Category: Ethics and Law

Categories : Ethics and LawTags :

Reinstate Whistleblower – Court Orders Eastern Cape Health MEC

On By ModernMedia

By Tania Broughton

The health department in the Eastern Cape has been ordered to reinstate a “whistleblower”. She was removed from her job in a district human resources office after she raised the alarm about a colleague attempting to get her niece short-listed for a job.

Eastern Cape Labour Court Judge Zolashe Lallie found that “an occupational detriment” had been committed against Vuyelwa Thelma Tanda. The judge ruled that in terms of the Protected Disclosures Act, Tanda had made a “protected disclosure” when she reported the attempted nepotism to her boss.

The judge ordered that she be compensated with R162 402 and that she must be given back her job.

Read the full judgment here

Tanda was initially employed as a data capturer at the Motherwell Community Health Centre. In January 2014, she was seconded to the human resources department in the district office, where she, and two fellow employees, were responsible for managing recruitment and selection processes. They had to report to the deputy director of human resources management, Charmain Jaggers, who in turn reported to the director, Mzoli Njalo.

In January 2018, the department advertised several administrative clerk posts and received a large number of applicants. Njalo’s wife, Phumla Njalo, who was also employed by the department, chaired the shortlisting panel.

The following day, Tanda’s colleague, Princess Makhulume, “got upset” and questioned why her niece had not been shortlisted.

A few days later Tanda was contacted by Mrs Njalo, who said there had been an oversight in the shortlisting process and instructed her to add the niece’s name to the shortlist.

Tanda refused, saying that HR policies and procedures did not permit her to comply with such an instruction. She explained that the correct procedure was to reconvene the selection panel.

Tanda said she reported the instruction to Jaggers, but she did not want to intervene. Jaggers advised her to call a meeting of the selection panel.

When the meeting was held, the issue remained unresolved, because only Mrs Njalo wanted Makhulume’s niece to be shortlisted.

Tanda again spoke to Jaggers, who again expressed unwillingness to intervene. Ultimately, the selection panel took a final decision not to shortlist Makhulume’s niece.

Shortly after the incident, Tanda said she was reprimanded by Jaggers for attending a memorial service for a nurse and taking files home.

She said Jaggers had given her permission to attend the service – and she denied taking files home.

She was then barred from attending HR staff meetings, removed from the department’s WhatsApp group, and her files were taken away from her.

After Tanda launched a grievance, it was recommended that she be “removed from the HR department”. She left at the end of March 2019 and was given a job as a data capturer at the information section of the district office.

Judge Lallie said Jaggers denied ill-treating or victimising Tanda after she reported Mrs Njalo’s conduct. She said Tanda had become rebellious and failed to perform her duties properly.

Lawyers for the health MEC argued that in terms of the Protected Disclosures Act, a disclosure made in the normal scope of employment could not be protected.

However, Judge Lallie said the argument that Tanda had not made a protected disclosure was not supported by the evidence that Mrs Njalo was “intentionally acting in breach of recruitment procedures” and attempting to give Mkhuluma’s niece an unfair advantage.

“In the circumstances of this case … the report that Mrs Njalo was instructing Tanda to be complicit in nepotism in violation of the recruitment policy constituted a protected disclosure. The report was made in good faith to Jaggers.”

Judge Lallie said it was common cause that Jaggers had refused to intervene in the matter.

Tanda had given a detailed account of how Jaggers victimised her shortly after she made the disclosure. “I cannot accept the version that the relationship between Tanda and Jaggers changed because of Tanda’s misconduct and incompetence. Tanda had worked in the HR office for four years without any complaint,” said the judge.

Judge Lallie said Tanda had been “punished” and that Jaggers had abused her seniority.

“Tanda has proved that solatium (compensation) is due to her as a result of humiliation, hurt and the violation of her right to dignity which she suffered in the hands of Jaggers for making the protected disclosure.”

Judge Lallie ordered compensation equivalent to the pay she would have earned over a period of ten months, at the rate she was earning when she made the protected disclosure, and that she be given back her job, and that the MEC pay her costs.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Ethics and Law HospitalsTags :

Health MEC Liable for Patient Who Fell to His Death, Court Rules

On By ModernMedia
Photo by Tingey Injury Law Firm on Unsplash

By Tania Broughton for GroundUp

The High Court in Gqeberha has found that the Eastern Cape MEC for Health and Livingstone Hospital are liable to pay damages to the widow of a man who died after falling from the fifth floor of the hospital.

In the ruling last week, Acting Judge Ivana Bands found that the patient, George Williams, had not been properly medicated or monitored. She said that had this been done, Williams would not have been “pacing up and down the ward, in confused, restless and disoriented state”, and would not have fallen to his death from the window.

Judge Bands said the conduct of the medical and nursing personnel who treated Williams after he was admitted to the hospital on 3 October 2013, “fell far short of what is regarded as sound practice” in dealing with patients suffering from alcohol withdrawal – delirium tremens which involves sudden and severe mental or nervous system changes – and secondary schizophrenia.

“Had he been properly medicated, it cannot be gainsaid [denied] that he would have been reduced to a calm and lightly dozing state. This would have enabled the medical and nursing staff to monitor his vital signs and his condition appropriately until such time that delirium tremens had abated,” Judge Bands said.

Read the judgment

Judge Bands’s finding of negligence means that Williams’s widow Jeanine can now pursue a monetary damages claim against the MEC and hospital. This could be determined at another trial or through negotiation.

Jeanine Williams, in her papers, contended that the hospital staff were under a legal duty to provide her husband with adequate and timeous medical treatment; that they had not properly sedated him, restricted his movements and monitored his condition.

The defendants, however, argued that Williams had been treated with sedatives, including diazepam (Valium) and that he had been put in an “enclosed locked ward” close to the nurses’ station.

Bands said Wiliams was a known alcoholic who was admitted to the hospital late on 3 October 2013. In the early hours of the morning, he had been given diazepam, with little effect. During the evening of 4 October, he was given more sedatives and an antipsychotic agent, also with no effect.

Soon after, at about 10:30pm, Williams broke the outside entrance glass door of the nurses’ tearoom and fell from the fifth floor. He died about an hour later.

Two key witnesses during the trial were Dr Candice Harris, a professional nurse and general practitioner, who testified for Williams, and Dr Michelle Walsh, a general surgeon, who testified for the MEC and the hospital.

In her evidence, Harris had said delirium tremens was a “medical emergency” and, according to guidelines, immediate management of the condition was necessary. She had stressed the importance of re-orientating the patient and said it was the nurse’s duty to inform the doctor if the patient was not responding to medication.

The judge said Walsh’s evidence was that it was not that the hospital was doing nothing – “they were doing something”.

“She said the sedation prescribed is usually based on what the assessing doctor thinks will have the desired effect to calm the patient to the extent that they would sit calmly in a chair. It is common cause that this desired state was never reached,” the judge said.

“Not only was he under-sedated, there is no evidence that the initial dose, which had no effect, was ever increased as per the published guidelines, in spite of multiple entries in the hospital records that he remained confused, disorientated, restless and walking up and down – and that he had become so agitated that the nursing staff feared he would assault them,” the judge said.

Bands said Williams had not been treated according to the guidelines, thus the MEC and the hospital are liable for any proven damages.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Ethics and Law Medical IndustryTags :

Private Equity Firms Acquire Medical Practices and Squeeze Them for Profit

On By ModernMedia
Photo by Marek Studzinski on Unsplash

New research has found that private equity firms that acquire physician-owned medical practices seem to be imposing measures to squeeze out more profits. After their acquisition by private equity firms, the clinics saw more patients and billed more for visits among a large, commercially insured population, according to a study published in JAMA Health Forum.

Researchers from Oregon Health & Science University and other institutions examined a total of 578 US physician practices specialising in dermatology, gastroenterology and ophthalmology that were acquired by private equity firms from 2016 to 2020.

“The reason this is of concern to patients and policymakers is that private equity is often driven by profit margins of 20% or more,” said senior author Jane M. Zhu, MD, assistant professor of medicine in the OHSU School of Medicine. “To do that, they have to generate higher revenues or reduce costs. Increasing private equity in these physician practices may be a symptom of the continuing corporatisation of health care.”

While it is unclear whether these practices hurt clinical outcomes for patients, the findings raise concerning parallels with the rapid growth of private equity acquisition of nursing homes and hospital systems.

“Private equity investment in nursing homes has been associated with an increase in short-term mortality and changes to staffing,” the authors wrote, citing previous research.

In the new study, researchers found an increase in the overall number of patients seen in these clinics. The study also reviewed commercial insurance claims data that showed an increased share of visits longer than 30 minutes, even though the complexity of cases remained similar to cases prior to being bought out.

“These billing patterns could mean more efficient documentation of services provided, or it could mean upcoding or up-charging insurance companies to make more money,” Asst Prof Zhu said.

She believes more evidence is needed about how private equity impacts practice patterns.

Recently, the same study team found that ~5% of US physicians are currently employed by private equity-owned practices. Researchers cited quality of care and patient satisfaction as key areas for future research as this trend continues.

“Private equity ownership of physician practices has added a distinctly private and market-driven influence to the broader trends in corporate consolidation of physicians by health systems and insurers,” they concluded. “This study contributes evidence for potential overutilisation and higher spending of care that will be important for policymakers to monitor.”

Source: Oregon Health & Science University

Categories : Ethics and Law Metabolic DisordersTags :

Major Review Urges Tackling of Weight Stigma in Healthcare

On By ModernMedia
Obesity
Image source: Pixabay CC0

Weight stigma is a negative bias known to limit both access to health services and treatments. A joint international consensus statement was recently published in Nature, aiming to end weight stigma in healthcare globally.

Researchers conducted a large review of over 3700 studies to evaluate weight stigma reduction strategies in healthcare practice and healthcare education, with a view to provide recommendations for interventions, learning, and research. The findings, published in Obesity Reviews, indicate that there is a need to move away from a weight-centric approach to healthcare.

Lead author, Dr Anastasia Kalea said: “Sadly healthcare, including general practice, is one of the most common settings for weight stigmatisation and we know this acts as a barrier to the services and treatments that can help people manage weight.

“A common misconception among medics and others, is that obesity is caused by factors within a person’s control, focusing on diet and exercise without recognition of, for instance, social and environmental determinants.

“In this review, it was clear more needs to be done to educate healthcare professionals and medical students on the complex range of factors regulating body weight, and to address weight stigma, explicitly emphasising its prevalence, origins, and impact.”

Researchers undertook a systematic review of 3773 international research articles. This included 25 weight stigma interventional initiatives, comprising a total of 3554 participants.

Weight-inclusive approaches to education in healthcare were identified as effective in challenging stereotypes and improving attitudes. They identified stigma reduction strategies in healthcare, which included ethics seminars discussing patient experiences, embedding virtual story-telling of patient case studies, or empathy evoking activities in the curriculum, such as following a calorie restricted diet or participation in clinical encounters with patients living with overweight and obesity. However, other methods such as video presentations and short lectures were not equally effective in improving attitudes in the long term.

Researchers are now calling on medical schools in both the UK and globally to ensure effective and sustained weight-inclusive teaching is embedded in medical doctor training and is added to the continuing professional development of clinicians.

Dr Kalea said: “Weight stigma needs to be addressed early on and continuously throughout healthcare education and practice, by teaching the genetic and socioenvironmental determinants of weight, by discussing the sources, impact and recognising the implications of stigma on treatment. We need to move away from a solely weight-centric approach to healthcare to a health-focussed weight-inclusive one. And it is equally important to assess the effects of weight stigma in epidemiological research.”

The urgency of tackling the obesity and overweight has been brought to the fore by evidence of the link to an increased risk from COVID.

Dr Kalea added: “Stigma reduction interventions are a current research priority. Improving the ways we educate healthcare professionals early on is a starting point, keeping the focus on our patients; we need to communicate better, listen carefully to our patients needs and let these inform our teaching and research agendas.”

Weight stigma is also known to cause ‘internalised weight bias’ (IWB), which is when a person applies negative societal or cultural beliefs about body weight to themselves. This can lead to psychological distress, depression, anxiety, low self-esteem and often leads to decreased health motivation and maladaptive coping such as avoidance of timely healthcare, social isolation, reduced physical activity and disordered eating behaviours.

Weight stigma has also been shown to increase risk of developing obesity, and healthcare is one of the most common contexts where weight stigmatisation occurs. Physicians have been reported as the second most common source of weight stigma and discrimination.

Source: University College London

Categories : Cancer Ethics and LawTags :

Towards Larger, More Representative Lung Cancer Clinical Trials

On By ModernMedia
Source: NCI

Filling clinical trials and enrolling sufficiently diverse, representative groups of patients, has long been a challenge, partly due to stringent participation guidelines. In an effort to attain larger and more diverse trial groups, an international team of researchers and policymakers has written new recommendations on how to determine eligibility criteria for lung cancer clinical trials.

The group was led in part by David Gerber, MD, along with representatives from the Food and Drug Administration (FDA), National Cancer Institute, European Medicines Agency, pharmaceutical companies, and the LUNGevity Foundation.

The recommendations, published today in JAMA Oncology, offer the first publicly available outline of upcoming FDA draft guidance on lung cancer clinical trials that are expected to make it easier to include more patients.

“This paper is the public’s first look at the FDA’s proposed changes to how we determine who can participate in a lung cancer clinical trial,” said Professor Gerber in the Hematology/Oncology Division at UTSW. “If these changes are successful, they could make clinical trials for lung cancer as well as other cancers more powerful and more representative.”

Ensuring that people from diverse backgrounds join clinical trials is key to properly evaluating how a new treatment will work among patients of all races and ethnicities. But today, only about 5% of all cancer patients enrol in a clinical trial, and only 11% of cancer clinical trial participants identify as a racial or ethnic minority.

For patients with cancer, participation in clinical trials requires not just a decision to try an experimental treatment, but time and energy spent understanding the trial, enrolling in it, and often attending extra testing or clinic appointments. Many researchers agree that complicated, inconsistent, poorly explained, and overly strict eligibility requirements to join a cancer clinical trial exacerbate this problem and are a key reason for the low number of underrepresented minorities in clinical trials.

“So many clinical trials never finish enrollment, close prematurely, or don’t recruit a population that lets researchers generalise the results,” Dr. Gerber said. “I think there’s widespread recognition that eligibility criteria have become too stringent.”

Addressing this for one cancer subtype, advanced non-small cell lung cancer (NSCLC), – the LUNGevity Foundation convened a roundtable discussion with experts from academia, industry, and regulatory bodies. The team assembled a prioritised list of eligibility categories that should be included in the descriptions of all NSCLC clinical trials and recommended criteria for each category. Some suggestions were more lenient than what has typically been included in previous NSCLC trial eligibility criteria; for instance, the team recommended that most patients with prior or concurrent cancers, most patients with brain metastases, and most patients with mild liver impairment – all of whom would likely have been excluded in the past – still be included in trials.

The team also suggested that these categories be clearly laid out on public websites advertising clinical trials in an easily searchable format.

The FDA will be releasing draft guidance on NSCLC clinical trials in the near future and hold a public comment period before finalising them. Other interdisciplinary teams have already convened to standardise eligibility requirements for clinical trials of other cancer types.

If the new guidelines prove effective, Prof Gerber said that clinical trials will likely be easier to fill and provide more complete and timely data on new cancer interventions.

“If you can involve more patients in clinical trials, you’re more likely to complete those trials quickly. That’s going to lead to new treatments faster,” he said.

Source: UT Southwestern Medical Center

Categories : Ethics and Law PaediatricsTags :

UK Children’s Gender Identity Clinic to Close after Controversies

On By ModernMedia
Photo by Sharon McCutcheon on Unsplash

Following a highly critical independent report and accusations of inadequate and unsafe care, the UK will shut down the Tavistock gender identity clinic for children – the only one in the country. It will be replaced by a number of smaller facilities with closer links with mental health care.

The Tavistock and Portman NHS Foundation Trust clinic, named the Gender Identity Development Service (GIDS), had faced complaints of both long waiting lists for a burgeoning number of referrals, as well as rushing to assign puberty-blocking drugs and cross-sex hormones to children experiencing gender dysphoria.

Concerns had been voiced as early as 2005, when a nurse working at the clinic said that patients were being assessed too quickly and giving in to pressure from interest groups. Nevertheless, demand for its services skyrocketed in later years, from less than 100 per year in 2010 to nearly 2500 by 2018. In 2018, concerns were raised anew, with staff going on to make serious public accusations.

In July 2019, Dr Kirsy Entwhisle, a psychologist at GIDS Leeds hub, said that staff misled patients and made decisions about young people’s “bodies and lives” without “robust evidence”. Some of the children had suffered “very traumatic early experiences” which had not been addressed by the staff. The trust’s safeguarding lead, Sonia Appleby, won a claim from an employment tribunal after trust managers tried to stop her from carrying out her role when staff raised concerns.

One of the loudest critics of Tavistock Centre is Keira Bell, who at 16 was assigned puberty blockers, then cross-sex hormones at 17, and had a double mastectomy at 20 before later de-transitioning.

The former patient, who said she was suffering from anxiety and depression at the time she received treatment, said medics should have considered her mental health issues, “not just reaffirm my naïve hope that everything could be solved with hormones and surgery”.

Along with the unnamed parent of an autistic girl at the clinic, she won a ruling against the NHS assigning cross-sex hormones to children under 16 – but was overturned on appeal.

Helen, a parent of a patient at the clinic, welcomed its closure, but expressed concern for the future of her son’s treatments, according to LGBT site Pink News. While she said her son was treated quickly and received puberty blocking drugs, “From that point on, it felt like it was a little bit like they were winging it,” she said.

During therapy sessions at Tavistock, she said her son was asked a lot of questions and treated “almost like a little bit of an academic curiosity”. She criticised the fact that the same staff evaluated children for medical interventions and also offered therapy session, creating “a fear that they would stop access to medical support”. In contrast to the legal claims of Keira Bell’s and the unnamed patient, she said that GIDS refused to even discuss cross-sex hormones.

Dr David Bell (no relation to Keira Bell) welcomed the closure of Tavistock, telling the BBC: “Some children have got the double problem of living with the wrong treatment, and the original problems weren’t addressed – with complex problems like trauma, depression, large instances of autism.”

Categories : Cancer Ethics and Law Neurodegenerative DiseasesTags : 1 Comment

‘Red Flags’ Uncovered in Alzheimer’s and Cancer Research

On By ModernMedia
Image source: National Cancer Institute

The fields of Alzheimer’s disease and cancer research have both been shaken by recent investigations which have revealed image falsification and plagiarism. These findings call into question specific avenues of research which have received considerable funding.

Neuroscientist Matthew Schrag, a junior professor studying Alzheimer’s, had already ruffled some feathers criticising the FDA approval of the Alzheimer’s drug Aduhelm when he was approached by an attorney to investigate Simufilam, another Alzheimer’s drug under development.

According to Science, he used funding given to him by the attorney to investigate the data behind the drug’s development. The research focuses on amyloid beta (Aβ) plaques, long thought to be the culprit behind Alzheimer’s.

Schrag identified apparently altered or duplicated images in dozens of journal articles, and sent them to the National Institutes of Health (NIH), which had funded tens of millions of dollars. 

The investigation drew him towards a bedrock of modern Alzheimer’s research, a 2006 Nature study by Sylvain Lesné of the University of Minnesota in the laboratory of Karen Ashe, which identified an amyloid beta protein.

Schrag avoids describing the suspicious data as fraud, since that would require unfettered access to the original material. “I focus on what we can see in the published images, and describe them as red flags, not final conclusions,” he said. “The data should speak for itself.”

The work focused on ‘toxic oligomers’, subtypes of Aβ that dissolve in some bodily fluids, a potential Alzheimer’s cause that had gained traction in the early 2000s partly due to their discovery in autopsied Alzheimer’s patients.

Using transgenic mice, the UMN team discovered a previously unknown oligomer species, Aβ*56. They isolated Aβ*56 and injected it into young rats, causing a reduction in cognitive ability.

This discovery, the first to show a direct cause, resulted in an explosion in related research, with related studies receiving $287 million in National Institutes of Health funding in 2021, compared to no funding in 2006.

In concert with molecular biologist Elisabeth Bik, no less than 20 of Lesné’s papers were flagged, 10 of which related to Aβ*56. A finding which some Alzheimer’s experts say calls into question 16 years of amyloid beta research. Some had been suspicious and had failed to replicate the findings, but journals are reluctant to publish research which proves a negative or which contradicts a prominent researcher’s findings.

Cancer research has been dogged by its own crisis with fabricated data, according to an investigative report by Nature. For years, a prominent US cancer-research laboratory run by leading cancer geneticist Carlo Croce at the Ohio State University (OSU) had been dogged by allegations of plagiarism and falsified images. To date 11 papers he has co-authored have been retracted, and 21 have needed corrections.

In 2017, The New York Times first reported on allegations of research misconduct against Croce, when OSU opened inquiries into papers from Croce’s lab. These proceeded to formal investigations, Nature learnt, two of which found multiple instances of research misconduct, including data falsification and plagiarism, by scientists Michela Garofalo and Flavia Pichiorri, in papers they’d authored while in Croce’s laboratory.

Garofalo claimed she did not received proper image manipulation training and Pichiorri said she did not understand plagiarism at the time. They have since moved on from OSU.

OSU declined to charge Croce with misconduct as his involvement did not relate to direct plagiarism or image fabrication, but did note that these cases resulted out of his “poor mentorship and lack of oversight.”

Croce was removed from a number of his positions – for which he attempted to sue – but is still employed by OSU, and many of the papers identified by OSU have not been retracted by their journals.

Categories : COVID Ethics and LawTags :

COVID Experience may Have Changed Doctors’ Willingness to Resuscitate

On By ModernMedia
Source: Martha Dominguez de Gouveia on Unsplash

The pandemic may have changed doctors’ end of life decision-making, making them more willing to not resuscitate very sick and/or frail patients and raising the ICU transfer threshold, suggest the results of a snapshot survey of UK doctors published in the Journal of Medical Ethics.

Views on euthanasia and physician-assisted dying remain unchanged however, with around a third of respondents still strongly opposed to these policies.

The COVID pandemic transformed many aspects of clinical medicine, including end-of-life care, prompted by thousands more patients than usual requiring it, the researchers said. 

Because of this, they wanted to find out if the pandemic significantly changed the way in which doctors make end-of-life decisions, specifically in respect of ‘Do Not Attempt Cardio-Pulmonary Resuscitation’ (DNACPR) and treatment escalation to ICU.

These aspects of end-of-life care were chosen because of the controversy surrounding DNACPR decisions, in part prompted by an increase in cardiac arrests associated with COVID infections, and concerns about ICU capacity strained by the pandemic. 

The researchers also wanted to know if the pandemic had changed doctors’ views on euthanasia and physician assisted suicide as surveys on these issues by the British Medical Association (BMA) and the Royal Colleges of Physicians and General Practitioners had been carried out before it started.

The online survey was open to doctors of all grades and specialties between May and August 2021, when hospital admissions for COVID in the UK were relatively low.

In all, 231 responses were received: 15 from foundation year 1 junior doctors (6.5%); 146 from senior junior doctors (SHOs) (63%); 42 from hospital specialty trainees or equivalent (18%); 24 from consultants or GPs (10.5%); and 4 others (2%).

In respect of DNACPR, which refers to the decision not to attempt to restart a patient’s heart when it or breathing stops, over half the respondents were more willing to do this than they had been previously.

When the responses were weighted to represent the different medical grades in the NHS national workforce, the results were: ‘significantly less’ 0%; ‘somewhat less’ 2%; ‘same or unsure’ 35%; ‘somewhat more’ 41.5%; ‘significantly more’ 13%; and ‘not applicable’ 8.5%.

When asked about the contributory factors, the most frequently cited were: ‘likely futility of CPR’ (88% pre-pandemic, 91% now): co-existing conditions (89% both pre-pandemic and now): and patient wishes (83.5% pre-pandemic, 80.5% now). Advance care plans and ‘quality of life’ after resuscitation also received large vote-share.

The number of respondents who stated that ‘patient age’ was a major factor informing their decision increased from 50.5% pre-pandemic to around 60%. And the proportion who cited a patient’s frailty rose by 15% from 58% pre-pandemic to 73%. 

But the biggest change in vote-share was ‘resource limitation’, which increased by 20%, from 2.5% to 22.5%. 

When asked whether the thresholds for escalating patients to intensive care or providing palliative care had changed, the largest vote-share was the ‘same or unsure’: 46% (weighted) for referral; 64.5% (weighted) for palliative care.

But a substantial minority said that now they had a higher threshold for referral to intensive care (22.5% weighted) and a lower threshold for palliation (18.5% weighted).

When it came to the legalisation of euthanasia and physician assisted suicide, the responses showed that the pandemic has led to marginal, but not statistically significant, changes of opinion.

Nearly half (48%) were strongly or somewhat opposed to the legalisation of euthanasia, 20% were neutral or unsure, and around a third were somewhat or strongly in favour before the pandemic. These proportions changed to 47%, 18%, and 35%, respectively. 

But a substantial minority said that now they had a higher threshold for referral to intensive care (22.5% weighted) and a lower threshold for palliation (18.5% weighted).

When it came to the legalisation of euthanasia and physician-assisted suicide, there was no statistically significant change in opinion.

Nearly half (48%) were strongly or somewhat opposed to the legalisation of euthanasia, 20% were neutral or unsure, and around a third were somewhat or strongly in favour before the pandemic. These proportions changed to 47%, 18%, and 35%, respectively. 

Similarly, just over half (51%) said they had strongly or somewhat opposed the legalisation of physician assisted suicide, 24% had been neutral or unsure, and 25% had been somewhat or strongly in favour.  These proportions changed to 52%, 22%, and 26%, respectively. 

The impetus to make more patients DNACPR, prompted by pressures of the pandemic, persisted among many clinicians even when COVID hospital cases returned to low levels, the researchers noted. The factors informing it were compatible with regulatory (GMC) ethical guidance, with the exception of limited resources.

“At the start of the pandemic, the BMA advised clinicians that in the event of NHS resources becoming unable to meet demand, resource allocation decisions should follow a utilitarian ethic.

“However, what is clear from our results is that for a significant proportion of clinicians, resource limitation continued to factor into clinical decision making even when pressures on NHS resources had returned to near-normal levels,” they wrote.

The survey results also suggest that the pandemic has helped clinicians gain a greater understanding of the risks, burdens, and limitations of intensive care and had further educated them in the early recognition of dying patients, and the value of early palliative care, they added. 

“What is yet to be determined is whether these changes will now stay the same indefinitely, revert back to pre-pandemic practices, or evolve even further,” they conclude.

Source: EurekAlert!

Categories : Ethics and Law Medical IndustryTags :

Systematic Bias in Industry-sponsored Cost-effectiveness Studies

On By ModernMedia
Photo by Marek Studzinski on Unsplash

Industry-sponsored studies on a new drug or health technology are more likely to be found ‘cost-effective’ than independent studies, across a range of diseases, according to findings from a study published in The BMJ.

In a linked editorial, experts make a call for better reporting of results, more transparency, open-source cost-effectiveness models, and more independent studies, to reduce decision makers’ reliance on potentially biased cost-effectiveness analyses.

A cost-effectiveness analysis (CEA) provided the manufacturer is required by some countries to weigh up a product’s costs and effects.

This cost analysis evidence can be used to set the price for a drug or health technology or decide whether insurance policies will cover them. New drugs covered by insurance plans can be much more profitable than those not covered, which could lead to bias in CEAs funded by the drug and technology manufacturing industry.

While previous studies have consistently shown sponsorship bias in CEAs, most studies were limited to specific diseases, and are out of date. To fill in the gaps, Feng Xie and Ting Zhou from McMaster University, Canada, analysed data from all eligible CEAs published between 1976 and March 2021. 

They selected CEAs that reported an incremental cost-effectiveness ratio (ICER) using quality-adjusted life years or QALYs – a ‘value for money’ metric of years lived in good health.

The authors used data from the Tufts Cost-Effectiveness Analysis Registry. In total, 8192 CEAs were included in the study, of which nearly 30% were sponsored by industry. 

The study defined CEA industry sponsorship as an analysis funded by drug, medical device, or biotechnology companies, either wholly or in part. 

The results show that the industry-sponsored CEAs were significantly more likely to conclude that the new medicine or health technology was cost-effective than those not sponsored by industry.

For example, industry-sponsored studies were more likely to report the intervention being studied as cost-effective below the commonly used threshold of $50 000 per QALY gained than non-industry sponsored studies.

Among 5877 CEAs that reported the intervention was more effective but more expensive than the comparator, the ICERs from industry sponsored studies were one third (33%) lower than those from non-industry sponsored studies.

While only having the registry information to work with was a limitation, the authors said their analysis provides a basis for comparison with previous investigations.

As such, they suggested that “sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs.”

In lower and middle-income countries, industry bias can increase drug prices, where fewer resources mean decision-makers often need to rely on published, rather than independent CEAs. 

In a linked editorial, Adam Raymakers at Cancer Control Research, Canada, and Aaron Kesselheim at Brigham and Women’s Hospital, USA, argue that decision-makers “should exercise caution when using published cost-effectiveness analysis in coverage decisions.”

They say finding solutions to tackle bias is more important than ever, and make the case for open-source analysis models, increased transparency, and increased funding for independent analyses, to help minimise reliance on industry-sponsored cost analyses.

Source: The BMJ

Categories : Ethics and LawTags :

Understanding the Basic Steps to Obtaining Informed Consent

On By ModernMedia

Taking the time to obtain proper informed consent is one of the most effective ways to avoid medico-legal challenges. Other than building the doctor-patient relationship, it ensures that patients do not encounter unpleasant surprises on their care journey which may result in unnecessary anger and blame. 

Informed consent is a process where you provide information sufficient to enable the patient to make an informed decision relating to their healthcare. Although the signature of a consent form often constitutes completion of the consent process, a signature on a consent form without a balanced discussion does not constitute informed consent.

Informed consent is both a legal and ethical requirement. The National Health Act gives patients the right to be informed of the various treatment options available, and the benefits, risks and costs of each treatment option. It also gives patients the right to participate in decisions regarding their treatment and the right to consent before any treatment is given unless it is an emergency and they aren’t able to consent. From an ethical perspective, informed consent has two main objectives, firstly to respect and promote patients’ autonomy and secondly, to protect patients from potential harm. Medical intervention with a patient’s body is potentially an infringement of the constitutional right to bodily integrity and is legally wrongful unless there is a ground of justification. One such ground of justification is patient consent.

  • Knowing your patient will help focus the discussion during the informed consent process. Enquire about your patient’s personal circumstances, expectations and fears, and assess their understanding of medical concepts and ability to make decisions.  
  • Use simple language and avoid technical terminology when discussing medical facts.
  • Ensure your patient understands their medical condition and its natural history before discussing treatment options. This lets them know what to expect without treatment.
  • List the range of diagnostic procedures and treatment options generally available.  For each, highlight potential benefits and risks, including recognised complications and any potential follow-up treatment.
  • Explain the possible need for emergency management of unforeseen conditions that may emerge.
  • Discuss cost implications and payment responsibility. This considers medical aid coverage, any out-of-pocket costs, the cost of the different procedures, as well as any complications.
  • Allow an opportunity for questions and answers.  Encourage your patient to ask questions. Test your patient’s understanding. Let patients contact you prior to the planned procedure, if they have more questions or concerns.

If a patient has specified that they would rather a procedure didn’t go ahead in the event of certain clinical findings, the patient’s decision must be recorded and respected.

If the patient decides to consent to an intervention, obtain their signed written consent. The patient’s details, health status, the treatment options discussed and the procedure to be performed must be entered into your consent form.

Document complications that have a reasonable likelihood of occurring and/or which are likely to be of importance to your patient, considering personal circumstances.

For example, an abnormal sense of touch after carpal tunnel syndrome surgery may affect a practising dentist more significantly than a retired librarian. 

  • Ensure that your consent form documents that no guarantees or promises have been made regarding the outcomes of the procedure and the patient has a right to refuse the procedure.
  • Your consent form must include any discussions relating to financial consent, the use of anaesthesia and blood products and the need for emergency management in the event of unforeseen complications.
  • Check that the patient initials the document and signs with the correct date. Countersign and date the consent form. Attach any relevant patient information sheet to the informed consent form and allow the patient to take a copy and keep one for the practice.

Consent remains valid until it is withdrawn by the patient or until their circumstances change in a meaningful way. However, if significant time has passed since the original consent was obtained, you may need to update and document your discussion with the patient. Additions or corrections to the consent form must be dated, timed and signed by both parties.

Trust EthiQal to provide you with local legal advice and professional support when you need it most.

EthiQal is a division of Constantia Insurance Company Limited, a licenced non-life insurer and an authorised Financial Services Provider (FSP 31111).