Advisory Committees

Pregnancy morbidity is one of the clinical manifestations used for classification criteria of antiphospholipid syndrome (APS). During the 14th International Congress on Antiphospholipid Antibodies (aPL), a Task Force with internationally-known experts was created to carry out a critical appraisal of the literature available regarding the association of aPL with obstetric manifestations present in actual classification criteria (recurrent early miscarriage, fetal death, preeclampsia and placental insufficiency) and the quality of the evidence that treatment(s) provide benefit in terms of avoiding recurrent adverse obstetric outcomes. The association of infertility with aPL and the effectiveness of the treatment of patients with infertility and positive aPL was also investigated. This report presents current knowledge and limitations of published studies regarding pregnancy morbidity, infertility and aPL, identifying areas that need better investigative efforts and proposing how critical flaws could be avoided in future studies, as suggested by participants of the Task Force. Except for fetal death, there are limitations in the quality of the data supporting the association of aPL with obstetric complications included in the current APS classification criteria. Recommended treatments for all pregnancy morbidity associated to APS also lack well-designed studies to confirm its efficacy. APL does not seem to be associated with infertility and treatment does not improve the outcomes in infertile patients with aPL. In another section of the Task Force, Dr. Jane Salmon reviewed complement-mediated inflammation in reproductive failure in APS, considering new therapeutic targets to obstetric APS (Ob APS).

Demand for intensive care unit (ICU) resources often exceeds supply, and shortages of ICU beds and staff are likely to persist. Triage requires careful weighing of the benefits and risks involved in ICU admission while striving to guarantee fair distribution of available resources. We must ensure that the patients who occupy ICU beds are those most likely to benefit from the ICU's specialized technology and professionals. Although prognosticating is not an exact science, preference should be given to patients who are more likely to survive if admitted to the ICU but unlikely to survive or likely to have more significant morbidity if not admitted. To provide general guidance for intensivists in ICU triage decisions, a task force of the World Federation of Societies of Intensive and Critical Care Medicine addressed 4 basic questions regarding this process. The team made recommendations and concluded that triage should be led by intensivists considering input from nurses, emergency...

Gomez's account of the Dutch ex-perience is largely accurate and his analysis is searching, cogent, and per-suasive. Indeed, there are five ways in which it could have been even more so. First, his analysis of jurisprudential developments could have been deeper. He could, ...

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) was established to harmonise clinical antimicrobial breakpoints and to define breakpoints for new agents in Europe. Data from the European Antimicrobial Resistance Surveillance Network (EARS-Net) external quality assessment (EQA) exercises from 2009 to 2012, from the United Kingdom External Quality Assessment Scheme (UK NEQAS) from November 2009 to March 2013 and data collected by EUCAST through a questionnaire in the first quarter of 2013 were analysed to investigate implementation of EUCAST guidelines in Europe. A rapid change to use of EUCAST breakpoints was observed over time. Figures for implementation of EUCAST breakpoints at the end of the studied period were 61.2% from EARSNet data and 73.2% from UK NEQAS data. Responses to the EUCAST questionnaire indicated that EUCAST breakpoints were used by over 50% of laboratories in 18 countries, by 10 to 50% of laboratories in eight countries and by less than 10% ...

This document provides an update to the European Respiratory Society (ERS)/American Thoracic Society (ATS) technical standards for single-breath carbon monoxide uptake in the lung that was last updated in 2005. Although both DLCO (diffusing capacity) and TLCO (transfer factor) are valid terms to describe the uptake of carbon monoxide in the lung, the term DLCO is used in this document. A joint taskforce appointed by the ERS and ATS reviewed the recent literature on the measurement of DLCO and surveyed the current technical capabilities of instrumentation being manufactured around the world. The recommendations in this document represent the consensus of the taskforce members in regard to the evidence available for various aspects of DLCO measurement. Furthermore, it reflects the expert opinion of the taskforce members on areas in which peer-reviewed evidence was either not available or was incomplete. The major changes in these technical standards relate to DLCO measurement with sys...

Consumer and carer involvement in mental health research is a growing and developing field. Whilst there has been policy and in-principle support for such involvement from governments around the world, lived experience researchers conducting academic research in partnership with other consumers and carers remains uncommon. The Australian Capital Territory Consumer and Carer Mental Health Research Unit is based at The Australian National University and employs academic researchers with lived experience to undertake research directly relevant to the needs of mental health consumers and carers with the aim of influencing policy and practice. In this study, we share our experience of developing and conducting research within ACACIA to provide a model for meaningfully engaging mental health consumers and carers throughout the research process.

This document summarizes the current consensus opinion of the Exaggerated Pharmacology (EP) Subcommittee of the Oligonucleotide Safety Working Group on the appropriate strategies to assess potential adverse effects caused by an "exaggerated" degree of the intended pharmacologic activity of an oligonucleotide (ON). The Subcommittee focused its discussions primarily on the ON subclasses that impact expression of "host" (i.e., human gene products--antisense, small interfering RNAs, and related ONs that target messenger RNA), with later and more limited discussions on aptamer, immunostimulatory, and microRNA subclasses. It is expected that many of these principles will be relevant to other subclasses but will need to be carefully considered as those development programs advance towards clinical trials. The recommendations may also serve as a frame of reference when designing Good Laboratory Practice safety studies with ONs, with regard to the study design elements th...

New Zealand has one of the best value health care systems in the world, but as a proportion of GDP our spending on health care has increased every year since 1999. Further, there are issues of quality and safety in our system we must address, including rates of adverse events. The Health Quality and Safety Commission was formed in 2010 as a crown agent to influence, encourage, guide and support improvement in health care practice in New Zealand. The New Zealand Triple Aim has been defined as: improved quality, safety and experience of care; improved health and equity for all populations; and best value for public health system resources. The Commission is pursuing the Triple Aim via two fundamental objectives: doing the right thing by providing care supported by the best evidence available, focused on what matters to each individual patient, and doing the right thing right, first time, by making sure health care is safe and of the highest quality possible. Improvement efforts must b...

This Task Force document explores the ethical issues involved in the debate about the scope of genetic screening of gamete donors. Calls for expanded donor screening arise against the background of both occasional findings of serious but rare genetic conditions in donors or donor offspring that were not detected through present screening procedures and the advent of new genomic technologies promising affordable testing of donors for a wide range of conditions. Ethical principles require that all stakeholders' interests are taken into account, including those of candidate donors. The message of the profession should be that avoiding all risks is impossible and that testing should remain proportional.

Although the term attachment disorder is ambiguous, attachment therapies are increasingly used with children who are maltreated, particularly those in foster care or adoptive homes. Some children described as having attachment disorders show extreme disturbances. The needs of these children and their caretakers are real. How to meet their needs is less clear. A number of attachment-based treatment and parenting approaches purport to help children described as attachment disordered. Attachment therapy is a young and diverse field, and the benefits and risks of many treatments remain scientifically undetermined. Controversies have arisen about potentially harmful attachment therapy techniques used by a subset of attachment therapists. In this report, the Task Force reviews the controversy and makes recommendations for assessment, treatment, and practices. The report reflects American Professional Society on the Abuse of Children's (APSAC) position and also was endorsed by the Amer...

Mentoring of junior faculty members continues to be a widespread need in academic pharmacy in both new programs and established schools. The American Association of Colleges of Pharmacy (AACP) Joint Council Task Force on Mentoring was charged with gathering information from member colleges and schools and from the literature to determine best practices that could be shared with the academy. The task force summarized their findings regarding the needs and responsibilities for mentors and protégés at all faculty levels; what mentoring pieces are in existence, which need improvement, and which need to be created; and how effective mentoring is defined and could be measured. Based on these findings, the task force developed several recommendations as well as the PAIRS Faculty Mentorship Checklist. Academic institutions can benefit from the checklist whether they are planning to implement a faculty mentorship program or are interested in modifying existing programs.

This document is the report of a task group of the Radiation Therapy Committee of the AAPM and has been prepared primarily to advise hospital physicists involved in external beam treatment of patients with pelvic malignancies who have high atomic number (Z) hip prostheses. The purpose of the report is to make the radiation oncology community aware of the problems arising from the presence of these devices in the radiation beam, to quantify the dose perturbations they cause, and, finally, to provide recommendations for treatment planning and delivery. Some of the data and recommendations are also applicable to patients having implanted high-Z prosthetic devices such as pins, humeral head replacements. The scientific understanding and methodology of clinical dosimetry for these situations is still incomplete. This report is intended to reflect the current state of scientific understanding and technical methodology in clinical dosimetry for radiation oncology patients with high-Z hip p...

Medical research is a fundamental tool to achieve the advancement of science, through the improvement of strategies aimed to protect, promote and restore an individual's and society's health. Three characteristics are required to obtain approval of the research proposal: scientific relevance, technical quality and the accomplishment of ethical issues. The present review aimed at the determination of the specific criteria to perform a critical review of research proposals. A research was carried out in the PubMed, Medline, Ovid and Google Scholar databases, using the terms: peer review, research proposals, review and protocols, and reviewers. A total of 3546 related articles were reviewed, without finding a guide to critically assess research proposals. The guides to assess research articles consider that the quality criteria of the study should have been present since the study's conception; many of the issues described to review articles are incorporated in the review o...