The Passaic River Creel/Angler Survey: Expert Panel Review,Findings, and Recommendations

A Creel/Angler Survey (CAS) was conducted to provide site-specific information on recreational fishing in the lower six miles of the Passaic River (Study Area). Information collected during the CAS will be used to develop site-specific exposure factors, including fish consumption rates, for use in the human health risk assessment required by an Administrative Order on Consent as part of the Remedial Investigation/Feasibility Study for the Study Area. An expert panel was convened to provide an independent opinion regarding the need for, design of, and implementation of the CAS. The expert panel was charged with evaluating whether the conduct of a CAS is necessary to support an accurate risk assessment for the Study Area and whether the proposed CAS is sufficient to characterize local fish consumption behavior for risk assessment purposes. The expert panel agreed that a CAS is necessary and concluded that the proposed CAS, with specific modifications to the study design and data analysis, would provide the information necessary to estimate site-specific fish consumption rates. Revision of the CAS to accommodate the expert panel recommendations enhanced the quality of the data collected and ensured that the data will support the assessment of human health risks from consumption of fish from the Study Area.     

The Role of Bromocriptine-Qr in the Management of Type 2 Diabetes Expert Panel Recommendations

ObjectiveTo review available data on the efficacy and safety of bromocriptine-QR (BQR) and to consider its role in the management of Type 2 diabetes mellitus (T2DM).MethodsPublished literature reporting the efficacy and safety of BQR in the treatment of T2DM was reviewed, including peer-reviewed abstracts and poster presentations.ResultsBQR is an oral hypoglycemic agent with a novel mechanism of action that appears to involve enhancement of morning central nervous system (CNS) dopaminergic activity, resulting in improved insulin sensitivity and reduced hepatic glucose output. Adjunctive treatment with BQR in the dosing range of 1.6 to 4.8 mg/d may result in a mean (95% confidence interval [CI]) reduction in glycated hemoglobin (A1c) levels of 0.69% (0.97%, 0.41%). Treatment with BQR appears to be associated with minimal intrinsic risk of hypoglycemia, and does not appear to be associated with clinically significant adverse effects on weight, triglycerides, free fatty acids, or blood pressure.ConclusionThe favorable cardiovascular risk profile of BQR suggests that it may be useful in the treatment of patients with T2DM with a history of cardiovascular disease (CVD) or who have significant risk factors for CVD. However, knowledge of the efficacy and safety of BQR is limited by the relatively small clinical trials database. As a result, there is currently insufficient information on the safety and efficacy of adjunctive BQR in T2DM patients being treated with several common diabetes regimens (e.g., thiazolidinediones, insulin). (Endocr Pract. 2013;19:100-106)     

Expanding Disease Definitions in Guidelines and Expert Panel Ties to Industry: A Cross-sectional Study of Common Conditions in the United States

Background

Financial ties between health professionals and industry may unduly influence professional judgments and some researchers have suggested that widening disease definitions may be one driver of over-diagnosis, bringing potentially unnecessary labeling and harm. We aimed to identify guidelines in which disease definitions were changed, to assess whether any proposed changes would increase the numbers of individuals considered to have the disease, whether potential harms of expanding disease definitions were investigated, and the extent of members'' industry ties.

Methods and Findings

We undertook a cross-sectional study of the most recent publication between 2000 and 2013 from national and international guideline panels making decisions about definitions or diagnostic criteria for common conditions in the United States. We assessed whether proposed changes widened or narrowed disease definitions, rationales offered, mention of potential harms of those changes, and the nature and extent of disclosed ties between members and pharmaceutical or device companies.Of 16 publications on 14 common conditions, ten proposed changes widening and one narrowing definitions. For five, impact was unclear. Widening fell into three categories: creating “pre-disease”; lowering diagnostic thresholds; and proposing earlier or different diagnostic methods. Rationales included standardising diagnostic criteria and new evidence about risks for people previously considered to not have the disease. No publication included rigorous assessment of potential harms of proposed changes.Among 14 panels with disclosures, the average proportion of members with industry ties was 75%. Twelve were chaired by people with ties. For members with ties, the median number of companies to which they had ties was seven. Companies with ties to the highest proportions of members were active in the relevant therapeutic area. Limitations arise from reliance on only disclosed ties, and exclusion of conditions too broad to enable analysis of single panel publications.

Conclusions

For the common conditions studied, a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, and most had a majority of members disclosing financial ties to pharmaceutical companies. Please see later in the article for the Editors'' Summary     

Expert Panel on Weight Loss Surgery: Executive Report Update

Rapid shifts in the demographics and techniques of weight loss surgery (WLS) have led to new issues, new data, new concerns, and new challenges. In 2004, this journal published comprehensive evidence‐based guidelines on WLS. In this issue, we've updated those guidelines to assure patient safety in this fast‐changing field. WLS involves a uniquely vulnerable population in need of specialized resources and ongoing multidisciplinary care. Timely best‐practice updates are required to identify new risks, develop strategies to address them, and optimize treatment. Findings in these reports are based on a comprehensive review of the most current literature on WLS; they directly link patient safety to methods for setting evidence‐based guidelines developed from peer‐reviewed scientific publications. Among other outcomes, these reports show that WLS reduces chronic disease risk factors, improves health, and confers a survival benefit on those who undergo it. The literature also shows that laparoscopy has displaced open surgery as the predominant approach; that government agencies and insurers only reimburse procedures performed at accredited WLS centers; that best practice care requires close collaboration between members of a multidisciplinary team; and that new and existing facilities require wide‐ranging changes to accommodate growing numbers of severely obese patients. More than 100 specialists from across the state of Massachusetts and across the many disciplines involved in WLS came together to develop these new standards. We expect them to have far‐reaching effects of the development of health care policy and the practice of WLS.     

Time at Treatment of Severe Retinopathy of Prematurity in China: Recommendations for Guidelines in More Mature Infants

PurposeTo investigate the postmenstrual (PMA) age at treatment of severe retinopathy of prematurity (i.e. Type 1 prethreshold or threshold) in infants in a tertiary referral center in China.SignificanceThe Chinese guidelines regarding timing of the first examination are appropriate for infants with BW <2000g, but more mature infants should be examined a little earlier, at 3 weeks after birth, in order to detect Type 1 prethreshold disease which has a better prognosis than threshold.     

Hyponatremia: Mechanisms and Newer Treatments

ObjectiveTo review the neural and renal mechanisms of osmotic homeostasis, provide a rationale for the sensitivity of the central nervous system to hyponatremia, and outline modern approaches to therapy of acute and chronic hyponatremia.MethodsReview of relevant literature with focus on physiologic mechanisms.ResultsWith careful monitoring, acute hyponatremia can be managed, while minimizing risks both of continued hyponatremia and the osmotic demyelination that can occur with overly rapid correction of severe hyponatremia. Chronic hyponatremia due to disorders of volume regulation (congestive heart failure or cirrhosis) or to syndrome of inappropriate antidiuretic hormone release can be managed effectively with vasopressin V2 receptor antagonists, but there is no evidence that controlling the hyponatremia enhances survival associated with the underlying diseases.ConclusionsTherapy in the acute setting balances the risk of the osmotic disturbance with the risk of overly rapid correction. The V2 receptor antagonist tolvaptan has enhanced our ability to improve chronic hyponatremia in conditions such as congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone hypersecretion. (Endocr Pract. 2010;16:882-887)     

Defining the physician's duty to warn: consensus statement of Ontario's Medical Expert Panel on Duty to Inform

Ontario''s Medical Expert Panel on Duty to Inform was formed to consider the duty of Ontario physicians in circumstances where a patient threatens to kill or cause serious bodily harm to a third party. The panel was concerned about the implications of any duty to inform on the integrity of the physician-patient relationship, particularly with respect to confidentiality. The panel agreed that regulations safeguarding the confidentiality of patient information ought to be changed only if there is a critical reason for doing so, but, after deliberation, the panel members concluded that the need to protect the public from serious risk of harm is a paramount concern that should supersede the duty of confidentiality. The recommendations reported here were endorsed in principle by the panelists and the groups they represented (the Royal College of Physicians and Surgeons of Canada, the Canadian Medical Protective Association, the College of Physicians and Surgeons of Ontario, the Ontario College of Family Physicians and the Ontario Medical Association) and are being implemented by the College of Physicians and Surgeons of Ontario.     

Yeast Infections of the Lower Urinary Tract: Recommendations for Diagnosis and Treatment

Yeast infections of the lower urinary tract are common, with the vast majority due to Candida species. Though not life-threatening, candiduria may be a marker for overall severity of illness in hospitalized patients, as it appears to predict increased mortality, particularly in critically ill patients. Diagnosis is relatively simple through culture, but exact definitions of clinical disease are elusive. Management of asymptomatic patients is generally observation with reduction of predisposing factors, whereas symptomatic patients should be treated. Therapeutic options for these infections are limited and not well studied compared with therapies for systemic candidiasis. Further studies are needed to optimize management of these patients.     

Radiotherapy after Radical Prostatectomy: Treatment Recommendations Differ between Urologists and Radiation Oncologists

Purpose

There is no consensus on optimal use of radiotherapy following radical prostatectomy. The purpose of this study was to describe opinions of urologists and radiation oncologists regarding adjuvant and salvage radiotherapy following radical prostatectomy.

Methods

Urologists and genitourinary radiation oncologists were solicited to participate in an online survey. Respondent characteristics included demographics, training, practice setting, patient volume/experience, and access to radiotherapy. Participant practice patterns and attitudes towards use of adjuvant and salvage radiotherapy in standardized clinical scenarios were assessed.

Results

One hundred and forty-six staff physicians participated in the survey (104 urologists and 42 genitourinary radiation oncologists). Overall, high Gleason score (Gleason 7 vs. 6, RR 1.37 95% CI 1.19-1.56, p<0.0001 and Gleason 8-10 vs. 6, RR 1.56 95% CI 1.37-1.78, p<0.0001), positive surgical margin (RR 1.43 95% CI 1.26-1.62, p<0.0001), and extraprostatic tumour extension (RR 1.16 95% CI 1.05-1.28, p<0.002) conferred an increased probability of recommending adjuvant radiotherapy. Radiation oncologists were more likely to recommend adjuvant radiotherapy across all clinical scenarios (RR 1.48, 95% CI 1.39, 1.60, p <0.001). Major differences were found for patients with Gleason 6 and isolated positive surgical margin (radiotherapy selected by 21% of urologists vs. 70% of radiation oncologists), and patients with extraprostatic extension and negative surgical margins (radiotherapy selected by 18% of urologist vs. 57% of radiation oncologists).

Conclusions

Urologists and radiation oncologists frequently disagree about recommendation for post-prostatectomy adjuvant radiotherapy. Since clinical equipoise exists between adjuvant versus early salvage post-operative radiotherapy, support of clinical trials comparing these approaches is strongly encouraged.     

Drug Abuse—Recommendations for California Treatment and Research Facilities

The California Legislature has directed the Regents of the University of California to collect and act as an information exchange on research and services relating to drug abuse, and to provide advice with respect to fields in which research is needed.The current report, prepared under that directive, outlines the method by which data on drug abuse research and treatment facilities will be collected, and how this data will be prepared so that appropriate recommendations can be made to the state legislature.This initial report also outlines areas of immediate concern in the area of drug abuse for the benefit of the state legislature. These areas include current state policies which interfere with investigators competing for federal research funds; pharmacological misclassification of various agents of drug abuse (including marijuana, cocaine and mescaline); lack of awareness of the major adolescent drug abuse problem in California, namely that associated with methamphetamine abuse; the inconsistent and destructive effects of current Nalline clinic programs, and legal restraints which interfere with the proper treatment of drug abusers by physicians trained in treating such patients.     

Clinical Guidelines for Management of Bone Health in Rett Syndrome Based on Expert Consensus and Available Evidence

Objectives

We developed clinical guidelines for the management of bone health in Rett syndrome through evidence review and the consensus of an expert panel of clinicians.

Methods

An initial guidelines draft was created which included statements based upon literature review and 11 open-ended questions where literature was lacking. The international expert panel reviewed the draft online using a 2-stage Delphi process to reach consensus agreement. Items describe the clinical assessment of bone health, bone mineral density assessment and technique, and pharmacological and non-pharmacological interventions.

Results

Agreement was reached on 39 statements which were formulated from 41 statements and 11 questions. When assessing bone health in Rett syndrome a comprehensive assessment of fracture history, mutation type, prescribed medication, pubertal development, mobility level, dietary intake and biochemical bone markers is recommended. A baseline densitometry assessment should be performed with accommodations made for size, with the frequency of surveillance determined according to individual risk. Lateral spine x-rays are also suggested. Increasing physical activity and initiating calcium and vitamin D supplementation when low are the first approaches to optimizing bone health in Rett syndrome. If individuals with Rett syndrome meet the ISCD criterion for osteoporosis in children, the use of bisphosphonates is recommended.

Conclusion

A clinically significant history of fracture in combination with low bone densitometry findings is necessary for a diagnosis of osteoporosis. These evidence and consensus-based guidelines have the potential to improve bone health in those with Rett syndrome, reduce the frequency of fractures, and stimulate further research that aims to ameliorate the impacts of this serious comorbidity.