INFORMED CONSENT STATUS IN OBSERVATIONAL STUDIES WITH RETROSPECTIVE DESIGN: A POOR SHOW

ABSTRACTObjective: Informed consent is very important to protect the rights of patients and is obtained as a vital component of any clinical study. Requirementof patient consent in retrospective research continues to stir controversy even today. Some of directions of regulatory authorities even waive off theconsent for retrospective studies, whereas few recommend that at least clearance from the Ethical Review Board may be taken or information topatient may be given or oral consent must be given by patient for usage of the data in any retrospective study. The aim of this study was to analyze thecurrent status of informed consent procedures in observational studies with retrospective design.Methods: This review was intended to find out the current status of procedures involved in informed consent in India and abroad. A total of 100retrospective studies were searched for this objective from the internet and other literature sources.Results: Data show that in 65% of studies neither informed consent/oral consent nor ethical clearance was taken. Only 1% of studies have beenconducted with informed consent as well as ethical clearance. Only 14% of studies were conducted with informed consent and 21% with ethicalapproval.Conclusion: The study reflects very poor status of informed consent in retrospective studies and noncompliance of ICH guidelines for clinical researchin relation to informed consent.Keywords: Clinical research, Informed consent, Retrospective studies

Patient safety content and delivery in pre-registration nursing curricula: A national cross-sectional survey study

Background: Patient safety is a core principle of health professional practice and as such requires significant attention within undergraduate curricula. However, patient safety practice is complex requiring a broad range of skills and behaviours including the application of sound clinical knowledge within a range of health care contexts and cultures. There is very little research that explores how this is taught within Australian nursing curricula. Objectives: To examine how Australia nursing curricula address patient safety; identify where and how patient safety learning occurs; and describe who is responsible for facilitating this learning. Design and Setting: A cross-sectional descriptive study of nursing undergraduate curricula using a nine-item survey tool. Participants were key informants from 18 universities across seven Australian States and Territories. Conclusion: Although there is consensus in relation to the importance of patient safety across universities, and similarity in views about what knowledge, skills and attitudes should be taught, there were differences in: the amount of time allocated, who was responsible for the teaching and learning, and in which setting the learning occurred and was assessed. There was little indication of the existence of a systematic approach to learning patient safety, with most participants reporting emphasis on learning applied to infection control and medication safety. Wide variation across universities, was reported, particularly in terms of how teaching occured, in what setting and by whom. There was evidence of both integrated and explicit concentration on patient safety learning but also fragmentation. Little evidence of the systematic development of critical reasoning and patient safety knowledge and skills across the years of the nursing program and across the classroom/ laboratory and clinical environments was apparent

Human factors in robotic assisted surgery: Lessons from studies ‘in the Wild’

This article reviews studies conducted "in the wild" that explore the "ironies of automation" in Robotic Assisted Surgery (RAS). Workload may be reduced for the surgeon, but increased for other team members, with postural stress relocated rather than reduced, and the introduction of a range of new challenges, for example, in the need to control multiple arms, with multiple instruments; and the increased demands of being physically separated from the team. Workflow disruptions do not appear to be more frequent, the prevalence of equipment and training disruptions differs from other types of surgeries. A consistent observation is that communication and coordination problems are relatively frequent, suggesting that specific verbal and non-verbal cues may need to be trained. RAS also changes the necessary size of the operating room instrument cleaning processes. These studies demonstrate the value of clinically-based human factors engineers working alongside surgical teams to improve the delivery of RAS

Lean Six Sigma Body of Knowledge for Healthcare Industry Administrators: Implementation of Lessons Learned in Applied Engineering

The purpose of this paper is to propose a Lean Six Sigma (LSS) course curriculum for healthcare administration and management majors. It identifies the relevant opportunities and challenges for the application of LSS within the healthcare industry. The paper also discusses the cultural changes necessary to provide an appropriate climate for its long-term success. This work contains a comprehensive description of the body of knowledge in LSS, which were successful in applied engineering. Additionally, the paper describes how LSS may be applied in the hospital setting to improve processes in patient-care services. Upon successful completion of the course, the healthcare administration managers would not only acquire comprehensive understanding by learning theory and but also completion of term projects by applying it to case studies. While obstacles to LSS implementation exist, the process improvements and resulting cultural changes are worthwhile and noteworthy. The paper serves as a guide for how LSS methodology can be utilized in the healthcare-education setting. It may not touch all the aspects of LSS. Other researchers and practitioners may use the paper as a practical orientation to LSS in the university setting

The Impact of Nursing Hours and Hospital and Patient Characteristics on Medicare Hospital Acquired Conditions: A National Pooled Cross-Sectional Secondary Data Model and Analysis

Background: Previous research and quality improvement initiatives have underscored the prevalence of healthcare acquired conditions (HACs) and their associated costs in American hospitals. In response to these findings, in 2008, The Centers for Medicare and Medicaid Services identified 10 condition categories that they would no longer pay for if acquired during hospitalization. The conditions were selected based on high cost, high volume, or both, assigned to a higher paying medical severity diagnostic related group (MS-DRG), and were deemed preventable through application of evidence-based guidelines. The Health Quality Outcomes Model and a Path Model guided the study. Objective: To quantify the association between patient and hospital characteristics, and nursing care intensity of HACs. Data Sources: Medicare Provider Analysis and Review file, Provider of Service file, 2010 Medicare Occupational Mix Adjustment Survey for Acute Care Hospitals, Medicare Hospital and Hospital Health Care Complex Cost Report, and Magnet Hospital List. Methods: Pooled cross-sectional secondary analysis of a random set of Medicare beneficiaries admitted to an inpatient prospective payment system hospital (2009 - 2011). Descriptive statistics, correlation analysis, and multivariate regression analyses were computed. Results: The significant predictors of a reported HAC were length of stay (LOS) and severity of illness (SOI). Patients with a high SOI were 9-times more likely than patients with a lower SOI to incur an HAC. Controlling for LOS, the likelihood of a patient incurring an HAC declined almost 1/3 (OR= 8.9 vs. 12.8). High (\u3e20.1) RN hours per patient day were significantly (p= Conclusions: The hospital acquired condition program is a significant step in aligning pay-for-performance incentives for reducing hospital-acquired conditions and infections. This policy has important implications for health care quality and costs and research should be conducted to evaluate the long term consequences of this policy

Implementing an Integrated Care Pathway For General Foot Screening

It is evident from the literature that foot problems can lead to discomfort, pain, ulceration and increased risk of falling in older people. Good and timely foot care can help individuals remain independent, active and mobile and, more importantly, prevent footwear related falls in older people. According to Age Action Ireland, the population of Ireland is ageing rapidly and the number of people aged 65 and over will rise from 532,000 in 2011 to almost 1.4 million by 2046. The Health Service Executive currently provides a range of foot care services for older people but these services are not well developed or standardised nationally. This project aims to design and implement an Integrated Care Pathway for general foot care and to improve the quality of the foot clinic services in one of the Health Service Executive nursing homes. The HSE Change Model was used to guide the implementation of the change project and quantitative tools were used to inform the change process. Data in regards to inappropriate referrals, waiting times and documentation audit were collected prior to implementation of the change process and were used to evaluate the impact of the change process, which showed significant improvement as a result of the successful implementation of care pathway. The limitation of the project was the small data size used for evaluation. Based on the success of the change process, the implication for replicating the project was made