Standards for preclinical research and publications in developmental anaesthetic neurotoxicity: expert opinion statement from the SmartTots preclinical working group.
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ABSTRACT:
SUBMITTER: Chinn GA
PROVIDER: S-EPMC7424895 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundReporting guidelines for different study designs are currently available to report studies with accuracy and transparency. There is a need to develop supplementary guideline items that are specific to areas within Pediatric Dentistry. This study aims to develop Reporting stAndards for research in PedIatric Dentistry (RAPID) guidelines using a pre-defined expert consensus-based Delphi process.MethodsThe development of the RAPID guidelines was based on the Guidance for Developers of Health Research Reporting Guidelines. Following a comprehensive search of the literature, the Executive Group identified ten themes in Pediatric Dentistry and compiled a draft checklist of items under each theme. The themes were categorized as: General, Oral Medicine, Pathology and Radiology, Children with Special Health Care Needs, Sedation and Hospital Dentistry, Behavior Guidance, Dental Caries, Preventive and Restorative Dentistry, Pulp Therapy, Traumatology, and Interceptive Orthodontics. A RAPID Delphi Group (RDG) was formed comprising of 69 members from 15 countries across six continents. Items were scored using a 9-point rating Likert scale. Items achieving a score of seven and above, marked by at least 70% of RDG members were accepted into the RAPID checklist items. Weighted mean scores were calculated for each item. Statistical significance was set at p < 0.05 and one-way ANOVA was used to calculate the difference in the weighted mean scores between the themes.ResultsThe final RAPID checklist comprised of 128 items that were finalized and approved by the RDG members in the online consensus meeting. The percentage for high scores (scores 7 to 9) ranged from 69.57 to 100% for individual items. The overall weighted mean score of the final items ranged from 7.51 to 8.28 (out of 9) and the difference was statistically significant between the themes (p < 0.05).ConclusionsThe RAPID statement provides guidance to researchers, authors, reviewers and editors, to ensure that all elements relevant to particular studies are adequately reported.
| S-EPMC8299173 | biostudies-literature
Project description:An American Hepato-Pancreato-Biliary Association (AHPBA)-sponsored consensus meeting of expert panellists met on 15 January 2014 to review current evidence on the management of intrahepatic cholangiocarcinoma (ICC) in order to establish practice guidelines and to agree on consensus statements. The treatment of ICC requires a coordinated, multidisciplinary approach to optimize survival. Biopsy is not necessary if the surgeon suspects ICC and is planning curative resection, although biopsy should be obtained before systemic or locoregional therapies are initiated. Assessment of resectability is best accomplished using cross-sectional imaging [computed tomography (CT) or magnetic resonance imaging (MRI)], but the role of positron emission tomography (PET) is unclear. Resectability in ICC is defined by the ability to completely remove the disease while leaving an adequate liver remnant. Extrahepatic disease, multiple bilobar or multicentric tumours, and lymph node metastases beyond the primary echelon are contraindications to resection. Regional lymphadenectomy should be considered a standard part of surgical therapy. In patients with high-risk features, the routine use of diagnostic laparoscopy is recommended. The preoperative diagnosis of combined hepatocellular carcinoma and cholangiocarcinoma (cHCC-CC) by imaging studies is extremely difficult. Surgical resection remains the mainstay of treatment, but survival is worse than in HCC alone. There are no adequately powered, randomized Phase III trials that can provide definitive recommendations for adjuvant therapy for ICC. Patients with high-risk features (lymphovascular invasion, multicentricity or satellitosis, large tumours) should be encouraged to enrol in clinical trials and to consider adjuvant therapy. Cisplatin plus gemcitabine represents the standard-of-care, front-line systemic therapy for metastatic ICC. Genomic analyses of biliary cancers support the development of targeted therapeutic interventions.
| S-EPMC4527852 | biostudies-literature
Project description:AimInfection after anterior cruciate ligament (ACL) reconstruction, though rare, is a potentially devastating complication and the evidence-based recommendation on the various topics in its management is limited. The purpose of this study was to develop recommendations for the prevention and management of infections in ACL reconstruction surgery by performing a structured expert consensus survey using Delphi methodology.Materials and methods22 topics of relevance in the prevention and management of infection following ACL reconstruction were chosen from an extensive literature review. 30 panelists were requested to respond to a three-round survey, with feedback, to develop a consensus statement on the topics.ResultsConsensus statements could be prepared in eleven out of twenty-two topics including: the graft is retained at the first arthroscopic debridement, the graft is removed when repeated debridement are needed, and revision ACL reconstruction is needed only if the patient develops instability. Concurrence could be obtained in the topics including: longer duration of antibiotics is needed in immunocompromised patients, soaking graft in antibiotic solution reduces infection risk, and knee swelling without warmth does not suggest infection.ConclusionsA proper skin preparation, a longer course of antibiotics in immunocompromised patients, and soaking the graft in antibiotics reduces the risk of infection. In case of infection, a healthy-looking graft must be retained at the first debridement and if the graft must be removed, revision ACL reconstruction is advised only if the patient develops instability.Supplementary informationThe online version contains supplementary material available at 10.1007/s43465-021-00363-z.
| S-EPMC8046894 | biostudies-literature
Project description:Innovation in agriculture is pervasive. However, in spite of the success stories of twentieth century plant breeding, the twenty-first century has ushered in a set of challenges that solutions from the past century are unlikely to address. However, sustained research and the amalgamation of a number of disciplines has resulted in new breeding techniques (NBTs), such as genome editing, which offer the promise of new opportunities to resolve some of the issues. Here we present the results of an expert survey on the added potential benefits of genome-edited crops compared to those developed through genetic modification (GM) and conventional breeding. Overall, survey results reveal a consensus among experts on the enhanced agronomic performance and product quality of genome-edited crops over alternatives. The majority of experts indicated that the regulations for health and safety, followed by export markets, consumers, and the media play a major role in determining where and how NBTs, including genome editing, will be developed and used in agriculture. Further research is needed to gauge expert opinion after the Court of Justice of the European Union ruling establishing that site-specific mutagenic breeding technologies are to be regulated in the same fashion as GM crops, regardless of whether foreign DNA is present in the final variety.
| S-EPMC6440930 | biostudies-literature
Project description:Osteoarthritis (OA) is a leading cause of disability among older adults worldwide. Treatment aims are to alleviate inflammatory pain and improve physical function through non-pharmacological and pharmacological interventions. Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line therapy. However, selection is challenged by patient age, comorbidities and polypharmacy, and by the drug's benefit/risk balance, all of which together influence the risk of cardiovascular (CV), gastrointestinal (GI) and renal adverse events (AEs). While the efficacy profile of the various NSAIDs is delineated, the differences in their safety profile are not straightforward. This narrative review provides practical indications by a multidisciplinary Italian expert panel for general practitioners and specialists managing OA patients with chronic inflammatory pain; the goal is to maximize therapy efficacy while reducing untoward effects caused by inappropriate NSAID use. The discussion on the best approach to NSAIDs spanned the following topics: (1) patient evaluation: investigate pain origin, duration and components together with possible risk factors for CV, GI and renal AEs; (2) non-pharmacological interventions: the physiatrist provides a person-centered, holistic approach accounting for all patient aspects; (3) pharmacological interventions: patient profile and drugs' pharmacological properties affect NSAID selection, which drugs to be used in combination or to be avoided, formulation and therapy duration; (4) the pharmacologist's, general practitioner's and pain therapist's points of view; (5) NSAID safety: the individual baseline risk and the drug's safety profile are major determinants of CV, GI and renal risk; consider possible drug-drug interactions; (6) periodical re-evaluation of treatment response and adherence, using scales to assess pain and function.
| S-EPMC8586433 | biostudies-literature
Project description:Implementation studies are often poorly reported and indexed, reducing their potential to inform initiatives to improve healthcare services. The Standards for Reporting Implementation Studies (StaRI) initiative aimed to develop guidelines for transparent and accurate reporting of implementation studies. Informed by the findings of a systematic review and a consensus-building e-Delphi exercise, an international working group of implementation science experts discussed and agreed the StaRI Checklist comprising 27 items. It prompts researchers to describe both the implementation strategy (techniques used to promote implementation of an underused evidence-based intervention) and the effectiveness of the intervention that was being implemented. An accompanying Explanation and Elaboration document (published in BMJ Open, doi:10.1136/bmjopen-2016-013318) details each of the items, explains the rationale, and provides examples of good reporting practice. Adoption of StaRI will improve the reporting of implementation studies, potentially facilitating translation of research into practice and improving the health of individuals and populations.
| S-EPMC5421438 | biostudies-literature
Project description:The interdisciplinary group of experts has compiled a clinical guidance for manifest dabigatran-induced haemorrhage and envisaged invasive interventions on patients under dabigatran. It recommends an escalation of treatment measures as summarized in a pocket guide (see electronic supplementary material online and insert in the print issue).
| S-EPMC3838590 | biostudies-literature
Project description:This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.
| S-EPMC6097873 | biostudies-other
Project description:BackgroundThe aim of this study was to report on key informant opinions of Councils on Chiropractic Education (CCE) regarding recent research findings reporting on improving accreditation standards and processes for chiropractic programs (CPs).MethodsThis qualitative study employed in-depth semi-structured interviews with key experienced personnel from the five CCEs in June and July of 2018. The interviews consisted of open-ended questions on a range of issues surrounding accreditation, graduate competency standards and processes. All interviews were audio-recorded, and transcribed verbatim. The transcripts were analysed to develop codes and themes using thematic analysis techniques assisted by NVivo coding software. The study followed the COREQ guidelines for qualitative studies.ResultsSix themes were isolated from the interview transcripts; they were: professional differences; keep it in the family; to focus on outcomes or be prescriptive?; more resources please; inter-profession integration; and CPs making ends meet. Most respondents saw a need for CCEs standards and processes to improve interdisciplinarity while at the same time preserving the 'uniqueness' of chiropractic. Additionally, informants viewed CCEs as carrying out their functions with limited resources while simultaneously dealing with vocal disparate interest groups. Diverse views were observed on how CCEs should go about their business of assessing chiropractic programs for accreditation and re-accreditation.ConclusionsAn overarching confounder for positive changes in CCE accreditation standards and processes is the inability to clearly define basic and fundamental terms such as 'chiropractic' and its resultant scope of practice. This is said to be because of vocal, diverse and disparate interest groups within the chiropractic profession. Silence or nebulous definitions negotiated in order to allow a diversity of chiropractic practice to co-exist, appears to have complicated and hindered the activities of CCEs. Recommendations are made including an adoption of an evidence-based approach to accreditation standards and processes and the use of expertise from other health professions. Further, the focus of attention should be moved away from professional interests and toward that of protection of the public and the patient.
| S-EPMC6740036 | biostudies-literature
Project description:OBJECTIVE:An expert panel convened to reach a consensus on common misconceptions surrounding buprenorphine, a Schedule III partial µ-opioid receptor agonist indicated for chronic pain. The panel also provided clinical recommendations on the appropriate use of buprenorphine and conversion strategies for switching to buprenorphine from a full µ-opioid receptor agonist for chronic pain management. METHODS:The consensus panel met on March 25, 2019, to discuss relevant literature and provide recommendations on interpreting buprenorphine as a partial µ-opioid receptor agonist, prescribing buprenorphine before some Schedule II, III, or IV options, perioperative/trauma management of patients taking buprenorphine, and converting patients from a full µ-opioid receptor agonist to buprenorphine. RESULTS:The panel recommended that buprenorphine's classification as a partial µ-opioid receptor agonist not be clinically translated to mean partial analgesic efficacy. The panel also recommended that buprenorphine be considered before some Schedule II, III, or IV opioids in patients with a favorable risk/benefit profile on the basis of metabolic factors, abuse potential, and tolerability and that buprenorphine be continued during the perioperative/trauma period. In addition, switching patients from a full µ-opioid receptor agonist to buprenorphine should be considered with no weaning period at starting doses that are based on the previous opioid dose. CONCLUSIONS:These recommendations provide a framework for clinicians to address most clinical scenarios regarding buprenorphine use. The overall consensus of the panel was that buprenorphine is a unique Schedule III opioid with favorable pharmacologic properties and a safety profile that may be desirable for chronic pain management.
| S-EPMC7139205 | biostudies-literature