Flaws In Study Design Research Articles

HMG-CoA reductase inhibitors and COVID-19 mortality in Stockholm, Sweden: A registry-based cohort study.

The relationship between statin treatment and Coronavirus Disease 2019 (COVID-19) mortality has been discussed due to the pleiotropic effects of statins on coagulation and immune mechanisms. However, available observational studies are hampered by study design flaws, resulting in substantial heterogeneity and ambiguities. Here, we aim to determine the relationship between statin treatment and COVID-19 mortality. This cohort study included all Stockholm residents aged 45 or older (N = 963,876), followed up from 1 March 2020 until 11 November 2020. The exposure was statin treatment initiated before the COVID-19-pandemic, defined as recorded statin dispensation in the Swedish Prescribed Drug Register between 1 March 2019 and 29 February 2020. COVID-19-specific mortality was ascertained from the Swedish Cause of Death Registry. Hazard ratios (HRs) were calculated using multivariable Cox regression models. We further performed a target trial emulation restricted to initiators of statins. In the cohort (51.6% female), 169,642 individuals (17.6%) were statin users. Statin users were older (71.0 versus 58.0 years), more likely to be male (53.3% versus 46.7%), more often diagnosed with comorbidities (for example, ischemic heart disease 23.3% versus 1.6%), more frequently on anticoagulant and antihypertensive treatments, less likely to have a university-level education (34.5% versus 45.4%), and more likely to have a low disposable income (20.6% versus 25.2%), but less likely to reside in crowded housing (6.1% versus 10.3%). A total of 2,545 individuals died from COVID-19 during follow-up, including 765 (0.5%) of the statin users and 1,780 (0.2%) of the nonusers. Statin treatment was associated with a lowered COVID-19 mortality (adjusted HR, 0.88; 95% CI, 0.79 to 0.97, P = 0.01), and this association did not vary appreciably across age groups, sexes, or COVID-19 risk groups. The confounder adjusted HR for statin treatment initiators was 0.78 (95% CI, 0.59 to 1.05, P = 0.10) in the emulated target trial. Limitations of this study include the observational design, reliance on dispensation data, and the inability to study specific drug regimens. Statin treatment had a modest negative association with COVID-19 mortality. While this finding needs confirmation from randomized clinical trials, it supports the continued use of statin treatment for medical prevention according to current recommendations also during the COVID-19 pandemic.

Comparison between the Effectiveness of Kinesio Taping and Stretching Exercise in Contemporary Dancers with Chronic Shin Splints

The purpose of the present study was to compare the effectiveness of kinesio taping and stretching exercises in contemporary dancers with chronic shin splints. In the present study, purposively review the published evidence regarding risk factor associated with chronic shin splints in contemporary dancers, assess the effectiveness of kinesio taping, and stretching exercises, of the 45 citations identified, we emphasised results of the nine reports that compare the effect of kinesio taping method to prevent shin splints, twenty-three reports on the effect of shin splints in contemporary dancers, seventeen reports the effect of stretching exercises in shin splints, and two reports the effect of both kinesis taping and stretching exercises on contemporary dancers with repetitive stress and overused activities. The result of the kinesio taping and stretching exercises programs in contemporary dancers with chronic shin splints have undergone assessment of controlled trials. There is no strong support for any of these interventions, and each of four control trials is limited methodologically. The most encouraging evidence for effective prevention of chronic shin splints involves the use of stretching exercise programs. However, serious flaws in study design and implementation constraints the work in this field thus far.
 Keywords: Kinesio taping technique, Stretching exercise program, Chronic Shin Splints, Contemporary dancers.

Prevalence of Avoidable and Bias-Inflicting Methodological Pitfalls in Real-World Studies of Medication Safety and Effectiveness.

Many real-word evidence (RWE) studies that utilize existing healthcare data to evaluate treatment effects incur substantial but avoidable bias from methodologically flawed study design; however, the extent of preventable methodological pitfalls in current RWE is unknown. To characterize the prevalence of avoidable methodological pitfalls with potential for bias in published claims-based studies of medication safety or effectiveness, we conducted an English-language search of PubMed for articles published from January 1, 2010 to May 20, 2019 and randomly selected 75 studies (10 case-control and 65 cohort studies) that evaluated safety or effectiveness of cardiovascular, diabetes, or osteoporosis medications using US health insurance claims. General and methodological study characteristics were extracted independently by two reviewers, and potential for bias was assessed across nine bias domains. Nearly all studies (95%) had at least one avoidable methodological issue known to incur bias, and 81% had potentially at least one of the four issues considered major due to their potential to undermine study validity: time-related bias (57%), potential for depletion of outcome-susceptible individuals (44%), inappropriate adjustment for postbaseline variables (41%), or potential for reverse causation (39%). The median number of major issues per study was 2 (interquartile range (IQR), 1-3) and was lower in cohort studies with a new-user, active-comparator design (median 1, IQR 0-1) than in cohort studies of prevalent users with a nonuser comparator (median 3, IQR 3-4). Recognizing and avoiding known methodological study design pitfalls could substantially improve the utility of RWE and confidence in its validity.

Study design flaws and statistical challenges in evaluating fertility treatments.

SummaryHealth interventions should be tested before being introduced into clinical practice, to find out whether they work and whether they are harmful. However, research studies will only provide reliable answers to these questions if they are appropriately designed and analysed. But these are not trivial tasks. We review some methodological challenges that arise when evaluating fertility interventions and explain the implications for a non-statistical audience. These include flexibility in outcomes and analyses; use of surrogate outcomes instead of live birth; use of inappropriate denominators; evaluating cumulative outcomes and time to live birth; allowing each patient or couple to contribute to a research study more than once. We highlight recurring errors and present solutions. We conclude by highlighting the importance of collaboration between clinical and methodological experts, as well as people with experience of subfertility, for realising high-quality research.Lay summaryWe do research to find out whether fertility treatments are beneficial and to make sure they don’t cause harm. However, research will only provide reliable answers if it is done properly. It is not unusual for researchers to make mistakes when they are designing research studies and analysing the data that we get from them. In this review, we describe some of the mistakes people make when they do research about fertility treatments and explain how to avoid them. These include challenges which arise due to the large number of things that can be measured and reported when looking to see if fertility treatments work; failure to check whether the treatment increases the number of live births; failing to include all study participants in calculations;challenges in studies where participants may have more than one treatment attempt. We conclude by highlighting the importance of collaboration between clinical and methodological experts, as well as people with experience of fertility problems.

Comparison of Outcomes After Robotic-Assisted or Conventional Total Hip Arthroplasty at a Minimum 2-Year Follow-up: A Systematic Review.

This systematic review aimed to present an updated analysis of the evidence comparing outcomes between robotic-assisted total hip arthroplasty (robotic THA) and conventional manual total hip arthroplasty (manual THA). A PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) systematic review was performed using the Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, PubMed, MEDLINE, and Embase. Controlled studies comparing primary robotic THA and manual THA utilizing patient-reported outcome measures (PROMs) at a minimum follow-up of 2 years were included. We also compared radiographic outcomes, dislocation rates, and revision surgical procedures between groups. The ROBINS-I (Risk of Bias in Non-Randomized Studies - of Interventions) and Cochrane Risk of Bias 2.0 tools were used to assess study quality and risk of bias. Of 765 studies identified, 7 articles comparing robotic THA with manual THA met inclusion criteria. A total of 658 patients were assessed, 335 of whom underwent robotic THA. The majority of studies found no significant differences (p > 0.05) in PROMs between the 2 techniques. Two low-quality studies (Level III) found significantly better postoperative PROMs favoring robotic THA at 2 years. When assessing radiographic outcomes, 6 studies showed that robotic THA resulted in more consistent and accurate component placement. No differences in postoperative dislocations, complications, or revision rates were found between groups except in 1 study, which found significantly more dislocations and revisions in the robotic THA cohort. Reported operative times were a mean of 12 to 25 minutes longer when using robotic THA. The existing literature comparing robotic THA and manual THA is scarce and low-quality, with findings limited by methodological flaws in study design. Although evidence exists to support increased accuracy and reproducibility of THA component placement with robotic THA, this has not been shown to reduce postoperative dislocation and revision rates. Based on the available evidence, functional outcomes are comparable between techniques, and robotic THA appears to be associated with longer operative times. To fully evaluate the utility of robotic THA, additional well-designed, prospective controlled studies with continuous long-term monitoring are required. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The use of experimental vignette studies to identify drivers of variations in the delivery of health care: a scoping review

BackgroundIdentifying how unwarranted variations in healthcare delivery arise is challenging. Experimental vignette studies can help, by isolating and manipulating potential drivers of differences in care. There is a lack of methodological and practical guidance on how to design and conduct these studies robustly. The aim of this study was to locate, methodologically assess, and synthesise the contribution of experimental vignette studies to the identification of drivers of unwarranted variations in healthcare delivery.MethodsWe used a scoping review approach. We searched MEDLINE, Embase, Web of Science and CINAHL databases (2007–2019) using terms relating to vignettes and variations in healthcare. We screened title/abstracts and full text to identify studies using experimental vignettes to examine drivers of variations in healthcare delivery. Included papers were assessed against a methodological framework synthesised from vignette study design recommendations within and beyond healthcare.ResultsWe located 21 eligible studies. Study participants were almost exclusively clinicians (18/21). Vignettes were delivered via text (n = 6), pictures (n = 6), video (n = 6) or interactively, using face-to-face, telephone or online simulated consultations (n = 3). Few studies evaluated the credibility of vignettes, and many had flaws in their wider study design. Ten were of good methodological quality. Studies contributed to understanding variations in care, most commonly by testing hypotheses that could not be examined directly using real patients.ConclusionsExperimental vignette studies can be an important methodological tool for identifying how unwarranted variations in care can arise. Flaws in study design or conduct can limit their credibility or produce biased results. Their full potential has yet to be realised.

Editor's Letter: State of the Journal

As the Editor-in-Chief of the Journal of Ultrasound in Medicine (JUM), I am proud to provide this overview of the state of your journal. Last year (2020), JUM had arguably one of its best years on record, building on its reputation as the leading international educational and scientific journal for all fields of ultrasound. In 2020, JUM saw a significant increase in the number of original manuscript submissions. In fact, it was the first time JUM received more than 1500 submissions, ending the year with 1728—a 31.6% increase over 2019's record. Of course, this increase in submissions meant that JUM had to be more selective. The result is that the acceptance rate dipped to 17%, a record low. When it comes to deciding which articles are accepted, the editors and the article reviewers play a very important role. In addition to being able to immediately reject articles (you would be surprised by how many submitted articles do not even mention ultrasound), the editors select from a vast pool of reviewers to help score the merits of each article. The top reasons most articles are rejected are because they do not substantially add to the literature, they have a flawed study design, or the manuscript has translation issues. Of course, we also reject more articles than we would like because of academic misconduct or plagiarism. I would be remiss if I did not thank the hundreds of individuals who reviewed at least 1 article for JUM last year. While finding reviewers does tend to consume a significant amount of time, we did have some standouts last year. I am proud that 36 individuals reviewed at least 10 articles, 5 reviewed at least 20 articles, and Dr Giovanna Ferraioli reviewed an incredible 60 articles! In 2020, the Advisory Editorial Board completed 34% of all reviews with an average review time of just 9 days. JUM does not succeed without a strong Board, and as you can see, we are in good hands. As mentioned earlier, JUM is truly an international journal, with readership and authorship from across the globe. JUM received at least 10 article submissions from people in each of nearly 20 countries, with writers and researchers from 4 countries submitting at least 100 articles. A little more than one-fifth (20.4%) of all submissions came from the United States. The fact that JUM is global is also shown in the number of digital downloads. From around the world, readers and researchers downloaded 2.5 million articles from the JUM—a 39% increase over 2019. This increase in downloads and readership has also affected other metrics, including the impact factor, which increased to 1.759. In addition, JUM's h-index jumped to 31. This means 31 articles from the JUM were cited at least 31 times. In 2019, that number was 18. Other key metrics also saw improvement in 2020. The time to first decision dropped to 15 days, and the time from acceptance to online publication hit a record low of just 30 days. Just a few years ago, that took 216 days. I want to personally thank those who have made the journal flourish over the last few years, including the Deputy Editors, subspecialty editors, advisory editorial board members, the CME test writers and reviewers, the editorial staff, the peer review management staff, and the production staff. There is one person I want to single out: Bruce Totaro. Most of you do not know Bruce, but I can tell you he is one of the best technical editors on the planet. At the end of last year, after 20 years of working on the JUM, Bruce retired. While we certainly wish him the best of luck, he will be desperately missed. Thank you, Bruce. As you can see, it was an exciting year for JUM, and it took many people to make that happen. As we venture into 2021, there is even more on the horizon, including more focus on Early View articles, new virtual issues, enhancements to the JUM app (that you can find in the Apple App and Google Play stores), and more focused education. I look forward to an even bigger brighter future for JUM with your continued support.

Art of publication: A beginner's guide to understanding the non-linear dynamics between research and publication

Unlike the mainstream academic curriculum, research orientation is not part of the hospital-based medicine syllabus. At present, there is a dearth of training in research for young scholars starting their careers as junior residents for obtaining a postgraduate degree in any discipline of medicine. These individuals often experience helplessness as untrained researchers. It is evident that the current academic system, especially in developing countries, is not going to evolve in the near future or offer appropriate training in research methodology and publication. Therefore, the last resort is to go through a self-learning module on how to conduct research and publish articles. This article is designed as a self-help module for those interested in research and publication, particularly in the field of oncology. Why do researchers publish articles? The most appropriate reason would be that they have discovered some new science/philosophy and would like the world to know about it. A less altruistic and rather materialistic reason is to get higher academic degrees, such as Doctor of Philosophy (PhD) and Doctor of Medicine (MD). For a young researcher who aspires to have a good publication record, it is indispensable to know the methodology of publishing an article. Discovering new science although a prerequisite may not be sufficient for the publication of an article. The hurdles associated with a good publication include a flawed study design and inappropriate methodology, lack of clarity and reproducibility, and most importantly, difficulty in translating research into a publication.[1] Therefore, the art of publishing is not proportional to the significance of the invention; the dynamics are typically non-linear. A search on Google Scholar with the search strings, “how to write a scientific paper” and “how to write a paper” returned about 1.8 million and 3.7 million results, respectively, making it one of the most investigated topics. There is plenty of literature in the form of articles and books which describes the technique of writing a paper. Numerous authors have already elaborately discussed how to write scientific articles and respond to critics.[1,2] Therefore, in this article, I have attempted to briefly discuss only the salient features of the technique of writing a research paper. This article provides guidelines for research beginners on how to publish scientific articles, with a detailed flowchart of the various stages of publication [Figure 1]. Although these guidelines can be applied across all the disciplines of science, technology, and medicine, they have been described in the context of oncology and its associated interdisciplinary subjects, like medical physics. Additionally, the issues faced during publication by those pursuing higher academic degrees such as MD, Master of Surgery (MS), Diplomate of National Board (DNB), and PhD in India are also discussed. Open in a separate window Figure 1: Publication flowchart

Evaluation of potential gastrointestinal carcinogenicity associated with the ingestion of asbestos.

The inhalation of asbestos, depending on the fiber type and dose, may be associated with the development of mesothelioma and other asbestos-related diseases. However, little is known about the potential adverse effects associated with the ingestion of asbestos. Evidence of asbestos fibers released from asbestos-cement pipes used in water distribution systems has led to concerns of potentially contaminated drinking water. The purpose of this study is to determine whether ingestion of asbestos fibers may lead to cancerous effects on the gastrointestinal (GI) tract. Data from animal and human studies were analyzed using a weight-of-evidence approach to evaluate the potential risk of GI cancers associated with asbestos ingestion. Seventeen human and 23 animal studies were identified and evaluated in this study. Animal studies were conducted in multiple species with inconsistent dosing protocols. Overall, animal studies reported that the asbestos fibers, irrespective of fiber type and dose, failed to produce any definitive GI carcinogenic effect. The 17 identified human epidemiological studies reported the ingestion of asbestos-contaminated water with concentrations from 1 to 71,350 million fibers per liter (MFL). A majority of the epidemiology studies reported statistically significant increases in multiple GI-specific cancers. However, these findings are confounded due to several critical study limitations including flawed study design, small sample size, selection bias, lack of individual exposure history, lack of adequate latency, and the inability to account for confounders including occupational history, diet, and smoking history. Based on our weight-of-evidence assessment, there is insufficient evidence of causality between the ingestion of asbestos and an increased incidence of GI cancers.

The extended pessary interval for care (EPIC) study: a failed randomized clinical trial

To describe study design flaws and limited outcomes of a randomized trial that intended to compare satisfaction and complication rates between patients managing their pelvic organ prolapse with a pessary at different maintenance intervals. A randomized clinical trial was conducted at two tertiary pessary clinics. After a successful fitting, patients were randomly allocated to follow-up at 3-month or 6-month intervals and followed for 12months. Symptoms, complications, and pelvic examination characteristics were recorded at each visit. At 6 and 12months, patient satisfaction with the pessary was also recorded. Sample size calculation was based on the minimal relevant difference in Pessary Satisfaction score (created for this study). With a power of 0.8 and an alpha of 0.05, the minimum number of patients required in each group was 28. We were unable to reach our sample size as most patients did not meet inclusion criteria. After 2years we were only able to recruit 20/56 patients, with 9 patients in the 3-month group and 11 patients in the 6-month group. Additionally, seven patients dropped out of the study. Overall satisfaction was high and similar between groups at 6- and 12-month follow-up visits. Pessary complications were noted in both groups but in low numbers. Pessary use is associated with high patient satisfaction and low complication rates, regardless of the follow-up interval. The recruitment failure demonstrated that a randomized trial is not feasible for this research question. Optimally, pessary follow-up should be based on patient symptoms and scheduling preference.

Human and Rodent Skeletal Muscles Express Angiotensin II Type 1 Receptors.

Abundant evidence reveals that activation of the renin-angiotensin system promotes skeletal muscle atrophy in several conditions including congestive heart failure, chronic kidney disease, and prolonged mechanical ventilation. However, controversy exists about whether circulating angiotensin II (AngII) promotes skeletal muscle atrophy by direct or indirect effects; the centerpiece of this debate is the issue of whether skeletal muscle fibers express AngII type 1 receptors (AT1Rs). While some investigators assert that skeletal muscle expresses AT1Rs, others argue that skeletal muscle fibers do not contain AT1Rs. These discordant findings in the literature are likely the result of study design flaws and additional research using a rigorous experimental approach is required to resolve this issue. We tested the hypothesis that AT1Rs are expressed in both human and rat skeletal muscle fibers. Our premise was tested using a rigorous, multi-technique experimental design. First, we established both the location and abundance of AT1Rs on human and rat skeletal muscle fibers by means of an AngII ligand-binding assay. Second, using a new and highly selective AT1R antibody, we carried out Western blotting and determined the abundance of AT1R protein within isolated single muscle fibers from humans and rats. Finally, we confirmed the presence of AT1R mRNA in isolated single muscle fibers from rats. Our results support the hypothesis that AT1Rs are present in both human and rat skeletal muscle fibers. Moreover, our experiments provide the first evidence that AT1Rs are more abundant in fast, type II muscle fibers as compared with slow, type I fibers. Together, these discoveries provide the foundation for an improved understanding of the mechanism(s) responsible for AngII-induced skeletal muscle atrophy.

Correction to: Design Flaws in Study of Mortality and Hospitalization After Post-Pancreatitis Diabetes Mellitus and Type 2 Diabetes Mellitus.

Correction to: Design Flaws in Study of Mortality and Hospitalization After Post-Pancreatitis Diabetes Mellitus and Type 2 Diabetes Mellitus.

Free vascularised medial femoral condyle periosteal flaps in recalcitrant long bone non-union: a systematic review.

In adults, treatment of recalcitrant long bone non-union is extremely challenging, with poorly vascularised and atrophic defects unresponsive to standard non-vascularised bone graft treatment. Recent studies have documented the use of free vascularised periosteal flaps to achieve union in refractory long bone fracture non-union, yet its use is not well established. This systematic review aims to assess the evidence for free vascularised periosteal flaps in recalcitrant long bone non-union. The MEDLINE®/PubMed® and Embase databases were searched for the Medical Subject Heading (MeSH) terms periosteal flap/vascularised flap/long bone/non-union/non united fracture in accordance with the PRISMA guidelines. Bibliographies were scrutinised for additional articles. Pooled data from 14 studies met the inclusions criteria, comprising 137 cases of non-union, with 117 relating to long bone non-union. Pooled data indicated an overall 99% (116/117) successful union rate. All studies were of mid- to low-level evidence (Level III, IV and V). Only one study directly compared vascularised periosteal flaps to non-vascularised bone grafts, showing union rates of 100% versus 80% and faster time to union (2 versus 5.5months). Free vascularised periosteal flaps are promising with pooled data showing a 99% success rate in achieving union in refractory long bone non-union. This compares favourably with standard orthopaedic care consisting of revision fixation and non-vascularised bone graft union rates of approximately 80%. However, study design flaws should be addressed by validated outcome measures plus adequate blinding, and further comparative studies with greater patient numbers are required.

Current Resources for Evidence-Based Practice, January/February 2020.

Current Resources for Evidence-Based Practice, January/February 2020.

Detection of tissue factor in platelets: why is it so troublesome?

Tissue factor (TF) is the most important trigger for the extrinsic coagulation pathway. TF, earlier denoted as thromboplastin, has always been a mystery since its discovery due to its abundant presence in most human tissues but not blood. The latter has been extensively studied in a vast quest for possible sources of blood-borne TF yielding many conflicting findings and confusing conclusions regarding the presence of TF mRNA, protein or functional procoagulant activity in virtually all blood cells. Platelets, in particular, have been heavily scrutinized by investigators eager to demonstrate expression of TF. However, some investigators including our own groups have not found evidence for TF in platelets. This article discusses notable reports and possible reasons for erroneous detection of platelet TF antigen and activity including artificially hyper-stimulated platelets, suboptimal purity of cell preparations, flaws in study design and/or choice of reagents.

Graphical Depiction of Longitudinal Study Designs in Health Care Databases.

Pharmacoepidemiologic and pharmacoeconomic analysis of health care databases has become a vital source of evidence to support health care decision making and efficient management of health care organizations. However, decision makers often consider studies done in nonrandomized health care databases more difficult to review than randomized trials because many design choices need to be considered. This is perceived as an important barrier to decision making about the effectiveness and safety of medical products. Design flaws in longitudinal database studies are avoidable but can be unintentionally obscured in the convoluted prose of methods sections, which often lack specificity. We propose a simple framework of graphical representation that visualizes study design implementations in a comprehensive, unambiguous, and intuitive way; contains a level of detail that enables reproduction of key study design variables; and uses standardized structure and terminology to simplify review and communication to a broad audience of decision makers. Visualization of design details will make database studies more reproducible, quicker to review, and easier to communicate to a broad audience of decision makers.

Manual Acupuncture for Optic Atrophy: A Systematic Review and Meta-Analysis.

Objectives. This systematic review aims to critically evaluate the efficacy of manual acupuncture for optic atrophy. Eight English and Chinese databases, including Cochrane Library, EMbase, PubMed, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal Database (VIP), and Chinese Biomedical Literature Database (CBM), as well as ongoing trials registered with the WHO International Clinical Trials Registry Platform, were searched to identify eligible randomized controlled trials (RCTs) studying manual acupuncture for optic atrophy compared to medication alone. The quality of evidence was assessed using Cochrane Collaboration's risk of bias tool. Meta-analysis was performed using Review Manager version 5.3. Nine studies were identified and included for meta-analysis. The meta-analysis showed significant differences in favor of manual acupuncture or manual acupuncture plus medication compared with medication alone in the following outcome measures: visual acuity (MD = 0.18, 95% CI [0.17, 0.20], P < 0.00001), mean sensitivity of visual field (MD = 2.11, 95% CI [1.90, 2.32], P < 0.00001), the latent period of P-VEP100 (MD = -6.80, 95% CI [-8.94, -4.66], P < 0.00001), the total effectiveness (264 eyes) (OR = 3.22, 95% CI [1.88, 5.51], P<0.0001), and the total effectiveness (344 participants) (OR = 4.29, 95% CI [2.56, 7.19], P < 0.00001). Despite statistical advantages of manual acupuncture in the literature, due to serious methodological flaws in study design, it cannot be concluded that manual acupuncture is more effective than medicine alone. It is essential that a properly controlled clinical trial is designed and controls are established to exclude placebo effects.

The Efficacy and Safety of Vertebral Augmentation: A Second ASBMR Task Force Report

Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40-70%. © 2018 American Society for Bone and Mineral Research.

Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV)

IntroductionChemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and...

Reasons for Manuscript Rejection After Peer Review From the Journal Headache.

To identify and characterize the reasons manuscripts are rejected after peer review from the journal Headache. Numerous editorials, reviews, and research manuscripts have been published on the topic of manuscript rejection. However, few of these papers evaluate the reasons for rejection after peer review systematically. None are specific to the field of neurology or headache medicine. A retrospective analysis of all submissions to Headache from January 1, 2014 through December 31, 2016 was performed. Peer reviewer and editor comments for each manuscript were reviewed, and unlimited reasons for rejection were coded for each manuscript. Detailed reasons for rejection were then grouped into 9 broader categories. A total of 784 submissions were received from January 1, 2014 through December 31, 2016. Of those, 336 were immediately rejected and 434 went on to peer review. During this period, the overall rejection rate was 62.6% and the rejection rate after peer review was 35.7%. The 6 most common reasons for rejection after peer review were: flaws in methodology and study design, poor reporting of methodology, poor statistical analysis, overstatement of conclusions, problems with covariates or outcomes, and problems with the control or case group. Flaws in methodology and study design were the most common reasons for rejection after peer review from Headache between 2014-2016.