Category: Ethics and Law

Categories : COVID Ethics and LawTags :

COVID Experience may Have Changed Doctors’ Willingness to Resuscitate

On By ModernMedia
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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
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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).

Categories : Ethics and Law Obstetrics & GynaecologyTags :

How Will Roe v Wade Decision Influence the World?

On By ModernMedia
Photo by Andy Feliciotti on Unsplash

With the US Supreme Court’s overturning the Roe v Wade decision, abortion rights are now up to individual US states. However, while there are no legal implications for the rest of the world, it will undoubtedly have a huge influence on other countries’ abortion campaigning and lawmaking decisions. Future anti-abortion efforts in the US may also impact the country’s funding of reproductive services in regions such as Africa.

Without access to legal, safe abortion, many pregnant people will turn to unsafe methods. According to the World Health Organization, 97% of all unsafe abortions happen in developing countries. Some 4.7–13.2% of maternal deaths are attributable to unsafe abortion.

Although Roe v Wade does not have a legal effect in Africa, it was frequently invoked in abortion. Tunisia liberalised its abortion law just nine months after the Roe v Wade ruling – allowing women to access the service on demand. Additionally, in 1986, Cape Verde allowed for abortion on request prior to 12 weeks gestation which aligns with Roe v Wade holding of the same.

In South Africa, the right to abortion is not directly enshrined in the Constitution, but the 1996 Choice in Termination of Pregnancy Act greatly widened accessibility to safe, legal abortions, causing a 90% drop in abortion mortality from 1994 to 2001. The previous apartheid-era laws and their enforcement were predictably stained by racism: abortion was limited to encourage white population growth while contraceptives were promoted to control the population growth of black and coloured people. Wealthy whites could fly to England for an abortion there if they could not arrange one. The 1996 Act was met with significant opposition on religious grounds, and it is speculated that had the ANC done this with an open vote, it would not have passed with such a wide margin.

Even today, research shows that abortion remains highly stigmatised among South Africans, with 75.4% of people surveyed indicating that it was “always wrong” in case of family poverty, and 52.5% indicating the same for either foetal abnormality or family poverty. Provincial splits are apparent, with Gauteng and Limpopo having a > 1 odds ratio of being against abortion.

The 2003 Maputo Protocol adopted by the African Union requires countries to authorise medical abortions in cases of sexual assault, rape, incest, or where the health of the mother is endangered. This specific provision draws from the 1979 United Nations Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), whose clause on access to safe abortion was based on on Roe v Wade. However, 12 AU members have not ratified the protocol, and many of those who did have not fully brought their laws into line. South Africa is only one of six African nations that effectively allow elective abortions. Of these, Mozambique and Benin only fully changed their laws in 2020 and 2021.

Abortion opponents led by the Catholic Church and its affiliates enjoy widespread political and social support in many African countries. In 2020, Bhekisisa investigated African pregnancy crisis centres funded by US anti-abortion groups. These centres actively discourage abortion, exerting pressure on girls and women and are rife with misinformation, such as grossly exaggerating the size and development of the foetus in early stages of pregnancy. One NGO offered training to say that abortion would “turn” women’s partners gay if they got an abortion.

Thus, while the legal outcome of Roe v Wade being overturned will have no bearing on South Africa, it will conceivably embolden anti-abortion groups both domestically and abroad and likely to increase the influence they already exert in the country.

Categories : Ethics and Law Obstetrics & GynaecologyTags :

High Court Wrong about Law on Foetuses under 26 Weeks, Concourt Rules

On By ModernMedia
Gavel
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The Constitutional Court has declined to confirm the constitutional invalidity of sections of the Births and Deaths Registration Act. This comes after the Pretoria High Court found that the Act denied parents the right to bury the remains of a foetus less than 26-weeks.

The application was brought by The Voice of the Unborn Baby NPC and the Catholic Archdiocese of Durban against the ministers of Home Affairs and Health.

The applicants argued that the Act was “insensitive, hurtful and disrespectful” as it only allows for a death certificate to be issued in “stillborn” cases when the foetus is more than 26-weeks.

High Court Judge Nomonde Mngqibisa-Thusi agreed and ruled that sections of the Act are unconstitutional on the basis it “deemed a foetus less than 26-weeks to be medical waste that must be incinerated”.

However, the Constitutional Court, in a unanimous judgment, said the judge was wrong. Acting Judge Pula Tlaletsi said the applicants had submitted that the provisions of the Act had the effect that no burial order could be issued for foetuses lost through miscarriage before the 26-week mark, and that the regulations only made provision for the burial of corpses and human remains, but not foetal remains.

“While it may be true, as the applicants argued, that throughout the years the practice has been to deny parents this right in the apparent belief that this is what the law provides, matters not. The Act contains no such prohibition,” Judge Tlaletsi said.

“The relevant sections cannot be declared inconsistent with the Constitution because of such omission … the Act does not stand in the way of that burial,” he said, noting that the Act only regulated the burial of “dead human bodies or still-born children”.

The Judge said that the court was not in a position to grant the relief.

Read the judgment here

The question as to what medical staff at public hospitals must do if parents expressed the wish to bury or cremate pre-viable foetal remains was not clear, he said.

“Such a burial or cremation would no doubt require the cooperation of healthcare professionals and public hospitals would be expected to allocate the necessary resources.

“Because of the way the case was pleaded, we do not have the necessary evidence to evaluate considerations relating to how hospitals would manage this … There may be other restrictions, for example, limitations imposed by municipal regulations (regarding cemeteries and crematoriums).”

The Catholic Church, arguing that its members held “sincere religious beliefs” that they become parents from the moment of conception, said the burial right should also extend to lost pregnancies “due to human intervention”, including termination of pregnancies.

But two amici in the case — the Women’s Legal Centre Trust and the Sexual and Reproductive Justice Coalition — said this would have a profound impact on the termination of pregnancy services offered to women, and the attached confidentiality.

This burden, they said, would lead to a decrease in facilities offering termination and a diminution of sexual and reproductive rights.

However, the apex court did not comment on this.

By Tania Broughton

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

Source: GroundUp

Categories : Ethics and Law TransplantsTags :

Experimental Surgeon Convicted for Tracheal Implant Death

On By ModernMedia
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A Swedish court has convicted Paolo Macchiarini, a formerly lauded trachea surgeon, of causing bodily harm to a patient through negligence during a highly experimental stem-cell trachea transplant. For this, the court handed down a two-year probational sentence. He was acquitted of assault charges on two other patients; all three died in the months and years after the surgeries.

In 2010, Macchiarini was hired by the Karolinska Institute (KI) and the Karolinska University Hospital to support Sweden’s regenerative medicine innovation. His specialty was replacing damaged tracheae with artificial ones that combined stem cells with polymer scaffolds or decellularised donor tracheae. Starting in 2011, he began operating on patients as an experimental life-saving measure but his work at at KI was suspended in 2013 after the second of his three patients died. However, he continued performing surgeries in Russia.

Yet there were already hints that something was amiss even before the first surgeries. In 2011, another academic, Pierre Delaere of UZ Leuven in Belgium accused Macchiarini of misrepresenting research findings in published articles. In 2012, Macchiarini was arrested in Italy and charged with fraud and attempted extortion. 

By 2014, after the death of his first patient, three separate allegations were raised of scientific misconduct in reporting the cases. He would later be cleared of these, but in 2016 a TV documentary called ‘The Experiment’ described the suffering and deaths patients of failed artificial tracheas transplants, and raised many issues concerning care and research ethics. The severe public backlash caused KI to launch another investigation into Macchiarini, amid an upheaval which saw a string of resignations and an overhaul of hiring and ethics. He was found to have falsified his CV, and published papers with false or misleading data that were subsequently retracted. By March, he had been fired and criminal charges filed against him.

BBC News reported that at least seven people had died following the surgeries. In 2018, KI found seven researchers guilty of academic misconduct. Swedish authorities decided to reopen investigations into the three deaths.

Matthias Corbascio, a cardiac surgeon at KI who testified in the trial, told SVT Nyheter that he doesn’t believe justice has been done. “My reaction is that it is very meager. It is a terrible scandal and terrible for the patients’ families that he could get away so easily,” he said.

Chief judge Bjoern Skaensberg said the court had agreed with prosecutors that the surgery had not been consistent with “science and proven experience”. However, he told public broadcaster SVT that it had concluded that “two of the interventions were justifiable, but not the third”.

The court had found that all three patients had suffered serious bodily injury, Judge Skaensberg said. But Macchiarini was cleared of assault as no intent to harm had been proven.

Macchiarini had always denied any wrongdoing, arguing that the transplants were aimed at saving the patients’ lives.

However, whistleblower Dr Matthias Corbascio told SVT that the verdict was a scandal and there had never been any chance of the operations succeeding.

The suspended sentence means he will be on probation for the next two years.

Source: BBC News

Categories : Ethics and Law Medical Research & TechnologyTags :

Scientists Sound Alarm on Badly Run Medical Studies

On By ModernMedia
Woman using lab equipment
Source: NCI on Unsplash

A new research paper has signalled a crisis in medical research: “over 60% of trials are so methodologically flawed we cannot believe their results”. Researchers estimate that 88% of trial spending is wasted.

Dodgy research design and bad statistical methodology mean that most randomised trials are a waste of time, money and effort, and of no or dubious scientific value, say Stefania Pirosca, Frances Shiely, Mike Clarke and Shaun Treweek, in a new paper published in the journal Trials in early June.

Their paper examined 1659 randomised trials, involving 400,000 participants, that took place between May 2020 and April 2021 in 84 countries as well as 193 multinational trials. 

The majority of trials (62%) showed a high risk of bias. More than half of trial participants were in these high risk of bias trials. Trials where the risk of bias was unclear accounted for 30% of those reviewed, while trials with a low risk of bias – those that can be trusted – accounted for just 8% of the total.

Bad trials – ones where we have little confidence in the results – are not just common, they represent the majority of trials in all countries and across most clinical areas. For instance, all trials looking at drugs and alcohol exhibited a high risk of bias. The most reliable field was anaesthesia, with 60% of trials exhibiting a low risk of bias.

The research team drew trial data from 96 reviews from 49 of the 53 clinical Cochrane Review Groups. Cochrane is an international organisation that helps to gather and propagate the results of medical research to better guide medical decision-making. This is done by experts compiling and evaluating research trials and results in “standardised, high-quality systematic reviews”.

Bad science was common everywhere. “No patient or member of the public should be in a bad trial and ethical committees, like funders, have a duty to stop this happening,” the paper’s authors write.

South Africa was bad, but Spain and Germany may be worse

In the seven trials reviewed that took place in South Africa, four had a high risk of bias, two had an unclear bias risk, and one trial was “good science”. This share of bad science is roughly similar to those found in the clinical trials done in the UK and USA. The most reliable health research science was done in multinational trials – with these, 23% of trials were a low risk of bias. (The authors didn’t identify the trials.)

The least reliable science, in countries that conducted 20 or more RCTs, was done in Spain and Germany, with 86% and 83% of the trials exhibiting a high risk of bias.

While results from just one year were interrogated, the paper’s authors found that their results map to similar studies, and that bad science can be expected to be the norm, over time.

This amounts to a massive waste of money and effort.

Statisticians and research method experts have been sounding the alarm on biased research for years, since Doug Altman’s 1994 paper in the British Medical Journal, “The scandal of poor medical research”.

Doctors want to know if they can rely on a particular treatment to produce a desired outcome, and need research that confers a degree of confidence. One way to do that – the most popular – is randomised control trials.

Randomised trials are great – but you need statisticians

Randomised control trials, also known as randomised trials, or RCTs, are for many (though not all), the gold standard for achieving scientific knowledge about a medical intervention – whether a drug or another type of therapy. The way that RCTs are conducted is crucial, as it is adherence to the method that gives people relying on the research confidence that the results produce scientific knowledge. See this explainer video for more: How do we know vaccines work?

But, if there is a high risk that the results were biased by errors in how they were conducted and how results were achieved, they should not be relied on. Pirosca and colleagues did not examine the type (or domain) of bias in the studies, arguing that having a high risk in one type of bias is sufficient to undermine the trial’s results.

In short, for Pirosca and colleagues, health research in randomised trials is bad when there is an identifiable risk of bias in the way that the results were obtained.

The large number of high risk of bias trials appears to be due to “a lack of input from methodologists and statisticians at the trial planning stage combined with insufficient knowledge of research methods among the trial teams”. You would not, they say by analogy, think it appropriate that a statistician conduct surgery, just because they are doing work in a surgical domain.

Bad science during COVID

Recent medical scandals in the headlines have highlighted the risks of bad science in medicine. The Covid pandemic has brought a boom in medical research, and popular attention to the results of medical research. This environment has produced some remarkable science, but it has also created scientific fiascos, like the one that surrounded ivermectin.

As GroundUp has previously reported, a review of studies investigating ivermectin as a possible therapy for Covid initially suggested that the deworming drug led to better outcomes in those that used it. On the face of it, the small studies that supported this conclusion seemed to provide promise for a low-cost, life-saving Covid intervention. But once the methodology and statistics were looked at closely, many of these papers were deemed unscientific – for instance, patients were excluded from analysis for no good reason. And once these trials were excluded from the review, the drug’s promise as a Covid treatment vanished.

Medical research watchdog Retraction Watch currently lists 12 papers purporting to investigate ivermectin that were subsequently withdrawn or for which concerns have been expressed. According to their records, 235 Covid papers have been withdrawn to date.

But the crisis is not insurmountable. Pirosca and colleagues say that relatively simple fixes would dramatically reduce the amount of untrustworthy health research – by ensuring that methodological principles that underlie RCTs are not compromised.

More expenditure on statistical expertise will save money

A 2015 review examined 142 trials that exhibited a high risk of bias. The authors found that in half of the high risk trials, the methodological adjustments required to reduce the risk of bias would have been low or zero cost. Easy adjustments at the design stage would have made important improvements to 42% of trials that exhibited high risk of bias.

Pirosca and colleagues propose that no medical RCT should be funded or given ethical approval if it cannot prove that the team conducting the trial has a member that has methodological and statistical expertise. Every RCT should, in its design, use risk of bias tools to make sure that results are not compromised.

The expertise that could restore the worth to medical research is in short supply.

More methodologists and statisticians are needed, and money should be invested in training people with this expertise, and investing in applied methodology research and supporting infrastructure. The authors call for 10% of a funder’s budget.

This might seem like a lot of money, but, argue Pirosca and co, it would be a fraction of the cost of the wasted research in the year under review – estimated to be billions of rands.

The task is urgent: “Randomised trials have the potential to improve health and wellbeing, change lives for the better and support economies through healthier populations … Society will only see the potential benefits of randomised trials if these studies are good, and, at the moment, most are not.”

Written by James Stent

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

Source: GroundUp

Categories : Ethics and Law Expert OpinionTags :

Why Independent Healthcare inside Prisons is Vital

On By ModernMedia
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Judge Edwin Cameron, Inspecting Judge of Correctional Services, writes about the need for healthcare professionals working in prisons should be shifted to the Department of Health.

Our country’s healthcare system is a cumbersome double-decker bus: on top are those of us who have access of some kind to private healthcare (a high estimate is around 27% of the population). The great majority of necessity rely on public healthcare. But, within public healthcare, there is a further divide, an overlooked layer at the very lowermost – the healthcare afforded to people in prison.

During apartheid, healthcare for those inside prison and in police custody was used as a “tool of manipulation and coercion”. There was medical negligence, poor quality care, false medical and autopsy reports, and warped medical ethics. (Bram Fischer, in his dying days, received no treatment for his crippling cancer).

Some doctors and other medics were complicit in abuses, turning a blind eye to what was happening before them.

The Truth and Reconciliation Commission (TRC) Special Hearings on Prisons showed how basic access to medical treatment was used to punish. Henry Magkothi recounted how difficult it was to gain access on Robben Island to the hospital. “The doctor didn’t come often enough and even then there were so many obstacles they placed in your way.”

The problem was not only one of medical ethics. There was a “fragmented approach and a general lack of clarity” in governing what health professionals did to those in their custodial care, wrote Laurel Baldwin-Ragaven, Leslie London and Jeanelle De Gruchy in their book An Ambulance of the Wrong Colour: Health Professionals, Human Rights and Ethics in South Africa.

Not only did doctors have to have security clearance to work in prisons, but there were split institutional loyalties. Some health professionals were employed by the Department of Health and others by the Department of Prisons (now the Department of Correctional Services — DCS). This led to a dilemma of “dual obligations”, where the lines of authority for healthcare and custodial care were blurred. Health professionals owed loyalty to their patients (the inmates). But they had obligations to, and pressure from, their employers (the prison authorities).

Healthcare must be separated from prison administration

This blighted history led Dr Judith van Heerden, an expert in this area, to recommend to the TRC that prison healthcare “must be separated completely from custodial care”. All healthcare professionals in prisons “should be appointed, paid and responsible to the Department of Health” – and no longer to the prison authorities.

The TRC embraced this sound advice in its recommendations. It suggested that: the Department of Health should assume control over prison healthcare; prison health responsibilities and obligations should be clearly defined with an independent line of authority.

These recommendations accord with international guidelines. The UN Mandela Rules entail a demarcation between healthcare and custodial care; there shall be “full clinical independence”. Healthcare professionals “shall not have any role in the imposition of disciplinary sanctions or other restrictive measures”. And clinical decisions may only be taken by healthcare professionals “and may not be overruled or ignored by non-medical prison staff”.

Experts have underscored the importance of providing health services in prison that are separate from the prison administration. The World Health Organisation and the United Nations Office on Drugs and Crime note that healthcare professionals should act “completely independent of prison authorities” and in “alignment with public health services.”

Furthermore, the Association for the Prevention of Torture advocates for the “integration of the prison health service into the national health service” to guard the “professional and ethical independence of the health staff” and “provide recourse to an independent body in case of conflicts.”

Did democratic South Africa heed this advice? No.

Medical ethicist Professor Solomon Benatar observes that the Department of Health “began to dismantle the District Surgeon Services” and “[i]t became possible for DCS to appoint nurses and other medical staff to deliver healthcare” in our prisons.

This is evident in the plain wording of the Correctional Services Act of 1998. Section 12(1) states that DCS “must provide, within its available resources, adequate health care services” and section 12(2)(b) outlines that medical treatment “must be provided by a correctional medical practitioner, medical practitioners or by a specialist or health care institution or person or institution identified by such correctional medical practitioner”. And according to section 12(3), if an inmate opts to be “visited and examined by a medical practitioner of [their] choice” it is “subject to the permission of the Head of Centre”.

Post-apartheid, healthcare in prisons is still not independent. Benatar slates this “retrogressive step”; “diverting some responsibilities for healthcare away from the Department of Health” and towards DCS, diminishes the “loyalty of some health professionals” as it ranks “allegiance to prison authorities higher than professional responsibility to patients.”

A special duty of care

In his book Health and Health Promotion in Prisons, Professor Michael Ross states that depriving inmates of liberty does not mean we may deprive them of access to healthcare. On the contrary, their deprivation of liberty means we owe them a “special duty of care”. Critically, Ross acknowledges that we provide “good care to bad people because we are professional, and because we, and they, are human” and if bad care is given “the humanity we degrade is also ours, not only theirs”.

Those in prison should have the same quality of healthcare as the public outside. This is the “equivalence of care” principle. It means that you don’t add poor healthcare treatment on top of imprisonment to punish. As I have written before, “prison health affects our health” and “equivalence of care” should be considered a minimum threshold. In light of the higher mortality rates in prisons; government may have to provide higher standards of healthcare in prisons.

We know that injuries and the use of anti-depressants are warning signs of trouble. Many cases of claimed abuse (especially sexual violations, assaults, use of force and torture) are reported to nurses and doctors. Later, investigators, both internal and external, rely on medical reports. Ross emphasises that one must ensure health assessments of inmates are based on medical criteria and inmates ought to trust their healthcare providers and feel safe to report and speak out about abuse.

In addition, nurses, psychologists and other medical practitioners play a role in how prisons are run. For example, they are expected to visit inmates in segregation (sometimes in solitary confinement). The Act provides that segregation “must be discontinued” if medical practitioners determine that “it poses a threat to the health of the inmate”.

Further, independent healthcare can provide another significant layer of independent monitoring over our closed-off prisons.

Two parallel healthcare systems are not advisable. Does DCS have adequate training facilities to ensure training and updates on clinical care for clinicians on its payroll? The Judicial Inspectorate for Correctional Services (JICS), which I head, believes not. DCS clinicians often miss out on training opportunities. Further, DCS’s data systems are standalone – they are not linked to the Department of Health’s facilities (connecting them would ensure continuity of care when inmates are released).

And a heartening thought – why not allocate community service doctors to prisons? This would alleviate costs and skills scarcity.

The state of healthcare in our prisons

Grievously, our prisons are a microcosm of all our country’s social ills. This is true of healthcare, but perhaps it is worse, since, notoriously, prisons are epidemiologic pumps for the spread of infectious viruses and diseases.

The 2020-2021 annual report of the Judicial Inspectorate for Correctional Services paints an agonising picture of the state of prison healthcare.

Inmates do not get regular access to nurses and doctors, clinics in prisons are cramped and there is limited privacy for consultations, correctional officials are not always available to escort inmates to healthcare facilities, medications are not always dispensed on time, some medications have expired, health check-ups and screenings upon admission are not always conducted and medical files are not always updated.

Healthcare professionals in prisons, especially psychologists and social workers, are working with a desperate population. In the single year covered in the report, JICS reported 86 hunger strikes, 66 attempted suicides and 27 suicides. According to DCS’s annual report “suicide is the leading cause of [unnatural] deaths in correctional facilities”.

JICS’s recent quarterly report lists 40 unnatural deaths. We don’t know the cause of most; seemingly healthy inmates died. This requires JICS’s close investigative scrutiny of the post-mortem and medico-legal documents, which are in the hands of DCS and sometimes mysteriously go missing.

Further, there were 113 deaths as a result of natural causes, including pneumonia, cancer, meningitis, septicaemia and asthma. Could some of these deaths have been avoided with early detection, close monitoring and regular access to medical assistance? JICS thinks so.

JICS is also alarmed by the 116 declared state patients in prison; these are individuals whom the courts have found are suffering from mental unwellness challenges. As they wait indefinite periods for a transfer to a psychiatric hospital, they are wrongly housed in correctional facilities. State patients should not be a DCS responsibility. JICS has raised its voice on this: correctional facilities are not conducive for state patients, and correctional officials and fellow inmates are not trained to properly accommodate them.

To end off

While inspecting prisons, I have met passionate nurses and committed doctors. Prisons are tough, dangerous and complicated places. I acknowledge that DCS has worked hard to progress in dealing with Covid, HIV and TB behind bars. But we have to do better.

We need institutional reform. Healthcare professionals working in prisons ought to be independent of DCS. This means shifting all healthcare professionals to the Department of Health and ensuring proper channels of authority and oversight within prisons. In addition, healthcare professionals need specific and ongoing training for the prison environment. We also need more healthcare professionals working in prisons – and they must be accessible, proactive and willing to speak out.

That takes us back to where we started. Our Department of Health must be well-resourced, well-capacitated and well-run – and healthcare professionals must be trained and supported and have job security. And this goes to the heart of whether we have a capable state, strong institutions and a culture of accountability.

Judge Cameron is Inspecting Judge of Correctional Services.

Views expressed are not necessarily those of GroundUp.

This article is republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Ethics and Law General InterestTags :

Good for the Soul: How Helping Others Reignited my Passion for South Africa

On By ModernMedia
Neil Tabatznik, founder of the Tshemba Foundation

In an opinion piece, Neil Tabatznik reflects on how starting the Tshemba Foundation reignited his passion for his native South Africa.

South Africa is not only the most unequal country in the world, it also does not care well enough for its weak and sick. Its inequitable access to healthcare is iniquitous in many parts of the developing world. But to me, a former South African who left the country during one of South Africa’s darkest periods in history, which was rife with government oppression at the time, it reflects the legacy of apartheid.

Having departed for England in 1971, where I practiced law before leaving for Canada, South Africa became a distant and awful memory: I had planned to leave and never come back.

I stayed away for 36 years and cut all ties with the country.

However, seventeen years ago, I returned to South Africa, for personal reasons: my son’s bar mitzvah. With family dispersed across North America, Europe and Australia, South Africa felt like a central place to congregate. It was during the new, post-apartheid period in South Africa that I fell in love with the country all over again.

I started the Tshemba Foundation in Hoedspruit, Mpumalanga, out of complete selfishness initially: It was an excuse to come back to South Africa, while doing good.

At the time, The Tshemba Foundation approached the provincial health department, pitched the concept and offered to bring skilled medical volunteers to the region – and a partnership was born.

The Foundation operates a medical volunteer programme that serves as a model of public-private partnership in the healthcare sector. Initially, I had reached out to colleagues and friends approaching retirement in the UK and Canada, recognising that they had immense skills, time on their hands, and could easily be enticed to come and help while staying at a lodge we had set up on a game reserve in South Africa. The Health Professions Council of SA (HPCSA) proved to be a barrier to this idea, because they refused to register any doctor who had left SA during the Apartheid era (intending never to return) demanding that they pay membership fees accruing during the intervening years. Although this barrier remains, we have still been able to recruit hundreds of volunteers from South Africa and abroad.

Designed to connect skilled professionals from the medical and allied professions with a desire to give back to rural communities in need, we have operated out of the Tintswalo Hospital, a 423-bed public hospital, and surrounding clinics, since 2017.

The Foundation relies on medical volunteers to bridge the gaps in patient care in rural Mpumalanga: Professionals who give up their time and expertise to bring value to underprivileged and underserved communities, while supporting existing staff with training, educational opportunities and fresh perspectives. We assist volunteers with HPCSA registration, to allow them to volunteer in South Africa, but they have to make their own way to Mpumalanga and are provided with free lodging.

Tintswalo Hospital is one of the biggest in the province, serving a rural, underserved population of about 300 000. The hospital has no specialist doctor posts, and if any staff member leaves, from groundsman to senior doctor, it is extremely difficult to replace them due to severe budgetary constraints.

Our “leave of purpose” programme recruits both local and international medics to volunteer their services in these rural areas. They cover a wide range of disciplines, from generalists and dentists to ophthalmologists that perform cataract surgeries and specialist researchers who are spearheading a rural ultrasound project.

Our flagship projects, offered in partnership with the Mpumalanga Department of Health and Tintswalo Hospital, are a state-of-the-art eye clinic and cataract operating theatre, which screens and remedies common, treatable eye diseases, and the Hlokomela Women’s Clinic where pap smears, cryotherapy, and breast, pelvis, abdomen and pregnancy ultrasounds are offered. Women no longer need to travel vast distances to receive screening and treatment: they can get such specialist care at Tintswalo.

Tshemba’s eye clinic volunteers have helped over 700 elderly patients – many of whom were being cared for by grandchildren and other family members, thereby depriving them of access to education and employment.

The programme would not have been possible without the cooperation and enthusiasm of medics, the community, the Mpumalanga Department of Health and international benefactors.

To date, we have attracted about 200 local and global volunteers, mostly from the US, Canada, Europe and Australia, who have devoted the equivalent of over 9,000 healthcare professional days, treated 19,630 patients and held 294 training sessions. These training sessions not only assist local healthcare professionals with continuing professional development and informal clinical teaching, but they also ensure that the Foundation makes a lasting and sustainable impact on the quality of rural healthcare.

Now, the challenge is to make The Tshemba Foundation sustainable. We are registering it as a charity in the UK, Canada and the United States, but we need more support.

We hope to strengthen our relationship with the province to improve healthcare, without flooding hospitals with volunteers. Instead, we would like to build on the power of the clinics by posting medics to smaller healthcare centres.

Our work makes a real difference, not only in the lives of the communities who lack access to healthcare that people in urban centres take for granted, but also in the lives of those who volunteer their services.

Categories : Ethics and Law Obstetrics & GynaecologyTags :

Children Must be Psychologically Assessed Before Mother’s Surrogacy, Court Rules

On By ModernMedia
pregnant woman holding her belly
Source: Anna Hecker on Unsplash

The existing children of a woman who agrees to a surrogate pregnancy must be psychologically assessed before an agreement can be sanctioned. This is according to a recent ruling by Judge Brenda Neukircher at the High Court in Pretoria.

In her ruling, Judge Neukircher laid down further guidelines to be followed in surrogacy agreements which come before courts for approval. Some of the guidelines are in terms of the Constitutionally-entrenched principle of the “best interest of the child”.

Judge Neukircher ruled that, “Were it to be found that the surrogacy may have a harmful effect on their psychological well-being, this would be a factor that a court would be able to weigh up in the consideration of whether the agreement should be confirmed or not.”

Setting out the history of surrogacy laws in South Africa, Neukircher said that one provision was that a surrogate mother must have a documented history of at least one pregnancy, a “viable delivery”, and a living child of her own.

Neukircher noted the importance for the courts to consider the impact a surrogate pregnancy would have on the woman’s existing child or children. “How does a surrogate pregnancy affect the surrogate mother’s own child/children? Bearing in mind that they watch her pregnancy for nine months, know she is carrying a child and see her going to hospital to deliver a baby and then comes home without a baby in her arms. Is it important that the interest of these children be protected and, if so, how does a court do that?” she stated.

The applicants in the matter before Neukircher were financially stable. They already had a ten-month-old baby born through a previous surrogate arrangement with the same surrogate mother. The surrogate mother had previously been a surrogate for other couples and had once given birth to twins.

Neukircher said the couple had one frozen egg left and now wanted another child with the surrogate mother. “In all respects, they function as a stable family unit and I’m satisfied that they are able to care for a second child financially, emotionally, physically and educationally. Any child that will be born of this surrogacy will have his/her best interests catered to in every aspect of the (Children’s Act),” the Judge said.

Turning to the surrogate mother, Judge Neukircher said she was married and had two children of her own aged ten and seven years old. “At the time of the first surrogacy, they were six and three. Each time their mother carries a child as a surrogate, they are confronted by her pregnancy which does not end in a child being brought home to join their family. My concern was how healthy, psychologically, it is for children to go through this process?”

Neukircher said she had ordered that expert reports be compiled on the surrogate’s physical suitability to have another child, and the effect, if any, of her surrogate pregnancies on her own children.

She said the report revealed that both the surrogate’s children did not want her to have more children of her own. “Both were proud of the fact that she was helping others have a family and it seems both have adjusted to the fact that she acts as a surrogate….they do not see [the babies] as being part of their own family….they do not want their mother to bring baby home”.

She said the “invaluable report” highlighted the importance that the children of surrogate mothers needed to be prepared for the pregnancy “which goes a long way to alleviating any possible anxiety”.

The Judge said lawyers for both the commissioning parents and the surrogate mother and her husband had agreed that in not requiring such expert reports, the legislature had overlooked the “best interests” principle when it came to existing children. She said the Act laid down compliance factors for surrogacy agreements, including that a court must consider the personal circumstances and family situation of all concerned.

Going forward, Neukircher said, this must include an assessment of children already born. In this matter, she granted an order confirming the agreement.

Written by Tania Broughton for GroundUp.

Source: GroundUp