencies in the underlying evidence) were confirmed by a DynaMed editor and two Cochrane Review authors. Thirty-one Cochrane Reviews (0.65%) had confirmed deficiencies in conduct and reporting as the reason for classifying 37 assessed clinical conclusions (0.72%) as level 2 evidence. In all cases, it was not feasible for the assessors to specify a clear criticism of the studies included in the reviews. The deficiencies were specific to not accounting for dropouts (2) or inadequate assessment and reporting of allocation concealment (11), other specific trial quality criteria (14), or all trial quality criteria (4). Cochrane Reviews provide high-quality assessment and synthesis of evidence, with fewer than 1% of Cochrane Reviews having limitations which hinder the summary of best current evidence for clinical decision-making. We expect this will further decrease following recent Cochrane quality initiatives. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

The ambiguity of patient-centred practices: the case of a Dutch fertility clinic.

PubMed

Gerrits, Trudie

2014-01-01

When in-vitro fertilization (IVF) was introduced in the 1970s, doctors were criticized for not properly informing prospective users about its possible risks and limited success rates as well as for medicalizing fertility problems. Nowadays, many fertility clinics are seeking to improve their accountability to stakeholders through patient-centred practices. Based on an ethnographic study of a Dutch fertility clinic, outspoken in its aims to provide patient-centred medicine and to empower clients, this paper addresses how patient-centred medicine affects couples' decision-making to use IVF and related reproductive technologies. The author contends that while patient-centred practices facilitate informed decision-making and support couples emotionally, they may also have unintended disciplining and normalizing effects. The information and support provided, the trust couples have in clinic staff, the ongoing visualization of conception mediated by medical technology--all can be seen as practices that strengthen lay people's 'medical gaze' in how they come to view their bodies, fertility problems and possible solutions. These unintended effects are labelled 'the ambiguity of patient-centeredness' as they (may) interfere with processes of autonomous decision-making.

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder.

PubMed

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1-10. Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD.

A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

PubMed Central

Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

2018-01-01

Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid prescriptions and 2) reduce pain in patients at low risk of developing OUD. PMID:29379313

Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies

PubMed Central

Hooijmans, Carlijn R.; de Vries, Rob B. M.; Ritskes-Hoitinga, Merel; Rovers, Maroeska M.; Leeflang, Mariska M.; IntHout, Joanna; Wever, Kimberley E.; Hooft, Lotty; de Beer, Hans; Kuijpers, Ton; Macleod, Malcolm R.; Sena, Emily S.; ter Riet, Gerben; Morgan, Rebecca L.; Thayer, Kristina A.; Rooney, Andrew A.; Guyatt, Gordon H.; Schünemann, Holger J.

2018-01-01

Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions. Systematic reviews and meta-analyses are important tools to provide robust and informative evidence summaries of these animal studies. Rating how certain we are about the evidence could provide important information about the translational probability of findings in experimental animal studies to clinical practice and probably improve it. Evidence summaries and certainty in the evidence ratings could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used framework to rate the certainty in the evidence and strength of health care recommendations. Here we present how the GRADE approach could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions. We also discuss the methodological challenges that we identified, and for which further work is needed. Examples are defining the importance of consistency within and across animal species and using GRADE’s indirectness domain as a tool to predict translation from animal models to humans. PMID:29324741

Facilitating healthcare decisions by assessing the certainty in the evidence from preclinical animal studies.

PubMed

Hooijmans, Carlijn R; de Vries, Rob B M; Ritskes-Hoitinga, Merel; Rovers, Maroeska M; Leeflang, Mariska M; IntHout, Joanna; Wever, Kimberley E; Hooft, Lotty; de Beer, Hans; Kuijpers, Ton; Macleod, Malcolm R; Sena, Emily S; Ter Riet, Gerben; Morgan, Rebecca L; Thayer, Kristina A; Rooney, Andrew A; Guyatt, Gordon H; Schünemann, Holger J; Langendam, Miranda W

2018-01-01

Laboratory animal studies are used in a wide range of human health related research areas, such as basic biomedical research, drug research, experimental surgery and environmental health. The results of these studies can be used to inform decisions regarding clinical research in humans, for example the decision to proceed to clinical trials. If the research question relates to potential harms with no expectation of benefit (e.g., toxicology), studies in experimental animals may provide the only relevant or controlled data and directly inform clinical management decisions. Systematic reviews and meta-analyses are important tools to provide robust and informative evidence summaries of these animal studies. Rating how certain we are about the evidence could provide important information about the translational probability of findings in experimental animal studies to clinical practice and probably improve it. Evidence summaries and certainty in the evidence ratings could also be used (1) to support selection of interventions with best therapeutic potential to be tested in clinical trials, (2) to justify a regulatory decision limiting human exposure (to drug or toxin), or to (3) support decisions on the utility of further animal experiments. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is the most widely used framework to rate the certainty in the evidence and strength of health care recommendations. Here we present how the GRADE approach could be used to rate the certainty in the evidence of preclinical animal studies in the context of therapeutic interventions. We also discuss the methodological challenges that we identified, and for which further work is needed. Examples are defining the importance of consistency within and across animal species and using GRADE's indirectness domain as a tool to predict translation from animal models to humans.

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Mendoza Rodriguez, Vladimir; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-03-19

To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

Examining chronic care patient preferences for involvement in health-care decision making: the case of Parkinson's disease patients in a patient-centred clinic.

PubMed

Zizzo, Natalie; Bell, Emily; Lafontaine, Anne-Louise; Racine, Eric

2017-08-01

Patient-centred care is a recommended model of care for Parkinson's disease (PD). It aims to provide care that is respectful and responsive to patient preferences, values and perspectives. Provision of patient-centred care should entail considering how patients want to be involved in their care. To understand the participation preferences of patients with PD from a patient-centred care clinic in health-care decision-making processes. Mixed-methods study with early-stage Parkinson's disease patients from a patient-centred care clinic. Study involved a modified Autonomy Preference Index survey (N=65) and qualitative, semi-structured in-depth interviews, analysed using thematic qualitative content analysis (N=20, purposefully selected from survey participants). Interviews examined (i) the patient preferences for involvement in health-care decision making; (ii) patient perspectives on the patient-physician relationship; and (iii) patient preferences for communication of information relevant to decision making. Preferences for participation in decision making varied between individuals and also within individuals depending on decision type, relational and contextual factors. Patients had high preferences for communication of information, but with acknowledged limits. The importance of communication in the patient-physician relationship was emphasized. Patient preferences for involvement in decision making are dynamic and support shared decision making. Relational autonomy corresponds to how patients envision their participation in decision making. Clinicians may need to assess patient preferences on an on-going basis. Our results highlight the complexities of decision-making processes. Improved understanding of individual preferences could enhance respect for persons and make for patient-centred care that is truly respectful of individual patients' wants, needs and values. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

Objective consensus from decision trees.

PubMed

Putora, Paul Martin; Panje, Cedric M; Papachristofilou, Alexandros; Dal Pra, Alan; Hundsberger, Thomas; Plasswilm, Ludwig

2014-12-05

Consensus-based approaches provide an alternative to evidence-based decision making, especially in situations where high-level evidence is limited. Our aim was to demonstrate a novel source of information, objective consensus based on recommendations in decision tree format from multiple sources. Based on nine sample recommendations in decision tree format a representative analysis was performed. The most common (mode) recommendations for each eventuality (each permutation of parameters) were determined. The same procedure was applied to real clinical recommendations for primary radiotherapy for prostate cancer. Data was collected from 16 radiation oncology centres, converted into decision tree format and analyzed in order to determine the objective consensus. Based on information from multiple sources in decision tree format, treatment recommendations can be assessed for every parameter combination. An objective consensus can be determined by means of mode recommendations without compromise or confrontation among the parties. In the clinical example involving prostate cancer therapy, three parameters were used with two cut-off values each (Gleason score, PSA, T-stage) resulting in a total of 27 possible combinations per decision tree. Despite significant variations among the recommendations, a mode recommendation could be found for specific combinations of parameters. Recommendations represented as decision trees can serve as a basis for objective consensus among multiple parties.

Clinical decisions for anterior restorations: the concept of restorative volume.

PubMed

Cardoso, Jorge André; Almeida, Paulo Júlio; Fischer, Alex; Phaxay, Somano Luang

2012-12-01

The choice of the most appropriate restoration for anterior teeth is often a difficult decision. Numerous clinical and technical factors play an important role in selecting the treatment option that best suits the patient and the restorative team. Experienced clinicians have developed decision processes that are often more complex than may seem. Less experienced professionals may find difficulties making treatment decisions because of the widely varied restorative materials available and often numerous similar products offered by different manufacturers. The authors reviewed available evidence and integrated their clinical experience to select relevant factors that could provide a logical and practical guideline for restorative decisions in anterior teeth. The presented concept of restorative volume is based on structural, optical, and periodontal factors. Each of these factors will influence the short- and long-term behavior of restorations in terms of esthetics, biology, and function. Despite the marked evolution of esthetic restorative techniques and materials, significant limitations still exist, which should be addressed by researchers. The presented guidelines must be regarded as a mere orientation for risk analysis. A comprehensive individual approach should always be the core of restorative esthetic treatments. The complex decision process for anterior esthetic restorations can be clarified by a systematized examination of structural, optical, and periodontal factors. The basis for the proposed thought process is the concept of restorative volume that is a contemporary interpretation of restoration categories and their application. © 2012 Wiley Periodicals, Inc.

The Pharmacokinetics of Second-Generation Long-Acting Injectable Antipsychotics: Limitations of Monograph Values.

PubMed

Lee, Lik Hang N; Choi, Charles; Collier, Abby C; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

2015-12-01

Product monographs (also known by terms such as Summary of Product Characteristics and Highlights of Prescribing Information, depending on the jurisdiction) provide essential information to ensure the safe and effective use of a drug. Medical practitioners often rely on these monographs for guidance on matters related to pharmacokinetics as well as indications, contraindications, clinical pharmacology, and adverse reactions. The clinical and scientific information found within these documents, forming the basis for decision making, are presumed to be derived from well-designed studies. The objective of this review is to examine the source and validity of the pharmacokinetic data used in establishing the half-lives and times to steady-state reported in the product monographs of second-generation long-acting injectable antipsychotics. Thus, we have critically evaluated the clinical trials from which the pharmacokinetic parameters listed in the product monographs were determined. In many cases, the pharmacokinetic information presented in product monographs is of limited use to clinicians wishing to optimize the effectiveness and tolerability of second-generation long-acting injectable antipsychotics. Under such circumstances, off-label prescribing practices may actually produce better clinical outcomes than if decisions were made based on the product monographs alone.

[Why controlled studies may lead to misleading and unconfirmed therapeutic concepts--a critical view of evidence-based medicine].

PubMed

Flachskampf, F A

2002-03-01

The concept of evidence-based medicine has gathered widespread support during recent years. While this concept has clear merits in compiling and qualifying up-to-date information for clinical decisions, it should be viewed with caution as the sole valid knowledge source for clinical decision-making. The limitations of such an approach are particularly striking when reviewing two key developments in modern cardiology, fibrinolysis and acute percutaneous intervention in acute myocardial infarction. In both cases, early studies and meta-analyses showed no benefit for these therapeutic interventions over earlier treatment. Only after further refinement (mainly in dosage, time window, concomitant heparin therapy for fibrinolysis, and the introduction of stents and IIb/IIIa inhibitors for acute intervention) did these therapies become universally acknowledged. It is therefore crucial to understand that especially for physicians actively participating in the development of a clinical field clinical decisions cannot be exclusively based on published evidence. Another important problem to consider is the time gap between the emergence of new therapies and the publication and reception by the medical audience, in particular in rapidly evolving fields as cardiology. While it is clear that clinical decision-making must be backed by solid knowledge of the published evidence, in particular the specialist involved in-depth in the field may use not yet proven therapeutic concepts and measures to the patient's advantage.

Ensuring Resident Competence: A Narrative Review of the Literature on Group Decision Making to Inform the Work of Clinical Competency Committees.

PubMed

Hauer, Karen E; Cate, Olle Ten; Boscardin, Christy K; Iobst, William; Holmboe, Eric S; Chesluk, Benjamin; Baron, Robert B; O'Sullivan, Patricia S

2016-05-01

Background The expectation for graduate medical education programs to ensure that trainees are progressing toward competence for unsupervised practice prompted requirements for a committee to make decisions regarding residents' progress, termed a clinical competency committee (CCC). The literature on the composition of these committees and how they share information and render decisions can inform the work of CCCs by highlighting vulnerabilities and best practices. Objective We conducted a narrative review of the literature on group decision making that can help characterize the work of CCCs, including how they are populated and how they use information. Methods English language studies of group decision making in medical education, psychology, and organizational behavior were used. Results The results highlighted 2 major themes. Group member composition showcased the value placed on the complementarity of members' experience and lessons they had learned about performance review through their teaching and committee work. Group processes revealed strengths and limitations in groups' understanding of their work, leader role, and information-sharing procedures. Time pressure was a threat to the quality of group work. Conclusions Implications of the findings include the risks for committees that arise with homogeneous membership, limitations to available resident performance information, and processes that arise through experience rather than deriving from a well-articulated purpose of their work. Recommendations are presented to maximize the effectiveness of CCC processes, including their membership and access to, and interpretation of, information to yield evidence-based, well-reasoned judgments.

Ensuring Resident Competence: A Narrative Review of the Literature on Group Decision Making to Inform the Work of Clinical Competency Committees

PubMed Central

Hauer, Karen E.; Cate, Olle ten; Boscardin, Christy K.; Iobst, William; Holmboe, Eric S.; Chesluk, Benjamin; Baron, Robert B.; O'Sullivan, Patricia S.

2016-01-01

Background The expectation for graduate medical education programs to ensure that trainees are progressing toward competence for unsupervised practice prompted requirements for a committee to make decisions regarding residents' progress, termed a clinical competency committee (CCC). The literature on the composition of these committees and how they share information and render decisions can inform the work of CCCs by highlighting vulnerabilities and best practices. Objective We conducted a narrative review of the literature on group decision making that can help characterize the work of CCCs, including how they are populated and how they use information. Methods English language studies of group decision making in medical education, psychology, and organizational behavior were used. Results The results highlighted 2 major themes. Group member composition showcased the value placed on the complementarity of members' experience and lessons they had learned about performance review through their teaching and committee work. Group processes revealed strengths and limitations in groups' understanding of their work, leader role, and information-sharing procedures. Time pressure was a threat to the quality of group work. Conclusions Implications of the findings include the risks for committees that arise with homogeneous membership, limitations to available resident performance information, and processes that arise through experience rather than deriving from a well-articulated purpose of their work. Recommendations are presented to maximize the effectiveness of CCC processes, including their membership and access to, and interpretation of, information to yield evidence-based, well-reasoned judgments. PMID:27168881

Medicine Based Evidence for Individualized Decision Making: Case Study of Systemic Lupus Erythematosus.

PubMed

Wivel, Ashley E; Lapane, Kate; Kleoudis, Christi; Singer, Burton H; Horwitz, Ralph I

2017-11-01

To guide management decisions for an index patient, evidence is required from comparisons between approximate matches to the profile of the index case, where some matches contain responses to treatment and others act as controls. We describe a method for constructing clinically relevant histories/profiles using data collected but unreported from 2 recent phase 3 randomized controlled trials assessing belimumab in subjects with clinically active and serologically positive systemic lupus erythematosus. Outcome was the Systemic lupus erythematosus Responder Index (SRI) measured at 52 weeks. Among 1175 subjects, we constructed an algorithm utilizing 11 trajectory variables including 4 biological, 2 clinical, and 5 social/behavioral. Across all biological and social/behavioral variables, the proportion of responders based on the SRI whose value indicated clinical worsening or no improvement ranged from 27.5% to 42.3%. Kappa values suggested poor agreement, indicating that each biological and patient-reported outcome provides different information than gleaned from the SRI. The richly detailed patient profiles needed to guide decision-making in clinical practice are sharply at odds with the limited information utilized in conventional randomized controlled trial analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Role of the anesthesiologist in the wider governance of healthcare and health economics.

PubMed

Martin, Janet; Cheng, Davy

2013-09-01

Healthcare resources will always be limited, and as a result, difficult decisions must be made about how to allocate limited resources across unlimited demands in order to maximize health gains per resource expended. Governments and hospitals now in severe financial deficits recognize that reengagement of physicians is central to their ability to contain the runaway healthcare costs. Health economic analysis provides tools and techniques to assess which investments in healthcare provide good value for money vs which options should be forgone. Robust decision-making in healthcare requires objective consideration of evidence in order to balance clinical and economic benefits vs risks. Surveys of the literature reveal very few economic analyses related to anesthesia and perioperative medicine despite increasing recognition of the need. Now is an opportune time for anesthesiologists to become familiar with the tools and methodologies of health economics in order to facilitate and lead robust decision-making in quality-based procedures. For most technologies used in anesthesia and perioperative medicine, the responsibility to determine cost-effectiveness falls to those tasked with the governance and stewardship of limited resources for unlimited demands using best evidence plus economics at the local, regional, and national levels. Applicable cost-effectiveness, cost-utility, and cost-benefits in health economics are reviewed in this article with clinical examples in anesthesia. Anesthesiologists can make a difference in the wider governance of healthcare and health economics if we advance our knowledge and skills beyond the technical to address the "other" dimensions of decision-making--most notably, the economic aspects in a value-based healthcare system.

Clinical utility of gene expression profiling data for clinical decision-making regarding adjuvant therapy in early stage, node-negative breast cancer: a case report.

PubMed

Schuster, Steven R; Pockaj, Barbara A; Bothe, Mary R; David, Paru S; Northfelt, Donald W

2012-09-10

Breast cancer is the most common malignancy among women in the United States with the second highest incidence of cancer-related death following lung cancer. The decision-making process regarding adjuvant therapy is a time intensive dialogue between the patient and her oncologist. There are multiple tools that help individualize the treatment options for a patient. Population-based analysis with Adjuvant! Online and genomic profiling with Oncotype DX are two commonly used tools in patients with early stage, node-negative breast cancer. This case report illustrates a situation in which the population-based prognostic and predictive information differed dramatically from that obtained from genomic profiling and affected the patient's decision. In light of this case, we discuss the benefits and limitations of these tools.

Extending the Reach of Evidence-Based Medicine: A Proposed Categorization of Lower-Level Evidence.

PubMed

Detterbeck, Frank C; Gould, Michael K; Lewis, Sandra Zelman; Patel, Sheena

2018-02-01

Clinical practice involves making many treatment decisions for which only limited formal evidence exists. While the methodology of evidence-based medicine (EBM) has evolved tremendously, there is a need to better characterize lower-level evidence. This should enhance the ability to appropriately weigh the evidence against other considerations, and counter the temptation to think it is more robust than it actually is. A framework to categorize lower-level evidence is proposed, consisting of nonrandomized comparisons, extrapolation using indirect evidence, rationale, and clinical experience (ie, an accumulated general impression). Subtypes are recognized within these categories, based on the degree of confounding in nonrandomized comparisons, the uncertainty involved in extrapolation from indirect evidence, and the plausibility of a rationale. Categorizing the available evidence in this way can promote a better understanding of the strengths and limitations of using such evidence as the basis for treatment decisions in clinically relevant areas that are devoid of higher-level evidence. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Challenges in shared decision making in advanced cancer care: a qualitative longitudinal observational and interview study.

PubMed

Brom, Linda; De Snoo-Trimp, Janine C; Onwuteaka-Philipsen, Bregje D; Widdershoven, Guy A M; Stiggelbout, Anne M; Pasman, H Roeline W

2017-02-01

Patients' preferences and expectations should be taken into account in treatment decision making in the last phase of life. Shared decision making (SDM) is regarded as a way to give the patient a central role in decision making. Little is known about how SDM is used in clinical practice in advanced cancer care. To examine whether and how the steps of SDM can be recognized in decision making about second- and third-line chemotherapy. Fourteen advanced cancer patients were followed over time using face-to-face in-depth interviews and observations of the patients' out-clinic visits. Interviews and outpatient clinic visits in which treatment options were discussed or decisions made were transcribed verbatim and analysed using open coding. Patients were satisfied with the decision-making process, but the steps of SDM were barely seen in daily practice. The creation of awareness about available treatment options by physicians was limited and not discussed in an equal way. Patients' wishes and concerns were not explicitly assessed, which led to different expectations about improved survival from subsequent lines of chemotherapy. To reach SDM in daily practice, physicians should create awareness of all treatment options, including forgoing treatment, and communicate the risk of benefit and harm. Open and honest communication is needed in which patients' expectations and concerns are discussed. Through this, the difficult process of decision making in the last phase of life can be facilitated and the focus on the best care for the specific patient is strengthened. © 2015 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

What can paper-based clinical information systems tell us about the design of computerized clinical information systems (CIS) in the ICU?

PubMed

Miller, A; Pilcher, D; Mercaldo, N; Leong, T; Scheinkestel, C; Schildcrout, J

2010-08-01

Screen designs in computerized clinical information systems (CIS) have been modeled on their paper predecessors. However, limited understanding about how paper forms support clinical work means that we risk repeating old mistakes and creating new opportunities for error and inefficiency as illustrated by problems associated with computerized provider order entry systems. This study was designed to elucidate principles underlying a successful ICU paper-based CIS. The research was guided by two exploratory hypotheses: (1) paper-based artefacts (charts, notes, equipment, order forms) are used differently by nurses, doctors and other healthcare professionals in different (formal and informal) conversation contexts and (2) different artefacts support different decision processes that are distributed across role-based conversations. All conversations undertaken at the bedsides of five patients were recorded with any supporting artefacts for five days per patient. Data was coded according to conversational role-holders, clinical decision process, conversational context and artefacts. 2133 data points were analyzed using Poisson logistic regression analyses. Results show significant interactions between artefacts used during different professional conversations in different contexts (chi(2)((df=16))=55.8, p<0.0001). The interaction between artefacts used during different professional conversations for different clinical decision processes was not statistically significant although all two-way interactions were statistically significant. Paper-based CIS have evolved to support complex interdisciplinary decision processes. The translation of two design principles - support interdisciplinary perspectives and integrate decision processes - from paper to computerized CIS may minimize the risks associated with computerization. 2010 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Deepening the quality of clinical reasoning and decision-making in rural hospital nursing practice.

PubMed

Sedgwick, M G; Grigg, L; Dersch, S

2014-01-01

Rural acute care nursing requires an extensive breadth and depth of knowledge as well as the ability to quickly reason through problems in order to make sound clinical decisions. This reasoning often occurs within an environment that has minimal medical or ancillary support. Registered nurses (RN) new to rural nursing, and employers, have raised concerns about patient safety while new nurses make the transition into rural practice. In addition, feeling unprepared for the rigors of rural hospital nursing practice is a central issue influencing RN recruitment and retention. Understanding how rural RNs reason is a key element for identifying professional development needs and may support recruitment and retention of skilled rural nurses. The purpose of this study was to explore how rural RNs reason through clinical problems as well as to assess the quality of such reasoning. This study used a non-traditional approach for data collection. Fifteen rural acute care nurses with varying years of experience working in southern Alberta, Canada, were observed while they provided care to patients of varying acuity within a simulated rural setting. Following the simulation, semi-structured interviews were conducted using a substantive approach to critical thinking. Findings revealed that the ability to engage in deep clinical reasoning varied considerably among participants despite being given the same information under the same circumstances. Furthermore, the number of years of experience did not seem to be directly linked to the ability to engage in sound clinical reasoning. Novice nurses, however, did rely heavily on others in their decision making in order to ensure they were making the right decision. Hence, their relationships with other staff members influenced their ability to engage in clinical reasoning and decision making. In situations where the patient's condition was deteriorating quickly, regardless of years of experience, all of the participants depended on their colleagues when making decisions and reasoning throughout the simulation. Deep clinical reasoning and decision making is a function of reflection and self-correction that requires a critical self-awareness and is more about how nurses think than what they think. The degree of sophistication in reasoning of experts and novices is at times equivalent in that the reasoning of experts and novices can be somewhat limited and focused primarily on human physicality and less on conceptual knowledge. To become proficient in clinical reasoning, practice is necessary. The study supports the accumulating evidence that using clinical simulation and reflective interviewing that emphasize how clinical decisions are made enhances reasoning skills and confidence.

Applying principles from the game theory to acute stroke care: Learning from the prisoner's dilemma, stag-hunt, and other strategies.

PubMed

Saposnik, Gustavo; Johnston, S Claiborne

2016-04-01

Acute stroke care represents a challenge for decision makers. Decisions based on erroneous assessments may generate false expectations of patients and their family members, and potentially inappropriate medical advice. Game theory is the analysis of interactions between individuals to study how conflict and cooperation affect our decisions. We reviewed principles of game theory that could be applied to medical decisions under uncertainty. Medical decisions in acute stroke care are usually made under constrains: short period of time, with imperfect clinical information, limit understanding about patients and families' values and beliefs. Game theory brings some strategies to help us manage complex medical situations under uncertainty. For example, it offers a different perspective by encouraging the consideration of different alternatives through the understanding of patients' preferences and the careful evaluation of cognitive distortions when applying 'real-world' data. The stag-hunt game teaches us the importance of trust to strength cooperation for a successful patient-physician interaction that is beyond a good or poor clinical outcome. The application of game theory to stroke care may improve our understanding of complex medical situations and help clinicians make practical decisions under uncertainty. © 2016 World Stroke Organization.

Balancing the benefits and costs of antibiotic drugs: the TREAT model.

PubMed

Leibovici, L; Paul, M; Andreassen, S

2010-12-01

TREAT is a computerized decision support system aimed at improving empirical antibiotic treatment of inpatients with suspected bacterial infections. It contains a model that balances, for each antibiotic choice (including 'no antibiotics'), expected benefit and expected costs. The main benefit afforded by appropriate, empirical, early antibiotic treatment in moderate to severe infections is a better chance of survival. Each antibiotic drug was consigned three cost components: cost of the drug and administration; cost of side effects; and costs of future resistance. 'No treatment' incurs no costs. The model worked well for decision support. Its analysis showed, yet again, that for moderate to severe infections, a model that does not include costs of resistance to future patients will always return maximum antibiotic treatment. Two major moral decisions are hidden in the model: how to take into account the limited life-expectancy and limited quality of life of old or very sick patients; and how to assign a value for a life-year of a future, unnamed patient vs. the present, individual patient. © 2010 The Authors. Clinical Microbiology and Infection © 2010 European Society of Clinical Microbiology and Infectious Diseases.

Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

PubMed

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

[Cognitive traps and clinical decisions].

PubMed

Motterlini, Matteo

2017-12-01

We are fallible, we have limited computational capabilities, limited access to information, little memory. Moreover, in everyday life, we feel joy, fear, anger, and other emotions that influence our decisions in a little, "calculated" way. Not everyone, however, is also aware that the mistakes we make are often systematic and therefore, in particular circumstances, are foreseeable. Doctors and patients are constantly called upon to make decisions. They need to identify relevant information (for example, the symptoms or outcome of an examination), formulate a judgment (for example a diagnosis), choose an action course among the various possible ones based on one's own preferences (e.g. medication or surgery), so act. The exact size of the medical error is unknown, but probably huge. In fact, the more we investigate and the more we find. Often these mistakes depend on the cognitive process. Any (rational) decision requires, in particular, an assessment of the possible effects of the action it implements; for example how much pleasure or pain it will cause us. In the medical field, too, the principle of informed consent provides that the patient's preferences and values are to guide clinical choices. Yet, not always the preferences that people express before making an experience match with their preferences after living that experience. Some ingenious experiments suggest (in a seemingly paradoxical way) that before a direct experience, people prefer less pain; after that experience they prefer more, but with a better memory.

Use of statistical and pharmacokinetic-pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference.

PubMed

Kimko, Holly; Berry, Seth; O'Kelly, Michael; Mehrotra, Nitin; Hutmacher, Matthew; Sethuraman, Venkat

2017-01-01

The application of modeling and simulation (M&S) methods to improve decision-making was discussed during the Trends & Innovations in Clinical Trial Statistics Conference held in Durham, North Carolina, USA on May 1-4, 2016. Uses of both pharmacometric and statistical M&S were presented during the conference, highlighting the diversity of the methods employed by pharmacometricians and statisticians to address a broad range of quantitative issues in drug development. Five presentations are summarized herein, which cover the development strategy of employing M&S to drive decision-making; European initiatives on best practice in M&S; case studies of pharmacokinetic/pharmacodynamics modeling in regulatory decisions; estimation of exposure-response relationships in the presence of confounding; and the utility of estimating the probability of a correct decision for dose selection when prior information is limited. While M&S has been widely used during the last few decades, it is expected to play an essential role as more quantitative assessments are employed in the decision-making process. By integrating M&S as a tool to compile the totality of evidence collected throughout the drug development program, more informed decisions will be made.

Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

PubMed

Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

2012-01-01

Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect for the primary outcome that favored the intervention. The first study compared an educational meeting and a patient-mediated intervention with another patient-mediated intervention (median improvement of 74%). The second compared an educational meeting, a patient-mediated intervention, and audit and feedback with an educational meeting on an alternative topic (improvement of 227%). The third compared an educational meeting and a patient-mediated intervention with usual care (p = 0.003). All three studies were limited to the patient-physician dyad. To reduce bias, future studies should improve methods and reporting, and should analyze costs and benefits, including those associated with training of health professionals. Multifaceted interventions that include educating health professionals about sharing decisions with patients and patient-mediated interventions, such as patient decision aids, appear promising for improving health professionals' adoption of shared decision making in routine clinical practice as seen by patients.

Reformulations of practice: beyond experience in paramedic airway management.

PubMed

Mausz, Justin; Donovan, Seanan; McConnell, Meghan; Lapalme, Corey; Webb, Andrea; Feres, Elizabeth; Tavares, Walter

2017-07-01

"Deliberate practice" and "feedback" are necessary for the development of expertise. We explored clinical performance in settings where these features are inconsistent or limited, hypothesizing that even in algorithmic domains of practice, clinical performance reformulates in ways that may threaten patient safety, and that experience fails to predict performance. Paramedics participated in two recorded simulation sessions involving airway management, which were analyzed three ways: first, we identified variations in "decision paths" by coding the actions of the participants according to an airway management algorithm. Second, we identified cognitive schemas driving behavior using qualitative descriptive analysis. Third, clinical performances were evaluated using a global rating scale, checklist, and time to achieve ventilation; the relationship between experience and these metrics was assessed using Pearson's correlation. Thirty participants completed a total of 59 simulations. Mean experience was 7.2 (SD=5.8) years. We observed highly variable practice patterns and identified idiosyncratic decision paths and schemas governing practice. We revealed problematic performance deficiencies related to situation awareness, decision making, and procedural skills. There was no association between experience and clinical performance (Scenario 1: r=0.13, p=0.47; Scenario 2: r=-0.10, p=0.58), or the number of errors (Scenario 1: r=.10, p=0.57; Scenario 2: r=0.25, p=0.17) or the time to achieve ventilation (Scenario 1: r=0.53, p=0.78; Scenario 2: r=0.27, p=0.15). Clinical performance was highly variable when approaching an algorithmic problem, and procedural and cognitive errors were not attenuated by provider experience. These findings suggest reformulations of practice emerge in settings where feedback and deliberate practice are limited.

42 CFR 482.98 - Condition of participation: Human resources.

Code of Federal Regulations, 2014 CFR

2014-10-01

... issues. The clinical transplant coordinator's responsibilities must include, but are not limited to, the... the prospective living donor's decision whether to donate and the ability to discuss these issues with..., nursing, nutrition, social services, transplant coordination, and pharmacology. (f) Standard: Resource...

42 CFR 482.98 - Condition of participation: Human resources.

Code of Federal Regulations, 2011 CFR

2011-10-01

... issues. The clinical transplant coordinator's responsibilities must include, but are not limited to, the... the prospective living donor's decision whether to donate and the ability to discuss these issues with..., nursing, nutrition, social services, transplant coordination, and pharmacology. (f) Standard: Resource...

42 CFR 482.98 - Condition of participation: Human resources.

Code of Federal Regulations, 2013 CFR

2013-10-01

... issues. The clinical transplant coordinator's responsibilities must include, but are not limited to, the... the prospective living donor's decision whether to donate and the ability to discuss these issues with..., nursing, nutrition, social services, transplant coordination, and pharmacology. (f) Standard: Resource...

42 CFR 482.98 - Condition of participation: Human resources.

Code of Federal Regulations, 2012 CFR

2012-10-01

... issues. The clinical transplant coordinator's responsibilities must include, but are not limited to, the... the prospective living donor's decision whether to donate and the ability to discuss these issues with..., nursing, nutrition, social services, transplant coordination, and pharmacology. (f) Standard: Resource...

Decision Making and Cancer

PubMed Central

Reyna, Valerie F.; Nelson, Wendy L.; Han, Paul K.; Pignone, Michael P.

2014-01-01

We review decision-making along the cancer continuum in the contemporary context of informed and shared decision making, in which patients are encouraged to take a more active role in their health care. We discuss challenges to achieving informed and shared decision making, including cognitive limitations and emotional factors, but argue that understanding the mechanisms of decision making offers hope for improving decision support. Theoretical approaches to decision making that explain cognition, emotion, and their interaction are described, including classical psychophysical approaches, dual-process approaches that focus on conflicts between emotion versus cognition (or reason), and modern integrative approaches such as fuzzy-trace theory. In contrast to the earlier emphasis on rote use of numerical detail, modern approaches emphasize understanding the bottom-line gist of options (which encompasses emotion and other influences on meaning) and retrieving relevant social and moral values to apply to those gist representations. Finally, research on interventions to support better decision making in clinical settings is reviewed, drawing out implications for future research on decision making and cancer. PMID:25730718

Blunt Cerebrovascular Injuries: Advances in Screening, Imaging, and Management Trends.

PubMed

Nagpal, P; Policeni, B A; Bathla, G; Khandelwal, A; Derdeyn, C; Skeete, D

2017-10-12

Blunt cerebrovascular injury is a relatively uncommon but sometimes life-threatening injury, particularly in patients presenting with ischemic symptoms in that vascular territory. The decision to pursue vascular imaging (generally CT angiography) is based on clinical and imaging findings. Several grading scales or screening criteria have been developed to guide the decision to pursue vascular imaging, as well as to recommend different treatment options for various injuries. The data supporting many of these guidelines and options are limited however. The purpose of this article is to review and compare these scales and criteria and the data supporting clinical efficacy and to make recommendations for future research in this area. © 2017 by American Journal of Neuroradiology.

Using the Situated Clinical Decision-Making framework to guide analysis of nurses' clinical decision-making.

PubMed

Gillespie, Mary

2010-11-01

Nurses' clinical decision-making is a complex process that holds potential to influence the quality of care provided and patient outcomes. The evolution of nurses' decision-making that occurs with experience has been well documented. In addition, literature includes numerous strategies and approaches purported to support development of nurses' clinical decision-making. There has been, however, significantly less attention given to the process of assessing nurses' clinical decision-making and novice clinical educators are often challenged with knowing how to best support nurses and nursing students in developing their clinical decision-making capacity. The Situated Clinical Decision-Making framework is presented for use by clinical educators: it provides a structured approach to analyzing nursing students' and novice nurses' decision-making in clinical nursing practice, assists educators in identifying specific issues within nurses' clinical decision-making, and guides selection of relevant strategies to support development of clinical decision-making. A series of questions is offered as a guide for clinical educators when assessing nurses' clinical decision-making. The discussion presents key considerations related to analysis of various decision-making components, including common sources of challenge and errors that may occur within nurses' clinical decision-making. An exemplar illustrates use of the framework and guiding questions. Implications of this approach for selection of strategies that support development of clinical decision-making are highlighted. Copyright © 2010 Elsevier Ltd. All rights reserved.

Designing healthcare information technology to catalyse change in clinical care.

PubMed

Lester, William T; Zai, Adrian H; Grant, Richard W; Chueh, Henry C

2008-01-01

The gap between best practice and actual patient care continues to be a pervasive problem in our healthcare system. Efforts to improve on this knowledge-performance gap have included computerised disease management programs designed to improve guideline adherence. However, current computerised reminder and decision support interventions directed at changing physician behaviour have had only a limited and variable effect on clinical outcomes. Further, immediate pay-for-performance financial pressures on institutions have created an environment where disease management systems are often created under duress, appended to existing clinical systems and poorly integrated into the existing workflow, potentially limiting their real-world effectiveness. The authors present a review of disease management as well as a conceptual framework to guide the development of more effective health information technology (HIT) tools for translating clinical information into clinical action.

Machine Learning Approaches for Clinical Psychology and Psychiatry.

PubMed

Dwyer, Dominic B; Falkai, Peter; Koutsouleris, Nikolaos

2018-05-07

Machine learning approaches for clinical psychology and psychiatry explicitly focus on learning statistical functions from multidimensional data sets to make generalizable predictions about individuals. The goal of this review is to provide an accessible understanding of why this approach is important for future practice given its potential to augment decisions associated with the diagnosis, prognosis, and treatment of people suffering from mental illness using clinical and biological data. To this end, the limitations of current statistical paradigms in mental health research are critiqued, and an introduction is provided to critical machine learning methods used in clinical studies. A selective literature review is then presented aiming to reinforce the usefulness of machine learning methods and provide evidence of their potential. In the context of promising initial results, the current limitations of machine learning approaches are addressed, and considerations for future clinical translation are outlined.

A critical comparison of clinical decision instruments for computed tomographic scanning in mild closed traumatic brain injury in adolescents and adults.

PubMed

Stein, Sherman C; Fabbri, Andrea; Servadei, Franco; Glick, Henry A

2009-02-01

A number of clinical decision aids have been introduced to limit unnecessary computed tomographic scans in patients with mild traumatic brain injury. These aids differ in the risk factors they use to recommend a scan. We compare the instruments according to their sensitivity and specificity and recommend ones based on incremental benefit of correctly classifying patients as having surgical, nonsurgical, or no intracranial lesions. We performed a secondary analysis of prospectively collected database from 7,955 patients aged 10 years or older with mild traumatic brain injury to compare sensitivity and specificity of 6 common clinical decision strategies: the Canadian CT Head Rule, the Neurotraumatology Committee of the World Federation of Neurosurgical Societies, the New Orleans, the National Emergency X-Radiography Utilization Study II (NEXUS-II), the National Institute of Clinical Excellence guideline, and the Scandinavian Neurotrauma Committee guideline. Excluded from the database were patients for whom the history of trauma was unclear, the initial Glasgow Coma Scale score was less than 14, the injury was penetrating, vital signs were unstable, or who refused diagnostic tests. Patients revisiting the emergency department within 7 days were counted only once. The percentage of scans that would have been required by applying each of the 6 aids were Canadian CT head rule (high risk only) 53%, Canadian (medium & high risk) 56%, the Neurotraumatology Committee of the World Federation of Neurosurgical Societies 56%, New Orleans 69%, NEXUS-II 56%, National Institute of Clinical Excellence 71%, and the Scandinavian 50%. The 6 decision aids' sensitivities for surgical hematomas could not be distinguished statistically (P>.05). Sensitivity was 100% (95% confidence interval [CI] 96% to 100%) for NEXUS-II, 98.1% (95% CI 93% to 100%) for National Institute of Clinical Excellence, and 99.1% (95% CI 94% to 100%) for the other 4 clinical decision instruments. Sensitivity for any intracranial lesion ranged from 95.7% (95% CI 93% to 97%) (Scandinavian) to 100% (95% CI 98% to 100%) (National Institute of Clinical Excellence). In contrast, specificities varied between 30.9% (95% CI 30% to 32%) (National Institute of Clinical Excellence) and 52.9% (95% CI 52% to 54) (Scandinavian). NEXUS-II and the Scandinavian clinical decision aids displayed the best combination of sensitivity and specificity in this patient population. However, we cannot demonstrate that the higher sensitivity of NEXUS-II for surgical hematomas is statistically significant. Therefore, choosing which of the 2 clinical decision instruments to use must be based on decisionmakers' attitudes toward risk.

Weathering the storm: Improving therapeutic interventions for cytokine storm syndromes by targeting disease pathogenesis.

PubMed

Weaver, Lehn K; Behrens, Edward M

2017-03-01

Cytokine storm syndromes require rapid diagnosis and treatment to limit the morbidity and mortality caused by the hyperinflammatory state that characterizes these devastating conditions. Herein, we discuss the current knowledge that guides our therapeutic decision-making and personalization of treatment for patients with cytokine storm syndromes. Firstly, ICU-level supportive care is often required to stabilize patients with fulminant disease while additional diagnostic evaluations proceed to determine the underlying cause of cytokine storm. Pharmacologic interventions should be focused on removing the inciting trigger of inflammation and initiation of an individualized immunosuppressive regimen when immune activation is central to the underlying disease pathophysiology. Monitoring for a clinical response is required to ensure that changes in the therapeutic regimen can be made as clinically warranted. Escalation of immunosuppression may be required if patients respond poorly to the initial therapeutic interventions, while a slow wean of immunosuppression in patients who improve can limit medication-related toxicities. In certain scenarios, a decision must be made whether an individual patient requires hematopoietic cell transplantation to prevent recurrence of disease. Despite these interventions, significant morbidity and mortality remains for cytokine storm patients. Therefore, we use this review to propose a clinical schema to guide current and future attempts to design rational therapeutic interventions for patients suffering from these devastating conditions, which we believe speeds the diagnosis of disease, limits medication-related toxicities, and improves clinical outcomes by targeting the heterogeneous and dynamic mechanisms driving disease in each individual patient.

Back to the Bedside: Developing a Bedside Aid for Concussion and Brain Injury Decisions in the Emergency Department

PubMed Central

Melnick, Edward R.; Lopez, Kevin; Hess, Erik P.; Abujarad, Fuad; Brandt, Cynthia A.; Shiffman, Richard N.; Post, Lori A.

2015-01-01

Context: Current information-rich electronic health record (EHR) interfaces require large, high-resolution screens running on desktop computers. This interface compromises the provider’s already limited time at the bedside by physically separating the patient from the doctor. The case study presented here describes a patient-centered clinical decision support (CDS) design process that aims to bring the physician back to the bedside by integrating a patient decision aid with CDS for shared use by the patient and provider on a touchscreen tablet computer for deciding whether or not to obtain a CT scan for minor head injury in the emergency department, a clinical scenario that could benefit from CDS but has failed previous implementation attempts. Case Description: This case study follows the user-centered design (UCD) approach to build a bedside aid that is useful and usable, and that promotes shared decision-making between patients and their providers using a tablet computer at the bedside. The patient-centered decision support design process focuses on the prototype build using agile software development, but also describes the following: (1) the requirement gathering phase including triangulated qualitative research (focus groups and cognitive task analysis) to understand current challenges, (2) features for patient education, the physician, and shared decision-making, (3) system architecture and technical requirements, and (4) future plans for formative usability testing and field testing. Lessons Learned: We share specific lessons learned and general recommendations from critical insights gained in the patient-centered decision support design process about early stakeholder engagement, EHR integration, external expert feedback, challenges to two users on a single device, project management, and accessibility. Conclusions: Successful implementation of this tool will require seamless integration into the provider’s workflow. This protocol can create an effective interface for shared decision-making and safe resource reduction at the bedside in the austere and dynamic clinical environment of the ED and is generalizable for these purposes in other clinical environments as well. PMID:26290885

Back to the Bedside: Developing a Bedside Aid for Concussion and Brain Injury Decisions in the Emergency Department.

PubMed

Melnick, Edward R; Lopez, Kevin; Hess, Erik P; Abujarad, Fuad; Brandt, Cynthia A; Shiffman, Richard N; Post, Lori A

2015-01-01

Current information-rich electronic health record (EHR) interfaces require large, high-resolution screens running on desktop computers. This interface compromises the provider's already limited time at the bedside by physically separating the patient from the doctor. The case study presented here describes a patient-centered clinical decision support (CDS) design process that aims to bring the physician back to the bedside by integrating a patient decision aid with CDS for shared use by the patient and provider on a touchscreen tablet computer for deciding whether or not to obtain a CT scan for minor head injury in the emergency department, a clinical scenario that could benefit from CDS but has failed previous implementation attempts. This case study follows the user-centered design (UCD) approach to build a bedside aid that is useful and usable, and that promotes shared decision-making between patients and their providers using a tablet computer at the bedside. The patient-centered decision support design process focuses on the prototype build using agile software development, but also describes the following: (1) the requirement gathering phase including triangulated qualitative research (focus groups and cognitive task analysis) to understand current challenges, (2) features for patient education, the physician, and shared decision-making, (3) system architecture and technical requirements, and (4) future plans for formative usability testing and field testing. We share specific lessons learned and general recommendations from critical insights gained in the patient-centered decision support design process about early stakeholder engagement, EHR integration, external expert feedback, challenges to two users on a single device, project management, and accessibility. Successful implementation of this tool will require seamless integration into the provider's workflow. This protocol can create an effective interface for shared decision-making and safe resource reduction at the bedside in the austere and dynamic clinical environment of the ED and is generalizable for these purposes in other clinical environments as well.

Shared decision making and patient decision aids: knowledge, attitudes, and practices among Hawai'i physicians.

PubMed

Alden, Dana L; Friend, John; Chun, Maria B J

2013-11-01

As the health care field moves toward patient-centered care (PCC), increasing emphasis has been placed on the benefits of patient decision aids for promoting shared decision making (SDM). This study provides a baseline measure of knowledge, attitudes, and practices (KAP) among Hawai'i's physicians with respect to patient decision aids (DAs). Physicians throughout the State of Hawai'i were invited to complete a survey assessing their knowledge, attitudes, and practices with respect to the clinical use of DAs. One hundred and seventy four valid surveys were analyzed. Reported awareness and use of DAs were low, but recognition of the benefits of SDM and openness to the use of DAs were very high. The leading perceived barriers to the implementation of DAs were lack of awareness, lack of resources, and limited physician time to learn about DA technology. However, a significant majority of the respondents reported that DAs could empower patients by improving knowledge (88%), increasing satisfaction with the consultation process (81%), and increasing compliance (74%). Among physicians currently employing DAs, use of brochures or options matrix sheets was the most common aid tool. However, leading recommended DA formats were paper-based brochures for clinic use (75%) and interactive online website programs for outside clinic use (73.5%). Given growing emphasis on the PCC model and the recognized desire of many patients to participate in the medical decision making process, positive responses toward SDM and the use of DAs by Hawai'i physicians are promising.

Changing Provider Behavior in the Context of Chronic Disease Management: Focus on Clinical Inertia.

PubMed

Lavoie, Kim L; Rash, Joshua A; Campbell, Tavis S

2017-01-06

Widespread acceptance of evidence-based medicine has led to the proliferation of clinical practice guidelines as the primary mode of communicating current best practices across a range of chronic diseases. Despite overwhelming evidence supporting the benefits of their use, there is a long history of poor uptake by providers. Nonadherence to clinical practice guidelines is referred to as clinical inertia and represents provider failure to initiate or intensify treatment despite a clear indication to do so. Here we review evidence for the ubiquity of clinical inertia across a variety of chronic health conditions, as well as the organizational and system, patient, and provider factors that serve to maintain it. Limitations are highlighted in the emerging literature examining interventions to reduce clinical inertia. An evidence-based framework to address these limitations is proposed that uses behavior change theory and advocates for shared decision making and enhanced guideline development and dissemination.

Combined single photon emission computerized tomography and conventional computerized tomography: Clinical value for the shoulder surgeons?

PubMed Central

Hirschmann, Michael T.; Schmid, Rahel; Dhawan, Ranju; Skarvan, Jiri; Rasch, Helmut; Friederich, Niklaus F.; Emery, Roger

2011-01-01

With the cases described, we strive to introduce single photon emission computerized tomography in combination with conventional computer tomography (SPECT/CT) to shoulder surgeons, illustrate the possible clinical value it may offer as new diagnostic radiologic modality, and discuss its limitations. SPECT/CT may facilitate the establishment of diagnosis, process of decision making, and further treatment for complex shoulder pathologies. Some of these advantages were highlighted in cases that are frequently seen in most shoulder clinics. PMID:22058640

Ethnic bias and clinical decision-making among New Zealand medical students: an observational study.

PubMed

Harris, Ricci; Cormack, Donna; Stanley, James; Curtis, Elana; Jones, Rhys; Lacey, Cameron

2018-01-23

Health professional racial/ethnic bias may impact on clinical decision-making and contribute to subsequent ethnic health inequities. However, limited research has been undertaken among medical students. This paper presents findings from the Bias and Decision-Making in Medicine (BDMM) study, which sought to examine ethnic bias (Māori (indigenous peoples) compared with New Zealand European) among medical students and associations with clinical decision-making. All final year New Zealand (NZ) medical students in 2014 and 2015 (n = 888) were invited to participate in a cross-sectional online study. Key components included: two chronic disease vignettes (cardiovascular disease (CVD) and depression) with randomized patient ethnicity (Māori or NZ European) and questions on patient management; implicit bias measures (an ethnicity preference Implicit Association Test (IAT) and an ethnicity and compliant patient IAT); and, explicit ethnic bias questions. Associations between ethnic bias and clinical decision-making responses to vignettes were tested using linear regression. Three hundred and two students participated (34% response rate). Implicit and explicit ethnic bias favoring NZ Europeans was apparent among medical students. In the CVD vignette, no significant differences in clinical decision-making by patient ethnicity were observed. There were also no differential associations by patient ethnicity between any measures of ethnic bias (implicit or explicit) and patient management responses in the CVD vignette. In the depression vignette, some differences in the ranking of recommended treatment options were observed by patient ethnicity and explicit preference for NZ Europeans was associated with increased reporting that NZ European patients would benefit from treatment but not Māori (slope difference 0.34, 95% CI 0.08, 0.60; p = 0.011), although this was the only significant finding in these analyses. NZ medical students demonstrated ethnic bias, although overall this was not associated with clinical decision-making. This study both adds to the small body of literature internationally on racial/ethnic bias among medical students and provides relevant and important information for medical education on indigenous health and ethnic health inequities in New Zealand.

Survey of clinical infant lung function testing practices.

PubMed

Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

2014-02-01

Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

[Human body meridian spatial decision support system for clinical treatment and teaching of acupuncture and moxibustion].

PubMed

Wu, Dehua

2016-01-01

The spatial position and distribution of human body meridian are expressed limitedly in the decision support system (DSS) of acupuncture and moxibustion at present, which leads to the failure to give the effective quantitative analysis on the spatial range and the difficulty for the decision-maker to provide a realistic spatial decision environment. Focusing on the limit spatial expression in DSS of acupuncture and moxibustion, it was proposed that on the basis of the geographic information system, in association of DSS technology, the design idea was developed on the human body meridian spatial DSS. With the 4-layer service-oriented architecture adopted, the data center integrated development platform was taken as the system development environment. The hierarchical organization was done for the spatial data of human body meridian via the directory tree. The structured query language (SQL) server was used to achieve the unified management of spatial data and attribute data. The technologies of architecture, configuration and plug-in development model were integrated to achieve the data inquiry, buffer analysis and program evaluation of the human body meridian spatial DSS. The research results show that the human body meridian spatial DSS could reflect realistically the spatial characteristics of the spatial position and distribution of human body meridian and met the constantly changeable demand of users. It has the powerful spatial analysis function and assists with the scientific decision in clinical treatment and teaching of acupuncture and moxibustion. It is the new attempt to the informatization research of human body meridian.

Next generation terminology infrastructure to support interprofessional care planning.

PubMed

Collins, Sarah; Klinkenberg-Ramirez, Stephanie; Tsivkin, Kira; Mar, Perry L; Iskhakova, Dina; Nandigam, Hari; Samal, Lipika; Rocha, Roberto A

2017-11-01

Develop a prototype of an interprofessional terminology and information model infrastructure that can enable care planning applications to facilitate patient-centered care, learn care plan linkages and associations, provide decision support, and enable automated, prospective analytics. The study steps included a 3 step approach: (1) Process model and clinical scenario development, and (2) Requirements analysis, and (3) Development and validation of information and terminology models. Components of the terminology model include: Health Concerns, Goals, Decisions, Interventions, Assessments, and Evaluations. A terminology infrastructure should: (A) Include discrete care plan concepts; (B) Include sets of profession-specific concerns, decisions, and interventions; (C) Communicate rationales, anticipatory guidance, and guidelines that inform decisions among the care team; (D) Define semantic linkages across clinical events and professions; (E) Define sets of shared patient goals and sub-goals, including patient stated goals; (F) Capture evaluation toward achievement of goals. These requirements were mapped to AHRQ Care Coordination Measures Framework. This study used a constrained set of clinician-validated clinical scenarios. Terminology models for goals and decisions are unavailable in SNOMED CT, limiting the ability to evaluate these aspects of the proposed infrastructure. Defining and linking subsets of care planning concepts appears to be feasible, but also essential to model interprofessional care planning for common co-occurring conditions and chronic diseases. We recommend the creation of goal dynamics and decision concepts in SNOMED CT to further enable the necessary models. Systems with flexible terminology management infrastructure may enable intelligent decision support to identify conflicting and aligned concerns, goals, decisions, and interventions in shared care plans, ultimately decreasing documentation effort and cognitive burden for clinicians and patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Does Patient Preference Measurement in Decision Aids Improve Decisional Conflict? A Randomized Trial in Men with Prostate Cancer.

PubMed

Shirk, Joseph D; Crespi, Catherine M; Saucedo, Josemanuel D; Lambrechts, Sylvia; Dahan, Ely; Kaplan, Robert; Saigal, Christopher

2017-12-01

Shared decision making (SDM) has been advocated as an approach to medical decision making that can improve decisional quality. Decision aids are tools that facilitate SDM in the context of limited physician time; however, many decision aids do not incorporate preference measurement. We aim to understand whether adding preference measurement to a standard patient educational intervention improves decisional quality and is feasible in a busy clinical setting. Men with incident localized prostate cancer (n = 122) were recruited from the Greater Los Angeles Veterans Affairs (VA) Medical Center urology clinic, Olive View UCLA Medical Center, and Harbor UCLA Medical Center from January 2011 to May 2015 and randomized to education with a brochure about prostate cancer treatment or software-based preference assessment in addition to the brochure. Men undergoing preference assessment received a report detailing the relative strength of their preferences for treatment outcomes used in review with their doctor. Participants completed instruments measuring decisional conflict, knowledge, SDM, and patient satisfaction with care before and/or after their cancer consultation. Baseline knowledge scores were low (mean 62%). The baseline mean total score on the Decisional Conflict Scale was 2.3 (±0.9), signifying moderate decisional conflict. Men undergoing preference assessment had a significantly larger decrease in decisional conflict total score (p = 0.023) and the Perceived Effective Decision Making subscale (p = 0.003) post consult compared with those receiving education only. Improvements in satisfaction with care, SDM, and knowledge were similar between groups. Individual-level preference assessment is feasible in the clinic setting. Patients with prostate cancer who undergo preference assessment are more certain about their treatment decisions and report decreased levels of decisional conflict when making these decisions.

Multimorbidity, clinical decision making and health care delivery in New Zealand Primary care: a qualitative study.

PubMed

Stokes, Tim; Tumilty, Emma; Doolan-Noble, Fiona; Gauld, Robin

2017-04-05

Multimorbidity is a major issue for primary care. We aimed to explore primary care professionals' accounts of managing multimorbidity and its impact on clinical decision making and regional health care delivery. Qualitative interviews with 12 General Practitioners and 4 Primary Care Nurses in New Zealand's Otago region. Thematic analysis was conducted using the constant comparative method. Primary care professionals encountered challenges in providing care to patients with multimorbidity with respect to both clinical decision making and health care delivery. Clinical decision making occurred in time-limited consultations where the challenges of complexity and inadequacy of single disease guidelines were managed through the use of "satisficing" (care deemed satisfactory and sufficient for a given patient) and sequential consultations utilising relational continuity of care. The New Zealand primary care co-payment funding model was seen as a barrier to the delivery of care as it discourages sequential consultations, a problem only partially addressed through the use of the additional capitation based funding stream of Care Plus. Fragmentation of care also occurred within general practice and across the primary/secondary care interface. These findings highlight specific New Zealand barriers to the delivery of primary care to patients living with multimorbidity. There is a need to develop, implement and nationally evaluate a revised version of Care Plus that takes account of these barriers.

Design and Development of a Sharable Clinical Decision Support System Based on a Semantic Web Service Framework.

PubMed

Zhang, Yi-Fan; Gou, Ling; Tian, Yu; Li, Tian-Chang; Zhang, Mao; Li, Jing-Song

2016-05-01

Clinical decision support (CDS) systems provide clinicians and other health care stakeholders with patient-specific assessments or recommendations to aid in the clinical decision-making process. Despite their demonstrated potential for improving health care quality, the widespread availability of CDS systems has been limited mainly by the difficulty and cost of sharing CDS knowledge among heterogeneous healthcare information systems. The purpose of this study was to design and develop a sharable clinical decision support (S-CDS) system that meets this challenge. The fundamental knowledge base consists of independent and reusable knowledge modules (KMs) to meet core CDS needs, wherein each KM is semantically well defined based on the standard information model, terminologies, and representation formalisms. A semantic web service framework was developed to identify, access, and leverage these KMs across diverse CDS applications and care settings. The S-CDS system has been validated in two distinct client CDS applications. Model-level evaluation results confirmed coherent knowledge representation. Application-level evaluation results reached an overall accuracy of 98.66 % and a completeness of 96.98 %. The evaluation results demonstrated the technical feasibility and application prospect of our approach. Compared with other CDS engineering efforts, our approach facilitates system development and implementation and improves system maintainability, scalability and efficiency, which contribute to the widespread adoption of effective CDS within the healthcare domain.

Validating a decision tree for serious infection: diagnostic accuracy in acutely ill children in ambulatory care.

PubMed

Verbakel, Jan Y; Lemiengre, Marieke B; De Burghgraeve, Tine; De Sutter, An; Aertgeerts, Bert; Bullens, Dominique M A; Shinkins, Bethany; Van den Bruel, Ann; Buntinx, Frank

2015-08-07

Acute infection is the most common presentation of children in primary care with only few having a serious infection (eg, sepsis, meningitis, pneumonia). To avoid complications or death, early recognition and adequate referral are essential. Clinical prediction rules have the potential to improve diagnostic decision-making for rare but serious conditions. In this study, we aimed to validate a recently developed decision tree in a new but similar population. Diagnostic accuracy study validating a clinical prediction rule. Acutely ill children presenting to ambulatory care in Flanders, Belgium, consisting of general practice and paediatric assessment in outpatient clinics or the emergency department. Physicians were asked to score the decision tree in every child. The outcome of interest was hospital admission for at least 24 h with a serious infection within 5 days after initial presentation. We report the diagnostic accuracy of the decision tree in sensitivity, specificity, likelihood ratios and predictive values. In total, 8962 acute illness episodes were included, of which 283 lead to admission to hospital with a serious infection. Sensitivity of the decision tree was 100% (95% CI 71.5% to 100%) at a specificity of 83.6% (95% CI 82.3% to 84.9%) in the general practitioner setting with 17% of children testing positive. In the paediatric outpatient and emergency department setting, sensitivities were below 92%, with specificities below 44.8%. In an independent validation cohort, this clinical prediction rule has shown to be extremely sensitive to identify children at risk of hospital admission for a serious infection in general practice, making it suitable for ruling out. NCT02024282. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The ambiguity of patient-centred practices: the case of a Dutch fertility clinic

PubMed Central

Gerrits, Trudie

2014-01-01

When in-vitro fertilization (IVF) was introduced in the 1970s, doctors were criticized for not properly informing prospective users about its possible risks and limited success rates as well as for medicalizing fertility problems. Nowadays, many fertility clinics are seeking to improve their accountability to stakeholders through patient-centred practices. Based on an ethnographic study of a Dutch fertility clinic, outspoken in its aims to provide patient-centred medicine and to empower clients, this paper addresses how patient-centred medicine affects couples’ decision-making to use IVF and related reproductive technologies. The author contends that while patient-centred practices facilitate informed decision-making and support couples emotionally, they may also have unintended disciplining and normalizing effects. The information and support provided, the trust couples have in clinic staff, the ongoing visualization of conception mediated by medical technology – all can be seen as practices that strengthen lay people's ‘medical gaze’ in how they come to view their bodies, fertility problems and possible solutions. These unintended effects are labelled ‘the ambiguity of patient-centeredness’ as they (may) interfere with processes of autonomous decision-making. PMID:24827743

Diabetes Information Technology: Designing Informatics Systems to Catalyze Change in Clinical Care

PubMed Central

Lester, William T.; Zai, Adrian H.; Chueh, Henry C.; Grant, Richard W.

2008-01-01

Current computerized reminder and decision support systems intended to improve diabetes care have had a limited effect on clinical outcomes. Increasing pressures on health care networks to meet standards of diabetes care have created an environment where information technology systems for diabetes management are often created under duress, appended to existing clinical systems, and poorly integrated into the existing workflow. After defining the components of diabetes disease management, the authors present an eight-step conceptual framework to guide the development of more effective diabetes information technology systems for translating clinical information into clinical action. PMID:19885355

Ecological relevance of the Iowa gambling task in patients with Alzheimer's disease and mild cognitive impairment.

PubMed

Jacus, J-P; Gély-Nargeot, M-C; Bayard, S

2018-05-01

In spite of their extensive use, the ecological relevance of tasks dedicated to assessing real-world decision-making in a laboratory setting remains unclear. Our study aimed to evaluate the relationship between decision-making and behavioral competency and awareness of limitations. A total of 20 patients with Alzheimer's disease (AD), 20 with amnestic mild cognitive impairment (aMCI) and 20 healthy controls (HC) were assessed for decision-making using the Iowa Gambling Task (IGT). Behavioral competency was evaluated by the Patient Competency Rating Scale (PCRS), which requires each participant and a relative to answer the same 30 questions on participant's competency and to rate each item, while awareness of limitations was evaluated by subtracting the self-rated score from the relative-rated score. Using the median-split approach, the proportion of disadvantageous decision-makers was higher in both the MCI and AD groups than in HC (P=0.02 and P=0.03, respectively), with no differences between clinical groups. The percentage of participants with poorer behavioral competency was also higher in the MCI and AD than in the HC (self-rated: P=0.025 and P=0.01, respectively; relative-rated: P=0.008 and P=0.008, respectively), again with no differences between MCI and AD. All groups were comparable in awareness. For all participants, disadvantageous decision-making was associated with both reduced behavioral competency and poor awareness of limitations (OR: 3.47, P=0.03 and OR: 5.4, P=0.004, respectively). Our findings support the ecological relevance of the IGT. Behavioral competency integrity and awareness of limitations are both associated with advantageous decision-making profiles. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Are the GFRUP's recommendations for withholding or withdrawing treatments in critically ill children applicable? Results of a two‐year survey

PubMed Central

Cremer, R; Binoche, A; Noizet, O; Fourier, C; Leteurtre, S; Moutel, G; Leclerc, F

2007-01-01

Objective To evaluate feasibility of the guidelines of the Groupe Francophone de Réanimation et Urgence Pédiatriques (French‐speaking group of paediatric intensive and emergency care; GFRUP) for limitation of treatments in the paediatric intensive care unit (PICU). Design A 2‐year prospective survey. Setting A 12‐bed PICU at the Hôpital Jeanne de Flandre, Lille, France. Patients Were included when limitation of treatments was expected. Results Of 967 children admitted, 55 were included with a 2‐day median delay. They were younger than others (24 v 60 months), had a higher paediatric risk of mortality (PRISM) score (14 v 4), and a higher paediatric overall performance category (POPC) score at admission (2 v 1); all p<0.002. 34 (50% of total deaths) children died. A limitation decision was made without meeting for 7 children who died: 6 received do‐not‐resuscitate orders (DNROs) and 1 received withholding decision. Decision‐making meetings were organised for 31 children, and the following decisions were made: 12 DNROs (6 deaths and 6 survivals), 4 withholding (1 death and 3 survivals), with 14 withdrawing (14 deaths) and 1 continuing treatment (survival). After limitation, 21 (31% of total deaths) children died and 10 survived (POPC score 4). 13 procedures were interrupted because of death and 11 because of clinical improvement (POPC score 4). Parents' opinions were obtained after 4 family conferences (for a total of 110 min), 3 days after inclusion. The first meeting was planned for 6 days after inclusion and held on the 7th day after inclusion; 80% of parents were immediately informed of the decision, which was implemented after half a day. Conclusions GFRUPs procedure was applicable in most cases. The main difficulties were anticipating the correct date for the meeting and involving nurses in the procedure. Children for whom the procedure was interrupted because of clinical improvement and who survived in poor condition without a formal decision pointed out the need for medical criteria for questioning, which should systematically lead to a formal decision‐making process. PMID:17329379

Quantitative risk stratification in Markov chains with limiting conditional distributions.

PubMed

Chan, David C; Pollett, Philip K; Weinstein, Milton C

2009-01-01

Many clinical decisions require patient risk stratification. The authors introduce the concept of limiting conditional distributions, which describe the equilibrium proportion of surviving patients occupying each disease state in a Markov chain with death. Such distributions can quantitatively describe risk stratification. The authors first establish conditions for the existence of a positive limiting conditional distribution in a general Markov chain and describe a framework for risk stratification using the limiting conditional distribution. They then apply their framework to a clinical example of a treatment indicated for high-risk patients, first to infer the risk of patients selected for treatment in clinical trials and then to predict the outcomes of expanding treatment to other populations of risk. For the general chain, a positive limiting conditional distribution exists only if patients in the earliest state have the lowest combined risk of progression or death. The authors show that in their general framework, outcomes and population risk are interchangeable. For the clinical example, they estimate that previous clinical trials have selected the upper quintile of patient risk for this treatment, but they also show that expanded treatment would weakly dominate this degree of targeted treatment, and universal treatment may be cost-effective. Limiting conditional distributions exist in most Markov models of progressive diseases and are well suited to represent risk stratification quantitatively. This framework can characterize patient risk in clinical trials and predict outcomes for other populations of risk.

The transition to clinical expert: enhanced decision making for children aged less than 5 years attending the paediatric ED with acute respiratory conditions.

PubMed

Bowen, Leah; Shaw, Alison; Lyttle, Mark D; Purdy, Sarah

2017-02-01

Rates of unplanned paediatric admissions are persistently high. Many admissions are short-stay events, lasting less than 48 hours. This qualitative research explores factors that influence clinical decision making in the paediatric ED (PED) for children under 5 attending with acute respiratory conditions, focusing on how management decisions adapt with increasing experience. Semi-structured interviews were conducted with 15 PED clinicians (doctors, emergency nurse practitioners and registered nurses) with varying levels of experience in paediatric emergency medicine (PEM), emergency medicine or paediatrics. Audio-recorded interviews were transcribed and analysed thematically. There were clear differences in decision-making approaches between experienced clinicians and junior staff. The latter were more risk adverse, relying heavily on guidelines, set admission criteria, clinical theory and second opinions. This was particularly true for doctors. 'Informal' learning was apparent in accounts from less-experienced doctors and nurses, whereby tacit knowledge and risk management played an increasing role in the development of clinical intuition that permitted rapid assessment and treatment of young patients. The emergence of intuition entwined with approaches to risk management and the role of these skills in clinical decision making, carry implications for the development of training programmes for clinicians working in PEM. Enhanced training for such groups to permit development of the supplementary skills described in this study could have the ability to improve care delivery and even reduce paediatric admissions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Implementation of standardization in clinical practice: not always an easy task.

PubMed

Panteghini, Mauro

2012-02-29

As soon as a new reference measurement system is adopted, clinical validation of correctly calibrated commercial methods should take place. Tracing back the calibration of routine assays to a reference system can actually modify the relation of analyte results to existing reference intervals and decision limits and this may invalidate some of the clinical decision-making criteria currently used. To maintain the accumulated clinical experience, the quantitative relationship to the previous calibration system should be established and, if necessary, the clinical decision-making criteria should be adjusted accordingly. The implementation of standardization should take place in a concerted action of laboratorians, manufacturers, external quality assessment scheme organizers and clinicians. Dedicated meetings with manufacturers should be organized to discuss the process of assay recalibration and studies should be performed to obtain convincing evidence that the standardization works, improving result comparability. Another important issue relates to the surveillance of the performance of standardized assays through the organization of appropriate analytical internal and external quality controls. Last but not least, uncertainty of measurement that fits for this purpose must be defined across the entire traceability chain, starting with the available reference materials, extending through the manufacturers and their processes for assignment of calibrator values and ultimately to the final result reported to clinicians by laboratories.

Impact of point-of-care ultrasound on clinical decision-making at an urban emergency department in Tanzania.

PubMed

Reynolds, Teri Ann; Amato, Stas; Kulola, Irene; Chen, Chuan-Jay Jeffrey; Mfinanga, Juma; Sawe, Hendry Robert

2018-01-01

Point of care ultrasound (PoCUS) is an efficient, inexpensive, safe, and portable imaging modality that can be particularly useful in resource-limited settings. However, its impact on clinical decision making in such settings has not been well studied. The objective of this study is to describe the utilization and impact of PoCUS on clinical decision making at an urban emergency department in Dar es Salaam, Tanzania. This was a prospective descriptive cross-sectional study of patients receiving PoCUS at Muhimbili National Hospital's Emergency Medical Department (MNH EMD). Data on PoCUS studies during a period of 10 months at MNH EMD was collected on consecutive patients during periods when research assistants were available. Data collected included patient age and sex, indications for ultrasound, findings, interpretations, and provider-reported diagnostic impression and disposition plan before and after PoCUS. Descriptive statistics, including medians and interquartile ranges, and counts and percentages, are reported. Pearson chi squared tests and p-values were used to evaluate categorical data for significant differences. PoCUS data was collected for 986 studies performed on 784 patients. Median patient age was 32 years; 56% of patients were male. Top indications for PoCUS included trauma, respiratory presentations, and abdomino-pelvic pain. The most frequent study types performed were eFAST, cardiac, and obstetric or gynaecologic studies. Overall, clinicians reported that the use of PoCUS changed either diagnostic impression or disposition plan in 29% of all cases. Rates of change in diagnostic impression or disposition plan increased to 45% in patients for whom more than one PoCUS study type was performed. In resource-limited emergency care settings, PoCUS can be utilized for a wide range of indications and has substantial impact on clinical decision making, especially when more than one study type is performed.

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

PubMed

Kalil, Andre C; Sun, Junfeng

2014-10-01

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

An official multi-society statement: the role of clinical research results in the practice of critical care medicine.

PubMed

Tonelli, Mark R; Curtis, J Randall; Guntupalli, Kalpalatha K; Rubenfeld, Gordon D; Arroliga, Alejandro C; Brochard, Laurent; Douglas, Ivor S; Gutterman, David D; Hall, Jesse R; Kavanagh, Brian P; Mancebo, Jordi; Misak, Cheryl J; Simpson, Steven Q; Slutsky, Arthur S; Suffredini, Anthony F; Thompson, B Taylor; Ware, Lorraine B; Wheeler, Arthur P; Levy, Mitchell M

2012-05-15

While the results of clinical research are clearly valuable in the care of critically ill patients, the limitations of such information and the role of other forms of medical knowledge for clinical decision making have not been carefully examined. The leadership of three large professional societies representing critical care practitioners convened a diverse group representing a wide variety of views regarding the role of clinical research results in clinical practice to develop a document to serve as a basis for agreement and a framework for ongoing discussion. Consensus was reached on several issues. While the results of rigorous clinical research are important in arriving at the best course of action for an individual critically ill patient, other forms of medical knowledge, including clinical experience and pathophysiologic reasoning, remain essential. No single source of knowledge is sufficient to guide clinical decisions, nor does one kind of knowledge always take precedence over others. Clinicians will find clinical research compelling for a variety of reasons that go beyond study design. While clinical practice guidelines and protocols based upon clinical research may improve care and decrease variability in practice, clinicians must be able to understand and articulate the rationale as to why a particular protocol or guideline is used or why an alternative approach is taken. Making this clinical reasoning explicit is necessary to understand practice variability. Understanding the strengths and weaknesses of different kinds of medical knowledge for clinical decision making and factors beyond study design that make clinical research compelling to clinicians can provide a framework for understanding the role of clinical research in practice.

Informed decision-making in elective major vascular surgery: analysis of 145 surgeon-patient consultations.

PubMed

Etchells, Edward; Ferrari, Michel; Kiss, Alex; Martyn, Nikki; Zinman, Deborah; Levinson, Wendy

2011-06-01

Prior studies show significant gaps in the informed decision-making process, a central goal of surgical care. These studies have been limited by their focus on low-risk decisions, single visits rather than entire consultations, or both. Our objectives were, first, to rate informed decision-making for major elective vascular surgery based on audiotapes of actual physician-patient conversations and, second, to compare ratings of informed decision-making for first visits to ratings for multiple visits by the same patient over time. We prospectively enrolled patients for whom vascular surgical treatment was a potential option at a tertiary care outpatient vascular surgery clinic. We audio-taped all surgeon-patient conversations, including multiple visits when necessary, until a decision was made. Using an existing method, we evaluated the transcripts for elements of decision-making, including basic elements (e.g., an explanation of the clinical condition), intermediate elements (e.g., risks and benefits) and complex elements (e.g., uncertainty around the decision). We analyzed 145 surgeon-patient consultations. Overall, 45% of consultations contained complex elements, whereas 23% did not contain the basic elements of decision-making. For the 67 consultations that involved multiple visits, ratings were significantly higher when evaluating all visits (50% complex elements) compared with evaluating only the first visit (33% complex elements, p < 0.001.) We found that 45% of consultations contained complex elements, which is higher than prior studies with similar methods. Analyzing decision-making over multiple visits yielded different results than analyzing decision-making for single visits.

Development and Validation of a Primary Care-Based Family Health History and Decision Support Program (MeTree)

PubMed Central

Orlando, Lori A.; Buchanan, Adam H.; Hahn, Susan E.; Christianson, Carol A.; Powell, Karen P.; Skinner, Celette Sugg; Chesnut, Blair; Blach, Colette; Due, Barbara; Ginsburg, Geoffrey S.; Henrich, Vincent C.

2016-01-01

INTRODUCTION Family health history is a strong predictor of disease risk. To reduce the morbidity and mortality of many chronic diseases, risk-stratified evidence-based guidelines strongly encourage the collection and synthesis of family health history to guide selection of primary prevention strategies. However, the collection and synthesis of such information is not well integrated into clinical practice. To address barriers to collection and use of family health histories, the Genomedical Connection developed and validated MeTree, a Web-based, patient-facing family health history collection and clinical decision support tool. MeTree is designed for integration into primary care practices as part of the genomic medicine model for primary care. METHODS We describe the guiding principles, operational characteristics, algorithm development, and coding used to develop MeTree. Validation was performed through stakeholder cognitive interviewing, a genetic counseling pilot program, and clinical practice pilot programs in 2 community-based primary care clinics. RESULTS Stakeholder feedback resulted in changes to MeTree’s interface and changes to the phrasing of clinical decision support documents. The pilot studies resulted in the identification and correction of coding errors and the reformatting of clinical decision support documents. MeTree’s strengths in comparison with other tools are its seamless integration into clinical practice and its provision of action-oriented recommendations guided by providers’ needs. LIMITATIONS The tool was validated in a small cohort. CONCLUSION MeTree can be integrated into primary care practices to help providers collect and synthesize family health history information from patients with the goal of improving adherence to risk-stratified evidence-based guidelines. PMID:24044145

A Closer Look at Racism and Heterosexism in Medical Students' Clinical Decision-Making Related to HIV Pre-Exposure Prophylaxis (PrEP): Implications for PrEP Education.

PubMed

Calabrese, Sarah K; Earnshaw, Valerie A; Krakower, Douglas S; Underhill, Kristen; Vincent, Wilson; Magnus, Manya; Hansen, Nathan B; Kershaw, Trace S; Mayer, Kenneth H; Betancourt, Joseph R; Dovidio, John F

2018-04-01

Social biases among healthcare providers could limit PrEP access. In this survey study of 115 US medical students, we examined associations between biases (racism and heterosexism) and PrEP clinical decision-making and explored prior PrEP education as a potential buffer. After viewing a vignette about a PrEP-seeking MSM patient, participants reported anticipated patient behavior (condomless sex, extra-relational sex, and adherence), intention to prescribe PrEP to the patient, biases, and background characteristics. Minimal evidence for racism affecting clinical decision-making emerged. In unadjusted analyses, heterosexism indirectly affected prescribing intention via all anticipated behaviors, tested as parallel mediators. Participants expressing greater heterosexism more strongly anticipated increased risk behavior and adherence problems, which were associated with lower prescribing intention. The indirect effect via condomless sex remained significant adjusting for background characteristics. Prior PrEP education did not buffer any indirect effects. Heterosexism may compromise PrEP provision to MSM and should be addressed in PrEP-related medical education.

[Application of evidence based medicine to the individual patient: the role of decision analysis].

PubMed

Housset, B; Junod, A F

2003-11-01

The objective of evidence based medicine (EBM) is to contribute to medical decision making by providing the best possible information in terms of validity and relevance. This allows evaluation in a specific manner of the benefits and risks of a decision. The limitations and hazards of this approach are discussed in relation to a clinical case where the diagnosis of pulmonary embolism was under consideration. The individual details and the limited availability of some technical procedures illustrate the need to adapt the data of EBM to the circumstances. The choice between two diagnostic tests (d-dimers and ultrasound of the legs) and their optimal timing is analysed with integration of the consequences for the patient of the treatments proposed. This allows discussion of the concept of utility and the use of sensitivity analysis. If EBM is the cornerstone of rational and explicit practise it should also allow for the constraints of real life. Decision analysis, which depends on the same critical demands as EBM but can also take account of the individual features of each patient and test the robustness of a decision, gives a unique opportunity reconcile rigorous reasoning with individualisation of management.

Impact of advanced monitoring variables on intraoperative clinical decision-making: an international survey.

PubMed

Joosten, Alexandre; Desebbe, Olivier; Suehiro, Koichi; Essiet, Mfonobong; Alexander, Brenton; Ricks, Cameron; Rinehart, Joseph; Faraoni, David; Cecconi, Maurizio; Van der Linden, Philippe; Cannesson, Maxime

2017-02-01

To assess the relationship between the addition of advanced monitoring variables and changes in clinical decision-making. A 15-questions survey was anonymously emailed to international experts and physician members of five anesthesia societies which focused on assessing treatment decisions of clinicians during three realistic clinical scenarios measured at two distinct time points. The first is when typical case information and basic monitoring (T1) were provided, and then once again after the addition of advanced monitoring variables (T2). We hypothesized that the addition of advanced variables would increase the incidence of an optimal therapeutic decision (a priori defined as the answer with the highest percentage of expert agreement) and decrease the variability among the physician's suggested treatments. The survey was completed by 18 experts and 839 physicians. Overall, adding advanced monitoring did not significantly increase physician response accuracy, with the least substantial changes noted on questions related to volume expansion or vasopressor administration. Moreover, advanced monitoring data did not significantly decrease the high level of initial practice variability in physician suggested treatments (P = 0.13), in contrast to the low variability observed within the expert group (P = 0.039). Additionally, 5-10 years of practice (P < 0.0001) and a cardiovascular subspecialty (P = 0.048) were both physician characteristics associated with a higher rate of optimal therapeutic decisions. The addition of advanced variables was of limited benefit for most physicians, further indicating the need for more in depth education on the clinical value and technical understanding of such variables.

IBM's Health Analytics and Clinical Decision Support.

PubMed

Kohn, M S; Sun, J; Knoop, S; Shabo, A; Carmeli, B; Sow, D; Syed-Mahmood, T; Rapp, W

2014-08-15

This survey explores the role of big data and health analytics developed by IBM in supporting the transformation of healthcare by augmenting evidence-based decision-making. Some problems in healthcare and strategies for change are described. It is argued that change requires better decisions, which, in turn, require better use of the many kinds of healthcare information. Analytic resources that address each of the information challenges are described. Examples of the role of each of the resources are given. There are powerful analytic tools that utilize the various kinds of big data in healthcare to help clinicians make more personalized, evidenced-based decisions. Such resources can extract relevant information and provide insights that clinicians can use to make evidence-supported decisions. There are early suggestions that these resources have clinical value. As with all analytic tools, they are limited by the amount and quality of data. Big data is an inevitable part of the future of healthcare. There is a compelling need to manage and use big data to make better decisions to support the transformation of healthcare to the personalized, evidence-supported model of the future. Cognitive computing resources are necessary to manage the challenges in employing big data in healthcare. Such tools have been and are being developed. The analytic resources, themselves, do not drive, but support healthcare transformation.

Fit for purpose: perspectives on rapid reviews from end-user interviews.

PubMed

Hartling, Lisa; Guise, Jeanne-Marie; Hempel, Susanne; Featherstone, Robin; Mitchell, Matthew D; Motu'apuaka, Makalapua L; Robinson, Karen A; Schoelles, Karen; Totten, Annette; Whitlock, Evelyn; Wilt, Timothy J; Anderson, Johanna; Berliner, Elise; Gozu, Aysegul; Kato, Elisabeth; Paynter, Robin; Umscheid, Craig A

2017-02-17

There is increasing demand for rapid reviews and timely evidence synthesis. The goal of this project was to understand end-user perspectives on the utility and limitations of rapid products including evidence inventories, rapid responses, and rapid reviews. Interviews were conducted with key informants representing: guideline developers (n = 3), health care providers/health system organizations (n = 3), research funders (n = 1), and payers/health insurers (n = 1). We elicited perspectives on important characteristics of systematic reviews, acceptable methods to streamline reviews, and uses of rapid products. We analyzed content of the interview transcripts and identified themes and subthemes. Key informants identified the following as critical features of evidence reviews: (1) originating from a reliable source (i.e., conducted by experienced reviewers from an established research organization), (2) addressing clinically relevant questions, and (3) trusted relationship between the user and producer. Key informants expressed strong preference for the following review methods and characteristics: use of evidence tables, quality rating of studies, assessments of total evidence quality/strength, and use of summary tables for results and conclusions. Most acceptable trade-offs to increase efficiencies were limiting the literature search (e.g., limiting search dates or language) and performing single screening of citations and full texts for relevance. Key informants perceived rapid products (particularly evidence inventories and rapid responses) as useful interim products to inform downstream investigation (e.g., whether to proceed with a full review or guideline, direction for future research). Most key informants indicated that evidence analysis/synthesis and quality/strength of evidence assessments were important for decision-making. They reported that rapid reviews in particular were useful for guideline development on narrow topics, policy decisions when a quick turn-around is needed, decision-making for practicing clinicians in nuanced clinical settings, and decisions about coverage by payers/health insurers. Rapid reviews may be more relevant within specific clinical settings or health systems; whereas, broad/national guidelines often need a traditional systematic review. Key informants interviewed in our study indicated that evidence inventories, rapid responses, and rapid reviews have utility in specific decisions and contexts. They indicated that the credibility of the review producer, relevance of key questions, and close working relationship between the end-user and producer are critical for any rapid product. Our findings are limited by the sample size which may have been too small to reach saturation for the themes described.

Beyond evidence-based nursing: tools for practice.

PubMed

Jutel, Annemarie

2008-05-01

This commentary shares my views of evidence-based nursing as a framework for practice, pointing out its limitations and identifying a wider base of appraisal tools required for making good clinical decisions. As the principles of evidence-based nursing take an increasingly greater hold on nursing education, policy and management, it is important to consider the range of other decision-making tools which are subordinated by this approach. This article summarizes nursing's simultaneous reliance on and critique of evidence-based practice (EBP) in a context of inadequate critical reasoning. It then provides an exemplar of the limitations of evidence-based practice and offers an alternative view of important precepts of decision-making. I identify means by which nurses can develop skills to engage in informed and robust critique of practices and their underpinning rationale. Nurses need to be able to locate and assess useful and reliable information for decision-making. This skill is based on a range of tools which include, but also go beyond EBP including: information literacy, humanities, social sciences, public health, statistics, marketing, ethics and much more. This essay prompts nursing managers to reflect upon whether a flurried enthusiasm to adopt EBP neglects other important decision-making skills which provide an even stronger foundation for robust nursing decisions.

Newly graduated nurses' use of knowledge sources in clinical decision-making: an ethnographic study.

PubMed

Voldbjerg, Siri Lygum; Grønkjaer, Mette; Wiechula, Rick; Sørensen, Erik Elgaard

2017-05-01

To explore which knowledge sources newly graduated nurses' use in clinical decision-making and why and how they are used. In spite of an increased educational focus on skills and competencies within evidence-based practice, newly graduated nurses' ability to use components within evidence-based practice with a conscious and reflective use of research evidence has been described as being poor. To understand why, it is relevant to explore which other knowledge sources are used. This may shed light on why research evidence is sparsely used and ultimately inform approaches to strengthen the knowledgebase used in clinical decision-making. Ethnographic study using participant-observation and individual semistructured interviews of nine Danish newly graduated nurses in medical and surgical hospital settings. Newly graduates use of knowledge sources was described within three main structures: 'other', 'oneself' and 'gut feeling'. Educational preparation, transition into clinical practice and the culture of the setting influenced the knowledge sources used. The sources ranged from overt easily articulated knowledge sources to covert sources that were difficult to articulate. The limited articulation of certain sources inhibited the critical reflection on the reasoning behind decisions. Reflection is a prerequisite for an evidence-based practice where decisions should be transparent in order to consider if other evidentiary sources could be used. Although there is a complexity and variety to knowledge sources used, there is an imbalance with the experienced nurse playing a key role, functioning both as predominant source and a role model as to which sources are valued and used in clinical decision-making. If newly graduates are to be supported in an articulate and reflective use of a variety of sources, they have to be allocated to experienced nurses who model a reflective, articulate and balanced use of knowledge sources. © 2016 John Wiley & Sons Ltd.

"It can be challenging, it can be scary, it can be gratifying": Obstetricians' narratives of negotiating patient choice, clinical experience, and standards of care in decision-making.

PubMed

Diamond-Brown, Lauren

2018-05-01

This paper examines obstetricians' perceptions of standards of care and patient-centered care in clinical decision-making in childbirth. Patient-centered care and standardization of medicine are two social movements that seek to change how physicians make clinical decisions. Sociologists question if these limit physician discretion and weaken their social power; the degree to which this occurs in everyday practice is up for debate. Of additional concern is how physicians deal with observed tensions between these ideals. These questions are answered through in-depth interviews with 50 self-selected obstetricians from Massachusetts, Louisiana, and Vermont collected between 2013 and 2015. Interview data was analyzed using a grounded theory and template approach. The author problematizes obstetricians' attitudes about standards of care and shared decision-making, mechanisms that encourage or discourage these approaches to decision-making, and how obstetricians negotiate tensions between patient choice, clinical experience, and standards. The key findings are that most obstetricians feel they have the authority to interpret the appropriateness of standards and patient choice on a case-by-case basis. They feel empowered and/or constrained by pressures to practice patient-centered care and standards depending upon their style of practice and the organizational context. Following standards of care is encouraged through organizational mechanisms such as pressure from colleagues, malpractice threat, hospital policy, and payer restrictions. Practicing shared decision-making is challenged when the patient wants something that violates the physician's clinical experience and/or standards of care. When obstetricians prioritize patient choice over experience and/or standards this is done for moral reasons, less so because of organizational pressures. These findings have implications for theorizing the social status of medical professionals, understanding how physicians deal with tensions between standardized and individualized ideals in medicine, and illuminating the way obstetricians interpret power in the physician-patient relationship. Copyright © 2018 Elsevier Ltd. All rights reserved.

"Suffering" in palliative sedation: Conceptual Analysis and Implications for Decision-Making in Clinical Practice.

PubMed

Bozzaro, Claudia; Schildmann, Jan

2018-04-21

Palliative sedation is an increasingly used and, simultaneously, challenging practice at the end of life. Many controversies associated with this therapy are rooted in implicit differences regarding the understanding of "suffering" as prerequisite for palliative sedation. The aim of this paper is to inform the current debates by a conceptual analysis of two different philosophical accounts of suffering, (1) the subjective and holistic concept and (2) the objective and gradual concept and by a clinical-ethical analysis of the implications of each account for decisions about palliative sedation. We will show that while the subjective and holistic account of suffering fits well with the holistic approach of palliative care, there are considerable challenges to justify limits to requests for palliative sedation. By contrast, the objective and gradual account fits well with the need for an objective basis for clinical decisions in the context of palliative sedation, but runs the risk of falling short when considering the individual and subjective experience of suffering at the end of life. We will conclude with a plea for the necessity of further combined conceptual and empirical research to develop a sound and feasible understanding of suffering which can contribute to consistent decision-making about palliative sedation. Copyright © 2018. Published by Elsevier Inc.

Losing Your Gut Feelings. Intuition in Depression

PubMed Central

Remmers, Carina; Michalak, Johannes

2016-01-01

Whereas in basic research, intuition has become a topic of great interest, clinical research and depression research in specific have not applied to the topic of intuition, yet. This is astonishing because a well-known phenomenon during depression is that patients have difficulties to judge and decide. In contrast to healthy individuals who take most daily life decisions intuitively (Kahneman, 2011), depressed individuals seem to have difficulties to come to fast and adaptive decisions. The current article pursues three goals. First, our aim is to establish the hypothesis that intuition is impaired in depression against the background of influential theoretical accounts as well as empirical evidence from basic and clinical research. The second aim of the current paper is to provide explanations for recent findings on the depression-intuition interplay and to present directions for future research that may help to broaden our understanding of decision difficulties in depression. Third, we seek to propose ideas on how therapeutic interventions can support depressed individuals in taking better decisions. Even though our knowledge regarding this topic is still limited, we will tentatively launch the idea that an important first step may be to enhance patients’ access to intuitions. Overall, this paper seeks to introduce the topic of intuition to clinical research on depression and to hereby set the stage for upcoming theory and practice. PMID:27602015

Losing Your Gut Feelings. Intuition in Depression.

PubMed

Remmers, Carina; Michalak, Johannes

2016-01-01

Whereas in basic research, intuition has become a topic of great interest, clinical research and depression research in specific have not applied to the topic of intuition, yet. This is astonishing because a well-known phenomenon during depression is that patients have difficulties to judge and decide. In contrast to healthy individuals who take most daily life decisions intuitively (Kahneman, 2011), depressed individuals seem to have difficulties to come to fast and adaptive decisions. The current article pursues three goals. First, our aim is to establish the hypothesis that intuition is impaired in depression against the background of influential theoretical accounts as well as empirical evidence from basic and clinical research. The second aim of the current paper is to provide explanations for recent findings on the depression-intuition interplay and to present directions for future research that may help to broaden our understanding of decision difficulties in depression. Third, we seek to propose ideas on how therapeutic interventions can support depressed individuals in taking better decisions. Even though our knowledge regarding this topic is still limited, we will tentatively launch the idea that an important first step may be to enhance patients' access to intuitions. Overall, this paper seeks to introduce the topic of intuition to clinical research on depression and to hereby set the stage for upcoming theory and practice.

Circulating tumor DNA for triple-negative breast cancer diagnosis and treatment decisions.

PubMed

Saliou, Adrien; Bidard, François-Clément; Lantz, Olivier; Stern, Marc-Henri; Vincent-Salomon, Anne; Proudhon, Charlotte; Pierga, Jean-Yves

2016-01-01

Triple-negative breast cancer (TNBC) is a highly aggressive disease characterized by a high number of relapses and poor overall survival. The heterogeneity of the disease and the limited treatment options compared to other breast cancer subtypes mainly explain these clinical outcomes. New biomarkers are urgently needed to improve the management of TNBC. Circulating tumor DNA, identified by tumor-related molecular alterations, could be used in the context of non-invasive "liquid biopsy" and help in TNBC diagnosis and treatment decisions. In this review, we discuss the key issues related to the potential of circulating tumor DNA to improve the management of this disease and the future steps to overcome before its implementation into clinical routine within the next 5 years.

Dementia Prevention: optimizing the use of observational data for personal, clinical, and public health decision-making.

PubMed

Dacks, Penny A; Andrieu, Sandrine; Blacker, Deborah; Carman, Aaron J; Green, Allan M; Grodstein, Francine; Henderson, Victor W; James, Bryan D; Lane, Rachel F; Lau, Joseph; Lin, Pei-Jung; Reeves, Barnaby C; Shah, Raj C; Vellas, Bruno; Yaffe, Kristine; Yurko-Mauro, Karin; Shineman, Diana W; Bennett, David A; Fillit, Howard M

2014-02-01

Worldwide, over 35 million people suffer from Alzheimer's disease and related dementias. This number is expected to triple over the next 40 years. How can we improve the evidence supporting strategies to reduce the rate of dementia in future generations? The risk of dementia is likely influenced by modifiable factors such as exercise, cognitive activity, and the clinical management of diabetes and hypertension. However, the quality of evidence is limited and it remains unclear whether specific interventions to reduce these modifiable risk factors can, in turn, reduce the risk of dementia. Although randomized controlled trials are the gold-standard for causality, the majority of evidence for long-term dementia prevention derives from, and will likely continue to derive from, observational studies. Although observational research has some unavoidable limitations, its utility for dementia prevention might be improved by, for example, better distinction between confirmatory and exploratory research, higher reporting standards, investment in effectiveness research enabled by increased data-pooling, and standardized exposure and outcome measures. Informed decision-making by the general public on low-risk health choices that could have broad potential benefits could be enabled by internet-based tools and decision-aids to communicate the evidence, its quality, and the estimated magnitude of effect.

Sideline Coverage

PubMed Central

Gould, Sara J.; Cardone, Dennis A.; Munyak, John; Underwood, Philipp J.; Gould, Stephen A.

2014-01-01

Context: Sidelines coverage presents unique challenges in the evaluation of injured athletes. Health care providers may be confronted with the question of when to obtain radiographs following an injury. Given that most sidelines coverage occurs outside the elite level, radiographs are not readily available at the time of injury, and the decision of when to send a player for radiographs must be made based on physical examination. Clinical tools have been developed to aid in identifying injuries that are likely to result in radiographically important fractures or dislocations. Evidence Acquisition: A search for the keywords x-ray and decision rule along with the anatomic locations shoulder, elbow, wrist, knee, and ankle was performed using the PubMed database. No limits were set regarding year of publication. We selected meta-analyses, randomized controlled trials, and survey results. Our selection focused on the largest, most well-studied published reports. We also attempted to include studies that reported the application of the rules to the field of sports medicine. Study Design: Retrospective literature review. Level of Evidence: Level 4. Results: The Ottawa Foot and Ankle Rules have been validated and implemented and are appropriate for use in both pediatric and adult populations. The Ottawa Knee Rules have been widely studied, validated, and accepted for evaluation of knee injuries. There are promising studies of decision rules for clinically important fractures of the wrist, but these studies have not been validated. The elbow has been evaluated with good outcomes via the elbow extension test, which has been validated in both single and multicenter studies. Currently, there are no reliable clinical decision tools for traumatic sports injuries to the shoulder to aid in the decision of when to obtain radiographs. Conclusion: Clinical decision tools have been developed to aid in the diagnosis and management of injuries commonly sustained during sporting events. Tools that have been appropriately validated in populations outside the initial study population can assist sports medicine physicians in the decision of when to get radiographs from the sidelines. PMID:24790698

The Effect of a Microprocessor Prosthetic Foot on Function and Quality of Life in Transtibial Amputees Who Are Limited Community Ambulators

DTIC Science & Technology

2017-09-01

parallel, randomized, controlled clinical trial designed to determine if a microprocessor controlled prosthetic foot (MPF), with greater range of...clinical trial designed to determine if a microprocessor controlled prosthetic foot (MPF), with greater range of motion and active power, will...Department of the Army position, policy or decision unless so designated by other documentation. CONTRACTING ORGANIZATION: University of Tennessee

End-of-life decisions in Malaysia: Adequacies of ethical codes and developing legal standards.

PubMed

Kassim, Puteri Nemie Jahn; Alias, Fadhlina

2015-06-01

End-of-life decision-making is an area of medical practice in which ethical dilemmas and legal interventions have become increasingly prevalent. Decisions are no longer confined to clinical assessments; rather, they involve wider considerations such as a patient's religious and cultural beliefs, financial constraints, and the wishes and needs of family members. These decisions affect everyone concerned, including members of the community as a whole. Therefore it is imperative that clear ethical codes and legal standards are developed to help guide the medical profession on the best possible course of action for patients. This article considers the relevant ethical, codes and legal provisions in Malaysia governing certain aspects of end-of-life decision-making. It highlights the lack of judicial decisions in this area as well as the limitations with the Malaysian regulatory system. The article recommends the development of comprehensive ethical codes and legal standards to guide end-of-life decision-making in Malaysia.

PAlliative Care in chronic Kidney diSease: the PACKS study--quality of life, decision making, costs and impact on carers in people managed without dialysis.

PubMed

Noble, Helen Rose; Agus, Ashley; Brazil, Kevin; Burns, Aine; Goodfellow, Nicola A; Guiney, Mary; McCourt, Fiona; McDowell, Cliona; Normand, Charles; Roderick, Paul; Thompson, Colin; Maxwell, A P; Yaqoob, M M

2015-07-11

The number of patients with advanced chronic kidney disease opting for conservative management rather than dialysis is unknown but likely to be growing as increasingly frail patients with advanced renal disease present to renal services. Conservative kidney management includes ongoing medical input and support from a multidisciplinary team. There is limited evidence concerning patient and carer experience of this choice. This study will explore quality of life, symptoms, cognition, frailty, performance decision making, costs and impact on carers in people with advanced chronic kidney disease managed without dialysis and is funded by the National Institute of Health Research in the UK. In this prospective, multicentre, longitudinal study, patients will be recruited in the UK, by renal research nurses, once they have made the decision not to embark on dialysis. Carers will be asked to 'opt-in' with consent from patients. The approach includes longitudinal quantitative surveys of quality of life, symptoms, decision making and costs for patients and quality of life and costs for carers, with questionnaires administered quarterly over 12 months. Additionally, the decision making process will be explored via qualitative interviews with renal physicians/clinical nurse specialists. The study is designed to capture patient and carer profiles when conservative kidney management is implemented, and understand trajectories of care-receiving and care-giving with the aim of optimising palliative care for this population. It will explore the interactions that lead to clinical care decisions and the impact of these decisions on informal carers with the intention of improving clinical outcomes for patients and the experiences of care givers.

Understanding surgeon decision making in the use of radiotherapy as neoadjuvant treatment in rectal cancer.

PubMed

Ansari, Nabila; Young, Christopher J; Schlub, Timothy E; Dhillon, Haryana M; Solomon, Michael J

2015-12-01

Strong evidence supports the use of neoadjuvant radiotherapy in rectal cancer to improve local control. This randomised controlled trial aimed to determine the effect of clinical and non-clinical factors on decision making by colorectal surgeons in patients with rectal cancer. Two surveys comprising vignettes of alternating short (4) and long (12) cues identified previously as important in rectal cancer, were randomly assigned to all members of the CSSANZ. Respondents chose from three possible treatments: long course chemoradiotherapy (LC), short course radiotherapy (SC) or surgery alone to investigate the effects on surgeon decision and confidence in decisions. Choice data were analysed using multinomial logistic regression models. 106 of 165 (64%) surgeons responded. LC was the preferred treatment choice in 73% of vignettes. Surgeons were more likely to recommend LC over SC (OR 1.79) or surgery alone (OR 1.99) when presented with the shorter, four-cue scenarios. There was no significant difference in confidence in decisions made when surgeons were presented with long cue vignettes (P = 0.57). Significant effects on the choice between LC, SC and surgery alone were tumour stage (P < 0.001), nodal status (P < 0.001), tumour position in the rectum (P < 0.001) and the circumferential location of the tumour (P < 0.001). A T4 tumour was the factor most likely associated with a recommendation against surgery alone (OR 335.96) or SC (OR 61.73). This study shows that clinical factors exert the greatest influence on surgeon decision making, which follows a "fast and frugal" heuristic decision making model. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Analyzing the effectiveness of teaching and factors in clinical decision-making.

PubMed

Hsieh, Ming-Chen; Lee, Ming-Shinn; Chen, Tsung-Ying; Tsai, Tsuen-Chiuan; Pai, Yi-Fong; Sheu, Min-Muh

2017-01-01

The aim of this study is to prepare junior physicians, clinical education should focus on the teaching of clinical decision-making. This research is designed to explore teaching of clinical decision-making and to analyze the benefits of an "Analogy guide clinical decision-making" as a learning intervention for junior doctors. This study had a "quasi-experimental design" and was conducted in a medical center in eastern Taiwan. Participants and Program Description: Thirty junior doctors and three clinical teachers were involved in the study. The experimental group (15) received 1 h of instruction from the "Analogy guide for teaching clinical decision-making" every day for 3 months. Program Evaluation: A "Clinical decision-making self-evaluation form" was used as the assessment tool to evaluate participant learning efficiency before and after the teaching program. Semi-structured qualitative research interviews were also conducted. We found using the analogy guide for teaching clinical decision-making could help enhance junior doctors' self-confidence. Important factors influencing clinical decision-making included workload, decision-making, and past experience. Clinical teaching using the analogy guide for clinical decision-making may be a helpful tool for training and can contribute to a more comprehensive understanding of decision-making.

Time trends and patterns of reported egg consumption in the U.S. by sociodemographic characteristics

USDA-ARS?s Scientific Manuscript database

Eggs have the potential to contribute essential nutrients to nutritionally vulnerable populations on limited food budgets. Further research is needed to better understand patterns of egg consumption across diverse sociodemographic groups in order to inform clinical practice and industry decision-mak...

Fertility preservation and cancer: Challenges for adolescent and young adult patients

PubMed Central

Benedict, Catherine; Thom, Bridgette; Kelvin, Joanne

2016-01-01

Purpose of review With increasing survival rates, fertility is an important quality of life concern for many young cancer patients. There is a critical need for improvements in clinical care to ensure patients are well informed about infertility risks and fertility preservation (FP) options and to support them in their reproductive decision-making prior to treatment. Recent findings A number of barriers prevent fertility from being adequately addressed in the clinical context. Providers’ and patients’ incomplete or inaccurate understanding of infertility risks exacerbate patients’ reproductive concerns. For female patients in particular, making decisions about FP before treatment often leads to decision conflict, reducing the likelihood of making informed, values-based decisions, and post-treatment regret and distress. Recent empirically-based interventions to improve provider training around fertility issues and to support patient decision-making about FP show promise. Summary Providers should be knowledgeable about the infertility risks associated with cancer therapies and proactively address fertility with all patients who might one day wish to have a child. Comprehensive counseling should also include related issues such as contraceptive use and health implications of early menopause, regardless of desire for future children. Although the negative psychosocial impact of cancer-related infertility is now well accepted, limited work has been done to explore how to improve clinical management of fertility issues in the context of cancer care. Evidence-based interventions should be developed to address barriers and provide psychosocial and decision-making support to patients who are concerned about their fertility and interested in FP options. PMID:26730794

Decision making and cancer.

PubMed

Reyna, Valerie F; Nelson, Wendy L; Han, Paul K; Pignone, Michael P

2015-01-01

We review decision making along the cancer continuum in the contemporary context of informed and shared decision making in which patients are encouraged to take a more active role in their health care. We discuss challenges to achieving informed and shared decision making, including cognitive limitations and emotional factors, but argue that understanding the mechanisms of decision making offers hope for improving decision support. Theoretical approaches to decision making that explain cognition, emotion, and their interaction are described, including classical psychophysical approaches, dual-process approaches that focus on conflicts between emotion versus cognition (or reason), and modern integrative approaches such as fuzzy-trace theory. In contrast to the earlier emphasis on rote use of numerical detail, modern approaches emphasize understanding the bottom-line gist of options (which encompasses emotion and other influences on meaning) and retrieving relevant social and moral values to apply to those gist representations. Finally, research on interventions to support better decision making in clinical settings is reviewed, drawing out implications for future research on decision making and cancer. PsycINFO Database Record (c) 2015 APA, all rights reserved.

Diagnostic Performance of Electronic Syndromic Surveillance Systems in Acute Care

PubMed Central

Kashiouris, M.; O’Horo, J.C.; Pickering, B.W.; Herasevich, V.

2013-01-01

Context Healthcare Electronic Syndromic Surveillance (ESS) is the systematic collection, analysis and interpretation of ongoing clinical data with subsequent dissemination of results, which aid clinical decision-making. Objective To evaluate, classify and analyze the diagnostic performance, strengths and limitations of existing acute care ESS systems. Data Sources All available to us studies in Ovid MEDLINE, Ovid EMBASE, CINAHL and Scopus databases, from as early as January 1972 through the first week of September 2012. Study Selection: Prospective and retrospective trials, examining the diagnostic performance of inpatient ESS and providing objective diagnostic data including sensitivity, specificity, positive and negative predictive values. Data Extraction Two independent reviewers extracted diagnostic performance data on ESS systems, including clinical area, number of decision points, sensitivity and specificity. Positive and negative likelihood ratios were calculated for each healthcare ESS system. A likelihood matrix summarizing the various ESS systems performance was created. Results The described search strategy yielded 1639 articles. Of these, 1497 were excluded on abstract information. After full text review, abstraction and arbitration with a third reviewer, 33 studies met inclusion criteria, reporting 102,611 ESS decision points. The yielded I2 was high (98.8%), precluding meta-analysis. Performance was variable, with sensitivities ranging from 21% –100% and specificities ranging from 5%-100%. Conclusions There is significant heterogeneity in the diagnostic performance of the available ESS implements in acute care, stemming from the wide spectrum of different clinical entities and ESS systems. Based on the results, we introduce a conceptual framework using a likelihood ratio matrix for evaluation and meaningful application of future, frontline clinical decision support systems. PMID:23874359

The Evolving Landscape of HIV Drug Resistance Diagnostics for Expanding Testing in Resource-Limited Settings.

PubMed

Inzaule, Seth C; Hamers, Ralph L; Paredes, Roger; Yang, Chunfu; Schuurman, Rob; Rinke de Wit, Tobias F

2017-01-01

Global scale-up of antiretroviral treatment has dramatically changed the prospects of HIV/AIDS disease, rendering life-long chronic care and treatment a reality for millions of HIV-infected patients. Affordable technologies to monitor antiretroviral treatment are needed to ensure long-term durability of limited available drug regimens. HIV drug resistance tests can complement existing strategies in optimizing clinical decision-making for patients with treatment failure, in addition to facilitating population-based surveillance of HIV drug resistance. This review assesses the current landscape of HIV drug resistance technologies and discusses the strengths and limitations of existing assays available for expanding testing in resource-limited settings. These include sequencing-based assays (Sanger sequencing assays and nextgeneration sequencing), point mutation assays, and genotype-free data-based prediction systems. Sanger assays are currently considered the gold standard genotyping technology, though only available at a limited number of resource-limited setting reference and regional laboratories, but high capital and test costs have limited their wide expansion. Point mutation assays present opportunities for simplified laboratory assays, but HIV genetic variability, extensive codon redundancy at or near the mutation target sites with limited multiplexing capability have restricted their utility. Next-generation sequencing, despite high costs, may have potential to reduce the testing cost significantly through multiplexing in high-throughput facilities, although the level of bioinformatics expertise required for data analysis is currently still complex and expensive and lacks standardization. Web-based genotype-free prediction systems may provide enhanced antiretroviral treatment decision-making without the need for laboratory testing, but require further clinical field evaluation and implementation scientific research in resource-limited settings.

DXplain: a Web-based diagnostic decision support system for medical students.

PubMed

London, S

1998-01-01

DXplain is a diagnostic decision support program, with a new World Wide Web interface, designed to help medical students and physicians formulate differential diagnoses based on clinical findings. It covers over 2000 diseases and 5000 clinical manifestations. DXplain suggests possible diagnoses, and provides brief descriptions of every disease in the database. Not all diseases are included, nor does DXplain take into account preexisting conditions or the chronological sequence of clinical manifestations. Despite these limitations, it is a useful educational tool, particularly for problem-based learning (PBL) cases and for students in clinical rotations, as it fills a niche not adequately covered by MEDLINE or medical texts. The system is relatively self-explanatory, requiring little or no end-user training. Medical libraries offering, or planning to offer, their users access to Web-based materials and resources may find this system a valuable addition to their electronic collections. Should it prove popular with the local users, provision of access may also establish or enhance the library's image as a partner in medical education.

Accuracy of dengue clinical diagnosis with and without NS1 antigen rapid test: Comparison between human and Bayesian network model decision.

PubMed

Sa-Ngamuang, Chaitawat; Haddawy, Peter; Luvira, Viravarn; Piyaphanee, Watcharapong; Iamsirithaworn, Sopon; Lawpoolsri, Saranath

2018-06-18

Differentiating dengue patients from other acute febrile illness patients is a great challenge among physicians. Several dengue diagnosis methods are recommended by WHO. The application of specific laboratory tests is still limited due to high cost, lack of equipment, and uncertain validity. Therefore, clinical diagnosis remains a common practice especially in resource limited settings. Bayesian networks have been shown to be a useful tool for diagnostic decision support. This study aimed to construct Bayesian network models using basic demographic, clinical, and laboratory profiles of acute febrile illness patients to diagnose dengue. Data of 397 acute undifferentiated febrile illness patients who visited the fever clinic of the Bangkok Hospital for Tropical Diseases, Thailand, were used for model construction and validation. The two best final models were selected: one with and one without NS1 rapid test result. The diagnostic accuracy of the models was compared with that of physicians on the same set of patients. The Bayesian network models provided good diagnostic accuracy of dengue infection, with ROC AUC of 0.80 and 0.75 for models with and without NS1 rapid test result, respectively. The models had approximately 80% specificity and 70% sensitivity, similar to the diagnostic accuracy of the hospital's fellows in infectious disease. Including information on NS1 rapid test improved the specificity, but reduced the sensitivity, both in model and physician diagnoses. The Bayesian network model developed in this study could be useful to assist physicians in diagnosing dengue, particularly in regions where experienced physicians and laboratory confirmation tests are limited.

Constructing diagnostic likelihood: clinical decisions using subjective versus statistical probability.

PubMed

Kinnear, John; Jackson, Ruth

2017-07-01

Although physicians are highly trained in the application of evidence-based medicine, and are assumed to make rational decisions, there is evidence that their decision making is prone to biases. One of the biases that has been shown to affect accuracy of judgements is that of representativeness and base-rate neglect, where the saliency of a person's features leads to overestimation of their likelihood of belonging to a group. This results in the substitution of 'subjective' probability for statistical probability. This study examines clinicians' propensity to make estimations of subjective probability when presented with clinical information that is considered typical of a medical condition. The strength of the representativeness bias is tested by presenting choices in textual and graphic form. Understanding of statistical probability is also tested by omitting all clinical information. For the questions that included clinical information, 46.7% and 45.5% of clinicians made judgements of statistical probability, respectively. Where the question omitted clinical information, 79.9% of clinicians made a judgement consistent with statistical probability. There was a statistically significant difference in responses to the questions with and without representativeness information (χ2 (1, n=254)=54.45, p<0.0001). Physicians are strongly influenced by a representativeness bias, leading to base-rate neglect, even though they understand the application of statistical probability. One of the causes for this representativeness bias may be the way clinical medicine is taught where stereotypic presentations are emphasised in diagnostic decision making. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Virtual clinics in glaucoma care: face-to-face versus remote decision-making.

PubMed

Clarke, Jonathan; Puertas, Renata; Kotecha, Aachal; Foster, Paul J; Barton, Keith

2017-07-01

To examine the agreement in clinical decisions of glaucoma status made in a virtual glaucoma clinic with those made during a face-to-face consultation. A trained nurse and technicians entered data prospectively for 204 patients into a proforma. A subsequent face-to-face clinical assessment was completed by either a glaucoma consultant or fellow. Proformas were reviewed remotely by one of two additional glaucoma consultants, and 12 months later, by the clinicians who had undertaken the original clinical examination. The interobserver and intraobserver decision-making agreements of virtual assessment versus standard care were calculated. We identified adverse disagreement between face-to-face and virtual review in 7/204 (3.4%, 95% CI 0.9% to 5.9%) patients, where virtual review failed to predict a need to accelerated follow-up identified in face-to-face review. Misclassification events were rare, occurring in 1.9% (95% CI 0.3% to 3.8%) of assessments. Interobserver κ (95% CI) showed only fair agreement (0.24 (0.04 to 0.43)); this improved to moderate agreement when only consultant decisions were compared against each other (κ=0.41 (0.16 to 0.65)). The intraobserver agreement κ (95% CI) for the consultant was 0.274 (0.073 to 0.476), and that for the fellow was 0.264 (0.031 to 0.497). The low rate of adverse misclassification, combined with the slowly progressive nature of most glaucoma, and the fact that patients will all be regularly reassessed, suggests that virtual clinics offer a safe, logistically viable option for selected patients with glaucoma. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

When is rational to order a diagnostic test, or prescribe treatment: the threshold model as an explanation of practice variation.

PubMed

Djulbegovic, Benjamin; van den Ende, Jef; Hamm, Robert M; Mayrhofer, Thomas; Hozo, Iztok; Pauker, Stephen G

2015-05-01

The threshold model represents an important advance in the field of medical decision-making. It is a linchpin between evidence (which exists on the continuum of credibility) and decision-making (which is a categorical exercise - we decide to act or not act). The threshold concept is closely related to the question of rational decision-making. When should the physician act, that is order a diagnostic test, or prescribe treatment? The threshold model embodies the decision theoretic rationality that says the most rational decision is to prescribe treatment when the expected treatment benefit outweighs its expected harms. However, the well-documented large variation in the way physicians order diagnostic tests or decide to administer treatments is consistent with a notion that physicians' individual action thresholds vary. We present a narrative review summarizing the existing literature on physicians' use of a threshold strategy for decision-making. We found that the observed variation in decision action thresholds is partially due to the way people integrate benefits and harms. That is, explanation of variation in clinical practice can be reduced to a consideration of thresholds. Limited evidence suggests that non-expected utility threshold (non-EUT) models, such as regret-based and dual-processing models, may explain current medical practice better. However, inclusion of costs and recognition of risk attitudes towards uncertain treatment effects and comorbidities may improve the explanatory and predictive value of the EUT-based threshold models. The decision when to act is closely related to the question of rational choice. We conclude that the medical community has not yet fully defined criteria for rational clinical decision-making. The traditional notion of rationality rooted in EUT may need to be supplemented by reflective rationality, which strives to integrate all aspects of medical practice - medical, humanistic and socio-economic - within a coherent reasoning system. © 2015 Stichting European Society for Clinical Investigation Journal Foundation.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update

PubMed Central

Krop, Ian; Ismaila, Nofisat; Andre, Fabrice; Bast, Robert C.; Barlow, William; Collyar, Deborah E.; Hammond, M. Elizabeth; Kuderer, Nicole M.; Liu, Minetta C.; Mennel, Robert G.; Van Poznak, Catherine; Wolff, Antonio C.; Stearns, Vered

2018-01-01

Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility. Recommendations If a patient has hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-negative breast cancer, the MammaPrint assay may be used in those with high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good-prognosis population with potentially limited chemotherapy benefit. Women in the low clinical risk category did not benefit from chemotherapy regardless of genomic MammaPrint risk group. Therefore, the MammaPrint assay does not have clinical utility in such patients. If a patient has hormone receptor–positive, HER2-negative, node-positive breast cancer, the MammaPrint assay may be used in patients with one to three positive nodes and a high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy. However, such patients should be informed that a benefit from chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. The clinician should not use the MammaPrint assay to guide decisions on adjuvant systemic therapy in patients with hormone receptor–positive, HER2-negative, node-positive breast cancer at low clinical risk, nor any patient with HER2-positive or triple-negative breast cancer, because of the lack of definitive data in these populations. Additional information can be found at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki. PMID:28692382

Supporting clinical rules engine in the adjustment of medication (SCREAM): protocol of a multicentre, prospective, randomised study.

PubMed

Mestres Gonzalvo, Carlota; de Wit, Hugo A J M; van Oijen, Brigit P C; Hurkens, Kim P G M; Janknegt, Rob; Schols, Jos M G A; Mulder, Wubbo J; Verhey, Frans R; Winkens, Bjorn; van der Kuy, Paul-Hugo M

2017-01-26

In the nursing home population, it is estimated that 1 in every 3 patients is polymedicated and given their considerable frailty, these patients are especially prone to adverse drug reactions. Clinical pharmacist-led medication reviews are considered successful interventions to improve medication safety in the inpatient setting. Due to the limited available evidence concerning the benefits of medication reviews performed in the nursing home setting, we propose a study aiming to demonstrate a positive effect that a clinical decision support system, as a health care intervention, may have on the target population. The primary objective of this study is to reduce the number of patients with at least one event when using the clinical decision support system compared to the regular care. These events consist of hospital referrals, delirium, falls, and/or deaths. This study is a multicentre, prospective, randomised study with a cluster group design. The randomisation will be per main nursing home physician and stratified per ward (somatic and psychogeriatric). In the intervention group the clinical decision support system will be used to screen medication list, laboratory values and medical history in order to obtain potential clinical relevant remarks. The remarks will be sent to the main physician and feedback will be provided whether the advice was followed or not. In the control group regular care will be applied. We strongly believe that by using a clinical decision support system, medication reviews are performed in a standardised way which leads to comparable results between patients. In addition, using a clinical decision support system eliminates the time factor to perform medication reviews as the major problems related to medication, laboratory values, indications and/or established patient characteristics will be directly available. In this way, and in order to make the medication review process complete, consultation within healthcare professionals and/or the patient itself will be time effective and the medication surveillance could be performed around the clock. The Netherlands National Trial Register NTR5165 . Registered 2nd April 2015.

Basic Principles of Health Economics Applied - How to Assess if Transcatheter Aortic Valve Implantation is Worth the Investment.

PubMed

Brunn, Matthias; Durand-Zaleski, Isabelle

2013-08-01

This article attempts to present some highlights from the rich economic literature pertaining to interventional cardiology and transcatheter aortic valve implantation (TAVI). There are currently more questions than answers, not surprisingly given the pace of technological change in interventional cardiology. For clinicians who work in a strictly regulated environment and have limited control over their use of medical technologies, this article will hopefully shed some light on the motives for policy decisions. For clinicians who make decisions on the resources used to treat their patients, it aims to provide the means of looking for evidence that will allow for informed decisions from both clinical and economic perspectives.

Putting the value into biosimilar decision making: the judgment value criteria.

PubMed

Mendes de Abreu, Mirhelen; Strand, Vibeke; Levy, Roger Abramino; Araujo, Denizar Vianna

2014-06-01

Uncertainties remain the key issue surrounding biosimilars, although decisions regarding their use must be made. The challenges for policymakers, doctors, patients and others seeking to navigate in the uncharted waters of biosimilars must be clarified. At the most basic level, scientific understanding of the issue remains limited and when making decisions, policymakers must consider all those affected by health policy decisions, particularly the ultimate recipients of these medicines: the patients. The biosimilar-value chain relies on measurement of comparabilities. The goal is to demonstrate how, from a molecular perspective, closely similar they are or are not and how potential small differences may be relevant to clinical outcomes. To critically understand these points, this conceptual paper will present a knowledge-value chain and discuss each dimension assigning value in the decision making process re-utilization of biosimilars. Copyright © 2014 Elsevier B.V. All rights reserved.

Building the Evidence Base for Decision-making in Cancer Genomic Medicine Using Comparative Effectiveness Research

PubMed Central

Goddard, Katrina A.B.; Knaus, William A.; Whitlock, Evelyn; Lyman, Gary H.; Feigelson, Heather Spencer; Schully, Sheri D.; Ramsey, Scott; Tunis, Sean; Freedman, Andrew N.; Khoury, Muin J.; Veenstra, David L.

2013-01-01

Background The clinical utility is uncertain for many cancer genomic applications. Comparative effectiveness research (CER) can provide evidence to clarify this uncertainty. Objectives To identify approaches to help stakeholders make evidence-based decisions, and to describe potential challenges and opportunities using CER to produce evidence-based guidance. Methods We identified general CER approaches for genomic applications through literature review, the authors’ experiences, and lessons learned from a recent, seven-site CER initiative in cancer genomic medicine. Case studies illustrate the use of CER approaches. Results Evidence generation and synthesis approaches include comparative observational and randomized trials, patient reported outcomes, decision modeling, and economic analysis. We identified significant challenges to conducting CER in cancer genomics: the rapid pace of innovation, the lack of regulation, the limited evidence for clinical utility, and the beliefs that genomic tests could have personal utility without having clinical utility. Opportunities to capitalize on CER methods in cancer genomics include improvements in the conduct of evidence synthesis, stakeholder engagement, increasing the number of comparative studies, and developing approaches to inform clinical guidelines and research prioritization. Conclusions CER offers a variety of methodological approaches to address stakeholders’ needs. Innovative approaches are needed to ensure an effective translation of genomic discoveries. PMID:22516979

Interpreting “statistical hypothesis testing” results in clinical research

PubMed Central

Sarmukaddam, Sanjeev B.

2012-01-01

Difference between “Clinical Significance and Statistical Significance” should be kept in mind while interpreting “statistical hypothesis testing” results in clinical research. This fact is already known to many but again pointed out here as philosophy of “statistical hypothesis testing” is sometimes unnecessarily criticized mainly due to failure in considering such distinction. Randomized controlled trials are also wrongly criticized similarly. Some scientific method may not be applicable in some peculiar/particular situation does not mean that the method is useless. Also remember that “statistical hypothesis testing” is not for decision making and the field of “decision analysis” is very much an integral part of science of statistics. It is not correct to say that “confidence intervals have nothing to do with confidence” unless one understands meaning of the word “confidence” as used in context of confidence interval. Interpretation of the results of every study should always consider all possible alternative explanations like chance, bias, and confounding. Statistical tests in inferential statistics are, in general, designed to answer the question “How likely is the difference found in random sample(s) is due to chance” and therefore limitation of relying only on statistical significance in making clinical decisions should be avoided. PMID:22707861

Patients With Limited Health Literacy Have Similar Preferences but Different Perceptions in Surgical Decision-making for Carpal Tunnel Release.

PubMed

Roh, Young Hak; Koh, Young Do; Kim, Jong Oh; Noh, Jung Ho; Gong, Hyun Sik; Baek, Goo Hyun

2018-04-01

Health literacy is the ability to obtain, process, and understand health information needed to make appropriate health decisions. The proper comprehension by patients regarding a given disease, its treatment, and the physician's instructions plays an important role in shared decision-making. Studies have disagreed over the degree to which differences in health literacy affect patients' preferences for shared decision-making; we therefore sought to evaluate this in the context of shared decision-making about carpal tunnel release. (1) Do patients with limited health literacy have different preferences of shared decision-making for carpal tunnel release than those with greater levels of health literacy? (2) How do patients with limited health literacy retrospectively perceive their role in shared decision-making after carpal tunnel release? Over a 32-month period, one surgeon surgically treated 149 patients for carpal tunnel syndrome. Patients were eligible if they had cognitive and language function to provide informed consent and complete a self-reported questionnaire and were not eligible if they had nerve entrapment other than carpal tunnel release or had workers compensation issues; based on those, 140 (94%) were approached for study. Of those, seven (5%) were lost to followup before 6 months, leaving 133 for analysis here. Their mean age was 55 years (range, 31-76 years), and 83% (111 of 133) were women. Thirty-three percent (44 of 133) of patients had less than a high school education. Health literacy was measured according to the Newest Vital Sign during the initial visit, and a score of ≤ 3 was considered limited health literacy. Forty-four percent of patients had limited health literacy. The Control Preferences Scale was used for patients to indicate their preferred role in surgical decision-making preoperatively and to assess their perceived level of involvement postoperatively. Bivariate and multivariable analyses were performed to determine whether patients' clinical, demographic, and health literacy factors accounted for the preoperative preferences and postoperative assessments of their role in shared decision-making. A total of 133 patients would provide 94% power for a medium effect size for linear regression with five main predictors. We found no differences between patients with lower levels of health literacy and those with greater health literacy in terms of preferences of shared decision-making for carpal tunnel release (3.0 ± 1.6 versus 2.7 ± 1.4; mean difference, 0.3; 95% confidence interval, -0.2 to 0.8; p = 0.25). A history of surgical procedures (coefficient = -0.32, p < 0.01) and a lower Disabilities of the Arm, Shoulder and Hand score (coefficient = 0.17, p = 0.02) were independently associated with a preference for an active role in shared decision-making. However, patients with limited health literacy (coefficient = -0.31, p = 0.01) and an absence of a caregiver (coefficient = -0.28, p = 0.03) perceived a more passive role in actual decision-making. Physicians should be aware of the discrepancy between preferences and perceptions of shared decision-making among patients with limited health literacy, and physicians should consider providing a decision aid tailored to basic levels of health literacy to help patients achieve their preferred role in decision-making. Level II, prognostic study.

Using best interests meetings for people in a prolonged disorder of consciousness to improve clinical and ethical management.

PubMed

Wade, Derick T

2018-05-01

Current management of people with prolonged disorders of consciousness is failing patients, families and society. The causes include a general lack of concern, knowledge and expertise; a legal and professional framework which impedes timely and appropriate decision-making and/or enactment of the decision; and the exclusive focus on the patient, with no legitimate means to consider the broader consequences of healthcare decisions. This article argues that a clinical pathway based on the principles of (a) the English Mental Capacity Act 2005 and (b) using time-limited treatment trials could greatly improve patient management and reduce stress on families. There needs to be early and continuing use of formal best interests meetings, starting between 7 and 21 days after onset of unconsciousness (from any cause, including progressive disorders). The treatment options need to evolve as the clinical state and prognosis becomes more certain. A formal discussion of treatment withdrawal should occur when the upper bound of predicted recovery falls below a level the patient would have considered acceptable, and it should always be discussed when the condition is considered permanent. Any decision to stop treatment should be contingent on a formal second opinion from an independent expert who should review the clinical situation and expected prognosis, but not the best interests decision. The article also asks how, if at all, the adverse effects on the family and the resource implications of long-term care of people left in a prolonged state of unconsciousness should be incorporated in the process. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Does accountability for reasonableness work? A protocol for a mixed methods study using an audit tool to evaluate the decision-making of clinical commissioning groups in England.

PubMed

Kieslich, Katharina; Littlejohns, Peter

2015-07-10

Clinical commissioning groups (CCGs) in England are tasked with making difficult decisions on which healthcare services to provide against the background of limited budgets. The question is how to ensure that these decisions are fair and legitimate. Accounts of what constitutes fair and legitimate priority setting in healthcare include Daniels' and Sabin's accountability for reasonableness (A4R) and Clark's and Weale's framework for the identification of social values. This study combines these accounts and asks whether the decisions of those CCGs that adhere to elements of such accounts are perceived as fairer and more legitimate by key stakeholders. The study addresses the empirical gap arising from a lack of research on whether frameworks such as A4R hold what they promise. It aims to understand the criteria that feature in CCG decision-making. Finally, it examines the usefulness of a decision-making audit tool (DMAT) in identifying the process and content criteria that CCGs apply when making decisions. The adherence of a sample of CCGs to criteria emerging from theories of fair priority setting will be examined using the DMAT developed by PL. The results will be triangulated with data from semistructured interviews with key stakeholders in the CCG sample to ascertain whether there is a correlation between those CCGs that performed well in the DMAT exercise and those whose decisions are perceived positively by interviewees. Descriptive statistical methods will be used to analyse the DMAT data. A combination of quantitative and qualitative content analysis methods will be used to analyse the interview transcripts. Full ethics approval was received by the King's College London Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee. The results of the study will be disseminated through publications in peer review journals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

PubMed

Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

2018-04-30

FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

Severity in irritable bowel syndrome: a Rome Foundation Working Team report.

PubMed

Drossman, Douglas A; Chang, L; Bellamy, N; Gallo-Torres, H E; Lembo, A; Mearin, F; Norton, N J; Whorwell, P

2011-10-01

The concept of severity in irritable bowel syndrome (IBS) is clinically recognized and operative in diagnostic decision making and treatment planning. Yet, there is no consensus on its definition, and there are limited data on the prevalence of severity subgroups, its medical and psychosocial determinants, and its association with other health status measures. The aims of the Rome Foundation Working Team Committee were to summarize current research, to develop a consensus of understanding on this concept, and to make recommendations for its use in research and clinical care. In 2006, a multinational committee of clinical investigators with expertise in IBS and/or psychometric research methods undertook a systematic review of the literature relating to severity in IBS. Owing to limited data, the Foundation commissioned three clinical studies to better characterize the concept of severity in IBS, and summary information and recommendations for future research and clinical care were developed. The main findings were: (i) severity in IBS is defined as a biopsychosocial composite of patient-reported gastrointestinal and extraintestinal symptoms, degree of disability, and illness-related perceptions and behaviors; (ii) both visceral and central nervous system physiological factors affect severity; as severity increases, the central nervous system provides a greater contribution; (iii) severity is related to and influences health-related quality of life and health behaviors and also guides diagnostic and therapeutic clinical decision making; (iv) severity can be subcategorized into clinically meaningful subgroups as mild (∼40%), moderate (∼35%), and severe (∼25%), and this provides a working model for use in future research and clinical care. Future work is required to understand more precisely the factors contributing to severity and to develop a valid patient-reported instrument to measure severity in IBS.

Return to play after infectious mononucleosis.

PubMed

Becker, Jonathan A; Smith, Julie Anne

2014-05-01

Infectious mononucleosis is a disease primarily of adolescence and early adulthood. The risk of splenic injury and chronic fatigue make return-to-play decisions a challenge for the clinician caring for athletes with infectious mononucleosis. Data were obtained from the PubMed and MEDLINE databases through December 2012 by searching for epidemiology, diagnosis, clinical manifestations, management, and the role of the spleen in infectious mononucleosis. Clinical review. Level 4. Infectious mononucleosis is commonly encountered in young athletes. Its disease pattern is variable and can affect multiple organ systems. Supportive care is the cornerstone, with little role for medications such as corticosteroids. Physical examination is unreliable for the spleen, and ultrasound imaging has limitations in its ability to guide return-to-play decisions. Exercise does not appear to place the young athlete at risk for chronic fatigue, but determining who is at risk for persistent symptoms is a challenge. Return-to-play decisions for the athlete with infectious mononucleosis need to be individualized because of the variable disease course and lack of evidence-based guidelines.

Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention--convened meeting.

PubMed

Broussard, Cheryl S; Frey, Meghan T; Hernandez-Diaz, Sonia; Greene, Michael F; Chambers, Christina D; Sahin, Leyla; Collins Sharp, Beth A; Honein, Margaret A

2014-09-01

To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. Published by Elsevier Inc.

Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention—convened meeting

PubMed Central

Broussard, Cheryl S.; Frey, Meghan T.; Hernandez-Diaz, Sonia; Greene, Michael F.; Chambers, Christina D.; Sahin, Leyla; Collins Sharp, Beth A.; Honein, Margaret A.

2015-01-01

To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. PMID:24881821

Eye-tracking for clinical decision support: A method to capture automatically what physicians are viewing in the EMR.

PubMed

King, Andrew J; Hochheiser, Harry; Visweswaran, Shyam; Clermont, Gilles; Cooper, Gregory F

2017-01-01

Eye-tracking is a valuable research tool that is used in laboratory and limited field environments. We take steps toward developing methods that enable widespread adoption of eye-tracking and its real-time application in clinical decision support. Eye-tracking will enhance awareness and enable intelligent views, more precise alerts, and other forms of decision support in the Electronic Medical Record (EMR). We evaluated a low-cost eye-tracking device and found the device's accuracy to be non-inferior to a more expensive device. We also developed and evaluated an automatic method for mapping eye-tracking data to interface elements in the EMR (e.g., a displayed laboratory test value). Mapping was 88% accurate across the six participants in our experiment. Finally, we piloted the use of the low-cost device and the automatic mapping method to label training data for a Learning EMR (LEMR) which is a system that highlights the EMR elements a physician is predicted to use.

Eye-tracking for clinical decision support: A method to capture automatically what physicians are viewing in the EMR

PubMed Central

King, Andrew J.; Hochheiser, Harry; Visweswaran, Shyam; Clermont, Gilles; Cooper, Gregory F.

2017-01-01

Eye-tracking is a valuable research tool that is used in laboratory and limited field environments. We take steps toward developing methods that enable widespread adoption of eye-tracking and its real-time application in clinical decision support. Eye-tracking will enhance awareness and enable intelligent views, more precise alerts, and other forms of decision support in the Electronic Medical Record (EMR). We evaluated a low-cost eye-tracking device and found the device’s accuracy to be non-inferior to a more expensive device. We also developed and evaluated an automatic method for mapping eye-tracking data to interface elements in the EMR (e.g., a displayed laboratory test value). Mapping was 88% accurate across the six participants in our experiment. Finally, we piloted the use of the low-cost device and the automatic mapping method to label training data for a Learning EMR (LEMR) which is a system that highlights the EMR elements a physician is predicted to use. PMID:28815151

Validation of Pre-operative Patient Self-Assessment of Cardiac Risk for Non-Cardiac Surgery: Foundations for Decision Support

PubMed Central

Manaktala, Sharad; Rockwood, Todd; Adam, Terrence J.

2013-01-01

Objectives: To better characterize patient understanding of their risk of cardiac complications from non-cardiac surgery and to develop a patient driven clinical decision support system for preoperative patient risk management. Methods: A patient-driven preoperative self-assessment decision support tool for perioperative assessment was created. Patient’ self-perception of cardiac risk and self-report data for risk factors were compared with gold standard preoperative physician assessment to evaluate agreement. Results: The patient generated cardiac risk profile was used for risk score generation and had excellent agreement with the expert physician assessment. However, patient subjective self-perception risk of cardiovascular complications had poor agreement with expert assessment. Conclusion: A patient driven cardiac risk assessment tool provides a high degree of agreement with expert provider assessment demonstrating clinical feasibility. The limited agreement between provider risk assessment and patient self-perception underscores a need for further work including focused preoperative patient education on cardiac risk. PMID:24551384

Uncertainty in assessing value of oncology treatments.

PubMed

Mullins, C Daniel; Montgomery, Russ; Tunis, Sean

2010-01-01

Patients, clinicians, payers, and policymakers face an environment of significant evidentiary uncertainty as they attempt to achieve maximum value, or the greatest level of benefit possible at a given level of cost in their respective health care decisions. This is particularly true in the area of oncology, for which published evidence from clinical trials is often incongruent with real-world patient care, and a substantial portion of clinical use is for off-label indications that have not been systematically evaluated. It is this uncertainty in the knowledge of the clinical harms and benefits associated with oncology treatments that prevents postregulatory decision makers from making accurate assessments of the value of these treatments. Because of the incentives inherent in the clinical research enterprise, randomized control trials (RCTs) are designed for the specific purpose of regulatory approval and maximizing market penetration. The pursuit of these goals results in RCT study designs that achieve maximal internal validity at the expense of generalizability to diverse real-world patient populations that may have significant comorbidities and other clinically mitigating factors. As such, systematic reviews for the purposes of coverage and treatment decisions often find relevant and high-quality evidence to be limited or nonexistent. For a number of reasons, including frequent off-label use of medications and the expedited approval process for cancer drugs by the U.S. Food and Drug Administration, this situation is exacerbated in the area of oncology. This paper investigates the convergence of incentives and circumstances that lead to widespread uncertainty in oncology and proposes new paradigms for clinical research, including pragmatic clinical trials, methodological guidance, and coverage with evidence development. Each of these initiatives would support the design of clinical research that is more informative for postregulatory decision makers, and would therefore reduce uncertainty and provide greater confidence in conclusions about the value of these treatments.

[A study on participation in clinical decision making by home healthcare nurses].

PubMed

Kim, Se Young

2010-12-01

This study was done to identify participation by home healthcare nurses in clinical decision making and factors influencing clinical decision making. A descriptive survey was used to collect data from 68 home healthcare nurses in 22 hospital-based home healthcare services in Korea. To investigate participation, the researcher developed 3 scenarios through interviews with 5 home healthcare nurses. A self-report questionnaire composed of tools for characteristics, factors of clinical decision making, and participation was used. Participation was relatively high, but significantly lower in the design phase (F=3.51, p=.032). Competency in clinical decision making (r=.45, p<.001), perception of the decision maker role (r=.47, p<.001), and perception of the utility of clinical practice guidelines (r=.25, p=.043) were significantly correlated with participation. Competency in clinical decision making (Odds ratio [OR]=41.79, p=.007) and perception of the decision maker role (OR=15.09, p=.007) were significant factors predicting participation in clinical decision making by home healthcare nurses. In order to encourage participation in clinical decision making, education programs should be provided to home healthcare nurses. Official clinical practice guidelines should be used to support home healthcare nurses' participation in clinical decision making in cases where they can identify and solve the patient health problems.

Predictive models in cancer management: A guide for clinicians.

PubMed

Kazem, Mohammed Ali

2017-04-01

Predictive tools in cancer management are used to predict different outcomes including survival probability or risk of recurrence. The uptake of these tools by clinicians involved in cancer management has not been as common as other clinical tools, which may be due to the complexity of some of these tools or a lack of understanding of how they can aid decision-making in particular clinical situations. The aim of this article is to improve clinicians' knowledge and understanding of predictive tools used in cancer management, including how they are built, how they can be applied to medical practice, and what their limitations may be. Literature review was conducted to investigate the role of predictive tools in cancer management. All predictive models share similar characteristics, but depending on the type of the tool its ability to predict an outcome will differ. Each type has its own pros and cons, and its generalisability will depend on the cohort used to build the tool. These factors will affect the clinician's decision whether to apply the model to their cohort or not. Before a model is used in clinical practice, it is important to appreciate how the model is constructed, what its use may add over and above traditional decision-making tools, and what problems or limitations may be associated with it. Understanding all the above is an important step for any clinician who wants to decide whether or not use predictive tools in their practice. Copyright © 2016 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Responding to intimate partner violence: Healthcare providers' current practices and views on integrating a safety decision aid into primary care settings.

PubMed

Alvarez, Carmen; Debnam, Katrina; Clough, Amber; Alexander, Kamila; Glass, Nancy E

2018-04-01

Supportive care for survivors of intimate partner violence (IPV) remains limited in primary care settings. Low-income and Spanish-speaking survivors of IPV are even more disadvantaged, given the dearth of linguistically and culturally appropriate interventions for IPV. We conducted semi-structured individual interviews with 17 healthcare workers, including physicians, nurses, and social workers, to describe how healthcare workers serving primarily low-income, Latina populations are currently screening and responding to IPV disclosure, and to explore the acceptability of integrating an interactive, personalized safety decision aid application-myPlan app-into the clinic setting. Despite recognition of IPV as a problem, none of the clinical sites had a protocol to guide screening and response to IPV disclosure. Screening practices varied across the sites, sometimes conducted by medical assistants prior to the provider visit and other times by the physician or nurse provider. When IPV was disclosed, it was often during assessment for a presenting problem such as poor sleep or anxiety. Most healthcare workers felt that clinical and community resources were limited for their patients experiencing IPV. The "warm hand-off" to a social worker was the most common response strategy when possible; otherwise, women were given information about available resources such as hotlines and safe houses. We discuss structural, family, and individual barriers to accessing safety resources for underserved women and review how an easily accessible safety decision app, such as myPlan, could be a resource for women to safely tailor an action plan for her situation. © 2018 Wiley Periodicals, Inc.

IBM’s Health Analytics and Clinical Decision Support

PubMed Central

Sun, J.; Knoop, S.; Shabo, A.; Carmeli, B.; Sow, D.; Syed-Mahmood, T.; Rapp, W.

2014-01-01

Summary Objectives This survey explores the role of big data and health analytics developed by IBM in supporting the transformation of healthcare by augmenting evidence-based decision-making. Methods Some problems in healthcare and strategies for change are described. It is argued that change requires better decisions, which, in turn, require better use of the many kinds of healthcare information. Analytic resources that address each of the information challenges are described. Examples of the role of each of the resources are given. Results There are powerful analytic tools that utilize the various kinds of big data in healthcare to help clinicians make more personalized, evidenced-based decisions. Such resources can extract relevant information and provide insights that clinicians can use to make evidence-supported decisions. There are early suggestions that these resources have clinical value. As with all analytic tools, they are limited by the amount and quality of data. Conclusion Big data is an inevitable part of the future of healthcare. There is a compelling need to manage and use big data to make better decisions to support the transformation of healthcare to the personalized, evidence-supported model of the future. Cognitive computing resources are necessary to manage the challenges in employing big data in healthcare. Such tools have been and are being developed. The analytic resources, themselves, do not drive, but support healthcare transformation. PMID:25123736

Beyond the Futility Argument: The Fair Process Approach and Time-Limited Trials for Managing Dialysis Conflict

PubMed Central

2013-01-01

Summary Futility is an ancient concept arising from Greek mythology that was resurrected for its medical application in the 1980s with the proliferation of many lifesaving technologies, including dialysis and renal transplantation. By that time, the domineering medical paternalism that characterized the pre-1960s physician–patient relationship morphed into assertive patient autonomy, and some patients began to claim the right to demand aggressive, high-technology interventions, despite physician disapproval. To counter this power struggle, the establishment of a precise definition of futility offered hope for a futility policy that would allow physicians to justify withholding or withdrawing treatment, despite patient and family objections. This article reviews the various attempts made to define medical futility and describes their limited applicability to dialysis. When futility concerns arise, physicians should recognize the opportunity to address conflict, using best practice communication skills. Physicians would also benefit from understanding the ethical principles of respect for patient autonomy, beneficence, nonmaleficence, justice, and professional integrity that underlie medical decision-making. Also reviewed is the use of a fair process approach or time-limited trial when conflict resolution cannot be achieved. These topics are addressed in the Renal Physician Association’s clinical practice guideline Shared Decision-Making in the Appropriate Initiation and Withdrawal from Dialysis, with which nephrologists should be well versed. A case presentation of intractable calciphylaxis in a new dialysis patient illustrates the pitfalls of physicians not fully appreciating the ethics of medical decision-making and failing to use effective conflict management approaches in the clinical practice guideline. PMID:23868900

Beyond the futility argument: the fair process approach and time-limited trials for managing dialysis conflict.

PubMed

Rinehart, Ann

2013-11-01

Futility is an ancient concept arising from Greek mythology that was resurrected for its medical application in the 1980s with the proliferation of many lifesaving technologies, including dialysis and renal transplantation. By that time, the domineering medical paternalism that characterized the pre-1960s physician-patient relationship morphed into assertive patient autonomy, and some patients began to claim the right to demand aggressive, high-technology interventions, despite physician disapproval. To counter this power struggle, the establishment of a precise definition of futility offered hope for a futility policy that would allow physicians to justify withholding or withdrawing treatment, despite patient and family objections. This article reviews the various attempts made to define medical futility and describes their limited applicability to dialysis. When futility concerns arise, physicians should recognize the opportunity to address conflict, using best practice communication skills. Physicians would also benefit from understanding the ethical principles of respect for patient autonomy, beneficence, nonmaleficence, justice, and professional integrity that underlie medical decision-making. Also reviewed is the use of a fair process approach or time-limited trial when conflict resolution cannot be achieved. These topics are addressed in the Renal Physician Association's clinical practice guideline Shared Decision-Making in the Appropriate Initiation and Withdrawal from Dialysis, with which nephrologists should be well versed. A case presentation of intractable calciphylaxis in a new dialysis patient illustrates the pitfalls of physicians not fully appreciating the ethics of medical decision-making and failing to use effective conflict management approaches in the clinical practice guideline.

Health economics in clinical research.

PubMed

Manns, Braden J

2015-01-01

The pressure for health care systems to provide more resource intensive health care and newer, more costly, therapies is significant, despite limited health care budgets. As such, demonstration that a new therapy is effective is no longer sufficient to ensure that it is funded within publicly funded health care systems. The impact of a therapy on health care costs is also an important consideration for decision-makers who must allocate scarce resources. The clinical benefits and costs of a new therapy can be estimated simultaneously using economic evaluation, the strengths and limitations of which are discussed herein. In addition, this chapter includes discussion of the important economic outcomes that can be collected within a clinical trial (alongside the clinical outcome data) enabling consideration of the impact of the therapy on overall resource use, thus enabling performance of an economic evaluation, if the therapy is shown to be effective.

Patients’ priorities for treatment decision making during periods of incapacity: quantitative survey

PubMed Central

RID, ANNETTE; WESLEY, ROBERT; PAVLICK, MARK; MAYNARD, SHARON; ROTH, KATALIN; WENDLER, DAVID

2017-01-01

Objective Clinical practice aims to respect patient autonomy by basing treatment decisions for incapacitated patients on their own preferences. Yet many patients do not complete an advance directive, and those who do frequently just designate a family member to make decisions for them. This finding raises the concern that clinical practice may be based on a mistaken understanding of patient priorities. The present study aimed to collect systematic data on how patients prioritize the goals of treatment decision making. Method We employed a self-administered, quantitative survey of patients in a tertiary care center. Results Some 80% or more of the 1169 respondents (response rate = 59.8%) ranked six of eight listed goals for treatment decision making as important. When asked which goal was most important, 38.8% identified obtaining desired or avoiding unwanted treatments, 20.0% identified minimizing stress or financial burden on their family, and 14.6% identified having their family help to make treatment decisions. No single goal was designated as most important by 25.0% of participants. Significance of Results Patients endorsed three primary goals with respect to decision making during periods of incapacity: being treated consistent with their own preferences; minimizing the burden on their family; and involving their family in the decision-making process. However, no single goal was prioritized by a clear majority of patients. These findings suggest that advance care planning should not be limited to documenting patients’ treatment preferences. Clinicians should also discuss and document patients’ priorities for how decisions are to be made. Moreover, future research should evaluate ways to modify current practice to promote all three of patients primary goals for treatment decision making. PMID:25273677

Patients' priorities for treatment decision making during periods of incapacity: quantitative survey.

PubMed

Rid, Annette; Wesley, Robert; Pavlick, Mark; Maynard, Sharon; Roth, Katalin; Wendler, David

2015-10-01

Clinical practice aims to respect patient autonomy by basing treatment decisions for incapacitated patients on their own preferences. Yet many patients do not complete an advance directive, and those who do frequently just designate a family member to make decisions for them. This finding raises the concern that clinical practice may be based on a mistaken understanding of patient priorities. The present study aimed to collect systematic data on how patients prioritize the goals of treatment decision making. We employed a self-administered, quantitative survey of patients in a tertiary care center. Some 80% or more of the 1169 respondents (response rate = 59.8%) ranked six of eight listed goals for treatment decision making as important. When asked which goal was most important, 38.8% identified obtaining desired or avoiding unwanted treatments, 20.0% identified minimizing stress or financial burden on their family, and 14.6% identified having their family help to make treatment decisions. No single goal was designated as most important by 25.0% of participants. Patients endorsed three primary goals with respect to decision making during periods of incapacity: being treated consistent with their own preferences; minimizing the burden on their family; and involving their family in the decision-making process. However, no single goal was prioritized by a clear majority of patients. These findings suggest that advance care planning should not be limited to documenting patients' treatment preferences. Clinicians should also discuss and document patients' priorities for how decisions are to be made. Moreover, future research should evaluate ways to modify current practice to promote all three of patients primary goals for treatment decision making.

Problems of the Randomization Test for AB Designs

ERIC Educational Resources Information Center

Manolov, Rumen; Solanas, Antonio

2009-01-01

N = 1 designs imply repeated registrations of the behaviour of the same experimental unit and the measurements obtained are often few due to time limitations, while they are also likely to be sequentially dependent. The analytical techniques needed to enhance statistical and clinical decision making have to deal with these problems. Different…

Beyond shared decision-making: Collaboration in the age of recovery from serious mental illness.

PubMed

Treichler, Emily B H; Spaulding, William D

2017-01-01

The role that people with serious mental illness (SMI) play in making decisions about their own treatment and rehabilitation is attracting increasing attention and scrutiny. This attention is embedded in a broader social/consumer movement, the recovery movement , whose agenda includes extensive reform of the mental health system and advancing respect for the dignity and autonomy of people with SMI. Shared decision-making (SDM) is an approach for enhancing consumer participation in health-care decision-making. SDM translates straightforwardly to specific clinical procedures that systematically identify domains of decision-making and guide the practitioner and consumer through making the decisions. In addition, Collaborative decision-making (CDM) is a set of guiding principles that avoids the connotations and limitations of SDM. CDM looks broadly at the range of decisions to be made in mental health care, and assigns consumers and providers equal responsibility and power in the decision-making process. It recognizes the diverse history, knowledge base, and values of each consumer by assuming patients can lead and contribute to decision-making, contributing both value-based information and technical information. This article further discusses the importance of CDM for people with SMI. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Automated in-clinic hematology instruments for small animal practitioners: what is available, what can they really do, and how do i make a choice?

PubMed

Welles, Elizabeth G

2012-01-01

To have an in-clinic hematology instrument in your practice and how it is used are decisions that precede the purchase of an instrument. Advantages and limitations of the various instruments should be considered. Initial purchase cost, reagent/disposable costs, costs of training personnel in the use and care of the instrument, and service/repair contract costs need to be considered. Once the decision is made to have an in-office hematology instrument in your practice you should benefit from having nearly immediate CBC data results that enable you to provide better quality medicine, more rapid clinical decisions, more closely monitor patients for complications of disease or response to treatment. It should also generate revenue and allow some of your staff members to expand and develop their technical skills as they learn the nuances of a new diagnostic tool and how to provide you with the most accurate CBC information. In the final assessment, the addition of an in-office hematology instrument should improve the quality and efficiency of the medical care you provide patients and generate additional practice income.

2018 International Olympic Committee consensus statement on prevention, diagnosis and management of paediatric anterior cruciate ligament (ACL) injuries

PubMed Central

Ekås, Guri Ranum; Grindem, Hege; Moksnes, Håvard; Anderson, Allen F; Chotel, Franck; Cohen, Moises; Forssblad, Magnus; Ganley, Theodore J; Feller, Julian A; Karlsson, Jón; Kocher, Minider S; LaPrade, Robert F; McNamee, Michael; Mandelbaum, Bert; Micheli, Lyle; Mohtadi, Nicholas; Reider, Bruce; Roe, Justin; Seil, Romain; Siebold, Rainer; Witvrouw, Erik; Engebretsen, Lars

2018-01-01

In October 2017, the International Olympic Committee hosted an international expert group of physiotherapists and orthopaedic surgeons who specialise in treating and researching paediatric ACL injuries. Representatives from the American Orthopaedic Society for Sports Medicine, European Paediatric Orthopaedic Society, European Society for Sports Traumatology, Knee Surgery & Arthroscopy, International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine, Pediatric Orthopaedic Society of North America and Sociedad Latinoamericana de Artroscopia, Rodilla y Deporte attended. Physiotherapists and orthopaedic surgeons with clinical and research experience in the field, and an ethics expert with substantial experience in the area of sports injuries also participated. Injury management is challenging in the current landscape of clinical uncertainty and limited scientific knowledge. Injury management decisions also occur against the backdrop of the complexity of shared decision-making with children and the potential long-term ramifications of the injury. This consensus statement addresses six fundamental clinical questions regarding the prevention, diagnosis and management of paediatric ACL injuries. The aim of this consensus statement is to provide a comprehensive, evidence-informed summary to support the clinician, and help children with ACL injury and their parents/guardians make the best possible decisions. PMID:29478021

A scoping review of the potential for chart stimulated recall as a clinical research method.

PubMed

Sinnott, Carol; Kelly, Martina A; Bradley, Colin P

2017-08-22

Chart-stimulated recall (CSR) is a case-based interviewing technique, which is used in the assessment of clinical decision-making in medical education and professional certification. Increasingly, clinical decision-making is a concern for clinical research in primary care. In this study, we review the prior application and utility of CSR as a technique for research interviews in primary care. Following Arksey & O'Malley's method for scoping reviews, we searched seven databases, grey literature, reference lists, and contacted experts in the field. We excluded studies on medical education or competence assessment. Retrieved citations were screened by one reviewer and full texts were ordered for all potentially relevant abstracts. Two researchers independently reviewed full texts and performed data extraction and quality appraisal if inclusion criteria were met. Data were collated and summarised using a published framework on the reporting of qualitative interview techniques, which was chosen a priori. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines informed the review report. From an initial list of 789 citations, eight studies using CSR in research interviews were included in the review: six from North America, one from the Netherlands, and one from Ireland. The most common purpose of included studies was to examine the influence of guidelines on physicians' decisions. The number of interviewees ranged from seven to twenty nine, while the number of charts discussed per interview ranged from one to twelve. CSR gave insights into physicians' reasoning for actions taken or not taken; the unrecorded social and clinical influences on decisions; and discrepancies between physicians' real and perceived practice. Ethical concerns and the training and influence of the researcher were poorly discussed in most of the studies. Potential pitfalls included the risk of recall, selection and observation biases. Despite the proven validity, reliability and acceptability of CSR in assessment interviews in medical education, its use in clinical research is limited. Application of CSR in qualitative research brings interview data closer to the reality of practice. Although further development of the approach is required, we recommend a role for CSR in research interviews on decision-making in clinical practice.

Skill sharing and delegation practice in two Queensland regional allied health cancer care services: a comparison of tasks.

PubMed

Passfield, Juanine; Nielsen, Ilsa; Brebner, Neil; Johnstone, Cara

2017-07-24

Objective Delegation and skill sharing are emerging service strategies for allied health (AH) professionals working in Queensland regional cancer care services. The aim of the present study was to describe the consistency between two services for the types and frequency of tasks provided and the agreement between teams in the decision to delegate or skill share clinical tasks, thereby determining the potential applicability to other services. Methods Datasets provided by two similar services were collated. Descriptive statistical analyses were used to assess the extent of agreement. Results In all, 214 tasks were identified as being undertaken by the services (92% agreement). Across the services, 70 tasks were identified as high frequency (equal to or more frequently than weekly) and 29 as not high frequency (46% agreement). Of the 68 tasks that were risk assessed, agreement was 66% for delegation and 60% for skill sharing, with high-frequency and intervention tasks more likely to be delegated. Conclusions Strong consistency was apparent for the clinical tasks undertaken by the two cancer care AH teams, with moderate agreement for the frequency of tasks performed. The proportion of tasks considered appropriate for skill sharing and/or delegation was similar, although variation at the task level was apparent. Further research is warranted to examine the range of factors that affect the decision to skill share or delegate. What is known about the topic? There is limited research evidence regarding the use of skill sharing and delegation service models for AH in cancer care services. In particular, the extent to which decisions about task safety and appropriateness for delegation or skill sharing can be generalised across services has not been investigated. What does this paper add? This study investigated the level of clinical task consistency between two similar AH cancer care teams in regional centres. It also examined the level of agreement with regard to delegation and skill sharing to provide an indication of the level of local service influence on workforce and service model decisions. What are the implications for practitioners? Local factors have a modest influence on delegation and skill sharing decisions of AH teams. Practitioners need to be actively engaged in decision making at the local level to ensure the clinical service model meets local needs. However, teams should also capitalise on commonalities between settings to limit duplication of training and resource development through collaborative networks.

Patient participation in clinical decision-making in nursing: A comparative study of nurses' and patients' perceptions.

PubMed

Florin, Jan; Ehrenberg, Anna; Ehnfors, Margareta

2006-12-01

The aim of this study was to compare the degree of concordance between patients and Registered Nurses' perceptions of the patients' preferences for participation in clinical decision-making in nursing care. A further aim was to compare patients' experienced participation with their preferred participatory role. Patient participation in clinical decision-making is valuable and has an effect on quality of care. However, there is limited knowledge about patient preferences for participation and how nurses perceive their patients' preferences. A comparative design was adopted with a convenient sample of 80 nurse-patient dyads. A modified version of the Control Preference Scale was used in conjunction with a questionnaire developed to elicit the experienced participation of the patient. A majority of the Registered Nurses perceived that their patients preferred a higher degree of participation in decision-making than did the patients. Differences in patient preferences were found in relation to age and social status but not to gender. Patients often experienced having a different role than what was initially preferred, e.g. a more passive role concerning needs related to communication, breathing and pain and a more active role related to activity and emotions/roles. Registered Nurses are not always aware of their patients' perspective and tend to overestimate patients' willingness to assume an active role. Registered Nurses do not successfully involve patients in clinical decision-making in nursing care according to their own perceptions and not even to the patients' more moderate preferences of participation. A thorough assessment of the individual's preferences for participation in decision-making seems to be the most appropriate approach to ascertain patient's involvement to the preferred level of participation. The categorization of patients as preferring a passive role, collaborative role or active role is seen as valuable information for Registered Nurses to tailor nursing care.

Lung cancer in the very elderly: incidence, presentation, and diagnostic decision-making. A retrospective analysis at a teaching community hospital

PubMed Central

Ayyappan, Sabarish; Gonzalez, Claudia; Yarlagadda, Roopa; Zakharia, Yousef; Woodlock, Timothy J.

2011-01-01

Background and objectives Lung cancer presentation and decision-making in the very elderly patient population, 80 years of age and older, was studied given the projected increase in cancer incidence in the very elderly and yet only limited management guidelines. Design and setting A 10-year experience at the Unity Health System of Rochester, NY, was reviewed using tumor registry data for the entire lung cancer population plus focused medical record review of very elderly patients. A questionnaire survey on the clinical approach to lung cancer in the elderly was distributed to medical staff involved in their care. Participants, measurements, and results Of 997 patients, approximately 100 cases each year, the very elderly comprised 18% of patients from year 1998 through 2002, and 23% from year 2003 through 2007. One-third of the very elderly were diagnosed with lung cancer on clinical grounds without tissue confirmation. The majority of this group had cardio-pulmonary symptoms and an advanced clinical stage. The very elderly had no tissue sampling as per their own decision in 12 of 44 of cases, per family decision in 28 of 44, and per physician and other input in 4 of 44. Physicians stated that patient wishes and health-related factors, more so than socio-economic factors, were primary concerns for management decision-making. Conclusions The number of very elderly lung cancer patients in this community setting has been significant and appears to be increasing. These patients were more likely to have an incomplete diagnostic work-up, with patient and family wishes being the major factor in medical decision-making. The physician approach to these patients emphasized patient autonomy and medical factors. PMID:23882335

Development and evaluation of a comprehensive clinical decision support taxonomy: comparison of front-end tools in commercial and internally developed electronic health record systems

PubMed Central

Sittig, Dean F; Ash, Joan S; Feblowitz, Joshua; Meltzer, Seth; McMullen, Carmit; Guappone, Ken; Carpenter, Jim; Richardson, Joshua; Simonaitis, Linas; Evans, R Scott; Nichol, W Paul; Middleton, Blackford

2011-01-01

Background Clinical decision support (CDS) is a valuable tool for improving healthcare quality and lowering costs. However, there is no comprehensive taxonomy of types of CDS and there has been limited research on the availability of various CDS tools across current electronic health record (EHR) systems. Objective To develop and validate a taxonomy of front-end CDS tools and to assess support for these tools in major commercial and internally developed EHRs. Study design and methods We used a modified Delphi approach with a panel of 11 decision support experts to develop a taxonomy of 53 front-end CDS tools. Based on this taxonomy, a survey on CDS tools was sent to a purposive sample of commercial EHR vendors (n=9) and leading healthcare institutions with internally developed state-of-the-art EHRs (n=4). Results Responses were received from all healthcare institutions and 7 of 9 EHR vendors (response rate: 85%). All 53 types of CDS tools identified in the taxonomy were found in at least one surveyed EHR system, but only 8 functions were present in all EHRs. Medication dosing support and order facilitators were the most commonly available classes of decision support, while expert systems (eg, diagnostic decision support, ventilator management suggestions) were the least common. Conclusion We developed and validated a comprehensive taxonomy of front-end CDS tools. A subsequent survey of commercial EHR vendors and leading healthcare institutions revealed a small core set of common CDS tools, but identified significant variability in the remainder of clinical decision support content. PMID:21415065

Lessons from the Johns Hopkins Multi-Disciplinary Venous Thromboembolism (VTE) Prevention Collaborative

PubMed Central

Streiff, Michael B; Carolan, Howard T; Hobson, Deborah B; Kraus, Peggy S; Holzmueller, Christine G; Demski, Renee; Lau, Brandyn D; Biscup-Horn, Paula; Pronovost, Peter J

2012-01-01

Problem Venous thromboembolism (VTE) is a common cause of potentially preventable mortality, morbidity, and increased medical costs. Risk-appropriate prophylaxis can prevent most VTE events, but only a small fraction of patients at risk receive this treatment. Design Prospective quality improvement programme. Setting Johns Hopkins Hospital, Baltimore, Maryland, USA. Strategies for change A multidisciplinary team established a VTE Prevention Collaborative in 2005. The collaborative applied the four step TRIP (translating research into practice) model to develop and implement a mandatory clinical decision support tool for VTE risk stratification and risk-appropriate VTE prophylaxis for all hospitalised adult patients. Initially, paper based VTE order sets were implemented, which were then converted into 16 specialty-specific, mandatory, computerised, clinical decision support modules. Key measures for improvement VTE risk stratification within 24 hours of hospital admission and provision of risk-appropriate, evidence based VTE prophylaxis. Effects of change The VTE team was able to increase VTE risk assessment and ordering of risk-appropriate prophylaxis with paper based order sets to a limited extent, but achieved higher compliance with a computerised clinical decision support tool and the data feedback which it enabled. Risk-appropriate VTE prophylaxis increased from 26% to 80% for surgical patients and from 25% to 92% for medical patients in 2011. Lessons learnt A computerised clinical decision support tool can increase VTE risk stratification and risk-appropriate VTE prophylaxis among hospitalised adult patients admitted to a large urban academic medical centre. It is important to ensure the tool is part of the clinician’s normal workflow, is mandatory (computerised forcing function), and offers the requisite modules needed for every clinical specialty. PMID:22718994

It's money that matters: the financial context of ethical decision-making in modern biomedicine.

PubMed

Hedgecoe, Adam M

2006-09-01

While the importance of patient autonomy is widely acknowledged and discussed in the bioethics literature, clinicians' autonomy, their ability to make the best choices about patients' care free from outside interference, is far less debated. This paper takes one form of external influence over clinical decisions - the cost of drugs - and applies it to a specific case, that of HER2 positive breast cancer and the use of the drug Herceptin in the UK. Drawing on interviews with clinicians, researchers and policymakers, I explore the way financial decisions about Herceptin shape clinicians' autonomy, and how clinicians as individuals and as professional groups respond to these limits and seek to provide treatment to the highest number of the most deserving patients they can. The point of this paper is not to castigate bioethicists for misguidedly focusing on patient autonomy but point out that clinicians' autonomy may be so circumscribed by external factors that it may make no sense to speak of their actions as stemming from ethical decisions. At the same time, I suggest that financial constraints create areas at the margin of clinical practice which are deserving of bioethical consideration.

Leveraging Electronic Tablets for General Pediatric Care

PubMed Central

McKee, S.; Dugan, T.M.; Downs, S.M.

2015-01-01

Summary Background We have previously shown that a scan-able paper based interface linked to a computerized clinical decision support system (CDSS) can effectively screen patients in pediatric waiting rooms and support the physician using evidence based care guidelines at the time of clinical encounter. However, the use of scan-able paper based interface has many inherent limitations including lacking real time communication with the CDSS and being prone to human and system errors. An electronic tablet based user interface can not only overcome these limitations, but may also support advanced functionality for clinical and research use. However, use of such devices for pediatric care is not well studied in clinical settings. Objective In this pilot study, we enhance our pediatric CDSS with an electronic tablet based user interface and evaluate it for usability as well as for changes in patient questionnaire completion rates. Methods Child Health Improvement through Computers Leveraging Electronic Tablets or CHICLET is an electronic tablet based user interface. It is developed to augment the existing scan-able paper interface to our CDSS. For the purposes of this study, we deployed CHICLET in one outpatient pediatric clinic. Usability factors for CHICLET were evaluated via caregiver and staff surveys. Results When compared to the scan-able paper based interface, we observed an 18% increase or 30% relative increase in question completion rates using CHICLET. This difference was statistically significant. Caregivers and staff survey results were positive for using CHICLET in clinical environment. Conclusions Electronic tablets are a viable interface for capturing patient self-report in pediatric waiting rooms. We further hypothesize that the use of electronic tablet based interfaces will drive advances in computerized clinical decision support and create opportunities for patient engagement. PMID:25848409

"Not clinically indicated": patients' interests or resource allocation?

PubMed Central

Hope, T; Sprigings, D; Crisp, R

1993-01-01

The decision that a particular intervention is not clinically indicated may conceal two quite different ethical assumptions. The first assumption is that the intervention is not of overall benefit to this patient. The second is that limited resources should not be used for this patient. These issues are discussed with reference to cardiac surgery in elderly patients with reference to the main theories of allocation: QALYs, needs theories, the sanctity of life theory, the lottery theory, and market forces. Images p380-a PMID:8461686

Measuring survival time: a probability-based approach useful in healthcare decision-making.

PubMed

2011-01-01

In some clinical situations, the choice between treatment options takes into account their impact on patient survival time. Due to practical constraints (such as loss to follow-up), survival time is usually estimated using a probability calculation based on data obtained in clinical studies or trials. The two techniques most commonly used to estimate survival times are the Kaplan-Meier method and the actuarial method. Despite their limitations, they provide useful information when choosing between treatment options.

Clinical decision rules, spinal pain classification and prediction of treatment outcome: A discussion of recent reports in the rehabilitation literature

PubMed Central

2012-01-01

Clinical decision rules are an increasingly common presence in the biomedical literature and represent one strategy of enhancing clinical-decision making with the goal of improving the efficiency and effectiveness of healthcare delivery. In the context of rehabilitation research, clinical decision rules have been predominantly aimed at classifying patients by predicting their treatment response to specific therapies. Traditionally, recommendations for developing clinical decision rules propose a multistep process (derivation, validation, impact analysis) using defined methodology. Research efforts aimed at developing a “diagnosis-based clinical decision rule” have departed from this convention. Recent publications in this line of research have used the modified terminology “diagnosis-based clinical decision guide.” Modifications to terminology and methodology surrounding clinical decision rules can make it more difficult for clinicians to recognize the level of evidence associated with a decision rule and understand how this evidence should be implemented to inform patient care. We provide a brief overview of clinical decision rule development in the context of the rehabilitation literature and two specific papers recently published in Chiropractic and Manual Therapies. PMID:22726639

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials

PubMed Central

Connor, Jason T.; Ayers, Gregory D; Alvarez, JoAnn

2014-01-01

Background Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. Purpose We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods. Results For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. Limitations Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval. Conclusions The use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision making process. PMID:24872363

Recommendation for the review of biological reference intervals in medical laboratories.

PubMed

Henny, Joseph; Vassault, Anne; Boursier, Guilaine; Vukasovic, Ines; Mesko Brguljan, Pika; Lohmander, Maria; Ghita, Irina; Andreu, Francisco A Bernabeu; Kroupis, Christos; Sprongl, Ludek; Thelen, Marc H M; Vanstapel, Florent J L A; Vodnik, Tatjana; Huisman, Willem; Vaubourdolle, Michel

2016-12-01

This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.

Ultrahigh field MRI in clinical neuroimmunology: a potential contribution to improved diagnostics and personalised disease management.

PubMed

Sinnecker, Tim; Kuchling, Joseph; Dusek, Petr; Dörr, Jan; Niendorf, Thoralf; Paul, Friedemann; Wuerfel, Jens

2015-01-01

Conventional magnetic resonance imaging (MRI) at 1.5 Tesla (T) is limited by modest spatial resolution and signal-to-noise ratio (SNR), impeding the identification and classification of inflammatory central nervous system changes in current clinical practice. Gaining from enhanced susceptibility effects and improved SNR, ultrahigh field MRI at 7 T depicts inflammatory brain lesions in great detail. This review summarises recent reports on 7 T MRI in neuroinflammatory diseases and addresses the question as to whether ultrahigh field MRI may eventually improve clinical decision-making and personalised disease management.

S4HARA: System for HIV/AIDS resource allocation.

PubMed

Lasry, Arielle; Carter, Michael W; Zaric, Gregory S

2008-03-26

HIV/AIDS resource allocation decisions are influenced by political, social, ethical and other factors that are difficult to quantify. Consequently, quantitative models of HIV/AIDS resource allocation have had limited impact on actual spending decisions. We propose a decision-support System for HIV/AIDS Resource Allocation (S4HARA) that takes into consideration both principles of efficient resource allocation and the role of non-quantifiable influences on the decision-making process for resource allocation. S4HARA is a four-step spreadsheet-based model. The first step serves to identify the factors currently influencing HIV/AIDS allocation decisions. The second step consists of prioritizing HIV/AIDS interventions. The third step involves allocating the budget to the HIV/AIDS interventions using a rational approach. Decision-makers can select from several rational models of resource allocation depending on availability of data and level of complexity. The last step combines the results of the first and third steps to highlight the influencing factors that act as barriers or facilitators to the results suggested by the rational resource allocation approach. Actionable recommendations are then made to improve the allocation. We illustrate S4HARA in the context of a primary healthcare clinic in South Africa. The clinic offers six types of HIV/AIDS interventions and spends US$750,000 annually on these programs. Current allocation decisions are influenced by donors, NGOs and the government as well as by ethical and religious factors. Without additional funding, an optimal allocation of the total budget suggests that the portion allotted to condom distribution be increased from 1% to 15% and the portion allotted to prevention and treatment of opportunistic infections be increased from 43% to 71%, while allocation to other interventions should decrease. Condom uptake at the clinic should be increased by changing the condom distribution policy from a pull system to a push system. NGOs and donors promoting antiretroviral programs at the clinic should be sensitized to the results of the model and urged to invest in wellness programs aimed at the prevention and treatment of opportunistic infections. S4HARA differentiates itself from other decision support tools by providing rational HIV/AIDS resource allocation capabilities as well as consideration of the realities facing authorities in their decision-making process.

DIFFERENTIAL DIAGNOSTIC PROCESS AND CLINICAL DECISION MAKING IN A YOUNG ADULT FEMALE WITH LATERAL HIP PAIN: A CASE REPORT.

PubMed

Livingston, Jennifer I; Deprey, Sara M; Hensley, Craig P

2015-10-01

differential diagnosis and clinical decision making. Young adults with lateral hip pain are often referred to physical therapy (PT). A thorough examination is required to obtain a diagnosis and guide management. The purpose of this case report is to describe the physical therapist's differential diagnostic process and clinical decision making for a subject with the referring diagnosis of trochanteric bursitis. A 29-year-old female presented to PT with limited sitting and running tolerance secondary to right lateral hip pain. Her symptoms began three months prior when she abruptly changed her running intensity and frequency of weight bearing activities, including running and low impact plyometrics for the lower extremity. Physical examination revealed a positive Trendelenburg sign, manual muscle test that was weak and painless of the right hip abductors, and pain elicited when performing a vertical hop on a concrete surface (+single leg hop test), but pain-free when performing the same single leg hop on a foam surface. Examination findings warranted discussion with the referring physician for further diagnostic imaging. Magnetic resonance imaging revealed a focus of edema in the posterior acetabulum, suspicious for an acetabular stress fracture. The subject was subsequently diagnosed with an acetabular stress fracture and restricted from running and plyometrics for four weeks. Thorough examination and appropriate clinical decision making by the physical therapist at the initial examination led to the diagnosis of an acetabular stress fracture in this subject. Clinicians must be aware of symptoms and signs which place the subject at risk for stress fracture for timely referral and management. 4.

A systematic review of decision aids that facilitate elements of shared decision-making in chronic illnesses: a review protocol.

PubMed

Wieringa, Thomas H; Kunneman, Marleen; Rodriguez-Gutierrez, Rene; Montori, Victor M; de Wit, Maartje; Smets, Ellen M A; Schoonmade, Linda J; Spencer-Bonilla, Gabriela; Snoek, Frank J

2017-08-07

Shared decision-making (SDM) is a patient-centred approach in which clinicians and patients work side-by-side to decide together on the best course of action for each patient's particular situation. Six key elements of SDM can be distinguished: situation diagnosis, choice awareness, option clarification, discussion of harms and benefits, deliberation of patient preferences and making the decision. Decision aids (DAs) are tools that facilitate SDM. The impact of DAs for chronic illnesses on SDM, clinical and patient reported outcomes remains uncertain. We will perform a systematic review aiming to describe (a) which SDM elements are incorporated in DAs for adult patients with chronic conditions and (b) the effects of DA use on SDM, clinical and patient reported outcomes. This manuscript reports on the protocol for this systematic review. The following databases will be searched for relevant articles: PubMed, Embase, Web of Science, CINAHL and PsycINFO, from their inception to October 2016. We will ascertain ongoing research by querying experts and searching trial registries. To enhance feasibility, we will limit the review to randomized controlled trials (RCTs) including patients with chronic cardiovascular and/or respiratory diseases and/or diabetes. SDM elements incorporated in DAs, DA effects and DA itself will be described. This study will characterize DAs for chronic illness and will provide an overview of their effects on SDM, clinical and patient reported outcomes. We anticipate this review will bring to light knowledge gaps and inform further research into the design and use of DAs for patients with chronic conditions. PROSPERO registration number: CRD42016050320 .

Multiple constraints compromise decision-making about implantable medical devices for individual patients: qualitative interviews with physicians.

PubMed

Gagliardi, Anna R; Ducey, Ariel; Lehoux, Pascale; Turgeon, Thomas; Kolbunik, Jeremy; Ross, Sue; Trbovich, Patricia; Easty, Anthony; Bell, Chaim; Urbach, David R

2017-12-22

Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.

Knowledge Translation and Barriers to Imaging Optimization in the Emergency Department: A Research Agenda.

PubMed

Probst, Marc A; Dayan, Peter S; Raja, Ali S; Slovis, Benjamin H; Yadav, Kabir; Lam, Samuel H; Shapiro, Jason S; Farris, Coreen; Babcock, Charlene I; Griffey, Richard T; Robey, Thomas E; Fortin, Emily M; Johnson, Jamlik O; Chong, Suzanne T; Davenport, Moira; Grigat, Daniel W; Lang, Eddy L

2015-12-01

Researchers have attempted to optimize imaging utilization by describing which clinical variables are more predictive of acute disease and, conversely, what combination of variables can obviate the need for imaging. These results are then used to develop evidence-based clinical pathways, clinical decision instruments, and clinical practice guidelines. Despite the validation of these results in subsequent studies, with some demonstrating improved outcomes, their actual use is often limited. This article outlines a research agenda to promote the dissemination and implementation (also known as knowledge translation) of evidence-based interventions for emergency department (ED) imaging, i.e., clinical pathways, clinical decision instruments, and clinical practice guidelines. We convened a multidisciplinary group of stakeholders and held online and telephone discussions over a 6-month period culminating in an in-person meeting at the 2015 Academic Emergency Medicine consensus conference. We identified the following four overarching research questions: 1) what determinants (barriers and facilitators) influence emergency physicians' use of evidence-based interventions when ordering imaging in the ED; 2) what implementation strategies at the institutional level can improve the use of evidence-based interventions for ED imaging; 3) what interventions at the health care policy level can facilitate the adoption of evidence-based interventions for ED imaging; and 4) how can health information technology, including electronic health records, clinical decision support, and health information exchanges, be used to increase awareness, use, and adherence to evidence-based interventions for ED imaging? Advancing research that addresses these questions will provide valuable information as to how we can use evidence-based interventions to optimize imaging utilization and ultimately improve patient care. © 2015 by the Society for Academic Emergency Medicine.

Predicting Appropriate Admission of Bronchiolitis Patients in the Emergency Department: Rationale and Methods.

PubMed

Luo, Gang; Stone, Bryan L; Johnson, Michael D; Nkoy, Flory L

2016-03-07

In young children, bronchiolitis is the most common illness resulting in hospitalization. For children less than age 2, bronchiolitis incurs an annual total inpatient cost of $1.73 billion. Each year in the United States, 287,000 emergency department (ED) visits occur because of bronchiolitis, with a hospital admission rate of 32%-40%. Due to a lack of evidence and objective criteria for managing bronchiolitis, ED disposition decisions (hospital admission or discharge to home) are often made subjectively, resulting in significant practice variation. Studies reviewing admission need suggest that up to 29% of admissions from the ED are unnecessary. About 6% of ED discharges for bronchiolitis result in ED returns with admission. These inappropriate dispositions waste limited health care resources, increase patient and parental distress, expose patients to iatrogenic risks, and worsen outcomes. Existing clinical guidelines for bronchiolitis offer limited improvement in patient outcomes. Methodological shortcomings include that the guidelines provide no specific thresholds for ED decisions to admit or to discharge, have an insufficient level of detail, and do not account for differences in patient and illness characteristics including co-morbidities. Predictive models are frequently used to complement clinical guidelines, reduce practice variation, and improve clinicians' decision making. Used in real time, predictive models can present objective criteria supported by historical data for an individualized disease management plan and guide admission decisions. However, existing predictive models for ED patients with bronchiolitis have limitations, including low accuracy and the assumption that the actual ED disposition decision was appropriate. To date, no operational definition of appropriate admission exists. No model has been built based on appropriate admissions, which include both actual admissions that were necessary and actual ED discharges that were unsafe. The goal of this study is to develop a predictive model to guide appropriate hospital admission for ED patients with bronchiolitis. This study will: (1) develop an operational definition of appropriate hospital admission for ED patients with bronchiolitis, (2) develop and test the accuracy of a new model to predict appropriate hospital admission for an ED patient with bronchiolitis, and (3) conduct simulations to estimate the impact of using the model on bronchiolitis outcomes. We are currently extracting administrative and clinical data from the enterprise data warehouse of an integrated health care system. Our goal is to finish this study by the end of 2019. This study will produce a new predictive model that can be operationalized to guide and improve disposition decisions for ED patients with bronchiolitis. Broad use of the model would reduce iatrogenic risk, patient and parental distress, health care use, and costs and improve outcomes for bronchiolitis patients.

The intelligent clinical laboratory as a tool to increase cancer care management productivity.

PubMed

Mohammadzadeh, Niloofar; Safdari, Reza

2014-01-01

Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.

Temporal characteristics of decisions in hospital encounters: a threshold for shared decision making? A qualitative study.

PubMed

Ofstad, Eirik H; Frich, Jan C; Schei, Edvin; Frankel, Richard M; Gulbrandsen, Pål

2014-11-01

To identify and characterize physicians' statements that contained evidence of clinically relevant decisions in encounters with patients in different hospital settings. Qualitative analysis of 50 videotaped encounters from wards, the emergency room (ER) and outpatient clinics in a department of internal medicine at a Norwegian university hospital. Clinical decisions could be grouped in a temporal order: decisions which had already been made, and were brought into the encounter by the physician (preformed decisions), decisions made in the present (here-and-now decisions), and decisions prescribing future actions given a certain course of events (conditional decisions). Preformed decisions were a hallmark in the ward and conditional decisions a main feature of ER encounters. Clinical decisions related to a patient-physician encounter spanned a time frame exceeding the duration of the encounter. While a distribution of decisions over time and space fosters sharing and dilution of responsibility between providers, it makes the decision making process hard to access for patients. In order to plan when and how to involve patients in decisions, physicians need increased awareness of when clinical decisions are made, who usually makes them, and who should make them. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Clinical reasoning and knowledge management in final year medical students: the role of Student-led Grand Rounds.

PubMed

Kandiah, David Arumaisingam

2017-01-01

The development of clinical reasoning and decision-making skills is often limited in medical school curricula. In reality, medical graduates acquire these skills during their first few years of residency. For many, this can be stressful as they may be working under limited supervision as a part of their rotations. Student-led Grand Rounds was developed to transfer both explicit and tacit knowledge to final year medical students. This pilot project was to apply the principles of knowledge management to allow students to be exposed to the reasoning and decision making of common clinical presentations. Student feedback through questionnaires was collated at the end of the program. Based on feedback and focus groups, modifications were made to produce a stable program in subsequent clinical rotations. Formal feedback was collated from all the 76 students who participated in the first year. This represented 100% of the cohort for this clinical school for that year. There was a 100% response rate as the feedback forms were given and collected at the end of the last session per block. The student responses were both in ratings defined in a feedback forms and in written comments. A total of 74 of the 76 students rated the program highly. They enjoyed the nonthreatening interactions. The remaining two students preferred more didactic teaching. This initiative allows an efficient transfer and utilization of knowledge. This could maximize the acquisition of practical knowledge by medical students as they finish their course in the transition to graduate medical practice.

Evidence-based medicine in primary care: qualitative study of family physicians.

PubMed

Tracy, C Shawn; Dantas, Guilherme Coelho; Upshur, Ross E G

2003-05-09

The objectives of this study were: a) to examine physician attitudes to and experience of the practice of evidence-based medicine (EBM) in primary care; b) to investigate the influence of patient preferences on clinical decision-making; and c) to explore the role of intuition in family practice. Qualitative analysis of semi-structured interviews of 15 family physicians purposively selected from respondents to a national survey on EBM mailed to a random sample of Canadian family physicians. Participants mainly welcomed the promotion of EBM in the primary care setting. A significant number of barriers and limitations to the implementation of EBM were identified. EBM is perceived by some physicians as a devaluation of the 'art of medicine' and a threat to their professional/clinical autonomy. Issues regarding the trustworthiness and credibility of evidence were of great concern, especially with respect to the influence of the pharmaceutical industry. Attempts to become more evidence-based often result in the experience of conflicts. Patient factors exert a powerful influence on clinical decision-making and can serve as trumps to research evidence. A widespread belief that intuition plays a vital role in primary care reinforced views that research evidence must be considered alongside other factors such as patient preferences and the clinical judgement and experience of the physician. Primary care physicians are increasingly keen to consider research evidence in clinical decision-making, but there are significant concerns about the current model of EBM. Our findings support the proposed revisions to EBM wherein greater emphasis is placed on clinical expertise and patient preferences, both of which remain powerful influences on physician behaviour.

Personalized Clinical Diagnosis in Data Bases for Treatment Support in Phthisiology.

PubMed

Lugovkina, T K; Skornyakov, S N; Golubev, D N; Egorov, E A; Medvinsky, I D

2016-01-01

The decision-making is a key event in the clinical practice. The program products with clinical decision support models in electronic data-base as well as with fixed decision moments of the real clinical practice and treatment results are very actual instruments for improving phthisiological practice and may be useful in the severe cases caused by the resistant strains of Mycobacterium tuberculosis. The methodology for gathering and structuring of useful information (critical clinical signals for decisions) is described. Additional coding of clinical diagnosis characteristics was implemented for numeric reflection of the personal situations. The created methodology for systematization and coding Clinical Events allowed to improve the clinical decision models for better clinical results.

Should dentistry be part of the National Health Information Infrastructure?

PubMed

Schleyer, Titus K L

2004-12-01

The National Health Information Infrastructure, or NHII, proposes to improve the effectiveness, efficiency and overall quality of health in the United States by establishing a national, electronic information network for health care. To date, dentistry's integration into this network has not been discussed widely. The author reviews the NHII and its goals and structure through published reports and background literature. The author evaluates the advantages and disadvantages of the NHII regarding their implications for the dental care system. The NHII proposes to implement computer-based patient records, or CPRs, for most Americans by 2014, connect personal health information with other clinical and public health information, and enable different types of care providers to access CPRs. Advantages of the NHII include transparency of health information across health care providers, potentially increased involvement of patients in their care, better clinical decision making through connecting patient-specific information with the best clinical evidence, increased efficiency, enhanced bioterrorism defense and potential cost savings. Challenges in the implementation of the NHII in dentistry include limited use of CPRs, required investments in information technology, limited availability and adoption of standards, and perceived threats to privacy and confidentiality. The implementation of the NHII is making rapid strides. Dentistry should become an active participant in the NHII and work to ensure that the needs of dental patients and the profession are met. Practice Implications. The NHII has far-reaching implications on dental practice by making it easier to access relevant patient information and by helping to improve clinical decision making.

Abortion foes get turn to ask Supreme Court for constitutional protection.

PubMed

Denniston, L

1994-04-28

The US Supreme Court began hearing arguments on the constitutionality of a Florida judge's order which placed limits on anti-abortion protesting. This case will be the last abortion--related decision for Justice Harry A. Blackmun, who was the author of the original decision granting the right to abortion in Roe vs. Wade, before retiring from the Court in September 1994. Anti-abortion activists claim 1st Amendment protection, much the same as Dr. Martin Luther King's marches in advancing Blacks' civil rights. The case involved a Melbourne abortion clinic. The murder of Dr. Gunn outside an abortion clinic in Pensacola, Florida, will be used to support the need for protection from extremist violence. The conflict appears to be over the right to save women's right to abortion and over simple, peaceful protests and prayers against abortion. One anti-abortion foe, affiliated with Operational Rescue and initiating the appeal to the Supreme Court, is scheduled to testify before the Court: Judy Madsen, a protester who has counseled outside clinics. Ms. Madsen says she is exercising her freedom to protect human life. Other testimony will come from Reverend Ed Martin of Ocala, Rescue America's founder, and Shirley Hobbs, a homemaker from Orlando. Representation will be made by lawyer Matthew Staver, who will argue that the ruling was directed to a political position. Other support will come from religious and anti-abortion groups and the AFL-CIO. Testifying for the clinic, the Aware Women's Center for Choice, will be the owner and operator Patricia Baird Windle. Over the past 5 years, the Melbourne Clinic had been a target for the nationwide anti-abortion campaign by Operation Rescue. Because of the conflicting rulings between the Florida Supreme Court, which ruled to keep protesters away from clinic grounds and staff homes, and 11th US Circuit Court of Appeals ruling of unconstitutionality, no protection is afforded the clinic. Previous protection had occurred due to a 1992 judge's order. Clinic lawyer, Talbot D'Alemberte, president of Florida State University and former president of the American Bar Association, will argue that the issue is about intimidation. The Clinton administration's Solicitor General Drew S. Days III will support Seminole County Circuit Court Judge Robert S. McGregor's decision limiting protester activity.

The reciprocal dynamic model of career decision ambiguity tolerance with career indecision: A longitudinal three-wave investigation.

PubMed

Xu, Hui; Tracey, Terence J G

2017-10-01

The current study investigated the dynamic interplay of career decision ambiguity tolerance and career indecision over 3 assessment times in a sample of college students (n = 583). While the previous research has repeatedly shown an association of career decision ambiguity tolerance with career indecision, the direction of this association has not been adequately assessed with longitudinal investigation. It was hypothesized in this study that there is a reciprocal pattern of career decision ambiguity tolerance leading to subsequent career indecision and career indecision leading to subsequent career decision ambiguity tolerance. Using a cross-lagged panel design, this study found support for the reciprocal pattern that aversion to ambiguity led to increased negative affect and choice anxiety in career decision making, while negative affect and choice anxiety led to increased aversion to ambiguity. Additionally, this study revealed that aversion led to decreased readiness for career decision making and readiness for career decision making led to increased interests in new information. The key findings were discussed with respect to the theoretical and clinical implications for career counseling along with limitations and suggestions for future research. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Supervisee self-disclosure: a clinical psychology perspective.

PubMed

Spence, Nicola; Fox, John R E; Golding, Laura; Daiches, Anna

2014-01-01

Clinical supervision is a multi-functional intervention within numerous psychotherapeutic professions, including clinical psychology. It often relies on supervisees' verbal disclosures of pertinent information. There is limited research on supervisee self-disclosure in the UK, and none using clinical psychology populations. This study aimed to address the limitations in the evidence base. It used a constructivist grounded theory methodology to investigate qualified UK clinical psychologists' use of self-disclosure in supervision in order to develop a theoretical understanding of their self-disclosure processes. Ten clinical psychologists from various time points across the career span were recruited to the study. Four core conceptual categories were identified in the analysis as being integral to participants' decision-making processes: 'Setting the Scene', 'Supervisory Relationship', 'Using Self-disclosure' and 'Reviewing Outcome of Self-disclosure'. These four categories are comprised of a number of subcategories. The study's findings are compared with the current literature base, and it is argued that there are tensions with the scientist-practitioner model as it could be interpreted to encourage an expert stance, which may limit the self-disclosure of qualified supervisees. The implications of this perspective are discussed. Supervision is a key process in supporting qualified clinical psychologists and the use of disclosure appears to be important in facilitating useful supervision. It appears that clinical psychologists go through a number of complex processes in deciding whether to self disclose. Copyright © 2012 John Wiley & Sons, Ltd.

Activating clinical trials: a process improvement approach.

PubMed

Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

2016-02-24

The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength of our framework lies in its system analysis approach that recognizes the stochastic duration of the activation process and the interdependence between process activities and entities.

A qualitative study of hospital pharmacists and antibiotic governance: negotiating interprofessional responsibilities, expertise and resource constraints.

PubMed

Broom, Alex; Plage, Stefanie; Broom, Jennifer; Kirby, Emma; Adams, Jon

2016-02-06

Antibiotic treatment options for common infections are diminishing due to the proliferation of antimicrobial resistance (AMR). The impact of Antimicrobial Stewardship (AMS) programs seeking to preserve viable antibiotic drugs by governing their use in hospitals has hitherto been limited. Pharmacists have been delegated a critical role in antibiotic governance in AMS teams within hospitals but the experience of pharmacists in influencing antibiotic use has received limited attention. In this study we explore the experiences of pharmacists in antibiotic decision-making in two Australian hospitals. We conducted 19 semi-structured interviews to explore hospital-based pharmacists' perceptions and experiences of antibiotic use and governance. The analysis was conducted with NVivo10 software, utilising the framework approach. Three major themes emerged in the pharmacist interviews including (1) the responsibilities of pharmacy in optimising antibiotic use and the interprofessional challenges therein; (2) the importance of antibiotic streamlining and the constraints placed on pharmacists in achieving this; and (3) the potential, but often under-utilised expertise, pharmacists bring to antibiotic optimisation. Pharmacists have a critical role in AMS teams but their capacity to enact change is limited by entrenched interprofessional dynamics. Identifying how hospital pharmacy's antibiotic gatekeeping is embedded in the interprofessional nature of clinical decision-making and limited by organisational environment has important implications for the implementation of hospital policies seeking to streamline antibiotic use. Resource constraints (i.e. time limitation and task prioritisation) in particular limit the capacity of pharmacists to overcome the interprofessional barriers through development of stronger collaborative relationships. The results of this study suggest that to enact change in antibiotic use in hospitals, pharmacists must be supported in their negotiations with doctors, have increased presence on hospital wards, and must be given opportunities to pass on specialist knowledge within multidisciplinary clinical teams.

Adjuvant chemotherapy for soft tissue sarcoma.

PubMed

Casali, Paolo G

2015-01-01

Adjuvant chemotherapy is not standard treatment in soft tissue sarcoma (STS). However, when the risk of relapse is high, it is an option for shared decision making with the patient in conditions of uncertainty. This is because available evidence is conflicting, even if several randomized clinical trials have been performed for 4 decades and also have been pooled into meta-analyses. Indeed, available meta-analyses point to a benefit in the 5% to 10% range in terms of survival and distant relapse rate. Some local benefit also was suggested by some trials. Placing chemotherapy in the preoperative setting may help gain a local advantage in terms of the quality of surgical margins or decreased sequelae. This may be done within a personalized approach according to the clinical presentation. Attempts to personalize treatment on the basis of the variegated pathology and molecular biology of STS subgroups are ongoing as well, according to what is done in the medical treatment of advanced STS. Thus, decision making for adjuvant and neoadjuvant indications deserves personalization in clinical research and in clinical practice, taking profit from all multidisciplinary clinical skills available at a sarcoma reference center, though with a degree of subjectivity because of the limitations of available evidence.

Information needs for the rapid response team electronic clinical tool.

PubMed

Barwise, Amelia; Caples, Sean; Jensen, Jeffrey; Pickering, Brian; Herasevich, Vitaly

2017-10-02

Information overload in healthcare is dangerous. It can lead to critical errors and delays. During Rapid Response Team (RRT) activations providers must make decisions quickly to rescue patients from physiological deterioration. In order to understand the clinical data required and how best to present that information in electronic systems we aimed to better assess the data needs of providers on the RRT when they respond to an event. A web based survey to evaluate clinical data requirements was created and distributed to all RRT providers at our institution. Participants were asked to rate the importance of each data item in guiding clinical decisions during a RRT event response. There were 96 surveys completed (24.5% response rate) with fairly even distribution throughout all clinical roles on the RRT. Physiological data including heart rate, respiratory rate, and blood pressure were ranked by more than 80% of responders as being critical information. Resuscitation status was also considered critically useful by more than 85% of providers. There is a limited dataset that is considered important during an RRT. The data is widely available in EMR. The findings from this study could be used to improve user-centered EMR interfaces.

Current state of prognostication and risk stratification in myelodysplastic syndromes.

PubMed

Zeidan, Amer M; Gore, Steven D; Padron, Eric; Komrokji, Rami S

2015-03-01

Myelodysplastic syndromes (MDS) are characterized by significant biologic and clinical heterogeneity. Because of the wide outcome variability, accurate prognostication is vital to high-quality risk-adaptive care of MDS patients. In this review, we discuss the current state of prognostic schemes for MDS and overview efforts aimed at utilizing molecular aberrations for prognostication in clinical practice. Several prognostic instruments have been developed and validated with increasing accuracy and complexity. Oncologists should be aware of the inherent limitations of these prognostic tools as they counsel patients and make clinical decisions. As more therapies are becoming available for MDS, the focus of model development is shifting from prognostic to treatment-specific predictive instruments. In addition to providing additional prognostic data beyond traditional clinical and pathologic parameters, the improved understanding of the genetic landscape and pathophysiologic consequences in MDS may allow the construction of treatment-specific predictive instruments. How to best use the results of molecular mutation testing to inform clinical decision making in MDS is still a work in progress. Important steps in this direction include standardization in performance and interpretation of assays and better understanding of the independent prognostic importance of the recurrent mutations, especially the less frequent ones.

Combined Clinical Parameters and Multiparametric Magnetic Resonance Imaging for Advanced Risk Modeling of Prostate Cancer-Patient-tailored Risk Stratification Can Reduce Unnecessary Biopsies.

PubMed

Radtke, Jan Philipp; Wiesenfarth, Manuel; Kesch, Claudia; Freitag, Martin T; Alt, Celine D; Celik, Kamil; Distler, Florian; Roth, Wilfried; Wieczorek, Kathrin; Stock, Christian; Duensing, Stefan; Roethke, Matthias C; Teber, Dogu; Schlemmer, Heinz-Peter; Hohenfellner, Markus; Bonekamp, David; Hadaschik, Boris A

2017-12-01

Multiparametric magnetic resonance imaging (mpMRI) is gaining widespread acceptance in prostate cancer (PC) diagnosis and improves significant PC (sPC; Gleason score≥3+4) detection. Decision making based on European Randomised Study of Screening for PC (ERSPC) risk-calculator (RC) parameters may overcome prostate-specific antigen (PSA) limitations. We added pre-biopsy mpMRI to ERSPC-RC parameters and developed risk models (RMs) to predict individual sPC risk for biopsy-naïve men and men after previous biopsy. We retrospectively analyzed clinical parameters of 1159 men who underwent mpMRI prior to MRI/transrectal ultrasound fusion biopsy between 2012 and 2015. Multivariate regression analyses were used to determine significant sPC predictors for RM development. The prediction performance was compared with ERSPC-RCs, RCs refitted on our cohort, Prostate Imaging Reporting and Data System (PI-RADS) v1.0, and ERSPC-RC plus PI-RADSv1.0 using receiver-operating characteristics (ROCs). Discrimination and calibration of the RM, as well as net decision and reduction curve analyses were evaluated based on resampling methods. PSA, prostate volume, digital-rectal examination, and PI-RADS were significant sPC predictors and included in the RMs together with age. The ROC area under the curve of the RM for biopsy-naïve men was comparable with ERSPC-RC3 plus PI-RADSv1.0 (0.83 vs 0.84) but larger compared with ERSPC-RC3 (0.81), refitted RC3 (0.80), and PI-RADS (0.76). For postbiopsy men, the novel RM's discrimination (0.81) was higher, compared with PI-RADS (0.78), ERSPC-RC4 (0.66), refitted RC4 (0.76), and ERSPC-RC4 plus PI-RADSv1.0 (0.78). Both RM benefits exceeded those of ERSPC-RCs and PI-RADS in the decision regarding which patient to receive biopsy and enabled the highest reduction rate of unnecessary biopsies. Limitations include a monocentric design and a lack of PI-RADSv2.0. The novel RMs, incorporating clinical parameters and PI-RADS, performed significantly better compared with RMs without PI-RADS and provided measurable benefit in making the decision to biopsy men at a suspicion of PC. For biopsy-naïve patients, both our RM and ERSPC-RC3 plus PI-RADSv1.0 exceeded the prediction performance compared with clinical parameters alone. Combined risk models including clinical and imaging parameters predict clinically relevant prostate cancer significantly better than clinical risk calculators and multiparametric magnetic resonance imaging alone. The risk models demonstrate a benefit in making a decision about which patient needs a biopsy and concurrently help avoid unnecessary biopsies. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Usefulness of questionnaires on advance directives in haemodialysis units.

PubMed

Jornet, Angel Rodríguez; Castellanos, Loreley Ana Betancourt; Contador, Maria Isabel Bolós; Morera, Juan Carlos Oliva; López, José Antonio Ibeas

2017-10-01

As renal replacement therapy has become universal practice in medicine, there is a need to consider whether this treatment is suitable for elderly people. These patients have high comorbidity and may require dialysis withdrawal in certain clinical circumstances. Advance directives (ADs) drawn up by patients facilitate treatment-related decisions if they lose cognitive capacity. Questionnaires dealing with possible extreme clinical circumstances can thus help clinicians and relatives reach pertinent decisions in such cases. We studied the usefulness of questionnaires on ADs in patients who started periodic haemodialysis over a period of 10 years. Telephone interviews were conducted to assess satisfaction level among relatives/representatives of deceased patients who had been advised to limit therapeutic efforts in certain clinical situations. The questionnaire was assessed using a six-factor degree of satisfaction. Four hundred and forty-three questionnaires were distributed over a period of 10 years. A total of 41.3% of patients stated that they wished to limit therapeutic efforts in the serious clinical situations presented; 37.9% refused to complete the questionnaire; 14.7% expressed their wishes without any written confirmation; and 6.1% expressed their wish to continue on dialysis in all situations. Two hundred and twenty-four patients had died by the study end date. The cause of death in 20.2% was scheduled dialysis withdrawal. Representatives reported an extremely high degree of satisfaction with the questionnaire (94.7%). Younger people, however, were more reluctant to consider and answer questionnaires on ADs. Questionnaires on ADs are a useful tool in daily nephrology practice and should be distributed to those patients willing to consider the limitation of therapeutic efforts in extreme clinical circumstances. In general terms, these questionnaires should be given to all elderly patients. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Exploring Provider Reactions to Decision Aid Distribution and Shared Decision Making: Lessons from Two Specialties.

PubMed

Hsu, Clarissa; Liss, David T; Frosch, Dominick L; Westbrook, Emily O; Arterburn, David

2017-01-01

A critical component of shared decision making (SDM) is the role played by health care providers in distributing decision aids (DAs) and initiating SDM conversations. Existing literature indicates that decisions about designing and implementing DAs must take provider perspectives into account. However, little is known about how differences in provider attitudes across specialties may impact DA implementation and how provider attitudes may shift after DA implementation. Group Health's Decision Aid Implementation project was carried out in six specialties using 12 video-based DAs for preference-sensitive conditions; this study focused on two of the six specialties. In-depth, qualitative interviews with specialty care providers in two specialties-orthopedics and cardiology-at two time points during DA implementation. Data were analyzed using a thematic analysis approach. We interviewed 19 care providers in orthopedics and cardiology. All respondents believed that providing patients with accurate information on their health conditions and treatment options was important and that most patients wanted an active role in decision making. However, respondents diverged in decision-making styles and views on the practicality and appropriateness of using the DAs and SDM. For example, cardiology specialists were ambivalent about DAs for coronary artery disease because many viewed DAs and SDM as unnecessary or inappropriate for this clinical condition. Provider attitudes towards DAs and SDM were generally stable over two years. Limitations include a lack of patient perspectives, social desirability bias, and possible selection bias. Successfully implementing DAs in clinical practice to promote SDM requires addressing individual provider attitudes, beliefs, and knowledge of SDM by specialty. During DA development and implementation, providers should be asked for input about the specific conditions and care processes that are most appropriate for SDM. © The Author(s) 2016.

What are the decision-making preferences of patients in vascular surgery? A mixed-methods study.

PubMed

Santema, T B Katrien; Stoffer, E Anniek; Kunneman, Marleen; Koelemay, Mark J W; Ubbink, Dirk T

2017-02-10

Shared decision-making (SDM) has been advocated as the preferred method of choosing a suitable treatment option. However, patient involvement in treatment decision-making is not yet common practice in the field of vascular surgery. The aim of this mixed-methods study was to explore patients' decision-making preferences and to investigate which facilitators and barriers patients perceive as important for the application of SDM in vascular surgery. Patients were invited to participate after visiting the vascular surgical outpatient clinic of an Academic Medical Center in the Netherlands. A treatment decision was made during the consultation for an abdominal aortic aneurysm or peripheral arterial occlusive disease. Patients filled in a number of questionnaires (quantitative part) and a random subgroup of patients participated in an in-depth interview (qualitative part). A total of 67 patients participated in this study. 58 per cent of them (n=39) indicated that they preferred a shared role in decision-making. In more than half of the patients (55%; n=37) their preferred role was in disagreement with what they had experienced. 31 per cent of the patients (n=21) preferred a more active role in the decision-making process than they had experienced. Patients indicated a good patient-doctor relationship as an important facilitator for the application of SDM. The vast majority of vascular surgical patients preferred, but did not experience a shared role in the decision-making process, although the concept of SDM was insufficiently clear to some patients. This emphasises the importance of explaining the concept of SDM and implementing it in the clinical encounter. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Respiratory support withdrawal in intensive care units: families, physicians and nurses views on two hypothetical clinical scenarios

PubMed Central

2010-01-01

Introduction Evidence suggests that dying patients' physical and emotional suffering is inadequately treated in intensive care units. Although there are recommendations regarding decisions to forgo life-sustaining therapy, deciding on withdrawal of life support is difficult, and it is also difficult to decide who should participate in this decision. Methods We distributed a self-administered questionnaire in 13 adult intensive care units (ICUs) assessing the attitudes of physicians and nurses regarding end-of-life decisions. Family members from a medical-surgical ICU in a tertiary cancer hospital were also invited to participate. Questions were related to two hypothetical clinical scenarios, one with a competent patient and the other with an incompetent patient, asking whether the ventilator treatment should be withdrawn and about who should make this decision. Results Physicians (155) and nurses (204) of 12 ICUs agreed to take part in this study, along with 300 family members. The vast majority of families (78.6%), physicians (74.8%) and nurses (75%) want to discuss end-of-life decisions with competent patients. Most of the physicians and nurses desire family involvement in end-of-life decisions. Physicians are more likely to propose withdrawal of the ventilator with competent patients than with incompetent patients (74.8% × 60.7%, P = 0.028). When the patient was incompetent, physicians (34.8%) were significantly less prone than nurses (23.0%) and families (14.7%) to propose decisions regarding withdrawal of the ventilator support (P < 0.001). Conclusions Physicians, nurses and families recommended limiting life-support therapy with terminally ill patients and favored family participation. In decisions concerning an incompetent patient, physicians were more likely to maintain the therapy. PMID:21190560

Respiratory support withdrawal in intensive care units: families, physicians and nurses views on two hypothetical clinical scenarios.

PubMed

Fumis, Renata R L; Deheinzelin, Daniel

2010-01-01

Evidence suggests that dying patients' physical and emotional suffering is inadequately treated in intensive care units. Although there are recommendations regarding decisions to forgo life-sustaining therapy, deciding on withdrawal of life support is difficult, and it is also difficult to decide who should participate in this decision. We distributed a self-administered questionnaire in 13 adult intensive care units (ICUs) assessing the attitudes of physicians and nurses regarding end-of-life decisions. Family members from a medical-surgical ICU in a tertiary cancer hospital were also invited to participate. Questions were related to two hypothetical clinical scenarios, one with a competent patient and the other with an incompetent patient, asking whether the ventilator treatment should be withdrawn and about who should make this decision. Physicians (155) and nurses (204) of 12 ICUs agreed to take part in this study, along with 300 family members. The vast majority of families (78.6%), physicians (74.8%) and nurses (75%) want to discuss end-of-life decisions with competent patients. Most of the physicians and nurses desire family involvement in end-of-life decisions. Physicians are more likely to propose withdrawal of the ventilator with competent patients than with incompetent patients (74.8% × 60.7%, P = 0.028). When the patient was incompetent, physicians (34.8%) were significantly less prone than nurses (23.0%) and families (14.7%) to propose decisions regarding withdrawal of the ventilator support (P < 0.001). Physicians, nurses and families recommended limiting life-support therapy with terminally ill patients and favored family participation. In decisions concerning an incompetent patient, physicians were more likely to maintain the therapy.

'Holding the line': a qualitative study of the role of evidence in early phase decision-making in the reconfiguration of stroke services in London.

PubMed

Fraser, Alec; Baeza, Juan I; Boaz, Annette

2017-06-09

Health service reconfigurations are of international interest but remain poorly understood. This article focuses on the use of evidence by senior managerial decision-makers involved in the reconfiguration of stroke services in London 2008-2012. Recent work comparing stroke service reconfiguration in London and Manchester emphasises the ability of senior managerial decision-makers in London to 'hold the line' in the crucial early phases of the stroke reconfiguration programme. In this article, we explore in detail how these decision-makers 'held the line' and ask what the broader power implications of doing so are for the interaction between evidence, health policy and system redesign. The research combined semi-structured interviews (n = 20) and documentary analysis of historically relevant policy papers and contemporary stroke reconfiguration documentation published by NHS London and other interested parties (n = 125). We applied a critical interpretive and reflexive approach to the analysis of the data. We identified two forms of power which senior managerial decision-makers drew upon in order to 'hold the line'. Firstly, discursive power, which through an emphasis on evidence, better patient outcomes, professional support and clinical credibility alongside a tightly managed consultation process, helped to set an agenda that was broadly receptive to the overall decision to change stroke services in the capital in a radical way. Secondly, once the essential parameters of the decision to change services had been agreed, senior managerial decision-makers 'held the line' through hierarchical New Public Management style power to minimise the traditional pressures to de-radicalise the reconfiguration through 'top down' decision-making. We problematise the concept of 'holding the line' and explore the power implications of such managerial approaches in the early phases of health service reconfiguration. We highlight the importance of evidence for senior managerial decision-makers in agenda setting and the limitations of clinical research findings in guiding politically sensitive policy decisions which impact upon regional healthcare systems.

What are the Essential Elements to Enable Patient Participation in Medical Decision Making?

PubMed Central

McGraw, Sarah

2007-01-01

BACKGROUND Patient participation in shared decision making (SDM) results in increased patient knowledge, adherence, and improved outcomes. Despite the benefits of the SDM model, many patients do not attain the level of participation they desire. OBJECTIVE To gain a more complete understanding of the essential elements, or the prerequisites, critical to active patient participation in medical decision making from the patient’s perspective. DESIGN Qualitative study. SETTING Individual, in-depth patient interviews were conducted until thematic saturation was reached. Two analysts independently read the transcripts and jointly developed a list of codes. PATIENTS Twenty-six consecutive subjects drawn from community dwelling subjects undergoing bone density measurements. MEASUREMENTS Respondents’ experiences and beliefs related to patient participation in SDM. RESULTS Five elements were repeatedly described by respondents as being essential to enable patient participation in medical decision making: (1) patient knowledge, (2) explicit encouragement of patient participation by physicians, (3) appreciation of the patient’s responsibility/rights to play an active role in decision making, (4) awareness of choice, and (5) time. LIMITATIONS The generalizability of the results is limited by the homogeneity of the study sample. CONCLUSIONS Our findings have important clinical implications and suggest that several needs must be met before patients can become active participants in decisions related to their health care. These needs include ensuring that patients (1) appreciate that there is uncertainty in medicine and “buy in” to the importance of active patient participation in decisions related to their health care, (2) understand the trade-offs related to available options, and (3) have the opportunity to discuss these options with their physician to arrive at a decision concordant with their values. PMID:17443368

Can access limits on sales representatives to physicians affect clinical prescription decisions? A study of recent events with diabetes and lipid drugs.

PubMed

Chressanthis, George A; Khedkar, Pratap; Jain, Nitin; Poddar, Prashant; Seiders, Michael G

2012-07-01

The authors explored to what extent important medical decisions by practitioners can be influenced by pharmaceutical representatives and, in particular, whether restricting such access could delay appropriate changes in clinical practice. Medical practices were divided into four categories based on the degree of sales representative access to clinicians: very low, low, medium, and high from a database compiled by ZS Associates called AccessMonitor (Evanston, IL) used extensively by many pharmaceutical companies. Clinical decisions of 58,647 to 72,114 physicians were statistically analyzed using prescription data from IMS Health (Danbury, CT) in three critical areas: an innovative drug for type 2 diabetes (sitagliptin), an older diabetes drug with a new Food and Drug Administration-required black box warning for cardiovascular safety (rosiglitazone), and a combination lipid therapy that had reported negative outcomes in a clinical trial (simvastatin+ezetimbe). For the uptake of the new diabetes agent, the authors found that physicians with very low access to representatives had the lowest adoption of this new therapy and took 1.4 and 4.6 times longer to adopt than physicians in the low- and medium-access restriction categories, respectively. In responding to the black box warning for rosiglitazone, the authors found that physicians with very low access were 4.0 times slower to reduce their use of this treatment than those with low access. Likewise, there was significantly less response in terms of changing prescribing to the negative news with the lipid therapy for physicians in more access-restricted offices. Overall, cardiologists were the most responsive to information changes relative to primary care physicians. These findings emphasize that limiting access to pharmaceutical representatives can have the unintended effect of reducing appropriate responses to negative information about drugs just as much as responses to positive information about innovative drugs. © 2012 Wiley Periodicals, Inc.

The key-features approach to assess clinical decisions: validity evidence to date.

PubMed

Bordage, G; Page, G

2018-05-17

The key-features (KFs) approach to assessment was initially proposed during the First Cambridge Conference on Medical Education in 1984 as a more efficient and effective means of assessing clinical decision-making skills. Over three decades later, we conducted a comprehensive, systematic review of the validity evidence gathered since then. The evidence was compiled according to the Standards for Educational and Psychological Testing's five sources of validity evidence, namely, Content, Response process, Internal structure, Relations to other variables, and Consequences, to which we added two other types related to Cost-feasibility and Acceptability. Of the 457 publications that referred to the KFs approach between 1984 and October 2017, 164 are cited here; the remaining 293 were either redundant or the authors simply mentioned the KFs concept in relation to their work. While one set of articles reported meeting the validity standards, another set examined KFs test development choices and score interpretation. The accumulated validity evidence for the KFs approach since its inception supports the decision-making construct measured and its use to assess clinical decision-making skills at all levels of training and practice and with various types of exam formats. Recognizing that gathering validity evidence is an ongoing process, areas with limited evidence, such as item factor analyses or consequences of testing, are identified as well as new topics needing further clarification, such as the use of the KFs approach for formative assessment and its place within a program of assessment.

Psychiatric patients' preferences and experiences in clinical decision-making: examining concordance and correlates of patients' preferences.

PubMed

De las Cuevas, Carlos; Peñate, Wenceslao; de Rivera, Luis

2014-08-01

To assess the concordance between patients' preferred role in clinical decision-making and the role they usually experience in their psychiatric consultations and to analyze the influence of socio-demographic, clinical and personality characteristics on patients' preferences. 677 consecutive psychiatric outpatients were invited to participate in a cross-sectional survey and 507 accepted. Patients completed Control Preference Scale twice consecutively before consultation, one for their preferences of participation and another for the style they usually experienced until then, and locus of control and self-efficacy scales. Sixty-three percent of psychiatric outpatients preferred a collaborative role in decision-making, 35% preferred a passive role and only a 2% an active one. A low concordance for preferred and experienced participation in medical decision-making was registered, with more than a half of patients wanting a more active role than they actually had. Age and doctors' health locus of control orientation were found to be the best correlates for participation preferences, while age and gender were for experienced. Psychiatric diagnoses registered significant differences in patients' preferences of participation but no concerning experiences. The limited concordance between preferred and experienced roles in psychiatric patients is indicative that clinicians need to raise their sensitivity regarding patient's participation. The assessment of patient's attribution style should be useful for psychiatrist to set objectives and priority in the communication with their patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

[Physician perspectives on the impact of patient preferences and the role of next-of-kin of patients in evidence-based decision-making: A qualitative interview study from oncology].

PubMed

Salloch, Sabine; Otte, Ina C; Reinacher-Schick, Anke; Vollmann, Jochen

2018-04-01

The impact of patient preferences in evidence-based medicine is a complex issue which touches on theoretical questions as well as medical practice in the clinical context. The interaction between evidence-based recommendations and value-related patient preferences in clinical practice is, however, highly complex and requires not only medical knowledge but social, psychological and communicative competencies on the side of the physician. The multi-layered process of oncology physicians' clinical decision-making was explored in 14 semi-structured interviews with respect to a first diagnosis of a pancreatic adenocarcinoma. A case vignette was used and the Q method ("card sorting") was applied to analyze the influence of different factors (such as evidence, patient preferences and the role of relatives) on physicians' deliberations. Content analysis (Mayring) was performed. The results show that the participating oncologists consider patient preferences as an important guidance which, however, is limited on certain occasions where the physicians assume a leadership role in decision-making. From the interviewees' perspectives, the preferences of the patients' relatives are likewise of high importance because debilitating oncologic treatments can only be carried out if patients have both social and psychological support. There is a need for an ongoing reflection of the physicians' own values and due consideration of the patients' social role within the context of shared decision-making. Copyright © 2018. Published by Elsevier GmbH.

Laboratory cost control and financial management software.

PubMed

Mayer, M

1998-02-09

Economical constraints within the health care system advocate the introduction of tighter control of costs in clinical laboratories. Detailed cost information forms the basis for cost control and financial management. Based on the cost information, proper decisions regarding priorities, procedure choices, personnel policies and investments can be made. This presentation outlines some principles of cost analysis, describes common limitations of cost analysis, and exemplifies use of software to achieve optimized cost control. One commercially available cost analysis software, LabCost, is described in some detail. In addition to provision of cost information, LabCost also serves as a general management tool for resource handling, accounting, inventory management and billing. The application of LabCost in the selection process of a new high throughput analyzer for a large clinical chemistry service is taken as an example for decisions that can be assisted by cost evaluation. It is concluded that laboratory management that wisely utilizes cost analysis to support the decision-making process will undoubtedly have a clear advantage over those laboratories that fail to employ cost considerations to guide their actions.

Return to Play After Infectious Mononucleosis

PubMed Central

Becker, Jonathan A.; Smith, Julie Anne

2014-01-01

Context: Infectious mononucleosis is a disease primarily of adolescence and early adulthood. The risk of splenic injury and chronic fatigue make return-to-play decisions a challenge for the clinician caring for athletes with infectious mononucleosis. Evidence Acquisition: Data were obtained from the PubMed and MEDLINE databases through December 2012 by searching for epidemiology, diagnosis, clinical manifestations, management, and the role of the spleen in infectious mononucleosis. Study Design: Clinical review. Level of Evidence: Level 4. Results: Infectious mononucleosis is commonly encountered in young athletes. Its disease pattern is variable and can affect multiple organ systems. Supportive care is the cornerstone, with little role for medications such as corticosteroids. Physical examination is unreliable for the spleen, and ultrasound imaging has limitations in its ability to guide return-to-play decisions. Exercise does not appear to place the young athlete at risk for chronic fatigue, but determining who is at risk for persistent symptoms is a challenge. Conclusion: Return-to-play decisions for the athlete with infectious mononucleosis need to be individualized because of the variable disease course and lack of evidence-based guidelines. PMID:24790693

Behaviour change in overweight and obese pregnancy: a decision tree to support the development of antenatal lifestyle interventions.

PubMed

Ainscough, Kate M; Lindsay, Karen L; O'Sullivan, Elizabeth J; Gibney, Eileen R; McAuliffe, Fionnuala M

2017-10-01

Antenatal healthy lifestyle interventions are frequently implemented in overweight and obese pregnancy, yet there is inconsistent reporting of the behaviour-change methods and behavioural outcomes. This limits our understanding of how and why such interventions were successful or not. The current paper discusses the application of behaviour-change theories and techniques within complex lifestyle interventions in overweight and obese pregnancy. The authors propose a decision tree to help guide researchers through intervention design, implementation and evaluation. The implications for adopting behaviour-change theories and techniques, and using appropriate guidance when constructing and evaluating interventions in research and clinical practice are also discussed. To enhance the evidence base for successful behaviour-change interventions during pregnancy, adoption of behaviour-change theories and techniques, and use of published guidelines when designing lifestyle interventions are necessary. The proposed decision tree may be a useful guide for researchers working to develop effective behaviour-change interventions in clinical settings. This guide directs researchers towards key literature sources that will be important in each stage of study development.

Future of electronic health records: implications for decision support.

PubMed

Rothman, Brian; Leonard, Joan C; Vigoda, Michael M

2012-01-01

The potential benefits of the electronic health record over traditional paper are many, including cost containment, reductions in errors, and improved compliance by utilizing real-time data. The highest functional level of the electronic health record (EHR) is clinical decision support (CDS) and process automation, which are expected to enhance patient health and healthcare. The authors provide an overview of the progress in using patient data more efficiently and effectively through clinical decision support to improve health care delivery, how decision support impacts anesthesia practice, and how some are leading the way using these systems to solve need-specific issues. Clinical decision support uses passive or active decision support to modify clinician behavior through recommendations of specific actions. Recommendations may reduce medication errors, which would result in considerable savings by avoiding adverse drug events. In selected studies, clinical decision support has been shown to decrease the time to follow-up actions, and prediction has proved useful in forecasting patient outcomes, avoiding costs, and correctly prompting treatment plan modifications by clinicians before engaging in decision-making. Clinical documentation accuracy and completeness is improved by an electronic health record and greater relevance of care data is delivered. Clinical decision support may increase clinician adherence to clinical guidelines, but educational workshops may be equally effective. Unintentional consequences of clinical decision support, such as alert desensitization, can decrease the effectiveness of a system. Current anesthesia clinical decision support use includes antibiotic administration timing, improved documentation, more timely billing, and postoperative nausea and vomiting prophylaxis. Electronic health record implementation offers data-mining opportunities to improve operational, financial, and clinical processes. Using electronic health record data in real-time for decision support and process automation has the potential to both reduce costs and improve the quality of patient care. © 2012 Mount Sinai School of Medicine.

A Novel Approach to Study Medical Decision Making in the Clinical Setting: The "Own-point-of-view" Perspective.

PubMed

Pelaccia, Thierry; Tardif, Jacques; Triby, Emmanuel; Charlin, Bernard

2017-07-01

Making diagnostic and therapeutic decisions is a critical activity among physicians. It relies on the ability of physicians to use cognitive processes and specific knowledge in the context of a clinical reasoning. This ability is a core competency in physicians, especially in the field of emergency medicine where the rate of diagnostic errors is high. Studies that explore medical decision making in an authentic setting are increasing significantly. They are based on the use of qualitative methods that are applied at two separate times: 1) a video recording of the subject's actual activity in an authentic setting and 2) an interview with the subject, supported by the video recording. Traditionally, activity is recorded from an "external perspective"; i.e., a camera is positioned in the room in which the consultation takes place. This approach has many limits, both technical and with respect to the validity of the data collected. The article aims at 1) describing how decision making is currently being studied, especially from a qualitative standpoint, and the reasons why new methods are needed, and 2) reporting how we used an original, innovative approach to study decision making in the field of emergency medicine and findings from these studies to guide further the use of this method. The method consists in recording the subject's activity from his own point of view, by fixing a microcamera on his temple or the branch of his glasses. An interview is then held on the basis of this recording, so that the subject being interviewed can relive the situation, to facilitate the explanation of his reasoning with respect to his decisions and actions. We describe how this method has been used successfully in investigating medical decision making in emergency medicine. We provide details on how to use it optimally, taking into account the constraints associated with the practice of emergency medicine and the benefits in the study of clinical reasoning. The "own-point-of-view" video technique is a promising method to study clinical decision making in emergency medicine. It is a powerful tool to stimulate recall and help physicians make their reasoning explicit, thanks to a greater psychological immersion. © 2017 by the Society for Academic Emergency Medicine.

International lessons in new methods for grading and integrating cost effectiveness evidence into clinical practice guidelines.

PubMed

Antioch, Kathryn M; Drummond, Michael F; Niessen, Louis W; Vondeling, Hindrik

2017-01-01

Economic evidence is influential in health technology assessment world-wide. Clinical Practice Guidelines (CPG) can enable economists to include economic information on health care provision. Application of economic evidence in CPGs, and its integration into clinical practice and national decision making is hampered by objections from professions, paucity of economic evidence or lack of policy commitment. The use of state-of-art economic methodologies will improve this. Economic evidence can be graded by 'checklists' to establish the best evidence for decision making given methodological rigor. New economic evaluation checklists, Multi-Criteria Decision Analyses (MCDA) and other decision criteria enable health economists to impact on decision making world-wide. We analyse the methodologies for integrating economic evidence into CPG agencies globally, including the Agency of Health Research and Quality (AHRQ) in the USA, National Health and Medical Research Council (NHMRC) and Australian political reforms. The Guidelines and Economists Network International (GENI) Board members from Australia, UK, Canada and Denmark presented the findings at the conference of the International Health Economists Association (IHEA) and we report conclusions and developments since. The Consolidated Guidelines for the Reporting of Economic Evaluations (CHEERS) 24 item check list can be used by AHRQ, NHMRC, other CPG and health organisations, in conjunction with the Drummond ten-point check list and a questionnaire that scores that checklist for grading studies, when assessing economic evidence. Cost-effectiveness Analysis (CEA) thresholds, opportunity cost and willingness-to-pay (WTP) are crucial issues for decision rules in CEA generally, including end-of-life therapies. Limitations of inter-rater reliability in checklists can be addressed by including more than one assessor to reach a consensus, especially when impacting on treatment decisions. We identify priority areas to generate economic evidence for CPGs by NHMRC, AHRQ, and other agencies. The evidence may cover demand for care issues such as involved time, logistics, innovation price, price sensitivity, substitutes and complements, WTP, absenteeism and presentism. Supply issues may include economies of scale, efficiency changes, and return on investment. Involved equity and efficiency measures may include cost-of-illness, disease burden, quality-of-life, budget impact, cost-effective ratios, net benefits and disparities in access and outcomes. Priority setting remains essential and trade-off decisions between policy criteria can be based on MCDA, both in evidence based clinical medicine and in health planning.

Factors influencing the clinical decision-making of midwives: a qualitative study.

PubMed

Daemers, Darie O A; van Limbeek, Evelien B M; Wijnen, Hennie A A; Nieuwenhuijze, Marianne J; de Vries, Raymond G

2017-10-06

Although midwives make clinical decisions that have an impact on the health and well-being of mothers and babies, little is known about how they make those decisions. Wide variation in intrapartum decisions to refer women to obstetrician-led care suggests that midwives' decisions are based on more than the evidence based medicine (EBM) model - i.e. clinical evidence, midwife's expertise, and woman's values - alone. With this study we aimed to explore the factors that influence clinical decision-making of midwives who work independently. We used a qualitative approach, conducting in-depth interviews with a purposive sample of 11 Dutch primary care midwives. Data collection took place between May and September 2015. The interviews were semi-structured, using written vignettes to solicit midwives' clinical decision-making processes (Think Aloud method). We performed thematic analysis on the transcripts. We identified five themes that influenced clinical decision-making: the pregnant woman as a whole person, sources of knowledge, the midwife as a whole person, the collaboration between maternity care professionals, and the organisation of care. Regarding the midwife, her decisions were shaped not only by her experience, intuition, and personal circumstances, but also by her attitudes about physiology, woman-centredness, shared decision-making, and collaboration with other professionals. The nature of the local collaboration between maternity care professionals and locally-developed protocols dominated midwives' clinical decision-making. When midwives and obstetricians had different philosophies of care and different practice styles, their collaborative efforts were challenged. Midwives' clinical decision-making is a more varied and complex process than the EBM framework suggests. If midwives are to succeed in their role as promoters and protectors of physiological pregnancy and birth, they need to understand how clinical decisions in a multidisciplinary context are actually made.

Critical thinking: concept analysis from the perspective of Rodger's evolutionary method of concept analysis

PubMed Central

Carbogim, Fábio da Costa; de Oliveira, Larissa Bertacchini; Püschel, Vilanice Alves de Araújo

2016-01-01

ABSTRACT Objective: to analyze the concept of critical thinking (CT) in Rodger's evolutionary perspective. Method: documentary research undertaken in the Cinahl, Lilacs, Bdenf and Dedalus databases, using the keywords of 'critical thinking' and 'Nursing', without limitation based on year of publication. The data were analyzed in accordance with the stages of Rodger's conceptual model. The following were included: books and articles in full, published in Portuguese, English or Spanish, which addressed CT in the teaching and practice of Nursing; articles which did not address aspects related to the concept of CT were excluded. Results: the sample was made up of 42 works. As a substitute term, emphasis is placed on 'analytical thinking', and, as a related factor, decision-making. In order, the most frequent preceding and consequent attributes were: ability to analyze, training of the student nurse, and clinical decision-making. As the implications of CT, emphasis is placed on achieving effective results in care for the patient, family and community. Conclusion: CT is a cognitive skill which involves analysis, logical reasoning and clinical judgment, geared towards the resolution of problems, and standing out in the training and practice of the nurse with a view to accurate clinical decision-making and the achieving of effective results. PMID:27598376

Referral criteria and clinical decision support: radiological protection aspects for justification.

PubMed

Pérez, M del Rosario

2015-06-01

Advanced imaging technology has opened new horizons for medical diagnostics and improved patient care. However, many procedures are unjustified and do not provide a net benefit. An area of particular concern is the unnecessary use of radiation when clinical evaluation or other imaging modalities could provide an accurate diagnosis. Referral criteria for medical imaging are consensus statements based on the best-available evidence to assist the decision-making process when choosing the best imaging procedure for a given patient. Although they are advisory rather than compulsory, physicians should have good reasons for deviation from these criteria. Voluntary use of referral criteria has shown limited success compared with integration into clinical decision support systems. These systems support good medical practice, can improve health service delivery, and foster safer, more efficient, fair, cost-effective care, thus contributing to the strengthening of health systems. Justification of procedures and optimisation of protection, the two pillars of radiological protection in health care, are implicit in the notion of good medical practice. However, some health professionals are not familiar with these principles, and have low awareness of radiological protection aspects of justification. A stronger collaboration between radiation protection and healthcare communities could contribute to improve the radiation protection culture in medical practice. © The Chartered Institution of Building Services Engineers 2014.

2018 International Olympic Committee Consensus Statement on Prevention, Diagnosis, and Management of Pediatric Anterior Cruciate Ligament Injuries

PubMed Central

Ardern, Clare L.; Ekås, Guri; Grindem, Hege; Moksnes, Håvard; Anderson, Allen F.; Chotel, Franck; Cohen, Moises; Forssblad, Magnus; Ganley, Theodore J.; Feller, Julian A.; Karlsson, Jón; Kocher, Mininder S.; LaPrade, Robert F.; McNamee, Mike; Mandelbaum, Bert; Micheli, Lyle; Mohtadi, Nicholas G.H.; Reider, Bruce; Roe, Justin P.; Seil, Romain; Siebold, Rainer; Silvers-Granelli, Holly J.; Soligard, Torbjørn; Witvrouw, Erik; Engebretsen, Lars

2018-01-01

In October 2017, the International Olympic Committee hosted an international expert group of physical therapists and orthopaedic surgeons who specialize in treating and researching pediatric anterior cruciate ligament (ACL) injuries. The purpose of this meeting was to provide a comprehensive, evidence-informed summary to support the clinician and help children with ACL injury and their parents/guardians make the best possible decisions. Representatives from the following societies attended: American Orthopaedic Society for Sports Medicine; European Paediatric Orthopaedic Society; European Society for Sports Traumatology, Knee Surgery, and Arthroscopy; International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine; Pediatric Orthopaedic Society of North America; and Sociedad Latinoamericana de Artroscopia, Rodilla, y Deporte. Physical therapists and orthopaedic surgeons with clinical and research experience in the field and an ethics expert with substantial experience in the area of sports injuries also participated. This consensus statement addresses 6 fundamental clinical questions regarding the prevention, diagnosis, and management of pediatric ACL injuries. Injury management is challenging in the current landscape of clinical uncertainty and limited scientific knowledge. Injury management decisions also occur against the backdrop of the complexity of shared decision making with children and the potential long-term ramifications of the injury. PMID:29594177

Factors and outcomes of decision making for cancer clinical trial participation.

PubMed

Biedrzycki, Barbara A

2011-09-01

To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial. Cross-sectional, descriptive. Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States. 197 patients with advanced gastrointestinal cancer. Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review. disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information. decision to accept or decline research participation and satisfaction with this decision. All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%). Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation. Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.

Creating and sharing clinical decision support content with Web 2.0: Issues and examples.

PubMed

Wright, Adam; Bates, David W; Middleton, Blackford; Hongsermeier, Tonya; Kashyap, Vipul; Thomas, Sean M; Sittig, Dean F

2009-04-01

Clinical decision support is a powerful tool for improving healthcare quality and patient safety. However, developing a comprehensive package of decision support interventions is costly and difficult. If used well, Web 2.0 methods may make it easier and less costly to develop decision support. Web 2.0 is characterized by online communities, open sharing, interactivity and collaboration. Although most previous attempts at sharing clinical decision support content have worked outside of the Web 2.0 framework, several initiatives are beginning to use Web 2.0 to share and collaborate on decision support content. We present case studies of three efforts: the Clinfowiki, a world-accessible wiki for developing decision support content; Partners Healthcare eRooms, web-based tools for developing decision support within a single organization; and Epic Systems Corporation's Community Library, a repository for sharing decision support content for customers of a single clinical system vendor. We evaluate the potential of Web 2.0 technologies to enable collaborative development and sharing of clinical decision support systems through the lens of three case studies; analyzing technical, legal and organizational issues for developers, consumers and organizers of clinical decision support content in Web 2.0. We believe the case for Web 2.0 as a tool for collaborating on clinical decision support content appears strong, particularly for collaborative content development within an organization.

Tumor Slice Culture: A New Avatar in Personalized Oncology

DTIC Science & Technology

2017-08-01

official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB No...sensitivity and to correlate the results with clinical and molecular data. 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT...differences in pre-operative treatments. Indeed, the viability scores significantly correlated with pathologic assessment of tumor viability/necrosis

Design and Usability Testing of an mHealth Application for Midwives in Rural Ghana

ERIC Educational Resources Information Center

Velez, Olivia

2011-01-01

Midwives in Ghana provide the majority of rural primary and maternal healthcare services, but have limited access to data for decision making and knowledge work. Few mobile health (mHealth) applications have been designed for midwives. The study purpose was to design and test an mHealth application (mClinic) that can improve data access and reduce…

Defining decision making: a qualitative study of international experts' views on surgical trainee decision making.

PubMed

Rennie, Sarah C; van Rij, Andre M; Jaye, Chrystal; Hall, Katherine H

2011-06-01

Decision making is a key competency of surgeons; however, how best to assess decisions and decision makers is not clearly established. The aim of the present study was to identify criteria that inform judgments about surgical trainees' decision-making skills. A qualitative free text web-based survey was distributed to recognized international experts in Surgery, Medical Education, and Cognitive Research. Half the participants were asked to identify features of good decisions, characteristics of good decision makers, and essential factors for developing good decision-making skills. The other half were asked to consider these areas in relation to poor decision making. Template analysis of free text responses was performed. Twenty-nine (52%) experts responded to the survey, identifying 13 categories for judging a decision and 14 for judging a decision maker. Twelve features/characteristics overlapped (considered, informed, well timed, aware of limitations, communicated, knowledgeable, collaborative, patient-focused, flexible, able to act on the decision, evidence-based, and coherent). Fifteen categories were generated for essential factors leading to development of decision-making skills that fall into three major themes (personal qualities, training, and culture). The categories compiled from the perspectives of good/poor were predominantly the inverse of each other; however, the weighting given to some categories varied. This study provides criteria described by experts when considering surgical decisions, decision makers, and development of decision-making skills. It proposes a working definition of a good decision maker. Understanding these criteria will enable clinical teachers to better recognize and encourage good decision-making skills and identify poor decision-making skills for remediation.

Role of biomarkers in the management of antibiotic therapy: an expert panel review: I – currently available biomarkers for clinical use in acute infections

PubMed Central

2013-01-01

In the context of worldwide increasing antimicrobial resistance, good antimicrobial prescribing in more needed than ever; unfortunately, information available to clinicians often are insufficient to rely on. Biomarkers might provide help for decision-making and improve antibiotic management. The purpose of this expert panel review was to examine currently available literature on the potential role of biomarkers to improve antimicrobial prescribing, by answering three questions: 1) Which are the biomarkers available for this purpose?; 2) What is their potential role in the initiation of antibiotic therapy?; and 3) What is their role in the decision to stop antibiotic therapy? To answer these questions, studies reviewed were limited to recent clinical studies (<15 years), involving a substantial number of patients (>50) and restricted to controlled trials and meta-analyses for answering questions 2 and 3. With regard to the first question concerning routinely available biomarkers, which might be useful for antibiotic management of acute infections, these are currently limited to C-reactive protein (CRP) and procalcitonin (PCT). Other promising biomarkers that may prove useful in the near future but need to undergo more extensive clinical testing include sTREM-1, suPAR, ProADM, and Presepsin. New approaches to biomarkers of infections include point-of-care testing and genomics. PMID:23837559

Biomarker-guided antibiotic therapy—strengths and limitations

PubMed Central

Salluh, Jorge; Martin-Loeches, Ignacio; Póvoa, Pedro

2017-01-01

Biomarkers as C-reactive protein (CRP) and procalcitonin (PCT) emerged as tools to help clinicians to diagnose infection and to properly initiate and define the duration of antibiotic therapy. Several randomized controlled trials, including adult critically ill patients, showed that PCT-guided antibiotic stewardship was repeatedly associated with a decrease in the duration of antibiotic therapy with no apparent harm. There are however some relevant limitations in these trials namely the low rate of compliance of PCT-guided algorithms, the high rate of exclusion (without including common clinical situations and pathogens) and the long duration of antibiotic therapy in control groups. Such limitations weakened the real impact of such algorithms in the clinical decision-making process and strengthened the concept that the initiation and the duration of antibiotic therapy cannot depend solely on a biomarker. Future efforts should address these limitations in order to better clarify the role of biomarkers on the complex and multifactorial issue of antibiotic management and to deeply understand its potential effect on mortality. PMID:28603723

Biomarker-guided antibiotic therapy-strengths and limitations.

PubMed

Nora, David; Salluh, Jorge; Martin-Loeches, Ignacio; Póvoa, Pedro

2017-05-01

Biomarkers as C-reactive protein (CRP) and procalcitonin (PCT) emerged as tools to help clinicians to diagnose infection and to properly initiate and define the duration of antibiotic therapy. Several randomized controlled trials, including adult critically ill patients, showed that PCT-guided antibiotic stewardship was repeatedly associated with a decrease in the duration of antibiotic therapy with no apparent harm. There are however some relevant limitations in these trials namely the low rate of compliance of PCT-guided algorithms, the high rate of exclusion (without including common clinical situations and pathogens) and the long duration of antibiotic therapy in control groups. Such limitations weakened the real impact of such algorithms in the clinical decision-making process and strengthened the concept that the initiation and the duration of antibiotic therapy cannot depend solely on a biomarker. Future efforts should address these limitations in order to better clarify the role of biomarkers on the complex and multifactorial issue of antibiotic management and to deeply understand its potential effect on mortality.

The cost analysis of cemented versus cementless total hip replacement operations on the NHS.

PubMed

Kallala, R; Anderson, P; Morris, S; Haddad, F S

2013-07-01

In a time of limited resources, the debate continues over which types of hip prosthesis are clinically superior and more cost-effective. Orthopaedic surgeons increasingly need robust economic evidence to understand the full value of the operation, and to aid decision making on the 'package' of procedures that are available and to justify their practice beyond traditional clinical preference. In this paper we explore the current economic debate about the merits of cemented and cementless total hip replacement, an issue that continues to divide the orthopaedic community.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick S; Ravani, Pietro

2015-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

On framing the research question and choosing the appropriate research design.

PubMed

Parfrey, Patrick; Ravani, Pietro

2009-01-01

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires the definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, ensure adequate samples, measure input and output variables appropriately, consider external and internal validities, limit bias, and address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

Computerized clinical decision support systems for chronic disease management: a decision-maker-researcher partnership systematic review.

PubMed

Roshanov, Pavel S; Misra, Shikha; Gerstein, Hertzel C; Garg, Amit X; Sebaldt, Rolf J; Mackay, Jean A; Weise-Kelly, Lorraine; Navarro, Tamara; Wilczynski, Nancy L; Haynes, R Brian

2011-08-03

The use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations). We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes. Of 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported. A small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes.

Computerized clinical decision support systems for chronic disease management: A decision-maker-researcher partnership systematic review

PubMed Central

2011-01-01

Background The use of computerized clinical decision support systems (CCDSSs) may improve chronic disease management, which requires recurrent visits to multiple health professionals, ongoing disease and treatment monitoring, and patient behavior modification. The objective of this review was to determine if CCDSSs improve the processes of chronic care (such as diagnosis, treatment, and monitoring of disease) and associated patient outcomes (such as effects on biomarkers and clinical exacerbations). Methods We conducted a decision-maker-researcher partnership systematic review. We searched MEDLINE, EMBASE, Ovid's EBM Reviews database, Inspec, and reference lists for potentially eligible articles published up to January 2010. We included randomized controlled trials that compared the use of CCDSSs to usual practice or non-CCDSS controls. Trials were eligible if at least one component of the CCDSS was designed to support chronic disease management. We considered studies 'positive' if they showed a statistically significant improvement in at least 50% of relevant outcomes. Results Of 55 included trials, 87% (n = 48) measured system impact on the process of care and 52% (n = 25) of those demonstrated statistically significant improvements. Sixty-five percent (36/55) of trials measured impact on, typically, non-major (surrogate) patient outcomes, and 31% (n = 11) of those demonstrated benefits. Factors of interest to decision makers, such as cost, user satisfaction, system interface and feature sets, unique design and deployment characteristics, and effects on user workflow were rarely investigated or reported. Conclusions A small majority (just over half) of CCDSSs improved care processes in chronic disease management and some improved patient health. Policy makers, healthcare administrators, and practitioners should be aware that the evidence of CCDSS effectiveness is limited, especially with respect to the small number and size of studies measuring patient outcomes. PMID:21824386

Using a patient decision aid for insulin initiation in patients with type 2 diabetes: a qualitative analysis of doctor–patient conversations in primary care consultations in Malaysia

PubMed Central

Syed, Ayeshah; Mohd Don, Zuraidah; Ng, Chirk Jenn; Lee, Yew Kong; Khoo, Ee Ming; Lee, Ping Yein; Lim Abdullah, Khatijah; Zainal, Azlin

2017-01-01

Objective To investigate whether the use of apatient decision aid (PDA) for insulin initiation fulfils its purpose of facilitating patient-centred decision-making through identifying how doctors and patients interact when using the PDA during primary care consultations. Design Conversation analysis of seven single cases of audio-recorded/video-recorded consultations between doctors and patients with type 2 diabetes, using a PDA on starting insulin. Setting Primary care in three healthcare settings: (1) one private clinic; (2) two public community clinics and (3) one primary care clinic in a public university hospital, in Negeri Sembilan and the Klang Valley in Malaysia. Participants Clinicians and seven patients with type 2 diabetes to whom insulin had been recommended. Purposive sampling was used to select a sample high in variance across healthcare settings, participant demographics and perspectives on insulin. Primary outcome measures Interaction between doctors and patients in a clinical consultation involving the use of a PDA about starting insulin. Results Doctors brought the PDA into the conversation mainly by asking information-focused ‘yes/no’ questions, and used the PDA for information exchange only if patients said they had not read it. While their contributions were limited by doctors’ questions, some patients disclosed issues or concerns. Although doctors’ PDA-related questions acted as a presequence to deliberation on starting insulin, their interactional practices raised questions on whether patients were informed and their preferences prioritised. Conclusions Interactional practices can hinder effective PDA implementation, with habits from ordinary conversation potentially influencing doctors’ practices and complicating their implementation of patient-centred decision-making. Effective interaction should therefore be emphasised in the design and delivery of PDAs and in training clinicians to use them. PMID:28490553

No decision about me without me: concordance operationalised.

PubMed

Snowden, Austyn; Marland, Glenn

2013-05-01

To demonstrate that concordance can be operationalised to the benefit of patients. Concordance can be understood as a composite of knowledge, health beliefs and collaboration. In discussing any clinical decision, it would be ideal if different views could be incorporated to reach the most coherent decision. This is a definition of concordance, a widely agreed ideal in nursing. There are limits, however, that make the practice of concordance problematic. Sometimes there is little time or willingness to discuss issues in depth. Some views of the world are considered more worthy than others. As a consequence, clinical guidelines currently prioritise easier to measure outcomes of negotiation, such as adherence. This discursive article argues that prioritising adherence is a fundamental error, incoherent with current strategic rhetoric such as the Department of Health's 'no decision about me without me'. The impact of prioritising concordance is contrasted with adherence-based interventions. Where adherence is a goal of treatment, non-adherence is considered problematic. This value judgment is not useful and does not occur in a consultation that prioritises concordance. However, concordance is difficult to translate into clinical practice. This article shows that concordance can be operationalised by considering it a composite of health beliefs, knowledge and collaboration. The main thesis is that different behaviours can always be incorporated into a concordance framework. This negates the necessity for adherence as an endpoint in itself. Fifty per cent of people do not take medicines as prescribed. Interventions focused towards improving adherence are only ever partially successful. This is because it presupposes the clinician is right. Concordance by contrast is more coherent with person centred care and thus more likely to generate clinically meaningful outcomes for patients. © 2012 Blackwell Publishing Ltd.

[Factors influencing nurses' clinical decision making--focusing on critical thinking disposition].

PubMed

Park, Seungmi; Kwon, In Gak

2007-10-01

The purpose of this study was to investigate the factors influencing nurses' clinical decision making focusing on critical thinking disposition. The subjects of this study consisted of 505 nurses working at one of the general hospitals located in Seoul. Data was collected by a self-administered questionnaire between December 2006 and January 2007. Data was analyzed by one way ANOVA, Pearson correlation coefficients, and stepwise multiple regression using SPSS Win 14.0. The mean scores of critical thinking disposition and clinical decision making were 99.10 and 134.32 respectively. Clinical decision making scores were significantly higher in groups under continuing education, with a master or higher degree, with clinical experience more than 5 years, or with experts. Critical thinking disposition and its subscales have a significant correlation with clinical decision making. Intellectual eagerness/curiosity, prudence, clinical experience, intellectual honesty, self-confidence, and healthy skepticism were important factors influencing clinical decision making(adjusted R(2)=33%). Results of this study suggest that various strategies such as retaining experienced nurses, encouraging them to continue with education and enhancing critical thinking disposition are warranted for development of clinical decision making.

Gathering Real World Evidence with Cluster Analysis for Clinical Decision Support.

PubMed

Xia, Eryu; Liu, Haifeng; Li, Jing; Mei, Jing; Li, Xuejun; Xu, Enliang; Li, Xiang; Hu, Gang; Xie, Guotong; Xu, Meilin

2017-01-01

Clinical decision support systems are information technology systems that assist clinical decision-making tasks, which have been shown to enhance clinical performance. Cluster analysis, which groups similar patients together, aims to separate patient cases into phenotypically heterogenous groups and defining therapeutically homogeneous patient subclasses. Useful as it is, the application of cluster analysis in clinical decision support systems is less reported. Here, we describe the usage of cluster analysis in clinical decision support systems, by first dividing patient cases into similar groups and then providing diagnosis or treatment suggestions based on the group profiles. This integration provides data for clinical decisions and compiles a wide range of clinical practices to inform the performance of individual clinicians. We also include an example usage of the system under the scenario of blood lipid management in type 2 diabetes. These efforts represent a step toward promoting patient-centered care and enabling precision medicine.

The strange case of Mr. H. Starting dialysis at 90 years of age: clinical choices impact on ethical decisions.

PubMed

Piccoli, Giorgina Barbara; Sofronie, Andreea Corina; Coindre, Jean-Philippe

2017-11-09

Starting dialysis at an advanced age is a clinical challenge and an ethical dilemma. The advantages of starting dialysis at "extreme" ages are questionable as high dialysis-related morbidity induces a reflection on the cost- benefit ratio of this demanding and expensive treatment in a person that has a short life expectancy. Where clinical advantages are doubtful, ethical analysis can help us reach decisions and find adapted solutions. Mr. H is a ninety-year-old patient with end-stage kidney disease that is no longer manageable with conservative care, in spite of optimal nutritional management, good blood pressure control and strict clinical and metabolic evaluations; dialysis is the next step, but its morbidity is challenging. The case is analysed according to principlism (beneficence, non-maleficence, justice and respect for autonomy). In the setting of care, dialysis is available without restriction; therefore the principle of justice only partially applied, in the absence of restraints on health-care expenditure. The final decision on whether or not to start dialysis rested with Mr. H (respect for autonomy). However, his choice depended on the balance between beneficence and non-maleficence. The advantages of dialysis in restoring metabolic equilibrium were clear, and the expected negative effects of dialysis were therefore decisive. Mr. H has a contraindication to peritoneal dialysis (severe arthritis impairing self-performance) and felt performing it with nursing help would be intrusive. Post dialysis fatigue, poor tolerance, hypotension and intrusiveness in daily life of haemodialysis patients are closely linked to the classic thrice-weekly, four-hour schedule. A personalized incremental dialysis approach, starting with one session per week, adapting the timing to the patient's daily life, can limit side effects and "dialysis shock". An individualized approach to complex decisions such as dialysis start can alter the delicate benefit/side-effect balance, ultimately affecting the patient's choice, and points to a narrative, tailor-made approach as an alternative to therapeutic nihilism, in very old and fragile patients.

The ESMO-Magnitude of Clinical Benefit Scale for novel oncology drugs: correspondence with three years of reimbursement decisions in Israel.

PubMed

Hammerman, Ariel; Greenberg-Dotan, Sari; Feldhamer, Ilan; Birnbaum, Yair; Cherny, Nathan I

2018-02-01

The European Society for Medical Oncology published in 2015 its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for cancer medicines. Our objective was to evaluate the association between Israel's national reimbursement decisions regarding novel cancer drugs, prior to the availability of ESMO-MCBS, and the later published ESMO-MCBS scores. ESMO-MCBS scores were obtained retrospectively for the cancer drugs that were candidates for reimbursement in Israel in 2013-2015 and were categorized to 'highest benefit' (ESMO-MCBS 4-5 or A) 'medium benefit' (3 or B) and 'lowest benefit' (0-2 or C). The reimbursement decisions were accessed and compared with the categorized ESMO scores. ESMO-MCBS score was available for 19/22 drugs approved for reimbursement and 15/16 non-approved drugs. 58% of the approved drugs gained a 'highest benefit' score and 37% were 'medium benefit'. 87% of the non-approved drugs had 'lowest benefit' scores. Median score for approved drugs was 4 vs. 1 for the non-approved (p < 0.05). The Israeli decisions regarding reimbursement of novel cancer drugs, demonstrated concordance with ESMO-MCBS scores. Incorporation of ESMO-MCBS data in reimbursement deliberations could assist in framing the appropriate use of the limited resources to deliver effective and affordable cancer care.

Interrupted time series design: a useful approach for studying interventions targeting participation.

PubMed

Anaby, Dana; Lal, Shalini; Huszczynski, Justine; Maich, Jana; Rogers, Jade; Law, Mary

2014-11-01

Comparative effectiveness research (CER) strives for evidence to inform clinical decisions for specific clients in typical health care settings. While the randomized controlled trial (RCT) is well-aligned with the objectives of CER, this design may not be feasible or applicable to all research questions, particularly those pertaining to clinical decision making and individually based change. It is important, therefore, to consider alternative approaches, especially when studying complex and subjective outcomes such as children's participation. We propose the use of interrupted time series (ITS) quasi-experimental design for its potential application in determining the effectiveness of participation-focused interventions. In this perspective, ITS design is described, ascertaining its advantages and limitations, and suggestions are provided to overcome challenges to implementation. Results of a case study using the ITS approach to evaluate changes in participation of an adolescent with physical disabilities are described. Finally, strategies to implement this design in practice are suggested.

Digital technology and clinical decision making in depression treatment: Current findings and future opportunities.

PubMed

Hallgren, Kevin A; Bauer, Amy M; Atkins, David C

2017-06-01

Clinical decision making encompasses a broad set of processes that contribute to the effectiveness of depression treatments. There is emerging interest in using digital technologies to support effective and efficient clinical decision making. In this paper, we provide "snapshots" of research and current directions on ways that digital technologies can support clinical decision making in depression treatment. Practical facets of clinical decision making are reviewed, then research, design, and implementation opportunities where technology can potentially enhance clinical decision making are outlined. Discussions of these opportunities are organized around three established movements designed to enhance clinical decision making for depression treatment, including measurement-based care, integrated care, and personalized medicine. Research, design, and implementation efforts may support clinical decision making for depression by (1) improving tools to incorporate depression symptom data into existing electronic health record systems, (2) enhancing measurement of treatment fidelity and treatment processes, (3) harnessing smartphone and biosensor data to inform clinical decision making, (4) enhancing tools that support communication and care coordination between patients and providers and within provider teams, and (5) leveraging treatment and outcome data from electronic health record systems to support personalized depression treatment. The current climate of rapid changes in both healthcare and digital technologies facilitates an urgent need for research, design, and implementation of digital technologies that explicitly support clinical decision making. Ensuring that such tools are efficient, effective, and usable in frontline treatment settings will be essential for their success and will require engagement of stakeholders from multiple domains. © 2017 Wiley Periodicals, Inc.

Current Use of Evidence-Based Medicine in Pediatric Spine Surgery.

PubMed

Oetgen, Matthew E

2018-04-01

Evidence-based medicine (EBM) is a process of decision-making aimed at making the best clinical decisions as they relate to patients' health. The current use of EBM in pediatric spine surgery is varied, based mainly on the availability of high-quality data. The use of EBM is limited in idiopathic scoliosis, whereas EBM has been used to investigate the treatment of pediatric spondylolysis. Studies on early onset scoliosis are of low quality, making EBM difficult in this condition. Future focus and commitment to study quality in pediatric spinal surgery will likely increase the role of EBM in these conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

Organisational capacity and chronic disease care: an Australian general practice perspective.

PubMed

Proudfoot, Judith; Infante, Fernando; Holton, Christine; Powell-Davies, Gawaine; Bubner, Tanya; Beilby, Justin; Harris, Mark

2007-04-01

Although we are rapidly improving our understanding of how to manage patients with chronic illness in Australian general practice, many patients are still receiving suboptimal care. General practices have limited organisational capacity to provide the structured care that is required for managing chronic conditions: regular monitoring, decision support, patient recall, supporting patient self management, team work, and information management. This requires a shift away from episodic, acute models. Overseas research has shown that areas such as team work, clinical information systems, decision support, linkages and leadership are also important in managing chronic illness, but we do not know which of these are most important in Australia.

Incentivizing shared decision making in the USA--where are we now?

PubMed

Durand, Marie-Anne; Barr, Paul J; Walsh, Thom; Elwyn, Glyn

2015-06-01

The Affordable Care Act raised significant interest in the process of shared decision making, the role of patient decision aids, and incentivizing their utilization. However, it has not been clear how best to put incentives into practice, and how the implementation of shared decision making and the use of patient decision aids would be measured. Our goal was to review developments and proposals put forward. We performed a qualitative document analysis following a pragmatic search of Medline, Google, Google Scholar, Business Source Complete (Ebscohost), and LexisNexis from 2009-2013 using the following key words: "Patient Protection and Affordable Care Act", "Decision Making", "Affordable Care Act", "Shared Decision Making", "measurement", "incentives", and "payment." We observed a lack of clarity about how to measure shared decision making, about how best to reward the use of patient decisions aids, and therefore how best to incentivize the process. Many documents clearly imply that providing and disseminating patient decision aids might be equivalent to shared decision making. However, there is little evidence that these tools, when used by patients in advance of clinical encounters, lead to significant change in patient-provider communication. The assessment of shared decision making for performance management remains challenging. Efforts to incentivize shared decision making are at risk of being limited to the promotion of patient decision aids, passing over the opportunity to influence the communication processes between patients and providers. Copyright © 2014 Elsevier Inc. All rights reserved.

Knowledge of Fecal Calprotectin and Infliximab Trough Levels Alters Clinical Decision-making for IBD Outpatients on Maintenance Infliximab Therapy.

PubMed

Huang, Vivian W; Prosser, Connie; Kroeker, Karen I; Wang, Haili; Shalapay, Carol; Dhami, Neil; Fedorak, Darryl K; Halloran, Brendan; Dieleman, Levinus A; Goodman, Karen J; Fedorak, Richard N

2015-06-01

Infliximab is an effective therapy for inflammatory bowel disease (IBD). However, more than 50% of patients lose response. Empiric dose intensification is not effective for all patients because not all patients have objective disease activity or subtherapeutic drug level. The aim was to determine how an objective marker of disease activity or therapeutic drug monitoring affects clinical decisions regarding maintenance infliximab therapy in outpatients with IBD. Consecutive patients with IBD on maintenance infliximab therapy were invited to participate by providing preinfusion stool and blood samples. Fecal calprotectin (FCP) and infliximab trough levels (ITLs) were measured by enzyme linked immunosorbent assay. Three decisions were compared: (1) actual clinical decision, (2) algorithmic FCP or ITL decisions, and (3) expert panel decision based on (a) clinical data, (b) clinical data plus FCP, and (c) clinical data plus FCP plus ITL. In secondary analysis, Receiver-operating curves were used to assess the ability of FCP and ITL in predicting clinical disease activity or remission. A total of 36 sets of blood and stool were available for analysis; median FCP 191.5 μg/g, median ITLs 7.3 μg/mL. The actual clinical decision differed from the hypothetical decision in 47.2% (FCP algorithm); 69.4% (ITL algorithm); 25.0% (expert panel clinical decision); 44.4% (expert panel clinical plus FCP); 58.3% (expert panel clinical plus FCP plus ITL) cases. FCP predicted clinical relapse (area under the curve [AUC] = 0.417; 95% confidence interval [CI], 0.197-0.641) and subtherapeutic ITL (AUC = 0.774; 95% CI, 0.536-1.000). ITL predicted clinical remission (AUC = 0.498; 95% CI, 0.254-0.742) and objective remission (AUC = 0.773; 95% CI, 0.622-0.924). Using FCP and ITLs in addition to clinical data results in an increased number of decisions to optimize management in outpatients with IBD on stable maintenance infliximab therapy.

Enhancing clinical decision making: development of a contiguous definition and conceptual framework.

PubMed

Tiffen, Jennifer; Corbridge, Susan J; Slimmer, Lynda

2014-01-01

Clinical decision making is a term frequently used to describe the fundamental role of the nurse practitioner; however, other terms have been used interchangeably. The purpose of this article is to begin the process of developing a definition and framework of clinical decision making. The developed definition was "Clinical decision making is a contextual, continuous, and evolving process, where data are gathered, interpreted, and evaluated in order to select an evidence-based choice of action." A contiguous framework for clinical decision making specific for nurse practitioners is also proposed. Having a clear and unique understanding of clinical decision making will allow for consistent use of the term, which is relevant given the changing educational requirements for nurse practitioners and broadening scope of practice. Copyright © 2014 Elsevier Inc. All rights reserved.

[Evidence-based aspects of clinical mastitis treatment].

PubMed

Mansion-de Vries, E M; Hoedemaker, M; Krömker, V

2015-01-01

Mastitis is one of the most common and expensive diseases in dairy cattle. The decision to treat clinical mastitis is usually made without any knowledge of the etiology, and can therefore only be evidence-based to a limited extent. Evidence-based medicine relies essentially on a combination of one's own clinical competence and scientific findings. In mastitis therapy, those insights depend mostly on pathogen-specific factors. Therefore, in evidence-based therapeutic decision making the pathogen identification should serve as a basis for the consideration of scientifically validated therapeutic concepts. The present paper considers evidence-based treatment of clinical mastitis based on a literature review. The authors conclude that an anti-inflammatory treatment using an NSAID should be conducted regardless of the pathogen. However, the choice of an antibiotic therapy depends on the mastitis causative pathogen, clinical symptoms and the animal itself. In principle, a local antibiotic treatment should be chosen for mild and moderate mastitis. It should be noted, that the benefit of an antibiotic therapy for coliform infections is questionable. With knowledge concerning the pathogen, it appears entirely reasonable to refrain from an antibiotic therapy. For severe (i.   e. feverish) mastitis, a parenteral antibiotic therapy should be selected. An extension of the antibiotic therapy beyond the manufacturer's information is only reasonable for streptococcal infections. It is important to make the decision on a prolonged antibiotic therapy only with the knowledge of the mastitis-causative pathogen. In terms of the therapy of a staphylococcus or streptococcus infection, a narrow-spectrum antibiotic from the penicillin family should be adopted when selecting the active agents.

Expert System Shells for Rapid Clinical Decision Support Module Development: An ESTA Demonstration of a Simple Rule-Based System for the Diagnosis of Vaginal Discharge

PubMed Central

2012-01-01

Objectives This study demonstrates the feasibility of using expert system shells for rapid clinical decision support module development. Methods A readily available expert system shell was used to build a simple rule-based system for the crude diagnosis of vaginal discharge. Pictures and 'canned text explanations' are extensively used throughout the program to enhance its intuitiveness and educational dimension. All the steps involved in developing the system are documented. Results The system runs under Microsoft Windows and is available as a free download at http://healthcybermap.org/vagdisch.zip (the distribution archive includes both the program's executable and the commented knowledge base source as a text document). The limitations of the demonstration system, such as the lack of provisions for assessing uncertainty or various degrees of severity of a sign or symptom, are discussed in detail. Ways of improving the system, such as porting it to the Web and packaging it as an app for smartphones and tablets, are also presented. Conclusions An easy-to-use expert system shell enables clinicians to rapidly become their own 'knowledge engineers' and develop concise evidence-based decision support modules of simple to moderate complexity, targeting clinical practitioners, medical and nursing students, as well as patients, their lay carers and the general public (where appropriate). In the spirit of the social Web, it is hoped that an online repository can be created to peer review, share and re-use knowledge base modules covering various clinical problems and algorithms, as a service to the clinical community. PMID:23346475

Use of antipsychotic blood levels in clinician decision making: A cross-over study using clinical vignettes of patients with schizophrenia.

PubMed

Savitz, Adam; Melkote, Rama; Riley, Ralph; Pobre, Maria A; McQuarrie, Kelly; Williamson, David; Banderas, Benjamin

2018-05-19

The cause of treatment failure of antipsychotic medications is often difficult to determine in patients with schizophrenia. Evaluation of antipsychotic blood levels (ABLs) may aid clinicians in determining the cause of antipsychotic failure. The Clinical Assessment of the Schizophrenia Patient (CASP) was developed to evaluate clinical decision making during outpatient visits. The CASP assesses changes in medications, psychosocial treatments, and acute interventions along with factors influencing clinical decision making. Nine vignettes representative of clinical situations in patients with schizophrenia were created in two versions (one with ABLs, one without ABLs). The CASP was used to evaluate clinical decisions using the vignettes. Thirty-four clinicians participated in the study. In 8 out of 9 vignettes, most clinicians (at least 89.7%) made a different clinical decision with ABLs compared to without ABLs. In assessing the usefulness of ABLs, a majority (60.7%-85.7%, depending on the vignette) of clinicians responded that ABLs changed their clinical decision for 8 vignettes. Most clinicians (79%-93%) responded that they were more confident in their decisions with ABL information. This study demonstrated that ABLs have the potential to influence clinical decision making in the treatment of patients with schizophrenia. Copyright © 2018. Published by Elsevier B.V.

Clinical decision regret among critical care nurses: a qualitative analysis.

PubMed

Arslanian-Engoren, Cynthia; Scott, Linda D

2014-01-01

Decision regret is a negative cognitive emotion associated with experiences of guilt and situations of interpersonal harm. These negative affective responses may contribute to emotional exhaustion in critical care nurses (CCNs), increased staff turnover rates and high medication error rates. Yet, little is known about clinical decision regret among CCNs or the conditions or situations (e.g., feeling sleepy) that may precipitate its occurrence. To examine decision regret among CCNs, with an emphasis on clinical decisions made when nurses were most sleepy. A content analytic approach was used to examine the narrative descriptions of clinical decisions by CCNs when sleepy. Six decision regret themes emerged that represented deviations in practice or performance behaviors that were attributed to fatigued CCNs. While 157 CCNs disclosed a clinical decision they made at work while sleepy, the prevalence may be underestimated and warrants further investigation. Copyright © 2014 Elsevier Inc. All rights reserved.

Electronic decision support for diagnostic imaging in a primary care setting

PubMed Central

Reed, Martin H

2011-01-01

Methods Clinical guideline adherence for diagnostic imaging (DI) and acceptance of electronic decision support in a rural community family practice clinic was assessed over 36 weeks. Physicians wrote 904 DI orders, 58% of which were addressed by the Canadian Association of Radiologists guidelines. Results Of those orders with guidelines, 76% were ordered correctly; 24% were inappropriate or unnecessary resulting in a prompt from clinical decision support. Physicians followed suggestions from decision support to improve their DI order on 25% of the initially inappropriate orders. The use of decision support was not mandatory, and there were significant variations in use rate. Initially, 40% reported decision support disruptive in their work flow, which dropped to 16% as physicians gained experience with the software. Conclusions Physicians supported the concept of clinical decision support but were reluctant to change clinical habits to incorporate decision support into routine work flow. PMID:21486884

[Limitation of therapeutic effort in Paediatric Intensive Care Units: Bioethical knowledge and attitudes of the medical profession].

PubMed

Morales Valdés, Gonzalo; Alvarado Romero, Tatiana; Zuleta Castro, Rodrigo

2016-01-01

Paediatric intensive care is a relatively new specialty, with significant technological advances that lead to the prolongation of the dying process. One of the most common bioethical problems is limitation of treatment, which is the adequacy and/or proportionality treatment, trying to avoid obstinacy and futility. To determine the experience of physicians working in Paediatric Intensive Care Units (PICU) when faced with bioethical decisions. An observational, descriptive and cross-sectional study was conducted using an anonymous questionnaire sent to physicians working in PICU. The data requested was related to potential ethical problems generated in the care of the critical child, and the procedure for their resolution. The study was approved by the Ethics Research Committee of the Faculty of Medicine UDD CAS. A total of 126 completed questionnaires were received from physicians working in 34 PICU in Chile. Almost all (98.41%) of them acknowledged having taken therapeutic limitation decisions (TLD). The most common type of TLD mentioned was the Do Not Resuscitate order (n=119), followed by the establishment of no medications (n=113), limited admission to PICU (n=81), with the withdrawal of treatment being the least mentioned (n=81). Around one-third (34.13%) felt that there were no ethical difference between introducing or removing certain treatments. Bioethical dilemmas are common in the PICU, with therapeutic limitation decisions being frequent. Many recognise not having expertise in clinical ethics, and they need continuing education in bioethics. Copyright © 2016 Sociedad Chilena de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

Shared decision making in endocrinology: present and future directions.

PubMed

Rodriguez-Gutierrez, Rene; Gionfriddo, Michael R; Ospina, Naykky Singh; Maraka, Spyridoula; Tamhane, Shrikant; Montori, Victor M; Brito, Juan P

2016-08-01

In medicine and endocrinology, there are few clinical circumstances in which clinicians can accurately predict what is best for their patients. As a result, patients and clinicians frequently have to make decisions about which there is uncertainty. Uncertainty results from limitations in the research evidence, unclear patient preferences, or an inability to predict how treatments will fit into patients' daily lives. The work that patients and clinicians do together to address the patient's situation and engage in a deliberative dialogue about reasonable treatment options is often called shared decision making. Decision aids are evidence-based tools that facilitate this process. Shared decision making is a patient-centred approach in which clinicians share information about the benefits, harms, and burden of different reasonable diagnostic and treatment options, and patients explain what matters to them in view of their particular values, preferences, and personal context. Beyond the ethical argument in support of this approach, decision aids have been shown to improve patients' knowledge about the available options, accuracy of risk estimates, and decisional comfort. Decision aids also promote patient participation in the decision-making process. Despite accumulating evidence from clinical trials, policy support, and expert recommendations in endocrinology practice guidelines, shared decision making is still not routinely implemented in endocrine practice. Additional work is needed to enrich the number of available tools and to implement them in practice workflows. Also, although the evidence from randomised controlled trials favours the use of this shared decision making in other settings, populations, and illnesses, the effect of this approach has been studied in a few endocrine disorders. Future pragmatic trials are needed to explore the effect and feasibility of shared decision making implementation into routine endocrinology and primary care practice. With the available evidence, however, endocrinologists can now start to practice shared decision making, partner with their patients, and use their expertise to formulate treatment plans that reflect patient preferences and are more likely to fit into the context of patients' lives. In this Personal View, we describe shared decision making, the evidence behind the approach, and why and how both endocrinologists and their patients could benefit from this approach. Copyright © 2016 Elsevier Ltd. All rights reserved.

Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic.

PubMed

Hajizadeh, Negin; Perez Figueroa, Rafael E; Uhler, Lauren M; Chiou, Erin; Perchonok, Jennifer E; Montague, Enid

2013-03-06

Computerized decision aids could facilitate shared decision-making at the point of outpatient clinical care. The objective of this study was to investigate whether a computerized shared decision aid would be feasible to implement in an inner-city clinic by evaluating the current practices in shared decision-making, clinicians' use of computers, patient and clinicians' attitudes and beliefs toward computerized decision aids, and the influence of time on shared decision-making. Qualitative data analysis of observations and semi-structured interviews with patients and clinicians at an inner-city outpatient clinic. The findings provided an exploratory look at the prevalence of shared decision-making and attitudes about health information technology and decision aids. A prominent barrier to clinicians engaging in shared decision-making was a lack of perceived patient understanding of medical information. Some patients preferred their clinicians make recommendations for them rather than engage in formal shared decision-making. Health information technology was an integral part of the clinic visit and welcomed by most clinicians and patients. Some patients expressed the desire to engage with health information technology such as viewing their medical information on the computer screen with their clinicians. All participants were receptive to the idea of a decision aid integrated within the clinic visit although some clinicians were concerned about the accuracy of prognostic estimates for complex medical problems. We identified several important considerations for the design and implementation of a computerized decision aid including opportunities to: bridge clinician-patient communication about medical information while taking into account individual patients' decision-making preferences, complement expert clinician judgment with prognostic estimates, take advantage of patient waiting times, and make tasks involved during the clinic visit more efficient. These findings should be incorporated into the design and implementation of a computerized shared decision aid at an inner-city hospital.

User-centered design to improve clinical decision support in primary care.

PubMed

Brunner, Julian; Chuang, Emmeline; Goldzweig, Caroline; Cain, Cindy L; Sugar, Catherine; Yano, Elizabeth M

2017-08-01

A growing literature has demonstrated the ability of user-centered design to make clinical decision support systems more effective and easier to use. However, studies of user-centered design have rarely examined more than a handful of sites at a time, and have frequently neglected the implementation climate and organizational resources that influence clinical decision support. The inclusion of such factors was identified by a systematic review as "the most important improvement that can be made in health IT evaluations." (1) Identify the prevalence of four user-centered design practices at United States Veterans Affairs (VA) primary care clinics and assess the perceived utility of clinical decision support at those clinics; (2) Evaluate the association between those user-centered design practices and the perceived utility of clinical decision support. We analyzed clinic-level survey data collected in 2006-2007 from 170 VA primary care clinics. We examined four user-centered design practices: 1) pilot testing, 2) provider satisfaction assessment, 3) formal usability assessment, and 4) analysis of impact on performance improvement. We used a regression model to evaluate the association between user-centered design practices and the perceived utility of clinical decision support, while accounting for other important factors at those clinics, including implementation climate, available resources, and structural characteristics. We also examined associations separately at community-based clinics and at hospital-based clinics. User-centered design practices for clinical decision support varied across clinics: 74% conducted pilot testing, 62% conducted provider satisfaction assessment, 36% conducted a formal usability assessment, and 79% conducted an analysis of impact on performance improvement. Overall perceived utility of clinical decision support was high, with a mean rating of 4.17 (±.67) out of 5 on a composite measure. "Analysis of impact on performance improvement" was the only user-centered design practice significantly associated with perceived utility of clinical decision support, b=.47 (p<.001). This association was present in hospital-based clinics, b=.34 (p<.05), but was stronger at community-based clinics, b=.61 (p<.001). Our findings are highly supportive of the practice of analyzing the impact of clinical decision support on performance metrics. This was the most common user-centered design practice in our study, and was the practice associated with higher perceived utility of clinical decision support. This practice may be particularly helpful at community-based clinics, which are typically less connected to VA medical center resources. Published by Elsevier B.V.

[Competency: general principles and applicability in dementia].

PubMed

Alvaro, L C

2012-06-01

Competency means the capacity to make responsible and balanced decisions. This may be performed in clinical settings (decision-making abilities on treatment or risky diagnostic procedures) and also in daily-life activities (financial matters, nursing home admittance, contracts, etc.). Competency is linked to the ethical principle of autonomy and to a horizontal doctor-patient interaction, far from ancient paternalistic relationships. It is contemplated in the Spanish law as the patient's right to be informed and to make free choices, particularly in cases of dementia. The competency that we assess is the so-called natural or working capacity. It is specific for an action or task. The level of required capacity depends on the decision: higher for critical ones, lower for low-risk decisions. The assessment process requires noting the patient's capacity to understand, analyse, self-refer and apply the information. There are some guides available that may be useful in competency assessments, but nevertheless the final statement must be defined by the physician in charge of the patient and clinical judgement. Capacity is directly related to the level of cognitive deterioration. Nevertheless, specific cognitive tests like MMSE (mini-mental) have a low predictive value. The loss of competency is more associated with the so-called legal standards of incapacity (LS). These encompass a five steps range (LS1-LS5), which may detect the incapacity from the mild levels of dementia. The cortical functions that are the best predictors of incapacity are language and executive dysfunctions. These explain the incapacity in cases of Alzheimer's and Parkinson's disease, and have been studied more. Incapacity is common and it influences the clinical decision-making process. We must be particularly cautious with clinical trials of dementia. It also involves other areas of daily life, particularly financially related ones, where limitations are present from the mild cognitive impairment level. The neurological community has already produced specific and invaluable documents like the one from Sitges, although in our opinion this community has to increase its awareness, and also its involvement as much in the clinical as in the research sides of this field. Copyright © 2011 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries.

PubMed

Kleijnen, S; Lipska, I; Leonardo Alves, T; Meijboom, K; Elsada, A; Vervölgyi, V; d'Andon, A; Timoney, A; Leufkens, H G; De Boer, A; Goettsch, W G

2016-09-01

There is a debate on the added clinical value of new, expensive, anticancer treatments. Among European decision makers, the relevance of commonly used end points in trials, especially overall survival (OS), progression-free survival (PFS) and quality of life (QoL), varies, leading to the available evidence being valued differently. This research studies the extent to which the value of end points for cancer medicines differs among European decision makers. We compared guidelines and relative effectiveness assessments (REAs) of medicines for pricing or reimbursement decisions in England, France, Germany, The Netherlands, Poland, and Scotland. Anticancer medicines that received marketing authorization in Europe between 2011 and 2013 with at least four available national REAs were evaluated. A total of 79 REAs were included. Health technology assessment (HTA) guidelines indicate a preference for clinically and patient relevant end points such as OS and QoL above surrogate end points. Most guidelines do not specify whether PFS is considered a surrogate or patient-relevant end point. The number of REAs included per jurisdiction varied between 7 (The Netherlands) and 18 (Germany). OS data were included in all REAs and were the preferred end point by HTA agencies, but these data were not always mature or robust. QoL data are included in only 54% of the REAs, with a limited impact on the recommendations. PFS data are included in 70% of the REAs, but the extent to which HTA agencies find PFS relevant varies. European decision-making on relative effectiveness of anticancer medicines is affected by a gap in requested versus available clinical evidence, mainly because the regulator is willing to accept some degree of clinical uncertainty. A multi-stakeholder debate would be essential to align concrete robust evidence requirements in oncology and a collectively shared definition for relevant clinical benefit, which will benefit patients and society in general. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evidence-based medicine in primary care: qualitative study of family physicians

PubMed Central

Tracy, C Shawn; Dantas, Guilherme Coelho; Upshur, Ross EG

2003-01-01

Background The objectives of this study were: a) to examine physician attitudes to and experience of the practice of evidence-based medicine (EBM) in primary care; b) to investigate the influence of patient preferences on clinical decision-making; and c) to explore the role of intuition in family practice. Method Qualitative analysis of semi-structured interviews of 15 family physicians purposively selected from respondents to a national survey on EBM mailed to a random sample of Canadian family physicians. Results Participants mainly welcomed the promotion of EBM in the primary care setting. A significant number of barriers and limitations to the implementation of EBM were identified. EBM is perceived by some physicians as a devaluation of the 'art of medicine' and a threat to their professional/clinical autonomy. Issues regarding the trustworthiness and credibility of evidence were of great concern, especially with respect to the influence of the pharmaceutical industry. Attempts to become more evidence-based often result in the experience of conflicts. Patient factors exert a powerful influence on clinical decision-making and can serve as trumps to research evidence. A widespread belief that intuition plays a vital role in primary care reinforced views that research evidence must be considered alongside other factors such as patient preferences and the clinical judgement and experience of the physician. Discussion Primary care physicians are increasingly keen to consider research evidence in clinical decision-making, but there are significant concerns about the current model of EBM. Our findings support the proposed revisions to EBM wherein greater emphasis is placed on clinical expertise and patient preferences, both of which remain powerful influences on physician behaviour. PMID:12740025

Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers.

PubMed

Trafton, Jodie; Martins, Susana; Michel, Martha; Lewis, Eleanor; Wang, Dan; Combs, Ann; Scates, Naquell; Tu, Samson; Goldstein, Mary K

2010-04-01

To develop and evaluate a clinical decision support system (CDSS) named Assessment and Treatment in Healthcare: Evidenced-Based Automation (ATHENA)-Opioid Therapy, which encourages safe and effective use of opioid therapy for chronic, noncancer pain. CDSS development and iterative evaluation using the analysis, design, development, implementation, and evaluation process including simulation-based and in-clinic assessments of usability for providers followed by targeted system revisions. Volunteers provided detailed feedback to guide improvements in the graphical user interface, and content and design changes to increase clinical usefulness, understandability, clinical workflow fit, and ease of completing guideline recommended practices. Revisions based on feedback increased CDSS usability ratings over time. Practice concerns outside the scope of the CDSS were also identified. Usability testing optimized the CDSS to better address barriers such as lack of provider education, confusion in dosing calculations and titration schedules, access to relevant patient information, provider discontinuity, documentation, and access to validated assessment tools. It also highlighted barriers to good clinical practice that are difficult to address with CDSS technology in its current conceptualization. For example, clinicians indicated that constraints on time and competing priorities in primary care, discomfort in patient-provider communications, and lack of evidence to guide opioid prescribing decisions impeded their ability to provide effective, guideline-adherent pain management. Iterative testing was essential for designing a highly usable and acceptable CDSS; however, identified barriers may limit the impact of the ATHENA-Opioid Therapy system and other CDSS on clinical practices and outcomes unless CDSS are paired with parallel initiatives to address these issues.

An activist's argument that participant values should guide risk-benefit ratio calculations in HIV cure research.

PubMed

Evans, David

2017-02-01

The patient empowerment movement, spurred by AIDS activism in the 1980s, quickly evolved to encompass how study participants are considered and treated in clinical research. Initially, people fearing death of AIDS sought early access to experimental medications that had not undergone rigorous testing in hopes of extending their lives. Thirty years on, scientists are asking a different set of ethical questions about clinical research, this time in the pursuit of either a sterilising cure or long-term remission for HIV. Instead of hastening access to experimental drugs for the sickest, researchers are now testing interventions for eradicating or controlling the virus in typically very healthy HIV-positive individuals who have the most to lose from such interventions if something goes wrong. While clinical researchers and ethicists debate the merits and limits of this type of research they should avoid discounting altruistic motivations as a powerful factor in a prospective study participant's decisions to assume risks. My conversations with four men who participated in HIV cure studies confirmed the capacity of these people to make carefully considered decisions about risks and the sometimes substantial influence/sway of non-clinical benefits that may come from participation in cure-oriented research. Studies must undergo ethical and clinical review before proceeding, and not all participants of such studies will be able to weigh or understand risks and benefits as those profiled here. But respecting the self-agency of people living with HIV should be a goal in the design and conduct of cure research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A Growing Consensus for Change in Interpretation of Clinical Research Evidence.

PubMed

Wilkerson, Gary B; Denegar, Craig R

2018-03-01

  The paradigm of evidence-based practice (EBP) is well established among the health care professions, but perspectives on the best methods for acquiring, analyzing, appraising, and using research evidence are evolving.   The EBP paradigm has shifted away from a hierarchy of research-evidence quality to recognize that multiple research methods can yield evidence to guide clinicians and patients through a decision-making process. Whereas the "frequentist" approach to data interpretation through hypothesis testing has been the dominant analytical method used by and taught to athletic training students and scholars, this approach is not optimal for integrating evidence into routine clinical practice. Moreover, the dichotomy of rejecting, or failing to reject, a null hypothesis is inconsistent with the Bayesian-like clinical decision-making process that skilled health care providers intuitively use. We propose that data derived from multiple research methods can be best interpreted by reporting a credible lower limit that represents the smallest treatment effect at a specified level of certainty, which should be judged in relation to the smallest effect considered to be clinically meaningful. Such an approach can provide a quantifiable estimate of certainty that an individual patient needs follow-up attention to prevent an adverse outcome or that a meaningful level of therapeutic benefit will be derived from a given intervention.   The practice of athletic training will be influenced by the evolution of the EBP paradigm. Contemporary practice will require clinicians to expand their critical-appraisal skills to effectively integrate the results derived from clinical research into the care of individual patients. Proper interpretation of a credible lower limit value for a magnitude ratio has the potential to increase the likelihood of favorable patient outcomes, thereby advancing the practice of evidence-based athletic training.

Models based on value and probability in health improve shared decision making.

PubMed

Ortendahl, Monica

2008-10-01

Diagnostic reasoning and treatment decisions are a key competence of doctors. A model based on values and probability provides a conceptual framework for clinical judgments and decisions, and also facilitates the integration of clinical and biomedical knowledge into a diagnostic decision. Both value and probability are usually estimated values in clinical decision making. Therefore, model assumptions and parameter estimates should be continually assessed against data, and models should be revised accordingly. Introducing parameter estimates for both value and probability, which usually pertain in clinical work, gives the model labelled subjective expected utility. Estimated values and probabilities are involved sequentially for every step in the decision-making process. Introducing decision-analytic modelling gives a more complete picture of variables that influence the decisions carried out by the doctor and the patient. A model revised for perceived values and probabilities by both the doctor and the patient could be used as a tool for engaging in a mutual and shared decision-making process in clinical work.

Using Best Practices to Extract, Organize, and Reuse Embedded Decision Support Content Knowledge Rules from Mature Clinical Systems.

PubMed

DesAutels, Spencer J; Fox, Zachary E; Giuse, Dario A; Williams, Annette M; Kou, Qing-Hua; Weitkamp, Asli; Neal R, Patel; Bettinsoli Giuse, Nunzia

2016-01-01

Clinical decision support (CDS) knowledge, embedded over time in mature medical systems, presents an interesting and complex opportunity for information organization, maintenance, and reuse. To have a holistic view of all decision support requires an in-depth understanding of each clinical system as well as expert knowledge of the latest evidence. This approach to clinical decision support presents an opportunity to unify and externalize the knowledge within rules-based decision support. Driven by an institutional need to prioritize decision support content for migration to new clinical systems, the Center for Knowledge Management and Health Information Technology teams applied their unique expertise to extract content from individual systems, organize it through a single extensible schema, and present it for discovery and reuse through a newly created Clinical Support Knowledge Acquisition and Archival Tool (CS-KAAT). CS-KAAT can build and maintain the underlying knowledge infrastructure needed by clinical systems.

The use of emotional intelligence capabilities in clinical reasoning and decision-making: A qualitative, exploratory study.

PubMed

Hutchinson, Marie; Hurley, John; Kozlowski, Desirée; Whitehair, Leeann

2018-02-01

To explore clinical nurses' experiences of using emotional intelligence capabilities during clinical reasoning and decision-making. There has been little research exploring whether, or how, nurses employ emotional intelligence (EI) in clinical reasoning and decision-making. Qualitative phase of a larger mixed-methods study. Semistructured qualitative interviews with a purposive sample of registered nurses (n = 12) following EI training and coaching. Constructivist thematic analysis was employed to analyse the narrative transcripts. Three themes emerged: the sensibility to engage EI capabilities in clinical contexts, motivation to actively engage with emotions in clinical decision-making and incorporating emotional and technical perspectives in decision-making. Continuing to separate cognition and emotion in research, theorising and scholarship on clinical reasoning is counterproductive. Understanding more about nurses' use of EI has the potential to improve the calibre of decisions, and the safety and quality of care delivered. © 2017 John Wiley & Sons Ltd.

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

PubMed

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-05-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

THE GAP BETWEEN ECONOMIC EVALUATIONS AND CLINICAL PRACTICE: A SYSTEMATIC REVIEW OF ECONOMIC EVALUATIONS ON DABIGATRAN FOR ATRIAL FIBRILLATION.

PubMed

Rolden, Herbert J A; van der Wilt, Gert Jan; Maas, Angela H E M; Grutters, Janneke P C

2018-06-18

As model-based economic evaluations (MBEEs) are widely used to make decisions in the context of policy, it is imperative that they represent clinical practice. Here, we assess the relevance of MBEEs on dabigatran for the prevention of stroke in patients with atrial fibrillation (AF). We performed a systematic review on the basis of a developed questionnaire, tailored to oral anticoagulation in patients with AF. Included studies had a full body text in English, compared dabigatran with a vitamin K antagonist, were not dedicated to one or more subgroup(s), and yielded an incremental cost-effectiveness ratio. The relevance of all MBEEs was assessed on the basis of ten context-independent factors, which encompassed clinical outcomes and treatment duration. The MBEEs performed for the United States were assessed on the basis of seventeen context-dependent factors, which were related to the country's target population and clinical environment. The search yielded twenty-nine MBEEs, of which six were performed for the United States. On average, 54 percent of the context-independent factors were included per study, and 37 percent of the seventeen context-dependent factors in the U.S. The share of relevant factors per study did not increase over time. MBEEs on dabigatran leave out several relevant factors, limiting their usefulness to decision makers. We strongly urge health economic researchers to improve the relevance of their MBEEs by including context-independent relevance factors, and modeling context-dependent factors befitting the decision context concerned.

Reducing inpatient heritable thrombophilia testing using a clinical decision-making tool.

PubMed

Smith, Tyler W; Pi, David; Hudoba, Monika; Lee, Agnes Y Y

2014-04-01

To evaluate the impact of a clinical decision-making tool, designed to educate physicians regarding heritable thrombophilia (HT) testing, on the volume of testing in hospitalised patients in the tertiary care setting. We performed a retrospective cohort study over a 6-year period (2007-2012) at a single tertiary care centre intervention site and two regional control sites. In January 2010, the intervention site instituted a policy change whereby physicians ordering HT testing on inpatients needed to complete a pre-preprinted order (PPO) form that outlined the limitations of HT testing in the hospitalised setting. Failure to complete the PPO within 24 h resulted in test cancellation. Our main outcome measure was the volume of HT testing performed at the three study sites. Introduction of the PPO resulted in a 79.4% (95% CI 71.2% to 87.6%) reduction in factor V Leiden (FVL) testing at the intervention site. This decrease was significantly greater compared with those in the two control teaching hospitals over the same time periods (33.7% and 43.6%; both p<0.001). Reductions in FVL testing postintervention were observed among all ordering specialists. Similar postintervention reductions in testing volumes were observed for antithrombin (57.4%), protein C (61.9%) and protein S (62.2%) activity assays. In a large tertiary care hospital, the introduction of a clinical decision-making tool significantly reduced HT testing in inpatients across clinical specialties. The impact on patient outcome should be assessed in further studies.

Using virtual human technology to provide immediate feedback about participants' use of demographic cues and knowledge of their cue use.

PubMed

Wandner, Laura D; Letzen, Janelle E; Torres, Calia A; Lok, Benjamin; Robinson, Michael E

2014-11-01

Demographic characteristics have been found to influence pain management decisions, but limited focus has been placed on participants' reactions to feedback about their use of sex, race, or age to make these decisions. The present study aimed to examine the effects of providing feedback about the use of demographic cues to participants making pain management decisions. Participants (N = 107) viewed 32 virtual human patients with standardized levels of pain and provided ratings for virtual humans' pain intensity and their treatment decisions. Real-time lens model idiographic analyses determined participants' decision policies based on cues used. Participants were subsequently informed about cue use and completed feedback questions. Frequency analyses were conducted on responses to these questions. Between 7.4 and 89.4% of participants indicated awareness of their use of demographic or pain expression cues. Of those individuals, 26.9 to 55.5% believed this awareness would change their future clinical decisions, and 66.6 to 75.9% endorsed that their attitudes affect their imagined clinical practice. Between 66.6 and 79.1% of participants who used cues reported willingness to complete an online tutorial about pain across demographic groups. This study was novel because it provided participants feedback about their cue use. Most participants who used cues indicated willingness to participate in an online intervention, suggesting this technology's utility for modifying biases. This is the first study to make individuals aware of whether a virtual human's sex, race, or age influences their decision making. Findings suggest that a majority of the individuals who were made aware of their use of demographic cues would be willing to participate in an online intervention. Copyright © 2014 American Pain Society. Published by Elsevier Inc. All rights reserved.

Decision Trees Predicting Tumor Shrinkage for Head and Neck Cancer: Implications for Adaptive Radiotherapy.

PubMed

Surucu, Murat; Shah, Karan K; Mescioglu, Ibrahim; Roeske, John C; Small, William; Choi, Mehee; Emami, Bahman

2016-02-01

To develop decision trees predicting for tumor volume reduction in patients with head and neck (H&N) cancer using pretreatment clinical and pathological parameters. Forty-eight patients treated with definitive concurrent chemoradiotherapy for squamous cell carcinoma of the nasopharynx, oropharynx, oral cavity, or hypopharynx were retrospectively analyzed. These patients were rescanned at a median dose of 37.8 Gy and replanned to account for anatomical changes. The percentages of gross tumor volume (GTV) change from initial to rescan computed tomography (CT; %GTVΔ) were calculated. Two decision trees were generated to correlate %GTVΔ in primary and nodal volumes with 14 characteristics including age, gender, Karnofsky performance status (KPS), site, human papilloma virus (HPV) status, tumor grade, primary tumor growth pattern (endophytic/exophytic), tumor/nodal/group stages, chemotherapy regimen, and primary, nodal, and total GTV volumes in the initial CT scan. The C4.5 Decision Tree induction algorithm was implemented. The median %GTVΔ for primary, nodal, and total GTVs was 26.8%, 43.0%, and 31.2%, respectively. Type of chemotherapy, age, primary tumor growth pattern, site, KPS, and HPV status were the most predictive parameters for primary %GTVΔ decision tree, whereas for nodal %GTVΔ, KPS, site, age, primary tumor growth pattern, initial primary GTV, and total GTV volumes were predictive. Both decision trees had an accuracy of 88%. There can be significant changes in primary and nodal tumor volumes during the course of H&N chemoradiotherapy. Considering the proposed decision trees, radiation oncologists can select patients predicted to have high %GTVΔ, who would theoretically gain the most benefit from adaptive radiotherapy, in order to better use limited clinical resources. © The Author(s) 2015.

Who does the numbers? The role of third-party technology assessment to inform health systems' decision-making about the funding of health technologies.

PubMed

Barbieri, Marco; Hawkins, Neil; Sculpher, Mark

2009-01-01

There is an increasing number of health-care systems using economic evaluations to inform decisions about the reimbursement of health technologies. There are usually two separate elements of this process: assembling relevant evidence and undertaking analyses (technology assessment), and decision-making. In most systems, technology assessment is undertaken by the manufacturer of the technology. In a few, "third-party" assessment is used. In the United Kingdom, the National Institute for Health and Clinical Excellence used a combination of third-party and manufacturer assessments between 1999 and 2005. After this point, a Single Technology Appraisal program (using manufacturer-based assessment) was instituted for some technologies. Here the role of third-party assessment is considered in this from of decision-making. The article reviews the requirements of economic evaluation to support decision-making, and considers the extent to which each type of assessment is likely to meet these requirements. It also attempts to address whether the two forms of assessment differ in their impact on decision-making using a comparison of the decisions made by National Institute for Health and Clinical Excellence (NICE) (under its multiple-technology appraisal system) and the Scottish Medicines Consortium (SMC), which relies on manufacturer assessment. The comparison is limited by the small number of technologies considered by both bodies. Nevertheless, it suggests that there are potentially important differences between the two bodies, with NICE generally placing more restrictions of the use of technologies. The article concludes that there are potential advantages to third-party assessment, but its cost and timing may preclude its use for all new technologies. A hybrid arrangement is suggested where third-party assessment is used in particular circumstances.

Types of vicarious learning experienced by pre-dialysis patients.

PubMed

McCarthy, Kate; Sturt, Jackie; Adams, Ann

2015-01-01

Haemodialysis and peritoneal dialysis renal replacement treatment options are in clinical equipoise, although the cost of haemodialysis to the National Health Service is £16,411/patient/year greater than peritoneal dialysis. Treatment decision-making takes place during the pre-dialysis year when estimated glomerular filtration rate drops to between 15 and 30 mL/min/1.73 m(2). Renal disease can be familial, and the majority of patients have considerable health service experience when they approach these treatment decisions. Factors affecting patient treatment decisions are currently unknown. The objective of this article is to explore data from a wider study in specific relation to the types of vicarious learning experiences reported by pre-dialysis patients. A qualitative study utilised unstructured interviews and grounded theory analysis during the participant's pre-dialysis year. The interview cohort comprised 20 pre-dialysis participants between 24 and 80 years of age. Grounded theory design entailed thematic sampling and analysis, scrutinised by secondary coding and checked with participants. Participants were recruited from routine renal clinics at two local hospitals when their estimated glomerular filtration rate was between 15 and 30 mL/min/1.73 m(2). Vicarious learning that contributed to treatment decision-making fell into three main categories: planned vicarious leaning, unplanned vicarious learning and historical vicarious experiences. Exploration and acknowledgement of service users' prior vicarious learning, by healthcare professionals, is important in understanding its potential influences on individuals' treatment decision-making. This will enable healthcare professionals to challenge heuristic decisions based on limited information and to encourage analytic thought processes.

A survey of views and practice patterns of dialysis medical directors toward end-of-life decision making for patients with end-stage renal disease.

PubMed

Fung, Enrica; Slesnick, Nate; Kurella Tamura, Manjula; Schiller, Brigitte

2016-07-01

Patients with end-stage renal disease report infrequent end-of-life discussions, and nephrology trainees report feeling unprepared for end-of-life decision making, but the views of dialysis medical directors have not been studied. Our objective is to understand dialysis medical directors' views and practice patterns on end-of-life decision making for patients with ESRD. We administered questionnaires to dialysis medical directors during medical director meetings of three different dialysis organizations in 2013. Survey questions corresponded to recommendations from the Renal Physicians Association clinical practice guidelines on initiation and withdrawal of dialysis. There were 121 medical director respondents from 28 states. The majority of respondents felt "very prepared" (66%) or "somewhat prepared" (29%) to participate in end-of-life decisions and most (80%) endorsed a model of shared decision making. If asked to do so, 70% of the respondents provided prognostic information "often" or "nearly always." For patients with a poor prognosis, 36% of respondents would offer a time-limited trial of dialysis "often" or "nearly always", while 56% of respondents would suggest withdrawal from dialysis "often" or "nearly always" for those with a poor prognosis currently receiving dialysis therapy. Patient resistance and fear of taking away hope were the most commonly cited barriers to end-of-life discussions. Views and reported practice patterns of medical directors are consistent with clinical practice guidelines for end-of-life decision making for patients with end-stage renal disease but inconsistent with patient perceptions. © The Author(s) 2016.

Prosthodontic decision-making relating to dentitions with compromised molars: the perspective of Swedish General Dental Practitioners.

PubMed

Korduner, E-K; Collin Bagewitz, I; Vult von Steyern, P; Wolf, E

2016-12-01

The aim of this investigation was to study the clinical prosthodontic decision-making process relating to dentitions with compromised molars among Swedish general dental practitioners (GDPs). Eleven Swedish GDPs were purposively selected, and all agreed to participate. Then, in-depth, semi-structured interviews were conducted and covered treatment considerations concerning two authentic patient cases, initially with complete dental arches, and later, a final treatment based on a shortened dental arch (SDA) was discussed. The cases involved patients with compromised teeth situated mainly in the molar regions. One patient suffered from extensive caries and the other from severe periodontal disease. Qualitative content analysis was used to analyse the data. In the systematic analysis, two main categories were identified: holistic and functional approach. Among the interviewed GDPs, focus was put on patients' needs, background history and motivation for treatment as well as the preservation of molar support. Within the limitations of this study, the following can be concluded: keeping a dental arch with molars seems to be important to Swedish general dental practitioners. The SDA concept does not seem to have a substantial impact on the prosthodontic decision-making relating to dentitions with compromised molars. The dentist's experiences, as well as colleagues' or consulting specialist advice together with aetiological factors and the patient's individual situation, influence the decision-making more than the SDA concept. The conflicting results in the prosthetic decision-making process concerning the relevance of age and the need for molar support need further investigation, for example based on decisions made in the dentist's own clinical practice. © 2016 John Wiley & Sons Ltd.

The Limits of Informed Consent for an Overwhelmed Patient: Clinicians' Role in Protecting Patients and Preventing Overwhelm.

PubMed

Bester, Johan; Cole, Cristie M; Kodish, Eric

2016-09-01

In this paper, we examine the limits of informed consent with particular focus on ways in which various factors can overwhelm decision-making capacity. We introduce overwhelm as a phenomenon commonly experienced by patients in clinical settings and distinguish between emotional overwhelm and informational overload. We argue that in these situations, a clinician's primary duty is prevention of harm and suggest ways in which clinicians can discharge this obligation. To illustrate our argument, we consider the clinical application of genetic sequencing testing, which involves scientific and technical information that can compromise the understanding and decisional capacity of most patients. Finally, we consider and rebut objections that this could lead to paternalism. © 2016 American Medical Association. All Rights Reserved.

Percutaneous coronary intervention in patients with multi-vessel coronary artery disease: a focus on physiology.

PubMed

Cho, Yun-Kyeong; Nam, Chang-Wook

2018-03-21

Multi-vessel coronary artery disease (MVD) frequently features ambiguous or intermediate lesions that may be both serial and complex, suggesting that multiple regions require revascularization. Percutaneous coronary intervention (PCI) is associated with various challenges such as appropriate identification of lesions that should be treated, the choice of an optimum revascularization method, and limitations of long-term outcomes. Optimal patient selection and careful targeting of lesions are key when planning treatment. Physiology-guided decision-making (based on the fractional flow reserve) can overcome the current limitations of PCI used to treat MVD regardless of clinical presentation or disease subtype, as confirmed in recent clinical trials. Here, we review the use of physiology-guided PCI for patients with MVD, and their early and late outcomes.

When to trust our learners? Clinical teachers' perceptions of decision variables in the entrustment process.

PubMed

Duijn, Chantal C M A; Welink, Lisanne S; Bok, Harold G J; Ten Cate, Olle T J

2018-06-01

Clinical training programs increasingly use entrustable professional activities (EPAs) as focus of assessment. However, questions remain about which information should ground decisions to trust learners. This qualitative study aimed to identify decision variables in the workplace that clinical teachers find relevant in the elaboration of the entrustment decision processes. The findings can substantiate entrustment decision-making in the clinical workplace. Focus groups were conducted with medical and veterinary clinical teachers, using the structured consensus method of the Nominal Group Technique to generate decision variables. A ranking was made based on a relevance score assigned by the clinical teachers to the different decision variables. Field notes, audio recordings and flip chart lists were analyzed and subsequently translated and, as a form of axial coding, merged into one list, combining the decision variables that were similar in their meaning. A list of 11 and 17 decision variables were acknowledged as relevant by the medical and veterinary teacher groups, respectively. The focus groups yielded 21 unique decision variables that were considered relevant to inform readiness to perform a clinical task on a designated level of supervision. The decision variables consisted of skills, generic qualities, characteristics, previous performance or other information. We were able to group the decision variables into five categories: ability, humility, integrity, reliability and adequate exposure. To entrust a learner to perform a task at a specific level of supervision, a supervisor needs information to support such a judgement. This trust cannot be credited on a single case at a single moment of assessment, but requires different variables and multiple sources of information. This study provides an overview of decision variables giving evidence to justify the multifactorial process of making an entrustment decision.

Creating and synthesizing evidence with decision makers in mind: integrating evidence from clinical trials and other study designs.

PubMed

Atkins, David

2007-10-01

Randomized controlled trials (RCTs) remain the accepted "gold standard" for determining the efficacy of new drugs or medical procedures. Randomized trials alone, however, cannot provide all the relevant information decision makers need to determine the relative risks and benefits when choosing the best treatment of individual patients or weighing the implications of particular policies affecting medical therapies. To demonstrate the limitations of RCTs in providing the information needed by medical decision makers, and to show how information from observational studies can supplement evidence from RCTs. Qualitative description of the limitations of RCTs in providing the information needed by medical decision makers, and demonstration of how evidence from additional sources can aid in decision making, using the examples of deciding whether a 60-year-old woman with mildly elevated blood pressure should take daily low-dose aspirin, and whether a hospital network should implement carotid artery surgery for asymptomatic patients. Even the most rigorously designed RCTs leave many questions central to medical decision making unanswered. Research using cohort and case-control designs, disease and intervention registries, and outcomes studies based on administrative data can all shed light on who is most likely to benefit from the treatment, and what the important tradeoffs are. This suggests the need to revise the traditional evidence hierarchy, whereby evidence progresses linearly from basic research to rigorous RCTs. This revised hierarchy recognizes that other research designs can provide important evidence to strengthen our understanding of how to apply research findings in practice.

Evaluating clinical librarian services: a systematic review.

PubMed

Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

2011-03-01

  Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

Setting priorities in the health care sector - the case of oral anticoagulants in nonvalvular atrial fibrillation in Denmark.

PubMed

Poulsen, Peter Bo; Johnsen, Søren Paaske; Hansen, Morten Lock; Brandes, Axel; Husted, Steen; Harboe, Louise; Dybro, Lars

2017-01-01

Resources devoted to health care are limited, therefore setting priorities is required. It differs between countries whether decision-making concerning health care technologies focus on broad economic perspectives or whether focus is narrow on single budgets ("silo mentality"). The cost perspective as one part of the full health economic analysis is important for decision-making. With the case of oral anticoagulants in patients with nonvalvular atrial fibrillation (NVAF), the aim is to discuss the implication of the use of different cost perspectives for decision-making and priority setting. In a cost analysis, the annual average total costs of five oral anticoagulants (warfarin and non-vitamin K oral anticoagulants [NOACs; dabigatran, rivaroxaban, apixaban, and edoxaban]) used in daily clinical practice in Denmark for the prevention of stroke in NVAF patients are analyzed. This is done in pairwise comparisons between warfarin and each NOAC based on five potential cost perspectives, from a "drug cost only" perspective up to a "societal" perspective. All comparisons of warfarin and NOACs show that the cost perspective based on all relevant costs, ie, total costs perspective, is essential for the choice of therapy. Focusing on the reimbursement costs of the drugs only, warfarin is the least costly option. However, with the aim of therapy to prevent strokes and limit bleedings, including the economic impact of this, all NOACs, except rivaroxaban, result in slightly lower health care costs compared with warfarin. The same picture was found applying the societal perspective. Many broad cost-effectiveness analyses of NOACs exist. However, in countries with budget focus in decision-making this information does not apply. The present study's case of oral anticoagulants has shown that decision-making should be based on health care or societal cost perspectives for optimal use of limited resources. Otherwise, the risk is that suboptimal decisions will be likely.

A two-stage clinical decision support system for early recognition and stratification of patients with sepsis: an observational cohort study.

PubMed

Amland, Robert C; Lyons, Jason J; Greene, Tracy L; Haley, James M

2015-10-01

To examine the diagnostic accuracy of a two-stage clinical decision support system for early recognition and stratification of patients with sepsis. Observational cohort study employing a two-stage sepsis clinical decision support to recognise and stratify patients with sepsis. The stage one component was comprised of a cloud-based clinical decision support with 24/7 surveillance to detect patients at risk of sepsis. The cloud-based clinical decision support delivered notifications to the patients' designated nurse, who then electronically contacted a provider. The second stage component comprised a sepsis screening and stratification form integrated into the patient electronic health record, essentially an evidence-based decision aid, used by providers to assess patients at bedside. Urban, 284 acute bed community hospital in the USA; 16,000 hospitalisations annually. Data on 2620 adult patients were collected retrospectively in 2014 after the clinical decision support was implemented. 'Suspected infection' was the established gold standard to assess clinical decision support clinimetric performance. A sepsis alert activated on 417 (16%) of 2620 adult patients hospitalised. Applying 'suspected infection' as standard, the patient population characteristics showed 72% sensitivity and 73% positive predictive value. A postalert screening conducted by providers at bedside of 417 patients achieved 81% sensitivity and 94% positive predictive value. Providers documented against 89% patients with an alert activated by clinical decision support and completed 75% of bedside screening and stratification of patients with sepsis within one hour from notification. A clinical decision support binary alarm system with cross-checking functionality improves early recognition and facilitates stratification of patients with sepsis.

Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study.

PubMed

Stacey, Dawn; Vandemheen, Katherine L; Hennessey, Rosamund; Gooyers, Tracy; Gaudet, Ena; Mallick, Ranjeeta; Salgado, Josette; Freitag, Andreas; Berthiaume, Yves; Brown, Neil; Aaron, Shawn D

2015-02-07

The decision to have lung transplantation as treatment for end-stage lung disease from cystic fibrosis (CF) has benefits and serious risks. Although patient decision aids are effective interventions for helping patients reach a quality decision, little is known about implementing them in clinical practice. Our study evaluated a sustainable approach for implementing a patient decision aid for adults with CF considering referral for lung transplantation. A prospective pragmatic observational study was guided by the Knowledge-to-Action Framework. Healthcare professionals in all 23 Canadian CF clinics were eligible. We surveyed participants regarding perceived barriers and facilitators to patient decision aid use. Interventions tailored to address modifiable identified barriers included training, access to decision aids, and conference calls. The primary outcome was >80% use of the decision aid in year 2. Of 23 adult CF clinics, 18 participated (78.2%) and 13 had healthcare professionals attend training. Baseline barriers were healthcare professionals' inadequate knowledge for supporting patients making decisions (55%), clarifying patients' values for outcomes of options (58%), and helping patients handle conflicting views of others (71%). Other barriers were lack of time (52%) and needing to change how transplantation is discussed (42%). Baseline facilitators were healthcare professionals feeling comfortable discussing bad transplantation outcomes (74%), agreeing the decision aid would be easy to experiment with (71%) and use in the CF clinic (87%), and agreeing that using the decision aid would not require reorganization of the CF clinic (90%). After implementing the decision aid with interventions tailored to the barriers, decision aid use increased from 29% at baseline to 85% during year 1 and 92% in year 2 (p < 0.001). Compared to baseline, more healthcare professionals at the end of the study were confident in supporting decision-making (p = 0.03) but continued to feel inadequate ability with supporting patients to handle conflicting views (p = 0.01). Most Canadian CF clinics agreed to participate in the study. Interventions were used to target identified modifiable barriers to using the patient decision aid in routine CF clinical practice. CF clinics reported using it with almost all patients in the second year.

The role of observational investigations in comparative effectiveness research.

PubMed

Marko, Nicholas F; Weil, Robert J

2010-12-01

Comparative effectiveness research (CER) seeks to inform clinical decisions between alternate treatment strategies using data that reflects real patient populations and real-world clinical scenarios for the purpose of improving patient outcomes. There are multiple clinical situations where the unique characteristics of observational investigations can inform medical decision-making within the CER paradigm. Accordingly, it is critical for clinicians to appreciate the strengths and limitations of observational research, particularly as they apply to CER. This review focuses on the role of observational research in CER. We discuss the concept of evidence hierarchies as they relate to observational research and CER, review the scope and nature of observational research, present the rationale for its inclusion in CER investigations, discuss potential sources of bias in observational investigations as well as strategies used to compensate for these biases, and discuss a framework to implement observational research in CER. The CER paradigm recognizes the limitations of hierarchical models of evidence and favors application of a strength-of-evidence model. In this model, observational research fills gaps in randomized clinical trial data and is particularly valuable to investigate effectiveness, harms, prognosis, and infrequent outcomes as well as in circumstances where randomization is not possible and in studies of many surgical populations. Observational investigations must be designed with careful consideration of potential sources of bias and must incorporate strategies to control such bias prospectively, and their results must be reported in a uniform and transparent fashion. When these conditions can be achieved, observational research represents a valuable and critical component of modern CER. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Mastitis therapy and antimicrobial susceptibility: a multispecies review with a focus on antibiotic treatment of mastitis in dairy cattle.

PubMed

Barlow, John

2011-12-01

Mastitis occurs in numerous species. Antimicrobial agents are used for treatment of infectious mastitis in dairy cattle, other livestock, companion animals, and humans. Mastitis is an economically important disease of dairy cattle and most mastitis research has focused on epidemiology and control of bovine mastitis. Antibiotic treatment of clinical and subclinical mastitis in dairy cattle is an established component of mastitis control programs. Research on the treatment of clinical and subclinical mastitis in other dairy species such as sheep and goats has been less frequent, although the general principles of mastitis therapy in small ruminants are similar to those of dairy cattle. Research on treatment of clinical mastitis in humans is limited and as for other species empirical treatment of mastitis appears to be common. While antimicrobial susceptibility testing is recommended to direct treatment decisions in many clinical settings, the use of susceptibility testing for antibiotic selection for mastitis treatments of dairy cattle has been challenged in a number of publications. The principle objective of this review is to summarize the literature evaluating the question, "Does antimicrobial susceptibility predict treatment outcome for intramammary infections caused by common bacterial pathogens?" This review also addresses current issues related to antimicrobial use and treatment decisions for mastitis in dairy cattle. Information on treatment of mastitis in other species, including humans, is included although research appears to be limited. Issues related to study design, gaps in current knowledge and opportunities for future research are identified for bovine mastitis therapy.

The Roles of Social Stress and Decision-Making in Non-Suicidal Self-Injury

PubMed Central

Schatten, Heather T.; Armey, Michael F.; Andover, Margaret S.

2015-01-01

Research suggests that individuals with a history of non-suicidal self-injury (NSSI) do not have difficulty generating alternatives to social problems but choose more negative solutions, suggesting a deficit in decision-making. However, studies report no significant differences in risky decision-making on a performance-based task among individuals with and without NSSI histories. A limitation of these studies is that decision-making was only assessed at baseline. As individuals with a history of NSSI typically self-injure when experiencing negative emotions, decision-making ability may become impaired specifically in the presence of these emotions. The aim of the current study was to investigate decision-making ability among individuals with and without NSSI histories both at baseline and following a distressing social exclusion task. We compared individuals with (n = 48) and without (n = 72) NSSI histories on the Iowa Gambling Task, a behavioral measure of risky decision-making, before and after exclusion or inclusion on the Cyberball task. Results indicated no significant group differences in performance regardless of condition. When participants were grouped by racial/ethnic minority status, results indicated that non-Hispanic White individuals with a history of NSSI exhibited deterioration in risky decision-making ability following social exclusion. Potential explanations for these findings and clinical implications are discussed. PMID:26260569

Clinical decision-making among new graduate nurses attending residency programs in Saudi Arabia.

PubMed

Al-Dossary, Reem Nassar; Kitsantas, Panagiota; Maddox, P J

2016-02-01

This study examined the impact of residency programs on clinical decision-making of new Saudi graduate nurses who completed a residency program compared to new Saudi graduate nurses who did not participate in residency programs. This descriptive study employed a convenience sample (N=98) of new graduate nurses from three hospitals in Saudi Arabia. A self-administered questionnaire was used to collect data. Clinical decision-making skills were measured using the Clinical Decision Making in Nursing Scale. Descriptive statistics, independent t-tests, and multiple linear regression analysis were utilized to examine the effect of residency programs on new graduate nurses' clinical decision-making skills. On average, resident nurses had significantly higher levels of clinical decision-making skills than non-residents (t=23.25, p=0.000). Enrollment in a residency program explained 86.9% of the variance in total clinical decision making controlling for age and overall grade point average. The findings of this study support evidence in the nursing literature conducted primarily in the US and Europe that residency programs have a positive influence on new graduate nurses' clinical decision-making skills. This is the first study to examine the impact of residency programs on clinical decision-making among new Saudi graduate nurses who completed a residency program. The findings of this study underscore the need for the development and implementation of residency programs for all new nurses. Copyright © 2015 Elsevier Inc. All rights reserved.

The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

PubMed

Homedes, Núria; Ugalde, Antonio

2015-06-01

To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Pain Assessment and Treatment Disparities: A Virtual Human Technology Investigation

PubMed Central

Hirsh, Adam T.; George, Steven Z.; Robinson, Michael E.

2009-01-01

Pain assessment and treatment is influenced by patient demographic characteristics and nonverbal expressions. Methodological challenges have limited the empirical investigation of these issues. The current analogue study employed an innovative research design and novel virtual human (VH) technology to investigate disparities in pain-related clinical decision making. Fifty-four nurses viewed vignettes consisting of a video clip of the VH patient and clinical summary information describing a post-surgical context. Participants made assessment (pain intensity and unpleasantness) and treatment (non-opioid and opioid medications) decisions on computerized visual analogue scales. VH demographic cues of sex, race, and age, as well as facial expression of pain, were systematically manipulated and hypothesized to influence decision ratings. Idiographic and nomothetic statistical analyses were conducted to test these hypotheses. Idiographic results indicated that sex, race, age, and pain expression cues accounted for significant, unique variance in decision policies among many nurses. Pain expression was the most salient cue in this context. Nomothetic results indicated differences within VH cues of interest; the size and consistency of these differences varied across policy domains. This study demonstrates the application of VH technology and lens model methodology to the study of disparities in pain-related decision making. Assessment and treatment of acute post-surgical pain often varies based on VH demographic and facial expression cues. These data contribute to the existing literature on disparities in pain practice and highlight the potential of a novel approach that may serve as a model for future investigation of these critical issues. PMID:19269742

Pain assessment and treatment disparities: a virtual human technology investigation.

PubMed

Hirsh, Adam T; George, Steven Z; Robinson, Michael E

2009-05-01

Pain assessment and treatment is influenced by patient demographic characteristics and nonverbal expressions. Methodological challenges have limited the empirical investigation of these issues. The current analogue study employed an innovative research design and novel virtual human (VH) technology to investigate disparities in pain-related clinical decision-making. Fifty-four nurses viewed vignettes consisting of a video clip of the VH patient and clinical summary information describing a post-surgical context. Participants made assessment (pain intensity and unpleasantness) and treatment (non-opioid and opioid medications) decisions on computerized visual analogue scales. VH demographic cues of sex, race, and age, as well as facial expression of pain, were systematically manipulated and hypothesized to influence decision ratings. Idiographic and nomothetic statistical analyses were conducted to test these hypotheses. Idiographic results indicated that sex, race, age, and pain expression cues accounted for significant, unique variance in decision policies among many nurses. Pain expression was the most salient cue in this context. Nomothetic results indicated differences within VH cues of interest; the size and consistency of these differences varied across policy domains. This study demonstrates the application of VH technology and lens model methodology to the study of disparities in pain-related decision-making. Assessment and treatment of acute post-surgical pain often varies based on VH demographic and facial expression cues. These data contribute to the existing literature on disparities in pain practice and highlight the potential of a novel approach that may serve as a model for future investigation of these critical issues.

The process of decision-making in home-care case management: implications for the introduction of universal assessment and information technology.

PubMed

Egan, Mary; Wells, Jennie; Byrne, Kerry; Jaglal, Susan; Stolee, Paul; Chesworth, Bert M; Hillier, Loretta M

2009-07-01

Increasingly, jurisdictions are adopting universal assessment procedures and information technology to aid in healthcare data collection and care planning. Before their potential can be realised, a better understanding is needed of how these systems can best be used to support clinical practice. We investigated the decision-making process and information needs of home-care case managers in Ontario, Canada, prior to the widespread use of universal assessment, with a view of determining how universal assessment and information technology could best support this work. Three focus groups and two individual interviews were conducted; questioning focused on decision-making in the post-acute care of individuals recovering from a hip fracture. We found that case managers' decisional process was one of a clinician-broker, combining clinical expertise and information about local services to support patient goals within the context of limited resources. This process represented expert decision-making, and the case managers valued their ability to carry out non-standardised interviews and override system directives when they noted that data may be misleading. Clear information needs were found in four areas: services available outside of their regions, patient medical information, patient pre-morbid functional status and partner/spouse health and functional status. Implications for the use of universal assessment are discussed. Recommendations are made for further research to determine the impact of universal assessment and information technology on the process and outcome of home-care case manager decision-making.

Interoceptive Awareness, Positive Affect, and Decision Making in Major Depressive Disorder

PubMed Central

Furman, Daniella J.; Waugh, Christian E.; Bhattacharjee, Kalpa; Thompson, Renee J.; Gotlib, Ian H.

2013-01-01

Background Little work has examined the relation between interoceptive awareness and symptoms of Major Depressive Disorder (MDD). Existing research suggests that depressed individuals exhibit impaired heartbeat perception, though the results of this research have been equivocal. Importantly, depressed participants in these studies have had comorbid anxiety disorders, making it difficult to draw inferences about interoceptive awareness in MDD. The current study addresses this issue by assessing heartbeat perception in depressed women without current anxiety disorders and exploring the relation between interoception and perturbations in both affective intensity and decision making, components of MDD postulated to be related to bodily awareness. Methods Depressed women without concurrent anxiety disorders (n=25) and never-disordered controls (n=36) performed a heartbeat perception task. Participants completed the self-report Affect Intensity Measure (AIM), and decision-making difficulty was assessed in MDD participants using the Structured Clinical Interview for DSM-IV. Results Depressed women exhibited poorer heartbeat perception accuracy than did control participants. Impaired accuracy in MDD participants was associated with reduced positive affectivity and difficulty in decision making. Limitations Our sample was composed exclusively of females and was heterogeneous with respect to treatment status, thereby limiting our ability to generalize results to depressed males and to exclude the contribution of exogenous factors to the observed group differences. Conclusions Results of this study suggest that for depressed individuals without anxiety comorbidities, disrupted perception of bodily responses reduces both the experience of positive arousal and the ability to use interoceptive feedback to inform decision making. PMID:23972662

Clinical Diagnosis of Dental Caries in the 21st Century: Introductory Paper - ORCA Saturday Afternoon Symposium, 2016.

PubMed

Machiulskiene, Vita; Carvalho, Joana Christina

2018-03-05

Classifications employed to measure dental caries should first of all reflect the dynamics of the disease, in order to provide a solid basis for subsequent treatment decisions and for further monitoring of dental health of individual patients and populations. The contemporary philosophy of dental caries management implies that nonoperative treatment of caries lesions should be implemented whenever possible, limiting operative interventions to the severe and irreversible cases. The ORCA Saturday Afternoon Symposium 2016, held back-to-back to the 63rd ORCA Congress in Athens, Greece, was intended to provide an update on general requirements for clinical caries diagnosis and to overview caries diagnostic classifications including their rationale, validation, advantages, and limitations. Clinical caries diagnostic criteria and caries management outcomes are interrelated, and any diagnostic classification disregarding this concept is outdated, according to the current understanding of oral health care. Choosing clinical caries diagnostic classifications that assess the activity status of detected lesions should be a priority for dental professionals since these classifications favor the best clinical practice directed towards nonoperative interventions. The choice of clinical caries diagnostic classifications in research, in clinical practice, and in public health services should be guided by the best available scientific evidence. The clinical caries diagnostic classifications should be universally applicable in all these fields. Policy making in oral health care and the underlying policy analyses should follow the same standards. Any clinical caries diagnostic classification disregarding the universality of its use is of limited or no interest in the context of the clinical caries diagnosis of today. © 2018 S. Karger AG, Basel.

Evaluating the MEDLINE Core Clinical Journals filter: data-driven evidence assessing clinical utility.

PubMed

Klein-Fedyshin, Michele; Ketchum, Andrea M; Arnold, Robert M; Fedyshin, Peter J

2014-12-01

MEDLINE offers the Core Clinical Journals filter to limit to clinically useful journals. To determine its effectiveness for searching and patient-centric decision making, this study compared literature used for Morning Report in Internal Medicine with journals in the filter. An EndNote library with references answering 327 patient-related questions during Morning Report from 2007 to 2012 was exported to a file listing variables including designated Core Clinical Journal, Impact Factor, date used and medical subject. Bradford's law of scattering was applied ranking the journals and reflecting their clinical utility. Recall (sensitivity) and precision of the Core Morning Report journals and non-Core set was calculated. This study applied bibliometrics to compare the 628 articles used against these criteria to determine journals impacting decision making. Analysis shows 30% of clinically used articles are from the Core Clinical Journals filter and 16% of the journals represented are Core titles. When Bradford-ranked, 55% of the top 20 journals are Core. Articles <5 years old furnish 63% of sources used. Among the 63 Morning Report subjects, 55 have <50% precision and 41 have <50% recall including 37 subjects with 0% precision and 0% recall. Low usage of publications within the Core Clinical Journals filter indicates less relevance for hospital-based care. The divergence from high-impact medicine titles suggests clinically valuable journals differ from academically important titles. With few subjects demonstrating high recall or precision, the MEDLINE Core Clinical Journals filter may require a review and update to better align with current clinical needs. © 2014 John Wiley & Sons, Ltd.

Development, implementation and evaluation of an evidence-based program for introduction of new health technologies and clinical practices in a local healthcare setting.

PubMed

Harris, Claire; Garrubba, Marie; Allen, Kelly; King, Richard; Kelly, Cate; Thiagarajan, Malar; Castleman, Beverley; Ramsey, Wayne; Farjou, Dina

2015-12-28

This paper reports the process of establishing a transparent, accountable, evidence-based program for introduction of new technologies and clinical practices (TCPs) in a large Australian healthcare network. Many countries have robust evidence-based processes for assessment of new TCPs at national level. However many decisions are made by local health services where the resources and expertise to undertake health technology assessment (HTA) are limited and a lack of structure, process and transparency has been reported. An evidence-based model for process change was used to establish the program. Evidence from research and local data, experience of health service staff and consumer perspectives were incorporated at each of four steps: identifying the need for change, developing a proposal, implementation and evaluation. Checklists assessing characteristics of success, factors for sustainability and barriers and enablers were applied and implementation strategies were based on these findings. Quantitative and qualitative methods were used for process and outcome evaluation. An action research approach underpinned ongoing refinement to systems, processes and resources. A Best Practice Guide developed from the literature and stakeholder consultation identified seven program components: Governance, Decision-Making, Application Process, Monitoring and Reporting, Resources, Administration, and Evaluation and Quality Improvement. The aims of transparency and accountability were achieved. The processes are explicit, decisions published, outcomes recorded and activities reported. The aim of ascertaining rigorous evidence-based information for decision-making was not achieved in all cases. Applicants proposing new TCPs provided the evidence from research literature and local data however the information was often incorrect or inadequate, overestimating benefits and underestimating costs. Due to these limitations the initial application process was replaced by an Expression of Interest from applicants followed by a rigorous HTA by independent in-house experts. The program is generalisable to most health care organisations. With one exception, the components would be achievable with minimal additional resources; the lack of skills and resources required for HTA will limit effective application in many settings. A toolkit containing details of the processes and sample materials is provided to facilitate replication or local adaptation by those wishing to establish a similar program.

Machine Learning and Decision Support in Critical Care

PubMed Central

Johnson, Alistair E. W.; Ghassemi, Mohammad M.; Nemati, Shamim; Niehaus, Katherine E.; Clifton, David A.; Clifford, Gari D.

2016-01-01

Clinical data management systems typically provide caregiver teams with useful information, derived from large, sometimes highly heterogeneous, data sources that are often changing dynamically. Over the last decade there has been a significant surge in interest in using these data sources, from simply re-using the standard clinical databases for event prediction or decision support, to including dynamic and patient-specific information into clinical monitoring and prediction problems. However, in most cases, commercial clinical databases have been designed to document clinical activity for reporting, liability and billing reasons, rather than for developing new algorithms. With increasing excitement surrounding “secondary use of medical records” and “Big Data” analytics, it is important to understand the limitations of current databases and what needs to change in order to enter an era of “precision medicine.” This review article covers many of the issues involved in the collection and preprocessing of critical care data. The three challenges in critical care are considered: compartmentalization, corruption, and complexity. A range of applications addressing these issues are covered, including the modernization of static acuity scoring; on-line patient tracking; personalized prediction and risk assessment; artifact detection; state estimation; and incorporation of multimodal data sources such as genomic and free text data. PMID:27765959

A review of the literature: midwifery decision-making and birth.

PubMed

Jefford, Elaine; Fahy, Kathleen; Sundin, Deborah

2010-12-01

Clinical decision-making was initially studied in medicine where hypothetico-deductive reasoning is the model for decision-making. The nursing perspective on clinical decision-making has largely been shaped by Patricia Benner's ground breaking work. Benner claimed expert nurses use humanistic-intuitive ways of making clinical decisions rather than the 'rational reasoning' as claimed by medicine. Clinical decision-making in midwifery is not the same as either nursing or medical decision-making because of the woman-midwife partnership where the woman is the ultimate decision-maker. CINHAL, Medline and Cochrane databases were systematically searched using key words derived from the guiding question. A review of the decision-making research literature in midwifery was undertaken where studies were published in English. The selection criteria for papers were: only research papers of direct relevance to the guiding research question were included in the review. Decision-making is under-researched in midwifery and more specifically birth, as only 4 research articles met the inclusion criteria in this review. Three of the studies involved qualified midwives, and one involved student midwives. Two studies were undertaken in England, one in Scotland and one in Sweden. The major findings synthesised from this review, are that; (1) midwifery decision-making during birth is socially negotiated involving hierarchies of surveillance and control; (2) the role of the woman in shared decision-making during birth has not been explored by midwifery research; (3) clinical decision-making encompasses clinical reasoning as essential but not sufficient for midwives to actually implement their preferred decision. We argue that existing research does not inform the discipline of the complexity of midwifery clinical decision-making during birth. A well-designed study would involve investigating the clinical reasoning skills of the midwife, her relationship with the woman, the context of the particular birthing unit and the employment status of the midwife. The role of the woman as decision-maker in her own care during birth also needs careful research attention. Copyright © 2010 Australian College of Midwives. All rights reserved.

Effects of Clinical Decision Topic on Patients' Involvement in and Satisfaction With Decisions and Their Subsequent Implementation.

PubMed

Freidl, Marion; Pesola, Francesca; Konrad, Jana; Puschner, Bernd; Kovacs, Attila Istvan; De Rosa, Corrado; Fiorillo, Andrea; Krogsgaard Bording, Malene; Kawohl, Wolfram; Rössler, Wulf; Nagy, Marietta; Munk-Jørgensen, Povl; Slade, Mike

2016-06-01

Clinical decision making is an important aspect of mental health care. Predictors of how patients experience decision making and whether decisions are implemented are underresearched. This study investigated the relationship between decision topic and involvement in the decision, satisfaction with it, and its subsequent implementation from both staff and patient perspectives. As part of the Clinical Decision Making and Outcome in Routine Care for People With Severe Mental Illness study, patients (N=588) and their providers (N=213) were recruited from community-based mental health services in six European countries. Both completed bimonthly assessments for one year using the Clinical Decision Making in Routine Care Scale to assess the decision topic and implementation; both also completed the Clinical Decision Making Involvement and Satisfaction Scale. Three categories of decision topics were determined: treatment (most frequently cited), social, and financial. The topic identified as most important remained stable over the follow-up. Patients were more likely to rate their involvement as active rather than passive for social decisions (odds ratio [OR]=5.7, p<.001) and financial decisions (OR=9.5, p<.001). They were more likely to report higher levels of satisfaction rather than lower levels for social decisions (OR=1.5, p=.01) and financial decisions (OR=1.7, p=.01). Social decisions were more likely to be partly implemented (OR=3.0, p<.001) or fully implemented (OR=1.7, p=.03) than not implemented. Patients reported poorer involvement, satisfaction, and implementation in regard to treatment-related decisions, compared with social and financial decisions. Clinicians may need to employ different interactional styles for different types of decisions to maximize satisfaction and decision implementation.

Palliative sedation for intolerable suffering.

PubMed

Maltoni, Marco; Scarpi, Emanuela; Nanni, Oriana

2014-07-01

The purpose of this review is to provide an update on palliative sedation in palliative and end-of-life care. Palliative sedation is the medical procedure used to deal with refractory symptoms in advanced cancer patients when all other specific approaches have failed. Palliative sedation, in the strictest sense of the term, is a proportionate (proportionate palliative sedation, PPS) and intrinsically variable procedure used on an individual basis to relieve refractory symptoms in terminally ill patients, without the intention of hastening death. Completely separate from any other end-of-life decision and not intended to hasten death, palliative sedation has been shown not to have a detrimental impact on survival. To maintain palliative sedation as a legitimate clinical procedure from any ethical or clinical point of view, it must be limited to the restricted area for which it was conceived, that is, relief from refractory suffering as deemed necessary by a patient and by an experienced palliative care team. In this way, there is no risk of associating palliative sedation with other end-of-life decisions. Close collaboration is needed between oncologists and palliative care physicians for this clinical procedure.

Leiomyosarcoma: Principles of management.

PubMed

Martin-Liberal, Juan

2013-11-01

The term soft-tissue sarcomas (STS) embraces more than 50 different sub-types that are often associated with poor prognosis. Only a very limited number of agents are active against STS. Doxorubicin and ifosfamide are widely accepted as the most effective compounds. However, their low response rates and poor impact on the overall survival of the patients illustrate the need for new treatment options. Among them, leiomyosarcomas are one of the most frequently occurring subtypes. In spite of the relatively high incidence of leiomyosarcomas, the overall effectiveness of the currently available systemic treatments is still poor. The heterogeneity of its biological origin, clinical behavior and responsiveness to chemotherapy, together with the scarcity of successful clinical trials, makes the treatment of leiomyosarcoma especially challenging. In addition, the evidence-based treatment for leiomyosarcoma comes from trials in which, in the majority of cases, no distinctions have been made among the different STS sub-types. As a result, every therapeutic decision should be made on an individual basis in collaboration with the patient. The results of new specific histology-designed clinical trials should aid decision making in this complex field.

An integrated, ethically driven environmental model of clinical decision making in emergency settings.

PubMed

Wolf, Lisa

2013-02-01

To explore the relationship between multiple variables within a model of critical thinking and moral reasoning. A quantitative descriptive correlational design using a purposive sample of 200 emergency nurses. Measured variables were accuracy in clinical decision-making, moral reasoning, perceived care environment, and demographics. Analysis was by bivariate correlation using Pearson's product-moment correlation coefficients, chi square and multiple linear regression analysis. The elements as identified in the integrated ethically-driven environmental model of clinical decision-making (IEDEM-CD) corrected depict moral reasoning and environment of care as factors significantly affecting accuracy in decision-making. The integrated, ethically driven environmental model of clinical decision making is a framework useful for predicting clinical decision making accuracy for emergency nurses in practice, with further implications in education, research and policy. A diagnostic and therapeutic framework for identifying and remediating individual and environmental challenges to accurate clinical decision making. © 2012, The Author. International Journal of Nursing Knowledge © 2012, NANDA International.

A MDMP for All Seasons: Modifying the MDMP for Success

DTIC Science & Technology

2004-05-26

4 Rational Decision - Making Theory ............................................................................. 5 Limited Rationality ... making instead of using the MDMP, which is an analytical decision - making process. Limited rationality and analytical decision - making will be discussed...limited rationality decision - making theories. FM 5.0 defines fundamentals of planning, such as commander’s involvement and developing creative plans

Barriers and Facilitators to Initiating and Completing Time-Limited Trials in Critical Care.

PubMed

Bruce, Courtenay R; Liang, Cecilia; Blumenthal-Barby, Jennifer S; Zimmerman, Janice; Downey, Andrea; Pham, Linda; Theriot, Lisette; Delgado, Estevan D; White, Douglas

2015-12-01

A time-limited trial is an agreement between clinicians and patients or surrogate decision makers to use medical therapies over a defined period of time to see if the patient improves or deteriorates according to agreed-upon clinical milestones. Although time-limited trials are broadly advocated, there is little empirical evidence of the benefits and risks of time-limited trials, when they are initiated, when and why they succeed or fail, and what facilitates completion of them. Our study objectives were to 1) identify the purposes for which clinicians use time-limited trials and 2) identify barriers and facilitators to initiating and completing time-limited trials. Semistructured interviews: We analyzed interviews using qualitative description with constant comparative techniques. Nine hundred-bed, academic, tertiary hospital in Houston, Texas. Interviewees were from open medical, surgical, neurosurgical, and cardiovascular ICUs. Thirty healthcare professionals were interviewed (nine surgeons, 16 intensivists, three nurse practitioners, and two "other" clinicians). None. Interviewees reported initiating time-limited trials for three different purposes: to prepare surrogates and clinicians for discussion and possible shifts toward comfort-care only therapies, build consensus, and refine prognostic information. The main barriers to initiating time-limited trials involve clinicians' or surrogate decision makers' disagreement on setting a time limit. Barriers to completing time-limited trials include 1) requesting more time; 2) communication breakdowns because of rotating call schedules; and 3) changes in clinical course. Finally, facilitators to completing time-limited trials include 1) having defined goals about what could be achieved during an ICU stay, either framed in narrow, numeric terms or broad goals focusing on achievable activities of daily living; 2) applying time-limited trials in certain types of cases; and 3) taking ownership to ensure completion of the trial. An understanding of barriers and facilitators to initiating and completing time-limited trials is an essential first step toward appropriate utilization of time-limited trials in the ICUs, as well as developing educational or communication interventions with clinicians to facilitate time-limited trial use. We provide practical suggestions on patient populations in whom time-limited trials may be successful, the setting, and clinicians likely to benefit from educational interventions, allowing clinicians to have a fuller sense of when and how to use time-limited trials.

[Parameter of evidence-based medicine in health care economics].

PubMed

Wasem, J; Siebert, U

1999-08-01

In the view of scarcity of resources, economic evaluations in health care, in which not only effects but also costs related to a medical intervention are examined and a incremental cost-outcome-ratio is build, are an important supplement to the program of evidence based medicine. Outcomes of a medical intervention can be measured by clinical effectiveness, quality-adjusted life years, and monetary evaluation of benefits. As far as costs are concerned, direct medical costs, direct non-medical costs and indirect costs have to be considered in an economic evaluation. Data can be used from primary studies or secondary analysis; metaanalysis for synthesizing of data may be adequate. For calculation of incremental cost-benefit-ratios, models of decision analysis (decision tree models, Markov-models) often are necessary. Methodological and ethical limits for application of the results of economic evaluation in resource allocation decision in health care have to be regarded: Economic evaluations and the calculation of cost-outcome-rations should only support decision making but cannot replace it.

Clinical decision-making of rural novice nurses.

PubMed

Seright, T J

2011-01-01

Nurses in rural settings are often the first to assess and interpret the patient's clinical presentations. Therefore, an understanding of how nurses experience decision-making is important in terms of educational preparation, resource allocation to rural areas, institutional cultures, and patient outcomes. Theory development was based on the in-depth investigation of 12 novice nurses practicing in rural critical access hospitals in a north central state. This grounded theory study consisted of face-to-face interviews with 12 registered nurses, nine of whom were observed during their work day. The participants were interviewed a second time, as a method of member checking, and during this interview they reviewed their transcripts, the emerging themes and categories. Directors of nursing from both the research sites and rural hospitals not involved in the study, experienced researchers, and nurse educators facilitated triangulation of the findings. 'Sociocentric rationalizing' emerged as the central phenomenon and referred to the sense of belonging and agency which impacted the decision-making in this small group of novice nurses in rural critical access hospitals. The observed consequences, which were conceptualized during the axial coding process and were derived from observations and interviews of the 12 novice nurses in this study include: (1) gathering information before making a decision included assessment of: the credibility of co-workers, patients' subjective and objective data, and one's own past and current experiences; (2) conferring with co-workers as a direct method of confirming/denying decisions being made was considered more realistic and expedient than policy books and decision trees; (3) rural practicum clinical experiences, along with support after orientation, provide for transition to the rural nurse role; (4) involved directors of nursing served as both models and protectors of novice nurses placed in high accountability positions early in their careers. These novice nurses were often working with a limited staff, while managing an ever-changing census and acuity of patients. The significance of interdependence and welcoming relationships with their co-workers and directors of nursing was pivotal in the clinical decision-making process. Despite access to a number of resources at their disposal (including policy books, decision trees, standing orders, textbooks, and in some cases internet resources), the 12 nurses in this study indicated collaboration with co-workers was a major means of facilitating their decision-making. Rural novice nurses require facilitation of social skills as much as critical thinking skills both within their programs of nursing and during their new employee orientation; however, decision-making must be guided by more experienced nurses who are willing to mentor novice nurses and advise them to to reflect upon their decisions as they care for patients using evidenced based practice. In a rural setting, this is especially important because novice nurses are tasked early in their career with decision-making, which often involves ill-structured problems set in dynamic and changing environments, in high-stakes situations where patient safety is a concern.

Deciding in the dark: advance directives and continuation of treatment in chronic critical illness.

PubMed

Camhi, Sharon L; Mercado, Alice F; Morrison, R Sean; Du, Qingling; Platt, David M; August, Gary I; Nelson, Judith E

2009-03-01

Chronic critical illness is a devastating syndrome for which treatment offers limited clinical benefit but imposes heavy burdens on patients, families, clinicians, and the health care system. We studied the availability of advance directives and appropriate surrogates to guide decisions about life-sustaining treatment for the chronically critically ill and the extent and timing of treatment limitation. Prospective cohort study. Respiratory Care Unit (RCU) in a large, tertiary, urban, university-affiliated, hospital. Two hundred three chronically critically ill adults transferred to RCU after tracheotomy for failure to wean from mechanical ventilation in the intensive care unit. None. We interviewed RCU caregivers and reviewed patient records to identify proxy appointments, living wills, or oral statements of treatment preferences, resuscitation directives, and withholding/withdrawal of mechanical ventilation, nutrition, hydration, renal replacement and vasopressors. Forty-three of 203 patients (21.2%) appointed a proxy and 33 (16.2%) expressed preferences in advance directives. Do not resuscitate directives were given for 71 patients (35.0%). Treatment was limited for 39 patients (19.2%). Variables significantly associated with treatment limitation were proxy appointment prior to study entry (time of tracheotomy/RCU transfer) (odds ratio = 6.7, 95% confidence interval [CI], 2.3-20.0, p = 0.0006) and palliative care consultation in the RCU (OR = 40.9, 95% CI, 13.1-127.4, p < 0.0001). Median (interquartile range) time to first treatment limitation was 39 (31.0-45.0) days after hospital admission and 13 (8.0-29.0) days after RCU admission. For patients dying after treatment limitation, median time from first limitation to death ranged from 3 days for mechanical ventilation and hydration to 7 days for renal replacement. Most chronically critically ill patients fail to designate a surrogate decision-maker or express preferences regarding life-sustaining treatments. Despite burdensome symptoms and poor outcomes, limitation of such treatments was rare and occurred late, when patients were near death. Opportunities exist to improve communication and decision-making in chronic critical illness.

The prompted optional randomization trial: a new design for comparative effectiveness research.

PubMed

Flory, James; Karlawish, Jason

2012-12-01

Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.

2018 International Olympic Committee consensus statement on prevention, diagnosis and management of paediatric anterior cruciate ligament (ACL) injuries.

PubMed

Ardern, Clare L; Ekås, Guri Ranum; Grindem, Hege; Moksnes, Håvard; Anderson, Allen F; Chotel, Franck; Cohen, Moises; Forssblad, Magnus; Ganley, Theodore J; Feller, Julian A; Karlsson, Jón; Kocher, Minider S; LaPrade, Robert F; McNamee, Michael; Mandelbaum, Bert; Micheli, Lyle; Mohtadi, Nicholas; Reider, Bruce; Roe, Justin; Seil, Romain; Siebold, Rainer; Silvers-Granelli, Holly J; Soligard, Torbjørn; Witvrouw, Erik; Engebretsen, Lars

2018-04-01

In October 2017, the International Olympic Committee hosted an international expert group of physiotherapists and orthopaedic surgeons who specialise in treating and researching paediatric ACL injuries. Representatives from the American Orthopaedic Society for Sports Medicine, European Paediatric Orthopaedic Society, European Society for Sports Traumatology, Knee Surgery & Arthroscopy, International Society of Arthroscopy Knee Surgery and Orthopaedic Sports Medicine, Pediatric Orthopaedic Society of North America and Sociedad Latinoamericana de Artroscopia, Rodilla y Deporte attended. Physiotherapists and orthopaedic surgeons with clinical and research experience in the field, and an ethics expert with substantial experience in the area of sports injuries also participated. Injury management is challenging in the current landscape of clinical uncertainty and limited scientific knowledge. Injury management decisions also occur against the backdrop of the complexity of shared decision-making with children and the potential long-term ramifications of the injury. This consensus statement addresses six fundamental clinical questions regarding the prevention, diagnosis and management of paediatric ACL injuries. The aim of this consensus statement is to provide a comprehensive, evidence-informed summary to support the clinician, and help children with ACL injury and their parents/guardians make the best possible decisions. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Parents, adolescents, children and the human papillomavirus vaccine: a review.

PubMed

Walhart, T

2012-09-01

Human papillomavirus (HPV) is a sexually transmitted infection (STI). HPV is the most common sexually transmitted infection worldwide. It is also the most common STI in adolescents. This highlights a great clinical and public health concern that must be addressed. Parents are typically involved in the clinical decision-making process of vaccine administration to children and adolescents. Therefore, understanding the acceptability of the HPV vaccination as a method to prevent STIs and certain cancers is critical.   To present the three primary themes that emerged from the literature: parental attitudes, parental beliefs and parental barrier towards vaccinating children and adolescents with the HPV vaccine. A literature search using Scopus to determine parents' attitudes and beliefs towards vaccinating children and adolescents with the HPV vaccine. The initial search included the key search terms of 'children' and 'HPV vaccine'. The publication year was limited from 2006 to present. The three themes greatly influence parents' decisions to vaccinate their children. In the future, more attention needs to be paid to specific subgroups. Future research should include groups that are currently under-represented: fathers, urban populations, low socio-economic status and ethnic minorities. Since nurses worldwide are often sought as healthcare resources by parents in the clinical decision-making process, their understanding of the attitude, beliefs and barriers parents have towards the HPV vaccine is paramount. © 2012 The Author. International Nursing Review © 2012 International Council of Nurses.

Fostering better policy adoption and inter-disciplinary communication in healthcare: A qualitative analysis of practicing physicians’ common interests

PubMed Central

Crowley-Matoka, Megan; Collins, Jeremy D.; Chrisman, Howard B.; Milad, Magdy P.; Vogelzang, Robert L.

2017-01-01

Purpose In response to limited physician adoption of various healthcare initiatives, we sought to propose and assess a novel approach to policy development where one first characterizes diverse physician groups’ common interests, using a medical student and constructivist grounded theory. Methods In 6 months, a medical student completed 36 semi-structured interviews with interventional radiologists, gynecologists, and vascular surgeons that were systematically analyzed according to constructivist grounded theory to identifying common themes. Common drivers of clinical decision making and professional values across 3 distinct specialty groups were derived from physicians’ descriptions of their clinical decision making, stories, and concerns. Results Common drivers of clinical decision making included patient preference/benefit, experience, reimbursement, busyness/volume, and referral networks. Common values included honesty, trustworthiness, loyalty, humble service, compassion and perseverance, and practical wisdom. Although personal gains were perceived as important interests, such values were easily sacrificed for the good of patients or other non-financial interests. This balance was largely dependent on the incentives and security provided by physicians’ environments. Conclusions Using a medical student interviewer and constructivist grounded theory is a feasible means of collecting rich qualitative data to guide policy development. Healthcare administrators and medical educators should consider incorporating this methodology early in policy development to anticipate how value differences between physician groups will influence their acceptance of policies and other broad healthcare initiatives. PMID:28235088

‘Someday it will be the norm’: physician perspectives on the utility of genome sequencing for patient care in the MedSeq Project

PubMed Central

Vassy, Jason L; Christensen, Kurt D; Slashinski, Melody J; Lautenbach, Denise M; Raghavan, Sridharan; Robinson, Jill Oliver; Blumenthal-Barby, Jennifer; Feuerman, Lindsay Zausmer; Lehmann, Lisa Soleymani; Murray, Michael F; Green, Robert C; McGuire, Amy L

2015-01-01

Aim To describe practicing physicians’ perceived clinical utility of genome sequencing. Materials & methods We conducted a mixed-methods analysis of data from 18 primary care physicians and cardiologists in a study of the clinical integration of whole-genome sequencing. Physicians underwent brief genomics continuing medical education before completing surveys and semi-structured interviews. Results Physicians described sequencing as currently lacking clinical utility because of its uncertain interpretation and limited impact on clinical decision-making, but they expressed the idea that its clinical integration was inevitable. Potential clinical uses for sequencing included complementing other clinical information, risk stratification, motivating patient behavior change and pharmacogenetics. Conclusion Physicians given genomics continuing medical education use the language of both evidence-based and personalized medicine in describing the utility of genome-wide testing in patient care. PMID:25642274

Evidence-based prosthodontics: fundamental considerations, limitations, and guidelines.

PubMed

Bidra, Avinash S

2014-01-01

Evidence-based dentistry is rapidly emerging to become an integral part of patient care, dental education, and research. Prosthodontics is a unique dental specialty that encompasses art, philosophy, and science and includes reversible and irreversible treatments. It not only affords good applicability of many principles of evidence-based dentistry but also poses numerous limitations. This article describes the epidemiologic background, fundamental considerations, scrutiny of levels of evidence, limitations, guidelines, and future perspectives of evidence-based prosthodontics. Understanding these principles can aid clinicians in appropriate appraisal of the prosthodontics literature and use the best available evidence for making confident clinical decisions and optimizing patient care. Copyright © 2014 Elsevier Inc. All rights reserved.

Using Best Practices to Extract, Organize, and Reuse Embedded Decision Support Content Knowledge Rules from Mature Clinical Systems

PubMed Central

DesAutels, Spencer J.; Fox, Zachary E.; Giuse, Dario A.; Williams, Annette M.; Kou, Qing-hua; Weitkamp, Asli; Neal R, Patel; Bettinsoli Giuse, Nunzia

2016-01-01

Clinical decision support (CDS) knowledge, embedded over time in mature medical systems, presents an interesting and complex opportunity for information organization, maintenance, and reuse. To have a holistic view of all decision support requires an in-depth understanding of each clinical system as well as expert knowledge of the latest evidence. This approach to clinical decision support presents an opportunity to unify and externalize the knowledge within rules-based decision support. Driven by an institutional need to prioritize decision support content for migration to new clinical systems, the Center for Knowledge Management and Health Information Technology teams applied their unique expertise to extract content from individual systems, organize it through a single extensible schema, and present it for discovery and reuse through a newly created Clinical Support Knowledge Acquisition and Archival Tool (CS-KAAT). CS-KAAT can build and maintain the underlying knowledge infrastructure needed by clinical systems. PMID:28269846

Separating Business Logic from Medical Knowledge in Digital Clinical Workflows Using Business Process Model and Notation and Arden Syntax.

PubMed

de Bruin, Jeroen S; Adlassnig, Klaus-Peter; Leitich, Harald; Rappelsberger, Andrea

2018-01-01

Evidence-based clinical guidelines have a major positive effect on the physician's decision-making process. Computer-executable clinical guidelines allow for automated guideline marshalling during a clinical diagnostic process, thus improving the decision-making process. Implementation of a digital clinical guideline for the prevention of mother-to-child transmission of hepatitis B as a computerized workflow, thereby separating business logic from medical knowledge and decision-making. We used the Business Process Model and Notation language system Activiti for business logic and workflow modeling. Medical decision-making was performed by an Arden-Syntax-based medical rule engine, which is part of the ARDENSUITE software. We succeeded in creating an electronic clinical workflow for the prevention of mother-to-child transmission of hepatitis B, where institution-specific medical decision-making processes could be adapted without modifying the workflow business logic. Separation of business logic and medical decision-making results in more easily reusable electronic clinical workflows.

Applying a family systems lens to proxy decision making in clinical practice and research.

PubMed

Rolland, John S; Emanuel, Linda L; Torke, Alexia M

2017-03-01

When patients are incapacitated and face serious illness, family members must make medical decisions for the patient. Medical decision sciences give only modest attention to the relationships among patients and their family members, including impact that these relationships have on the decision-making process. A review of the literature reveals little effort to systematically apply a theoretical framework to the role of family interactions in proxy decision making. A family systems perspective can provide a useful lens through which to understand the dynamics of proxy decision making. This article considers the mutual impact of family systems on the processes and outcomes of proxy decision making. The article first reviews medical decision science's evolution and focus on proxy decision making and then reviews a family systems approach, giving particular attention to Rolland's Family Systems Illness Model. A case illustrates how clinical practice and how research would benefit from bringing family systems thinking to proxy decisions. We recommend including a family systems approach in medical decision science research and clinical practices around proxy decisions making. We propose that clinical decisions could be less conflicted and less emotionally troubling for families and clinicians if family systems approaches were included. This perspective opens new directions for research and novel approaches to clinical care. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Accuracy of intuition in clinical decision-making among novice clinicians.

PubMed

Price, Amanda; Zulkosky, Kristen; White, Krista; Pretz, Jean

2017-05-01

To assess the reliance on intuitive and analytical approaches during clinical decision-making among novice clinicians and whether that reliance is associated with accurate decision-making. Nurse educators and managers tend to emphasize analysis over intuition during clinical decision-making though nurses typically report some reliance on intuition in their practice. We hypothesized that under certain conditions, reliance on intuition would support accurate decision-making, even among novices. This study utilized an experimental design with clinical complication (familiar vs. novel) and decision phase (cue acquisition, diagnosis and action) as within-subjects' factors, and simulation role (observer, family, auxiliary nurse and primary nurse) as between-subjects' factor. We examined clinical decision-making accuracy among final semester pre-licensure nursing students in a simulation experience. Students recorded their reasoning about emerging clinical complications with their patient during two distinct points in the simulation; one point involved a familiar complication and the other a relatively novel complication. All data were collected during Spring 2015. Although most participants relied more heavily on analysis than on intuition, use of intuition during the familiar complication was associated with more accurate decision-making, particularly in guiding attention to relevant cues. With the novel complication, use of intuition appeared to hamper decision-making, particularly for those in an observer role. Novice clinicians should be supported by educators and nurse managers to note when their intuitions are likely to be valid. Our findings emphasize the integrated nature of intuition and analysis in clinical decision-making. © 2016 John Wiley & Sons Ltd.

SANDS: a service-oriented architecture for clinical decision support in a National Health Information Network.

PubMed

Wright, Adam; Sittig, Dean F

2008-12-01

In this paper, we describe and evaluate a new distributed architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support), which leverages current health information exchange efforts and is based on the principles of a service-oriented architecture. The architecture allows disparate clinical information systems and clinical decision support systems to be seamlessly integrated over a network according to a set of interfaces and protocols described in this paper. The architecture described is fully defined and developed, and six use cases have been developed and tested using a prototype electronic health record which links to one of the existing prototype National Health Information Networks (NHIN): drug interaction checking, syndromic surveillance, diagnostic decision support, inappropriate prescribing in older adults, information at the point of care and a simple personal health record. Some of these use cases utilize existing decision support systems, which are either commercially or freely available at present, and developed outside of the SANDS project, while other use cases are based on decision support systems developed specifically for the project. Open source code for many of these components is available, and an open source reference parser is also available for comparison and testing of other clinical information systems and clinical decision support systems that wish to implement the SANDS architecture. The SANDS architecture for decision support has several significant advantages over other architectures for clinical decision support. The most salient of these are:

The economic case for precision medicine.

PubMed

Gavan, Sean P; Thompson, Alexander J; Payne, Katherine

2018-01-01

Introduction : The advancement of precision medicine into routine clinical practice has been highlighted as an agenda for national and international health care policy. A principle barrier to this advancement is in meeting requirements of the payer or reimbursement agency for health care. This special report aims to explain the economic case for precision medicine, by accounting for the explicit objectives defined by decision-makers responsible for the allocation of limited health care resources. Areas covered : The framework of cost-effectiveness analysis, a method of economic evaluation, is used to describe how precision medicine can, in theory, exploit identifiable patient-level heterogeneity to improve population health outcomes and the relative cost-effectiveness of health care. Four case studies are used to illustrate potential challenges when demonstrating the economic case for a precision medicine in practice. Expert commentary : The economic case for a precision medicine should be considered at an early stage during its research and development phase. Clinical and economic evidence can be generated iteratively and should be in alignment with the objectives and requirements of decision-makers. Programmes of further research, to demonstrate the economic case of a precision medicine, can be prioritized by the extent that they reduce the uncertainty expressed by decision-makers.

How to survive the medical misinformation mess.

PubMed

Ioannidis, John P A; Stuart, Michael E; Brownlee, Shannon; Strite, Sheri A

2017-11-01

Most physicians and other healthcare professionals are unaware of the pervasiveness of poor quality clinical evidence that contributes considerably to overuse, underuse, avoidable adverse events, missed opportunities for right care and wasted healthcare resources. The Medical Misinformation Mess comprises four key problems. First, much published medical research is not reliable or is of uncertain reliability, offers no benefit to patients, or is not useful to decision makers. Second, most healthcare professionals are not aware of this problem. Third, they also lack the skills necessary to evaluate the reliability and usefulness of medical evidence. Finally, patients and families frequently lack relevant, accurate medical evidence and skilled guidance at the time of medical decision-making. Increasing the reliability of available, published evidence may not be an imminently reachable goal. Therefore, efforts should focus on making healthcare professionals, more sensitive to the limitations of the evidence, training them to do critical appraisal, and enhancing their communication skills so that they can effectively summarize and discuss medical evidence with patients to improve decision-making. Similar efforts may need to target also patients, journalists, policy makers, the lay public and other healthcare stakeholders. © 2017 Stichting European Society for Clinical Investigation Journal Foundation.

Paediatric investigation plans for pain: painfully slow!

PubMed

Davies, Elin H; Ollivier, Cecile M; Saint Raymond, Agnes

2010-11-01

To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA). Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis. Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products. The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain.

The economic case for precision medicine

PubMed Central

Gavan, Sean P.; Thompson, Alexander J.; Payne, Katherine

2018-01-01

ABSTRACT Introduction: The advancement of precision medicine into routine clinical practice has been highlighted as an agenda for national and international health care policy. A principle barrier to this advancement is in meeting requirements of the payer or reimbursement agency for health care. This special report aims to explain the economic case for precision medicine, by accounting for the explicit objectives defined by decision-makers responsible for the allocation of limited health care resources. Areas covered: The framework of cost-effectiveness analysis, a method of economic evaluation, is used to describe how precision medicine can, in theory, exploit identifiable patient-level heterogeneity to improve population health outcomes and the relative cost-effectiveness of health care. Four case studies are used to illustrate potential challenges when demonstrating the economic case for a precision medicine in practice. Expert commentary: The economic case for a precision medicine should be considered at an early stage during its research and development phase. Clinical and economic evidence can be generated iteratively and should be in alignment with the objectives and requirements of decision-makers. Programmes of further research, to demonstrate the economic case of a precision medicine, can be prioritized by the extent that they reduce the uncertainty expressed by decision-makers. PMID:29682615

French national consensus clinical guidelines for the management of ulcerative colitis.

PubMed

Peyrin-Biroulet, Laurent; Bouhnik, Yoram; Roblin, Xavier; Bonnaud, Guillaume; Hagège, Hervé; Hébuterne, Xavier

2016-07-01

Ulcerative colitis (UC) is a chronic inflammatory bowel disease of multifactorial etiology that primarily affects the colonic mucosa. The disease progresses over time, and clinical management guidelines should reflect its dynamic nature. There is limited evidence supporting UC management in specific clinical situations, thus precluding an evidence-based approach. To use a formal consensus method - the nominal group technique (NGT) - to develop a clinical practice expert opinion to outline simple algorithms and practices, optimize UC management, and assist clinicians in making treatment decisions. The consensus was developed by an expert panel of 37 gastroenterologists from various professional organizations with experience in UC management using the qualitative and iterative NGT, incorporating deliberations based on the European Crohn's and Colitis Organisation recommendations, recent reviews of scientific literature, and pertinent discussion topics developed by a steering committee. Examples of clinical cases for which there are limited evidence-based data from clinical trials were used. Two working groups proposed and voted on treatment algorithms that were then discussed and voted for by the nominal group as a whole, in order to reach a consensus. A clinical practice guideline covering management of the following clinical situations was developed: (i) moderate and severe UC; (ii) acute severe UC; (iii) pouchitis; (iv) refractory proctitis, in the form of treatment algorithms. Given the limited available evidence-based data, a formal consensus methodology was used to develop simple treatment guidelines for UC management in different clinical situations that is now accessible via an online application. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

An Internationally Consented Standard for Nursing Process-Clinical Decision Support Systems in Electronic Health Records.

PubMed

Müller-Staub, Maria; de Graaf-Waar, Helen; Paans, Wolter

2016-11-01

Nurses are accountable to apply the nursing process, which is key for patient care: It is a problem-solving process providing the structure for care plans and documentation. The state-of-the art nursing process is based on classifications that contain standardized concepts, and therefore, it is named Advanced Nursing Process. It contains valid assessments, nursing diagnoses, interventions, and nursing-sensitive patient outcomes. Electronic decision support systems can assist nurses to apply the Advanced Nursing Process. However, nursing decision support systems are missing, and no "gold standard" is available. The study aim is to develop a valid Nursing Process-Clinical Decision Support System Standard to guide future developments of clinical decision support systems. In a multistep approach, a Nursing Process-Clinical Decision Support System Standard with 28 criteria was developed. After pilot testing (N = 29 nurses), the criteria were reduced to 25. The Nursing Process-Clinical Decision Support System Standard was then presented to eight internationally known experts, who performed qualitative interviews according to Mayring. Fourteen categories demonstrate expert consensus on the Nursing Process-Clinical Decision Support System Standard and its content validity. All experts agreed the Advanced Nursing Process should be the centerpiece for the Nursing Process-Clinical Decision Support System and should suggest research-based, predefined nursing diagnoses and correct linkages between diagnoses, evidence-based interventions, and patient outcomes.

Fundamentals of clinical methodology: 2. Etiology.

PubMed

Sadegh-Zadeh, K

1998-03-01

The concept of etiology is analyzed and the possibilities and limitations of deterministic, probabilistic, and fuzzy etiology are explored. Different kinds of formal structures for the relation of causation are introduced which enable us to explicate the notion of cause on qualitative, comparative, and quantitative levels. The conceptual framework developed is an approach to a theory of causality that may be useful in etiologic research, in building nosological systems, and in differential diagnosis, therapeutic decision-making, and controlled clinical trials. The bearings of the theory are exemplified by examining the current Chlamydia pneumoniae hypothesis on the incidence of myocardial infarction.

Evaluation of nursing practice: process and critique.

PubMed

Braunstein, M S

1998-01-01

This article describes the difficulties in conducting clinical trials to evaluate nursing practice models. Suggestions are offered for strengthening the process. A clinical trial of a nursing practice model based on a synthesis of Aristotelian theory with Rogers' science is described. The rationale for decisions regarding the research procedures used in presented. Methodological limitations of the study design and the specifications of the practice model are examined. It is concluded that clear specification of theoretical relationships within a practice model and clear identification of key intervening variables will enable researchers to better connect the treatment with the outcome.

Shared Decision-Making with Parents of Acutely Ill Children: A Narrative Review.

PubMed

Aronson, Paul L; Shapiro, Eugene D; Niccolai, Linda M; Fraenkel, Liana

Shared decision-making (SDM) has mostly been used with adults and parents in the primary care setting, and there is limited knowledge on the use of SDM with parents of acutely ill children. The objective of this study was to review the literature on SDM with parents in the management of acutely ill children. We searched MEDLINE, SCOPUS, PsycINFO, the Cochrane Library, and ClinicalTrials.gov for English language studies published from the time of database inception to February, 2017. Study eligibility criterion was use of SDM with parents for children aged 18 years or younger with an acute medical problem. We identified 2 ongoing clinical trials and 10 published studies that met inclusion criteria: 2 using hypothetical SDM scenarios, 1 mixed methods study, and 7 intervention studies. Only 1 study compared an SDM intervention with usual care in a randomized controlled trial. The limited literature shows that parents of acutely ill children have differing preferences for testing and/or treatment, and that they generally want the opportunity to express those preferences through an SDM process. Use of SDM often results in acutely ill children undergoing fewer and/or less intensive testing or treatment, although the effect on outcomes is unclear. Parents welcome participation in SDM for management decisions with their acutely ill child. Further investigation is needed to determine how best to implement SDM with parents of acutely ill children and to assess the effect of SDM on outcomes. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Bridging technology and clinical practice: innovating inpatient hyperglycaemia management in non-critical care settings.

PubMed

Thabit, H; Hovorka, R

2018-04-01

Emerging evidence shows that suboptimal glycaemic control is associated with increased morbidity and length of stay in hospital. Various guidelines for safe and effective inpatient glycaemic control in the non-critical care setting have been published. In spite of this, implementation in practice remains limited because of the increasing number of people with diabetes admitted to hospital and staff work burden. The use of technology in the outpatient setting has led to improved glycaemic outcomes and quality of life for people with diabetes. There remains an unmet need for technology utilisation in inpatient hyperglycaemia management in the non-critical care setting. Novel technologies have the potential to provide benefits in diabetes care in hospital by improving efficacy, safety and efficiency. Rapid analysis of glucose measurements by point-of-care devices help facilitate clinical decision-making and therapy adjustment in the hospital setting. Glucose treatment data integration with computerized glucose management systems underpins the effective use of decision support systems and may streamline clinical staff workflow. Continuous glucose monitoring and automation of insulin delivery through closed-loop systems may provide a safe and efficacious tool for hospital staff to manage inpatient hyperglycaemia whilst reducing staff workload. This review summarizes the evidence with regard to technological methods to manage inpatient glycaemic control, their limitations and the future outlook, as well as potential strategies by healthcare organizations such as the National Health Service to mediate the adoption, procurement and use of diabetes technologies in the hospital setting. © 2017 Diabetes UK.

Limitations of Medical Research and Evidence at the Patient-Clinician Encounter Scale

PubMed Central

Ioannidis, John P. A.

2013-01-01

We explore some philosophical and scientific underpinnings of clinical research and evidence at the patient-clinician encounter scale. Insufficient evidence and a common failure to use replicable and sound research methods limit us. Both patients and health care may be, in part, complex nonlinear chaotic systems, and predicting their outcomes is a challenge. When trustworthy (credible) evidence is lacking, making correct clinical choices is often a low-probability exercise. Thus, human (clinician) error and consequent injury to patients appear inevitable. Individual clinician decision-makers operate under the philosophical influence of Adam Smith’s “invisible hand” with resulting optimism that they will eventually make the right choices and cause health benefits. The presumption of an effective “invisible hand” operating in health-care delivery has supported a model in which individual clinicians struggle to practice medicine, as they see fit based on their own intuitions and preferences (and biases) despite the obvious complexity, errors, noise, and lack of evidence pervading the system. Not surprisingly, the “invisible hand” does not appear to produce the desired community health benefits. Obtaining a benefit at the patient-clinician encounter scale requires human (clinician) behavior modification. We believe that serious rethinking and restructuring of the clinical research and care delivery systems is necessary to assure the profession and the public that we continue to do more good than harm. We need to evaluate whether, and how, detailed decision-support tools may enable reproducible clinician behavior and beneficial use of evidence. PMID:23546485

Limitations of medical research and evidence at the patient-clinician encounter scale.

PubMed

Morris, Alan H; Ioannidis, John P A

2013-04-01

We explore some philosophical and scientific underpinnings of clinical research and evidence at the patient-clinician encounter scale. Insufficient evidence and a common failure to use replicable and sound research methods limit us. Both patients and health care may be, in part, complex nonlinear chaotic systems, and predicting their outcomes is a challenge. When trustworthy (credible) evidence is lacking, making correct clinical choices is often a low-probability exercise. Thus, human (clinician) error and consequent injury to patients appear inevitable. Individual clinician decision-makers operate under the philosophical influence of Adam Smith's "invisible hand" with resulting optimism that they will eventually make the right choices and cause health benefits. The presumption of an effective "invisible hand" operating in health-care delivery has supported a model in which individual clinicians struggle to practice medicine, as they see fit based on their own intuitions and preferences (and biases) despite the obvious complexity, errors, noise, and lack of evidence pervading the system. Not surprisingly, the "invisible hand" does not appear to produce the desired community health benefits. Obtaining a benefit at the patient-clinician encounter scale requires human (clinician) behavior modification. We believe that serious rethinking and restructuring of the clinical research and care delivery systems is necessary to assure the profession and the public that we continue to do more good than harm. We need to evaluate whether, and how, detailed decision-support tools may enable reproducible clinician behavior and beneficial use of evidence.

Lessons learned from implementing service-oriented clinical decision support at four sites: A qualitative study.

PubMed

Wright, Adam; Sittig, Dean F; Ash, Joan S; Erickson, Jessica L; Hickman, Trang T; Paterno, Marilyn; Gebhardt, Eric; McMullen, Carmit; Tsurikova, Ruslana; Dixon, Brian E; Fraser, Greg; Simonaitis, Linas; Sonnenberg, Frank A; Middleton, Blackford

2015-11-01

To identify challenges, lessons learned and best practices for service-oriented clinical decision support, based on the results of the Clinical Decision Support Consortium, a multi-site study which developed, implemented and evaluated clinical decision support services in a diverse range of electronic health records. Ethnographic investigation using the rapid assessment process, a procedure for agile qualitative data collection and analysis, including clinical observation, system demonstrations and analysis and 91 interviews. We identified challenges and lessons learned in eight dimensions: (1) hardware and software computing infrastructure, (2) clinical content, (3) human-computer interface, (4) people, (5) workflow and communication, (6) internal organizational policies, procedures, environment and culture, (7) external rules, regulations, and pressures and (8) system measurement and monitoring. Key challenges included performance issues (particularly related to data retrieval), differences in terminologies used across sites, workflow variability and the need for a legal framework. Based on the challenges and lessons learned, we identified eight best practices for developers and implementers of service-oriented clinical decision support: (1) optimize performance, or make asynchronous calls, (2) be liberal in what you accept (particularly for terminology), (3) foster clinical transparency, (4) develop a legal framework, (5) support a flexible front-end, (6) dedicate human resources, (7) support peer-to-peer communication, (8) improve standards. The Clinical Decision Support Consortium successfully developed a clinical decision support service and implemented it in four different electronic health records and four diverse clinical sites; however, the process was arduous. The lessons identified by the Consortium may be useful for other developers and implementers of clinical decision support services. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Assessing Generalisability in Model-Based Economic Evaluation Studies: A Structured Review in Osteoporosis

PubMed Central

Urdahl, Hege; Manca, Andrea; Sculpher, Mark J

2008-01-01

Background To support decision making many countries have now introduced some formal assessment process to evaluate whether health technologies represent good ‘value for money’. These often take the form of decision models which can be used to explore elements of importance to generalisability of study results across clinical settings and jurisdictions. The objectives of the present review were to assess: (i) whether the published studies clearly defined the decision-making audience for the model; (ii) the transparency of the reporting in terms of study question, structure and data inputs; (iii) the relevance of the data inputs used in the model to the stated decision-maker or jurisdiction; and (iv) how fully the robustness of the model's results to variation in data inputs between locations was assessed. Methods Articles reporting decision-analytic models in the area of osteoporosis were assessed to establish the extent to which the information provided enabled decision makers in different countries/jurisdictions to fully appreciate the variability of results according to location, and the relevance to their own. Results Of the 18 articles included in the review, only three explicitly stated the decision-making audience. It was not possible to infer a decision-making audience in eight studies. Target population was well reported, as was resource and cost data, and clinical data used for estimates of relative risk reduction. However, baseline risk was rarely adapted to the relevant jurisdiction, and when no decision-maker was explicit it was difficult to assess whether the reported cost and resource use data was in fact relevant. A few studies used sensitivity analysis to explore elements of generalisability, such as compliance rates and baseline fracture risk rates, although such analyses were generally restricted to evaluating parameter uncertainty. Conclusion This review found that variability in cost-effectiveness across locations is addressed to a varying extent in modelling studies in the field of osteoporosis, limiting their use for decision-makers across different locations. Transparency of reporting is expected to increase as methodology develops, and decision-makers publish “reference case” type guidance. PMID:17129074

International Society for the Study of Fatty Acids and Lipids 2016 Debate: For Science-Based Dietary Guidelines on Fats, Meta-Analysis and Systematic Reviews Are Decisive.

PubMed

Nettleton, Joyce A; von Schacky, Clemens; Brouwer, Ingeborg A; Koletzko, Berthold

2017-01-01

This paper summarizes a debate on whether meta-analyses and systematic reviews are decisive in formulating guidelines for dietary fat. Held during the 12th congress of the International Society for the Study of Fatty Acids and Lipids in Stellenbosch, South Africa, September 7, 2016, the debate was hosted by the International Union of Nutritional Sciences and the International Expert Movement to Improve Dietary Fat Quality (IEM, www.theiem.org). Clemens von Schacky, Ludwig Maximilians-University, Munich, Germany, supported the statement, describing the types of weaknesses in individual studies and clinical trials. With examples of how to overcome such limitations, he concluded that nutritional guidelines on fat need a proper scientific basis in which randomized controlled trials (RCTs) with clinical endpoints and their meta-analyses are essential and decisive. In contention, Ingeborg Brouwer, Vrije Universiteit, Amsterdam, declared that recommendations on dietary fat intake should always be based on the totality of the evidence, including physiologic and biochemical knowledge and associations from observational epidemiology. RCTs and meta-analyses have their shortcomings, but well-conducted systematic reviews and meta-analyses support a transparent process for developing dietary fat guidelines. Participants agreed that evidence-based decision-making for dietary guidance should consider all the best available evidence using a transparent, systematic review. © 2017 The Author(s) Published by S. Karger AG, Basel.

Interactive decision support in hepatic surgery

PubMed Central

Dugas, Martin; Schauer, Rolf; Volk, Andreas; Rau, Horst

2002-01-01

Background Hepatic surgery is characterized by complicated operations with a significant peri- and postoperative risk for the patient. We developed a web-based, high-granular research database for comprehensive documentation of all relevant variables to evaluate new surgical techniques. Methods To integrate this research system into the clinical setting, we designed an interactive decision support component. The objective is to provide relevant information for the surgeon and the patient to assess preoperatively the risk of a specific surgical procedure. Based on five established predictors of patient outcomes, the risk assessment tool searches for similar cases in the database and aggregates the information to estimate the risk for an individual patient. Results The physician can verify the analysis and exclude manually non-matching cases according to his expertise. The analysis is visualized by means of a Kaplan-Meier plot. To evaluate the decision support component we analyzed data on 165 patients diagnosed with hepatocellular carcinoma (period 1996–2000). The similarity search provides a two-peak distribution indicating there are groups of similar patients and singular cases which are quite different to the average. The results of the risk estimation are consistent with the observed survival data, but must be interpreted with caution because of the limited number of matching reference cases. Conclusion Critical issues for the decision support system are clinical integration, a transparent and reliable knowledge base and user feedback. PMID:12003639

Development, deployment and usability of a point-of-care decision support system for chronic disease management using the recently-approved HL7 decision support service standard.

PubMed

Lobach, David F; Kawamoto, Kensaku; Anstrom, Kevin J; Russell, Michael L; Woods, Peter; Smith, Dwight

2007-01-01

Clinical decision support is recognized as one potential remedy for the growing crisis in healthcare quality in the United States and other industrialized nations. While decision support systems have been shown to improve care quality and reduce errors, these systems are not widely available. This lack of availability arises in part because most decision support systems are not portable or scalable. The Health Level 7 international standard development organization recently adopted a draft standard known as the Decision Support Service standard to facilitate the implementation of clinical decision support systems using software services. In this paper, we report the first implementation of a clinical decision support system using this new standard. This system provides point-of-care chronic disease management for diabetes and other conditions and is deployed throughout a large regional health system. We also report process measures and usability data concerning the system. Use of the Decision Support Service standard provides a portable and scalable approach to clinical decision support that could facilitate the more extensive use of decision support systems.

SANDS: an architecture for clinical decision support in a National Health Information Network.

PubMed

Wright, Adam; Sittig, Dean F

2007-10-11

A new architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support) is introduced and its performance evaluated. The architecture provides a method for performing clinical decision support across a network, as in a health information exchange. Using the prototype we demonstrated that, first, a number of useful types of decision support can be carried out using our architecture; and, second, that the architecture exhibits desirable reliability and performance characteristics.

The bottom line on wound care standardization.

PubMed

McNees, Patrick; Kueven, John A

2011-03-01

North Mississippi Medical Center learned four important lessons in its effort to standardize wound care products and processes of care: Designate clinical champions. Limit the number of vendors that provide products for a specialty. Reduce the number of similar-function wound care products that are available for use, with decisions guided by clinicians. Provide transparent information related to cost, the intentions of the initiative, usage patterns, and the criteria for evaluation.

Patients' Values in Clinical Decision-Making.

PubMed

Faggion, Clovis Mariano; Pachur, Thorsten; Giannakopoulos, Nikolaos Nikitas

2017-09-01

Shared decision-making involves the participation of patient and dental practitioner. Well-informed decision-making requires that both parties understand important concepts that may influence the decision. This fourth article in a series of 4 aims to discuss the importance of patients' values when a clinical decision is made. We report on how to incorporate important concepts for well-informed, shared decision-making. Here, we present patient values as an important issue, in addition to previously established topics such as the risk of bias of a study, cost-effectiveness of treatment approaches, and a comparison of therapeutic benefit with potential side effects. We provide 2 clinical examples and suggestions for a decision tree, based on the available evidence. The information reported in this article may improve the relationship between patient and dental practitioner, resulting in more well-informed clinical decisions. Copyright © 2017 Elsevier Inc. All rights reserved.

An exploration of clinical decision making in mental health triage.

PubMed

Sands, Natisha

2009-08-01

Mental health (MH) triage is a specialist area of clinical nursing practice that involves complex decision making. The discussion in this article draws on the findings of a Ph.D. study that involved a statewide investigation of the scope of MH triage nursing practice in Victoria, Australia. Although the original Ph.D. study investigated a number of core practices in MH triage, the focus of the discussion in this article is specifically on the findings related to clinical decision making in MH triage, which have not previously been published. The study employed an exploratory descriptive research design that used mixed data collection methods including a survey questionnaire (n = 139) and semistructured interviews (n = 21). The study findings related to decision making revealed a lack of empirically tested evidence-based decision-making frameworks currently in use to support MH triage nursing practice. MH triage clinicians in Australia rely heavily on clinical experience to underpin decision making and have little of knowledge of theoretical models for practice, such as methodologies for rating urgency. A key recommendation arising from the study is the need to develop evidence-based decision-making frameworks such as clinical guidelines to inform and support MH triage clinical decision making.

ICADx: interpretable computer aided diagnosis of breast masses

NASA Astrophysics Data System (ADS)

Kim, Seong Tae; Lee, Hakmin; Kim, Hak Gu; Ro, Yong Man

2018-02-01

In this study, a novel computer aided diagnosis (CADx) framework is devised to investigate interpretability for classifying breast masses. Recently, a deep learning technology has been successfully applied to medical image analysis including CADx. Existing deep learning based CADx approaches, however, have a limitation in explaining the diagnostic decision. In real clinical practice, clinical decisions could be made with reasonable explanation. So current deep learning approaches in CADx are limited in real world deployment. In this paper, we investigate interpretability in CADx with the proposed interpretable CADx (ICADx) framework. The proposed framework is devised with a generative adversarial network, which consists of interpretable diagnosis network and synthetic lesion generative network to learn the relationship between malignancy and a standardized description (BI-RADS). The lesion generative network and the interpretable diagnosis network compete in an adversarial learning so that the two networks are improved. The effectiveness of the proposed method was validated on public mammogram database. Experimental results showed that the proposed ICADx framework could provide the interpretability of mass as well as mass classification. It was mainly attributed to the fact that the proposed method was effectively trained to find the relationship between malignancy and interpretations via the adversarial learning. These results imply that the proposed ICADx framework could be a promising approach to develop the CADx system.

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions

PubMed Central

2017-01-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy. PMID:29209469

Probability or Reasoning: Current Thinking and Realistic Strategies for Improved Medical Decisions.

PubMed

Nantha, Yogarabindranath Swarna

2017-11-01

A prescriptive model approach in decision making could help achieve better diagnostic accuracy in clinical practice through methods that are less reliant on probabilistic assessments. Various prescriptive measures aimed at regulating factors that influence heuristics and clinical reasoning could support clinical decision-making process. Clinicians could avoid time-consuming decision-making methods that require probabilistic calculations. Intuitively, they could rely on heuristics to obtain an accurate diagnosis in a given clinical setting. An extensive literature review of cognitive psychology and medical decision-making theory was performed to illustrate how heuristics could be effectively utilized in daily practice. Since physicians often rely on heuristics in realistic situations, probabilistic estimation might not be a useful tool in everyday clinical practice. Improvements in the descriptive model of decision making (heuristics) may allow for greater diagnostic accuracy.

Challenges in Measuring Cost and Value in Oncology: Making It Personal.

PubMed

Yu, Peter P

2016-01-01

Oncology patients often find themselves facing an incurable disease with limited treatment options and increasing patient fragility. The importance of patient preferences and values increases in shared decision making especially when the cost of cancer care is continuing its steep rise. As our understanding of cancer systems biology increases, we are justifiably optimistic about therapeutic improvements but recognize that this has complicated the traditional Food and Drug Administration approval of drug indications based on organ-specific cancer for a particular drug. Dynamic and agile clinical guidelines that reflect a rapidly changing knowledge base for decision-making support are needed. The American Society of Clinical Oncology (ASCO) has been working on three initiatives to tackle these complex issues. The first initiative is ASCO's collaboration with other international organizations to create a framework to assess drugs for the World Health Organization's Essential Medicines List, including nongenerics. The second initiative aims to define clinically meaningful outcomes as precision medicine expands the definition of cancers, leading to increased demand for the use of targeted drugs as single agents or in combination. The third initiative is ASCO's value framework, published in 2015, focusing on patient-physician shared decision making. The framework incorporates three parameters: 1) the meaningfulness of the clinical benefit, 2) the toxicity of the treatment, and 3) the patient's financial out-of-pocket cost. ASCO is concerned about the rising cost of cancer care when the clinical complexity and the pace of change in oncology are accelerating, and it is committed to help improve patient outcomes and value in cancer care as well as to engage the broader health care community in a process of collaborative improvement. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The reliability of clinical decisions based on the cervical vertebrae maturation staging method.

PubMed

Sohrabi, Aydin; Babay Ahari, Sahar; Moslemzadeh, Hossein; Rafighi, Ali; Aghazadeh, Zahra

2016-02-01

Of the various techniques used to determine the optimum timing for growth modification treatments, the cervical vertebrae maturation method has great advantages, including validity and no need for extra X-ray exposure. Recently, the reproducibility of this method has been questioned. The aim of this study was to investigate the cause of poor reproducibility of this method and to assess the reproducibility of the clinical decisions made based on it. Seventy lateral cephalograms of Iranian patients aged 9‒15 years were observed twice by five experienced orthodontists. In addition to determining the developmental stage, each single parameter involved in this method was assessed in terms of inter- and intra-observer reproducibility. In order to evaluate the reproducibility of clinical decisions based on this method, cervical vertebrae maturation staging (CVMS) I and II were considered as phase 1 and CVMS IV and V were considered as phase 3. By considering the clinical approach of the CVMS method, inter-observer reproducibility of this method increased from 0.48 to 0.61 (moderate to substantial) and intra-observer reproducibility enhanced from 0.72 to 0.74. 1. Complete visualization of the first four cervical vertebrae was an inclusion criterion, which also limits the clinical application of CVMS method. 2. These results can be generalized when determining growth modification treatments solely for Class II patients. Difficulty in determining the morphology of C3 and C4 leads to poor reproducibility of the CVMS method. Despite this, it has acceptable reproducibility in determining the timing of functional treatment for Class II patients. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Factors influencing alert acceptance: a novel approach for predicting the success of clinical decision support

PubMed Central

Seidling, Hanna M; Phansalkar, Shobha; Seger, Diane L; Paterno, Marilyn D; Shaykevich, Shimon; Haefeli, Walter E

2011-01-01

Background Clinical decision support systems can prevent knowledge-based prescription errors and improve patient outcomes. The clinical effectiveness of these systems, however, is substantially limited by poor user acceptance of presented warnings. To enhance alert acceptance it may be useful to quantify the impact of potential modulators of acceptance. Methods We built a logistic regression model to predict alert acceptance of drug–drug interaction (DDI) alerts in three different settings. Ten variables from the clinical and human factors literature were evaluated as potential modulators of provider alert acceptance. ORs were calculated for the impact of knowledge quality, alert display, textual information, prioritization, setting, patient age, dose-dependent toxicity, alert frequency, alert level, and required acknowledgment on acceptance of the DDI alert. Results 50 788 DDI alerts were analyzed. Providers accepted only 1.4% of non-interruptive alerts. For interruptive alerts, user acceptance positively correlated with frequency of the alert (OR 1.30, 95% CI 1.23 to 1.38), quality of display (4.75, 3.87 to 5.84), and alert level (1.74, 1.63 to 1.86). Alert acceptance was higher in inpatients (2.63, 2.32 to 2.97) and for drugs with dose-dependent toxicity (1.13, 1.07 to 1.21). The textual information influenced the mode of reaction and providers were more likely to modify the prescription if the message contained detailed advice on how to manage the DDI. Conclusion We evaluated potential modulators of alert acceptance by assessing content and human factors issues, and quantified the impact of a number of specific factors which influence alert acceptance. This information may help improve clinical decision support systems design. PMID:21571746

Guardianship and End-of-Life Decision Making

PubMed Central

Cohen, Andrew B.; Wright, Megan S.; Cooney, Leo; Fried, Terri

2015-01-01

As the population ages, more adults will develop impaired decision-making capacity and have no family members or friends available to make medical decisions on their behalf. In such situations, a professional guardian is often appointed by the court. This is an official who has no pre-existing relationship with the impaired individual but is paid to serve as a surrogate decision-maker. When a professional guardian is faced with decisions concerning life-sustaining treatment, substituted judgment may be impossible, and reports have repeatedly suggested that guardians are reluctant to make the decision to limit care. Clinicians are well positioned to assist guardians with these decisions and safeguard the rights of the vulnerable persons they represent. Doing so effectively requires knowledge of the laws governing end-of-life decisions by guardians. Clinicians, however, are often uncertain about whether guardians are empowered to withhold treatment and when their decisions require judicial review. To address this issue, we analyzed state guardianship statutes and reviewed recent legal cases in order to characterize the authority of a guardian over choices about end-of-life treatment. We found that a large majority of state guardianship statutes have no language about end-of-life decisions and identified just five legal cases over the past decade that addressed a guardian’s authority over these decisions, with only one case providing a broad framework applicable to clinical practice. Work to improve end-of-life decision-making by guardians may benefit from a multi-disciplinary effort to develop comprehensive standards that can guide clinicians and guardians when treatment decisions need to be made. PMID:26258634

Effect of experience on clinical decision making by cardiorespiratory physiotherapists in acute care settings.

PubMed

Smith, Megan; Higgs, Joy; Ellis, Elizabeth

2010-02-01

This article investigates clinical decision making in acute care hospitals by cardiorespiratory physiotherapists with differing degrees of clinical experience. Participants were observed as they engaged in their everyday practice and were interviewed about their decision making. Texts of the data were interpreted by using a hermeneutic approach that involved repeated reading and analysis of fieldnotes and interview transcripts to develop an understanding of the effect of experience on clinical decision making. Participants were classified into categories of cardiorespiratory physiotherapy experience: less experienced (<2 years), intermediate experience (2.5-4 years), and more experienced (>7 years). Four dimensions characteristic of increasing experience in cardiorespiratory physiotherapy clinical decision making were identified: 1) an individual practice model, 2) refined approaches to clinical decision making, 3) working in context, and 4) social and emotional capability. Underpinning these dimensions was evidence of reflection on practice, motivation to achieve best practice, critique of new knowledge, increasing confidence, and relationships with knowledgeable colleagues. These findings reflect characteristics of physiotherapy expertise that have been described in the literature. This study adds knowledge about the field of cardiorespiratory physiotherapy to the existing body of research on clinical decision making and broadens the existing understanding of characteristics of physiotherapy expertise.

Nurses' Clinical Decision Making on Adopting a Wound Clinical Decision Support System.

PubMed

Khong, Peck Chui Betty; Hoi, Shu Yin; Holroyd, Eleanor; Wang, Wenru

2015-07-01

Healthcare information technology systems are considered the ideal tool to inculcate evidence-based nursing practices. The wound clinical decision support system was built locally to support nurses to manage pressure ulcer wounds in their daily practice. However, its adoption rate is not optimal. The study's objective was to discover the concepts that informed the RNs' decisions to adopt the wound clinical decision support system as an evidence-based technology in their nursing practice. This was an exploratory, descriptive, and qualitative design using face-to-face interviews, individual interviews, and active participatory observation. A purposive, theoretical sample of 14 RNs was recruited from one of the largest public tertiary hospitals in Singapore after obtaining ethics approval. After consenting, the nurses were interviewed and observed separately. Recruitment stopped when data saturation was reached. All transcribed interview data underwent a concurrent thematic analysis, whereas observational data were content analyzed independently and subsequently triangulated with the interview data. Eight emerging themes were identified, namely, use of the wound clinical decision support system, beliefs in the wound clinical decision support system, influences of the workplace culture, extent of the benefits, professional control over nursing practices, use of knowledge, gut feelings, and emotions (fear, doubt, and frustration). These themes represented the nurses' mental outlook as they made decisions on adopting the wound clinical decision support system in light of the complexities of their roles and workloads. This research has provided insight on the nurses' thoughts regarding their decision to interact with the computer environment in a Singapore context. It captured the nurses' complex thoughts when deciding whether to adopt or reject information technology as they practice in a clinical setting.

The anatomy of clinical decision-making in multidisciplinary cancer meetings

PubMed Central

Soukup, Tayana; Petrides, Konstantinos V.; Lamb, Benjamin W.; Sarkar, Somita; Arora, Sonal; Shah, Sujay; Darzi, Ara; Green, James S. A.; Sevdalis, Nick

2016-01-01

Abstract In the UK, treatment recommendations for patients with cancer are routinely made by multidisciplinary teams in weekly meetings. However, their performance is variable. The aim of this study was to explore the underlying structure of multidisciplinary decision-making process, and examine how it relates to team ability to reach a decision. This is a cross-sectional observational study consisting of 1045 patient reviews across 4 multidisciplinary cancer teams from teaching and community hospitals in London, UK, from 2010 to 2014. Meetings were chaired by surgeons. We used a validated observational instrument (Metric for the Observation of Decision-making in Cancer Multidisciplinary Meetings) consisting of 13 items to assess the decision-making process of each patient discussion. Rated on a 5-point scale, the items measured quality of presented patient information, and contributions to review by individual disciplines. A dichotomous outcome (yes/no) measured team ability to reach a decision. Ratings were submitted to Exploratory Factor Analysis and regression analysis. The exploratory factor analysis produced 4 factors, labeled “Holistic and Clinical inputs” (patient views, psychosocial aspects, patient history, comorbidities, oncologists’, nurses’, and surgeons’ inputs), “Radiology” (radiology results, radiologists’ inputs), “Pathology” (pathology results, pathologists’ inputs), and “Meeting Management” (meeting chairs’ and coordinators’ inputs). A negative cross-loading was observed from surgeons’ input on the fourth factor with a follow-up analysis showing negative correlation (r = −0.19, P < 0.001). In logistic regression, all 4 factors predicted team ability to reach a decision (P < 0.001). Hawthorne effect is the main limitation of the study. The decision-making process in cancer meetings is driven by 4 underlying factors representing the complete patient profile and contributions to case review by all core disciplines. Evidence of dual-task interference was observed in relation to the meeting chairs’ input and their corresponding surgical input into case reviews. PMID:27310981

A novel computer based expert decision making model for prostate cancer disease management.

PubMed

Richman, Martin B; Forman, Ernest H; Bayazit, Yildirim; Einstein, Douglas B; Resnick, Martin I; Stovsky, Mark D

2005-12-01

We propose a strategic, computer based, prostate cancer decision making model based on the analytic hierarchy process. We developed a model that improves physician-patient joint decision making and enhances the treatment selection process by making this critical decision rational and evidence based. Two groups (patient and physician-expert) completed a clinical study comparing an initial disease management choice with the highest ranked option generated by the computer model. Participants made pairwise comparisons to derive priorities for the objectives and subobjectives related to the disease management decision. The weighted comparisons were then applied to treatment options to yield prioritized rank lists that reflect the likelihood that a given alternative will achieve the participant treatment goal. Aggregate data were evaluated by inconsistency ratio analysis and sensitivity analysis, which assessed the influence of individual objectives and subobjectives on the final rank list of treatment options. Inconsistency ratios less than 0.05 were reliably generated, indicating that judgments made within the model were mathematically rational. The aggregate prioritized list of treatment options was tabulated for the patient and physician groups with similar outcomes for the 2 groups. Analysis of the major defining objectives in the treatment selection decision demonstrated the same rank order for the patient and physician groups with cure, survival and quality of life being more important than controlling cancer, preventing major complications of treatment, preventing blood transfusion complications and limiting treatment cost. Analysis of subobjectives, including quality of life and sexual dysfunction, produced similar priority rankings for the patient and physician groups. Concordance between initial treatment choice and the highest weighted model option differed between the groups with the patient group having 59% concordance and the physician group having only 42% concordance. This study successfully validated the usefulness of a computer based prostate cancer management decision making model to produce individualized, rational, clinically appropriate disease management decisions without physician bias.

Provision of legal services to persons with HIV or AIDS: barriers and trends.

PubMed

Carey, R

Canadian HIV/AIDS legal clinics address their agendas, funding, activities, and observed trends. The HIV & AIDS Legal Clinic (Ontario) (HALCO) is profiled in the first of a series. HALCO is a poverty law clinic for HIV-positive people with limited financial means in Ontario. The profile of legal problems handled by HALCO includes government assistance payments, inadequate or too-expensive housing, wills and substitute decision making, bankruptcy, human rights, prison health issues, employment concerns, immigration issues, and family law. HALCO has a limited budget, and can only afford one full-time lawyer and one full-time community worker on staff. HALCO is tracking a trend of diminishing legal protections for HIV-positive employees. They have also recorded increased opposition in the insurance industry to cover HIV drug treatment. Medical malpractice litigations are also increasing due to the doctors failing to inform patients of their HIV status or to treat them adequately once they have been notified.

Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare.

PubMed

Dolan, James G

2010-01-01

Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers.Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine "hard data" with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings.The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP).

Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare

PubMed Central

Dolan, James G.

2010-01-01

Current models of healthcare quality recommend that patient management decisions be evidence-based and patient-centered. Evidence-based decisions require a thorough understanding of current information regarding the natural history of disease and the anticipated outcomes of different management options. Patient-centered decisions incorporate patient preferences, values, and unique personal circumstances into the decision making process and actively involve both patients along with health care providers as much as possible. Fundamentally, therefore, evidence-based, patient-centered decisions are multi-dimensional and typically involve multiple decision makers. Advances in the decision sciences have led to the development of a number of multiple criteria decision making methods. These multi-criteria methods are designed to help people make better choices when faced with complex decisions involving several dimensions. They are especially helpful when there is a need to combine “hard data” with subjective preferences, to make trade-offs between desired outcomes, and to involve multiple decision makers. Evidence-based, patient-centered clinical decision making has all of these characteristics. This close match suggests that clinical decision support systems based on multi-criteria decision making techniques have the potential to enable patients and providers to carry out the tasks required to implement evidence-based, patient-centered care effectively and efficiently in clinical settings. The goal of this paper is to give readers a general introduction to the range of multi-criteria methods available and show how they could be used to support clinical decision-making. Methods discussed include the balance sheet, the even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and the analytic hierarchy process (AHP) PMID:21394218

Shared decision-making – transferring research into practice: the Analytic Hierarchy Process (AHP)

PubMed Central

Dolan, James G.

2008-01-01

Objective To illustrate how the Analytic Hierarchy Process (AHP) can be used to promote shared decision-making and enhance clinician-patient communication. Methods Tutorial review. Results The AHP promotes shared decision making by creating a framework that is used to define the decision, summarize the information available, prioritize information needs, elicit preferences and values, and foster meaningful communication among decision stakeholders. Conclusions The AHP and related multi-criteria methods have the potential for improving the quality of clinical decisions and overcoming current barriers to implementing shared decision making in busy clinical settings. Further research is needed to determine the best way to implement these tools and to determine their effectiveness. Practice Implications Many clinical decisions involve preference-based trade-offs between competing risks and benefits. The AHP is a well-developed method that provides a practical approach for improving patient-provider communication, clinical decision-making, and the quality of patient care in these situations. PMID:18760559

Effect of patient decision aid was influenced by presurgical evaluation among patients with osteoarthritis of the knee.

PubMed

Boland, Laura; Taljaard, Monica; Dervin, Geoffrey; Trenaman, Logan; Tugwell, Peter; Pomey, Marie-Pascale; Stacey, Dawn

2017-12-01

Decision aids help patients make total joint arthroplasty decisions, but presurgical evaluation might influence the effects of a decision aid. We compared the effects of a decision aid among patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes. We performed a subgroup analysis of a randomized controlled trial. Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education. We compared the effects of decision quality, decisional conflict and surgery rate using Cochran-Mantel-Haenszel χ 2 tests and the Breslow-Day test. We evaluated 242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls). Results suggested a between-site difference in the effect of the decision aid on the patients' decision quality ( p = 0.09): at the academic site, patients who used the decision were more likely to make better-quality decisions than controls (54% v. 35%, p = 0.044), but not at the community site (47% v. 51%, p = 0.71). Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p = 0.007) (33% v. 52%, p = 0.05 at the academic site and 40% v. 24%, p = 0.08 at the community site). The effect of the decision aid on surgery rates did not differ between sites ( p = 0.65). The decision aid had a greater effect at the academic site than at the community site, which provided longer consultations with more verbal education. Hence, decision aids might be of greater value when more extensive total knee arthroplasty presurgical assessment and counselling are either impractical or unavailable.

Effect of patient decision aid was influenced by presurgical evaluation among patients with osteoarthritis of the knee.

PubMed

Boland, Laura; Taljaard, Monica; Dervin, Geoffrey; Trenaman, Logan; Tugwell, Peter; Pomey, Marie-Pascale; Stacey, Dawn

2018-02-01

Decision aids help patients make total joint arthroplasty decisions, but presurgical evaluation might influence the effects of a decision aid. We compared the effects of a decision aid among patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes. We performed a subgroup analysis of a randomized controlled trial. Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education. We compared the effects of decision quality, decisional conflict and surgery rate using Cochran-Mantel-Haenszel χ 2 tests and the Breslow-Day test. We evaluated 242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls). Results suggested a between-site difference in the effect of the decision aid on the patients' decision quality ( p = 0.09): at the academic site, patients who used the decision aid were more likely to make better-quality decisions than controls (54% v. 35%, p = 0.044), but not at the community site (47% v. 51%, p = 0.71). Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p = 0.007) (33% v. 52%, p = 0.05 at the academic site and 40% v. 24%, p = 0.08 at the community site). The effect of the decision aid on surgery rates did not differ between sites ( p = 0.65). The decision aid had a greater effect at the academic site than at the community site, which provided longer consultations with more verbal education. Hence, decision aids might be of greater value when more extensive total knee arthroplasty presurgical assessment and counselling are either impractical or unavailable.

The use of syndromic surveillance for decision-making during the H1N1 pandemic: a qualitative study.

PubMed

Chu, Anna; Savage, Rachel; Willison, Don; Crowcroft, Natasha S; Rosella, Laura C; Sider, Doug; Garay, Jason; Gemmill, Ian; Winter, Anne-Luise; Davies, Richard F; Johnson, Ian

2012-10-30

Although an increasing number of studies are documenting uses of syndromic surveillance by front line public health, few detail the value added from linking syndromic data to public health decision-making. This study seeks to understand how syndromic data informed specific public health actions during the 2009 H1N1 pandemic. Semi-structured telephone interviews were conducted with participants from Ontario's public health departments, the provincial ministry of health and federal public health agency to gather information about syndromic surveillance systems used and the role of syndromic data in informing specific public health actions taken during the pandemic. Responses were compared with how the same decisions were made by non-syndromic surveillance users. Findings from 56 interviews (82% response) show that syndromic data were most used for monitoring virus activity, measuring impact on the health care system and informing the opening of influenza assessment centres in several jurisdictions, and supporting communications and messaging, rather than its intended purpose of early outbreak detection. Syndromic data had limited impact on decisions that involved the operation of immunization clinics, school closures, sending information letters home with school children or providing recommendations to health care providers. Both syndromic surveillance users and non-users reported that guidance from the provincial ministry of health, communications with stakeholders and vaccine availability were driving factors in these public health decisions. Syndromic surveillance had limited use in decision-making during the 2009 H1N1 pandemic in Ontario. This study provides insights into the reasons why this occurred. Despite this, syndromic data were valued for providing situational awareness and confidence to support public communications and recommendations. Developing an understanding of how syndromic data are utilized during public health events provides valuable evidence to support future investments in public health surveillance.

Use of Low-Literacy Decision Aid to Enhance Knowledge and Reduce Decisional Conflict Among a Diverse Population of Adults With Rheumatoid Arthritis: Results of a Pilot Study.

PubMed

Barton, Jennifer L; Trupin, Laura; Schillinger, Dean; Evans-Young, Gina; Imboden, John; Montori, Victor M; Yelin, Edward

2016-07-01

Despite innovations in treatment of rheumatoid arthritis (RA), adherence is poor and disparities persist. Shared decision making (SDM) promotes patient engagement and enhances adherence; however, few tools support SDM in RA. Our objective was to pilot a low-literacy medication guide and decision aid to facilitate patient-clinician conversations about RA medications. RA patients were consecutively enrolled into 1 of 3 arms: 1) control; patients received existing medication guide prior to clinic visit, 2) adapted guide prior to visit, and 3) adapted guide prior to plus decision aid during visit. Outcomes were collected immediately postvisit, at 1-week, and at 3- and 6-month interviews. Eligible adults had to have failed at least 1 disease-modifying antirheumatic drug and fulfill 1 of the following: age >65 years, immigrant, non-English speaker, less than high school education, limited health literacy, and racial/ethnic minority. Primary outcomes were knowledge of RA medications, decisional conflict, and acceptability of interventions. The majority of 166 patients were immigrants (66%), non-English speakers (54%), and had limited health literacy (71%). Adequate RA knowledge postvisit in arm 3 was higher (78%) than arm 1 (53%; adjusted odds ratio 2.7, 95% confidence interval 1.2, 6.1). Among patients with a medication change, there was lower (better) mean decisional conflict in arms 2 and 3 (P = 0.03). There were no significant differences in acceptability. A low-literacy medication guide and decision aid was acceptable, improved knowledge, and reduced decisional conflict among vulnerable RA patients. Enhancing knowledge and patient engagement with decision support tools may lead to medication choices better aligned with RA patients' values and preferences. © 2016, American College of Rheumatology.

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial.

PubMed

Schwartz, Peter H; Perkins, Susan M; Schmidt, Karen K; Muriello, Paul F; Althouse, Sandra; Rawl, Susan M

2017-08-01

Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge. Primary care patients (n = 213) eligible for colorectal cancer screening viewed basic screening information and were randomized to view (a) quantitative information (quantitative module), (b) a nudge towards stool testing with the fecal immunochemical test (FIT) (nudge module), (c) neither a nor b, or (d) both a and b. Outcome measures were perceived colorectal cancer risk, screening intent, preferred test, and decision conflict, measured before and after viewing the decision aid, and screening behavior at 6 months. Patients viewing the quantitative module were more likely to be screened than those who did not ( P = 0.012). Patients viewing the nudge module had a greater increase in perceived colorectal cancer risk than those who did not ( P = 0.041). Those viewing the quantitative module had a smaller increase in perceived risk than those who did not ( P = 0.046), and the effect was moderated by numeracy. Among patients with high numeracy who did not view the nudge module, those who viewed the quantitative module had a greater increase in intent to undergo FIT ( P = 0.028) than did those who did not. The limitations of this study were the limited sample size and single healthcare system. Adding quantitative information to a decision aid increased uptake of colorectal cancer screening, while adding a nudge to undergo FIT did not increase uptake. Further research on quantitative information in decision aids is warranted.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

PubMed

Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

2012-08-21

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

Reasoning Backwards by Design: Commentary on "Moral Reasoning among HEC Members".

PubMed

Stephens, Ashley L; Heitman, Elizabeth

2015-01-01

Empirical assessment of the practice of clinical ethics is made difficult by the limited standardization of settings, structures, processes, roles, and training for ethics consultation, as well as by whether individual ethics consultants or hospital ethics committees (HECs) provide consultation. Efforts to study the relationship between theory and practice in the work of HECs likewise require the spelling out of assumptions and definition of key variables, based in knowledge of the core concepts of clinical ethics and logistics of clinical consultation. The survey of HEC members reported by Wasserman and colleagues illustrates the difficulty of such research and calls attention to need for studies of real-time, complex decision making to inform conclusions about how theory affects practice. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

The factors facilitating and inhibiting effective clinical decision-making in nursing: a qualitative study

PubMed Central

Hagbaghery, Mohsen Adib; Salsali, Mahvash; Ahmadi, Fazlolah

2004-01-01

Background Nurses' practice takes place in a context of ongoing advances in research and technology. The dynamic and uncertain nature of health care environment requires nurses to be competent decision-makers in order to respond to clients' needs. Recently, the public and the government have criticized Iranian nurses because of poor quality of patient care. However nurses' views and experiences on factors that affect their clinical function and clinical decision-making have rarely been studied. Methods Grounded theory methodology was used to analyze the participants' lived experiences and their viewpoints regarding the factors affecting their clinical function and clinical decision-making. Semi-structured interviews and participant observation methods were used to gather the data. Thirty-eight participants were interviewed and twelve sessions of observation were carried out. Constant comparative analysis method was used to analyze the data. Results Five main themes emerged from the data. From the participants' points of view, "feeling competent", "being self-confident", "organizational structure", "nursing education", and "being supported" were considered as important factors in effective clinical decision-making. Conclusion As participants in this research implied, being competent and self-confident are the most important personal factors influencing nurses clinical decision-making. Also external factors such as organizational structure, access to supportive resources and nursing education have strengthening or inhibiting effects on the nurses' decisions. Individual nurses, professional associations, schools of nursing, nurse educators, organizations that employ nurses and government all have responsibility for developing and finding strategies that facilitate nurses' effective clinical decision-making. They are responsible for identifying barriers and enhancing factors within the organizational structure that facilitate nurses' clinical decision-making. PMID:15068484

Expert opinion and controversies in sports and musculoskeletal medicine: concussion in the young athlete.

PubMed

Standaert, Christopher J; Herring, Stanley A; Cantu, Robert C

2007-08-01

Concussion is a common injury in young athletes and can be very challenging for clinicians to diagnose and manage. Debate exists over not only the incidence of long-term risks of multiple concussions but also the potential for catastrophic outcomes after sports-related head injury. Decisions on returning athletes to competition can be difficult, and there are limited prospective data on which to make these decisions. This has resulted in the existence of a number of published guidelines and consensus statements on the management of concussion in athletes. Athletes sustaining a concussion need appropriate on-field care and structured follow-up. Baseline cognitive assessments can be helpful, but clinicians must be aware that head trauma may result in a wide array of clinical signs and symptoms. Delivery of care and decisions on return to play need to be based on an individual assessment of the affected athlete.

Development of an integrated medical supply information system

NASA Astrophysics Data System (ADS)

Xu, Eric; Wermus, Marek; Blythe Bauman, Deborah

2011-08-01

The integrated medical supply inventory control system introduced in this study is a hybrid system that is shaped by the nature of medical supply, usage and storage capacity limitations of health care facilities. The system links demand, service provided at the clinic, health care service provider's information, inventory storage data and decision support tools into an integrated information system. ABC analysis method, economic order quantity model, two-bin method and safety stock concept are applied as decision support models to tackle inventory management issues at health care facilities. In the decision support module, each medical item and storage location has been scrutinised to determine the best-fit inventory control policy. The pilot case study demonstrates that the integrated medical supply information system holds several advantages for inventory managers, since it entails benefits of deploying enterprise information systems to manage medical supply and better patient services.

Addressing standards of care in resource-limited settings.

PubMed

Dawson, Liza; Klingman, Karin L; Marrazzo, Jeanne

2014-01-01

: The choice between "best-known" standards of care (SOC) or "best available" standards as the control arm in a clinical trial is a fundamental dilemma in clinical research in resource-limited settings (RLS). When the health system is delivering less than an optimal level of care, using highest standard of care in a clinical trial may produce results that cannot be implemented or sustained locally. On the other hand, using interventions that are more feasible in the local setting may involve suboptimal care, and clinical outcomes may be affected. The need for improved standards in health systems in RLS, and the difficulty in securing them, has led many researchers advocate for policy changes at the national or international level to improve clinical care more systemically. SOC decisions in a clinical trial affect the level of benefit provided to study participants and the policy implications of the trial findings. SOC choices should provide high-quality care to help advance the health care system in host countries participating in the trial, but balancing the scientific and ethical objectives of SOC choices is difficult, and there is no single formula for selecting the appropriate SOC. Despite the challenges, well-designed and conducted clinical trials can and should make significant contributions to health systems in RLS.

The clinical utility index as a practical multiattribute approach to drug development decisions.

PubMed

Poland, B; Hodge, F L; Khan, A; Clemen, R T; Wagner, J A; Dykstra, K; Krishna, R

2009-07-01

We identify some innovative approaches to predicting overall patient benefit from investigational drugs to support development decisions. We then illustrate calculation of a probabilistic clinical utility index (CUI), an implementation of multiattribute utility that focuses on clinical attributes. We recommend use of the CUI for the support of early drug development decisions because of its practicality, reasonable accuracy, and transparency to decision makers, at stages in which financial factors that may dominate later-phase decisions are less critical.

Collaborative learning using nursing student dyads in the clinical setting.

PubMed

Austria, Mary Jean; Baraki, Katie; Doig, Alexa K

2013-05-04

Formal pairing of student nurses to work collaboratively on one patient assignment is a strategy for improving the quality and efficiency of clinical instruction while better utilizing the limited resources at clinical agencies. The aim of this qualitative study was to explore the student nurse and patient experiences of collaborative learning when peer dyads are used in clinical nursing education. Interviews were conducted with 11 students and 9 patients. Students described the process of collaborative learning as information sharing, cross-checking when making clinical decisions, and group processing when assessing the outcomes of nursing interventions. Positive outcomes reported by students and patients included reduced student anxiety, increased confidence and task efficiency. Students' primary concern was reduced opportunity to perform hands-on skills which had to be negotiated within each dyad. Meeting the present and future challenges of educating nurses will require innovative models of clinical instruction such as collaborative learning using student peer dyads.

Primary Repair of Moderate Severity Rhegmatogenous Retinal Detachment: A Critical Decision-Making Algorithm.

PubMed

Velez-Montoya, Raul; Jacobo-Oceguera, Paola; Flores-Preciado, Javier; Dalma-Weiszhausz, Jose; Guerrero-Naranjo, Jose; Salcedo-Villanueva, Guillermo; Garcia-Aguirre, Gerardo; Fromow-Guerra, Jans; Morales-Canton, Virgilio

2016-01-01

We reviewed all the available data regarding the current management of non-complex rhegmatogenous retinal detachment and aimed to propose a new decision-making algorithm aimed to improve the single surgery success rate for mid-severity rhegmatogenous retinal detachment. An online review of the Pubmed database was performed. We searched for all available manuscripts about the anatomical and functional outcomes after the surgical management, by either scleral buckle or primary pars plana vitrectomy, of retinal detachment. The search was limited to articles published from January 1995 to December 2015. All articles obtained from the search were carefully screened and their references were manually reviewed for additional relevant data. Our search specifically focused on preoperative clinical data that were associated with the surgical outcomes. After categorizing the available data according to their level of evidence, with randomized-controlled clinical trials as the highest possible level of evidence, followed by retrospective studies, and retrospective case series as the lowest level of evidence, we proceeded to design a logical decision-making algorithm, enhanced by our experiences as retinal surgeons. A total of 7 randomized-controlled clinical trials, 19 retrospective studies, and 9 case series were considered. Additional articles were also included in order to support the observations further. Rhegmatogenous retinal detachment is a potentially blinding disorder. Its surgical management seems to depend more on a surgeon´s preference than solid scientific data or is based on a good clinical history and examination. The algorithms proposed herein strive to offer a more rational approach to improve both anatomical and functional outcomes after the first surgery.

More than the money: A review of the literature examining healthy volunteer motivations

PubMed Central

Stunkel, Leanne; Grady, Christine

2016-01-01

Background and Objective Few existing data report the motivations of healthy volunteers in clinical research trials. Some worry that volunteers consider only financial motivations. This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation. Study Selection A systematic PubMed search was conducted. Inclusion criteria captured English-language empirical studies on the self-reported motivations, reasons, or factors influencing the decision of healthy volunteers to enroll in clinical research. Twelve studies involving more than 2000 healthy volunteers met the criteria and were included in this review. Data Extraction Independent review by the authors and extraction of information about the sample, methodology and objective of the motivations study, description of the clinical trial and whether participation was actual or hypothetical, reported primary and secondary motivations of the healthy volunteers, risk evaluation, and reported differences in motivations related to sociodemographic variables. Results This review showed that although financial reward is the primary motivation for healthy volunteers to participate in clinical trials, financial motivations are one among many other reported motivations, including contributing to science or the health of others, accessing ancillary healthcare benefits, scientific interest or interest in the goals of the study, as well as meeting people and curiosity. Volunteers consider risk when making a decision about participation. Conclusions Although financial incentives are important in recruiting healthy volunteers, their motivations are not limited to financial motivations. Further research is needed to examine motivations in different contexts and countries, the decision making of healthy volunteers, and the dynamics of repeat participation. PMID:21146635

Primary Repair of Moderate Severity Rhegmatogenous Retinal Detachment: A Critical Decision-Making Algorithm

PubMed Central

VELEZ-MONTOYA, Raul; JACOBO-OCEGUERA, Paola; FLORES-PRECIADO, Javier; DALMA-WEISZHAUSZ, Jose; GUERRERO-NARANJO, Jose; SALCEDO-VILLANUEVA, Guillermo; GARCIA-AGUIRRE, Gerardo; FROMOW-GUERRA, Jans; MORALES-CANTON, Virgilio

2016-01-01

We reviewed all the available data regarding the current management of non-complex rhegmatogenous retinal detachment and aimed to propose a new decision-making algorithm aimed to improve the single surgery success rate for mid-severity rhegmatogenous retinal detachment. An online review of the Pubmed database was performed. We searched for all available manuscripts about the anatomical and functional outcomes after the surgical management, by either scleral buckle or primary pars plana vitrectomy, of retinal detachment. The search was limited to articles published from January 1995 to December 2015. All articles obtained from the search were carefully screened and their references were manually reviewed for additional relevant data. Our search specifically focused on preoperative clinical data that were associated with the surgical outcomes. After categorizing the available data according to their level of evidence, with randomized-controlled clinical trials as the highest possible level of evidence, followed by retrospective studies, and retrospective case series as the lowest level of evidence, we proceeded to design a logical decision-making algorithm, enhanced by our experiences as retinal surgeons. A total of 7 randomized-controlled clinical trials, 19 retrospective studies, and 9 case series were considered. Additional articles were also included in order to support the observations further. Rhegmatogenous retinal detachment is a potentially blinding disorder. Its surgical management seems to depend more on a surgeon´s preference than solid scientific data or is based on a good clinical history and examination. The algorithms proposed herein strive to offer a more rational approach to improve both anatomical and functional outcomes after the first surgery. PMID:28289689

Driving with roadmaps and dashboards: using information resources to structure the decision models in service organizations.

PubMed

Chorpita, Bruce F; Bernstein, Adam; Daleiden, Eric L

2008-03-01

This paper illustrates the application of design principles for tools that structure clinical decision-making. If the effort to implement evidence-based practices in community services organizations is to be effective, attention must be paid to the decision-making context in which such treatments are delivered. Clinical research trials commonly occur in an environment characterized by structured decision making and expert supports. Technology has great potential to serve mental health organizations by supporting these potentially important contextual features of the research environment, through organization and reporting of clinical data into interpretable information to support decisions and anchor decision-making procedures. This article describes one example of a behavioral health reporting system designed to facilitate clinical and administrative use of evidence-based practices. The design processes underlying this system-mapping of decision points and distillation of performance information at the individual, caseload, and organizational levels-can be implemented to support clinical practice in a wide variety of settings.

Prognosis of the individual course of disease: the elements of time, heterogeneity and precision.

PubMed

Daumer, Martin; Neuhaus, Anneke; Herbert, Joseph; Ebers, George

2009-12-01

There is no gold standard in monitoring disease activity for clinical trials in multiple sclerosis. Various outcome measures, including relapses, disability and magnetic resonance imaging (MRI) measures have been used to demonstrate the efficacy of the different available therapies for multiple sclerosis. Recently, the potential limitations of these measures have received increasing attention, and these have stimulated research into more appropriate and sensitive outcome measures for clinical trials. For example, it has been shown that widely-used MRI measures add little, if any, independent information to that provided by more clinically relevant measures such as relapses and disability. Similarly, the Expanded Disability status Scale (EDSS), which is the most widely-used measure of disability related to multiple sclerosis, is insufficiently sensitive to detect robust changes in disability over the timeframes usually used in clinical trials. An alternative to the EDSS is the Multiple Sclerosis Severity Score (MSSS), a severity scale which relates clinical disability to disease duration. The MSSS was originally developed from a database of nearly ten thousand patients from eleven European countries and Australia and has since been reproduced in an independent dataset of 1134 patients from the placebo arms of randomised clinical trials. Based on the MSSS score, disease severity can be defined, which shows stability over time and may provide evidence-based decision support for patient management. Another alternative to measure disability is the objective quantification of physical activity. There is evidence that recent developments in pervasive computing using tiny accelerometers may have the potential to increase the reliability and precision of motor assessment, especially in the mid-range of the EDSS. The outcome measures discussed have potential use as online tools for evidence-based decision support which are increasingly being used in medical research and clinical decision-making. Copyright 2009 Elsevier Ltd. All rights reserved.

When four principles are too many: bloodgate, integrity and an action-guiding model of ethical decision making in clinical practice.

PubMed

Muirhead, William

2012-04-01

Medical ethical analysis remains dominated by the principlist account first proposed by Beauchamp and Childress. This paper argues that the principlist model is unreflective of how ethical decisions are taken in clinical practice. Two kinds of medical ethical decisions are distinguished: biosocial ethics and clinical ethics. It is argued that principlism is an inappropriate model for clinical ethics as it is neither sufficiently action-guiding nor does it emphasise the professional integrity of the clinician. An alternative model is proposed for decision making in the realm of clinical ethics.

The perspectives of Iranian physicians and patients towards patient decision aids: a qualitative study.

PubMed

Rashidian, Hamideh; Nedjat, Saharnaz; Majdzadeh, Reza; Gholami, Jaleh; Haghjou, Leila; Abdollahi, Bahar Sadeghi; Davatchi, Fereydoun; Rashidian, Arash

2013-09-25

Patient preference is one of the main components of clinical decision making, therefore leading to the development of patient decision aids. The goal of this study was to describe physicians' and patients' viewpoints on the barriers and limitations of using patient decision aids in Iran, their proposed solutions, and, the benefits of using these tools. This qualitative study was conducted in 2011 in Iran by holding in-depth interviews with 14 physicians and 8 arthritis patient. Interviewees were selected through purposeful and maximum variation sampling. As an example, a patient decision aid on the treatment of knee arthritis was developed upon literature reviews and gathering expert opinion, and was presented at the time of interview. Thematic analysis was conducted to analyze the data by using the OpenCode software. The results were summarized into three categories and ten codes. The extracted categories were the perceived benefits of using the tools, as well as the patient-related and physician-related barriers in using decision aids. The following barriers in using patient decision aids were identified in this study: lack of patients and physicians' trainings in shared decision making, lack of specialist per capita, low treatment tariffs and lack of an exact evaluation system for patient participation in decision making. No doubt these barriers demand the health authorities' special attention. Hence, despite patients and physicians' inclination toward using patient decision aids, these problems have hindered the practical usage of these tools in Iran--as a developing country.

Management of Patients With Pancreatic Cysts: Analysis of Possible False-Negative Cases of Malignancy.

PubMed

Kowalski, Thomas; Siddiqui, Ali; Loren, David; Mertz, Howard R; Mallat, Damien; Haddad, Nadim; Malhotra, Nidhi; Sadowski, Brett; Lybik, Mark J; Patel, Sandeep N; Okoh, Emuejevoke; Rosenkranz, Laura; Karasik, Michael; Golioto, Michael; Linder, Jeffrey; Catalano, Marc F; Al-Haddad, Mohammad A

2016-09-01

To examine the utility of integrated molecular pathology (IMP) in managing surveillance of pancreatic cysts based on outcomes and analysis of false negatives (FNs) from a previously published cohort (n=492). In endoscopic ultrasound with fine-needle aspiration (EUS-FNA) of cyst fluid lacking malignant cytology, IMP demonstrated better risk stratification for malignancy at approximately 3 years' follow-up than International Consensus Guideline (Fukuoka) 2012 management recommendations in such cases. Patient outcomes and clinical features of Fukuoka and IMP FN cases were reviewed. Practical guidance for appropriate surveillance intervals and surgery decisions using IMP were derived from follow-up data, considering EUS-FNA sampling limitations and high-risk clinical circumstances observed. Surveillance intervals for patients based on IMP predictive value were compared with those of Fukuoka. Outcomes at follow-up for IMP low-risk diagnoses supported surveillance every 2 to 3 years, independent of cyst size, when EUS-FNA sampling limitations or high-risk clinical circumstances were absent. In 10 of 11 patients with FN IMP diagnoses (2% of cohort), EUS-FNA sampling limitations existed; Fukuoka identified high risk in 9 of 11 cases. In 4 of 6 FN cases by Fukuoka (1% of cohort), IMP identified high risk. Overall, 55% of cases had possible sampling limitations and 37% had high-risk clinical circumstances. Outcomes support more cautious management in such cases when using IMP. Adjunct use of IMP can provide evidence for relaxed surveillance of patients with benign cysts that meet Fukuoka criteria for closer observation or surgery. Although infrequent, FN results with IMP can be associated with EUS-FNA sampling limitations or high-risk clinical circumstances.

The roles of social stress and decision-making in non-suicidal self-injury.

PubMed

Schatten, Heather T; Andover, Margaret S; Armey, Michael F

2015-10-30

Research suggests that individuals with a history of non-suicidal self-injury (NSSI) do not have difficulty generating alternatives to social problems but choose more negative solutions, suggesting a deficit in decision-making. However, studies report no significant differences in risky decision-making on a performance-based task among individuals with and without NSSI histories. A limitation of these studies is that decision-making was only assessed at baseline. As individuals with a history of NSSI typically self-injure when experiencing negative emotions, decision-making ability may become impaired specifically in the presence of these emotions. The aim of the current study was to investigate decision-making ability among individuals with and without NSSI histories both at baseline and following a distressing social exclusion task. We compared individuals with (n=48) and without (n=72) NSSI histories on the Iowa Gambling Task, a behavioral measure of risky decision-making, before and after exclusion or inclusion on the Cyberball task. Results indicated no significant group differences in performance regardless of condition. When participants were grouped by racial/ethnic minority status, results indicated that non-Hispanic White individuals with a history of NSSI exhibited deterioration in risky decision-making ability following social exclusion. Potential explanations for these findings and clinical implications are discussed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

PubMed

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-01-01

Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

Pregnancy and Protection: The Ethics of Limiting a Pregnant Woman’s Participation in Clinical Trials

PubMed Central

Allesee, Lori; Gallagher, Colleen M.

2011-01-01

The call for the inclusion of pregnant women in clinical trials has received renewed attention recently. This interest springs from articles in various medical journals highlighting the gaps in medical knowledge and the need to improve health care for pregnant women. It is not a simple decision whether to include pregnant women in studies or not. The general thought is that it’s too dangerous for the baby if a pregnant woman is participating in a trial, and the absence of research on how medications work in pregnant women leave doctors guessing about how to safely and effectively treat patients through pregnancy. Excluding pregnant women from clinical trials are not automatic, not unethical nor is it arbitrarily determined. The regulatory framework is based on sound ethical and legal reasoning that demonstrates when inclusion in a clinical trial is appropriate or when clear and compelling reasons for exclusion are presented. Learning objective Readers will learn about limitations of research, history of the inclusion and exclusion of pregnant women in clinical trials, reticence for inclusions, as well as regulations designed using reasoned legal and ethical principles, such as: Principle of Autonomy, Informed Consent, and Beneficence and Nonmaleficence. PMID:21863146

Shared decision making and use of decision AIDS for localized prostate cancer : perceptions from radiation oncologists and urologists.

PubMed

Wang, Elyn H; Gross, Cary P; Tilburt, Jon C; Yu, James B; Nguyen, Paul L; Smaldone, Marc C; Shah, Nilay D; Abouassally, Robert; Sun, Maxine; Kim, Simon P

2015-05-01

The current attitudes of prostate cancer specialists toward decision aids and their use in clinical practice to facilitate shared decision making are poorly understood. To assess attitudes toward decision aids and their dissemination in clinical practice. A survey was mailed to a national random sample of 1422 specialists (711 radiation oncologists and 711 urologists) in the United States from November 1, 2011, through April 30, 2012. Respondents were asked about familiarity, perceptions, and use of decision aids for clinically localized prostate cancer and trust in various professional societies in developing decision aids. The Pearson χ2 test was used to test for bivariate associations between physician characteristics and outcomes. Similar response rates were observed for radiation oncologists and urologists (44.0% vs 46.1%; P=.46). Although most respondents had some familiarity with decision aids, only 35.5% currently use a decision aid in clinic practice. The most commonly cited barriers to decision aid use included the perception that their ability to estimate the risk of recurrence was superior to that of decision aids (7.7% in those not using decision aids and 26.2% in those using decision aids; P<.001) and the concern that patients could not process information from a decision aid (7.6% in those not using decision aids and 23.7% in those using decision aids; P<.001). In assessing trust in decision aids established by various professional medical societies, specialists consistently reported trust in favor of their respective organizations, with 9.2% being very confident and 59.2% being moderately confident (P=.01). Use of decision aids among specialists treating patients with prostate cancer is relatively low. Efforts to address barriers to clinical implementation of decision aids may facilitate greater shared decision making for patients diagnosed as having prostate cancer.

An evidence-based shared decision making programme on the prevention of myocardial infarction in type 2 diabetes: protocol of a randomised-controlled trial.

PubMed

Buhse, Susanne; Heller, Tabitha; Kasper, Jürgen; Mühlhauser, Ingrid; Müller, Ulrich Alfons; Lehmann, Thomas; Lenz, Matthias

2013-10-19

Lack of patient involvement in decision making has been suggested as one reason for limited treatment success. Concepts such as shared decision making may contribute to high quality healthcare by supporting patients to make informed decisions together with their physicians.A multi-component shared decision making programme on the prevention of heart attack in type 2 diabetes has been developed. It aims at improving the quality of decision-making by providing evidence-based patient information, enhancing patients' knowledge, and supporting them to actively participate in decision-making. In this study the efficacy of the programme is evaluated in the setting of a diabetes clinic. A single blinded randomised-controlled trial is conducted to compare the shared decision making programme with a control-intervention. The intervention consists of an evidence-based patient decision aid on the prevention of myocardial infarction and a corresponding counselling module provided by diabetes educators. Similar in duration and structure, the control-intervention targets nutrition, sports, and stress coping. A total of 154 patients between 40 and 69 years of age with type 2 diabetes and no previous diagnosis of ischaemic heart disease or stroke are enrolled and allocated either to the intervention or the control-intervention. Primary outcome measure is the patients' knowledge on benefits and harms of heart attack prevention captured by a standardised knowledge test. Key secondary outcome measure is the achievement of treatment goals prioritised by the individual patient. Treatment goals refer to statin taking, HbA1c-, blood pressure levels and smoking status. Outcomes are assessed directly after the counselling and at 6 months follow-up. Analyses will be carried out on intention-to-treat basis. Concurrent qualitative methods are used to explore intervention fidelity and to gain insight into implementation processes. Interventions to facilitate evidence-based shared decision making represent an innovative approach in diabetes care. The results of this study will provide information on the efficacy of such a concept in the setting of a diabetes clinic in Germany. ISRCTN84636255.

Midwives׳ clinical reasoning during second stage labour: Report on an interpretive study.

PubMed

Jefford, Elaine; Fahy, Kathleen

2015-05-01

clinical reasoning was once thought to be the exclusive domain of medicine - setting it apart from 'non-scientific' occupations like midwifery. Poor assessment, clinical reasoning and decision-making skills are well known contributors to adverse outcomes in maternity care. Midwifery decision-making models share a common deficit: they are insufficiently detailed to guide reasoning processes for midwives in practice. For these reasons we wanted to explore if midwives actively engaged in clinical reasoning processes within their clinical practice and if so to what extent. The study was conducted using post structural, feminist methodology. to what extent do midwives engage in clinical reasoning processes when making decisions in the second stage labour? twenty-six practising midwives were interviewed. Feminist interpretive analysis was conducted by two researchers guided by the steps of a model of clinical reasoning process. Six narratives were excluded from analysis because they did not sufficiently address the research question. The midwives narratives were prepared via data reduction. A theoretically informed analysis and interpretation was conducted. using a feminist, interpretive approach we created a model of midwifery clinical reasoning grounded in the literature and consistent with the data. Thirteen of the 20 participant narratives demonstrate analytical clinical reasoning abilities but only nine completed the process and implemented the decision. Seven midwives used non-analytical decision-making without adequately checking against assessment data. over half of the participants demonstrated the ability to use clinical reasoning skills. Less than half of the midwives demonstrated clinical reasoning as their way of making decisions. The new model of Midwifery Clinical Reasoning includes 'intuition' as a valued way of knowing. Using intuition, however, should not replace clinical reasoning which promotes through decision-making can be made transparent and be consensually validated. Copyright © 2015 Elsevier Ltd. All rights reserved.

Use of handheld computers in clinical practice: a systematic review.

PubMed

Mickan, Sharon; Atherton, Helen; Roberts, Nia Wyn; Heneghan, Carl; Tilson, Julie K

2014-07-06

Many healthcare professionals use smartphones and tablets to inform patient care. Contemporary research suggests that handheld computers may support aspects of clinical diagnosis and management. This systematic review was designed to synthesise high quality evidence to answer the question; Does healthcare professionals' use of handheld computers improve their access to information and support clinical decision making at the point of care? A detailed search was conducted using Cochrane, MEDLINE, EMBASE, PsycINFO, Science and Social Science Citation Indices since 2001. Interventions promoting healthcare professionals seeking information or making clinical decisions using handheld computers were included. Classroom learning and the use of laptop computers were excluded. Two authors independently selected studies, assessed quality using the Cochrane Risk of Bias tool and extracted data. High levels of data heterogeneity negated statistical synthesis. Instead, evidence for effectiveness was summarised narratively, according to each study's aim for assessing the impact of handheld computer use. We included seven randomised trials investigating medical or nursing staffs' use of Personal Digital Assistants. Effectiveness was demonstrated across three distinct functions that emerged from the data: accessing information for clinical knowledge, adherence to guidelines and diagnostic decision making. When healthcare professionals used handheld computers to access clinical information, their knowledge improved significantly more than peers who used paper resources. When clinical guideline recommendations were presented on handheld computers, clinicians made significantly safer prescribing decisions and adhered more closely to recommendations than peers using paper resources. Finally, healthcare professionals made significantly more appropriate diagnostic decisions using clinical decision making tools on handheld computers compared to colleagues who did not have access to these tools. For these clinical decisions, the numbers need to test/screen were all less than 11. Healthcare professionals' use of handheld computers may improve their information seeking, adherence to guidelines and clinical decision making. Handheld computers can provide real time access to and analysis of clinical information. The integration of clinical decision support systems within handheld computers offers clinicians the highest level of synthesised evidence at the point of care. Future research is needed to replicate these early results and to identify beneficial clinical outcomes.

Use of handheld computers in clinical practice: a systematic review

PubMed Central

2014-01-01

Background Many healthcare professionals use smartphones and tablets to inform patient care. Contemporary research suggests that handheld computers may support aspects of clinical diagnosis and management. This systematic review was designed to synthesise high quality evidence to answer the question; Does healthcare professionals’ use of handheld computers improve their access to information and support clinical decision making at the point of care? Methods A detailed search was conducted using Cochrane, MEDLINE, EMBASE, PsycINFO, Science and Social Science Citation Indices since 2001. Interventions promoting healthcare professionals seeking information or making clinical decisions using handheld computers were included. Classroom learning and the use of laptop computers were excluded. Two authors independently selected studies, assessed quality using the Cochrane Risk of Bias tool and extracted data. High levels of data heterogeneity negated statistical synthesis. Instead, evidence for effectiveness was summarised narratively, according to each study’s aim for assessing the impact of handheld computer use. Results We included seven randomised trials investigating medical or nursing staffs’ use of Personal Digital Assistants. Effectiveness was demonstrated across three distinct functions that emerged from the data: accessing information for clinical knowledge, adherence to guidelines and diagnostic decision making. When healthcare professionals used handheld computers to access clinical information, their knowledge improved significantly more than peers who used paper resources. When clinical guideline recommendations were presented on handheld computers, clinicians made significantly safer prescribing decisions and adhered more closely to recommendations than peers using paper resources. Finally, healthcare professionals made significantly more appropriate diagnostic decisions using clinical decision making tools on handheld computers compared to colleagues who did not have access to these tools. For these clinical decisions, the numbers need to test/screen were all less than 11. Conclusion Healthcare professionals’ use of handheld computers may improve their information seeking, adherence to guidelines and clinical decision making. Handheld computers can provide real time access to and analysis of clinical information. The integration of clinical decision support systems within handheld computers offers clinicians the highest level of synthesised evidence at the point of care. Future research is needed to replicate these early results and to identify beneficial clinical outcomes. PMID:24998515

A problem solving and decision making toolbox for approaching clinical problems and decisions.

PubMed

Margolis, C; Jotkowitz, A; Sitter, H

2004-08-01

In this paper, we begin by presenting three real patients and then review all the practical conceptual tools that have been suggested for systematically analyzing clinical problems. Each of these conceptual tools (e.g. Evidence-Based Medicine, Clinical Practice Guidelines, Decision Analysis) deals mainly with a different type or aspect of clinical problems. We suggest that all of these conceptual tools can be thought of as belonging in the clinician's toolbox for solving clinical problems and making clinical decisions. A heuristic for guiding the clinician in using the tools is proposed. The heuristic is then used to analyze management of the three patients presented at the outset. Copyright 2004 Birkhäuser Verlag, Basel

Professionalism and clinical autonomy in the practice of medicine.

PubMed

Morreim, E Haavi

2002-11-01

Professionalism in medicine requires a reasonable measure of freedom for physicians to determine patients needs based on their own judgment. However, because virtually every medical decision is also a spending decision, third-party payers concerned about rising health care costs have introduced cost-containment tactics that significantly limit physicians accustomed autonomy. In response, groups of physicians have filed class-action lawsuits against managed care plans, alleging causes of action such as fraud, breach of contract, extortion, and violations of federal RICO (Racketeer-Influenced and Corrupt Organizations) law. Such litigation may have merits, but it also faces significant obstacles, in part because the contracts involved may not actually have promised the broad measure of clinical autonomy that the physicians allege was promised, then denied. As physicians seek to restore and retain their professional autonomy, it will be important for them to be increasingly proactive in structuring or modifying the contracts under whose terms they practice as some physicians have successfully done.

Mother-caregiver expectations for function among survivors of childhood brain tumors

PubMed Central

Barakat, Lamia P.; Ulrich, Connie M.; Jones, Nora L.; Deatrick, Janet A.

2015-01-01

Purpose Children diagnosed with brain tumors increasingly survive to adulthood, although they do so with needs often requiring continued parental caregiving. We sought to describe the nature of caregivers’ expectations about survivors’ function and how expectations connect to ongoing management and decision-making. Methods Forty-five qualitative interviews with mother-caregivers were conducted and coded for themes related to expectations for their adolescent/young adult children living post-childhood brain tumors. Results Five main themes emerged as integral to mother-caregiver expectations: realizing a difference in the survivor, noticing limitations to independence in the survivor, memories of learning about clinical prognoses as understood from consent meetings and education, managing these realizations, and acknowledging unresolved challenges. Conclusions Caregiver expectations are influenced by both initial clinical interactions and contemporary family dynamics and require individual- and family-specific survivorship planning. As caregiver expectations can influence management behaviors that impact outcomes and possibly independence, implications for clinician-caregiver shared decision-making are substantial. PMID:26556212

Lessons Learned From A Study Of Genomics-Based Carrier Screening For Reproductive Decision Making.

PubMed

Wilfond, Benjamin S; Kauffman, Tia L; Jarvik, Gail P; Reiss, Jacob A; Richards, C Sue; McMullen, Carmit; Gilmore, Marian; Himes, Patricia; Kraft, Stephanie A; Porter, Kathryn M; Schneider, Jennifer L; Punj, Sumit; Leo, Michael C; Dickerson, John F; Lynch, Frances L; Clarke, Elizabeth; Rope, Alan F; Lutz, Kevin; Goddard, Katrina A B

2018-05-01

Genomics-based carrier screening is one of many opportunities to use genomic information to inform medical decision making, but clinicians, health care delivery systems, and payers need to determine whether to offer screening and how to do so in an efficient, ethical way. To shed light on this issue, we conducted a study in the period 2014-17 to inform the design of clinical screening programs and guide further health services research. Many of our results have been published elsewhere; this article summarizes the lessons we learned from that study and offers policy insights. Our experience can inform understanding of the potential impact of expanded carrier screening services on health system workflows and workforces-impacts that depend on the details of the screening approach. We found limited patient or health system harms from expanded screening. We also found that some patients valued the information they learned from the process. Future policy discussions should consider the value of offering such expanded carrier screening in health delivery systems with limited resources.

The impact of simulation sequencing on perceived clinical decision making.

PubMed

Woda, Aimee; Hansen, Jamie; Paquette, Mary; Topp, Robert

2017-09-01

An emerging nursing education trend is to utilize simulated learning experiences as a means to optimize competency and decision making skills. The purpose of this study was to examine differences in students' perception of clinical decision making and clinical decision making-related self-confidence and anxiety based on the sequence (order) in which they participated in a block of simulated versus hospital-based learning experiences. A quasi-experimental crossover design was used. Between and within group differences were found relative to self-confidence with the decision making process. When comparing groups, at baseline the simulation followed by hospital group had significantly higher self-confidence scores, however, at 14-weeks both groups were not significantly different. Significant within group differences were found in the simulation followed by hospital group only, demonstrating a significant decrease in clinical decision making related anxiety across the semester. Finally, there were no significant difference in; perceived clinical decision making within or between the groups at the two measurement points. Preliminary findings suggest that simulated learning experiences can be offered with alternating sequences without impacting the process, anxiety or confidence with clinical decision making. This study provides beginning evidence to guide curriculum development and allow flexibility based on student needs and available resources. Copyright © 2017. Published by Elsevier Ltd.

The role of law in decisions to withhold and withdraw life-sustaining treatment from adults who lack capacity: a cross-sectional study.

PubMed

White, Benjamin P; Willmott, Lindy; Williams, Gail; Cartwright, Colleen; Parker, Malcolm

2017-05-01

To determine the role played by law in medical specialists' decision-making about withholding and withdrawing life-sustaining treatment from adults who lack capacity, and the extent to which legal knowledge affects whether law is followed. Cross-sectional postal survey of medical specialists. The two largest Australian states by population. 649 medical specialists from seven specialties most likely to be involved in end-of-life decision-making in the acute setting. Compliance with law and the impact of legal knowledge on compliance. 649 medical specialists (of 2104 potential participants) completed the survey (response rate 31%). Responses to a hypothetical scenario found a potential low rate of legal compliance, 32% (95% CI 28% to 36%). Knowledge of the law and legal compliance were associated: within compliers, 86% (95% CI 83% to 91%) had specific knowledge of the relevant aspect of the law, compared with 60% (95% CI 55% to 65%) within non-compliers. However, the reasons medical specialists gave for making decisions did not vary according to legal knowledge. Medical specialists prioritise patient-related clinical factors over law when confronted with a scenario where legal compliance is inconsistent with what they believe is clinically indicated. Although legally knowledgeable specialists were more likely to comply with the law, compliance in the scenario was not motivated by an intention to follow law. Ethical considerations (which are different from, but often align with, law) are suggested as a more important influence in clinical decision-making. More education and training of doctors is needed to demonstrate the role, relevance and utility of law in end-of-life care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A matter of life and death: controversy at the interface between clinical and legal decision-making in prolonged disorders of consciousness.

PubMed

Turner-Stokes, Lynne

2017-07-01

Best interests decision-making and end-of-life care for patients in permanent vegetative or minimally conscious states (VS/MCS) is a complex area of clinical and legal practice, which is poorly understood by most clinicians, lawyers and members of the public. In recent weeks, the Oxford Shrieval lecture by Mr Justice Baker ('A Matter of Life and Death', 11 October 2016) and its subsequent reporting in the public press has sparked debate on the respective roles of clinicians, the Court of Protection and the Mental Capacity Act 2005 in decisions to withhold or withdraw life-sustaining treatments from patients with disorders of consciousness. The debate became polarised and confused by misquotation and inaccurate terminology, and highlighted a lack of knowledge about how patients in VS/MCS die in the absence of court approval. This article sets out the background and discussion and attempts to give a more accurate representation of the facts. In the spirit of transparency, I present a mortality review of all the patients in VS/MCS who have died under the care of my own unit in the last decade-with or without referral to the court, but always in accordance with the law. These data demonstrate that clinicians regularly undertake best interests decision-making in conjunction with families that may include life and death decisions (sometimes even the withdrawal or withholding of clinically assisted nutrition and hydration); and that these can be made within the current legal framework without necessarily involving the court in all cases. This is the first published case series of its kind. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

mHealth for Clinical Decision-Making in Sub-Saharan Africa: A Scoping Review

PubMed Central

Albersen, Bregje Joanna Antonia; De Brouwere, Vincent; van Roosmalen, Jos; Zweekhorst, Marjolein

2017-01-01

Background In a bid to deliver quality health services in resource-poor settings, mobile health (mHealth) is increasingly being adopted. The role of mHealth in facilitating evidence-based clinical decision-making through data collection, decision algorithms, and evidence-based guidelines, for example, is established in resource-rich settings. However, the extent to which mobile clinical decision support systems (mCDSS) have been adopted specifically in resource-poor settings such as Africa and the lessons learned about their use in such settings are yet to be established. Objective The aim of this study was to synthesize evidence on the use of mHealth for point-of-care decision support and improved quality of care by health care workers in Africa. Methods A scoping review of 4 peer-reviewed and 1 grey literature databases was conducted. No date limits were applied, but only articles in English language were selected. Using pre-established criteria, 2 reviewers screened articles and extracted data. Articles were analyzed using Microsoft Excel and MAXQDA. Results We retained 22 articles representing 11 different studies in 7 sub-Saharan African countries. Interventions were mainly in the domain of maternal health and ranged from simple text messaging (short message service, SMS) to complex multicomponent interventions. Although health workers are generally supportive of mCDSS and perceive them as useful, concerns about increased workload and altered workflow hinder sustainability. Facilitators and barriers to use of mCDSS include technical and infrastructural support, ownership, health system challenges, and training. Conclusions The use of mCDSS in sub-Saharan Africa is an indication of progress in mHealth, although their effect on quality of service delivery is yet to be fully explored. Lessons learned are useful for informing future research, policy, and practice for technologically supported health care delivery, especially in resource-poor settings. PMID:28336504

Quality and quantity of information in summary basis of decision documents issued by health Canada.

PubMed

Habibi, Roojin; Lexchin, Joel

2014-01-01

Health Canada's Summary Basis of Decision (SBD) documents outline the clinical trial information that was considered in approving a new drug. We examined the ability of SBDs to inform clinician decision-making. We asked if SBDs answered three questions that clinicians might have prior to prescribing a new drug: 1) Do the characteristics of patients enrolled in trials match those of patients in their practice? 2) What are the details concerning the drug's risks and benefits? 3) What are the basic characteristics of trials? 14 items of clinical trial information were identified from all SBDs published on or before April 2012. Each item received a score of 2 (present), 1 (unclear) or 0 (absent). The unit of analysis was the individual SBD, and an overall SBD score was derived based on the sum of points for each item. Scores were expressed as a percentage of the maximum possible points, and then classified into five descriptive categories based on that score. Additionally, three overall 'component' scores were tallied for each SBD: "patient characteristics", "benefit/risk information" and "basic trial characteristics". 161 documents, spanning 456 trials, were analyzed. The majority (126/161) were rated as having information sometimes present (score of >33 to 66%). No SBDs had either no information on any item, or 100% of the information. Items in the patient characteristics component scored poorest (mean component score of 40.4%), while items corresponding to basic trial information were most frequently provided (mean component score of 71%). The significant omissions in the level of clinical trial information in SBDs provide little to aid clinicians in their decision-making. Clinicians' preferred source of information is scientific knowledge, but in Canada, access to such information is limited. Consequently, we believe that clinicians are being denied crucial tools for decision-making.

Legal Considerations in Clinical Decision Making.

ERIC Educational Resources Information Center

Ursu, Samuel C.

1992-01-01

Discussion of legal issues in dental clinical decision making looks at the nature and elements of applicable law, especially malpractice, locus of responsibility, and standards of care. Greater use of formal decision analysis in clinical dentistry and better research on diagnosis and treatment are recommended, particularly in light of increasing…

Assessing the clinical benefit of nuclear matrix protein 22 in the surveillance of patients with nonmuscle-invasive bladder cancer and negative cytology: a decision-curve analysis.

PubMed

Shariat, Shahrokh F; Savage, Caroline; Chromecki, Thomas F; Sun, Maxine; Scherr, Douglas S; Lee, Richard K; Lughezzani, Giovanni; Remzi, Mesut; Marberger, Michael J; Karakiewicz, Pierre I; Vickers, Andrew J

2011-07-01

Several studies have demonstrated that abnormal levels of nuclear matrix protein 22 (NMP22) are associated with bladder cancer and have led to the approval of NMP22 as a urinary biomarker by the US Food and Drug Administration. Nonetheless, the clinical significance of NMP22 remains unclear. The objective of this study was to use decision analysis to determine whether NMP22 improves medical decision-making. The current study included 2222 patients who had a history of nonmuscle-invasive bladder cancer and current negative cytology. The authors developed models to predict cancer recurrence or progression to muscle-invasive disease using voided NMP22 levels, cystoscopy, age, and sex. Clinical net benefit was calculated by summing the benefits (true-positives), subtracting the harms (false-positives), and weighting these values by the threshold probability at which a patient or clinician would opt for cytoscopy. After cystoscopy, 581 patients (26%) had cancer identified. The NMP22 level was associated significantly with bladder cancer recurrence and progression (P < .001 for both). The use of NMP22 in a model with age and sex was associated with better patient outcomes than performing cystoscopy on everyone and produced threshold probabilities > 8% for recurrence and > 3% for progression. Only offering cystoscopy to those who had a risk > 15% reduced the number of cystoscopies by 229 while missing only 25 cancer recurrences per 1000 men with negative cytology. The current study was limited by its multicenter design. For clinicians who would perform a cystoscopy at a threshold of 5% for recurrence or 1% for progression, NMP22 did not aid clinical decision-making. For less risk-averse clinicians who would only perform a cystoscopy at a threshold probability >thinsp;8% for recurrence or > 3% for progression, NMP22 helped to indicate which patients required cystoscopy and which could be spared this procedure. Copyright © 2011 American Cancer Society.

[The effects of case-based learning using video on clinical decision making and learning motivation in undergraduate nursing students].

PubMed

Yoo, Moon-Sook; Park, Jin-Hee; Lee, Si-Ra

2010-12-01

The purpose of this study was to examine the effects of case-base learning (CBL) using video on clinical decision-making and learning motivation. This research was conducted between June 2009 and April 2010 as a nonequivalent control group non-synchronized design. The study population was 44 third year nursing students who enrolled in a college of nursing, A University in Korea. The nursing students were divided into the CBL and the control group. The intervention was the CBL with three cases using video. The controls attended a traditional live lecture on the same topics. With questionnaires objective clinical decision-making, subjective clinical decision-making, and learning motivation were measured before the intervention, and 10 weeks after the intervention. Significant group differences were observed in clinical decision-making and learning motivation. The post-test scores of clinical decision-making in the CBL group were statistically higher than the control group. Learning motivation was also significantly higher in the CBL group than in the control group. These results indicate that CBL using video is effective in enhancing clinical decision-making and motivating students to learn by encouraging self-directed learning and creating more interest and curiosity in learning.

Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial.

PubMed

Ledford, Christy J W; Womack, Jasmyne J; Rider, Heather A; Seehusen, Angela B; Conner, Stephen J; Lauters, Rebecca A; Hodge, Joshua A

2018-06-01

As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing mobile apps with other modalities of patient education and engagement tools. This study was designed to test the effectiveness of a mobile app as a replacement for a spiral notebook guide as a patient education and engagement tool in the prenatal clinical setting. This randomized controlled trial was conducted in the Women's Health Clinic and Family Health Clinic of three hospitals. Repeated-measures analysis of covariance was used to test intervention effects in the study sample of 205 patients. Mothers used a mobile app interface to more frequently record information about their pregnancy; however, across time, mothers using a mobile app reported a significant decrease in patient activation. The unexpected negative effects in the group of patients randomized to the mobile app prompt these authors to recommend that health systems pause before distributing their own version of mobile apps that may decrease patient activation. Mobile apps can be inherently empowering and engaging, but how a system encourages their use may ultimately determine their adoption and success.

Improving clinical models based on knowledge extracted from current datasets: a new approach.

PubMed

Mendes, D; Paredes, S; Rocha, T; Carvalho, P; Henriques, J; Morais, J

2016-08-01

The Cardiovascular Diseases (CVD) are the leading cause of death in the world, being prevention recognized to be a key intervention able to contradict this reality. In this context, although there are several models and scores currently used in clinical practice to assess the risk of a new cardiovascular event, they present some limitations. The goal of this paper is to improve the CVD risk prediction taking into account the current models as well as information extracted from real and recent datasets. This approach is based on a decision tree scheme in order to assure the clinical interpretability of the model. An innovative optimization strategy is developed in order to adjust the decision tree thresholds (rule structure is fixed) based on recent clinical datasets. A real dataset collected in the ambit of the National Registry on Acute Coronary Syndromes, Portuguese Society of Cardiology is applied to validate this work. In order to assess the performance of the new approach, the metrics sensitivity, specificity and accuracy are used. This new approach achieves sensitivity, a specificity and an accuracy values of, 80.52%, 74.19% and 77.27% respectively, which represents an improvement of about 26% in relation to the accuracy of the original score.

[Clinical reasoning in undergraduate nursing education: a scoping review].

PubMed

Menezes, Sáskia Sampaio Cipriano de; Corrêa, Consuelo Garcia; Silva, Rita de Cássia Gengo E; Cruz, Diná de Almeida Monteiro Lopes da

2015-12-01

This study aimed at analyzing the current state of knowledge on clinical reasoning in undergraduate nursing education. A systematic scoping review through a search strategy applied to the MEDLINE database, and an analysis of the material recovered by extracting data done by two independent reviewers. The extracted data were analyzed and synthesized in a narrative manner. From the 1380 citations retrieved in the search, 23 were kept for review and their contents were summarized into five categories: 1) the experience of developing critical thinking/clinical reasoning/decision-making process; 2) teaching strategies related to the development of critical thinking/clinical reasoning/decision-making process; 3) measurement of variables related to the critical thinking/clinical reasoning/decision-making process; 4) relationship of variables involved in the critical thinking/clinical reasoning/decision-making process; and 5) theoretical development models of critical thinking/clinical reasoning/decision-making process for students. The biggest challenge for developing knowledge on teaching clinical reasoning seems to be finding consistency between theoretical perspectives on the development of clinical reasoning and methodologies, methods, and procedures in research initiatives in this field.

Proposition of decision limits for serum lipids in Brazilian children aged one to 13 years.

PubMed

Slhessarenko, Natasha; Fontes, Cor J F; Slhessarenko, Maria Eduarda; Azevedo, Raymundo S; Andriolo, Adagmar

2018-03-09

To determine decision limits for total cholesterol, LDL-cholesterol, non-HDL cholesterol, HDL-cholesterol, and triglycerides in healthy children and adolescents from Cuiabá, Brazil. This was a cross-sectional study of 1866 healthy children and adolescents randomly selected from daycare centers and public schools in Cuiabá. The desirable levels of serum lipids were defined using the classic criteria, i.e., total cholesterol, LDL-cholesterol, non-HDL cholesterol, and triglycerides levels below the P75 percentile, and HDL-c above the P10 percentile. For CT, P75 was: 160mg/dL for the age range of 1 to <3 years, 170mg/dL for ≥3 to <9 years, and 176mg/dL for ≥9 to <13 years. For non-HDL cholesterol, it was 122mg/dL for the age range of 1 to <13 years. For LDL-c, it was 104mg/dL at the age range of 1 to <9 years and 106mg/dL from ≥9 to <13 years. For TG, it was 127mg/dL from 1 to <2 years; 98mg/dL from ≥2 to <6 years; and 92mg/dL from ≥6 to <13 years. As for HDL-cholesterol, P10 was 24mg/dL, 28mg/dL, 32mg/dL, and 36mg/dL, for the age ranges of 1 to <2 years, ≥2 to <3 years, ≥3 to <4 years, and ≥4 to <13 years, respectively. The decision limits for the serum lipid levels defined in this study differed from those observed in the current Brazilian and North-American guidelines, especially because it differentiates between the age ranges. Using these decision limits in clinical practice will certainly contribute to improve the diagnostic accuracy for dyslipidemia in this population group. Copyright © 2018 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

[Care concepts in mass casualty incidents and disasters. Concept for primary care clinic].

PubMed

Adams, H A; Flemming, A; Lange, C; Koppert, W; Krettek, C

2015-02-01

Patient care in mass casualty incidents and disaster strongly demand a joint approach of all preclinical and clinical forces. Special emphasis must be placed on immediate triage, establishment and preservation of transportability of high-risk patients and their clinical treatment as soon as possible. During limited mass casualties, the preclinical rescue station additionally serves as a buffer for patients, whereby in case of disaster, the focus on transportation of high-risk patients is imperative. Primary care hospitals are a decisive part in the chain of medical supply and are confronted with great challenges, which demand detailed emergency plans and also repeated exercises. In planning and exercises, special attention should be given to the cooperation with the fire department and other medical services.

28 CFR 40.7 - Operation and decision.

Code of Federal Regulations, 2010 CFR

2010-07-01

... review. (e) Fixed time limits. Responses shall be made within fixed time limits at each level of decision. Time limits may vary between institutions, but expeditious processing of grievances at each level of..., written responses. Each grievance shall be answered in writing at each level of decision and review. The...

Health literacy, health information seeking behaviors and internet use among patients attending a private and public clinic in the same geographic area.

PubMed

Gutierrez, Natalia; Kindratt, Tiffany B; Pagels, Patti; Foster, Barbara; Gimpel, Nora E

2014-02-01

Despite the growing body of health information available online, patients with limited health literacy may lack either internet access or skills necessary to utilize this information. Nonetheless, patients at all health literacy levels may prefer other primary sources to obtain health information. We conducted a cross-sectional study to measure health literacy of patients attending two clinics in Dallas, TX and determine associations between health literacy, health information access and internet usage before and after controlling for confounders. Patients from both clinics (county N = 265; private N = 233) completed a brief survey which included sociodemographics, internet patterns, confidence in filling out medical forms and a self-administered Newest Vital Sign to measure health literacy. In the county clinic, most patients (61.5 %) were Hispanic, had low income (<$19,000/year), limited education (<11th grade) and a high likelihood or possibility of limited health literacy (68.5 %). In the private clinic, participants were mostly black (40.4 %) or white (38.6 %), had higher incomes (≥$46,000), higher education (technical college or college) and adequate health literacy (75.1 %). The primary source of obtaining health information in both clinics was their health care professional (50.6 % county; 40.1 % private). In multivariate analyses to determine differences by health literacy level, there were no statistically significant differences between patients with limited and adequate health literacy and their primary information source. Regardless of health literacy, patients rely on their health care providers to obtain health information. These results showcase the importance of providers' effective communication with patients to make shared decisions about their health regardless of other factors.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Evidence-Based Medicine in judicial decisions concerning right to healthcare

PubMed Central

Dias, Eduardo Rocha; da Silva, Geraldo Bezerra

2016-01-01

ABSTRACT Objective To analyze, from the examination of decisions issued by Brazilian courts, how Evidence-Based Medicine was applied and if it led to well-founded decisions, searching the best scientific knowledge. Methods The decisions made by the Federal Courts were searched, with no time limits, at the website of the Federal Court Council, using the expression “Evidence-Based Medicine”. With regard to decisions issued by the court of the State of São Paulo, the search was done at the webpage and applying the same terms and criterion as to time. Next, a qualitative analysis of the decisions was conducted for each action, to verify if the patient/plaintiff’s situation, as well as the efficacy or inefficacy of treatments or drugs addressed in existing protocols were considered before the court granted the provision claimed by the plaintiff. Results In less than one-third of the decisions there was an appropriate discussion about efficacy of the procedure sought in court, in comparison to other procedures available in clinical guidelines adopted by the Brazilian Unified Health System (Sistema Único de Saúde) or by private health insurance plans, considering the individual situation. The majority of the decisions involved private health insurance plans (n=13, 68%). Conclusion The number of decisions that did consider scientific evidence and the peculiarities of each patient was a concern. Further discussion on Evidence-Based Medicine in judgments involving public healthcare are required. PMID:27074226

Advancing beyond the system: telemedicine nurses' clinical reasoning using a computerised decision support system for patients with COPD - an ethnographic study.

PubMed

Barken, Tina Lien; Thygesen, Elin; Söderhamn, Ulrika

2017-12-28

Telemedicine is changing traditional nursing care, and entails nurses performing advanced and complex care within a new clinical environment, and monitoring patients at a distance. Telemedicine practice requires complex disease management, advocating that the nurses' reasoning and decision-making processes are supported. Computerised decision support systems are being used increasingly to assist reasoning and decision-making in different situations. However, little research has focused on the clinical reasoning of nurses using a computerised decision support system in a telemedicine setting. Therefore, the objective of the study is to explore the process of telemedicine nurses' clinical reasoning when using a computerised decision support system for the management of patients with chronic obstructive pulmonary disease. The factors influencing the reasoning and decision-making processes were investigated. In this ethnographic study, a combination of data collection methods, including participatory observations, the think-aloud technique, and a focus group interview was employed. Collected data were analysed using qualitative content analysis. When telemedicine nurses used a computerised decision support system for the management of patients with complex, unstable chronic obstructive pulmonary disease, two categories emerged: "the process of telemedicine nurses' reasoning to assess health change" and "the influence of the telemedicine setting on nurses' reasoning and decision-making processes". An overall theme, termed "advancing beyond the system", represented the connection between the reasoning processes and the telemedicine work and setting, where being familiar with the patient functioned as a foundation for the nurses' clinical reasoning process. In the telemedicine setting, when supported by a computerised decision support system, nurses' reasoning was enabled by the continuous flow of digital clinical data, regular video-mediated contact and shared decision-making with the patient. These factors fostered an in-depth knowledge of the patients and acted as a foundation for the nurses' reasoning process. Nurses' reasoning frequently advanced beyond the computerised decision support system recommendations. Future studies are warranted to develop more accurate algorithms, increase system maturity, and improve the integration of the digital clinical information with clinical experiences, to support telemedicine nurses' reasoning process.

Understanding clinical and non-clinical decisions under uncertainty: a scenario-based survey.

PubMed

Simianu, Vlad V; Grounds, Margaret A; Joslyn, Susan L; LeClerc, Jared E; Ehlers, Anne P; Agrawal, Nidhi; Alfonso-Cristancho, Rafael; Flaxman, Abraham D; Flum, David R

2016-12-01

Prospect theory suggests that when faced with an uncertain outcome, people display loss aversion by preferring to risk a greater loss rather than incurring certain, lesser cost. Providing probability information improves decision making towards the economically optimal choice in these situations. Clinicians frequently make decisions when the outcome is uncertain, and loss aversion may influence choices. This study explores the extent to which prospect theory, loss aversion, and probability information in a non-clinical domain explains clinical decision making under uncertainty. Four hundred sixty two participants (n = 117 non-medical undergraduates, n = 113 medical students, n = 117 resident trainees, and n = 115 medical/surgical faculty) completed a three-part online task. First, participants completed an iced-road salting task using temperature forecasts with or without explicit probability information. Second, participants chose between less or more risk-averse ("defensive medicine") decisions in standardized scenarios. Last, participants chose between recommending therapy with certain outcomes or risking additional years gained or lost. In the road salting task, the mean expected value for decisions made by clinicians was better than for non-clinicians(-$1,022 vs -$1,061; <0.001). Probability information improved decision making for all participants, but non-clinicians improved more (mean improvement of $64 versus $33; p = 0.027). Mean defensive decisions decreased across training level (medical students 2.1 ± 0.9, residents 1.6 ± 0.8, faculty1.6 ± 1.1; p-trend < 0.001) and prospect-theory-concordant decisions increased (25.4%, 33.9%, and 40.7%;p-trend = 0.016). There was no relationship identified between road salting choices with defensive medicine and prospect-theory-concordant decisions. All participants made more economically-rational decisions when provided explicit probability information in a non-clinical domain. However, choices in the non-clinical domain were not related to prospect-theory concordant decision making and risk aversion tendencies in the clinical domain. Recognizing this discordance may be important when applying prospect theory to interventions aimed at improving clinical care.

Continuous quality improvement using intelligent infusion pump data analysis.

PubMed

Breland, Burnis D

2010-09-01

The use of continuous quality-improvement (CQI) processes in the implementation of intelligent infusion pumps in a community teaching hospital is described. After the decision was made to implement intelligent i.v. infusion pumps in a 413-bed, community teaching hospital, drug libraries for use in the safety software had to be created. Before drug libraries could be created, it was necessary to determine the epidemiology of medication use in various clinical care areas. Standardization of medication administration was performed through the CQI process, using practical knowledge of clinicians at the bedside and evidence-based drug safety parameters in the scientific literature. Post-implementation, CQI allowed refinement of clinically important safety limits while minimizing inappropriate, meaningless soft limit alerts on a few select agents. Assigning individual clinical care areas (CCAs) to individual patient care units facilitated customization of drug libraries and identification of specific CCA compliance concerns. Between June 2007 and June 2008, there were seven library updates. These involved drug additions and deletions, customization of individual CCAs, and alterations of limits. Overall compliance with safety software use rose over time, from 33% in November 2006 to over 98% in December 2009. Many potentially clinically significant dosing errors were intercepted by the safety software, prompting edits by end users. Only 4-6% of soft limit alerts resulted in edits. Compliance rates for use of infusion pump safety software varied among CCAs over time. Education, auditing, and refinement of drug libraries led to improved compliance in most CCAs.

Value for money in changing clinical practice: should decisions about guidelines and implementation strategies be made sequentially or simultaneously?

PubMed

Hoomans, Ties; Severens, Johan L; Evers, Silvia M A A; Ament, Andre J H A

2009-01-01

Decisions about clinical practice change, that is, which guidelines to adopt and how to implement them, can be made sequentially or simultaneously. Decision makers adopting a sequential approach first compare the costs and effects of alternative guidelines to select the best set of guideline recommendations for patient management and subsequently examine the implementation costs and effects to choose the best strategy to implement the selected guideline. In an integral approach, decision makers simultaneously decide about the guideline and the implementation strategy on the basis of the overall value for money in changing clinical practice. This article demonstrates that the decision to use a sequential v. an integral approach affects the need for detailed information and the complexity of the decision analytic process. More importantly, it may lead to different choices of guidelines and implementation strategies for clinical practice change. The differences in decision making and decision analysis between the alternative approaches are comprehensively illustrated using 2 hypothetical examples. We argue that, in most cases, an integral approach to deciding about change in clinical practice is preferred, as this provides more efficient use of scarce health-care resources.

Comparativism and the Grounds for Person-Centered Care and Shared Decision Making.

PubMed

Herlitz, Anders

2017-01-01

This article provides a new argument and a new value-theoretical ground for person-centered care and shared decision making that ascribes to it the role of enabling rational choice in situations involving clinical choice. Rather than referring to good health outcomes and/or ethical grounds such as patient autonomy, it argues that a plausible justification and ground for person-centered care and shared decision making is preservation of rationality in the face of comparative non-determinacy in clinical settings. Often, no alternative treatment will be better than or equal to every other alternative. In the face of such comparative non-determinacy, Ruth Chang has argued that we can make rational decisions by invoking reasons that are created through acts of willing. This article transfers this view to clinical decision making and argues that shared decision making provides a solution to non-determinacy problems in clinical settings. This view of the role of shared decision making provides a new understanding of its nature, and it also allows us to better understand when caregivers should engage in shared decision making and when they should not. Copyright 2017 The Journal of Clinical Ethics. All rights reserved.

Implementing shared decision making in routine mental health care

PubMed Central

Slade, Mike

2017-01-01

Shared decision making (SDM) in mental health care involves clinicians and patients working together to make decisions. The key elements of SDM have been identified, decision support tools have been developed, and SDM has been recommended in mental health at policy level. Yet implementation remains limited. Two justifications are typically advanced in support of SDM. The clinical justification is that SDM leads to improved outcome, yet the available empirical evidence base is inconclusive. The ethical justification is that SDM is a right, but clinicians need to balance the biomedical ethical principles of autonomy and justice with beneficence and non‐maleficence. It is argued that SDM is “polyvalent”, a sociological concept which describes an idea commanding superficial but not deep agreement between disparate stakeholders. Implementing SDM in routine mental health services is as much a cultural as a technical problem. Three challenges are identified: creating widespread access to high‐quality decision support tools; integrating SDM with other recovery‐supporting interventions; and responding to cultural changes as patients develop the normal expectations of citizenship. Two approaches which may inform responses in the mental health system to these cultural changes – social marketing and the hospitality industry – are identified. PMID:28498575

Effects of reflection on clinical decision-making of intensive care unit nurses.

PubMed

Razieh, Shahrokhi; Somayeh, Ghafari; Fariba, Haghani

2018-07-01

Nurses are one of the most influential factors in overcoming the main challenges faced by health systems throughout the world. Every health system should, hence, empower nurses in clinical judgment and decision-making skills. This study evaluated the effects of implementing Tanner's reflection method on clinical decision-making of nurses working in an intensive care unit (ICU). This study used an experimental, pretest, posttest design. The setting was the intensive care unit of Amin Hospital Isfahan, Iran. The convenience sample included 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). This clinical trial was performed on 60 nurses working in the ICU of Amin Hospital (Isfahan, Iran). The nurses were selected by census sampling and randomly allocated to either the case or the control group. Data were collected using a questionnaire containing demographic characteristics and the clinical decision-making scale developed by Laurie and Salantera (NDMI-14). The questionnaire was completed before and one week after the intervention. The data were analyzed using SPSS 21.0. The two groups were not significantly different in terms of the level and mean scores of clinical decision-making before the intervention (P = 0.786). Based on the results of independent t-test, the mean score of clinical decision-making one week after the intervention was significantly higher in the case group than in the control group (P = 0.009; t = -2.69). The results of Mann Whitney test showed that one week after the intervention, the nurses' level of clinical decision-making in the case group rose to the next level (P = 0.001). Reflection could improve the clinical decision-making of ICU nurses. It is, thus, recommended to incorporate this method into the nursing curriculum and care practices. Copyright © 2018. Published by Elsevier Ltd.

Decision technologies and the independent professional: the future's challenge to learning and leadership

PubMed Central

Dowie, J.

2001-01-01

Most references to "leadership" and "learning" as sources of quality improvement in medical care reflect an implicit commitment to the decision technology of "clinical judgement". All attempts to sustain this waning decision technology by clinical guidelines, care pathways, "evidence based practice", problem based curricula, and other stratagems only increase the gap between what is expected of doctors in today's clinical situation and what is humanly possible, hence the morale, stress, and health problems they are increasingly experiencing. Clinical guidance programmes based on decision analysis represent the coming decision technology, and proactive adaptation will produce independent doctors who can deliver excellent evidence based and preference driven care while concentrating on the human aspects of the therapeutic relation, having been relieved of the unbearable burdens of knowledge and information processing currently laid on them. History is full of examples of the incumbents of dominant technologies preferring to die than to adapt, and medicine needs both learning and leadership if it is to avoid repeating this mistake. Key Words: decision technology; clinical guidance programmes; decision analysis PMID:11700381

Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation.

PubMed

Levett, D Z H; Jack, S; Swart, M; Carlisle, J; Wilson, J; Snowden, C; Riley, M; Danjoux, G; Ward, S A; Older, P; Grocott, M P W

2018-03-01

The use of perioperative cardiopulmonary exercise testing (CPET) to evaluate the risk of adverse perioperative events and inform the perioperative management of patients undergoing surgery has increased over the last decade. CPET provides an objective assessment of exercise capacity preoperatively and identifies the causes of exercise limitation. This information may be used to assist clinicians and patients in decisions about the most appropriate surgical and non-surgical management during the perioperative period. Information gained from CPET can be used to estimate the likelihood of perioperative morbidity and mortality, to inform the processes of multidisciplinary collaborative decision making and consent, to triage patients for perioperative care (ward vs critical care), to direct preoperative interventions and optimization, to identify new comorbidities, to evaluate the effects of neoadjuvant cancer therapies, to guide prehabilitation and rehabilitation, and to guide intraoperative anaesthetic practice. With the rapid uptake of CPET, standardization is key to ensure valid, reproducible results that can inform clinical decision making. Recently, an international Perioperative Exercise Testing and Training Society has been established (POETTS www.poetts.co.uk) promoting the highest standards of care for patients undergoing exercise testing, training, or both in the perioperative setting. These clinical cardiopulmonary exercise testing guidelines have been developed by consensus by the Perioperative Exercise Testing and Training Society after systematic literature review. The guidelines have been endorsed by the Association of Respiratory Technology and Physiology (ARTP). Copyright © 2017. Published by Elsevier Ltd.

Assessment of the sunk-cost effect in clinical decision-making.

PubMed

Braverman, Jennifer A; Blumenthal-Barby, J S

2012-07-01

Despite the current push toward the practice of evidence-based medicine and comparative effectiveness research, clinicians' decisions may be influenced not only by evidence, but also by cognitive biases. A cognitive bias describes a tendency to make systematic errors in certain circumstances based on cognitive factors rather than evidence. Though health care providers have been shown in several studies to be susceptible to a variety of types of cognitive biases, research on the role of the sunk-cost bias in clinical decision-making is extremely limited. The sunk-cost bias is the tendency to pursue a course of action, even after it has proved to be suboptimal, because resources have been invested in that course of action. This study explores whether health care providers' medical treatment recommendations are affected by prior investments in a course of treatment. Specifically, we surveyed 389 health care providers in a large urban medical center in the United States during August 2009. We asked participants to make a treatment recommendation based on one of four hypothetical clinical scenarios that varied in the source and type of prior investment described. By comparing recommendations across scenarios, we found that providers did not demonstrate a sunk-cost effect; rather, they demonstrated a significant tendency to over-compensate for the effect. In addition, we found that more than one in ten health care providers recommended continuation of an ineffective treatment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Nordic couples' decision-making processes during assisted reproduction treatments.

PubMed

Sol Olafsdottir, Helga; Wikland, Matts; Möller, Anders

2013-06-01

To study couples' perceptions of their decision-making process during the first three years of infertility treatments. This study is a part of a larger project studying the decision-making processes of 22 infertile heterosexual couples, recruited from fertility clinics in all five Nordic countries, over a three year period. A descriptive qualitative method was used. Process of decision-making during assisted reproduction treatments. Seventeen couples had succeeded in becoming parents after approximately three years. Our study suggests that the decision-making process during fertility treatments has three phases: (i) recognizing the decisions to be made, with subcategories; the driving force, mutual project, (ii) gathering knowledge and experience about the options, with subcategories; trust, patient competence, personalized support, and (iii) adapting decisions to possible options, with subcategories; strategic planning, adaption. The core category was "maintaining control in a situation of uncertainty." Two parallel processes affect couples' decision-making process, one within themselves and their relationship, and the other in their contact with the fertility clinic. Couples struggle to make decisions, trusting clinic personnel for guidance, knowledge, and understanding. Nevertheless, couples expressed disappointment with the clinics' reactions to their requests for shared decision-making. Copyright © 2013 Elsevier B.V. All rights reserved.

The Counseling, Self-Care, Adherence Approach to Person-Centered Care and Shared Decision Making: Moral Psychology, Executive Autonomy, and Ethics in Multi-Dimensional Care Decisions.

PubMed

Herlitz, Anders; Munthe, Christian; Törner, Marianne; Forsander, Gun

2016-08-01

This article argues that standard models of person-centred care (PCC) and shared decision making (SDM) rely on simplistic, often unrealistic assumptions of patient capacities that entail that PCC/SDM might have detrimental effects in many applications. We suggest a complementary PCC/SDM approach to ensure that patients are able to execute rational decisions taken jointly with care professionals when performing self-care. Illustrated by concrete examples from a study of adolescent diabetes care, we suggest a combination of moral and psychological considerations to support the claim that standard PCC/SDM threatens to systematically undermine its own goals. This threat is due to a tension between the ethical requirements of SDM in ideal circumstances and more long-term needs actualized by the context of self-care handled by patients with limited capacities for taking responsibility and adhere to their own rational decisions. To improve this situation, we suggest a counseling, self-care, adherence approach to PCC/SDM, where more attention is given to how treatment goals are internalized by patients, how patients perceive choice situations, and what emotional feedback patients are given. This focus may involve less of a concentration on autonomous and rational clinical decision making otherwise stressed in standard PCC/SDM advocacy.

Can one do good medical ethics without principles?

PubMed

Macklin, Ruth

2015-01-01

The criteria for determining what it is to do good medical ethics are the quality of ethical analysis and ethical justifications for decisions and actions. Justifications for decisions and actions rely on ethical principles, be they the 'famous four' or subsidiary ethical principles relevant to specific contexts. Examples from clinical ethics, research ethics and public health ethics reveal that even when not stated explicitly, principles are involved in ethical justifications. Principles may come into conflict, however, and the resolution of an ethical dilemma requires providing good reasons for preferring one principle over another. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Attention as an effect not a cause

PubMed Central

Krauzlis, Richard J.; Bollimunta, Anil; Arcizet, Fabrice; Wang, Lupeng

2014-01-01

Attention is commonly thought to be important for managing the limited resources available in sensory areas of neocortex. Here we present an alternative view that attention arises as a byproduct of circuits centered on the basal ganglia involved in value-based decision-making. The central idea is that decision-making depends on properly estimating the current state of the animal and its environment, and that the weighted inputs to the currently prevailing estimate give rise to the filter-like properties of attention. After outlining this new framework, we describe findings from physiology, anatomy, computational and clinical work that support this point of view. We conclude that the brain mechanisms responsible for attention employ a conserved circuit motif that predates the emergence of the neocortex. PMID:24953964

The ethics of insurance limiting institutional medical care: It's all about the money.

PubMed

Jones, James W; McCullough, Laurence B

2016-04-01

Dr F. Inest practices surgery at a renowned medical center but is concerned because increasing numbers of medical insurers are excluding his institution from coverage. Many of his former referring physicians are beginning to send their patients elsewhere for this reason. The marketing people have been busy increasing their advertising buys and exploring new business models. There is even talk about reducing expensive clinical trials. However, regardless of his affiliation, he has little control over these and other organizational decisions that directly impact his practice clinically and fiscally. What should he do? Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Did the American Academy of Orthopaedic Surgeons osteoarthritis guidelines miss the mark?

PubMed

Bannuru, Raveendhara R; Vaysbrot, Elizaveta E; McIntyre, Louis F

2014-01-01

The American Academy of Orthopaedic Surgeons (AAOS) 2013 guidelines for knee osteoarthritis recommended against the use of viscosupplementation for failing to meet the criterion of minimum clinically important improvement (MCII). However, the AAOS's methodology contained numerous flaws in obtaining, displaying, and interpreting MCII-based results. The current state of research on MCII allows it to be used only as a supplementary instrument, not a basis for clinical decision making. The AAOS guidelines should reflect this consideration in their recommendations to avoid condemning potentially viable treatments in the context of limited available alternatives. Copyright © 2014 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Contracting for intensive care services.

PubMed

Dorman, S

1996-01-01

Purchasers will increasingly expect clinical services in the NHS internal market to provide objective measures of their benefits and cost effectiveness in order to maintain or develop current funding levels. There is limited scientific evidence to demonstrate the clinical effectiveness of intensive care services in terms of mortality/morbidity. Intensive care is a high-cost service and studies of cost-effectiveness need to take account of case-mix variations, differences in admission and discharge policies, and other differences between units. Decisions over development or rationalisation of intensive care services should be based on proper outcome studies of well defined patient groups. The purchasing function itself requires development in order to support effective contracting.

How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study.

PubMed

van der Weijden, Trudy; Pieterse, Arwen H; Koelewijn-van Loon, Marije S; Knaapen, Loes; Légaré, France; Boivin, Antoine; Burgers, Jako S; Stiggelbout, Anne M; Faber, Marjan; Elwyn, Glyn

2013-10-01

To explore how clinical practice guidelines can be adapted to facilitate shared decision making. This was a qualitative key-informant study with group discussions and semi-structured interviews. First, 75 experts in guideline development or shared decision making participated in group discussions at two international conferences. Next, health professionals known as experts in depression or breast cancer, experts on clinical practice guidelines and/or shared decision making, and patient representatives were interviewed (N=20). Using illustrative treatment decisions on depression or breast cancer, we asked the interviewees to indicate as specifically as they could how guidelines could be used to facilitate shared decision making. Interviewees suggested some generic strategies, namely to include a separate chapter on the importance of shared decision making, to use language that encourages patient involvement, and to develop patient versions of guidelines. Recommendation-specific strategies, related to specific decision points in the guideline, were also suggested: These include structuring the presentation of healthcare options to increase professionals' option awareness; structuring the deliberation process between professionals and patients; and providing relevant patient support tools embedded at important decision points in the guideline. This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

Four Factors of Clinical Decision Making: A Teaching Model.

ERIC Educational Resources Information Center

Leist, James C.; Konen, Joseph C.

1996-01-01

Four factors of clinical decision making identified by medical students include quality of care, cost, ethics, and legal concerns. This paper argues that physicians have two responsibilities in the clinical decision-making model: to be the primary advocate for quality health care and to ensure balance among the four factors, working in partnership…

Classifying clinical decision making: a unifying approach.

PubMed

Buckingham, C D; Adams, A

2000-10-01

This is the first of two linked papers exploring decision making in nursing which integrate research evidence from different clinical and academic disciplines. Currently there are many decision-making theories, each with their own distinctive concepts and terminology, and there is a tendency for separate disciplines to view their own decision-making processes as unique. Identifying good nursing decisions and where improvements can be made is therefore problematic, and this can undermine clinical and organizational effectiveness, as well as nurses' professional status. Within the unifying framework of psychological classification, the overall aim of the two papers is to clarify and compare terms, concepts and processes identified in a diversity of decision-making theories, and to demonstrate their underlying similarities. It is argued that the range of explanations used across disciplines can usefully be re-conceptualized as classification behaviour. This paper explores problems arising from multiple theories of decision making being applied to separate clinical disciplines. Attention is given to detrimental effects on nursing practice within the context of multidisciplinary health-care organizations and the changing role of nurses. The different theories are outlined and difficulties in applying them to nursing decisions highlighted. An alternative approach based on a general model of classification is then presented in detail to introduce its terminology and the unifying framework for interpreting all types of decisions. The classification model is used to provide the context for relating alternative philosophical approaches and to define decision-making activities common to all clinical domains. This may benefit nurses by improving multidisciplinary collaboration and weakening clinical elitism.

The tacit dimension of clinical judgment.

PubMed Central

Goldman, G. M.

1990-01-01

Two distinct views of the nature of clinical judgment are identified and contrasted. The dominant view that clinical judgment is a fully explicit process is compared to the relatively neglected view that tacit knowledge plays a substantial role in the clinician's mental operations. The tacit dimension of medical thinking is explored at length. The discussion suggests severe limits when applying decision analysis, expert systems, and computer-aided cost-benefit review to medicine. The goals and practices of postgraduate medical education are also examined from this perspective, as are various other implications for the clinician. The paper concludes that it is valuable to explore the nature of medical thinking in order to improve clinical practice and education. Such explorations should, however, take cognizance of the often overlooked tacit dimension of clinical judgment. Possible constraints on the medical applicability of both formal expert systems and heavily didactic instructional programs are considered. PMID:2356625

Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

PubMed

Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

2017-11-01

Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Framing in policy processes: a case study from hospital planning in the National Health Service in England.

PubMed

Jones, Lorelei; Exworthy, Mark

2015-01-01

This paper reports from an ethnographic study of hospital planning in England undertaken between 2006 and 2009. We explored how a policy to centralise hospital services was espoused in national policy documents, how this shifted over time and how it was translated in practice. We found that policy texts defined hospital planning as a clinical issue and framed decisions to close hospitals or hospital departments as based on the evidence and necessary to ensure safety. We interpreted this framing as a rhetorical strategy for implementing organisational change in the context of community resistance to service closure and a concomitant policy emphasising the importance of public and patient involvement in planning. Although the persuasive power of the framing was limited, a more insidious form of power was identified in the way the framing disguised the political nature of the issue by defining it as a clinical problem. We conclude by discussing how the clinical rationale constrains public participation in decisions about the delivery and organisation of healthcare and restricts the extent to which alternative courses of action can be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

Muscle Injuries in Sports: A New Evidence-Informed and Expert Consensus-Based Classification with Clinical Application.

PubMed

Valle, Xavier; Alentorn-Geli, Eduard; Tol, Johannes L; Hamilton, Bruce; Garrett, William E; Pruna, Ricard; Til, Lluís; Gutierrez, Josep Antoni; Alomar, Xavier; Balius, Ramón; Malliaropoulos, Nikos; Monllau, Joan Carles; Whiteley, Rodney; Witvrouw, Erik; Samuelsson, Kristian; Rodas, Gil

2017-07-01

Muscle injuries are among the most common injuries in sport and continue to be a major concern because of training and competition time loss, challenging decision making regarding treatment and return to sport, and a relatively high recurrence rate. An adequate classification of muscle injury is essential for a full understanding of the injury and to optimize its management and return-to-play process. The ongoing failure to establish a classification system with broad acceptance has resulted from factors such as limited clinical applicability, and the inclusion of subjective findings and ambiguous terminology. The purpose of this article was to describe a classification system for muscle injuries with easy clinical application, adequate grouping of injuries with similar functional impairment, and potential prognostic value. This evidence-informed and expert consensus-based classification system for muscle injuries is based on a four-letter initialism system: MLG-R, respectively referring to the mechanism of injury (M), location of injury (L), grading of severity (G), and number of muscle re-injuries (R). The goal of the classification is to enhance communication between healthcare and sports-related professionals and facilitate rehabilitation and return-to-play decision making.

The management of vocal fold nodules in children: a national survey of speech-language pathologists.

PubMed

Signorelli, Monique E; Madill, Catherine J; McCabe, Patricia

2011-06-01

The purpose of this study was to determine the management options and voice therapy techniques currently being used by practicing speech-language pathologists (SLPs) to treat vocal fold nodules (VFNs) in children. The sources used by SLPs to inform and guide their clinical decisions when managing VFNs in children were also explored. Sixty-two SLPs completed a 23-item web-based survey. Data was analysed using frequency counts, content analyses, and supplementary analyses. SLPs reported using a range of management options and voice therapy techniques to treat VFNs in children. Voice therapy was reportedly the most frequently used management option across all respondents, with the majority of SLPs using a combination of indirect and direct voice therapy techniques. When selecting voice therapy techniques, the majority of SLPs reported that they did not use the limited external evidence available to guide their clinical decisions. Additionally, the majority of SLPs reported that they frequently relied on lower levels of evidence or non-evidence-based sources to guide clinical practice both in the presence and absence of higher quality evidence. Further research needs to investigate strategies to remove the barriers that impede SLPs use of external evidence when managing VFNs in children.

Grand Challenges in Clinical Decision Support v10

PubMed Central

Sittig, Dean F.; Wright, Adam; Osheroff, Jerome A.; Middleton, Blackford; Teich, Jonathan M.; Ash, Joan S.; Campbell, Emily; Bates, David W.

2008-01-01

There is a pressing need for high-quality, effective means of designing, developing, presenting, implementing, evaluating, and maintaining all types of clinical decision support capabilities for clinicians, patients and consumers. Using an iterative, consensus-building process we identified a rank-ordered list of the top 10 grand challenges in clinical decision support. This list was created to educate and inspire researchers, developers, funders, and policy-makers. The list of challenges in order of importance that they be solved if patients and organizations are to begin realizing the fullest benefits possible of these systems consists of: Improve the human-computer interface; Disseminate best practices in CDS design, development, and implementation; Summarize patient-level information; Prioritize and filter recommendations to the user; Create an architecture for sharing executable CDS modules and services; Combine recommendations for patients with co-morbidities; Prioritize CDS content development and implementation; Create internet-accessible clinical decision support repositories; Use freetext information to drive clinical decision support; Mine large clinical databases to create new CDS. Identification of solutions to these challenges is critical if clinical decision support is to achieve its potential and improve the quality, safety and efficiency of healthcare. PMID:18029232

Hemispheric Activation Differences in Novice and Expert Clinicians during Clinical Decision Making

ERIC Educational Resources Information Center

Hruska, Pam; Hecker, Kent G.; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Krigolson, Olav

2016-01-01

Clinical decision making requires knowledge, experience and analytical/non-analytical types of decision processes. As clinicians progress from novice to expert, research indicates decision-making becomes less reliant on foundational biomedical knowledge and more on previous experience. In this study, we investigated how knowledge and experience…

Recurrent hamstring muscle injury: applying the limited evidence in the professional football setting with a seven-point programme

PubMed Central

Brukner, Peter; Nealon, Andrew; Morgan, Christopher; Burgess, Darren; Dunn, Andrew

2014-01-01

Recurrent hamstring injuries are a major problem in sports such as football. The aim of this paper was to use a clinical example to describe a treatment strategy for the management of recurrent hamstring injuries and examine the evidence for each intervention. A professional footballer sustained five hamstring injuries in a relatively short period of time. The injury was managed successfully with a seven-point programme—biomechanical assessment and correction, neurodynamics, core stability, eccentric strengthening, an overload running programme, injection therapies and stretching/relaxation. The evidence for each of these treatment options is reviewed. It is impossible to be definite about which aspects of the programme contributed to a successful outcome. Only limited evidence is available in most cases; therefore, decisions regarding the use of different treatment modalities must be made by using a combination of clinical experience and research evidence. PMID:23322894

Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics.

PubMed

Ruble, James

2012-06-01

For more than 60 years, regulations limited marketing of medications for off-label uses to very low levels. Some key policy changes in the late 1990s ushered in an era of deregulation of off-label marketing. Policy changes included revised United States federal law as well as modifications of Food and Drug Administration (FDA) regulations. Subsequent investigations documented an explosion in scope off-label prescribing. Attempts to limit off-label advertising by manufacturers were vigorously challenged in the courts. Other modalities are needed to maintain a clinical care environment that places the patients' best interests first. In many circumstances, an off-label medication may be in the patient's best interests; however, where there is a lower level of clinical justification, the informed consent of the patient and shared decision making of the patient is essential to optimize outcome.

Aspirin for acute stroke of unknown etiology in resource-limited settings: a decision analysis.

PubMed

Berkowitz, Aaron L; Westover, M Brandon; Bianchi, Matt T; Chou, Sherry H-Y

2014-08-26

To analyze the potential impact of aspirin on outcome at hospital discharge after acute stroke in resource-limited settings without access to neuroimaging to distinguish ischemic stroke from intracerebral hemorrhage (ICH). A decision analysis was conducted to evaluate aspirin use in all patients with acute stroke of unknown type for the duration of initial hospitalization. Data were obtained from the International Stroke Trial and Chinese Acute Stroke Trial. Predicted in-hospital mortality and stroke recurrence risk were determined across the worldwide reported range of the proportion of strokes caused by ICH. Sensitivity analyses were performed on aspirin-associated relative risks in patients with ICH. At the highest reported proportion of strokes due to ICH from a large epidemiologic study (34% in sub-Saharan Africa), aspirin initiation after acute stroke of undetermined etiology is predicted to reduce in-hospital mortality (from 85/1,000 without treatment to 81/1,000 with treatment), in-hospital stroke recurrence (58/1,000 to 50/1,000), and combined risk of in-hospital mortality or stroke recurrence (127/1,000 to 114/1,000). Benefits of aspirin therapy remained in sensitivity analyses across a range of plausible parameter estimates for relative risks associated with aspirin initiation after ICH. Aspirin treatment for the period of initial hospitalization after acute stroke of undetermined etiology is predicted to decrease acute stroke-related mortality and in-hospital stroke recurrence even at the highest reported proportion of acute strokes due to ICH. In the absence of clinical trials to test this approach empirically, clinical decisions require patient-specific evaluation of risks and benefits of aspirin in this context. © 2014 American Academy of Neurology.

Observational Study Designs for Comparative Effectiveness Research: An Alternative Approach to Close Evidence Gaps in Head-and-Neck Cancer

DOE Office of Scientific and Technical Information (OSTI.GOV)

Goulart, Bernardo H.L., E-mail: bhg@uw.edu; University of Washington, Seattle, Washington; Ramsey, Scott D.

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H and N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H and N RCTs, which limits the validity of their results to the broader H and N cancer patient population seenmore » in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H and N cancer, including treatment comparisons for rare types of H and N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H and N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H and N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design.« less

Observational study designs for comparative effectiveness research: an alternative approach to close evidence gaps in head-and-neck cancer.

PubMed

Goulart, Bernardo H L; Ramsey, Scott D; Parvathaneni, Upendra

2014-01-01

Comparative effectiveness research (CER) has emerged as an approach to improve quality of care and patient outcomes while reducing healthcare costs by providing evidence to guide healthcare decisions. Randomized controlled trials (RCTs) have represented the ideal study design to support treatment decisions in head-and-neck (H&N) cancers. In RCTs, formal chance (randomization) determines treatment allocation, which prevents selection bias from distorting the measure of treatment effects. Despite this advantage, only a minority of patients qualify for inclusion in H&N RCTs, which limits the validity of their results to the broader H&N cancer patient population seen in clinical practice. Randomized controlled trials often do not address other knowledge gaps in the management of H&N cancer, including treatment comparisons for rare types of H&N cancers, monitoring of rare or late toxicity events (eg, osteoradionecrosis), or in some instances an RCT is simply not feasible. Observational studies, or studies in which treatment allocation occurs independently of investigators' choice or randomization, may address several of these gaps in knowledge, thereby complementing the role of RCTs. This critical review discusses how observational CER studies complement RCTs in generating the evidence to inform healthcare decisions and improve the quality of care and outcomes of H&N cancer patients. Review topics include a balanced discussion about the strengths and limitations of both RCT and observational CER study designs; a brief description of design and analytic techniques to handle selection bias in observational studies; examples of observational studies that inform current clinical practices and management of H&N cancers; and suggestions for relevant CER questions that could be addressed by an observational study design. Copyright © 2014 Elsevier Inc. All rights reserved.

Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA.

PubMed

Walton, Surrey M; Schumock, Glen T; McLain, David Andrew

2010-09-01

Flavocoxid is a medical food used for the clinical dietary management of osteoarthritis (OA). The acquisition cost of flavocoxid is higher than most traditional, generic NSAIDs. However, flavocoxid may have more favorable gastrointestinal (GI) toxicity resulting in lower overall costs. These costs have not been previously examined. This study provides a decision analytic model to assess the net costs of using flavocoxid for OA from a Medicare perspective. A decision model was developed to estimate the total costs associated with flavocoxid versus naproxen for the management of Medicare patients with mild to moderate OA. Probabilities were obtained from literature and expert opinion, and costs were obtained from Medicare. Sensitivity analyses were conducted by varying probabilities and costs within clinically relevant ranges. The base case resulted in flavocoxid having lower total annual costs ($1482 per patient) compared to naproxen ($1592). Flavocoxid remained the lowest cost option when the cost inputs were varied by 25% (above and below the base case), and when the probability of GI events with flavocoxid were varied by 25%. However, when GI rates from the literature and implied relative risks from the expert panel were used, or if the cost of PPIs was $0, then naproxen was the less costly alternative, though saving less than the annual cost of flavocoxid. Key limitations were the limited outcomes in the model (only GI events), lack of consideration of adherence or combination therapy, and the reliance on expert opinion due to a lack of data for flavocoxid. In patients over 65 years of age who suffer from mild to moderate OA, flavocoxid may result in lower overall costs, despite a higher acquisition cost. Managed care organizations should consider total health care costs in the decision to include flavocoxid as a covered benefit.

Concept mapping in a critical care orientation program: a pilot study to develop critical thinking and decision-making skills in novice nurses.

PubMed

Wahl, Stacy E; Thompson, Anita M

2013-10-01

Newly graduated registered nurses who were hired into a critical care intensive care unit showed a lack of critical thinking skills to inform their clinical decision-making abilities. This study evaluated the effectiveness of concept mapping as a teaching tool to improve critical thinking and clinical decision-making skills in novice nurses. A self-evaluation tool was administered before and after the learning intervention. The 25-item tool measured five key indicators of the development of critical thinking skills: problem recognition, clinical decision-making, prioritization, clinical implementation, and reflection. Statistically significant improvements were seen in 10 items encompassing all five indicators. Concept maps are an effective tool for educators to use in assisting novice nurses to develop their critical thinking and clinical decision-making skills. Copyright 2013, SLACK Incorporated.

Decision making in midwifery: rationality and intuition.

PubMed

Steinhauer, Suyai

2015-04-01

Decision making in midwifery is a complex process that shapes and underpins clinical practice and determines, to a large extent, the quality of care. Effective decision making and professional accountability are central to clinical governance, and being able.to justify all decisions is a professional and legal requirement. At the same time, there is an emphasis in midwifery on shared decision making, and keeping women at the centre of their care, and research reveals that feelings of choice, control and autonomy are central to a positive birth experience. However the extent to which decisions are really shared and care truly woman-centred is debatable and affected by environment and culture. Using a case study of a decision made in clinical practice around amniotomy, this article explores the role of the intuitive thinking system in midwifery decision making, and highlights the importance of involving women in the decision making process.

42 CFR 456.126 - Time limits for final decision and notification of adverse decision.

Code of Federal Regulations, 2011 CFR

2011-10-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Utilization Control: Hospitals Ur Plan: Review of Need for Admission 1 § 456.126 Time limits for final... 42 Public Health 4 2011-10-01 2011-10-01 false Time limits for final decision and notification of...