What are local issues? The problem of the local review of research

Local review of research by ethics committees in the UK has long been held to be an important right of the local research ethics committee and, even with the introduction of the European Clinical Trials Directive, the governance arrangements for research ethics committees continue to allow for local review of multicentre studies. There is no requirement for local review in either the European Union directive or in the guidelines on good clinical practice, and there is little evidence of it anywhere else in Europe. The idea that there can be "local", as opposed to "central" ethical issues in research is an interesting one, which raises important issues about the nature of research ethics and ethical review. The aim of this paper is to argue that there are no such things as local issues in research ethics, and suggest that those questions currently addressed as local issues properly belong within the research governance framework.     

提高医院伦理委员会审查质量

伦理审查委员会的职责是保护临床研究中受试者的权益和安全。为了学习和借鉴发达国家较完善的经验,提高伦理审查质量,作者曾赴美国哈佛大学公共卫生学院伦理委员会学习,回国后对照国内相关法规要求、国际规则和国外经验,其所在的伦理委员会采取了一系列旨在提高伦理审查质量、规范伦理委员会管理的新举措,并在实践中进行了积极的尝试,深切体会到建立审查规则时要结合中国的实际情况、抓住保证审查质量的主要环节,对目前提高伦理委员会审查质量有非常重要的作用。     

Challenge studies of human volunteers: ethical issues

There is a long history of medical research that involves intentionally infecting healthy people in order to study diseases and their treatments. Such research-what might be called "human challenge studies"-are an important strand of much current research-for example, in the development of vaccinations. The many international and national guidelines about the proper conduct of medical research do not specifically address human challenge studies. In this paper we review the guidelines on the risk of harm that healthy volunteers may be exposed to in the course of medical research. We examine the ethical arguments that are implicit or explicit in these guidelines. We then ask whether there is reason for limiting such studies on grounds independent of risk of harm. We conclude that the major ethical concern with challenge studies is that of risk of harm and that the fact that a study is a challenge study is not a wrong in itself.     

One standard of care for all is not always practical

Multiple research guidelines address the issue of standard of care in international collaborative research. These guidelines fail to appreciate that differing standards may be present within the same country, which makes their application sometimes impracticable. In circumstances where ethics review committees follow one of these guidelines entirely and to the hilt, some relevant and useful research is rejected while the way for "me too" drug trials is paved. It should be acceptable to hold different researchers to separate standards of care on the basis of their intentions, their financial resources, their ultimate gains from the research, and subsequent utilisation of the results of the research, even when these researchers come from the same country where the research is being conducted.     

When is surgery research? Towards an operational definition of human research

The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative surgeries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. Some institutions tacitly allow the use of new surgical procedures in series of patients without informing individuals that they are participating in a scientific study, as long as no written protocol or hypothesis exists. Institutions can justify this practice by viewing human research in narrow terms as an activity outlined in a formal protocol. Application of limited definitions, however, erodes patients' rights and risks losing public confidence in how biomedical research is conducted. I propose an operational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge.     

Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry?

Potential conflicts of interest do not imply wrongdoing, but can create bias, distort decision making, and create a perception that practitioners are being "bought "or "bribed" by industry. Transparency alone may not be sufficient to erase the doubts created when authors of clinical practice guidelines or editorials declare potential conflicts of interest. Can the subconscious obligation for reciprocation that exists when gifts are offered and accepted be fully negated? Analyses of published clinical cancer research studies have found a positive association between pharmaceutical industry sponsorship and reporting of positive outcomes, manipulation of clinical trials, and hiding of "preliminary data sets". More problematic is the issue of clinical researchers leaking preliminary results to the investment industry. Influential literature reviews and treatment guidelines have been associated with widespread declarations of conflict of interest. Some potential solutions are: regulating pharmaceutical companies to declare all gifts to clinicians, or ban such gifts; for clinicians to carefully declare potential conflicts of interest or to provide pro bono advice without accepting industry sponsorship; and for all gifts and payments from industry to academic physicians to be coordinated by an independent review committee. Journals should only allow reviews, editorials, guidelines and opinion pieces to be written by those without significant conflicts of interest.     

Attitudes of women to fetal tissue research.

The use of human fetal tissue for scientific research has enormous potential but is subject to government legislation. In the United Kingdom the Polkinghorne Committee's guidelines were accepted by the Department of Health in 1990. These guidelines set out to protect women undergoing termination of pregnancy from exploitation but in so doing may significantly restrict potential research. Although the committee took evidence from a wide variety of experts they did not seek the views of the general public. We asked 108 women about to have a therapeutic abortion; 167 women who had had a pregnancy terminated in the past, and 419 women who had never had an abortion, their views on research using human fetal tissue. Regardless of their past experiences the women were overwhelmingly in favour of research using fetal tissue (94 per cent). They made little distinction between basic research and research with obvious clinical relevance and supported the concept of using transplanted fetal tissue for the treatment of adult disease such as Parkinsonism. Women about to undergo an abortion were significantly more likely (p < 0.001) to approve of all types of research including that aimed at improving methods of abortion and research using live fetuses in utero.     

Ministry of Health Clinical Practice Guidelines: Anxiety Disorders

The Ministry of Health (MOH) has developed the clinical practice guidelines on Anxiety Disorders to provide doctors and patients in Singapore with evidence-based treatment for anxiety disorders. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on anxiety disorders, for the information of SMJ readers. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

1.1 Background information

Anxiety disorders are known to be one of the most prevalent of psychiatric conditions, yet they often remain under-diagnosed and under-treated. Their chronic, disabling symptoms cause considerable burden not only to sufferers but also to their families, and contribute to poorer quality of life and considerable economic burden on society.In many instances, there is a delay in seeking treatment and in some cases such delay may stretch up to nearly ten years. This may result from ignorance of the condition, fear of taking medications, and the stigma of receiving a psychiatric diagnosis, and or having to accept psychiatric treatment.The anxiety disorders include panic disorder with or without agoraphobia, social anxiety disorder, specific phobia, obsessive-compulsive disorder, generalised anxiety disorder, acute stress disorder and post-traumatic stress disorder. In the clinical evaluation of anxiety disorders, it is important to ascertain the type of anxiety disorder present. This would allow treatment to be targeted at the specific type of disorder.These guidelines are developed to provide practical, evidence-based recommendations to primary care physicians and specialists in psychiatry for the diagnosis and management of the anxiety disorders.The first edition of the guidelines was published in 2003. In this edition, we present data from newer research as well as older data not previously reported in the earlier guidelines.For example, we examine the efficacy of combining medications with psychological therapy over medications alone, or psychological therapy alone. In view of the majority of anxiety sufferers being female we have made recommendations for pharmacotherapy during pregnancy and breastfeeding. As these guidelines are intended for use in the Singapore context, we have omitted treatments that are currently not available in Singapore.

1.2 Aim

These guidelines are developed to facilitate the diagnosis and assessment of the anxiety disorders, and to ensure that their management is appropriate and effective.

1.3 Scope

These guidelines will cover the management of anxiety disorders in adults and address the issues of medication use during pregnancy and breastfeeding.

1.4 Target group

The content of the guidelines will be useful for all doctors treating patients with anxiety disorders. Efforts have been made to ensure that the guidelines are particularly useful for primary care physicians and specialists in psychiatry, including all those involved in the assessment and management of patients with anxiety disorders in the community. The doctor treating the patient is ultimately responsible for clinical decisions made after reviewing the individual patient’s history, clinical presentation and treatment options available.

1.5 Development of guidelines

These guidelines have been produced by a committee of psychiatrists, a clinical psychologist, pharmacist, patient representative, and family practitioners appointed by the Ministry of Health. They were developed by revising the existing guidelines, reviewing relevant literature, including overseas clinical practice guidelines, and by expert clinical consensus of professionals with experience in treating patients in the local setting.The following principles underlie the development of these guidelines:

• Treatment recommendations are supported by scientific evidence whenever possible (randomised controlled clinical trials represent the highest level of evidence) and expert clinical consensus is used when such data are lacking.
• Treatment should maximise therapeutic benefits and minimise side effects.

1.6 What’s new in the revised guidelines

This edition of the guidelines contains updated recommendations based on latest evidence, as well as detailed discussions and recommendations on the management of anxiety disorders in adult populations.The following represent changes to the revised guidelines

• An extensive review of the literature, including new evidence. This involved the re-writing and extensive revision of the chapters.
• Length of treatment, which provides answers to a pertinent question.
• Use of medications during pregnancy and breastfeeding. Given that females are more likely to be at risk of being diagnosed with anxiety disorders, this is an important subject.

We are aware that the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) was released in 2013. In DSM-5, post-traumatic stress disorder and obsessive-compulsive disorder have been removed and classified separately from the rest of the anxiety disorders. If we were to adhere strictly to DSM-5, this would entail omitting discussion on post-traumatic stress disorder and obsessive-compulsive disorder. As it is our aim to provide an update on the 2003 guidelines, post-traumatic stress disorder and obsessive-compulsive disorder have been included in this edition of the guidelines.In addition, anxiety conditions in children are included in DSM-5. Since the present guidelines are meant to address only adult anxiety disorders, guidelines on children’s anxiety conditions are not included here.Hence, for purposes of these guidelines, we will continue to use classifications based on the International Classification of Diseases-10 (ICD-10) and DSM-IV-TR criteria.

1.7 Review of guidelines

Evidence-based clinical practice guidelines are only as current as the evidence that supports them. Users must keep in mind that new evidence could supersede recommendations in these guidelines. The workgroup advises that these guidelines be scheduled for review five years after publication, or when new evidence appears that requires substantive changes to the present recommendations.     

混合方法研究制定中医药临床实践指南及实例解读

中医药临床实践指南的制定是实现中医药标准化的重要工作内容。中医药指南对临床的指导意义极大,但目前仍存在临床实际使用情况不佳的现状,这可能与指南的内容有关。由于高质量的中医药临床研究数量较少,以循证医学证据,即定量研究结果为主导的指南,在指南推荐干预措施的确定上存在一定的局限性。而混合方法研究重视实用主义,其将定量研究与定性研究的结果相结合,在中医药指南的制定中存在一定优势。本文初步探讨混合方法研究在指南制定过程中的思路及作用,并以《中医药治疗流感临床实践指南》为例,探讨以定量研究为主导制定指南时遇到的问题及混合方法研究在指南制定中的具体应用。结果发现,混合方法研究可以弥补单纯依赖定量研究或定性研究结果的不足,有可能成为未来指南制定的主要方法之一,但仍存在一定的局限性,需进一步研究。     

缺血后处理及其在器官移植术中的应用

缺血后处理的概念自2002年提出后,此后5年间的研究证实其可对器官缺血再灌注损伤起到极为有效的保护作用,作用机制大部分与缺血预处理类似,但仍有其独有的特点.再灌注损伤在器官移植术中不可避免,减轻再灌注损伤程度可促进移植器官功能的迅速恢复.相对于缺血预处理,缺血后处理具有良好的可控性,有望在器官移植术中得到良好的应用前景.深入了解缺血后处理对器官再灌注损伤保护作用的特点及机制,将有利于推动其在器官移植领域中的应用.     

Diagnosis of acute flaccid paralysis: injection injury or polio?

In many countries, the treatment of choice for all fevers is one or more injections. These injections are associated with a risk of nerve damage. If cases of poliomyelitis are not to be missed, the diagnosis of injection trauma or traumatic neuritis (TN) must be exact. The guides for distinguishing between TN and polio are not clear. It is probable that some cases of polio are misdiagnosed as TN. As three-quarters of children with paralytic polio receive injections just before the onset of paralysis, their paralysis may be mistaken for TN. Clearer guidelines are proposed, together with suggestions for better documentation of muscles injected and paralysed. All cases of reported TN should be monitored and new diagnostic guidelines published. To protect their children, mothers must be educated to understand that injections for fever can cause harm. This must be an important part of the eradication programme for poliomyelitis.     

Ministry of Health Clinical Practice Guidelines: Diabetes Mellitus

The Ministry of Health (MOH) have updated the clinical practice guidelines on Diabetes Mellitus to provide doctors and patients in Singapore with evidence-based treatment for diabetes mellitus. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Diabetes Mellitus, for the information of SMJ readers. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

1.1 Objectives and scope of guideline

The first edition of the MOH clinical practice guidelines on diabetes mellitus for Singapore was published in 1999. Since that time, more facts about this important condition have emerged, not only with regard to its diagnosis and treatment, but also about whether or not type 2 diabetes may be prevented, and, if so, how this may be achieved.As diabetes mellitus has great public health significance in developed countries and developing nations alike, managing it properly involves a consideration, not just of clinical issues, but also of health economics. This second edition of the guidelines attempts to address some of these complex issues wherever evidence-based information pertaining to them is available.

1.2 Target group

The main aim of these guidelines is to help physicians make sound clinical decisions about diabetes mellitus by presenting up-to-date information about diagnosis, classification, treatment, outcomes, and follow-up.These guidelines are developed for all health care professionals in Singapore. We hope they would be helpful especially to primary care physicians who care for patients with diabetes mellitus.

1.3 Guideline development

These guidelines have been produced by a committee of endocrinologists, family practitioners and primary care specialists, ophthalmologist, dietitian, social worker, and patient representative, appointed by the Ministry of Health. They were developed by the adaptation of existing guidelines, by the review of relevant literature and by expert clinical consensus with consideration of local practice. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

1.4 What’s new in the revised guidelines

The following is a list of the major revisions and additions to the previous guidelines:

• In Chapter 3, we have explained the rationale for criteria in diagnosing diabetes. In particular, for asymptomatic patients with a first test that meets criteria, we have attempted to provide more clarity on how to choose a second test, and how to interpret the findings.
• Chapter 4 is a new chapter which brings emphasis to two areas contributing towards positive outcomes in diabetes care: diabetes self-management education, and psychosocial assessment and holistic care of the person with diabetes.
• Chapter 5 on pharmacotherapy in diabetes mellitus has been updated to take into account recent clinical trial evidence of the efficacy of the newer classes of pharmacological agents.
• Chapter 6 focuses on glycaemic control, and emphasizes the importance of individualised targets, balancing the benefits of achieving targets without incurring undue risk of hypoglycaemia or other adverse effects, and considering the risk profile of the patient.
• In Chapter 7 on prevention of cardiovascular disease in diabetes mellitus, recommendations on decision-making in the area of therapeutics have been updated and harmonised with current local guidance on lipid, blood pressure and cardiovascular management. Target blood pressure ranges and LDL levels are discussed, as well as the role of antiplatelet therapy.
• Chapter 8 on prevention and management of diabetic nephropathy has been revised to present recent clinical trial evidence regarding the efficacy of, and indications for, the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.
• Chapter 9 on the prevention and management of eye complications has been updated to include developments such as intravitreal injection of anti-vascular endothelial growth factor in patients with diabetic macular oedema.
• Chapter 11 on pre-gestational and gestational diabetes has been updated. Women at high risk for gestational diabetes, but who are not found to have glucose intolerance in early pregnancy, are now recommended to be re-evaluated with a 75 gram OGTT at 24–28 weeks gestation.
• Chapter 13 is a new chapter outlining key principles in the management of the adult with type 1 diabetes, relevant to the primary care healthcare professional.

1.5 Review of guidelines

Evidence-based clinical practice guidelines are only as current as the evidence that supports them. Users must keep in mind that new evidence could supersede recommendations in these guidelines. The workgroup advises that these guidelines be scheduled for review four years after publication, or earlier if new evidence emerges that necessitates substantive changes to the recommendations.Future revisions may include management of hypoglycaemia in persons with diabetes, and evolving areas like bariatric surgery and pancreas/islet cell transplantation.     

Can patients be sure they are fully informed when representatives of surgical equipment manufacturers attend their operations?

OBJECTIVE: To determine the practice in UK hospitals regarding the level of patient involvement and consent when representatives of commercial surgical device manufacturers attend and advise during operations. METHODS: An anonymous postal questionnaire was sent to the senior nurse in charge in all 236 UK gynaecology theatres in 2004. 79/236 (33%) replies were received. RESULTS: Operating departments were visited every 2 weeks on average by a representative of the surgical device manufacturer. Actual operations were attended every 10 weeks, although there was much variation. 33/79 (42%) units consistently obtained patient consent for visits, usually orally, whereas 40/79 (51%) units did not. 65/79 (82%) units had no guidelines for surgical device representative visits. 91% of nurses in charge believed that there should be guidelines to protect both patients and staff. 6/79 (8%) units were preparing local guidelines at the time of the survey. CONCLUSIONS: Currently, patient safety, confidentiality and autonomy are being protected by a minority of NHS operating theatres when surgical device representatives attend surgery. National guidelines would hopefully ensure that fully informed patient consent is obtained and that representatives are fully trained and supervised.     

Refuting the net risks test: a response to Wendler and Miller's "Assessing research risks systematically"

Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) protect research subjects; (2) allow clinical research to proceed; (3) explain how physicians may offer trial enrolment to their patients; (4) address the challenges posed by research containing a mixture of interventions and (5) define ethical standards according to which the risks and potential benefits of research may be consistently evaluated. This response argues that the net risks test meets none of these criteria and concludes that it is not a viable alternative to component analysis.     

Authorship of research papers: ethical and professional issues for short-term researchers

Although the International Committee of Medical Journal Editors has published clear guidance on the authorship of scientific papers, short-term contract research workers, who perform much of the research that is reported in the biomedical literature, are often at a disadvantage in terms of recognition, reward and career progression. This article identifies several professional, ethical and operational issues associated with the assignment of authorship, describes how a university department of primary care set about identifying and responding to the concerns of its contract research staff on authorship and describes a set of guidelines that were produced to deal with the ethical and professional issues raised. These guidelines include directions on how authorship should be negotiated and allocated and how short-term researchers can begin to develop as authors. They also deal with the structures required to support an equitable system, which deals with the needs of short-term researchers in ways that are realistic in the increasingly competitive world of research funding and publication, and may offer a model for more formal guidelines that could form part of institutional research policy.     

Research activities in toxicology and toxicological requirements of the FDA for food and color additives

The Center for Food Safety and Applied Nutrition of the Food and Drug Administration has published guidelines for the safety assessment of direct food and color additives. These guidelines are to be updated beginning in 1988. The safety of a food and color additive must be established prior to marketing by an evaluation of probable exposure of consumers and appropriate toxicological information. "Safe" and "safety" are defined as a reasonable certainty that a substance is not harmful under the intended conditions of use. A number of tests are used in determining the safety of food additives. Some of these are: subchronic toxicity studies, chronic toxicity studies, carcinogenicity, reproduction, teratogenicity, and occasionally short-term tests for carcinogenicity. The Center also has a research program in toxicology which in part focuses on diet/toxicity interaction and risk assessment. Examples of such activities are investigation of the teratogenicity of textured vegetable protein and of the potential of zinc to prevent or ameliorate such effects, the development of whole rat embryo cultures as a model to investigate the mechanisms by which teratogens may act, and a program in pharmacokinetics and molecular toxicology to aid in studying assumptions underlying risk assessment.     

Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers.

In this paper some of the general issues surrounding recently published guidelines for the practice of research ethics committees are outlined, concentrating in particular on the difficulties raised by research with psychiatric patients. Research is distinguished from ordinary clinical practice by the intention to advance knowledge. So defined, research with psychiatric patients should be governed by the same four principles as research with any other group--knowledge, necessity, benefit and consent. In applying these principles, however, particularly the principle of consent, many acute difficulties are raised by psychiatric patients. A number of proposals for addressing these difficulties are discussed. It is suggested that, notwithstanding the value of published guidelines, and the help that may be available from research ethics committees, the primary responsibility for maintaining high standards of practice in research rests with research workers themselves.     

Health care workers infected with the human immunodeficiency virus. The next steps.

The tragedy of five patients who contracted human immunodeficiency virus (HIV) infection from a seropositive dentist has alarmed the public. The Centers for Disease Control (CDC) recently revised its recommendations for preventing the transmission of HIV infection to patients during invasive procedures. The CDC abandoned a previous plan to list exposure-prone invasive procedures that HIV-infected health care workers should not perform. The CDC said "expert review panels" should decide on a case-by-case basis whether seropositive health care workers may perform invasive procedures. As of February 1992, the revised recommendations were under review by the US Department of Health and Human Services. Many issues remain to be clarified, such as how these panels will operate and whether decisions will be consistent in similar cases. Disregarding the CDC guidelines or infection-control precautions may further erode public trust and lead to draconian restrictions on HIV-infected health care workers. Physicians and dentists should respond more effectively to public fears about HIV transmission. The challenge is to protect patients while respecting the privacy and livelihood of health care workers.     

Academy of Medicine-Ministry of Health Clinical Practice Guidelines: Attention Deficit Hyperactivity Disorder

The Academy of Medicine (AMS) and the Ministry of Health (MOH) have developed the clinical practice guidelines on Attention Deficit Hyperactivity Disorder (ADHD) to provide doctors and patients in Singapore with evidence-based treatment for ADHD. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on ADHD, for the information of SMJ readers. Chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

1.1 Background information

Attention deficit hyperactivity disorder (ADHD) is a neuro-developmental disorder, characterised by the presence of early-onset persistent, pervasive and impairing hyperactive-impulsive and/or inattentive symptoms. The worldwide pooled prevalence was about 5.29%. While there has been no epidemiological study on the prevalence of this condition among children in Singapore, a local study reported the prevalence of externalising problems to be 4.9% among Singaporean primary school children. While ADHD symptoms decline with age, a meta-analysis reported that a significant proportion might have residual symptoms in adulthood. ADHD has been reported to be associated with negative outcomes, including poor academic achievement, reduced self-esteem and higher smoking rate. This condition is often picked up when the child is young, and children with ADHD are often treated by child psychiatrists and paediatricians.

1.2 Objectives and scope of guideline

These guidelines are not meant to be viewed as a protocol, but rather, to provide a framework to:

• Approach the assessment process, with the goals of arriving at a diagnosis and planning treatment.
• Inform the practitioner about the level of evidence for medication available in Singapore, to aid the decision about medication use.
• Inform about the evidence for non-pharmacological treatment approaches to help professionals plan treatment and discuss these with parents.

1.3 Target group

The target group of these guidelines are professionals who come into contact with children and adolescents below the age of 18 who have attention deficit hyperactivity disorder (ADHD). The information is intended to help professionals plan the treatment for such children and adolescents. Professionals should exercise caution when extrapolating the evidence beyond this stated age group.

1.4 Guideline development

These guidelines were produced by a multi-disciplinary workgroup appointed by the Academy of Medicine, Singapore. The workgroup comprised psychiatrists, paediatricians, educational psychologists, a medical social worker, a pharmacist, an advanced practice nurse and a parent representative.

1.5 Review of guidelines

Evidence-based clinical practice guidelines are only as current as the evidence that supports them. Users must keep in mind that new evidence could supersede recommendations in these guidelines. The workgroup advises that these guidelines be scheduled for review five years after publication, or earlier if new evidence appears that requires substantive changes to the recommendations.     

Australian medical schools and colleges working with developing countries

General practice is suffering a crisis of status, as shown by financial, power and intellectual markers. This is serious as a strong general-practice workforce is important to deliver cost-effective, high-quality healthcare. We argue that strengthening the intellectual aspects of general practice (particularly critical thinking) is essential. Most strategies to achieve this centre on research, with many initiatives in Australia and overseas to enhance research by general practitioners; there is still insufficient clinical research in general practice. Other ways to improve critical thinking include promoting use of evidence-based medicine, provided it is not implemented only via "cook-book" guidelines. Other innovations are desperately needed.