Association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: systematic review.

OBJECTIVE: To investigate the association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. DESIGN: Systematic review. ELIGIBILITY CRITERIA: Studies that compared the association between conflicts of interest and favourable recommendations of drugs or devices (eg, recommending a drug) in clinical guidelines, advisory committee reports, opinion pieces (eg, editorials), or narrative reviews. DATA SOURCES: PubMed, Embase, Cochrane Methodology Register (from inception to February 2020), reference lists, Web of Science, and grey literature. DATA EXTRACTION AND ANALYSIS: Two authors independently extracted data and assessed the methodological quality of the studies. Pooled relative risks and 95% confidence intervals were estimated using random effects models (relative risk >1 indicates that documents with conflicts of interest more often had favourable recommendations than documents with no conflicts of interest). Financial and non-financial conflicts of interest were analysed separately, and the four types of documents were analysed separately (preplanned) and combined (post hoc). RESULTS: 21 studies that analysed 106 clinical guidelines, 1809 advisory committee reports, 340 opinion pieces, and 497 narrative reviews were included. Unpublished data were received for 11 studies (eight full datasets and three summary datasets). 15 studies showed risk of confounding because the compared documents could differ in factors other than conflicts of interest (eg, different drugs used for different populations). The relative risk for associations between financial conflicts of interest and favourable recommendations for clinical guidelines was 1.26 (95% confidence interval 0.93 to 1.69; four studies of 86 clinical guidelines), for advisory committee reports was 1.20 (0.99 to 1.45; four studies of 629 advisory committee reports), for opinion pieces was 2.62 (0.91 to 7.55; four studies of 284 opinion pieces), and for narrative reviews was 1.20 (0.97 to 1.49; four studies of 457 narrative reviews). An analysis of all four types of documents combined supported these findings (1.26, 1.09 to 1.44). In one study that investigated specialty interests, the association between including radiologists as authors of guidelines and recommending routine breast cancer was: relative risk 2.10, 95% confidence interval 0.92 to 4.77; 12 clinical guidelines). CONCLUSIONS: We interpret our findings to indicate that financial conflicts of interest are associated with favourable recommendations of drugs and devices in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews. Limitations of this review were risk of confounding in the included studies and the statistical imprecision of individual analyses of each document type. It is not certain whether non-financial conflicts of interest influence recommendations. SYSTEMATIC REVIEW REGISTRATION: Cochrane Methodology Review Protocol MR000040.

[Standards for treatment in forensic committment according to § 63 and § 64 of the German criminal code : Interdisciplinary task force of the DGPPN]. / Standards für die Behandlung im Maßregelvollzug nach §§ 63 und 64 StGB : Interdisziplinäre Task-Force der DGPPN.

People who have been convicted of a crime due to a severe mental disorder and continue to be dangerous as a result of this disorder may be placed in a forensic psychiatric facility for improvement and safeguarding according to § 63 and § 64 of the German Criminal Code (StGB). In Germany, approximately 9000 patients are treated in clinics for forensic psychiatry and psychotherapy on the basis of § 63 of the StGB and in withdrawal centers on the basis of § 64 StGB. The laws for treatment of patients in forensic commitment are passed by the individual States, with the result that even the basic conditions differ in the individual States. While minimum requirements have already been published for the preparation of expert opinions on liability and legal prognosis, consensus standards for the treatment in forensic psychiatry have not yet been published. Against this background, in 2014 the German Society for Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) commissioned an interdisciplinary task force to develop professional standards for treatment in forensic psychiatry. Legal, ethical, structural, therapeutic and prognostic standards for forensic psychiatric treatment should be described according to the current state of science. After 3 years of work the results of the interdisciplinary working group were presented in early 2017 and approved by the board of the DGPPN. The standards for the treatment in the forensic psychiatric commitment aim to initiate a discussion in order to standardize the treatment conditions and to establish evidence-based recommendations.

[Asbestos: Social Legal and Scientific Controversies and Unsound Science in the Context with the Worldwide Asbestos Tragedy - Lessions to be Learned]. / Sozialjuristische und wissenschaftliche Kontroversen sowie Fehlinterpretationen im Kontext mit der weltweiten Asbest-Tragödie - Was ist daraus zu lernen?

8 to 15% of lung cancer cases and nearly all mesothelioma cases are caused by asbestos. Problems in compensation issues refer to high legal as well as insurance barriers in attesting the occupational diseases. Claiming of certain numbers of asbestos bodies or fibers in lung tissue is of special relevance in substantiating legal medical cases. Such evidence, which is disproved by a sound science, is also used by an influential US pathology department. Frequently, also epidemiological evidence with its causal relationships and exposure histories are ignored. Similar misleading arguments are currently found in industrializing countries where white asbestos which is carcinogenic and fibrogenic like other asbestos types, is efficiently promoted as less harm. As a result, the asbestos consumption is increasing in some of these countries. Beyond the worldwide asbestos tragedy a well-designed strategy of certain transnational or global acting industrial interest groups can be recognized. Their plan, hidden from the public eyes, follows rigorously sole economic interests, while leaving the resulting health harm to the public health systems.

Expert witness testimony guidelines: identifying areas for improvement.

Expert witnesses play an invaluable, if controversial, role by deciphering medical events for juries in cases of alleged negligence. We review expert witness guidelines among major surgical societies and identify gaps within these standards, as our hope is that this spurs discussion addressing areas for improvement. Of 8 surgical societies with accessible guidelines, none included specific compensation guidelines or limits, detailed reporting mechanisms regarding unethical behavior by legal professionals, or addressed the appropriateness of testifying frequently and exclusively for one side. Several processes possibly deterring grossly inaccurate testimony have been adopted by other surgical societies and should potentially be addressed by the American Academy of Otolaryngology-Head and Neck Surgery. These include offering an expert witness testimony certification path, strengthening the formalized grievance process, and encouraging members to sign an affirmation statement.

[Involuntary treatment in psychiatry]. / Zwangsunterbringung und Zwangsbehandlung in der Psychiatrie.

Involuntary treatment in psychiatry should be reflected under the German constitutional right of self-determination und the ethical principles of autonomy and beneficience. Forced treatment in psychiatry should be applied only as a last resort. A narrative perspective reconstructs the case of Gustl Mollath who was hospitalized in forensic-psychiatric institutions because of an alleged delusion. Psychiatric experts should be aware of the potential of misuse when defining what is real and what seems to be a delusion.

Ethical issues of expert witness testimony.

Being a surgical expert witness (EW) in professional liability claims implies ethical responsibilities, which are usually unknown to the parties who try to obtain such testimony as well as to the surgeons involved in providing the expert opinion required by the courts. Giving medical testimony can be included in the field of surgery since (1) being an expert medical witness and judge the performance of another surgeon means that the witness must have a medical license and preferably be board-certified as a surgeon, and (2) the EW opinion sets the standard of care to be applied in each particular case. Thus, the role of the surgeon EW in the legal arena must have the same degree of integrity as the surgeon in his practice with direct patient care and it should be reviewed and subject to regulation.

Moralidade e risco na interface médico-paciente na perícia médica da Previdência Social / Morality and risk in doctor-patient interface at medical expertise of Social Security

Uma dupla vulnerabilidade, doença e incapacidade para o trabalho: essa é a condição que deverá ser verificada pelos médicos peritos da Previdência Social entre os que solicitam o benefício auxílio-doença. Em uma sociedade organizada em torno da produção e consumo de bens, a ausência de rendimentos quase sempre significa o rebaixamento social e a privação. No contexto previdenciário, o ato médico ocorre sem que a conduta esteja voltada para o restabelecimento da saúde, tratamento ou prevenção do adoecimento, mas a ausência do compromisso assistencial seria suficiente para prescindirmos do exame moral dessa interface? Este artigo desenvolve o argumento de que a atividade médico-pericial de controle sobre a entrada e/ou permanência em auxílio-doença envolve um tipo específico de risco que decorre da singularidade da tarefa de controle. Nesta o compromisso com o paciente, ou pessoa em sofrimento, típico da medicina, é deslocado em decorrência da necessidade de controle do acesso ao benefício. Entre a beneficência para com o demandante e o interesse coletivo de preservar recursos pela observância estrita do regramento previdenciário, há um espaço discricionário preenchido pela atividade médica, o espaço de arriscar-se, de tensionamento e, por vezes, de disfunções. A especialização em reconhecer a incapacidade laborativa é moralmente conflitiva. A reflexão ativa e o julgamento consciencioso não eliminam o risco moral, mas tornam mais evidentes as condições de sua emergência e a necessidade de considerá-lo seriamente ao lidar com essas práticas de controle sobre a população...

Double vulnerability, disease and work disability: this condition must be verified by medical experts in the Brazilian Social Security system among those applying for sick leave benefits. In a society organized around the production and consumption of goods, lack of income often means downward social class mobility and social deprivation. In the context of Social Security, medical activity is not focused on health restoration, treatment or prevention of disease. However, would be the lack of focus on health care assistance an argument strong enough to ignore the moral exam of this patient-physician interface? Thus, this paper argues that the expert medical activity over the entry or stay on sick leave benefits involves a specific type of risk arising from the singularity of the control task. This commitment to the patient, typical of medicine, is shifted due the need to control access to benefit. Between beneficence towards the plaintiff and the collective interest of preserving resources for strict observance of pension rules, there is a discretionary space filled by medical activity, the space venture, tensioning and sometimes of malfunctions. Medical expertise in recognizing incapacity to work is morally conflictive. The active reflection and fair judgment do not eliminate the moral conflict, but the conditions of its emergence become more obvious as well as the need to consider moral conflicts seriously when dealing with these control practices over the population...

The dermatologist as expert witness-revisited: know the risks before you agree.

Legal Standards and requirements exist for dermatologists wishing to serve as expert witnesses. Case law, statutes and licensing/credentialing groups exist to regulate the practice to ensure honesty and integrity. Penalties and sanctions exist for deceptive and fraudulent opinions. However, conversely, private groups must be careful in their efforts to not libel savvy experts or interfere with their legitimate work.

Medical expert witness litmus.

Several years ago, Dr G. Breaking was the foremost proponent of a new surgical procedure, which was named after him. At a recent national meeting, he discussed a paper that modified the procedure and criticized the presenter's revisions as dangerous--risking increased paralysis. GB's unedited comments were published last month in the specialty's leading journal. Today, an attorney called the office representing a surgical patient who suffered paralysis after undergoing the modified procedure. GB has unremittingly avoided involvement in litigation. The plaintiff's attorney asks him to serve as an expert witness against the surgeon. What should GB do?

[Limits of pain treatment: medical and judicial aspects]. / Grenzen der Schmerztherapie: Medizinische und Juristische Aspekte.

Medical principles of pain treatment are generally in line with the judicial principles. To relieve pain is one of the fundamentals of medicine and this has also been acknowledged by the Federal Court in Germany. It is criminal bodily harm, when a physician denies a possible pain treatment. Whereas courts clearly see an obligation to basic and continuing education in pain diagnosis and therapy, pain is still not represented in the German licensing regulations for physicians. Only palliative medicine has been added to the obligatory curriculum. Very similar pain is not mandatory in many clinical disciplines leaving physicians without the needed knowledge to treat pain. The need for interdisciplinary treatment is not yet acknowledged sufficiently, although meanwhile chronic pain is regarded as a bio-psycho-social illness.Since 2009 the advance directive is regulated by law. However, still many physicians are unaware that not only the position of the patient but also of the relatives have been strengthened. In 2010 the Federal Court has pronounced a judgment allowing "passive euthanasia" in certain conditions but prohibiting any active handling even in line with the patient's will. This is also in line with the European Human Rights Convention. The judicial unpunished assisted suicide has provoked an ethical discussion within the medical profession. However, what is not illegal is not automatically accepted as ethical handling for physicians. Palliative medicine is at least one alternative in this discussion.

[Clinical autopsies. Practical approach, legal foundations and ethical considerations]. / Klinische Obduktionen. Praktisches Vorgehen, rechtliche Grundlagen und ethische Uberlegungen.

Only an autopsy can demonstrate topographical and morphological circumstances in detail and correlate the clinical and autopsy findings based on the examination of all organs. The practical approach in a fatality is described based on the example of the Lüdenscheid Hospital. A uniform legal regulation for dealing with corpses does not exist in Germany. There are two approaches to the question under which circumstances a clinical autopsy is allowed: the extended permission solution and the objection solution. Whether a clinical autopsy can be carried out is decided by the medical specialist selected on application. Autopsies can be necessary from insurance or administrative legal grounds or in the case of an anatomical autopsy is decided by the persons themselves. In order to guarantee the quality of an autopsy it is necessary to use a standardized approach with evaluation and assessment of the results, for example using a quality assurance protocol and the production of an autopsy report. Using this approach important information can be gained not only on the accuracy of the main diagnosis and cause of death but also on additional diseases, response to therapy and the course of the disease and under circumstances can lead to modifications in the approach.

Reviewing medical malpractice cases for a plaintiff's attorney: heresy or responsibility.

Many physicians refuse to provide an expert review of a medical malpractice case for a plaintiff's attorney. They consider it to be "sleeping with the enemy". However, one method of avoiding frivolous suits is for reputable vascular surgeons to provide an honest and thorough review of the care provided to a patient by another vascular surgeon. This article discusses the importance and some guidelines for providing these reviews.

[Delegation of medical responsibilities to non-medical personnel. Options and limits from a legal viewpoint]. / Delegation ärztlicher Aufgaben auf nichtärztliche Berufsgruppen. Möglichkeiten und Grenzen aus rechtlicher Sicht.

Increasing specialization and growing mechanization in medicine have strongly supported the transfer of originally medical responsibilities to non-medical personnel. The enormous pressure of costs as a result of limited financial resources in the health system make the delegation of previously medical functions to cheaper non-medical ancillary staff expedient and the sometimes obvious lack of physicians also gains importance by the delegation of many activities away from medical staff. In the German health system there is no legal norm which clearly and definitively describes the field of activity of a medical doctor. Fundamental for a reform of the areas of responsibility between physicians and non-medical personnel is a terminological differentiation between instruction-dependent, subordinate, non-independent assistance and the delegation of medical responsibilities which are transferred to non-medical personnel for independent and self-determined completion under the supervision and control of a physician. The inclination towards risk of medical activities, the need of protection of the patient and the intellectual prerequisites required for carrying out the necessary measures define the limitations for the delegation of medical responsibilities to non-medical ancillary staff. These criteria demarcate by expert assessment the exclusively medical field of activity in a sufficiently exact and convincing manner.