Characterizing Canadian Social Workers Willing to Be Involved in Medical Assistance in Dying for Persons Lacking Decisional Capacity.

Medical assistance in dying (MAID) is available in Canada for competent persons meeting the legal requirements. Extending access to persons lacking decisional capacity is being considered. Social workers may be called upon to accompany these persons through the MAID process. As part of a larger survey, we asked social workers from Quebec whether they would be willing to be involved should advance requests for MAID be legalized. Of the 367 respondents, 291 replied that they would. Using multivariable logistic regression, we identified characteristics that distinguish them from the other social workers surveyed: importance of religious or spiritual beliefs, being born in Canada, having received assisted-death requests from families, professional experiences with MAID, and dreading the prospect of participating in MAID for persons lacking decisional capacity. These findings underline the need for educational interventions that would increase social workers' confidence in providing high-quality care to clients who opt for MAID.

Real-world treatment patterns and diagnosis of charcot foot in franco-belgian diabetic foot expert centers (The EPiChar Study).

AIM: To evaluate the real-life diagnosis and therapeutic means of Charcot Neuroosteoarthropathy (CN) in French-Belgian diabetic foot expert centers. METHODS: We collected clinical characteristics, results of exams and therapeutic pathways of consecutive adult patients with diabetic osteoarthropathy seen in consultation or hospitalization from January 1 to December 31, 2019 in 31 diabetic foot expert centers. The primary outcome was to describe the diagnostic and management methods for CN according to patient clinical characteristics, the clinical-radiological characteristics of acute and chronic CN and discharge means. RESULTS: 467 patients were included: 364 with chronic CN and 103 in the acute phase. 101 patients had bilateral chronic CN. Most patients were male (73.4%), treated with insulin (73.3%), and with multicomplicated diabetes. In the acute phase, edema and increased foot temperature were present in 75% and 58.3% of cases, respectively. Diagnosis confirmation was usually by MRI and the mode of discharge was variable. In the chronic phase, orthopedic shoes were prescribed in 81.5% of cases. CONCLUSIONS: This observational study highlights the diagnostic and therapeutic practices in 31 diabetic foot centers. Our results highlight that the use of MRI and the modalities of offloading, an essential treatment in the acute phase, need to be better standardized. Centers were highly encouraging about creating a patient registry.

Social workers' experiences with medical assistance in dying: Survey findings from Quebec, Canada.

As part of a larger survey, we asked social workers whether they had been involved in medical assistance in dying (MAID) so far. Of the 367 survey participants, 141 reported that they had. These were invited to describe their roles, needs, and sense of competence, focusing on their last MAID experience. Roles were diversified, beginning before and extending beyond the provision of MAID. Nearly 60% needed training on MAID. Perceived competence was lower among those lacking training. Findings point to educational needs that must be addressed to ensure the quality of end-of-life care and the well-being of social workers who engage in MAID.

Trends in the relation between hyperglycemia correction and active Charcot neuroarthropathy: results from the EPICHAR study.

INTRODUCTION: The pathophysiology of Charcot neuroarthropathy (CN) remains unclear. There are a number of hypotheses but these are not exclusive. In its clinical presentation, this complication intersects with the semiology of diabetic-induced neuropathy, such as peripheral hypervascularization and the appearance of arteriovenous shunt. The EPICHAR study is as yet an unpublished cohort of people living with diabetes complicated by CN (in active or chronic phase). Based on the findings of the EPICHAR study, this study aimed to investigate whether a reduction in the rate of hyperglycemia accompanies the onset of an active phase of CN. RESEARCH DESIGN AND METHODS: Hemoglobin A1c (HbA1c) levels were assessed 3 months (M3) and 6 months (M6) before the diagnosis of active CN (M0). RESULTS: 103 patients living with diabetes and presenting active CN were included between January and December 2019 from the 31 centers participating in this study (30 in France and 1 in Belgium). The mean age of the participants was 60.2±12.2 years; the vast majority were men (71.8%) living with type 2 diabetes (75.5%). Mean HbA1c levels significantly declined between M6 (median 7.70; Q1, Q3: 7.00, 8.55) and M3 (median 7.65; Q1, Q3: 6.90, 8.50) (p=0.012), as well as between M6 and M0 (median 7.40; Q1, Q3: 6.50, 8.50) (p=0.014). No significant difference was found between M3 and M0 (p=0.072). CONCLUSIONS: A significant reduction in HbA1c levels seems to accompany the onset of the active phase of CN. TRIAL REGISTRATION NUMBER: NCM03744039.

Social Workers' Attitudes Toward Medical Assistance in Dying for Persons With Dementia: Findings From a Survey Conducted in Quebec, Canada.

Canada has legalized medical assistance in dying (MAID) for mentally competent persons who satisfy the legal requirements. Debate is ongoing as to whether MAID should be accessible to no-longer-competent persons through an advance request. We conducted an anonymous vignette-based survey among 367 social workers from Quebec to (1) elicit their attitudes toward MAID in the context of dementia; (2) assess their underlying values and beliefs; and (3) compare their attitudes to those of nurses (n = 291) and physicians (n = 136). Acceptability of MAID among social workers ranges from 42% in the case where the person depicted in the vignette was still competent to request MAID herself, to 92% in that where she was incompetent, had requested MAID in writing before losing capacity, showed signs of severe distress, and was close to death. Acceptability tends to be higher among social workers than among nurses and physicians. Forty-one per cent of social workers dread the prospect of participating in the MAID process for a person lacking decisional capacity. Nonetheless, 83% would agree to be involved. Should MAID become accessible to persons lacking decisional capacity, social workers willing to be involved will need to be educated and trained in participating in this emotionally-charged process.

Feasibility of Percutaneous Bone Biopsy as Part of the Management of Diabetic Foot Osteomyelitis in a 100% Neuropathic, Grade 3 IDSA/IWGDF Population on an Outpatient Basis.

The present study aimed to evaluate the feasibility of percutaneous bone biopsy in an ambulatory setting as part of the management of diabetic foot osteomyelitis (DFO) on an outpatient basis. DFO may complicate some cases of apparently nonsevere foot infections in patients with diabetes and greatly increase the risk of a lower extremity amputation. It has been suggested that bone culture-based antibiotic therapy is a predictive factor of success in patients with diabetes treated nonsurgically for osteomyelitis of the foot. It is recommended to identify the causative microorganism(s) by the means of either a surgical or percutaneous bone biopsy taken appropriately to select the proper antibiotic therapy. Percutaneous bone biopsy in patients not requiring surgery is, however, not performed in everyday practice as it should be according to the current recommendations. In the present retrospective study, we report a series of 23 consecutive patients with a suspicion of DFO in whom 28 bone samples were collected by percutaneous biopsy at the bedside in an outpatient setting. The percentage of positive cultures was in accordance with that reported in the literature. The mean number of isolates per specimen was 1.04. After a mean 12-month follow-up, the remission was almost of 78%. No adverse event related to the bone biopsy was noted. After a 1-year follow-up, no recurrence was recorded among the patients in remission. The results of the present study suggest that bedside percutaneous bone biopsy performed in the ambulatory setting is a valuable and safe tool in the management of DFO on an outpatient basis.

[A contact nurse coordinator for obese teenagers in the day hospital]. / Une infirmière référente pour l'adolescent obèse en hôpital de jour.

The putting in place of a cross-disciplinary therapeutic education programme for teenagers with obesity requires coordination between all those concerned: patients, parents and caregivers. Specially trained, the contact nurse coordinators put in place the shared educational assessment, evaluate the levers and the obstacles to providing the necessary support, and lead the care project with the teenager and his or her parents.

Decreasing rates of major lower-extremity amputation in people with diabetes but not in those without: a nationwide study in Belgium.

AIMS/HYPOTHESIS: The reduction of major lower-extremity amputations (LEAs) is one of the main goals in diabetes care. Our aim was to estimate annual LEA rates in individuals with and without diabetes in Belgium, and corresponding time trends. METHODS: Data for 2009-2013 were provided by the Belgian national health insurance funds, covering more than 99% of the Belgian population (about 11 million people). We estimated the age-sex standardised annual amputation rate (first per year) in the populations with and without diabetes for major and minor LEAs, and the corresponding relative risks. To test for time trends, Poisson regression models were fitted. RESULTS: A total of 5438 individuals (52.1% with diabetes) underwent a major LEA, 2884 people with above- and 3070 with below-the-knee major amputations. A significant decline in the major amputation rate was observed in people with diabetes (2009: 42.3; 2013: 29.9 per 100,000 person-years, 8% annual reduction, p < 0.001), which was particularly evident for major amputations above the knee. The annual major amputation rate remained stable in individuals without diabetes (2009: 6.1 per 100,000 person-years; 2013: 6.0 per 100,000 person-years, p = 0.324) and thus the relative risk reduced from 6.9 to 5.0 (p < 0.001). A significant but weaker decrease was observed for minor amputation in individuals with and without diabetes (5% and 3% annual reduction, respectively, p < 0.001). CONCLUSIONS/INTERPRETATION: In this nationwide study, the risk of undergoing a major LEA in Belgium gradually declined for individuals with diabetes between 2009 and 2013. However, continued efforts should be made to further reduce the number of unnecessary amputations.

Use of GBT013, a Collagen-Based Dressing, for the Healing of Diabetic Foot Ulcers.

The number of people with diabetes is expected to reach 592 million in the year 2035. Diabetic foot lesions are responsible for more hospitalizations than any other complication of diabetes. The aims of this study were to examine for the first time a new biocompatible and biodegradable tridimensional collagen-based matrix, GBT013, in humans for diabetic foot ulcer wound healing and to evaluate its ease of use to better define a protocol for a future clinical trial. Seven adult patients with a diabetic foot ulcer of grade 1A to 3D (University of Texas Diabetic Wound Classification) were treated using GBT013, a new collagen-based advance dressing and were monitored in two specialized foot care units for a maximum of 9 weeks. Five of seven wounds achieved complete healing in 4 to 7 weeks. Nonhealed ulcers showed a significant reduction of the wound surface (>44%). GBT013 was well tolerated and displayed positive wound healing outcomes as a new treatment strategy of chronic foot ulcers in diabetic patients.

Selling conscience short: a response to Schuklenk and Smalling on conscientious objections by medical professionals.

In a thought-provoking paper, Schuklenk and Smalling argue that no right to conscientious objection should be granted to medical professionals. First, they hold that it is impossible to assess either the truth of conscience-based claims or the sincerity of the objectors. Second, even a fettered right to conscientious refusal inevitably has adverse effects on the rights of patients. We argue that the main problem with their position is that it is not derived from a broader reflection on the meaning and implications of freedom of conscience and reasonable accommodation. We point out that they collapse two related but distinct questions, that is, the subjective conception of freedom of conscience and the sincerity test. We note that they do not successfully show that the standard norm according to which exemption claims should not impose undue hardship on others is unworkable. We suggest that the main reason why arguments such as no one is forced to be a medical professional are flawed is that public norms should not constrain citizens to choose between two of their basic rights unless it is necessary. In fine, Schuklenk and Smalling, who see conscience claims as arbitrary dislikes, sell freedom of conscience short and forego any attempts at balancing the competing rights involved. We maintain the authors neglect that most of legal reasoning is contextual and that the blanket restriction of healthcare professionals' freedom of conscience is disproportionate.

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for Large molecules bioanalysis using LBA and Immunogenicity. Part 1 (Small molecules bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input) were published in the Bioanalysis issues 6(22) and 6(23), respectively.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' input) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the upcoming issues of Bioanalysis.

Recommendations on incurred sample stability (ISS) by GCC.

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.

Choosing the appropriate matrix to perform a scientifically meaningful lipemic plasma test in bioanalytical method validation.

Laurence Mayrand-Provencher has obtained a Master of Science in Chemistry from Université de Montréal. With over 3 years of experience as a scientist in the bioanalysis industry, he is now a scientist in method development at Algorithme Pharma. His experiences have led him to conduct robust and effective method development of bioanalytical assays, specifically in the LC-MS/MS field. Many regulatory agencies include in their guidelines the need to investigate the effect of lipemic plasma on the reliability of the data as part of a bioanalytical assay validation. Lipids can cause matrix effect, specificity and recovery issues, which can potentially lead to inaccurate data if left unaccounted for. However, finding the appropriate matrix type to be used to perform a lipemic plasma test is a major challenge, as the differences between those commercially available are not well known. The work reported herein describes the differences in lipid content between normal plasma, synthetic lipemic plasma mixes, and two types of natural lipemic plasma. The results obtained show that natural plasma with high triglycerides content should be used to perform a scientifically meaningful lipemic plasma test.

Implementation of a quality improvement initiative in Belgian diabetic foot clinics: feasibility and initial results.

BACKGROUND: This article aims to describe the implementation and initial results of an audit-feedback quality improvement initiative in Belgian diabetic foot clinics. METHODS: Using self-developed software and questionnaires, diabetic foot clinics collected data in 2005, 2008 and 2011, covering characteristics, history and ulcer severity, management and outcome of the first 52 patients presenting with a Wagner grade ≥ 2 diabetic foot ulcer or acute neuropathic osteoarthropathy that year. Quality improvement was encouraged by meetings and by anonymous benchmarking of diabetic foot clinics. RESULTS: The first audit-feedback cycle was a pilot study. Subsequent audits, with a modified methodology, had increasing rates of participation and data completeness. Over 85% of diabetic foot clinics participated and 3372 unique patients were sampled between 2005 and 2011 (3312 with a diabetic foot ulcer and 111 with acute neuropathic osteoarthropathy). Median age was 70 years, median diabetes duration was 14 years and 64% were men. Of all diabetic foot ulcers, 51% were plantar and 29% were both ischaemic and deeply infected. Ulcer healing rate at 6 months significantly increased from 49% to 54% between 2008 and 2011. Management of diabetic foot ulcers varied between diabetic foot clinics: 88% of plantar mid-foot ulcers were off-loaded (P10-P90: 64-100%), and 42% of ischaemic limbs were revascularized (P10-P90: 22-69%) in 2011. CONCLUSIONS: A unique, nationwide quality improvement initiative was established among diabetic foot clinics, covering ulcer healing, lower limb amputation and many other aspects of diabetic foot care. Data completeness increased, thanks in part to questionnaire revision. Benchmarking remains challenging, given the many possible indicators and limited sample size. The optimized questionnaire allows future quality of care monitoring in diabetic foot clinics.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.