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Journal of the Royal Society of Medicine Apr 2018Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there...
Objective To describe the redactions in contemporary protocols for industry-sponsored randomised drug trials with patient relevant outcomes and to evaluate whether there was a legitimate rationale for the redactions. Design Cohort study. Under the Freedom of Information Act, we requested access to trial protocols approved by a research ethics committee in Denmark from October 2012 to March 2013. We received 17 consecutive protocols, which had been redacted before we got them, and nine protocols without redactions. In five additional cases, the companies refused to let the committees give us access, and in three other cases, documents were missing. Participants Not applicable. Setting Not applicable. Main outcome measure Amount and nature of redactions in 22 predefined key protocol variables. Results The redactions were most widespread in those sections of the protocol where there is empirical evidence of substantial problems with the trustworthiness of published drug trials: data analysis, handling of missing data, detection and analysis of adverse events, definition of the outcomes, interim analyses and premature termination of the study, sponsor's access to incoming data while the study is running, ownership to the data and investigators' publication rights. The parts of the text that were redacted differed widely, both between companies and within the same company. Conclusions We could not identify any legitimate rationale for the redactions. The current mistrust in industry-sponsored drug trials can only change if the industry offers unconditional access to its trial protocols and other relevant documents and data.
Topics: Denmark; Drug Industry; Ethics Committees, Research; Humans; Research Design; Treatment Outcome
PubMed: 29370569
DOI: 10.1177/0141076817750554 -
Open Heart Apr 2021The response to COVID-19 has required cancellation of all but the most urgent procedures; there is therefore a need for the reintroduction of a safe elective pathway.
BACKGROUND
The response to COVID-19 has required cancellation of all but the most urgent procedures; there is therefore a need for the reintroduction of a safe elective pathway.
METHODS
This was a study of a pilot pathway performed at Barts Heart Centre for the admission of patients requiring elective coronary and structural procedures during the COVID-19 pandemic (April-June 2020). All patients on coronary and structural waiting lists were screened for procedural indications, urgency and adverse features for COVID-19 prognosis and discussed at dedicated multidisciplinary teams. Dedicated admission pathways involving preadmission isolation, additional consent, COVID-19 PCR testing and dedicated clean areas were used.
RESULTS
143 patients (101 coronary and 42 structural) underwent procedures (coronary angiography, percutaneous coronary intervention, transcatheter aortic valve intervention and MitralClip) during the study period. The average age was 68.2; 74% were male; and over 93% had one or more moderate COVID-19 risk factors. All patients were COVID-19 PCR negative on admission with (8.1%) COVID-19 antibody positive (swab negative). All procedures were performed successfully with low rates of procedural complications (9.8%). At 2-week follow-up, no patients had symptoms or confirmed COVID-19 infection with significant improvements in quality if life and symptoms.
CONCLUSION
We demonstrated that patients undergoing coronary and structural procedures can be safely admitted during the COVID-19 pandemic, with no patients contracting COVID-19 during their admission. Reassuringly, patients reflective of typical practice, that is, those at moderate or higher risk, were treated successfully. This pilot provides important information applicable to other settings, specialties and areas to reintroduce services safely.
Topics: Aged; COVID-19; COVID-19 Testing; Cardiology Service, Hospital; Coronary Angiography; Elective Surgical Procedures; Female; Heart Valve Prosthesis Implantation; Humans; Infection Control; Male; Organizational Innovation; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Risk Adjustment; SARS-CoV-2; Safety Management; United Kingdom
PubMed: 33879506
DOI: 10.1136/openhrt-2020-001446 -
PloS One 2021Applying evidence-based practice during care provision is essential because it improves the quality of care, reduces health care costs, and increases patient and family...
BACKGROUND
Applying evidence-based practice during care provision is essential because it improves the quality of care, reduces health care costs, and increases patient and family satisfaction. However, information on evidence-based nursing practice and associated factors were not well studied and documented in the study area. Hence, this study aimed to assess utilization and associated factors of evidence-based practice among nurses working in Amhara Region Referral Hospitals, Ethiopia.
METHODS
An institution-based cross-sectional study was conducted from March 18 to April 16, 2019, in Amhara Region Referral Hospitals. A simple random sampling technique was used to select 684 respondents. Data were collected using a pretested and self-administered questionnaire. Data were entered into Epi Info version 7.1.2.0 and exported to SPSS version 22.0 for analysis. The bivariable analysis was used primarily and variables with p-value < 0.2 were further examined using a multivariable logistic regression model to control con-founders. Then, variables' p-value < 0.05 with 95% CI was used to determine associated factors.
RESULTS
From 684 proposed nurses, 671 of them completed the questionnaire giving 98.1% response rate. Of these, 55% (95% CI: 51.2, 58.9) of them had good evidence-based practice utilization. Variables including single (AOR = 1.662: 95% CI: 1.089-2.536), fewer work experience (AOR = 1.849: 95% CI: 1.049-3.257), good knowledge (AOR = 2.044: 95% CI: 1.406-2.972), effective communication skill (AOR = 2.537: 95% CI: 1.744-3.689), EBP training (AOR = 3.224 95% CI: 1.957-5.311), internet access (AOR = 1.655: 95% CI: 1.119-2.448) and evidence-based guideline availability (AOR = 1.827: 95% CI: 1.249-2.673) were found to be predictors of evidence-based practice utilization.
CONCLUSIONS
The study revealed that evidence-based practice utilization among nurses is low. Availing evidence-based guidelines in the work area, improving facilities' internet access, and building nurses' evidence-based practice competencies through either by giving separate training or incorporating as part of the curriculum would improve its utilization.
Topics: Adult; Ethiopia; Evidence-Based Practice; Female; Humans; Logistic Models; Male; Nurses; Referral and Consultation; Sample Size; Young Adult
PubMed: 33740000
DOI: 10.1371/journal.pone.0248834 -
BMJ Open Mar 2020Antimicrobial resistance (AMR) is a growing problem globally especially in Sub-Saharan Africa including Kenya. Without any intervention, lower/middle-income countries...
INTRODUCTION
Antimicrobial resistance (AMR) is a growing problem globally especially in Sub-Saharan Africa including Kenya. Without any intervention, lower/middle-income countries (LMICs) will be most affected due to already higher AMR levels compared with higher income countries and due to the far higher burden of diseases in the LMICs. Studies have consistently shown that inappropriate use of antimicrobials is the major driver of AMR. To address this challenge, hospitals are now implementing antibiotic stewardship programmes (ASPs), which have been shown to achieve reduced antibiotic usage, to decrease the prevalence of resistance and lead to significant economic benefits. However, the implementation of the guideline is highly dependent on the settings in which they are rolled out. This study, employing an implementation science approach, aims to address the knowledge gap in this area and provide critical data as well as practical experiences when using antibiotic guidelines and stewardship programmes in the public health sector. This will provide evidence of ASP performance and potentially contribute to the county, national and regional policies on antibiotics use.
METHODS AND ANALYSIS
The study will be conducted in three geographically diverse regions, each represented by two hospitals. A baseline study on antibiotic usage, resistance and de-escalation, duration of hospital stay, rates of readmission and costs will be carried out in the preimplementation phase. The intervention, that is, the use of antibiotic guidelines and ASPs will be instituted for 18 months using a stepwise implementation strategy that will facilitate learning and continuous improvement of stewardship activities and updating of guidelines to reflect the evolving antibiotic needs.
ETHICS AND DISSEMINATION
Approvals to carry out the study have been obtained from the National Commission for Science, Technology and Innovation and the Mount Kenya University Ethics Review Committee. The approvals from the two institutions were used to obtain permission to conduct the study at each of the participating hospitals. Study findings will be presented to policy stakeholders and published in peer-reviewed scientific journals. It is anticipated that the findings will inform the appropriate antibiotic use guidelines within our local context.
Topics: Antimicrobial Stewardship; Clinical Protocols; Developing Countries; Drug Resistance, Microbial; Guideline Adherence; Hospitals; Humans; Implementation Science; Inappropriate Prescribing; Kenya; Practice Guidelines as Topic; Research Design
PubMed: 32234736
DOI: 10.1136/bmjopen-2019-030823 -
Health Research Policy and Systems Feb 2020Given the complex mix of structural, cultural and institutional factors that produce barriers for women in science, an equally complex intervention is required to...
Understanding the Athena SWAN award scheme for gender equality as a complex social intervention in a complex system: analysis of Silver award action plans in a comparative European perspective.
BACKGROUND
Given the complex mix of structural, cultural and institutional factors that produce barriers for women in science, an equally complex intervention is required to understand and address them. The Athena SWAN Award Scheme for Gender Equality has become a widespread means to address barriers for women's advancement and leadership in the United Kingdom, Ireland, Australia, the United States of America and Canada, while the European Commission is exploring the introduction of a similar award scheme across Europe.
METHODS
This study analyses the design and implementation of 16 departmental Athena SWAN Silver Action Plans in Medical Sciences at one of the world's leading universities in Oxford, United Kingdom. Data pertaining to the design and implementation of gender equality interventions were extracted from the action plans, analysed thematically, coded using categories from the 2015 Athena SWAN Charter Awards Handbook and synthesised against a typology of gender equality interventions in the European Research Area. The results were further analysed against the complexity research literature framework, where research organisations are perceived as dynamic systems that adapt, interact and co-evolve with other systems.
RESULTS
Athena SWAN is a complex contextually embedded system of action planning within the context of universities. It depends on a multitude of contextual variables that relate in complex, non-linear ways and dynamically adapt to constantly moving targets and new emergent conditions. Athena SWAN Silver Action Plans conform to the key considerations of complexity - (1) multiple actions and areas of intervention with a focus on the complex system being embedded in local dynamics, (2) the non-linearity of interventions and the constantly emerging conditions, and (3) impact in terms of contribution to change, improved conditions to foster change and the increased probability that change can occur.
CONCLUSIONS
To enact effective sustainable structural and cultural change for gender equality, it is necessary to acknowledge and operationalise complexity as a frame of reference. Athena SWAN is the single most comprehensive and systemic gender equality scheme in Europe. It can be further strengthened by promoting the integration of sex and gender analysis in research and education. Gender equality policies in the wider European Research Area can benefit from exploring Athena SWAN's contextually embedded systemic approach to dynamic action planning and inclusive focus on all genders and categories of staff and students.
Topics: Awards and Prizes; Biomedical Research; Career Choice; Cultural Competency; Europe; Humans; Inservice Training; Leadership; Mentoring; Personnel Selection; Research Design; Sexism; Systems Analysis; Universities; Work-Life Balance
PubMed: 32059678
DOI: 10.1186/s12961-020-0527-x -
International Wound Journal Jul 2008
Topics: Acute Disease; Benchmarking; Chronic Disease; Cost-Benefit Analysis; Debridement; Evidence-Based Medicine; Exudates and Transudates; Humans; Negative-Pressure Wound Therapy; Nursing Assessment; Patient Care Planning; Patient Selection; Quality of Life; Research Design; Risk Assessment; Skin Care; Time Factors; Treatment Outcome; Wound Healing; Wounds and Injuries
PubMed: 18713128
DOI: 10.1111/j.1742-481X.2008.00537.x -
Human Resources For Health Mar 2020The need for greater flexibility is often used to justify reforms that redistribute tasks through the workforce. However, "flexibility" is never defined or empirically...
BACKGROUND
The need for greater flexibility is often used to justify reforms that redistribute tasks through the workforce. However, "flexibility" is never defined or empirically examined. This study explores the nature of flexibility in a team of emergency doctors, nurse practitioners (NPs), and registered nurses (RNs), with the aim of clarifying the concept of workforce flexibility. Taking a holistic perspective on the team's division of labor, it measures task distribution to establish the extent of multiskilling and role overlap, and explores the behaviors and organizational conditions that drive flexibly.
METHODS
The explanatory sequential mixed methods study was set in the Fast Track area of a metropolitan emergency department (ED) in Sydney, Australia. In phase 1, an observational time study measured the tasks undertaken by each role (151 h), compared as a proportion of time (Kruskal Wallis, Mann-Whitney U), and frequency (Pearson chi-square). The time study was augmented with qualitative field notes. In phase 2, 19 semi-structured interviews sought to explain the phase 1 observations and were analyzed thematically.
RESULTS
The roles were occupationally specialized: "Assessment and Diagnosis" tasks consumed the largest proportion of doctors' (51.1%) and NPs' (38.1%) time, and "Organization of Care" tasks for RNs (27.6%). However, all three roles were also multiskilled, which created an overlap in the tasks they performed. The team used this role overlap to work flexibly in response to patients' needs and adapt to changing demands. Flexibility was driven by the urgent and unpredictable workload in the ED and enabled by the stability provided by a core group of experienced doctors and nurses.
CONCLUSION
Not every healthcare team requires the type of flexibility found in this study since that was shaped by patient needs and the specific organizational conditions of the ED. The roles, tasks, and teamwork that a team requires to "be flexible" (i.e., responsive and adaptable) are highly context dependent. Workforce flexibility therefore cannot be defined as a particular type of reform or role; rather, it should be understood as the capacity of a team to respond and adapt to patients' needs within its organizational context. The study's findings suggest that solutions for a more flexible workforce may lay in the organization of healthcare work.
Topics: Australia; Efficiency, Organizational; Emergency Service, Hospital; Humans; Interviews as Topic; Observation; Patient Care Team; Qualitative Research; Task Performance and Analysis; Time and Motion Studies
PubMed: 32143632
DOI: 10.1186/s12960-020-0460-7 -
BMJ Open Jul 2018There is a growing body of evidence to indicate that both primary and subsequent caesarean sections are associated with increased maternal and perinatal morbidity....
INTRODUCTION
There is a growing body of evidence to indicate that both primary and subsequent caesarean sections are associated with increased maternal and perinatal morbidity. Efforts to reduce the number of clinically unnecessary caesarean sections are urgently required. Our objective is to systematically review published evidence on the effectiveness of maternity service organisational interventions, such as models of maternity care, that aim to reduce caesarean section rates.
METHODS AND ANALYSIS
Databases will be searched, including the Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, Maternity and Infant Care, EMBASE and SCOPUS. Search terms related to caesarean section and organisational intervention will be used. Research published before 1980 will be excluded and only randomised controlled trials, cluster-randomised controlled trials, quasi-randomised controlled trials, controlled before and after studies and interrupted time series studies will be included. Data extraction and quality assessments will be undertaken by two authors.
ETHICS AND DISSEMINATION
Ethics approval is not required for this systematic review. The results of this study will be disseminated via peer-reviewed publication and presentation at professional conferences.
PROSPERO REGISTRATION NUMBER
CRD42016039458.
Topics: Cesarean Section; Clinical Protocols; Community Health Centers; Health Personnel; Humans; Obstetrics and Gynecology Department, Hospital; Organizational Policy; Research Design; Systematic Reviews as Topic; Unnecessary Procedures
PubMed: 30002008
DOI: 10.1136/bmjopen-2017-021120 -
British Medical Journal Sep 1978
Topics: Communication; Hospital Units; Methods; Patient Acceptance of Health Care; Psychiatric Department, Hospital
PubMed: 698673
DOI: 10.1136/bmj.2.6138.699-c -
Health Services Research Jun 2009
Review
Topics: Data Collection; Efficiency, Organizational; Health Services Research; Humans; Models, Economic; Quality of Health Care; Research Design; Resource Allocation; Sociology, Medical
PubMed: 19674426
DOI: 10.1111/j.1475-6773.2009.00970.x