Search

An editorial is presented on the mitigating the July effect. Topics include the arrival of a crop of newly graduated medical students beginning their internships, the influx of so many freshly trained physicians arriving at the same time always triggers concern, and the belief in a July effect with presumed adverse consequences for patient safety and quality of care.

Stroke is among the top 10 causes of death in children and survivors carry resulting disabilities for decades, at substantial cost to themselves and their families. Children are not currently able to access reperfusion therapies, due to limited evidence supporting safety and efficacy and long diagnostic delays. The Australian Clinical Consensus Guideline for the Diagnosis and Acute Management of Childhood Stroke was developed to minimize unwarranted variations in care and document best evidence on the risk factors, etiologies, and conditions mimicking stroke that differ from adults. Clinical questions were formulated to inform systematic database searches from 2007 to 2017, limited to English and pediatric studies. SIGN methodology and the National Health and Medical Research Council system were used to screen and classify the evidence. The Grades of Recommendation, Assessment, Development, and Evaluation system (GRADE) was used to grade evidence as strong or weak. The Guideline provides more than 60 evidence-based recommendations to assist prehospital and acute care clinicians in the rapid identification of childhood stroke, choice of initial investigation, to confirm diagnosis, determine etiology, selection of the most appropriate interventions to salvage brain at risk, and prevent recurrence. Recommendations include advice regarding the management of intracranial pressure and congenital heart disease. Implementation of the Guideline will require reorganization of prehospital and emergency care systems, including the development of regional stroke networks, pediatric Code Stroke, rapid magnetic resonance imaging and accreditation of primary pediatric stroke centers with the capacity to offer reperfusion therapies. The Guideline will allow auditing to benchmark timelines of care, access to acute interventions, and outcomes. It will also facilitate the development of an Australian childhood stroke registry, with data linkage to international registries, to allow for accurate data collection on stroke incidence, treatment, and outcomes.

This article, taken from a presentation to the Medico-Legal Society, discusses the prospects for patient safety and access to justice in the wake of the Mid Staffordshire NHS Foundation Trust public inquiry and the Legal Aid Sentencing and Punishment of Offenders Act. Particular reference is made to the arguments for and against a statutory Duty of Candour; clinical negligence litigation; patient complaints and specialist advice and support for people affected by medical accidents.

Galloway-Mowat syndrome is a rare condition that is likely hereditary though the underlying offending gene has not been identified, and is characterized by microcephaly and severe nephrotic syndrome culminating in childhood death. Some of the reported cases have abnormalities in neuronal migration and intractable seizures, but many of the described cases focus on the renal pathology and emphasize a diversity of clinical and pathological features. The case described herein includes a thorough neuropathological description, and when the neuroradiology and neuropathology of the previously published cases is scrutinized, a fairly consistent clinical and neuropathological phenotype emerges.

Lord Saatchi’s Medical Innovation Bill (also known as the ‘Saatchi Bill’) had its second reading in the House of Lords on 27 June and at the time of writing is about to start the committee stage. It purports to encourage innovative medical treatment by removing the fear of litigation. In my view, the Bill is both unnecessary and poses a grave threat to both patient safety and access to justice. The level of debate so far has been disappointing, but once peers appreciate the seriousness of what is being proposed and its (hopefully) unintended consequences, I am hopeful that it will receive proper scrutiny. The Bill is based on what most serious commentators seem to agree is a completely false premise – that innovative and potentially life-saving treatment is being denied to patients because of doctors’ fear of clinical negligence litigation. Lord Saatchi has failed to provide any evidence to back his assertion that this is the case, whereas those who are in the best position to know, including the likes of the NHS Litigation Authority, the Medical Defence Union, and the British Medical Association, all confirm that there is no evidence of such a problem. If treatment is refused, it is likely that this is either because the NHS will not fund the treatment, or simply because the doctor does not think it is the right treatment or safe. However, the Bill ignores all of that and would sweep away current definitions of negligence. It would allow an individual doctor to carry out any treatment provided that the patient consents to it, even if this flies in the face of all the evidence and advice from experts. The Bill has been presented by Lord Saatchi and his considerable publicity machine as if it is all about providing a last chance for cancer patients who have exhausted all evidence-based treatment options. However, that is not the case. As was confirmed in the debate in the Lords, as currently worded the changes would apply to any kind of medical treatment, including cosmetic treatment. All the doctor would need to do to be in the clear is persuade the patient and to ‘consult’ others (not to get approval from anyone). This has serious patient safety implications. Anyone who is familiar with the case of Dr Ian Paterson who damaged scores of women in the Midlands whom he persuaded to agree to his own variation of breast surgery can see how getting consent from patients is not a sufficient safeguard on its own. The strongest voice of reason in the Lords debate came from cross-bench peer Baroness Masham, who is a longstanding advocate of patients’ rights. As well as the threat to patient safety, she pointed out that the Bill would leave patients who have been harmed by negligent treatment (as we would define it now) without any redress. This is something which supporters of the Bill and many of the peers who took part in the debate do not even seem to have recognised as something worth worrying about. She challenged Lord Saatchi for evidence to support his claim that innovative treatment is being denied because of fear of litigation – but with no response. Lord Saatchi made it clear that he expects the Bill to sail through the Lords and to become law before the next election (in 2015). Those who value patient safety and justice must hope that it does not, and that the Bill receives the scrutiny that such an important topic deserves. Basing legislation on an emotional response to the death of loved ones and pure anecdote is not a good idea. Parliament must not sleepwalk into this dangerous and unnecessary legislation.

The dust is finally beginning to settle following the Government’s response to the Francis report, and we are beginning to see what is actually going to change as a result. A few things still need to be bottomed out of course – not least the question of whether England introduces a full statutory Duty of Candour or some pale shadow of it, which could actually make things worse. This was discussed in some detail in a previous issue. At the time of writing, an announcement has yet to be made about this. However, whilst we eagerly await the Government’s decision – arguably the most central and important potential outcome from the inquiry – some things are becoming clearer. The Government has made much of accepting the ‘vast majority’ of Francis’ recommendations. However, a closer look shows that many of these are accepted ‘in principle’, but the Government is actually going to do something rather different from what was recommended, if anything at all. Perhaps, the most noticeable changes have come in the approach to regulation, the need for which was so graphically exposed by the inquiry. Whilst some of the details of the recommendations such as merger of Monitor with the Care Quality Commission (CQC) were not accepted, the main thrust at least was taken to heart. We are already beginning to see a completely different approach from the CQC. A beefed-up inspection regime; a willingness to engage with and act on intelligence from patients and whistleblowers; and a much more open and principled style of leadership. Some of the disappointments were the refusal to accept recommendations about introducing guidance on minimum staffing levels or to bring in regulation of healthcare assistants. These are decisions which I fear may come back to haunt ministers. Questions about staffing levels and skill mix, and indeed the effect of 12-hour shift patterns are, I fear, going to remain a huge issue. Even more so due to the strain on resources. The issues are commonly a red hot topic of debate in Wales, which has been facing its own Stafford-style scandals. More of that later. Action against Medical Accidents (AvMA)

This edition’s content has a strong emphasis on medicolegal issues concerning older people. We are particularly grateful to Dr Rai and Dr Abdulla for their article on care of the elderly in the context of the Mental Health Act and Equalities Act, and to Dan Bennett for his article on claims concerning neglect of the elderly. By the time this edition is published, the report from the public inquiry into Mid Staffordshire NHS Foundation Trust should also have been published. AvMA was a core participant in the inquiry and we are confident that the submissions we and others made regarding the care of older people will not be lost on the Chairman, Robert Francis QC. While Stafford was unique as regards the sheer scale of neglect and breakdown of clinical governance, regulation, professionalism and compassion, elements of what went on at Stafford can be found in many of our hospitals. AvMA sees this day in day out in the casework and helpline calls we deal with. A common theme in so many of them involves what can only be called “neglect”, and all too often this is with regard to older people. The Reports by the Care Quality Commission “Dignity and Nutrition for Older People” (October 2011) found that less than half of the hospitals inspected were fully compliant with essential standards. The standard of care that some older patients receive in some of our hospitals has rightly been described as truly shocking and alarming. The question that many of us, not least Robert Francis QC, have been grappling with is “How can things get this bad in a service which, for the most part, can be proud of its excellent care?” and “How can we prevent this?” One of the pieces of evidence to the inquiry which most struck me was that of a young male student nurse. His comments found resonance with the vast majority of the great and good assembled by Robert Francis QC for a workshop on care of the elderly. He decried the way that nurses are recruited based mainly on their academic ability rather than their caring attitude; the inadequate practical experience in training; and the low esteem given to those doing the “basics” of nursing, caring for the elderly. Clearly, it is not just about these issues, but they do seem to be a credible critique of the current situation. Personally, I also think that we should not allow anyone to forget that staffing numbers has a crucial role to play. We must have clear guidelines and minimum requirements regarding staff numbers on wards. However, I am not sure all of this answers the question that perplexes me, as to how anyone who calls themselves a health professional can ignore the calls for help from a sick older person or leave an older patient lying in a soiled bed. It will be interesting to see how far the inquiry report moves us forward.

The reform of health professional regulation has been a hot potato since Dame Janet Smith’s devastating criticisms of the General Medical Council in the Shipman Inquiry report. A host of other high profile scandals and inquiries involving doctors led to a Government White Paper, Trust Assurance and Safety: Health Professional Regulation in the 21sty Century. After that, the Department of Health set in train a mammoth programme of working parties involving a wide range of stakeholders, including AvMA, in coming up with recommendations about how to move forward. It would be wrong to say that nothing has changed since. We have seen the introduction of “Responsible Officers” for example and at least a start on planning the introduction of revalidation for doctors. Oh, and of course the small matter of a change of Government intent on making its own stamp on the subject and injecting yet more cynicism about the role of regulation per se. It published “Enabling Excellence” in 2011. However, it has never been made clear whether that policy statement makes all other work on the subject conducted under the previous Government redundant or not. It is simply silent on the matter. Meanwhile many people including ourselves are wondering what, if anything, is happening with all the recommendations from the working groups, including Tackling Concerns Locally, of which I was a member and which contained some of the most important recommendations for improving regulation in our view. Civil servants simply look askance when you ask them. What for example is happening about the recommendation to fund a specialist independent advice and support service for people considering referring a health professional to a fitness to practice investigation? Or the recommendation to make it a statutory responsibility for employers to have to refer concerns about health professionals to regulators and co-operate with their investigations? Or about the information that should be publicly available about regulators dealings with health professionals? When we heard that the Law Commission had been given the task of reviewing the legislation concerning health professional regulation we were delighted. It is an opportunity to deal with the confusion and huge inconsistency between the regulators. We assumed that they would be doing this in the context of what was happening with all those recommendations which are vital to how effectiveness of health professional regulation. However, that is not the case. This is as much a mystery to them as to the rest of us. They have now published their initial report and recommendations. It is open for consultation until 31 May. The report has some very welcome recommendations but is in danger of being a wasted opportunity to get real consistency and accountability into the system and win back public confidence. It appears to have been written on the basis of making recommendations that are likely to enjoy current political favour, rather than from an objective viewpoint based on the public interest. A consistent theme is allowing the regulators themselves more autonomy and flexibility. A recurring phrase throughout the report is that “Regulators would have broad powers to. . .”. Whilst more flexibility than at present is needed for the regulators to be able to do their jobs appropriately I do not think they have got the balance right. It is not right that every regulator should be able to develop its procedures in the way it sees fit. That would lead to even more inconsistency than at present. Moreover, all of the rules and regulations need to be re-written with patient safety in mind. At present they are developed in ad hoc fashion and on occasions work directly against patient safety. Take for example the GMC ‘five year rule’ which exempts most doctors from investigation if the subject of an allegation is more than five years old. (Other regulators do not have such a provision). Also, the fact that a health professional can be exempted from regulatory action necessary to protect the public simply on the basis of some ‘abuse of process’ on the part of a regulator earlier in the process. From AvMA’s own caseload, we are aware of cases where potentially unfit and dangerous doctors have been deemed to be untouchable by the GMC on these grounds. This makes a mockery of stating that regulators’ overriding aim is to protect the public, even if that were to be clearly stated in the legislation. Whilst we welcome the Commission’s recommendation that each regulator have an internal appeal process for decisions not to investigate a health professional, I can see no logic in there not being any statutory provision for appealing such allegedly wrongful decisions. The principle of needing a safety net for challenging a fitness to practise decision is well established – the CHRE has the power to challenge these. If regulators can get it wrong after a full investigation and Fitness to Practise process, it stands to reason they will get it wrong at earlier stages of the process. The risk and potential consequences are higher here for a dangerous professional slipping through the net. The CHRE could be given the power, in exceptional cases which have already been reviewed internally, to challenge erroneous decisions. At the time of writing the Council for Health Regulatory Excellence (CHRE) has just published its interim report on the review it has been asked by the Government to carry out on one of the largest and most significant regulators – the Nursing and Midwifery Council (NMC). It makes depressing reading. The NMC does not seem to have recovered from its recent dark days and has now gone through two sets of chief executives and chairs leaving in unpleasant circumstances in a handful of years. Health professional regulation is ripe for reform and has been for years. It is a vital part of upholding professional standards and patient safety. We must ensure that the opportunity is taken now to radically overhaul the system to protect patients (as it says “on the tin”) rather than simply tinkering or playing to the political appetite of the day.