Search

"Spin" refers to misleading reporting, interpretation, and extrapolation of findings in primary and secondary research (such as in systematic reviews). The study of spin primarily focuses on beneficial outcomes. The objectives of this research were threefold: first, to develop a framework for identifying spin associated with harms in systematic reviews of interventions; second, to apply the framework to a set of reviews, thereby pinpointing instances where spin may be present; and finally, to revise the spin examples, offering guidance on how spin can be rectified., The authors developed their framework through an iterative process that engaged an international group of researchers specializing in spin and reporting bias. The framework comprises 12 specific types of spin for harms, grouped by 7 categories across the 3 domains (reporting, interpretation, and extrapolation). The authors subsequently gathered instances of spin from a random sample of 100 systematic reviews of interventions. Of the 58 reviews that assessed harm and the 42 that did not, they found that 28 (48%) and 6 (14%), respectively, had at least 1 of the 12 types of spin for harms. Inappropriate extrapolation of the results and conclusions for harms to populations, interventions, outcomes, or settings not assessed in a review was the most common category of spin in 17 of 100 reviews., The authors revised the examples to remove spin, taking into consideration the context (for example, medical discipline, source population), findings for harms, and methodological limitations of the original reviews. They provide guidance for authors, peer reviewers, and editors in recognizing and rectifying or (preferably) avoiding spin, ultimately enhancing the clarity and accuracy of harms reporting in systematic review publications., Competing Interests: Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M24-0771.

Objectives: Despite evidence for heightened psychiatric risk and unique parenting challenges during the COVID-19 pandemic, no research exists on the specific needs of parents of infants and responsiveness of pediatric care to their needs. We aimed to describe the support needs of new parents and explore their experiences with pediatric care., Methods: In late 2020 we conducted semi-structured interviews with 30 mothers of babies born or due that year. Interviews addressed perinatal experiences during the pandemic, with an emphasis on experiences related to social support. In an iterative, inductive process, thematic analysis was used to analyze the data., Results: This study identifies a set of support needs specific to the context of parenting an infant during the COVID-19 crisis: coping with the compound psychological impacts of the postpartum period and a pandemic; parenting in the absence of expected social support; risk assessment to keep infant and family safe. This study finds that policies implemented by health care providers to reduce risk of COVID-19 transmission came at a cost to new parents and parent-provider relationships. Participants reported mixed experiences with in-person and telehealth pediatric care, including inadequate and/or uncomfortable postpartum mental health screening and breastfeeding support, and identified specific features that constituted responsive care during the pandemic., Conclusions: Normative changes associated with the postpartum period combined with complex adaptations necessitated by the COVID-19 pandemic presented substantial challenges for families with infants, even relatively privileged families. Providers can incorporate these findings to enhance support for families and promote maternal and child health., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Honorary authorship refers to the practice of naming an individual who has made little or no contribution to a publication as an author. Honorary authorship inflates the output estimates of honorary authors and deflates the value of the work by authors who truly merit authorship. This manuscript presents the protocol for a systematic review that will assess the prevalence of five honorary authorship issues in health sciences., Methods: Surveys of authors of scientific publications in health sciences that assess prevalence estimates will be eligible. No selection criteria will be set for the time point for measuring outcomes, the setting, the language of the publication, and the publication status. Eligible manuscripts are searched from inception onwards in PubMed, Lens.org , and Dimensions.ai. Two calibrated authors will independently search, determine eligibility of manuscripts, and conduct data extraction. The quality of each review outcome for each eligible manuscript will be assessed with a 14-item checklist developed and piloted for this review. Data will be qualitatively synthesized and quantitative syntheses will be performed where feasible. Criteria for precluding quantitative syntheses were defined a priori. The pooled random effects double arcsine transformed summary event rates of five outcomes on honorary authorship issues with the pertinent 95% confidence intervals will be calculated if these criteria are met. Summary estimates will be displayed after back-transformation. Stata software (Stata Corporation, College Station, TX, USA) version 16 will be used for all statistical analyses. Statistical heterogeneity will be assessed using Tau 2 and Chi 2 tests and I 2 to quantify inconsistency., Discussion: The outcomes of the planned systematic review will give insights in the magnitude of honorary authorship in health sciences and could direct new research studies to develop and implement strategies to address this problem. However, the validity of the outcomes could be influenced by low response rates, inadequate research design, weighting issues, and recall bias in the eligible surveys., Systematic Review Registration: This protocol was registered a priori in the Open Science Framework (OSF) link: https://osf.io/5nvar/ ., (© 2022. The Author(s).)

Supportive father involvement during pregnancy can positively impact maternal and child outcomes. Father participation in prenatal care is increasing, yet little research exists to understand how mothers and fathers experience father participation in prenatal care and their preferences for father participation. We interviewed expectant first-time mothers (N = 22) and fathers (N = 20) to learn about fathers' participation in prenatal care, perceptions of providers' treatment of fathers, and preferences for father participation. Interviews were coded using principles of grounded theory. Father participation ranged from attendance at visits considered "important" (e.g., ultrasounds) to attendance at every appointment. Experiences of father participation varied, with many describing it as both an important act of support for the mother and part of assuming the role of father. Most participants saw great value in father participation in prenatal care as an opportunity for fathers to learn how to support a healthy pregnancy, bond with their developing baby, and share joy and/or worries with mothers. Participants generally felt that fathers were made to feel welcome and wanted providers to be inclusive of fathers during appointments. Results of this study suggest that father participation presents an opportunity for prenatal care providers to foster fathers' positive involvement in pregnancy, support for mothers, and preparation to parent., (© 2021 Michigan Association for Infant Mental Health.)

The COVID-19 pandemic has been characterized by an unprecedented amount of published scientific articles. The aim of this study is to assess the type of articles published during the first 3 months of the COVID-19 pandemic and to compare them with articles published during 2009 H1N1 swine influenza pandemic. Two operators independently extracted and assessed all articles on COVID-19 and on H1N1 swine influenza that had an abstract and were indexed in PubMed during the first 3 months of these pandemics. Of the 2482 articles retrieved on COVID-19, 1165 were included. Over half of them were secondary articles (590, 50.6%). Common primary articles were: human medical research (340, 59.1%), in silico studies (182, 31.7%) and in vitro studies (26, 4.5%). Of the human medical research, the vast majority were observational studies and cases series, followed by single case reports and one randomized controlled trial. Secondary articles were mainly reviews, viewpoints and editorials (373, 63.2%). Limitations were reported in 42 out of 1165 abstracts (3.6%), with 10 abstracts reporting actual methodological limitations. In a similar timeframe, there were 223 articles published on the H1N1 pandemic in 2009. During the COVID-19 pandemic there was a higher prevalence of reviews and guidance articles and a lower prevalence of in vitro and animal research studies compared with the H1N1 pandemic. In conclusions, compared to the H1N1 pandemic, the majority of early publications on COVID-19 does not provide new information, possibly diluting the original data published on this disease and consequently slowing down the development of a valid knowledge base on this disease. Also, only a negligible number of published articles reports limitations in the abstracts, hindering a rapid interpretation of their shortcomings. Researchers, peer reviewers, and editors should take action to flatten the curve of secondary articles., Competing Interests: Conflicts of interestThe authors declare no competing interests nor conflict of interests., (© Akadémiai Kiadó, Budapest, Hungary 2020.)

Objectives: The objective of the study was to assess the prevalence, the reporting quality, the need, and the consequences of contacting of authors by Cochrane reviewers to obtain additional information for their reviews., Study Design and Setting: Cross-sectional study and survey on all new Cochrane intervention reviews published between January 1, 2016 and January 31, 2017., Results: The cross-sectional study found that reviewers had contacted or had tried to contact studies to obtain additional information in 73.4% (234/319) of reviews but reported poorly on the methods, outcomes, and consequences of this procedure. Most eligible studies in the reviews were poorly reported, but few reviewers 21.2% (65/306) reported that they had contacted these studies. The survey showed that risk of bias scores, Grading of Recommendations, Assessment, Development and Evaluation scores, the summary primary or secondary outcomes, and the summary effect size of the primary outcome of the review were changed as a consequence of contacting of authors. Thirty-five of one hundred and thirty (26.9%) reviews scored opposite outcomes for the same question in the cross-sectional study compared with the survey., Conclusions: Our findings on contacting of authors by Cochrane reviewers showed relevant shortcomings in the current standards and transparency of Cochrane reviews. These shortcomings can compromise the validity and reproducibility of these reviews and affect a wide audience., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: The validity of outcomes of systematic reviews is highly dependent on the extent of bias in the included primary studies. This study reports the risk of bias (ROB) of primary studies included in systematic reviews of diagnostic accuracy., Study Design and Setting: All systematic reviews of diagnostic accuracy studies published in the Cochrane database in 2015 and 2016 that used the Quality Assessment of Diagnostic Accuracy Studies-2 ROB tool and reported results with the ROB figure were eligible. The primary outcome was the prevalence of "high" or "unclear" ROB scores for the four Quality Assessment of Diagnostic Accuracy Studies-2 domains: "patient selection," "index test," "reference standard," and "flow and timing"., Results: Of 46 eligible reviews, 35 fulfilled the inclusion criteria. A total of 1045 primary studies with 4133 bias assessments were identified. Of those, 56% (2319/4133) were assessed to be at "high" or "unclear" ROB and 44% (1814/4133) at low ROB. For all domains except "flow and timing," most outcomes were scored as "high" or "unclear" ROB. A total of 47 (47/1045; 4.5%, 3.4 to 5.9%) primary studies were scored at low ROB for all domains. Older article age was significantly associated with likelihood of "high" or "unclear" ROB (odds ratio: 1.02; 95% confidence interval: 1.01 to 1.03; P < 0.001)., Conclusion: Systematic reviews of diagnostic accuracy are based on studies with a majority of "high" or "unclear" bias assessments. The age of the articles explained only a small part of the variability of the score assessments, therefore not justifying an a priori exclusion of older articles in systematic reviews. There is an urgent need to improve the quality of design, conduct, and reporting of diagnostic accuracy studies., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Synthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned., Methods for the Cross-Sectional Study: Eligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review., Methods for the Survey: The same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations, Assessment, Development and Evaluation scores and the primary and secondary outcomes of the review., Discussion: The findings of this study could help improve methods of contacting authors and reporting of these procedures and their outcomes. Patients, clinicians, researchers, guideline developers, research sponsors, and the general public will all be beneficiaries.

Developing and conducting systematic reviews and meta-analyses is a complex process that requires many judgments and the input from a wide variety of stakeholders. This article presents an introduction on how to develop, conduct, and report these research studies. Veterinary clinicians should seek systematic reviews to address their research questions. Criteria for including meta-analyses in a systematic review are presented. However, before applying the findings of systematic reviews and meta-analyses to a particular patient, clinicians should weigh a variety of issues. The quality of the review is particularly important., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Numerous surveys have shown that orthodontic mini implants (OMIs) are underused in clinical practice. To investigate this implementation issue, we conducted a systematic review to (1) identify barriers and facilitators to the implementation of OMIs for all potential stakeholders and (2) quantify these implementation constructs, i.e., record their prevalence. We also recorded the prevalence of clinicians in the eligible studies that do not use OMIs., Methods: Methods were based on our published protocol. Broad-spectrum eligibility criteria were defined. A barrier was defined as any variable that impedes or obstructs the use of OMIs and a facilitator as any variable that eases and promotes their use. Over 30 databases including gray literature were searched until 15 January 2016. The Joanna Briggs Institute tool for studies reporting prevalence and incidence data was used to critically appraise the included studies. Outcomes were qualitatively synthesized, and meta-analyses were only conducted when pre-set criteria were fulfilled. Three reviewers conducted all research procedures independently. We also contacted authors of eligible studies to obtain additional information., Results: Three surveys fulfilled the eligibility criteria. Seventeen implementation constructs were identified in these studies and were extracted from a total of 165 patients and 1391 clinicians. Eight of the 17 constructs were scored by more than 50 % of the pertinent stakeholders. Three of these constructs overlapped between studies. Contacting of authors clarified various uncertainties but was not always successful. Limitations of the eligible studies included (1) the small number of studies; (2) not defining the research questions, i.e., the primary outcomes; (3) the research design (surveys) of the studies and the exclusive use of closed-ended questions; (4) not consulting standards for identifying implementation constructs; (5) the lack of pilot testing; (6) high heterogeneity; (7) the risk of reporting bias; and (8) additional shortcomings. Meta-analyses were not possible because of these limitations. Two eligible studies found that respectively 56.3 % (952/1691) and 40.16 % (439/1093) of clinicians do not use OMIs., Conclusions: Notwithstanding the limitations of the eligible studies, their findings were important because (1) 17 implementation constructs were identified of which 8 were scored by more than 50 % of the stakeholders; (2) the various shortcomings showed how to improve on future implementation studies; and (3) the underuse of OMIs in the selected studies and in the literature demonstrated the need to identify, quantify, and address implementation constructs. Prioritizing of future research questions on OMIs with all pertinent stakeholders is an important first step and could redirect research studies on OMIs towards implementation issues. Patients, clinicians, researchers, policymakers, insurance companies, implant companies, and research sponsors will all be beneficiaries.

Background: Most orthodontic mini-implants (OMIs) are inserted between dental roots. The prevalence of contacting these structures is high. Such contacts can cause permanent root damage and implant instability. Increased torque levels during implant insertion (the index test) could be a more accurate and immediate measure for diagnosing implant-root contact (the target condition) than radiographs (the reference standard) and could ultimately lead to a reduction or elimination of X-ray exposure. To address this issue, we asked three questions: (1) whether OMIs with root contact had higher insertion torque values than those without, (2) what is the accuracy of the index test compared with the reference standard to diagnose the target condition and what are the adverse effects of the index test, and (3) whether intermediate torque values have clinical diagnostic utility., Methods: Methods were conducted according to our published protocol, which was based on the PRISMA-P 2015 statement. We applied broad spectrum eligibility criteria that included randomized and non-randomized studies on clinical, animal, and cadaver models. Not including such models would be unethical because it could slow down knowledge creation on the adverse effects of implant insertion. We conducted searches in more than 40 electronic databases including MEDLINE and 10 journals were hand-searched. Grey literature and reference lists were also searched. All research procedures were conducted independently by three reviewers. Authors of selected studies were contacted to obtain additional information. Outcomes on the three different research models were analysed separately. Systematic error was assessed with the Cochrane 'Risk of bias tool' for non-randomized studies., Results: One clinical, two animal, and two cadaver studies fulfilled the eligibility criteria of the first research question. All studies and subgroups demonstrated higher insertion torque values for OMIs with the target condition than those without. Mean differences (MD) between these effect estimates were statistically significant in one beagle model (MD, 4.64; 95 % CI, 3.50 to 5.79) and three subgroups of cadaver studies (MD, 2.70; 95 % CI, 1.42 to 3.98) (MD, 3.97; 95 % CI, 2.17 to 5.78) (MD, 0.93; 95 % CI, 0.67 to 1.20). Highest mean differences were identified in most self-drilling compared with pre-drilling groups. Clinical heterogeneity between studies was high, and many items were underreported. All studies except one cadaver study scored at least one domain as 'serious risk' of bias. No studies addressed the second research question. One cadaver study addressed the third question which showed the importance of recording torque levels during the entire implant insertion process. Responses of contacted authors were helpful, but often difficult to obtain. Implants fractured in one animal and in one cadaver model., Conclusions: All eligible studies scored higher insertion torque values for implants with root contact than those without, but none of these studies assessed the diagnostic accuracy of the index test. The inclusion of non-randomized and animal and cadaver models in this systematic review provided key findings that otherwise would have been wasted. Such studies are important in the context of the wide applicability of this test, the high prevalence of the target condition, and the underreporting of adverse effects of interventions. A protocol for a potential new diagnostic pathway was presented, and the importance of contacting authors was addressed. The applicability of the findings should be interpreted in the context of underreporting and the many limitations of the included studies.

Background: Most orthodontic treatment plans need some form of anchorage to control the reciprocal forces of tooth movement. Orthodontic mini implants (OMIs) have been hailed for having revolutionized orthodontics, because they provide anchorage without depending on the collaboration of patients, they have a favorable effectiveness compared with conventional anchorage devices, and they can be used for a wide scale of treatment objectives. However, surveys have shown that many orthodontists never or rarely use them. To understand the rationale behind this knowledge-to-action gap, we will conduct a systematic review that will identify and quantify potential barriers and facilitators to the implementation of OMIs in clinical practice for all potential stakeholders, i.e., patients, family members, clinicians, office staff, clinic owners, policy makers, etc. The prevalence of clinicians that do not use OMIs will be our secondary outcome., Methods: The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 Statement was adopted as the framework for reporting this manuscript. We will apply broad-spectrum search strategies and will search MEDLINE and more than 40 other databases. We will conduct searches in the gray literature, screen reference lists, and hand-search 12 journals. All study designs, stakeholders, interventions, settings, and languages will be eligible. We will search studies that report on barriers or facilitators to the implementation of orthodontic mini implants (OMIs) in clinical practice. Implementation constructs and their prevalence among pertinent stakeholders will be our primary outcomes. All searching and data extraction procedures will be conducted by three experienced reviewers. We will also contact authors and investigators to obtain additional information on data items and unidentified studies. Risk of bias will be scored with tools designed for the specific study designs. We will assess heterogeneity, meta-biases, and the robustness of the overall evidence of outcomes. We will present findings in a systematic narrative synthesis and plan meta-analyses when pertinent criteria are met., Discussion: Knowledge creation on this research topic could identify and quantify both expected and unexpected implementation constructs and their stakeholders. Such knowledge can help develop strategies to address implementation issues and redirect future studies on OMIs towards knowledge translation. This could lead to improved patient-health experiences and a reduction in research waste.

The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2-58.8%) of veterinary EoI articles, against 87% (321/371; 82.5-89.7%) of human EoI articles (adjusted OR:9.2; 3.4-24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45-2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients.

Background: Hitting a dental root during the insertion of orthodontic mini-implants (OMIs) is a common adverse effect of this intervention. This condition can permanently damage these structures and can cause implant instability. Increased torque levels (index test) recorded during the insertion of OMIs may provide a more accurate and immediate diagnosis of implant-root contact (target condition) than radiographic imaging (reference standard). An accurate index test could reduce or eliminate X-ray exposure. These issues, the common use of OMIs, the high prevalence of the target condition, and because most OMIs are placed between roots warrant a systematic review. We will assess 1) the diagnostic accuracy and the adverse effects of the index test, 2) whether OMIs with root contact have higher insertion torque values than those without, and 3) whether intermediate torque values have clinical diagnostic utility., Methods: The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 statement was used as a the guideline for reporting this protocol. Inserting implants deliberately into dental roots of human participants would not be approved by ethical review boards and adverse effects of interventions are generally underreported. We will therefore apply broad spectrum eligibility criteria, which will include clinical, animal and cadaver models. Not including these models could slow down knowledge translation. Both randomized and non-randomized research studies will be included. Comparisons of interest and subgroups are pre-specified. We will conduct searches in MEDLINE and more than 40 other electronic databases. We will search the grey literature and reference lists and hand-search ten journals. All methodological procedures will be conducted by three reviewers. Study selection, data extraction and analyses, and protocols for contacting authors and resolving conflicts between reviewers are described. Designed specific risk of bias tools will be tailored to the research question. Different research models will be analysed separately. Parameters for exploring statistical heterogeneity and conducting meta-analyses are pre-specified. The quality of evidence for outcomes will be assessed through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach., Discussion: The findings of this systematic review will be useful for patients, clinicians, researchers, guideline developers, policymakers, and surgical companies.

This article systematically reviewed the literature to (1) identify variables that were associated with maximum insertion torque values during the insertion of orthodontic mini-implants into artificial bone, (2) quantify such associations and (3) assess adverse effects of this procedure. Computerized and manual searches were conducted up to 24 February 2012. Selection criteria included studies that (1) recorded maximum insertion torque during the insertion of orthodontic mini-implants into artificial bone, (2) used sample sizes of five screws or more, (3) assessed maximum insertion torque with electronic torque sensors, and (4) used orthodontic mini-implants with a diameter smaller than 2.5 mm. ASTM Standards F543-07(ε1) and F1839-08(ε1) and the Cochrane Handbook for Systematic Reviews were used as guidelines for this systematic review. Quality assessments were rated according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. A total of 23 studies were selected, many of which were multiple publications of the same study. Many domains in the risk of bias assessments were scored as "high" or "unclear" risk of bias. A wide variety of implant, test block, and insertion procedure-related associations with maximum insertion torque were recorded. The quality of most outcomes was classified as "moderate." Outcomes could not be combined in a meta-analysis because of high risk of bias, poor standardization, high heterogeneity, or inconsistency in direction of outcomes within or between studies. Adverse effects were only assessed in one study. Future studies should control publication bias, consult existing standards for conducting torque tests, and focus on transparent reporting.

Alzheimer's disease (AD) therapies are increasingly being tested in global clinical trials. A search of ClincalTrials.gov revealed that of 269 currently active trials, 28% are currently being conducted in the United States; the majority of trials and the majority of trial sites are ex-US. The US has the largest number of trial sites of any single country; cumulatively, nearly half of all sites are outside the US. The US conducts more trials in all phases of drug development but has a greater proportion of phase 3 trials. The increasing importance of global participants in clinical trials emphasizes the importance of considering the ethnic and international factors that may influence trial outcome. The International Conference on Harmonization guidelines divide ethnic factors that may affect drug development into intrinsic and extrinsic influences. These include language, cultural factors, educational levels, the general level of health and standard of care, as well as nutrition and diet. Ethnic influences on pharmacokinetics are known for some metabolic pathways. The biology of AD may also differ among the world's populations. The frequency of the apolipoprotein e4 allele, a major risk factor for AD, differs internationally. Genetic variations might also affect inflammatory, excitotoxic, and oxidative components of AD. Diagnostic standards and experience vary from country to country. Levels of practitioner training and experience, diagnostic approaches to AD, and attitudes regarding aging and AD may differ. Experience and sophistication with regard to clinical trial conduct also vary within and between countries. Experience with conducting the necessary examinations, as well as the linguistic and cultural validity of instrument translations, may affect trial outcomes. Operational and regulatory aspects of clinical trials vary and provide important barriers to seamless conduct of multiregional clinical trials. Collection and testing of biological samples, continuous provision of drug substance, and protection of the integrity of supply lines may be difficult in some international circumstances. Attention to these potential influences on clinical trials will determine the success of global drug development programs and the utility of global trials for developing new AD therapeutics.

Radiological Picture Archiving and Communication Systems (PACS) have only relatively recently become abundant. Many hospitals have made the transition to PACS about a decade ago. During that decade requirements and available technology have changed considerably. In this paper we look at factors that influence the design of tomorrow's systems, especially those in larger multidisciplinary hospitals. We discuss their impact on PACS architecture (a technological perspective) as well as their impact on radiology (a management perspective). We emphasize that many of these influencing factors originate outside radiology and that radiology has little impact on these factors. That makes it the more important for managers in radiology to be aware of architectural aspects and it may change cooperation of radiology with, among others, the hospital's central IT department., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Introduction: In this article, we systematically reviewed the literature to quantify success and complications encountered with the use of mini-implants for orthodontic anchorage, and to analyze factors associated with success or failure., Methods: Computerized and manual searches were conducted up to March 31, 2008, for clinical studies that addressed these objectives. The selection criteria required that these studies (1) reported the success rates of mini-implants on samples sizes of 10 implants or more, (2) gave a definition of success, (3) used implants with a diameter smaller than 2.5 mm, and (4) applied forces for a minimum duration of 3 months. Factors associated with implant success were accepted only if potentially influencing variables were controlled. The Cochrane Handbook for Systematic Reviews of Interventions was used as the guideline for this article., Results: Nineteen reports met the inclusion criteria, but definitions of success, duration of force application, and quality of the methodology of these studies varied widely. Rates of primary outcomes ranged from 0% to 100%, but most articles reported success rates greater than 80% if mobile and displaced implants were included as successful. Adverse effects of miniscrews included biologic damage, inflammation, and pain and discomfort. Only a few articles reported negative outcomes. All proposed correlations between clinical success and specific variables such as implant, patient, location, surgery, orthodontic, and implant-maintenance factors were rejected because they did not meet the selection criteria for controlling those variables., Conclusions: Mini-implants can be used as temporary anchorage devices, but research in this field is still in its infancy. Interpretation of findings was conditioned by lack of clarity and poor methodology of most studies. Questions concerning patient acceptability, rate and severity of adverse effects of miniscrews, and variables that influenced success remain unanswered. This article includes a guideline for future studies of these issues, based on specific definitions of primary and secondary outcomes correlated with specific operational variables.

Unlabelled: Combined embolization and surgical excision as a safe treatment for a high flow superficial upper eyelid anteriovenous malformation., Introduction: Orbital arteriovenous malformations (AVM) may cause significant morbidity including chronic pain and cosmetic disfigurement. These rare lesions require a multidisciplinary approach. A case of an orbital high-flow AVM treated subsequently by an mterventional radiologist and oculoplastic surgeon is presented., Materials and Methods: Clinical assessment, computed tomography and digital substruction angiography revealed a high-flow AVM. Transvenous and percutaneous embolization was followed by surgical excision., Results: A 1.5 cm, slowly growing, compressible pulsating lesion in the left upper eyelid of a 23 year old man was found. Eye motility and ophthalmologic examination were normal. Valsava manoeuvre didn't increase the size. Imaging revealed a high-flow AVM feeded by the arteria temporalis superficialis (itself feeded by the a. supraorbitalis and supratrochlearis). Draining vessels were the superior ophthalmic vein and a superficial lateral orbital vein. This malformation was first embolized. To prevent iatrogenic embolization of the sinus cavernous, the vein draining into the superior ophthalmic was occluded by a transvenous approach, followed by a percutaneous injection with diluted glue (equal amounts of glubran-2 and lipiodol). The remaining low-flow lesion was then safely excised., Conclusion: High-flow orbital AVM represent a considerable treatment challenge. Good cosmetical and functional outcome was obtained safely by subsequent embolization and surgical excision. When treating these rare malformations it is of the highest importance to coordinate the interdisciplinary efforts.

Of the information items that must be easily available to the different actors involved in the care process, radiological images are not the least important. While until recently it was not feasible to include these into the medical information system, this situation has changed. Still, emphasis in PACS (Picture Archiving and Communication Systems) is primarily on the technological aspects. In this paper, in contrast, we stress the importance of integration of images into the overall workflow and into the overall medical record. We do so using illustrations from the PACS project of the University Hospitals Leuven. We briefly indicate that tight integration at the user interface level is needed, and that this requires more than standardized communication between subsystems.

The orthodontist has been both accused of causing and complimented for curing temporomandibular dysfunction. To better understand the origins of these conflicting opinions, a review of the orthodontic and temporomandibular joint journals was performed for articles published since 1966. A total of 91 publications that discussed the relationship between orthodontics and temporomandibular disorders was found, and these articles were divided in three categories: viewpoint publications, case reports, and sample studies. Among the areas scrutinized in each category was the method that has led to the diversity of viewpoints. From this analysis, the following conclusions were drawn: (1) viewpoint publications and case reports were excessively represented in comparison with the number of sample studies; (2) viewpoint publications and case reports described a wide variety of conflicting opinions on the relationship between orthodontics and temporomandibular disorders; (3) unlike sample studies, viewpoint publications and case reports have little or no value in assessment of the relationship between orthodontics and temporomandibular disorders; (4) sample studies indicate that orthodontic treatment is not responsible for creating temporomandibular disorders, regardless of the orthodontic technique; and (5) sample studies indicate that orthodontic treatment is not specific or necessary to cure signs and symptoms of temporomandibular dysfunction.