Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013

Objective For patients with diabetes, regular self-monitoring of blood glucose (SMBG) is essential to ensure adequate glycemic control. Therefore, accurate and reliable blood glucose measurements with SMBG systems are necessary. The international standard ISO 15197 describes requirements for SMBG systems, such as limits within which 95% of glucose results have to fall to reach acceptable system accuracy. The 2013 version of this standard sets higher demands, especially regarding system accuracy, than the currently still valid edition. ISO 15197 can be applied by manufacturers to receive a CE mark for their system.

Research design and methods This study was an accuracy evaluation following ISO 15197:2013 section 6.3 of two recently updated SMBG systems (Contour**Contour is a registered trademark of Bayer Health Care LLC, Pittsburgh, PA, USA and Contour TS; Bayer Consumer Care AG, Basel, Switzerland) with an improved algorithm to investigate whether the systems fulfill the requirements of the new standard. For this purpose, capillary blood samples of approximately 100 participants were measured with three test strip lots of both systems and deviations from glucose values obtained with a hexokinase-based comparison method (Cobas Integra??Cobas Integra is a trademark of Roche Diagnostics Operations Inc., Indianapolis, IN, USA 400 plus; Roche Instrument Center, Rotkreuz, Switzerland) were determined. Percentages of values within the acceptance criteria of ISO 15197:2013 were calculated. This study was registered at clinicaltrials.gov (NCT02358408).

Main outcome Both updated systems fulfilled the system accuracy requirements of ISO 15197:2013 as 98.5% to 100% of the results were within the stipulated limits. Furthermore, all results were within the clinically non-critical zones A and B of the consensus error grid for type 1 diabetes.

Conclusions The technical improvement of the systems ensured compliance with ISO 15197 in the hands of healthcare professionals even in its more stringent 2013 version. Alternative presentation of system accuracy results in radar plots provides additional information with certain advantages. In addition, the surveillance error grid offers a modern tool to assess a system’s clinical performance.     

Development of a national protocol to screen Dutch cancer survivors on late cancer treatment effects

PURPOSES: The development of a national protocol to formalize the screening of Dutch cancer survivors on potential late cancer treatment effects and the medical terminology used in describing the patient follow up procedures. METHODS: A combined evidence-based and qualitative approach, the Glaser's State of the Art Strategy, was used to reach consensus on how to screen Dutch cancer survivors on late cancer treatment effects. A core working group set up a first proposal of a screening protocol and a handbook of medical term definitions by incorporating available research evidence (1980-2003), clinical expertise and definitions from Dutch medical dictionaries and textbooks. External experts reviewed this proposal in a cycle of two postal and two discussion rounds. The follow-up procedures and medical term definitions described in the draft screening protocol were to be accepted if consensus among external experts was > or =50%. RESULTS: A protocol for screening cancer survivors on late cancer treatment effects was developed describing the follow-up procedures for cancer survivors according to previous therapeutic exposures. Four hundred and twenty one medical terms were used in describing these follow-up procedures. One hundred and fifteen of these terms were classified as multi-interpretable and 101 of these terms were defined. No definitions could be found for the remaining 14 medical terms. CONCLUSIONS: We succeeded in reaching consensus throughout The Netherlands on a protocol to screen cancer survivors on late cancer treatment effects. This protocol is now in use by all Dutch outpatient clinics and warrants that the screening of cancer survivors is consistent across The Netherlands. The screening protocol specifies in detail how screening of cancer survivors should take place and can therefore be used by clinicians who were not involved in the consensus study.     

Using consensus methods in developing clinical guidelines for exercise in managing persistent low back pain

Objectives

To generate expert consensus evidence for the purpose of developing more complete guidelines for people with persistent low back pain than is possible using current research evidence alone. Gaps in research evidence lead to incomplete practice recommendations unless a scientific process can provide supplementary consensus evidence that is a basis for additional recommendations.

Design

A modified Nominal Group Technique (NGT). This followed a systematic review indicating incomplete research evidence.

Setting

UK-wide coordinated by the Chartered Society of Physiotherapy.

Participants

Twenty-three individuals selected for their expertise as clinicians, researchers, managers and patients.

Methods

Three stages: a first-round questionnaire of clinical questions unanswered by the systematic review; an electronic conference for outstanding questions unanswered by the first questionnaire; and a second-round questionnaire for these outstanding questions. All three stages were carried out electronically.

Results

Of 17 clinical questions unanswered by the systematic review, consensus evidence was generated for 14 questions by the modified NGT and this led to 14 recommendations for practice. Consensus was not reached for the remaining three questions.

Conclusions

The modified NGT was a practical and cost-effective way of generating consensus evidence from a UK-wide group. The consensus evidence was the basis of appropriately graded recommendations for effective care of people with persistent low back pain. Consensus methods have been little used in physiotherapy to date but are likely to be valuable in developing clinically useful, evidence-based tools for future practice.     

Integrated Knowledge Translation Guiding Principles for Conducting and Disseminating Spinal Cord Injury Research in Partnership

ObjectiveTo address a gap between spinal cord injury (SCI) research and practice by rigorously and systematically co-developing integrated knowledge translation (IKT) guiding principles for conducting and disseminating SCI research in partnership with research users.DesignThe process was guided by the internationally accepted The Appraisal of Guidelines for REsearch & Evaluation (AGREE) II Instrument for evaluating the development of clinical practice guidelines.SettingNorth American SCI research system (ie, SCI researchers, research users, funders).ParticipantsThe multidisciplinary expert panel (n=17) and end users (n=35) included individuals from a North American partnership of SCI researchers, research users, and funders who have expertise in research partnerships.InterventionsNot applicable.Main Outcome MeasuresClarity, usefulness, and appropriateness of the principles.ResultsData regarding 125 principles of partnered research were systematically collected from 4 sources (review of reviews, scoping review, interviews, Delphi consensus exercise). A multidisciplinary expert panel held a 2-day meeting to establish consensus, select guiding principles, and draft the guidance. The panel reached 100% consensus on the principles and guidance document. The final document includes a preamble, 8 guiding principles, and a glossary. Survey data showed that the principles and guidance document were perceived by potential end users as clear, useful, and appropriate.ConclusionsThe IKT Guiding Principles represent the first rigorously co-developed, consensus-based guidance to support meaningful SCI research partnerships. The principles are a foundational tool with the potential to improve the relevance and impact of SCI research, mitigate tokenism, and advance the science of IKT.     

解读2012年中国炎性肠病诊断与治疗共识意见中一些热点问题

炎性肠病近10多年来已逐渐成为我国消化界不可忽视的常见病．目前正面临着其发病率迅速增加而总体诊疗水平仍然落后的局面。中华医学会消化病学分会炎性肠病学组在2012年形成了最新的共识意见．本文就其中的一些热点问题进行解读。     

Secondary progressive multiple sclerosis: A national consensus paper on diagnostic criteria

BackgroundIn clinical practice, the diagnosis of secondary progressive multiple sclerosis (SPMS) is often delayed, retrospective and non-reproducible, as there are no consensus criteria that define the advent of SPMS. Early identification of SPMS is essential to improve patient care.MethodsEight regional board meetings in France involving 56 multiple sclerosis (MS) experts (neurologists) were convened to discuss diagnostic criteria for SPMS. Subsequently, a national board meeting of 13 neurologists (with an expert representing each geographical region) was held to review points of convergence or divergence between regions and to develop a national consensus document.ResultsBased on the discussions from the regional boards, the MS experts at the national board retained the worsening of the EDSS score, with compatible clinical features, as the only consensus criterion for the diagnosis of SPMS in clinical practice. The patient should have experienced during at least the previous 6 months and in the absence of any relapse, a worsening in the EDSS score of +1.0 point (if the previous EDSS was ≤ 5.0) or of +0.5 point (if the previous EDSS was ≥ 5.5), with a pyramidal or cerebellar functional system score ≥ 2 and without setting a minimum EDSS score; or, in case of a stable EDSS score ≥ 4.0, a worsening of a functional score. This worsening should be confirmed within 3 to 6 months. According to the MS experts, the patient's age, duration of illness and a minimal threshold EDSS score are only risk factors for transition to SPMS. Patient reports during consultation and cognitive impairment are important warning signs, which should trigger an objective assessment with specific tests or closer monitoring. Clinical relapse and/or MRI activities are non-discriminatory for making the diagnosis of SPMS.ConclusionsThe experts defined precise diagnostic criteria adapted to clinical practice for earlier identification of SPMS, paving the way for better management of this stage of the disease.     

Documento nacional de recomendaciones sobre el seguimiento del paciente con carcinoma de células renales

Objectives

This document was developed to establish directives for the follow-up of patients with renal cell carcinoma (RCC) based on the best available scientific evidence and on expert opinions, which can help urologists in the decision-making process and standardise the criteria at the national level.

Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases

Background

Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure.

First Surgical National Consensus Conference of the Italian Breast Surgeons association (ANISC) on breast cancer management in neoadjuvant setting: Results and summary

RationaleOn October 15th, 2020, the first Surgical National Consensus Conference on neoadjuvant chemotherapy (NACT) was promoted by the Italian Association of Breast Surgeons (ANISC).MethodThe Consensus Conference was entirely held online due to anti-Covid-19 restrictions and after an introductory four lectures held by national and international experts in the field, a total of nine questions were presented and a digital “real-time” voting system was obtained. A consensus was reached if 75% or more of all panelists agreed on a given question.ResultsA total of 202 physicians, from 76 different Italian Breast Centers homogeneously distributed throughout the Italian country, participated to the Conference. Most participants were surgeons (75%). Consensus was reached for seven out of the nine considered topics, including management of margins and lymph nodes at surgery, and there was good correspondence between the 32 “Expert Panelists” and the “Participants” to the Conference. Consensus was not achieved regarding the indications to NACT for high-grade luminal-like breast tumors, and the need to perform an axillary lymph node dissection in case of micrometastases in the sentinel lymph node after NACT.ConclusionsNACT is a topic of major interest among surgeons, and there is need to develop shared guidelines. While a Consensus was obtained for most issues presented at this Conference, controversies still exist regarding indications to NACT in luminal B-like tumors and management of lymph node micrometastases. There is need for clinical studies and analysis of large databases to improve our knowledge on this subject.