Recent advances in research relevant to electric and magnetic field exposure guidelines

Limits on exposures to extremely low-frequency electric fields, magnetic fields and contact currents, designated as voluntary guidelines or standards by several organizations worldwide, are specified so as to minimize the possibility of neural stimulation. The limits, which we refer to as guidelines, derive from "basic restrictions" either on electric fields or current density within tissue, or on avoidance of annoying or startling interactions that may be experienced with spark discharge or contact current. Further, the guidelines specify more conservative permissible doses and exposure levels for the general public than for exposures in controlled environments, which most typically involve occupational settings. In 2001 we published an update on guideline science. This paper covers more recent developments that are relevant to the formulation and implementation of the next generation of guidelines. The paper deals with neurostimulation thresholds and the relevance of magnetophosphenes to setting guideline levels; dosimetry associated with contact current benchmarked against basic restrictions; tissue and cellular dosimetry from spark discharge; assessment of exposures to high electric fields in realistic situations (e.g., line worker in a transmission tower); a simplified approach to magnetic field assessment in non-uniform magnetic fields; and a quantitative approach to sampling workplace exposure for assessing compliance.     

Enabling Policy Planning and Innovation Management through Patent Information and Co-Authorship Network Analyses: A Study of Tuberculosis in Brazil

Introduction

New tools and approaches are necessary to facilitate public policy planning and foster the management of innovation in countries'' public health systems. To this end, an understanding of the integrated way in which the various actors who produce scientific knowledge and inventions in technological areas of interest operate, where they are located and how they relate to one another is of great relevance. Tuberculosis has been chosen as a model for the present study as it is a current challenge for Brazilian research and innovation.

Methodology

Publications about tuberculosis written by Brazilian authors were accessed from international databases, analyzed, processed with text searching tools and networks of coauthors were constructed and visualized. Patent applications about tuberculosis in Brazil were retrieved from the Brazilian National Institute of Industrial Property (INPI) and the European Patent Office databases, through the use of International Patent Classification and keywords and then categorized and analyzed.

Results/Conclusions

Brazilian authorship of articles about tuberculosis jumped from 1% in 1995 to 5% in 2010. Article production and patent filings of national origin have been concentrated in public universities and research institutions while the participation of private industry in the filing of Brazilian patents has remained limited. The goals of national patenting efforts have still not been reached, as up to the present none of the applications filed have been granted a patent. The analysis of all this data about TB publishing and patents clearly demonstrates the importance of maintaining the continuity of Brazil''s production development policies as well as government support for infrastructure projects to be employed in transforming the potential of research. This policy, which already exists for the promotion of new products and processes that, in addition to bringing diverse economic benefits to the country, will also contribute to effective dealing with public health problems affecting Brazil and the World.     

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

Objective

To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.

Materials and Methods

Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.

Results

Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.

Discussion

Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.     

Harmonic Allocation of Authorship Credit: Source-Level Correction of Bibliometric Bias Assures Accurate Publication and Citation Analysis

Authorship credit for multi-authored scientific publications is routinely allocated either by issuing full publication credit repeatedly to all coauthors, or by dividing one credit equally among all coauthors. The ensuing inflationary and equalizing biases distort derived bibliometric measures of merit by systematically benefiting secondary authors at the expense of primary authors. Here I show how harmonic counting, which allocates credit according to authorship rank and the number of coauthors, provides simultaneous source-level correction for both biases as well as accommodating further decoding of byline information. I also demonstrate large and erratic effects of counting bias on the original h-index, and show how the harmonic version of the h-index provides unbiased bibliometric ranking of scientific merit while retaining the original''s essential simplicity, transparency and intended fairness. Harmonic decoding of byline information resolves the conundrum of authorship credit allocation by providing a simple recipe for source-level correction of inflationary and equalizing bias. Harmonic counting could also offer unrivalled accuracy in automated assessments of scientific productivity, impact and achievement.     

Conflict of Interest Disclosures for Clinical Practice Guidelines in the National Guideline Clearinghouse

Background

Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs) and high rates of COI among guideline authors have been reported in the past. Our objective was to report current rates of disclosure and specific author COI across a broad range of CPGs and to examine whether CPG characteristics were associated with the presence of disclosures and of conflicts.

Methods and Findings

We selected a random sample of 250 CPGs listed in the National Guideline Clearinghouse on November 22, 2010, representing approximately a 10% sample of guidelines listed in the NGC on that date. We abstracted information on author COI from each CPG and examined predictors of the disclosures and COI using a logistic generalized estimating equation regression model. 87% of organizations developing guidelines had a CPG-specific policy, however, 40% of CPGs did not indicate that they had collected disclosures from guideline authors. In addition, 42% of organizations that did collect author disclosures did not have those disclosures available in the public domain. Of CPGs where we had disclosures for all authors, 60% had one or more authors with a conflict. On average, 28% of the authors of CPGs with available disclosures had a COI. Guidelines that were published in journals with an impact factor greater than 5.0 were more likely to have one or more authors with a COI than guidelines not published in journals.

Conclusions

Rates of disclosure of author COI and the public availability of that information are unacceptably low, however rates of COI among guideline authors may have decreased in recent years. Continued efforts are needed to establish and enforce optimal COI policies in clinical practice guideline development in order to minimize the risk of bias associated with those conflicts.     

What Affects Authors’ and Editors’ Use of Reporting Guidelines? Findings from an Online Survey and Qualitative Interviews

Objectives

To identify and understand, through data from multiple sources, some of the factors that affect authors’ and editors’ decisions to use reporting guidelines in the publication of health research.

Design

Mixed methods study comprising an online survey and semi-structured interviews with a sample of authors (online survey: n = 56; response rate = 32%; semi-structured interviews: n = 5) and journal editors (online survey: n = 43; response rate = 27%; semi-structured interviews: n = 6) involved in publishing health and medical research. Participants were recruited from an earlier study examining the effectiveness of the TREND reporting guideline.

Results

Four types of factors interacted to affect authors’ and editors’ likelihood of reporting guideline use; individual (e.g. having multiple reasons for use of reporting guidelines); the professional culture in which people work; environmental (e.g. policies of journals); and, practical (e.g. having time to use reporting guidelines). Having multiple reasons for using reporting guidelines was a particularly salient factor in facilitating reporting guidelines use for both groups of participants.

Conclusions

Improving the completeness and consistency of reporting of research studies is critical to the integrity and synthesis of health research. The use of reporting guidelines offers one potentially efficient and effective means for achieving this, but decisions to use (or not use) reporting guidelines take many factors into account. These findings could be used to inform future studies that might, for example, test the factors that we have identified within a wider theoretical framework for understanding changes in professional practices. The use of reporting guidelines by senior professionals appears to shape the expectations of what constitutes best practice and can be assimilated into the culture of a field or discipline. Without evidence of effectiveness of reporting guidelines, and sustained, multifaceted efforts to improve reporting, little progress seems likely to be made.     

Guidelines on anticoagulant treatment in atrial fibrillation in Great Britain: variation in content and implications for treatment.

OBJECTIVE: To describe the content of guidelines on the use of anticoagulant treatment in patients with atrial fibrillation and the impact of variations in guidelines on treatment. DESIGN: Postal survey of guidelines, semistructured interview with lead developers of guidelines, and application of guidelines to patient sample. SUBJECTS: 15 lead developers of the 20 guidelines identified in the postal survey were interviewed. 100 patients over 65 with atrial fibrillation to whom the guidelines were applied. MAIN OUTCOME MEASURES: Evaluation of guidelines and the methods of dissemination, implementation, review, and evaluation; proportion of patients recommended for anticoagulant treatment by each guideline; and level of agreement between guidelines. RESULTS: There was considerable variation in whether anticoagulant treatment was recommended for subjects (range 13% to 100%, kappa = 0.12). Guidelines varied greatly in advice on treatment by age, the use of echocardiography, and the target value or range of the international normalised ratio (8 of the 20 guidelines included values unlikely to be effective). Development was unsystematic; evidence based approaches were rarely used, 9 of the 15 lead developers had developed the guidelines themselves, and the 6 guidelines developed by groups relied on informal consensus. Methods to support effective dissemination, implementation, and evaluation were limited. CONCLUSION: The widespread non-systematic production of guidelines has led to considerable variation with implications for the quality of care and clinical decision making. There is a need for a central, well funded programme of guideline development to ensure that valid guidelines are produced and disseminated.     

Conflicts of Interest among Authors of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

Background

Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs).

Objectives

To examine rates of disclosure of COI, including financial interests in companies that manufacture drugs that are recommended in CPGs on glycemic control in type 2 diabetes mellitus, and to explore the relationship between recommendations for specific drugs in a guideline and author COI.

Methods

We identified a cohort of relevant guidelines from the National Guideline Clearinghouse (NGC) and abstracted COI disclosures from all guideline authors for this observational, cross-sectional study. We determined which hypoglycemic drugs were recommended in each guideline, and explored the relationship between specific disclosures and whether a drug was recommended.

Results

Among 13 included guidelines, the percentage of authors with one or more financial disclosures varied from 0 to 94% (mean 44.2%), and was particularly high for two US-based guidelines (91% and 94%). Three guidelines disclosed no author financial COI. The percentage of authors with disclosures of financial interests in manufacturers of recommended drugs was also high (mean 30%). On average, 56% of manufacturers of patented drugs recommended in each guideline had one or more authors with a financial interest in their company. We did not find a significant relationship between financial interests and whether a drug was recommended in our sample; US-based guidelines were more likely to make recommendations for a specific drug compared to non-US based guidelines.

Discussion

Authors of this cohort of guidelines have financial interests directly related to the drugs that they are recommending. Although we did not find an association between author COI and drugs recommended in these guidelines and we cannot draw conclusions about the validity of the recommendations, the credibility of many of these guidelines is in doubt.     

Towards an updated ESTRO-EFOMP core curriculum for education and training of medical physics experts in radiotherapy – A survey of current education and training practice in Europe

PurposeESTRO-EFOMP intend to update the core curriculum (CC) for education and training of medical physicists in radiotherapy in line with the European Commission (EC) guidelines on Medical Physics Experts (MPE), the CanMEDS methodology and recent developments in radiotherapy. As input, a survey of the current structure of radiotherapy MPE national training schemes (NTS) in Europe was carried out.MethodsA 35-question survey was sent to all European medical physics national societies (NS) with a focus on existence of an NTS, its format and duration, required entry-level education, and financial support for trainees.ResultsTwenty-six of 36 NS responded. Twenty had an NTS. Minimum required pre-training education varied from BSc in physics or related sciences (5/2) to MSc in medical physics, physics or related sciences (6/5/2) with 50–210 ECTS in fundamental physics and mathematics. The training period varied from 1 to 5 years (median 3 years with 50% dedicated to radiotherapy). The ratio of time spent on university lectures versus hospital training was most commonly 25%/75%. In 14 of 20 countries with an NTS, a research project was mandatory. Residents were paid in 17 of 20 countries. The recognition was mostly obtained by examination. Medical physics is recognised as a healthcare profession in 19 of 26 countries.ConclusionsThe NTS entrance level, duration and curriculum showed significant variations. This survey serves to inform the design of the updated CC to define a realistic minimum training level for safe and effective practice aiming at further harmonization in line with EC guidelines.     

Number and type of guideline implementation tools varies by guideline,clinical condition,country of origin,and type of developer organization: content analysis of guidelines

Background

Guideline implementation tools (GI tools) can improve clinician behavior and patient outcomes. Analyses of guidelines published before 2010 found that many did not offer GI tools. Since 2010 standards, frameworks and instructions for GI tools have emerged. This study analyzed the number and types of GI tools offered by guidelines published in 2010 or later.

Methods

Content analysis and a published GI tool framework were used to categorize GI tools by condition, country, and type of organization. English-language guidelines on arthritis, asthma, colorectal cancer, depression, diabetes, heart failure, and stroke management were identified in the National Guideline Clearinghouse. Screening and data extraction were in triplicate. Findings were reported with summary statistics.

Results

Eighty-five (67.5%) of 126 eligible guidelines published between 2010 and 2017 offered one or more of a total of 464 GI tools. The mean number of GI tools per guideline was 5.5 (median 4.0, range 1 to 28) and increased over time. The majority of GI tools were for clinicians (239, 51.5%), few were for patients (113, 24.4%), and fewer still were to support implementation (66, 14.3%) or evaluation (46, 9.9%). Most clinician GI tools were guideline summaries (116, 48.5%), and most patient GI tools were condition-specific information (92, 81.4%). Government agencies (patient 23.5%, clinician 28.9%, implementation 24.1%, evaluation 23.5%) and developers in the UK (patient 18.5%, clinician 25.2%, implementation 27.2%, evaluation 29.1%) were more likely to generate guidelines that offered all four types of GI tools. Professional societies were more likely to generate guidelines that included clinician GI tools.

Conclusions

Many guidelines do not include any GI tools, or a variety of GI tools for different stakeholders that may be more likely to prompt guideline uptake (point-of-care forms or checklists for clinicians, decision-making or self-management tools for patients, implementation and evaluation tools for managers and policy-makers). While this may vary by country and type of organization, and suggests that developers could improve the range of GI tools they develop, further research is needed to identify determinants and potential solutions. Research is also needed to examine the cost-effectiveness of various types of GI tools so that developers know where to direct their efforts and scarce resources.

     

The vexed question of authorship: views of researchers in a British medical faculty.

OBJECTIVE: To assess knowledge, views, and behaviour of researchers on criteria for authorship and causes and control of gift authorship. DESIGN: Interview survey of stratified sample of researchers. SETTING: University medical faculty. SUBJECTS: 66 staff (94% response rate) comprising several levels of university academic and research appointments. MAIN OUTCOME MEASURES: Awareness and use of criteria for authorship, views on which contributions to research merit authorship, perceptions about gift authorship and strategies for reducing it, and experiences of authorship problems. RESULTS: 50 (76%) respondents supported criteria for authorship, but few knew about or used available criteria. Of the five people who could specify all three criteria of the International Committee of Medical Journal Editors, only one knew that all criteria had to be met. Forty one respondents (62%) disagreed with this stipulation. A range of practical and academic contributions were seen as sufficient for authorship. Gift authorship was perceived as common, promoted by pressure to publish, to motivate research teams, and to maintain working relationships. A signed statement justifying authorship and a published statement of the contribution of each author were perceived as practical ways of tackling gift authorship. Most researchers had experienced problems with authorship, most commonly the perception that authorship had been deserved but not awarded (49%). CONCLUSION: There seems to be a gap between editors'' criteria for authorship and researchers'' practice. Lack of awareness of criteria is only a partial explanation. Researchers give more weight than editors to practical research contributions. Future criteria should be agreed by researchers and not be imposed by editors.     

The malaria testing and treatment landscape in Kenya: results from a nationally representative survey among the public and private sector in 2016

Background

Since 2004, Kenya’s national malaria treatment guidelines have stipulated artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria, and since 2014, confirmatory diagnosis of malaria in all cases before treatment has been recommended. A number of strategies to support national guidelines have been implemented in the public and private sectors in recent years. A nationally-representative malaria outlet survey, implemented across four epidemiological zones, was conducted between June and August 2016 to provide practical evidence to inform strategies and policies in Kenya towards achieving national malaria control goals.

Results

A total of 17,852 outlets were screened and 2271 outlets were eligible and interviewed. 78.3% of all screened public health facilities stocked both malaria diagnostic testing and quality-assured ACT (QAACT). Sulfadoxine–pyrimethamine (SP) for intermittent preventive treatment in pregnancy was available in 70% of public health facilities in endemic areas where it is recommended for treatment. SP was rarely found in the public sector outside of the endemic areas (< 0.5%). The anti-malaria stocking private sector had lower levels of QAACT (46.7%) and malaria blood testing (20.8%) availability but accounted for majority of anti-malarial distribution (70.6% of the national market share). More than 40% of anti-malarials were distributed by unregistered pharmacies (37.3%) and general retailers (7.1%). QAACT accounted for 58.2% of the total anti-malarial market share, while market share for non-QAACT was 15.8% and for SP, 24.8%. In endemic areas, 74.9% of anti-malarials distributed were QAACT. Elsewhere, QAACT market share was 49.4% in the endemic-prone areas, 33.2% in seasonal-transmission areas and 37.9% in low-risk areas.

Conclusion

Although public sector availability of QAACT and malaria diagnosis is relatively high, there is a gap in availability of both testing and treatment that must be addressed. The private sector in Kenya, where the majority of anti-malarials are distributed, is also critical for achieving universal coverage with appropriate malaria case management. There is need for a renewed commitment and effective strategies to ensure access to affordable QAACT and confirmatory testing in the private sector, and should consider how to address malaria case management among informal providers responsible for a substantial proportion of the anti-malarial market share.

     

Understanding variation in rates of referral among general practitioners: are inappropriate referrals important and would guidelines help to reduce rates?

OBJECTIVES--To determine the extent to which variation in rates of referral among general practitioners may be explained by inappropriate referrals and to estimate the effect of implementing referral guidelines. SETTING--Practices within Cambridge Health Authority and Addenbrooke''s Hospital, Cambridge. MAIN OUTCOME MEASURES--Data on practice referral rates from hospital computers, inappropriate referrals as judged by hospital consultants, and inappropriate referrals as judged against referral guidelines which had been developed locally between general practitioners and specialists. Effect of referral guidelines on referral patterns as judged by general practitioners using the guidelines in clinical practice. RESULTS--There was 2.5-fold variation in referral rates among general practices. According to the specialists, 9.6% (95% confidence interval 6.4% to 12.9%) of referrals by general practitioners and 8.9% (2.6% to 15.2%) of referrals from other specialists were judged possibly or definitely inappropriate. Against locally determined referral guidelines 15.9% of referrals by general practitioners were judged possibly inappropriate (11.8% to 20.0%). Elimination of all possibly inappropriate referrals could reduce variation in practice referral rates only from 2.5-fold to 2.1-fold. An estimate of the effect of using referral guidelines for 60 common conditions in routine general practice suggested that application of guidelines would have been unlikely to reduce rates of referral in hospital (95% confidence interval -4.5% to 8.6% of consultations resulting in referral). CONCLUSION--The variation in referral rates among general practitioners in Cambridge could not be explained by inappropriate referrals. Application of referral guidelines would be unlikely to reduce the number of patients referred to hospital.