Browsing by Subject "Clinical"
Now showing 1 - 10 of 15
Results Per Page
Sort Options
Item A user-centered evaluation of medication therapy management alerts for community pharmacists: Recommendations to improve usability and usefulness(Elsevier, 2021) Snyder, Margie E.; Adeoye-Olatunde, Omolola A.; Gernant, Stephanie A.; DiIulio, Julie; Jaynes, Heather A.; Doucette, William R.; Russ-Jara, Alissa L.; Medicine, School of MedicineBackground: Community pharmacists provide comprehensive medication reviews (CMRs) through pharmacy contracts with medication therapy management (MTM) vendors. These CMRs are documented in the vendors' web-based MTM software platforms, which often integrate alerts to assist pharmacists in the detection of medication therapy problems. Understanding pharmacists' experiences with MTM alerts is critical to optimizing alert design for patient care. Objectives: The objectives of this study were to 1) assess the usability and usefulness of MTM alerts for MTM vendor-contracted community pharmacists and 2) generate recommendations for improving MTM alerts for use by community pharmacists. Methods: This was a convergent, parallel mixed-methods evaluation of data collected from 3 sources, with individual pharmacists contributing data to one or more sources: 1) community pharmacists' submissions of observational data about MTM alerts encountered during routine MTM provision, 2) videos of naturalistic usability testing of MTM alerts, and 3) semi-structured interviews to elicit pharmacists' perspectives on MTM alert usefulness and usability. MTM alert data submitted by pharmacists were summarized with descriptive statistics. Usability testing videos were analyzed to determine pharmacists' time spent on MTM alerts and to identify negative usability incidents. Interview transcripts were analyzed using a hybrid approach of deductive and inductive codes to identify emergent themes. Triangulation of data (i.e., determination of convergence/divergence in findings across all data sources) occurred through investigator discussion and identified overarching findings pertaining to key MTM alert challenges. These resulted in actionable recommendations to improve MTM alerts for use by community pharmacists. Results: Collectively, two and four overarching key challenges pertaining to MTM alert usability and usefulness, respectively, were identified, resulting in 15 actionable recommendations for improving the design of MTM alerts from a user-centered perspective. Conclusions: Recommendations are expected to inform enhanced MTM alert designs that can improve pharmacist efficiency, patient and prescriber satisfaction with MTM, and patient outcomes.Item Analysis of the efficacy of EPIONE therapies to treat phantom limb pain(2017-03) Comoglio, Caleb C.; Yoshida, KenThe primary objectives of this thesis are (1) to discuss the current understanding of phenomena associated with, proposed mechanisms of, and suggested treatments for amputation related pain, (2) to describe the software developed for analyzing results of a clinical study for the treatment of phantom limb pain (PLP), (3) to discuss the methods for a multi-center trial by the EPIONE consortium along with presenting preliminary results, and (4) to discuss the methods and results of a case study involving a new therapy modality for alleviating PLP. Each objective has been expanded into a chapter as described below. Chapter 1 serves as a literature review introducing the topic of amputation, associ- ated phenomena, and proposed mechanisms. The chapter also discusses the currently available treatments and the instruments used to measure PLP. Key topics include the definition of PLP, the prevalence of PLP, current treatment options for PLP, and experimental measurement of PLP. The final objective of this chapter is to introduce topics related to the investigation paradigm utilized for the studies following in Chapter 4 and Chapter 5. Therefore, a minor emphasis has been put on surface electrical stimulation (SES) and operant conditioning. As with any multi-center clinical study, coordination is key. Chapter 2 introduces the common clinical protocol (CCP) and methods of analysis for the clinical trials conducted by the EPIONE consortium. In order to analyze results in an automated fashion, a software tool was developed. This tool, the EPIONE Extraction Program (EEP) along with its extension the Group Analysis Module (GAM), is the focus of Chapter 3. A high-level overview of the requirements, process flow, and software testing are described. This chapter also discusses the methods of analysis for several self-report instruments used to determine effect size in Chapter 4 and Chapter 5. The outputs of the software tools make up the results presented and described in these chapters. In addition to the details included in Chapter 3, supplemental information is available in Appendix A and Appendix B, which are the detailed User Guides for the EEP and GAM. Chapter 4 reviews the pilot study data conducted by the EPIONE consortium. The primary and two secondary instruments used for analysis are discussed. This chapter provides a brief overview of results from the group. Each clinical site used slightly different variations of a common clinical protocol to better understand what effectively drives alleviation of PLP and to allow comparison of results. The work done at Indiana University - Purdue University Indianapolis (IUPUI) represents a small part of several other universities involved in the EPIONE consortium. Chapter 5 focuses on a case study at IUPUI with a more in-depth review of data collected throughout the study period. Using SES, we seek to reverse cortical reorganization by giving meaningful stimuli through existing circuitry. In this chapter the present work is discussed by introducing a case study in detail with an analysis of psychophysical data.Item Clinical and educational impact of pharmacogenomics testing: a case series from the INGENIOUS trial(Future Medicine, 2017-06) Pierson, Rebecca C.; Gufford, Brandon T.; Desta, Zeruesenay; Eadon, Michael T.; Medicine, School of MedicinePharmacogenomic testing has become increasingly widespread. However, there remains a need to bridge the gap between test results and providers lacking the expertise required to interpret these results. The Indiana Genomics Implementation trial is underway at our institution to examine total healthcare cost and patient outcomes after genotyping in a safety-net healthcare system. As part of the study, trial investigators and clinical pharmacology fellows interpret genotype results, review patient histories and medication lists and evaluate potential drug-drug interactions. We present a case series of patients in whom pharmacogenomic consultations aided providers in appropriately applying pharmacogenomic results within the clinical context. Formal consultations not only provide valuable patient care information but educational opportunities for the fellows to cement pharmacogenomic concepts.Item Clinical Pharmacology of Antihypertensive Therapy for the Treatment of Hypertension in CKD(American Society of Nephrology, 2019-05-07) Sinha, Arjun D.; Agarwal, Rajiv; Medicine, School of MedicineCKD is common and frequently complicated with hypertension both predialysis and in ESKD. As a major modifiable risk factor for cardiovascular disease in this high-risk population, treatment of hypertension in CKD is important. We review the mechanisms and indications for the major classes of antihypertensive drugs, including angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-adrenergic blocking agents, dihydropyridine calcium channel blockers, thiazide diuretics, loop diuretics, mineralocorticoid receptor blockers, direct vasodilators, and centrally acting α-agonists. Recent evidence suggests that β-adrenergic blocking agents may have a greater role in patients on dialysis and that thiazide diuretics may have a greater role in patients with advanced CKD. We conclude with sharing our general prescribing algorithm for both patients with predialysis CKD and patients with ESKD on dialysis.Item Clinician Responses to a Clinical Decision Support Advisory for High Risk of Torsades de Pointes(American Heart Association, 2022) Gallo, Tyler; Heise, C. William; Woosley, Raymond L.; Tisdale, James E.; Tan, Malinda S.; Gephart, Sheila M.; Antonescu, Corneliu C.; Malone, Daniel C.; Medicine, School of MedicineBackground: Torsade de pointes (TdP) is a potentially fatal cardiac arrhythmia that is often drug induced. Clinical decision support (CDS) may help minimize TdP risk by guiding decision making in patients at risk. CDS has been shown to decrease prescribing of high‐risk medications in patients at risk of TdP, but alerts are often ignored. Other risk‐management options can potentially be incorporated in TdP risk CDS. Our goal was to evaluate actions clinicians take in response to a CDS advisory that uses a modified Tisdale QT risk score and presents management options that are easily selected (eg, single click). Methods and Results: We implemented an inpatient TdP risk advisory systemwide across a large health care system comprising 30 hospitals. This CDS was programmed to appear when prescribers attempted ordering medications with a known risk of TdP in a patient with a QT risk score ≥12. The CDS displayed patient‐specific information and offered relevant management options including canceling offending medications and ordering electrolyte replacement protocols or ECGs. We retrospectively studied the actions clinicians took within the advisory and separated by drug class. During an 8‐month period, 7794 TdP risk advisories were issued. Antibiotics were the most frequent trigger of the advisory (n=2578, 33.1%). At least 1 action was taken within the advisory window for 2700 (34.6%) of the advisories. The most frequent action taken was ordering an ECG (n=1584, 20.3%). Incoming medication orders were canceled in 793 (10.2%) of the advisories. The frequency of each action taken varied by drug class (P<0.05 for all actions). Conclusions: A modified Tisdale QT risk score–based CDS that offered relevant single‐click management options yielded a high action/response rate. Actions taken by clinicians varied depending on the class of the medication that evoked the TdP risk advisory, but the most frequent was ordering an ECG.Item Comparison of Open-Source Electronic Health Record Systems Based on Functional and User Performance Criteria(The Korean Society of Medical Informatics, 2019-04) Purkayastha, Saptarshi; Allam, Roshini; Maity, Pallavi; Gichoya, Judy W.; BioHealth Informatics, School of Informatics and ComputingObjectives: Open-source Electronic Health Record (EHR) systems have gained importance. The main aim of our research is to guide organizational choice by comparing the features, functionality, and user-facing system performance of the five most popular open-source EHR systems. Methods: We performed qualitative content analysis with a directed approach on recently published literature (2012-2017) to develop an integrated set of criteria to compare the EHR systems. The functional criteria are an integration of the literature, meaningful use criteria, and the Institute of Medicine's functional requirements of EHR, whereas the user-facing system performance is based on the time required to perform basic tasks within the EHR system. Results: Based on the Alexa web ranking and Google Trends, the five most popular EHR systems at the time of our study were OSHERA VistA, GNU Health, the Open Medical Record System (OpenMRS), Open Electronic Medical Record (OpenEMR), and OpenEHR. We also found the trends in popularity of the EHR systems and the locations where they were more popular than others. OpenEMR met all the 32 functional criteria, OSHERA VistA met 28, OpenMRS met 12 fully and 11 partially, OpenEHR-based EHR met 10 fully and 3 partially, and GNU Health met the least with only 10 criteria fully and 2 partially. Conclusions: Based on our functional criteria, OpenEMR is the most promising EHR system, closely followed by VistA. With regards to user-facing system performance, OpenMRS has superior performance in comparison to OpenEMR.Item Delirium Detection using GAMMA Wave and Machine Learning: A Pilot Study(Wiley, 2022) Mulkey, Malissa; Albanese, Thomas; Kim, Sunghan; Huang, Huyanting; Yang, Baijain; School of NursingDelirium occurs in as many as 80% of critically ill older adults and is associated with increased long-term cognitive impairment, institutionalization, and mortality. Less than half of delirium cases are identified using currently available subjective assessment tools. Electroencephalogram (EEG) has been identified as a reliable objective measure but has not been feasible. This study was a prospective pilot proof-of-concept study, to examine the use of machine learning methods evaluating the use of gamma band to predict delirium from EEG data derived from a limited lead rapid response handheld device. Data from 13 critically ill participants aged 50 or older requiring mechanical ventilation for more than 12 h were enrolled. Across the three models, accuracy of predicting delirium was 70 or greater. Stepwise discriminant analysis provided the best overall method. While additional research is needed to determine the best cut points and efficacy, use of a handheld limited lead rapid response EEG device capable of monitoring all five cerebral lobes of the brain for predicting delirium hold promise.Item Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines(Elsevier, 2023) Cavestro, Giulia Martina; Mannucci, Alessandro; Balaguer, Francesc; Hampel, Heather; Kupfer, Sonia S.; Repici, Alessandro; Sartore-Bianchi, Andrea; Seppälä, Toni T.; Valentini, Vincenzo; Boland, Clement Richard; Brand, Randall E.; Buffart, Tineke E.; Burke, Carol A.; Caccialanza, Riccardo; Cannizzaro, Renato; Cascinu, Stefano; Cercek, Andrea; Crosbie, Emma J.; Danese, Silvio; Dekker, Evelien; Daca-Alvarez, Maria; Deni, Francesco; Dominguez-Valentin, Mev; Eng, Cathy; Goel, Ajay; Guillem, Josè G.; Houwen, Britt B. S. L.; Kahi, Charles; Kalady, Matthew F.; Kastrinos, Fay; Kühn, Florian; Laghi, Luigi; Latchford, Andrew; Liska, David; Lynch, Patrick; Malesci, Alberto; Mauri, Gianluca; Meldolesi, Elisa; Møller, Pål; Monahan, Kevin J.; Möslein, Gabriela; Murphy, Caitlin C.; Nass, Karlijn; Ng, Kimmie; Oliani, Cristina; Papaleo, Enrico; Patel, Swati G.; Puzzono, Marta; Remo, Andrea; Ricciardiello, Luigi; Ripamonti, Carla Ida; Siena, Salvatore; Singh, Satish K.; Stadler, Zsofia K.; Stanich, Peter P.; Syngal, Sapna; Turi, Stefano; Urso, Emanuele Damiano; Valle, Laura; Vanni, Valeria Stella; Vilar, Eduardo; Vitellaro, Marco; You, Yi-Qian Nancy; Yurgelun, Matthew B.; Zuppardo, Raffaella Alessia; Stoffel, Elena M.; Associazione Italiana Familiarità Ereditarietà Tumori; Collaborative Group of the Americas on Inherited Gastrointestinal Cancer; European Hereditary Tumour Group; International Society for Gastrointestinal Hereditary Tumours; Medicine, School of MedicineBackground & aims: Patients with early-onset colorectal cancer (eoCRC) are managed according to guidelines that are not age-specific. A multidisciplinary international group (DIRECt), composed of 69 experts, was convened to develop the first evidence-based consensus recommendations for eoCRC. Methods: After reviewing the published literature, a Delphi methodology was used to draft and respond to clinically relevant questions. Each statement underwent 3 rounds of voting and reached a consensus level of agreement of ≥80%. Results: The DIRECt group produced 31 statements in 7 areas of interest: diagnosis, risk factors, genetics, pathology-oncology, endoscopy, therapy, and supportive care. There was strong consensus that all individuals younger than 50 should undergo CRC risk stratification and prompt symptom assessment. All newly diagnosed eoCRC patients should receive germline genetic testing, ideally before surgery. On the basis of current evidence, endoscopic, surgical, and oncologic treatment of eoCRC should not differ from later-onset CRC, except for individuals with pathogenic or likely pathogenic germline variants. The evidence on chemotherapy is not sufficient to recommend changes to established therapeutic protocols. Fertility preservation and sexual health are important to address in eoCRC survivors. The DIRECt group highlighted areas with knowledge gaps that should be prioritized in future research efforts, including age at first screening for the general population, use of fecal immunochemical tests, chemotherapy, endoscopic therapy, and post-treatment surveillance for eoCRC patients. Conclusions: The DIRECt group produced the first consensus recommendations on eoCRC. All statements should be considered together with the accompanying comments and literature reviews. We highlighted areas where research should be prioritized. These guidelines represent a useful tool for clinicians caring for patients with eoCRC.Item Disposable Patterned Electroceutical Dressing (PED-10) Is Safe for Treatment of Open Clinical Chronic Wounds(Mary Ann Liebert, 2019-04-01) Roy, Sashwati; Prakash, Shaurya; Mathew-Steiner, Shomita S.; Das Ghatak, Piya; Lochab, Varun; Jones, Travis H.; Mohana Sundaram, Prashanth; Gordillo, Gayle M.; Subramaniam, Vish V.; Sen, Chandan K.; Surgery, School of MedicineObjective: To evaluate if patterned electroceutical dressing (PED) is safe for human chronic wounds treatment as reported by wound care providers. Approach: This work reports a pilot feasibility study with the primary objective to determine physically observable effects of PED application on host tissue response from a safety evaluation point of view. For this pilot study, patients receiving a lower extremity amputation with at least one open wound on the part to be amputated were enrolled. Patients were identified through the Ohio State University Wexner Medical Center (OSUWMC) based on inclusion and exclusion criteria through prescreening through the Comprehensive Wound Center's (CWC) Limb Preservation Program and wound physicians and/or providers at OSUWMC. Wounds were treated with the PED before amputation surgery. Results: The intent of the study was to identify if PED was safe for clinical application based on visual observations of adverse or lack of adverse events on skin and wound tissue. The pilot testing performed on a small cohort (N = 8) of patients showed that with engineered voltage regulation of current flow to the open wound, the PED can be used with little to no visually observable adverse effects on chronic human skin wounds. Innovation: The PED was developed as a second-generation tunable electroceutical wound care dressing, which could potentially be used to treat wounds with deeper infections compared with current state of the art that treats wounds with treatment zone limited to the surface near topical application. Conclusion: Technology advances in design and fabrication of electroceutical dressings were leveraged to develop a tunable laboratory prototype that could be used as a disposable low-cost electroceutical wound care dressing on chronic wounds. Design revisions of PED-1 (1 kΩ ballast resistor) circumvented previously observed adverse effects on the skin in the vicinity of an open wound. PED-10 (including a 10 kΩ ballast resistor) was well tolerated in the small cohort of patients (N = 8) on whom it was tested, and the observations reported here warrant a larger study to determine the clinical impact on human wound healing and infection control.Item Extracorporeal membrane oxygenation support for SARS-CoV-2: a multi-centered, prospective, observational study in critically ill 92 patients in Saudi Arabia(BMC, 2021-12-09) Alhumaid, Saad; Al Mutair, Abbas; Alghazal, Header A.; Alhaddad, Ali J.; Al‑Helal, Hassan; Al Salman, Sadiq A.; Alali, Jalal; Almahmoud, Sana; Alhejy, Zulfa M.; Albagshi, Ahmad A.; Muhammad, Javed; Khan, Amjad; Sulaiman, Tarek; Al‑Mozaini, Maha; Dhama, Kuldeep; Al‑Tawfiq, Jaffar A.; Rabaan, Ali A.; Medicine, School of MedicineBackground: Extracorporeal membrane oxygenation (ECMO) has been used as a rescue strategy in patients with severe with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 infection, but there has been little evidence of its efficacy. Objectives: To describe the effect of ECMO rescue therapy on patient-important outcomes in patients with severe SARS-CoV-2. Methods: A case series study was conducted for the laboratory-confirmed SARS-CoV-2 patients who were admitted to the ICUs of 22 Saudi hospitals, between March 1, 2020, and October 30, 2020, by reviewing patient's medical records prospectively. Results: ECMO use was associated with higher in-hospital mortality (40.2% vs. 48.9%; p = 0.000); lower COVID-19 virological cure (41.3% vs 14.1%, p = 0.000); and longer hospitalization (20.2 days vs 29.1 days; p = 0.000), ICU stay (12.6 vs 26 days; p = 0.000) and mechanical ventilation use (14.2 days vs 22.4 days; p = 0.000) compared to non-ECMO group. Also, there was a high number of patients with septic shock (19.6%) and multiple organ failure (10.9%); and more complications occurred at any time during hospitalization [pneumothorax (5% vs 29.3%, p = 0.000), bleeding requiring blood transfusion (7.1% vs 38%, p = 0.000), pulmonary embolism (6.4% vs 15.2%, p = 0.016), and gastrointestinal bleeding (3.3% vs 8.7%, p = 0.017)] in the ECMO group. However, PaO2 was significantly higher in the 72-h post-ECMO initiation group and PCO2 was significantly lower in the 72-h post-ECMO start group than those in the 12-h pre-ECMO group (62.9 vs. 70 mmHg, p = 0.002 and 61.8 vs. 51 mmHg, p = 0.042, respectively). Conclusion: Following the use of ECMO, the mortality rate of patients and length of ICU and hospital stay were not improved. However, these findings need to be carefully interpreted, as most of our cohort patients were relatively old and had multiple severe comorbidities. Future randomized trials, although challenging to conduct, are highly needed to confirm or dispute reported observations.