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Prevention and management of foot problems in diabetes: A Summary guidance for Daily Practice 2015, based on the IWGDF guidance documents

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DIABETES RESEARCH AND CLINICAL PRACTICE 2017年 124卷 84-92页

作者： Schaper, N. C. Van Netten, J. J. Apelqvist, J. Lipsky, B. A. Bakker, K. CARIM MUMC Div Endocrinol Maastricht Netherlands Almelo Ziekenhuisgroep Twente Dept Surg Hengelo Netherlands Malmo Univ Hosp Dept Endocrinol Malmo Sweden Univ Hosp Geneva Geneva Switzerland Fac Med Geneva Switzerland Univ Oxford Div Med Sci Oxford England IWGDF Heemsteedse Dreef 90 NL-2102 KN Heemstede Netherlands

Foot problems complicating diabetes are a source of major patient suffering and societal costs. To prevent, or at least reduce, the adverse effects of foot problems in diabetes, the International Working Group on the Diabetic Foot (IWGDF;www. iwgdf. org) was founded in 1996, consisting of experts from almost all the disciplines involved in the care of patients with diabetes and foot problems. An important output of the IWGDF is the international consensus guidance, continuously updated since 1999. To date, the publications have been translated into 26 languages, and more than 100,000 copies have been distributed globally. The "Summary guidance for Daily Practice" summarises the essentials of prevention and management of foot problems in persons with diabetes for clinicians who work with these patients on a daily basis. This guidance is the result of a long and careful process that started with the empaneling in 2013 of five working groups consisting of 49 international experts. These experts performed seven targeted systematic reviews to provide the evidence supporting the five chapters of the IWGDF guidance on prevention;footwear and offloading;diagnosis, prognosis and management of peripheral artery disease;diagnosis and management of foot infections;interventions to enhance healing. In total almost 80,000 studies were detected by our literature review. After review of the title and abstract the reviewers of the different working groups selected only studies that fulfilled a minimal set of quality criteria and ended up with 429 articles for complete quality analysis. The GRADE system was used to translate the evidence from the studies into recommendations for daily clinical practice. The rating of each recommendation takes into account both the strength and the quality of the evidence. The IWGDF guidance 2015 makes a total of 77 recommendations on prevention and management of foot problems in diabetes. These recommendations were condensed by the editorial board in

关键词： Diabetic foot Guidelines guidance IWGDF Daily Practice Implementation

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Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance

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TRIALS 2018年第1期19卷 653-653页

作者： Miles, Lisa M. Elbourne, Diana Farmer, Andrew Gulliford, Martin Locock, Louise McCambridge, Jim Sutton, Stephen French, David P. Univ Manchester Manchester Ctr Hlth Psychol Oxford Rd Manchester Lancs England London Sch Hyg & Trop Med Dept Med Stat Keppel St London England Univ Oxford Nuffield Dept Primary Care Hlth Sci Oxford England Kings Coll London Sch Populat Hlth & Environm Sci London England Univ Aberdeen Hlth Serv Res Unit Aberdeen Scotland Univ York Dept Hlth Sci York N Yorkshire England Univ Cambridge Dept Publ Hlth & Primary Care Cambridge England

Background: There is now clear systematic review evidence that measurement can affect the people being measured;much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs. Methods: The MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity;(2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health. Discussion: Our ambition is to produce MRC guidance on measurement reactions in trials which will be used by future t

关键词： Measurement Reactivity Measurement reactions guidance Trials Bias Hawthorne effect

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"What do I do with all these shells?" Basic guidance for the recovery, processing and retention of archaeological marine shells

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QUATERNARY INTERNATIONAL 2017年第PartA期427卷 13-20页

作者： Campbell, Greg Naive Chemist 150 Essex Rd Southsea PO4 8DJ Hants England

Marine shells can be common on archaeological sites (even forming sites), and provide large amounts of information about the human past if recovered appropriately. However, guidance for appropriate recovery remains unformulated or not explicitly formulated, leading to too many, too few, and too biased assemblages being excavated, extracted, processed and archived. guidance is derived for minimum and maximum sample sizes, field sampling methods and deposit priorities, extracting shells from the matrix, and accepting and retaining shells in archive. (C) 2015 Elsevier Ltd and INQUA. All rights reserved.

关键词： Archaeological marine shells guidance Recovery Sampling Archiving

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Combined Partial Penectomy With Bilateral Robotic Inguinal Lymphadenectomy Using Near-infrared Fluorescence guidance

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UROLOGY 2018年第1期113卷 251-251页

作者： Savio, Luis Felipe Barboza, Marcelo Panizzutti Alameddine, Mahmoud Ahdoot, Michael Alonzo, David Ritch, Chad R. Univ Miami Miller Sch Med Dept Urol Miami FL 33136 USA

Objective To describe our novel technique for performing a combined partial penectomy and bilateral robotic inguinal lymphadenectomy using intraoperative near-infrared (NIR) fluorescence guidance with indocyanine green (ICG) and the DaVinci Firefly camera *** A 58-year-old man presented status post recent excisional biopsy of a 2-cm lesion on the left coronal aspect of the glans penis. Pathology revealed “invasive squamous cell carcinoma of the penis with multifocal positive margins.” His examination was suspicious for cT2 primary and his inguinal nodes were cN0. He was counseled to undergo partial penectomy with possible combined vs staged bilateral robotic inguinal lymphadenectomy. Preoperative computed tomography scan was negative for pathologic lymphadenopathy. Before incision, 5 mL of ICG was injected subcutaneously beneath the tumor. Bilateral thigh pockets were then developed simultaneously and a right, then left robotic modified inguinal lymphadenectomy was performed using NIR fluorescence guidance via the DaVinci Firefly camera. A partial penectomy was then performed in the standard *** The combined procedure was performed successfully without complication. Total operative time was 379 minutes and total robotic console time was 95 minutes for the right and 58 minutes to the left. Estimated blood loss on the right and left were 15 and 25 mL, respectively. A total of 24 lymph nodes were *** This video demonstrates a safe and feasible approach for combined partial penectomy and bilateral inguinal lymphadenectomy with NIR guidance using ICG and the DaVinci Firefly camera system. The combined robotic approach has minimal morbidity and avoids the need for a staged procedure. Furthermore, use of NIR guidance with ICG during robotic inguinal lymphadenectomy is feasible and may help identify sentinel lymph nodes and improve the quality of dissection. Further studies are needed to confirm the utility of NIR guidance for robotic

关键词： penis carcinoma amputation of penis Lampyridae Epidermoid Carcinoma of Penis guidance Lymph Node Dissection inguinal lymphadenectomy

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Effects of visual and auditory guidance on bimanual coordination complexity

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HUMAN MOVEMENT SCIENCE 2017年 54卷 13-23页

作者： Vaz, Daniela V. Kay, Bruce A. Turvey, Michael T. Univ Fed Minas Gerais Ave Pres Antonio Carlos 6627 BR-31270901 Belo Horizonte MG Brazil Univ Connecticut Dept Psychol 406 Babbidge RdUnit 1020 Storrs CT 06269 USA

Perceptual guidance of movement with simple visual or temporal information can facilitate performance of difficult coordination patterns. guidance may override coordination constraints that usually limit stability of bimanual coordination to only in-phase and anti phase. Movement dynamics, however, might not have the same characteristics with and without perceptual guidance. Do visual and auditory guidance produce qualitatively different dynamical organization of movement? An anti-phase wrist flexion and extension coordination task was performed under no specific perceptual guidance, under temporal guidance with a metronome, and under visual guidance with a Lissajous plot. For the time series of amplitudes, periods and relative phases, temporal correlations were measured with Detrended Fluctuation Analysis and complexity levels were measured with multiscale entropy. Temporal correlations of amplitudes and relative phases deviated from the typical 1/f variation towards more random variation under visual guidance. The same was observed for the series of periods under temporal guidance. Complexity levels for all time series were lower in visual guidance, but higher for periods under temporal guidance. Perceptual simplification of the task's goal may produce enhancement of performance, but it is accompanied by changes in the details of movement organization that may be relevant to explain dependence and poor retention after practice under guidance. (C) 2017 Elsevier B.V. All rights reserved.

关键词： guidance Lissajous Bimanual coordination Complexity

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Public consultation changes guidance on the use of health-care interventions. An observational study

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HEALTH EXPECTATIONS 2017年第2期20卷 361-368页

作者： Campbell, Bruce Tabiri-Essuman, Jeffrey Gallo, Helen Verdiel, Vassilia Mandava, Lakshmi Azhar, Mohamed Ansaf Powell, John Natl Inst Hlth & Care Excellence Intervent Procedures Advisory Comm London England Royal Devon & Exeter Hosp Exeter Devon England Natl Inst Hlth & Care Excellence Ctr Hlth Technol Evaluat London England Sandwell Metropolitan Borough Council Publ Hlth Oldbury England Univ Oxford Hlth Experiences Res Grp Nuffield Dept Primary Care Hlth Sci Oxford England

Objectives To investigate the responses to public consultation on draft guidance on interventional procedures (IP) for the UK National Health Services, and the changes made as a result of consultation. Design Retrospective review of responses received during public consultation for 183 pieces of draft guidance, and subsequent changes made. Setting The National Institute for Health and Care Excellence in the UK. guidance produced December 2009-December 2014. Main outcome measures Numbers (%) of public consultations receiving responses, and resulting changes made to draft guidance. Results Responses were received during 159 (86.9%) periods of public consultation, from a total of 853 people or organizations (median number per consultation 3;range 0-82;interquartile range 1-5). Changes were made to draft guidance following 136 (74.3%) consultations. These changes were to the category (2.7%) or wording (8.7%) of the main recommendation;to other recommendations (about consent, patient selection, training and future research) (31.1%);and to other sections of guidance (description of the procedure and of the evidence on its efficacy and safety) (70.5%). Additional published evidence was proffered for 22.4%. Health-care professionals or their specialist societies were the most frequent responders to consultation (68.8%), patients or patient organizations accounted for 22.4% and medical device companies accounted for 8.8%. Conclusions This study shows substantial engagement with public consultation and frequent changes made to draft guidance as a result. These findings are likely to be relevant to other areas of health-care and national policymaking that seek to be responsive to their stakeholders.

关键词： guidance health policy public consultation

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Choosing the target difference ('effect size') for a randomised controlled trial - DELTA² guidance protocol

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TRIALS 2017年第1期18卷 1-7页

作者： Cook, Jonathan A. Julious, Steven A. Sones, William Rothwell, Joanne C. Ramsay, Craig R. Hampson, Lisa V. Emsley, Richard Walters, Stephen J. Hewitt, Catherine Bland, Martin Fergusson, Dean A. Berlin, Jesse A. Altman, Doug Vale, Luke D. Univ Oxford Nuffield Orthopaed Ctr Nuffield Dept Orthopaed Rheumatol & Musculoskelet Ctr Stat MedBotnar Res Ctr Windmill Rd Oxford OX3 7LD England Univ Sheffield Med Stat Grp Sch Hlth & Related Res ScHARR 30 Regent St Sheffield S1 4DA S Yorkshire England Univ Aberdeen Hlth Serv Res Unit Hlth Sci BldgForesterhill Aberdeen AB25 2ZD Scotland Univ Lancaster Dept Math & Stat Lancaster LA1 4YF England AstraZeneca Adv Analyt Ctr Stat Innovat Grp Riverside BldgGranta Pk Cambridge CB21 6GH England Univ Manchester Sch Hlth Sci Ctr Biostat Jean McFarlane BldgOxford Rd Manchester M13 9PL Lancs England Univ York Dept Hlth Sci Seebohm Rowntree Bldg York YO10 5DD N Yorkshire England Ottawa Hosp Res Inst Clin Epidemiol Program 501 Smyth Rd Ottawa ON K1H 8L6 Canada Johnson & Johnson 1125 Trenton Harbourton RdMS TE3-15POB 200 Titusville NJ 08560 USA Newcastle Univ Inst Hlth & Soc Baddiley Clark BldgRichardson Rd Newcastle Upon Tyne NE2 4AX Tyne & Wear England

Background: A key step in the design of a randomised controlled trial (RCT) is the estimation of the number of participants needed. By far the most common approach is to specify a target difference and then estimate the corresponding sample size;this sample size is chosen to provide reassurance that the trial will have high statistical power to detect such a difference between the randomised groups (at the planned statistical significance level). The sample size has many implications for the conduct of the study, as well as carrying scientific and ethical aspects to its choice. Despite the critical role of the target difference for the primary outcome in the design of an RCT, the manner in which it is determined has received little attention. This article reports the protocol of the Difference ELicitation in TriAls (DELTA(2)) project, which will produce guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for RCTs. Methods/design: The DELTA(2) project has five components: systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2);a Delphi study (stage 3);a 2-day consensus meeting bringing together researchers, funders and patient representatives, as well as one-off engagement sessions at relevant stakeholder meetings (stage 4);and the preparation and dissemination of a guidance document (stage 5). Discussion: Specification of the target difference for the primary outcome is a key component of the design of an RCT. There is a need for better guidance for researchers and funders regarding specification and reporting of this aspect of trial design. The aim of this project is to produce consensus based guidance for researchers and funders.

关键词： Target difference Clinically important difference Sample size guidance Randomised controlled trial Pilot study Effect size

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Gametophytic Pollen Tube guidance: Attractant Peptides, Gametic Controls, and Receptors

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PLANT PHYSIOLOGY 2017年第1期173卷 112-121页

作者： Higashiyama, Tetsuya Yang, Wei-cai Nagoya Univ Inst Transformat Biomol Chikusa Ku Furo Cho Nagoya Aichi 4648601 Japan Nagoya Univ Grad Sch Sci Div Biol Sci Chikusa Ku Furo Cho Nagoya Aichi 4648602 Japan Nagoya Univ JST ERATO Higashiyama Live Holon Project Chikusa Ku Furo Cho Nagoya Aichi 4648602 Japan Chinese Acad Sci Inst Genet & Dev Biol State Key Lab Mol Dev Biol Beijing 100101 Peoples R China

Pollen tube guidance in flowering plants is a unique and critical process for successful sexual reproduction. The pollen tube that grows from pollen, which is the male gametophyte, precisely navigates to the embryo sac, which is the female gametophyte, within the pistil. Recent advances have clarified the molecular framework of gametophytic pollen tube guidance. Multiple species- specific attractant peptides are secreted from synergid cells, the proper development and function of which are regulated by female gametes. Multiple receptor-like kinases on the pollen tube tip are involved in sensing species-specific attractant peptides. In this Update article, recent progress in our understanding of the mechanism of gametophytic pollen tube guidance is reviewed, including attraction by synergid cells, control of pollen tube guidance by female gametes, and directional growth of the pollen tube by directional cue sensing. Future directions in the study of pollen tube guidance also are discussed.

关键词： Pollen Tube Ovum guidance embryo sac Female Gametophytes flowering plant

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Effect of US Food and Drug Administration's Cardiovascular Safety guidance on Diabetes Drug Development

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2017年第2期102卷 290-296页

作者： Hwang, T. J. Franklin, J. M. Kesselheim, A. S. Brigham & Womens Hosp Dept Med Div Pharmacoepidemiol & Pharmacoecon Program Regulat Therapeut & Law PORTAL 75 Francis St Boston MA 02115 USA Harvard Med Sch Boston MA 02115 USA

In 2008, the US Food and Drug Administration (FDA) issued guidance on the need for cardiovascular outcome trials to assess the safety of new diabetes medications. Using two large commercial databases, we evaluated the effect of the FDA's cardiovascular safety guidance on drug development for type 2 diabetes as well as a comparison group of drugs intended to treat other alimentary andmetabolic conditions. The FDA's guidance was associated with a 31% differential decrease in the rate of diabetes drugs entering phase II trials, but the remaining drugs were significantly more likely to target novel biological pathways (72% of drugs had novel mechanisms after the guidance vs. 49% before the guidance). No differential changes were observed for phase I and phase III trials. There was no measurable improvement during the study period in glycemic efficacy among investigational products entering phase III trials. This research highlights how regulatory actions can impact pharmaceutical innovation.

关键词： Clinical Trials, Phase III as Topic Trials United States drug development Pharmaceutical Preparations guidance Cardiovascular System experimentation Diabetes Mellitus

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Magnetic anchor guidance for endoscopic submucosal dissection and other endoscopic procedures

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World Journal of Gastroenterology 2017年第16期23卷 2883-2890页

作者： Mohamed Mortagy Neal Mehta Mansour A Parsi Seiichiro Abe Tyler Stevens John J Vargo Yutaka Saito Amit Bhatt Department of Internal Medicine Homer Stryker MD School of MedicineWestern Michigan UniversityKalamazooMI 49008United States Department of Internal Medicine Medicine InstituteCleveland ClinicClevelandOH 44195United States Department of Gastroenterology and Hepatology Digestive Disease InstituteCleveland ClinicClevelandOH 44195United States Endoscopy Division National Cancer Center HospitalTokyo 104-0045Japan

Endoscopic submucosal dissection(ESD) is a wellestablished, minimally invasive treatment for superficial neoplasms of the gastrointestinal tract. The universal adoption of ESD has been limited by its slow learning curve, long procedure times, and high risk of complications. One technical challenge is the lack of a second hand that can provide traction, as in conventional surgery. Reliable tissue retraction that exposes the submucosal plane of dissection would allow for safer and more efficient dissection. Magnetic anchor guided endoscopic submucosal dissection(MAGESD) has potential benefits compared to other current traction methods. MAG-ESD offers dynamic tissue retraction independent of the endoscope mimicking a surgeon's "second hand". Two types of magnets can be used: electromagnets and permanent magnets. In this article we review the MAG-ESD technology, published work and studies of magnets in ESD. We also review the use of magnetic anchor guidance systems in natural orifice transluminal endoscopic surgery and the idea of magnetic non-contact retraction using surface ferromagentization. We discuss the current limitations, the future potential of MAG-ESD and the developments needed for adoption of this technology.

关键词： Endoscopic submucosal dissection Gastric cancer Magnetic anchor guidance Esophageal cancer Magnets Traction Natural orifice transluminal endoscopic surgery

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