INAHTA IMPACT STORY: LEGISLATIVE AND ACCREDITATION REQUIREMENTS FOR OFFICE-BASED SURGERY IN AUSTRALIA

2017 ◽  
Vol 33 (4) ◽  
pp. 434-441 ◽  
Author(s):  
David Tivey ◽  
Ning Ma ◽  
Joanna Duncan ◽  
Yasoba Atukorale ◽  
Robyn Lambert ◽  
...  
Keyword(s):  
Web Sites ◽  
Day Surgery ◽  
Accreditation Process ◽  
Rapid Review ◽  
Regulatory Oversight ◽  
Serious Adverse Events ◽  
Healthcare Facilities ◽  
Government Web Sites ◽  
Increased Risk ◽  
Reimbursement Scheme

Background:There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia.Methods:Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process.Results:Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery.Conclusions:The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.

Effects of Intensive Blood Pressure Control in Patients with Evident Cardiovascular Disease: An Investigation Using the SPRINT Study Data

2019 ◽  
Vol 17 (3) ◽  
pp. 298-306 ◽  
Author(s):  
Charalambos Vlachopoulos ◽  
Dimitrios Terentes-Printzios ◽  
Konstantinos Aznaouridis ◽  
Nikolaos Ioakeimidis ◽  
Panagiotis Xaplanteris ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Cardiovascular Disease ◽  
Beneficial Effect ◽  
Harmful Effect ◽  
Adverse Outcomes ◽  
Intensive Treatment ◽  
Serious Adverse Events ◽  
Stroke Incidence ◽  
Increased Risk ◽  
All Cause Mortality

Background: Recent data advocate adoption of a more intensive treatment strategy for management of blood pressure (BP). </P><P> Objective: We investigated whether the overall effects of the Systolic Blood Pressure Intervention Trial (SPRINT) are applicable to cardiovascular disease (CVD) patients. </P><P> Methods: In a post hoc analysis we analyzed data from SPRINT that randomly assigned 9361 individuals to a systolic BP (SBP) target of <120 mmHg (intensive treatment) or <140 mmHg (standard treatment). 1562 patients had clinically evident CVD (age=70.3±9.3 years, 24% females) at study entry and were followed for 3.1 years. Further, we assessed the effect of low (<150 mmHg) baseline SBP on outcome. </P><P> Results: In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; p=0.0509). Further, while there was no increase in serious adverse events (SAE) in the intensive group, there was increased risk for study-related SAE, acute renal failure and electrolyte abnormalities. In patients with low baseline SBP there was a beneficial effect on allcause mortality (HR: 0.56; 95% CI: 0.33 to 0.96; p=0.033), but with greater stroke incidence (HR: 2.94; 95% CI: 1.04 to 8.29; p=0.042). </P><P> Conclusion: We confirm the beneficial effect of the intensive strategy in SPRINT study on all-cause mortality and the harmful effect on specific adverse outcomes in patients with CVD. However, in patients with low baseline SBP stroke may increase.

scholarly journals 416 - Risk of Mortality Associated with Antipsychotics in Alzheimer's Disease

2020 ◽  
Vol 32 (S1) ◽  
pp. 132-132
Author(s):  
Liliana P. Ferreira ◽  
Núria Santos ◽  
Nuno Fernandes ◽  
Carla Ferreira
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Mortality Risk ◽  
Antipsychotic Treatment ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Mesh Terms ◽  
Risk Of Mortality ◽  
Increased Risk

Objectives: Alzheimer's disease (AD) is the most common cause of dementia and it is associated with increased mortality. The use of antipsychotics is common among the elderly, especially in those with dementia. Evidence suggests an increased risk of mortality associated with antipsychotic use. Despite the short-term benefit of antipsychotic treatment to reduce the behavioral and psychological symptoms of dementia, it increases the risk of mortality in patients with AD. Our aim is to discuss the findings from the literature about risk of mortality associated with the use of antipsychotics in AD.Methods: We searched Internet databases indexed at MEDLINE using following MeSH terms: "Antipsychotic Agents" AND "Alzheimer Disease" OR "Dementia" AND "Mortality" and selected articles published in the last 5 years.Results: Antipsychotics are widely used in the pharmacological treatment of agitation and aggression in elderly patients with AD, but their benefit is limited. Serious adverse events associated with antipsychotics include increased risk of death. The risk of mortality is associated with both typical and atypical antipsychotics. Antipsychotic polypharmacy is associated with a higher mortality risk than monotherapy and should be avoided. The mortality risk increases after the first few days of treatment, gradually reducing but continues to increase after two years of treatment. Haloperidol is associated with a higher mortality risk and quetiapine with a lower risk than risperidone.Conclusions: If the use of antipsychotics is considered necessary, the lowest effective dose should be chosen and the duration should be limited because the mortality risk remains high with long-term use. The risk / benefit should be considered when choosing the antipsychotic. Further studies on the efficacy and risk of adverse events with antipsychotics are needed for a better choice of treatment and adequate monitoring with risk reduction.

scholarly journals Questionable safety of thyroid surgery with same day discharge

2012 ◽  
Vol 94 (8) ◽  
pp. 543-547 ◽  
Author(s):  
HE Doran ◽  
J England ◽  
F Palazzo
Keyword(s):  
Surgical Procedures ◽  
Thyroid Surgery ◽  
Evidence Base ◽  
Day Surgery ◽  
Hospital Environment ◽  
British Association ◽  
Outpatient Basis ◽  
Day Case ◽  
Increased Risk ◽  
Same Day Discharge

INTRODUCTION Over the last two decades increasing numbers of surgical procedures have been performed on an outpatient basis. In 2000 the National Health Service in England set the target of performing 75% or more of all elective surgical procedures as day cases and in 2001 the British Association of Day Surgery added thyroidectomy to the list of day case procedures. However, same day discharge following thyroidectomies has been adopted by only a very small number of UK centres. The aim of this review was to establish the evidence base surrounding same day discharge thyroid surgery. METHODS The British Association of Endocrine and Thyroid Surgeons commissioned the authors to perform a review of the best available evidence regarding day case thyroid surgery as a part of a consensus position to be adopted by the organisation. A MEDLINE® review of the English medical literature was performed and the relevant articles were collated and reviewed. RESULTS There are limited comparative data on day case thyroid surgery. It is feasible and may save individual hospitals the cost of inpatient stay. However, the risk of airway compromising and life threatening post-operative bleeding remains a major concern since it is not possible to positively identify those patients most and least at risk of bleeding after thyroidectomy. It is estimated that half of all post-thyroidectomy bleeds would occur outside of the hospital environment if patients were discharged six hours after surgery. CONCLUSIONS Same day discharge in a UK setting cannot be endorsed. Any financial benefits may be outweighed by the exposure of patients to an increased risk of an adverse outcome. Consequently, 23-hour surgery is recommended.

scholarly journals 32 Quantifying the Prevalence of Frailty in Drug Trials and the Relationship with Serious Adverse Events

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Disease Severity ◽  
Negative Binomial ◽  
Frailty Index ◽  
Chronic Obstructive ◽  
Drug Trials ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI &gt;0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.

scholarly journals Comparison of COVID-19 outcomes in organ transplant recipients (OTr) and non-transplant patients: a study protocol for rapid review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Alexis H. Lerner ◽  
Elizabeth J. Klein ◽  
Anna Hardesty ◽  
Orestis A. Panagiotou ◽  
Chelsea Misquith ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Organ Transplant ◽  
Open Science ◽  
Rapid Review ◽  
Secondary Outcome ◽  
Severe Illness ◽  
Link Type ◽  
Increased Risk ◽  
Potential Sources ◽  
Measure Of Association

Abstract Background The COVID-19 pandemic has devastated the global community with nearly 4.9 million deaths as of October 2021. While organ transplant (OT) recipients (OTr) may be at increased risk for severe COVID-19 due to their chronic immunocompromised state, outcomes for OTr with COVID-19 remain disputed in the literature. This review will examine whether OTr with COVID-19 are at higher risk for severe illness and death than non-immunocompromised individuals. Methods MEDLINE (via Ovid and PubMed) and EMBASE (via Embase.com) will be searched from December 2019 to October 2021 for observational studies (including cohort and case-control) that compare COVID-19 clinical outcomes in OTr to those in individuals without history of OT. The primary outcome of interest will be mortality as defined in each study, with possible further analyses of in-hospital mortality, 28 or 30-day mortality, and all-cause mortality versus mortality attributable to COVID-19. The secondary outcome of interest will be the severity of COVID-19 disease, most frequently defined as requiring intensive care unit admission or mechanical ventilation. Two reviewers will independently screen all abstracts and full-text articles. Potential conflicts will be resolved by a third reviewer and potentially discussion among all investigators. Methodological quality will be appraised using the Newcastle-Ottawa Scale. If data permit, we will perform random-effects meta-analysis with the Sidik-Jonkman estimator and the Hartung-Knapp adjustment for confidence intervals to estimate a summary measure of association between histories of transplant with each outcome. Potential sources of heterogeneity will be explored using meta-regression. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g., subgroup analysis) considering least minimal adjustment for confounders. Discussion This rapid review will assess the available evidence on whether OTr diagnosed with COVID-19 are at higher risk for severe illness and death compared to non-immunocompromised individuals. Such knowledge is clinically relevant and may impact risk stratification, allocation of organs and healthcare resources, and organ transplantation protocols during this, and future, pandemics. Systematic review registration Open Science Framework (OSF) registration DOI: 10.17605/osf.io/4n9d7.

scholarly journals Tiotropium (SPIRIVA®) in mild COPD: Is it worth it?

2019 ◽  
Vol 46 (1) ◽  
Author(s):  
Lina Mahmoud ◽  
Hannah Ng ◽  
Jade Roberts
Keyword(s):  
Quality Of Life ◽  
Exercise Duration ◽  
Cochrane Library ◽  
Chronic Obstructive ◽  
Serious Adverse Events ◽  
Main Trial ◽  
Copd Exacerbations ◽  
Increased Risk ◽  
Significant Difference

Purpose:Tiotropium (SPIRIVA®) is used in the treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in patients with persistent dyspnea despite using a short acting bronchodilator (SABD).This paper explores the role of tiotropium in the treatment of mild COPD. Methods:The Cochrane Library, EMBASE, Pubmed, and Clinicaltrials.gov were searched on February 2018.We included randomized controlled trials (RCTs) that evaluated tiotropium in patients with mild COPD.Three authors assessed studies for eligibility. Outcomes included symptoms, quality of life, exercise duration, lung function, COPD exacerbations and hospitalizations, and serious adverse events. Results: Three RCTs were selected as the best available evidence. Based on the results of the main trial, quality of life and symptoms were improved with tiotropium as compared to placebo with a difference between groups at 24 months to be 1.2 (95% CI: 0.5 to 1.9; p=0.0011) using the COPD Assessment test (CAT) score. Frequency of acute exacerbations of COPD (AECOPD) requiring hospitalization was reduced by 10.3% (28.9% with tiotropium vs 39.2% with placebo) in patients receiving tiotropium. One RCT reported no statistically significant difference in exercise duration (27 ± 27 secs) in the tiotropium group vs 50 ± 21 secs in the placebo group; (p=0.4153). Oropharyngeal discomfort was more common with tiotropium (number needed to harm of 12) compared to placebo. Conclusions: Evidence suggests that tiotropium may reduce COPD exacerbations and hospitalizations and improve quality of life in patients with mild COPD.There is an increased risk of oropharyngeal discomfort with tiotropium.

Comorbidity of Medical and Psychiatric Disorders in Geriatric Population

2018 ◽  
pp. 448-474
Author(s):  
Pratima Kaushik
Keyword(s):  
Health Services ◽  
Effective Treatment ◽  
Related Factors ◽  
Geriatric Population ◽  
Healthcare Facilities ◽  
Age Related ◽  
Increased Risk ◽  
Co Morbidity ◽  
The Social ◽  
Health Related

Ageing is a universal phenomenon that has not only social but also economic, political, and health-related implications. With the advancement in healthcare facilities and better availability of health services, the geriatric population is gradually increasing. But, this group is at an increased risk of developing both physical and psychological co-morbidities due to age-related factors and changes in the social circumstances. The present chapter proposes the concept and issues related to co-morbidity in the geriatric population. After discussing the issues and consequences of medical and psychiatric co-morbidities, their effective treatment regime and care/management in relation to the geriatric population are addressed.

A Framework for Citizen-Centric Government Websites

2010 ◽  
pp. 20-34 ◽  
Author(s):  
F. Dianne Lux Wigand
Keyword(s):  
Information And Communication Technologies ◽  
Web Sites ◽  
Communication Technologies ◽  
Public Administrators ◽  
End User ◽  
Government Services ◽  
Government Web Sites ◽  
Information And Communication ◽  
Government Websites ◽  
To Come

This author argues for a stronger end-user and citizen-centric approach to the development and evaluation of e-government services provided via the Internet. Over the past decade government agencies at all levels have created web sites that provide primarily information and only offer few two-way transactions. The predicted and hoped for resulting transformation of government at all levels due to the advent of Internet services seems yet to occur. The overall development of e-government services has been slow and uneven. To add value to existing and future government web sites, public administrators need to come to grips with a framework presented here and to understand the nature of and relationships among three variables: End-user, task, and channel characteristics and then consider their respective role and impact on channel selection. This framework along with an end-user perspective enables public administrators to assess not only the value of current information and service channels, but newer information and communication technologies such as those found in Web 2.0 or social media developments. Recommendations are offered.

User Help and Service Navigation Features in Government Web Sites

2011 ◽  
pp. 2643-2656
Author(s):  
Genie N.L. Stowers
Keyword(s):  
Public Sector ◽  
Digital Divide ◽  
Web Sites ◽  
Web Site ◽  
Government Structure ◽  
The Public ◽  
Government Services ◽  
Government Web Sites ◽  
Web Developers ◽  
Lack Of Knowledge

This article examines the user help and service navigation features in government Web sites and compares them across levels of government. These features are critical to ensuring that users unfamiliar with government are able to successfully and easily access e-government services and information. The research finds clear patterns in the use of similar help and navigation features across governments, leading to a conclusion that these features are diffusing in the public sector Web development field. The article concludes by stating that Web developers should work to overcome a second digital divide, one of a lack of knowledge of Web site organization and government structure. Users need to be actively assisted to find information by Web developers.

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