Evidence Supporting the Value of Surgical Procedures: Can We Do Better?

2020 ◽  
pp. 000313482097979
Author(s):  
Jonathan J. Darrow ◽  
Christopher T. Robertson ◽  
Willard S. Kasoff
Keyword(s):  
Health Care ◽  
Surgical Procedures ◽  
Evidence Base ◽  
Surgical Research ◽  
Ethical Challenges ◽  
Device Development ◽  
Legal Challenges ◽  
Sentinel Initiative ◽  
Care Agency ◽  
Quality Evidence

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. These legal and market dynamics differ substantially from those surrounding new drug or device development. Nevertheless, obstacles could be overcome and overall expenditures could be reduced if a share of federal health care agency budgets were reallocated to generating randomized trial data, standardizing outcome measures, and conducting observational studies analogous to those that have been facilitated for drugs via the Food and Drug Administration’s Sentinel Initiative. Until better quality evidence is available, ethical principles require adequate disclosure of the limited evidence base supporting current surgical procedures.

scholarly journals Decision-making about children's mental health care: ethical challenges

2004 ◽  
Vol 10 (4) ◽  
pp. 301-311 ◽  
Author(s):  
Moli Paul
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Decision Making ◽  
Young People ◽  
Health Services ◽  
Decision Makers ◽  
Duty Of Care ◽  
Ethical Challenges ◽  
Children And Young People ◽  
Legal Challenges

Children and young people are usually referred to specialist child and adolescent mental health services (CAMHS) by adults because of concerns raised by other adults. Most CAMHS consider them from a developmental perspective and as individuals in the context of their families and other relationships/systems. In this article I discuss ethical and legal challenges posed by making decisions with and about children and young people within CAMHS, with particular reference to duty of care; the rights of minors' and parents'; capacity and consent; and disagreement between decision-makers. It is important to involve children and young people in decision-making, and I suggest ways of acheiving this.

scholarly journals Conducting epigenetics research with refugees and asylum seekers: attending to the ethical challenges

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Faten Taki ◽  
Inmaculada de Melo-Martin
Keyword(s):  
Asylum Seekers ◽  
Evidence Base ◽  
Ethical Challenges ◽  
Physical And Mental Health ◽  
Healthcare Barriers ◽  
Humanitarian Action ◽  
Disease States ◽  
Conducting Research ◽  
Refugees And Asylum Seekers ◽  
Epigenetic Research

AbstractAn increase in global violence has forced the displacement of more than 70 million people, including 26 million refugees and 3.5 asylum seekers. Refugees and asylum seekers face serious socioeconomic and healthcare barriers and are therefore particularly vulnerable to physical and mental health risks, which are sometimes exacerbated by immigration policies and local social discriminations. Calls for a strong evidence base for humanitarian action have encouraged conducting research to address the barriers and needs of refugees and asylum seekers. Given the role of epigenetics factors to mediate the effect of psychological and environmental exposures, epigenetic modifications have been used as biomarkers for life adversity and disease states. Therefore, epigenetic research can be potentially beneficial to address some of the issues associated with refugees and asylum seekers. Here, we review the value of previous and ongoing epigenetic studies with traumatized populations, explore some of the ethical challenges associated with epigenetic research with refugees and asylees and offer suggestions to address or mitigate some of these challenges. Researchers have an ethical responsibility to implement strategies to minimize the harms and maximize the short and long-term benefits to refugee and asylee participants.

scholarly journals Paradigm Shift in Clinical Practice of Sexual Health in Men During COVID-19 Pandemic

2021 ◽  
pp. 263183182110323
Author(s):  
Aditya Prakash Sharma ◽  
Japleen Kaur ◽  
Ravimohan S. Mavuduru ◽  
Shrawan K. Singh
Keyword(s):  
Health Care ◽  
Sexual Health ◽  
Surgical Procedures ◽  
Care Center ◽  
Tertiary Care ◽  
Health Care Seeking ◽  
Care Seeking ◽  
Health Seeking ◽  
Number Of Patients ◽  
The Impact

Sexual health-care seeking behavior and practices have been affected during COVID-19 pandemic. The impact of COVID-19 on this subspecialty is far reaching. This study aimed to assess the impact of COVID-19 on health-care seeking practice pertaining to sexual health in men in our tertiary care center and review the relevant literature regarding impact of COVID-19 on sexual health seeking practice and challenges faced. Outpatient data was analyzed from January 2019 to April 2021. Patients awaiting surgical procedures due to COVID were documented. A narrative synthesis of literature based on systematic search using the keywords sexual health, sexual health seeking, sexual health practice, andrology, and COVID with operators “AND” and “OR” was carried out in three search engines PubMed, Scopus, and Embase. The study outcomes were obtained by comparing data of outpatient attendance and compiling the reviewed literature. The mean attendance fell significantly from 95.11±11.17 to 17.25±13.70 persons (P <.0001) per outpatient clinic, March 2020 being the reference point. Teleconsultation has taken over physical consultation. In 98/949 cases, teleconsult could not be provided despite registration. Over 25 patients were waiting for surgical procedures pertaining to andrology due to shut down of elective services. Similar trends have been reported from other countries. Number of patients seeking consultation for sexual health problems has dramatically decreased during COVID-19 era. Establishment of data safe teleconsultation facility and its widespread advertisement is needed to encourage patients to seek consult.

scholarly journals Community Pharmacy Response in the Aftermath of Natural Disasters: Time-Sensitive Opportunity for Research and Evaluation

2018 ◽  
Vol 9 ◽  
pp. 215013271881349 ◽  
Author(s):  
Kyle Melin ◽  
Carlos E. Rodríguez-Díaz
Keyword(s):  
Health Care ◽  
Puerto Rico ◽  
Community Pharmacy ◽  
Natural Disaster ◽  
Community Pharmacists ◽  
Evidence Base ◽  
Third Party ◽  
Future Research ◽  
Prescription Medications ◽  
Collaborative Practice Agreement

One year ago, Hurricane Maria passed over the archipelago of Puerto Rico, leaving widespread disruption of nearly all human services, including the health care sector. In the aftermath of the hurricane, limited access to medical care and prescription medications presented a serious challenge to maintaining control of preexisting chronic diseases. Many patients did not have access to refrigeration for heat-sensitive medications. Significant dietary changes due to the limited availability of shelf-stable foods further exacerbated chronic conditions such as heart failure and diabetes. The role of community pharmacists following a natural disaster has previously been documented, and may include the triage of evacuees, assessment of immunization needs, and provision of prescription medications under a collaborative practice agreement. However, our experience in Puerto Rico demonstrated a variety of barriers limited pharmacists’ ability to adequately respond to the magnitude of this disaster. These included medication shortages, extended loss of power, and limited telecommunications for contacting prescribers, disaster relief agencies, and third-party payers. Ultimately, the lack of preexisting emergency protocols made overcoming such barriers difficult. As the first and sometimes only accessible health care provider to many patients following a natural disaster, we must build a solid evidence base and better understanding of the individual, interpersonal, and environmental factors that contribute to the community pharmacist response. To date, however, a paucity of data exists on both the pharmacist and patient factors, which may contribute to an effective immediate response to patient needs at the community pharmacy following a natural disaster. Future research must focus on these multi-level factors to better inform public policy and effective disaster planning. Ultimately, such research and planning will lead to increased resiliency in our primary health care systems in the face of future disasters.

Ethical challenges of whole genome sequencing in translational research and answers by the EURAT-project

2015 ◽  
Vol 38 (4) ◽  
Author(s):  
Eva C. Winkler ◽  
Christoph Schickhardt
Keyword(s):  
Translational Research ◽  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Incidental Findings ◽  
Whole Genome ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Translation Research ◽  
Legal Questions ◽  
Legal Challenges

Abstract:The use of whole genome sequencing in translational research not only holds promise for finding new targeted therapies but also raises several ethical and legal questions. The four main ethical and legal challenges are as follows: (1) the handling of additional or incidental findings stemming from whole genome sequencing in research contexts; (2) the compatibility and balancing of data protection and research that is based on broad data sharing; (3) the responsibility of researchers, particularly of non-physician researchers, working in the field of genome sequencing; and (4) the process of informing and asking patients or research subjects for informed consent to the sequencing of their genome. In this paper, first, these four challenges are illustrated and, second, concrete solutions are proposed, as elaborated by the interdisciplinary Heidelberg EURAT project group, as guidelines for the use of genome sequencing in translation research and therapy in Heidelberg.

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.

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