Search

Little knowledge exists on how evaluators in child custody and child maltreatment cases are informed by guidelines, the kinds of qualifications required and the types of training provided in different countries. The purpose of this paper is to provide an international preliminary comparison on how child custody and child maltreatment risk assessments are conducted in selected Western countries, and how the assessments are informed by best practice guidelines. Another aim is to increase knowledge on how the guidelines and best-practice standards could be developed further to reflect recent research findings. A total number of 18 guidelines were included in the analyses: four from Canada, five from the United States, three from the United Kingdom, three from the Netherlands, two from Finland, and one from Germany. We conducted a content analysis of the included guidelines in the database, focusing on how the guidelines address the best interest of the child criteria, guidelines for conducting the assessments, considerations for evaluative criteria, and specific guidance for conducting specific assessment procedures (e.g., interviews and observations). Findings show that the qualifications of and training provided to evaluators in child custody and child maltreatment risk evaluations are largely heterogeneous across the countries represented. Guidelines differ in whether and how they highlight the importance of evidence-based practices and scientifically validated assessment measures. Implications are drawn from the review and contextualized by international expert authors in the fields of forensic psychology, and family law. After the content analysis, discussion sessions within the expert group were held. The authors provide both commentaries and suggestions to improve the development of standard methods for conducting both child custody and child maltreatment risk evaluations and to consider a more transparent and judicious use of social science research to guide methods and the recommendations offered within these assessments.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

Luotettavasti laaditut hoitosuositukset ovat työväline, jolla tarjotun hoidon laatua voidaan tutkitusti parantaa. Hoitosuositusten laatiminen on kuitenkin moniulotteinen prosessi, johon ei ole yhtä yksiselitteisesti oikeaa menetelmää ja joka sisältää näytön tulkinnan lisäksi myös monenlaisia arvovalintoja. Siksi hoitosuositusten laatimisprosessi on altis myös päätöksenteon systemaattisille vinoumille. Koska ne eivät johdu yksilöiden tietoisista valinnoista, niiden tehokkaat ehkäisykeinot ovat rakenteellisia. Käsittelemme tässä katsausartikkelissa mekanismeja, joilla päätöksenteko saattaa vinoutua, ja esitämme rakenteellisia ratkaisuja niiden ehkäisemiseksi. Kaksi erityisen merkittävää tekijää, jotka altistavat hoitosuositukset systemaattisille vinoumille, ovat taloudelliset sidonnaisuudet ja ammattikuntaedut. Vinoumien ehkäisykeinoiksi esitämme puolueettomien asiantuntijoiden käyttöä, metodologisen osaamisen vahvistamista ja moniammatillisia työryhmiä. publishedVersion

Category: Ethics Introduction/Purpose: The objective of our study was to analyze COI nondisclosure for US based research articles that were published to three prevalent orthopaedic journals from the beginning of 2014 to the end of 2016. Methods: All US-based research articles published to FAI, JBJS, and JOA from the beginning of 2014 to the end of 2016 were reviewed. COI disclosure sections were analyzed to determine if a disclosure was made for first and/or last authors. Authors disclosing any financial relationship involving employment, royalties/licensing, speaking, and consulting fees were recorded as having disclosed a potential COI. First and last authors were then searched for using CMS Open Payments search tool to determine if they had received any of the aforementioned payment types. To determine if a COI nondisclosure (disclosure discrepancy) was present, an author’s disclosure statement for a published article was compared to CMS Open Payments data from the year prior to publication of the article. We used CMS data from the year prior to a publication to account for the time it takes to construct a paper and have it published. Results: Across all journals and years, we obtained disclosure accuracy data for 3,465 total first and last authors publishing 1,770 research articles. Within this sample, 7.1% (245/3,465) of the authors had a recorded undisclosed conflict-of-interest and 13.2% (233/1,770) of articles had a first and/or last author with an undisclosed potential conflict-of-interest. When looking at each journal individually over the three-year period, FAI contained the highest percentage of authors with undisclosed COI’s (42.3%), JBJS contained the lowest percent of authors with an undisclosed COI (4.6%), and JOA had an intermediate amount of authors with an undisclosed COI (7.0%). Conclusion: Discrepancies between payment disclosures made by authors and those published in the CMS database were present in all three journals reviewed in this study. The percentage of articles containing an author with a disclosure discrepancy varies widely between these journals. However, when analyzing the percentage of disclosure discrepancies by year, no trend was found.

Introduction Interactions between pharmaceutical companies and healthcare providers are increasingly scrutinized by academics, professionals, media, and politicians. Most empirical studies and professional guidelines focus on unilateral donor-recipient types of interaction and overlook, or fail to distinguish between, more reciprocal types of interaction. However, the degree of goal alignment and potential for value creation differs in these two types of interactions. Failing to differentiate between these two forms of interaction between pharmaceutical companies and healthcare providers could thus lead to biased conclusions regarding their desirability. This study reviews the empirical literature regarding the effects of bilateral forms of interactions between pharmaceutical companies and healthcare providers in order to explore their effects. Material and methods We searched two medical databases (i.e. PubMed and Cochrane Library) and one business database (i.e. EBSCO) for empirical, peer-reviewed articles concerning any type of bilateral interaction between pharmaceutical companies and healthcare providers. We included quantitative articles which were written in English and published between January 1 st, 2000 and October 31 st, 2016, and where the title or abstract included a combination of synonyms of the following keywords: pharmaceutical companies, healthcare providers, interaction, and effects. Results Our search results yielded 10 studies which were included in our analysis. These studies focused on either research-oriented interaction or on education-oriented interaction. The included studies reported various outcomes of interaction such as prescribing behavior, ethical dilemmas, and research output. Regardless of the type of interaction, the studies either reported no significant effects or ambivalent outcomes such as affected clinical practice or ethical issues. Discussion and conclusion The effects of bilateral interactions reported in the literature are similar to those reported in studies concerning unilateral interactions. The theoretical notion that bilateral interactions between pharmaceutical companies and healthcare providers have different effects given their increased level of goal alignment thus does not seem to hold. However, most of the empirical studies focus on intermediary, provider-level, outcomes such as altered prescribing behavior. Outcomes at the health system level such as overall costs and quality of care are overlooked. Further research is necessary in order to disentangle various forms of value created by different types of interactions between pharmaceutical companies and healthcare providers.

We examine the impact of the international diversification of banks on the value of their advice in 1,705 cross-border merger and acquisition (M&A) transactions. We find that bidders engaging internationally diversified advisors face lower announcement returns. An increase of one standard deviation in advisor diversification is associated with an announcement return lower by 92 basis points for a bidder acquiring a listed target. The lower bidder returns are attributable to the lower synergies of the deals being completed. Our evidence suggests that internationally diversified advisors offer lower-quality advice to their clients, since their reputational concerns are weakened by having access to multiple geographies from which they can derive fee-based income. We present further evidence that financial incentives in the form of the advisor’s involvement in deal financing and market incentives in the form of the potential to gain market share in the bidder country may mitigate some of the negative effects of the international diversification of the advisors. Data, as supplemental material, are available at http://dx.doi.org/10.1287/mnsc.2015.2396 . This paper was accepted by Wei Jiang, finance.

Objective: Clinical practice guidelines disagree on whether health care professionals should screen women for depression during pregnancy or postpartum. The objective of this systematic review was to determine whether depression screening improves depression outcomes among women during pregnancy or the postpartum period.Methods: Searches included the CINAHL, EMBASE, ISI, MEDLINE, and PsycINFO databases through April 1,2013; manual journal searches; reference list reviews; citation tracking of included articles; and trial registry reviews. RCTs in any language that compared depression outcomes between women during pregnancy or postpartum randomized to undergo depression screening versus women not screened were eligible.Results: There were 9,242 unique titles/abstracts and 15 full-text articles reviewed. Only 1 RCT of screening postpartum was included, but none during pregnancy. The eligible postpartum study evaluated screening in mothers in Hong Kong with 2-month-old babies (N = 462) and reported a standardized mean difference for symptoms of depression at 6 months postpartum of 0.34 (95% confidence interval = 0.15 to 0.52, P Conclusion: There is currently no evidence from any well-designed and conducted RCT that screening for depression would benefit women in pregnancy or postpartum. Existing guidelines that recommend depression screening during pregnancy or postpartum should be re-considered. (C) 2014 Elsevier Inc. All rights reserved.

Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol., In a document analysis of trial protocols and publications, Erik von Elm and colleagues investigate the potential impact of publication agreements between industry sponsors and academic investigators., Author Summary Why Was This Study Done? Many randomized trials are designed and sponsored by for-profit companies that contract academic investigators to recruit and manage patients. Clinical research under these circumstances is a business transaction that bears the potential for conflicts of interest, in particular with respect to trial publication. Besides evidence from a small sample, it was unclear how often trial protocols included publication agreements between industry and academic investigators, whether these agreements constrained the investigators’ publication rights, and how consistent such agreements stated in trial protocols were with those reported in corresponding publications. What Did the Researchers Do and Find? We investigated publication agreements in 647 randomized trial protocols approved in 2000–2003 by six research ethics committees in Switzerland, Canada, and Germany, and in 388 corresponding journal publications. Seventy percent of protocols mentioned an agreement on publication rights between industry and academic investigators; in 86% of those agreements, industry retained the right to disapprove or at least review manuscripts before publication. Seventy-four percent of agreements documented in protocols were not mentioned in corresponding journal articles. What Do These Findings Mean? Publication agreements constraining academic investigators’ independence are incompletely reported in publications; this may compromise the scientific evidence base established by randomized clinical trials. More transparency on publication constraints is warranted. Half of the included journal articles were published before 2008, leaving open the possibility that these findings do not reflect current reporting practice.

In this paper we build a formal model to study market environments where information is costly to acquire and is of use also to potential competitors. In such situations a market for information may form, where reports - of unverifiable quality - over the information acquired are sold. A complete characterization of the equilibria of the game is provided. We find that information is acquired when its costs are not too high and in that case it is also sold, though reports are typically noisy. Also, the market for information tends to be a monopoly, and there is typically inefficiency given by underinvestment in information acquisition. Regulatory interventions in the form of firewalls, limiting the access to the sale of information to third parties, uninterested in trading the underlying object, only make the inefficiency worse. On the other hand, efficiency can be attained with a monopolist selling differentiated information, provided entry is blocked. The above findings hold when information has a prevalent horizontal differentiation component. When that is not the case, and the vertical differentiation element is more important, firewalls can in fact be beneficial.

Objective: Clinical practice guidelines disagree on whether health care professionals should screen women for depression during pregnancy or postpartum. The objective of this systematic review was to determine whether depression screening improves depression outcomes among women during pregnancy or the postpartum period. Methods: Searches included the CINAHL, EMBASE, ISI, MEDLINE, and PsycINFO databases through April 1,2013; manual journal searches; reference list reviews; citation tracking of included articles; and trial registry reviews. RCTs in any language that compared depression outcomes between women during pregnancy or postpartum randomized to undergo depression screening versus women not screened were eligible. Results: There were 9,242 unique titles/abstracts and 15 full-text articles reviewed. Only 1 RCT of screening postpartum was included, but none during pregnancy. The eligible postpartum study evaluated screening in mothers in Hong Kong with 2-month-old babies (N = 462) and reported a standardized mean difference for symptoms of depression at 6 months postpartum of 0.34 (95% confidence interval = 0.15 to 0.52, P