Annotated Bibliography: Understanding Ambulatory Care Practices in the Context of Patient Safety and Quality Improvement.

The ambulatory care setting is an increasingly important component of the patient safety conversation. Inpatient safety is the primary focus of the vast majority of safety research and interventions, but the ambulatory setting is actually where most medical care is administered. Recent attention has shifted toward examining ambulatory care in order to implement better health care quality and safety practices. This annotated bibliography was created to analyze and augment the current literature on ambulatory care practices with regard to patient safety and quality improvement. By providing a thorough examination of current practices, potential improvement strategies in ambulatory care health care settings can be suggested. A better understanding of the myriad factors that influence delivery of patient care will catalyze future health care system development and implementation in the ambulatory setting

Committed to Safety: Ten Case Studies on Reducing Harm to Patients

Presents case studies of healthcare organizations, clinical teams, and learning collaborations to illustrate successful innovations for improving patient safety nationwide. Includes actions taken, results achieved, lessons learned, and recommendations

Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016.

OBJECTIVE: To provide an update to "Surviving Sepsis Campaign Guidelines for Management of Sepsis and Septic Shock: 2012." DESIGN: A consensus committee of 55 international experts representing 25 international organizations was convened. Nominal groups were assembled at key international meetings (for those committee members attending the conference). A formal conflict-of-interest (COI) policy was developed at the onset of the process and enforced throughout. A stand-alone meeting was held for all panel members in December 2015. Teleconferences and electronic-based discussion among subgroups and among the entire committee served as an integral part of the development. METHODS: The panel consisted of five sections: hemodynamics, infection, adjunctive therapies, metabolic, and ventilation. Population, intervention, comparison, and outcomes (PICO) questions were reviewed and updated as needed, and evidence profiles were generated. Each subgroup generated a list of questions, searched for best available evidence, and then followed the principles of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system to assess the quality of evidence from high to very low, and to formulate recommendations as strong or weak, or best practice statement when applicable. RESULTS: The Surviving Sepsis Guideline panel provided 93 statements on early management and resuscitation of patients with sepsis or septic shock. Overall, 32 were strong recommendations, 39 were weak recommendations, and 18 were best-practice statements. No recommendation was provided for four questions. CONCLUSIONS: Substantial agreement exists among a large cohort of international experts regarding many strong recommendations for the best care of patients with sepsis. Although a significant number of aspects of care have relatively weak support, evidence-based recommendations regarding the acute management of sepsis and septic shock are the foundation of improved outcomes for these critically ill patients with high mortality

The Use of Routinely Collected Data in Clinical Trial Research

RCTs are the gold standard for assessing the effects of medical interventions, but they also pose many challenges, including the often-high costs in conducting them and a potential lack of generalizability of their findings. The recent increase in the availability of so called routinely collected data (RCD) sources has led to great interest in their application to support RCTs in an effort to increase the efficiency of conducting clinical trials. We define all RCTs augmented by RCD in any form as RCD-RCTs. A major subset of RCD-RCTs are performed at the point of care using electronic health records (EHRs) and are referred to as point-of-care research (POC-R). RCD-RCTs offer several advantages over traditional trials regarding patient recruitment and data collection, and beyond. Using highly standardized EHR and registry data allows to assess patient characteristics for trial eligibility and to examine treatment effects through routinely collected endpoints or by linkage to other data sources like mortality registries. Thus, RCD can be used to augment traditional RCTs by providing a sampling framework for patient recruitment and by directly measuring patient relevant outcomes. The result of these efforts is the generation of real-world evidence (RWE). Nevertheless, the utilization of RCD in clinical research brings novel methodological challenges, and issues related to data quality are frequently discussed, which need to be considered for RCD-RCTs. Some of the limitations surrounding RCD use in RCTs relate to data quality, data availability, ethical and informed consent challenges, and lack of endpoint adjudication which may all lead to uncertainties in the validity of their results. The purpose of this thesis is to help fill the aforementioned research gaps in RCD-RCTs, encompassing tasks such as assessing their current application in clinical research and evaluating the methodological and technical challenges in performing them. Furthermore, it aims to assess the reporting quality of published reports on RCD-RCTs

The use of computerised clinical decision support systems in emergency care : a substantive review of the literature

Objectives: This paper provides a substantive review of international literature evaluating the impact of computerised clinical decision support systems (CCDSS) on the care of emergency department (ED) patients. Material and Methods: A literature search was conducted using Medline, CINAHL, EMBASE electronic resources and grey literature. Studies were selected if they compared the use of a CCDSS with usual care in a face-to-face clinical interaction in an ED. Results: Of the 23 studies included approximately half demonstrated a statistically significant positive impact on aspects of clinical care with the use of CCDSSs. The remaining studies showed small improvements, mainly around documentation. However, the methodological quality of the studies was poor with few or no controls to mitigate against confounding variables. The risk of bias was high in all but six studies. Discussion: The ED environment is complex and does not lend itself to robust quantitative designs such as Randomised Controlled Trials. The quality of the research in approximately 75% of the studies was poor and therefore conclusions cannot be drawn from these results. However the studies with a more robust design show evidence of the positive impact of CCDSSs on ED patient care. Conclusion This is the first review to consider the role of CCDSSs in emergency care and expose the research in this area. The role of CCDSSs in Emergency Care may provide some solutions to the current challenges in EDs but further high quality research is needed to better understand what technological solutions can offer clinicians and patients. OBJECTIVES This paper provides a description of a substantive review of published international literature evaluating the impact of computerised clinical decision support systems (CCDSS) on the care of emergency department (ED) patients. The principal aims of this review are: to identify the body of CCDSS research undertaken in EDs, the research methods used, their quality and the impact of CCDSSs on clinical care in EDs. The discussion synthesises what is known and not known about the effectiveness of CCDSSs in Emergency Care and the quality of the current evidence base

Enhancing Healthcare Quality in Hospitals through Electronic Health Records: A Systematic Review

Background: The evolution of information technology has continued to put pressure on healthcare systems to switch from manual to electronic systems. The electronic health record is a leading information technology system that has drawn considerable interest from governments and private health facilities. However, EHR implementation has proved to be a problematic endeavor, especially in developing countries. Objective: This review sought to determine the influence of EHR implementation on healthcare quality in hospitals and identifying applicable lessons for EHR implementers in hospital settings. Methods: Relevant literature was searched in the identified databases, including Scopus, PubMed, CINAHL, PsycInfo, and Cochrane Library. Websites such as the World Health Organization and the National Institute for Health and Care Excellence were searched for policies and guidelines. The study used several terms and their variations to create a search strategy, including electronic health records, hospitals and, healthcare quality. The literature search was constrained to the English language and studies published between 2010 and 2020. The study carried out a narrative synthesis of results from the included studies. Results: Overall, the findings of the systematic review demonstrated that EHR has a significant positive influence on healthcare quality by enhancing patient safety and ensuring effective, efficient, timely, equitable, and patient-centered care. Some of the EHR functionalities that facilitate quality healthcare include, practice management, communication, documentation or data entry, and medication management, decision support functionality, computerized drug prescription, electronic nursing documentation, and electronic management records. EHR implementation is faced with several challenges, which can be grouped into institutional side factors, human resource factors, technological factors, and ethical issues. Conclusion: We established a significant effect of EHR implementation on several healthcare quality indicators, namely patient safety, effective care, efficient care, timely care, equitable and patient-centered care. EHR implementation is faced with challenges emanating from the healthcare institutions, healthcare professionals, technology, and ethical issues. There is a need to devise an effective mechanism that would minimize the challenges that prevent successful EHR implementation in hospitals

HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer.

BackgroundHuman epidermal growth factor receptor 2 (HER2)-positive breast cancer is a particularly aggressive form of the disease, and ultimately progresses in patients with metastases on standard therapies. Anthracyclines, such as doxorubicin, are an effective treatment for HER2-positive breast cancer, particularly when administered in combination with trastuzumab - however, doxorubicin-related cardiotoxicity has limited its use. Many patients are therefore never treated with anthracyclines, even upon disease progression, despite the potential for benefit. MM-302 is a novel, HER2-targeted antibody-liposomal doxorubicin conjugate that specifically targets HER2-overexpressing cells. Preclinical and Phase 1 data suggest that MM-302, as a monotherapy or in combination with trastuzumab, could be effective for managing previously treated, anthracycline-naïve, HER2-positive breast cancer, without the cardiotoxicity observed with free doxorubicin formulations.Methods/designHERMIONE is an open-label, multicenter, randomized (1:1) Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice (gemcitabine, capecitabine, or vinorelbine) plus trastuzumab planned to enroll 250 anthracycline-naïve patients with locally advanced/metastatic HER2-positive breast cancer. Key inclusion criteria are: previous treatment with trastuzumab (with or without pertuzumab) in any setting; refractory or intolerant to pertuzumab (refractory to pertuzumab defined as progression in the locally advanced or metastatic setting, or disease recurrence during or within 12 months of completing pertuzumab-containing neoadjuvant and/or adjuvant therapy); and disease progression on, or intolerant to, ado-trastuzumab emtansine for locally advanced or metastatic disease. The trial is currently being conducted at sites in the USA, Canada, and Western Europe. Treatment will be administered in 21-day cycles, and will be continued until disease progression or unacceptable toxicity. The primary endpoint is independently assessed progression-free survival (PFS). Tumor response will be assessed every 6 weeks, and defined according to RECIST v1.1. Secondary endpoints include investigator-assessed PFS, overall survival (OS), OS rates at 6 months and 1 year, objective response rates, safety and tolerability, quality of life, and the pharmacokinetic profile of MM-302 plus trastuzumab.DiscussionThe HERMIONE study will evaluate the efficacy and safety of MM-302 plus trastuzumab in patients with refractory HER2-positive advanced/metastatic breast cancer for whom there are no standard of care therapies with a proven survival advantage.Trial registrationClinicaltrials.gov identifier: NCT02213744 . Registration date: 06AUG2014