Not quite what the patient ordered

In the last of the group of papers from the conference on inatrogenic disease which we are publishing is this issue Katharine Whitehorn told the audience mainly of doctors and doctors in training - and tells many more through this Journal - what the patient expects from them. She envisages a generation of doctors who are coming to see their role rather differently from that of their fathers, and perhaps in the future a new medical scene.     

Publishing protocols of systematic reviews: comparing what was done to what was planned

Context  Publication of research protocols minimizes bias by explicitly stating a priori hypotheses and methods without prior knowledge of results. Methods  We conducted a retrospective comparative study to assess the extent to which the content of published Cochrane reviews had changed compared with their previously published protocols and to assess any potential impact these changes may have had in introducing bias to the study. We identified previously published protocols for new Cochrane reviews appearing in The Cochrane Library; 2000, issue 3. The texts of published protocols and completed reviews were compared. Two raters independently identified changes to the different sections of the protocol and classified the changes as none, minor, or major. Results  Of the 66 new Cochrane reviews, we identified a previously published protocol for 47 reviews. Of these, 43 reviews had at least 1 section that had undergone a major change compared with the most recently published protocol. The greatest variation between protocols and reviews was in the methods section, in which 68% of reviews (n = 32) had undergone a major change. Changes made in other sections that may have resulted in the introduction of bias included narrowing of objectives, addition of comparisons or new outcome measures, broadening of criteria for the types of study design included, and narrowing of types of participants included. Conclusions  Research protocols, even if published, are likely to remain, at least to some extent, iterative documents. We found that a large number of changes were made to Cochrane reviews, some of which could be prone to influence by prior knowledge of results. Even if many of the changes between protocol and review improve the overall study, the reasons for making these should be clearly identified and documented within the final review.      

Informed consent: what does it mean?

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered.     

General practitioners' retirement plans and what influences them

The results of a study of the attitudes of 197 general practitioners aged 55 and over towards retirement and their plans for retirement are reported. Few wished to retire very early, and only a further 40% definitely planned a clean break from practice. Nearly half planned on taking "24 hour retirement," even though most (78%) will be entitled to full pension rights. Job satisfaction and health were the most important factors influencing the timing of the retirement. Seventy seven per cent thought that there should be no formal retirement policy, 79% wanted no compulsory retirement age, and 80% wanted no further controls or safeguards directed at older practising general practitioners. Half of the general practitioners in the sample were not looking forward to retirement. Personal discussions with respondents aged 65 and over suggested that there are many older general practitioners who plan to practise for some time, who feel that they will know when the time has come to stop, but who often express the hope that they may "die in harness." A large proportion of older doctors are in single-handed practice. In view of this, and also of the evidence from North America which suggests that older doctors may practise inferior medicine, it is thought that the ability of such general practitioners to evaluate their competence should be studied by methods such as peer assessment techniques.     

Age-related macular degeneration: what can a family physician do?

Age-related macular degeneration (ARMD) is the most common cause of blindness in Canada, and, as the name suggests, its incidence increases rapidly with age. Atrophic maculopathy, one of the forms of ARMD, is associated with only mild to moderate visual loss but is not treatable. On the other hand, exudative maculopathy, another form, is characterized by the formation of neovascular membranes and causes acute visual disturbances; however, it is potentially treatable by means of laser photocoagulation. In symptomatic patients blood, lipids or serous fluid seen on funduscopic examination indicates occult neovascularization, even if no neovascular membrane is visible. In asymptomatic patients their age, the presence of soft drusen and the coarse pigmentary disturbance have the greatest correlation with the risk of neovascularization. Suitability for laser photocoagulation depends on the stage of exudative maculopathy, the duration of symptoms and the patient's visual acuity. Therefore, family physicians must know what the earliest symptoms are and how to identify patients at highest risk so that intervention in terms of education, screening and prompt referral to an ophthalmologist for confirmation and subsequent treatment can be instituted.     

Bioequivalence of generic aerosol bronchodilators: what are the issues?

I have attempted to address some critical issues relating to the introduction of generic aerosol bronchodilators in Canada. I approached Genpharm to obtain information on the data submitted to the HPB, including the number of subjects involved, but the company refused to divulge this information because it was concerned about the use of such information by its competitors. In addition to the in-vitro testing conducted by the HPB, should a single pharmacodynamic study be sufficient to demonstrate the safety and efficacy of a drug that serves such a critical role in the prevention of serious illness and possibly death? If so, what will constitute the minimum requirements for the design of such a study? In general, what should be the minimum standards required for safety, efficacy and bioequivalence of aerosol bronchodilators? The next phase rests with the provincial governments. What criteria will they use to determine whether a generic aerosol bronchodilator will be considered bioequivalent? It is essential that the criteria for bioequivalence be developed by experts, and ideally those criteria should be agreed upon and accepted by federal and provincial regulatory bodies before a product is given the status of bioequivalence. Unless such a step is taken it will be difficult to have confidence that products can be considered interchangeable. The issue of interchangeability of aerosol bronchodilators demands immediate attention. Regulatory agencies are caught between those groups with vested interests on both sides. Since patients will either benefit or suffer as a consequence of regulatory decisions, action must be taken to ensure that the best decisions are made. Scientists, clinicians and government officials should convene as soon as possible to formulate a satisfactory approach to this problem of interchangeability. The medical and pharmaceutical professions need reliable information, and patients should not be denied less expensive generic drugs if it can be determined that they are comparable to the innovator's product.     

'Relapse' of chronic active hepatitis--not always what it seems.

Immune chronic active hepatitis is a disease notorious for its unpredictability. In a patient with chronic hepatitis who has already suffered relapses a search for a second cause of jaundice is not usually necessary. This report emphasises the essential role of liver biopsy.     

Imaging of the spleen: what the clinician needs to know

The spleen is considered ‘the forgotten organ’ among radiologists and clinicians, although it is well visualised on abdominal computed tomography and magnetic resonance imaging. Moreover, the spleen is commonly involved in a wide range of pathologic disorders. These include congenital anomalies, infectious and inflammatory diseases, vascular disorders, benign and malignant tumours, and systemic disorders. In this review, we focus on the key imaging findings of the normal spleen, its variants, as well as relevant congenital and acquired abnormalities. It is of utmost importance to recognise and correctly interpret the variable spectrum of abnormalities that may involve the spleen, in order to avoid unnecessary invasive procedures and to guide adequate treatment.     

Homocystinuria: what about mild hyperhomocysteinaemia?

Hyperhomocysteinaemia is associated with an increased risk of atherosclerotic vascular disease and thromboembolism, in both men and women. A variety of conditions can lead to elevated homocysteine levels, but the relation between high levels and vascular disease is present regardless of the underlying cause. Pooled data from a large number of studies demonstrate that mild hyperhomocysteinaemia after a standard methionine load is present in 21% of young patients with coronary artery disease, in 24% of patients with cerebrovascular disease, and in 32% of patients with peripheral vascular disease. From such data an odds ratio of 13.0 (95% confidence interval 5.9 to 28.1), as an estimate of the relative risk of vascular disease at a young age, can be calculated in subjects with an abnormal response to methionine loading. Furthermore, mild hyperhomo-cysteinaemia can lead to a two- or three-fold increase in the risk of recurrent venous thrombosis. Elevated homocysteine levels can be reduced to normal in virtually all cases by simple and safe treatment with vitamin B6, folic acid, and betaine, each of which is involved in methionine metabolism. A clinically beneficial effect of such an intervention, currently under investigation, would make large-scale screening for this risk factor mandatory.     

如何应对患者知情不同意带来的伦理困惑

患者拒绝医生的诊疗方案,是实现患者知情同意权的一个重要方面,但在医疗实践中生发出许多伦理困惑,成为和谐医患关系建立的障碍,作者试从患者、医生、法律的角度出发,探讨应对的方法.     

Medical ethics: who decides what?

The FME symposium on teaching medical ethics takes up the issue of competence and responsibility in matters concerning bioethics (1). Foreseeably, the medical participants argue that physicians are prepared, or can be easily prepared, to handle all relevant aspects of medical ethics. The contrary position is sustained by the philosophically trained participants, who believe that physicians do not, in fact cannot, sufficiently manage medico-ethical problems. This paper sees a role for both parties. Medical ethicists should properly be involved in medical education and in analytical and systematic study of medical ethics. They should not generally be involved in clinical medico-moral decision-making, which is properly the realm of patient and (ethically competent) doctor.     

Nasal Trauma: Who Nose what happens to the non-manipulated?

Background:Nasal trauma is the most common facial injury worldwide. Prompt assessment allows for recognition of injuries requiring surgical intervention in the form of nasal bone manipulation. The literature is unclear to what extent patients undergoing conservative management subsequently require surgical intervention.Methods:A retrospective chart review of all patients presenting with nasal injury between July 2017 and July 2018 who underwent conservative and surgical management was undertaken. Re-referral and subsequent surgical intervention were documented.Results:In a cohort of 390 patients with nasal injury 229 patients underwent conservative management. Average age was 29 years. Males comprised 60% of our conservative cohort and 81% of the manipulated cohort. 8.3% of patients managed conservatively and 12% of those undergoing manipulation were re-referred.Conclusion:Nasal trauma assessment is a significant workload for an ENT unit. Conservative management is appropriate following clinical assessment and does not lead to increased intervention compared with those who are surgically manipulated.     

Neonatal herpes: what lessons to learn

Vesicular rashes in neonates are challenging in terms of diagnosis and management. Herpes infection is an important diagnostic consideration. We report two illustrative neonatal cases of herpesvirus infections with vesicular rashes. Such babies may be remarkably asymptomatic. A high index of suspicion leading to a prompt diagnosis, timely quarantine measures, and institution of antiviral treatment are pivotal for desirable outcomes.     

Psychiatric testimony: what are its limits?

The psychiatrist's role as an expert witness was discussed by Arthur F. Sullwood, M.D., and Gerald T. Bennett, J.D., at the annual meeting of the American Academy of Forensic Sciences (AAFS). Their thesis that there are inherent limits to the application of psychiatry to legal questions was addressed by participants in conjunction with a Supreme Court decision permitting such testimony. Sullwood stated that psychiatrists attempting to predict dangerous behavior are disguising lay opinion as psychiatric theory. Dr. Walter Bromberg, president of the AAFS, disagreed, saying that psychiatrists do have a valid role in helping courts reach an assessment of an offender's personality and mental state.     

Adolescent health issues: what is our role?

The state of US children's health and recommendations for improvement are reported. The 1st table identifies youth as risk, i.e., at the current rate, 1 in 10 women will give birth by the time they turn 18. Among black children, white children 1-4 years, and blacks 15-24 years, death rates actually increased from 1985 to 1987. Injuries, particularly due to violence, have replaced communicable diseases as the primary cause of death among adolescents. Since 1976, immunization has deteriorated. There is a refusal to recognize sexually active adolescents, in spite of 2.5 million cases of sexually transmitted disease. The 6 strategies discussed intervention begin with providing high quality preschool education programs for all children. The 2nd urges educational programs from kindergarten through 12th grade that help children make healthy choices, improve their self-esteem, and accept as much responsibility for their own lives as possible. Parenting education, as the 3rd strategy, promotes the education and support of parents, especially for young and poor parents. The 4th strategy involves male responsibility and instruction on obligations in pregnancy and parenthood, including a requirement of financial commitment from fathers and identification of the father by Social Security number on an infant's birth certificate. The 5th strategy is the provision for school-based health services, including family life counseling and contraceptive services for adolescents. The 6th strategy is to provide free college tuition and books at a state supported school for students with at least a B average, good citizenship record, and a family income of $20,000. It is cheaper to offer children opportunity than to pay the costs of the consequences of poverty.     

MRI contrast media: what clinicians need to know

Magnetic resonance imaging (MRI) is an imaging modality that uses the differential spinning of protons (hydrogen) in the body when exposed to an external magnetic field, to produce cross-sectional images of the body. The advent of MRI is a boon to mankind as it does not involve ionizing radiation and provides superior soft tissue contrast even without administration of contrast media. The contrast media used in MRI were developed many years after MRI was already in use, the first being gadopentetate dimeglumine--a non-specific extracellular gadolinium chelate. Extracellular agents are the most widely used, although tissue-specific agents have been developed and are used as problem-solving tools in specific conditions. Tolerance to gadolinium-based contrast agents is excellent. The tissue-specific agents do have some adverse effects, though none of them are life-threatening. However, identification of a condition called nephrogenic systemic fibrosis has forced a rethink about the liberal usage of MRI contrast agents.     

At what level of collective equipoise does a clinical trial become ethical?

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable.     

Pharmacotherapeutics: what a difference five decades makes!

Our ability to prevent, cure or modify disease, as compared with relieving symptoms, has changed beyond recognition in the past half century. With the completion of the Human Genome Project and rapid advances in understanding of molecular biology and in technologies, our ability to target disease mechanisms and optimise an individual's responses will improve exponentially.     

AIDS prevention: what are we talking about?

A psychiatrist from Calcutta objects to the colonial culture which still dominates India. Specifically the call for prevention of AIDS and the spread of HIV made by developed countries, yet socioeconomic conditions in India hinder any prevention efforts. India faces other more common and preventable fatal diseases. The basic needs (food, shelter, health, and education) of most people cannot even be met. Thus an AIDS prevention program is an expensive luxury and probably would not reach those whose needs are already not met. 65% of AIDS cases are in Africa especially central Africa and almost 90% of AIDS cases in developing countries are in the most productive age group (20-49 years). The HIV/AIDS epidemic is indeed dealing countries an economic blow. For example, in 1988, AIDS related medical costs in the US stood at US$8.5 billion; lost wages US$55.6 billion; and research, education, and blood screening US$2.3 billion. Developing countries cannot absorb such an economic impact. The AIDS epidemic can strain a developing country's health system such as Zaire. For example, the cost of providing proper care for only 10 AIDS patients is higher than the entire budget of the largest hospital. Yet this hospital's physicians diagnose as many as 15 new cases daily. Economic loss/year due to AIDS deaths in Zaire will equal 8% of the gross national product by 1995. The poor often do not have access to health services. illiteracy (88%) in Brazil impedes AIDS prevention messages from reaching remote rural populations. Brazil already faces a high infant mortality rate and 33% of the population has malaria. Health and social problems in developing countries are so common that AIDS is just 1 more disease. Another obstacle to AIDS prevention in developing countries is that the poor cannot afford to buy condoms. The root cause of AIDS in developing countries is poverty.