Why are medical and health-related studies not being published? A systematic review of reasons given by investigators

Objective: About half of medical and health related studies are not published. We conducted a systematic review of reports on reasons given by investigators for not publishing their studies in peer-reviewed journals. Methods: MEDLINE, EMBASE, PsycINFO, and SCOPUS (until 13/09/2013), and references of identified articles were searched to identify reports of surveys that provided data on reasons given by investigators for not publishing studies. The proportion of non-submission and reasons for non-publication was calculated using the number of unpublished studies as the denominator. Because of heterogeneity across studies, quantitative pooling was not conducted. Exploratory subgroup analyses were conducted. Results: We included 54 survey reports. Data from 38 included reports were available to estimate proportions of at least one reason given for not publishing studies. The proportion of non-submission among unpublished studies ranged from 55% to 100%, with a median of 85%. The reasons given by investigators for not publishing their studies included: lack of time or low priority (median 33%), studies being incomplete (median 15%), study not for publication (median 14%), manuscript in preparation or under review (median 12%), unimportant or negative result (median 12%), poor study quality or design (median 11%), fear of rejection (median 12%), rejection by journals (median 6%), author or co-author problems (median 10%), and sponsor or funder problems (median 9%). In general, the frequency of reasons given for non-publication was not associated with the source of unpublished studies, study design, or time when a survey was conducted. Conclusions: Non-submission of studies for publication remains the main cause of non-publication of studies. Measures to reduce non-publication of studies and alternative models of research dissemination need to be developed to address the main reasons given by investigators for not publishing their studies, such as lack of time or low priority and fear of being rejected by journals

The Case for Legal Regulation of Physicians’ Off-Label Prescribing

Deafness has been associated with poor abilities to deal with digits in the context of arithmetic and memory, and language modality-specific differences in the phonological similarity of digits have been shown to influence short-term memory (STM). Therefore, the overall aim of the present thesis was to find out whether language modality-specific differences in phonological processing between sign and speech can explain why deaf signers perform at lower levels than hearing peers when dealing with digits. To explore this aim, the role of phonological processing in digit-based arithmetic and memory tasks was investigated, using both behavioural and neuroimaging methods, in adult deaf signers and hearing non-signers, carefully matched on age, sex, education and non-verbal intelligence. To make task demands as equal as possible for both groups, and to control for material effects, arithmetic, phonological processing, STM and working memory (WM) were all assessed using the same presentation and response mode for both groups. The results suggested that in digit-based STM, phonological similarity of manual numerals causes deaf signers to perform more poorly than hearing non-signers. However, for  digit-based WM there was no difference between the groups, possibly due to differences in allocation of resources during WM. This indicates that similar WM for the two groups can be generalized from lexical items to digits. Further, we found that in the present work deaf signers performed better than expected and on a par with hearing peers on all arithmetic tasks, except for multiplication, possibly because the groups studied here were very carefully matched. However, the neural networks recruited for arithmetic and phonology differed between groups. During multiplication tasks, deaf signers showed an increased  reliance on cortex of the right parietal lobe complemented by the left inferior frontal gyrus. In contrast, hearing non-signers relied on cortex of the left frontal and parietal lobes during multiplication. This suggests that while hearing non-signers recruit phonology-dependent arithmetic fact retrieval processes for multiplication, deaf signers recruit non-verbal magnitude manipulation processes. For phonology, the hearing non-signers engaged left lateralized frontal and parietal areas within the classical perisylvian language network. In deaf signers, however, phonological processing was limited to cortex of the left occipital lobe, suggesting that sign-based phonological processing does not necessarily activate the classical language network. In conclusion, the findings of the present thesis suggest that language modality-specific differences between sign and speech in different ways can explain why deaf signers perform at lower levels than hearing non-signers on tasks that include dealing with digits.Dövhet har kopplats till bristande förmåga att hantera siffror inom områdena aritmetik och minne. Särskilt har språkmodalitetsspecifika skillnader i fonologisk likhet för siffror visat sig påverka korttidsminnet. Det övergripande syftet med den här avhandlingen var därför att undersöka om språkmodalitetsspecifika skillnader i fonologisk bearbetning mellan teckenoch talspråk kan förklara varför döva presterar sämre än hörande på sifferuppgifter. För att utforska det området undersöktes fonologisk bearbetning i sifferbaserade minnesuppgifter och aritmetik med hjälp av både beteendevetenskapliga metoder och hjärnavbildning hos grupper av teckenspråkiga döva och talspråkiga hörande som matchats noggrant på ålder, kön, utbildning och icke-verbal intelligens. För att testförhållandena skulle bli så likartade som möjligt för de båda grupperna, och för att förebygga materialeffekter, användes samma presentations- och svarssätt för båda grupperna. Resultaten visade att vid sifferbaserat korttidsminne påverkas de dövas prestation av de tecknade siffrornas fonologiska likhet. Däremot fanns det ingen skillnad mellan grupperna gällande sifferbaserat arbetsminne, vilket kan bero på att de båda grupperna fördelar sina kognitiva resurser på olika sätt. Dessutom fann vi att den grupp teckenspråkiga döva som deltog i studien presterade bättre på aritmetik än vad tidigare forskning visat och de skiljde sig bara från hörande på multiplikationsuppgifter, vilket kan bero på att grupperna var så noggrant matchade. Däremot fanns det skillnader mellan grupperna i vilka neurobiologiska nätverk som aktiverades vid aritmetik och fonologi. Vid multiplikationsuppgifter aktiverades cortex i höger parietallob och vänster frontallob för de teckenspråkiga döva, medan cortex i vänster frontal- och parietallob aktiverades för de talspråkiga hörande. Detta indikerar att de talspråkiga hörande förlitar sig på fonologiberoende minnesstrategier medan de teckenspråkiga döva förlitar sig på ickeverbal magnitudmanipulering och artikulatoriska processer. Under den fonologiska uppgiften aktiverade de talspråkiga hörande vänsterlateraliserade frontala och parietala områden inom det klassiska språknätverket. För de teckenspråkiga döva var fonologibearbetningen begränsad till cortex i vänster occipitallob, vilket tyder på att teckenspråksbaserad fonologi inte behöver aktivera det klassiska språknätverket. Sammanfattningsvis visar fynden i den här avhandlingen att språkmodalitetsspecifika skillnader mellan tecken- och talspråk på olika sätt kan förklara varför döva presterar sämre än hörande på vissa sifferbaserade uppgifter

Confronting the Ghost: Legal Strategies to Oust Medical Ghostwriters

Articles published in medical journals contribute significantly to public health by disseminating medical information to physicians, thereby influencing prescribing practices. However, the information guiding treatment decisions becomes distorted by selective publishing and medical ghostwriting, which negatively affects overall patient care. Although there is general consensus in the medical community that these practices of publication bias represent a moral failing, the issue is rarely framed as a wrong that necessitates legal consequences. This Note takes the stance that medical ghostwriting constitutes an act prohibited under the Racketeer Influenced and Corrupt Organizations Act (RICO) and argues that physicians fraudulently named as authors should be held civilly liable under RICO. This Note explores civil RICO, its origin, its legislative and judicial history, and the evolution of RICO to areas beyond traditional organized crime. By applying the elements of civil RICO to medical ghostwriting, this Note argues that physicians named as authors who knowingly fail to fulfill journal authorship criteria should be held accountable for their role in disseminating misleading medical information. This Note argues that, at the very least, current regulations governing the medical publication framework should be better enforced and revised to mandate authorship disclosure

A simplified guide to randomized controlled trials.

A randomized controlled trial (RCT) is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. The RCT is the most rigorous and robust research method of determining whether a cause-effect relationship exists between an intervention and an outcome. High quality evidence can be generated by performing an RCT when evaluating the effectiveness and safety of an intervention. Furthermore, RCTs yield themselves well to systematic review and meta-analysis providing a solid base for synthesizing evidence generated by such studies. Evidence-based clinical practice improves patient outcomes, safety, and is generally cost-effective. Therefore, RCTs are becoming increasingly popular in all areas of clinical medicine including perinatology. However, designing and conducting an RCT, analyzing data, interpreting findings and disseminating results can be challenging as there are several practicalities to be considered. In this review, we provide a simple descriptive guidance on planning, conducting, analyzing and reporting RCTs

Pharmacological interventions for agitation in patients with traumatic brain injury: protocol for a systematic review and meta-analysis

Abstract Background Traumatic brain injury (TBI) is a worldwide leading cause of mortality and disability. Among TBI complications, agitation is a frequent behavioural problem. Agitation causes potential harm to patients and caregivers, interferes with treatments, leads to unnecessary chemical and physical restraints, increases hospital length of stay, delays rehabilitation, and impedes functional independence. Pharmacological treatments are often considered for agitation management following TBI. Several types of agents have been proposed for the treatment of agitation. However, the benefit and safety of these agents in TBI patients as well as their differential effects and interactions are uncertain. In addition, animal studies and observational studies have suggested impaired cognitive function with the use of certain antipsychotics and benzodiazepines. Hence, a safe and effective treatment for agitation, which does not interfere with neurological recovery, remains to be identified. Methods/design With the help of Health Sciences librarian, we will design a search strategy in the following databases: PubMed, Ovid MEDLINE®, EMBASE, CINAHL, PsycINFO, Cochrane Library, Google Scholar, Directory of Open Access Journals, LILACS, Web of Science, and Prospero. A grey literature search will be performed using the resources suggested in CADTH’s Grey Matters. We will include all randomized controlled, quasi-experimental, and observational studies with control groups. The population of interest is all patients, including children and adults, who have suffered a TBI. We will include studies in which agitation, not further defined, was the presenting symptom or one of the presenting symptoms. We will also include studies where agitation was not the presenting symptom but was measured as an outcome variable and studies assessing the safety of these pharmacological interventions in TBI patients. We will include studies evaluating all pharmacological interventions including beta-adrenergic blockers, typical and atypical antipsychotics, anticonvulsants, dopamine agonists, psychostimulants, antidepressants, alpha-2-adrenergic agonists, hypnotics, and anxiolytics. Discussion Although agitation is frequent following TBI and pharmacological agents that are often used, there is no consensus on the most efficacious and safest strategy to treat these complications. There is a need for an updated systematic review to summarize the evidence in order to inform practice and future research. Systematic review registration PROSPERO CRD4201603314

Operator-based approaches to harm minimisation in gambling: summary, review and future directions

In this report we give critical consideration to the nature and effectiveness of harm minimisation in gambling. We identify gambling-related harm as both personal (e.g., health, wellbeing, relationships) and economic (e.g., financial) harm that occurs from exceeding one’s disposable income or disposable leisure time. We have elected to use the term ‘harm minimisation’ as the most appropriate term for reducing the impact of problem gambling, given its breadth in regard to the range of goals it seeks to achieve, and the range of means by which they may be achieved. The extent to which an employee can proactively identify a problem gambler in a gambling venue is uncertain. Research suggests that indicators do exist, such as sessional information (e.g., duration or frequency of play) and negative emotional responses to gambling losses. However, the practical implications of requiring employees to identify and interact with customers suspected of experiencing harm are questionable, particularly as the employees may not possess the clinical intervention skills which may be necessary. Based on emerging evidence, behavioural indicators identifiable in industryheld data, could be used to identify customers experiencing harm. A programme of research is underway in Great Britain and in other jurisdiction