Expert Panel Recommendations Research Articles

The role of acute in-patient rehabilitation on short-term outcomes after liver transplantation: A systematic review of the literature and expert panel recommendations.

The indication and surgical complexity of orthotopic liver transplantation underscore the need for strategies to optimize the recovery for transplant recipients. We conducted a systematic review aimed at identifying, evaluating, and synthesizing the evidence examining the effect of in-patient rehabilitation for liver transplant recipients and provide related practice recommendations. Health research databases were systematically reviewed for studies that included adults who received liver transplantation and participated in acute, post-transplant rehabilitation. Postoperative morbidity, mortality, length of hospital stay, length of intensive care unit stay, and other markers of surgical recovery were extracted. Practice recommendations are provided by an international panel using GRADE. Twelve studies were included in the review (including 3901 participants). Rehabilitation interventions varied widely in design and composition; however, details regarding intervention delivery were poorly described in general. The quality of evidence was rated as very low largely owing to "very serious" imprecision, poor reporting, and limited data from comparative studies. Overall, the studies suggest that in-patient rehabilitation for recipients of liver transplantation is safe, tolerable, and feasible, and may benefit functional outcomes. Two practice recommendations related to in-patient rehabilitation following LT were yielded from this review: (1) it is safe, tolerable, and feasible; and (2) it improves postoperative functional outcomes. Each of the recommendations are weak and supported by low quality of evidence. No recommendation could be made related to benefits or harms for clinical, physiological, and other outcomes. Adequately powered and high quality randomized controlled trials are urgently needed in this area.

A Framework for Introducing Global Health Innovations to the US.

Background:Across the globe, there are successful health innovations that could help improve public health in US communities at lower cost and with higher effectiveness than standard practice. However, which factors should be considered to heighten the likelihood of successful transfer of global health ideas to the US still warrants more empirical investigation.Objective:This study aimed to develop a conceptual framework delineating important factors to be considered for successful introduction of global health innovations to US communities, based on diffusion of innovations literature and case studies of global health innovations that have been adopted in US communities.Methods:Five global health innovations adopted in US communities were selected based on expert panel recommendations and a review of academic and gray literatures. These innovations had diverse origins (Columbia, Mexico, South Africa, Sweden, and Wales) and exhibited various means of achieving desired health outcomes. We conducted archival research and 27 interviews (42 interviewees) with leaders and stakeholders of the five innovations to identify important factors for the transfer of global health innovations to the US.Findings:Six factors were determined to be important for global health innovation adoption in the US: (1) innovation attributes, (2) linking agents, (3) inter-organizational partnerships, (4) scale up strategies, (5) implementation processes and outcomes in US communities, and (6) policy and social context. These factors correspond well to factors emphasized in the diffusion of innovation literature, although the importance of some sub-factors (e.g., stigma regarding the origin of innovations) diverged from the literature.Conclusions:Based on our findings, we developed the Designing for Diffusion Framework for Global Health Innovations. The framework provides a comprehensive picture of factors that can be facilitators or hindrances for moving a global health innovation to the US to help smooth the diffusion process for better adoption and implementation in US communities.

Organ donation by Maastricht-III pediatric patients: Recommendations of the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP) and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française (ADARPEF) Part I: Ethical considerations and family care

The French Transplant Health Authority (Agence de la Biomédecine) has broadened its organ- and tissue-donation criteria to include pediatric patients whose death is defined by circulatory criteria and after the planned withdrawal of life-sustaining therapies (WLST) (Maastricht category III). A panel of pediatric experts convened to translate data in the international literature into recommendations for organ and tissue donation in this patient subgroup. The panel estimated that, among children aged 5 years or over with severe irreversible neurological injury (due to primary neurological injury or post-anoxic brain injury) and no progression to brain death, the number of potential donors, although small, deserves attention. The experts emphasized the importance of adhering strictly to the collegial procedure for deciding to withdraw life support. Once this decision is made, the available data should be used to evaluate whether the patient might be a potential donor, before suggesting organ donation to the parents. This suggestion should be reserved for parents who have unequivocally manifested their acceptance of WLST. The discussion with the parents should include both the pediatric intensive care unit (PICU) team under the responsibility of a senior physician and the hospital organ- and tissue-procurement team. All recommendations about family care during the end of life of a child in the PICU must be followed. The course and potential challenges of organ donation in Maastricht-III pediatric patients must be anticipated. The panel of experts recommended strict compliance with French recommendations (by the Groupe Francophone de Réanimation et Urgences Pédiatriques) about WLST and providing deep and continuous sedation until circulatory arrest. The experts identified the PICU as the best place to implement life-support discontinuation and emphasized the importance of returning the body to the PICU after organ donation. French law prohibits the transfer of these patients from one hospital to another. A description of the expert-panel recommendations regarding the organization and techniques appropriate for children who die after controlled circulatory arrest (Maastricht III) is published simultaneously in the current issue of this journal..

Development of the National Institute for Occupational Safety and Health Worker Well-Being Questionnaire.

This article describes development of the National Institute for Occupational Safety and Health (NIOSH) Worker Well-Being Questionnaire (WellBQ). The NIOSH WellBQ was developed through literature reviews and expert panel recommendations. We drew from a representative sample of the civilian, noninstitutionalized, US working population to pilot the questionnaire. Psychometric analyses were performed on data from 975 respondents to finalize items and optimize the NIOSH WellBQ's psychometric properties. The final questionnaire consists of 16 scales, 5 indices, and 31 single items across 5 domains: (1) work evaluation and experience; (2) workplace policies and culture; (3) workplace physical environment and safety climate; (4) health status; and (5) home, community, and society (experiences and activities outside of work). The instrument demonstrated adequate reliability and validity. The NIOSH WellBQ is a reliable and valid instrument that comprehensively measures worker well-being.

Recommendations for outcome measurement for deprescribing intervention studies.

Interpreting results from deprescribing interventions to generate actionable evidence is challenging owing to inconsistent and heterogeneous outcome definitions between studies. We sought to characterize deprescribing intervention outcomes and recommend approaches to measure outcomes for future studies. A scoping literature review focused on deprescribing interventions for polypharmacy and informed a series of expert panel discussions and recommendations. Twelve experts in deprescribing research, policy, and clinical practice interventions participating in the Measures Workgroup of the US Deprescribing Research Network sought to characterize deprescribing outcomes and recommend approaches to measure outcomes for future studies. The scoping review identified 125 papers reflecting 107 deprescribing studies. Common outcomes included medication discontinuation, medication appropriateness, and a broad range of clinical outcomes potentially resulting from medication reduction. Panel recommendations included clearly defining clinically meaningful medication outcomes (e.g., number of chronic medications, dose reductions), ensuring adequate sample size and follow-up time to capture clinical outcomes resulting from medication discontinuation (e.g., quality of life [QOL]), and selecting appropriate and feasible data sources. A new conceptual model illustrates how downstream clinical outcomes (e.g., reduction in falls) should be interpreted in the context of initial changes in medication measures (e.g., reduction in mean total medications). Areas needing further development include implementation outcomes specific to deprescribing interventions and measures of adverse drug withdrawal events. Generating evidence to guide deprescribing is essential to address patient, caregiver, and clinician concerns about the benefits and harms of medication discontinuation. This article provides recommendations and an initial conceptual framework for selecting and applying appropriate intervention outcomes to support deprescribing research.

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations.

Bleeding in spine surgery is a common occurrence but when bleeding is uncontrolled the consequences can be severe due to the potential for spinal cord compression and damage to the central nervous system. There are many factors that influence bleeding during spine surgery including patient factors and those related to the type of surgery and the surgical approach to bleeding. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Hemostatic agents are available in a variety of forms and materials and with considerable variation in cost, but specific evidence to support their use in spine surgery is sparse. A literature review was conducted to identify the pre-, peri-, and postsurgical considerations around bleeding in spine surgery. The review generated a set of recommendations that were discussed and ratified by a wider expert group of spine surgeons. The results are intended to provide a practical guide to the selection of hemostats for specific bleeding situations that may be encountered in spine surgery.

Meta-Analyses of Glyphosate and Non-Hodgkin's Lymphoma: Expert Panel Conclusions and Recommendations

An expert panel was assembled to support a review of a series of recent publications using a modified Delphi format. These publications were scored based on a consideration of confidence in their methods, results, conclusions, and applicability to risk-based decision making. Mean confidence scores for the papers reviewed ranged from 53 to 74 (maximum score = 100), and key strengths and concerns were identified. This review highlights the need for transparency in meta-analyses.

Conduction Disturbance, Pacemaker Rates, and Hospital Length of Stay Following Transcatheter Aortic Valve Implantation with the Sapien 3 Valve

BackgroundIn the absence of randomized data, an expert panel recently proposed an algorithm for conduction disturbance management in transcatheter aortic valve implantation (TAVI) recipients. However, external validations of its recommendations are limited. MethodsWe retrospectively identified 808 patients without a pre-existing pacing device who underwent transfemoral TAVI with the Sapien 3 valve at our institution in 2018-2019. Patients were grouped based on pre-existing conduction disturbance and immediate post-TAVI electrocardiogram. Timing of temporary pacemaker (TPM) removal and hospital discharge were compared with those of the expert panel recommendations to evaluate the associated risk of TPM reinsertion and permanent pacemaker (PPM) implantation. ResultsIn most group 1 patients (no electrocardiogram changes without pre-existing right bundle branch block), the timing of TPM removal and discharge were concordant with those of the expert panel recommendations, with low TPM reinsertion (0.8%) and postdischarge PPM (0.8%) rates. In the majority of group 5 patients (procedural high-degree/complete atrioventricular block), TPM was maintained, followed by PPM implantation, compatible with the expert panel recommendations. In contrast, in groups 2-4 (pre-existing/new conduction disturbances), earlier TPM removal than recommended by the expert panel (mostly, immediately after procedure) was feasible in 97.5%-100% of patients, with a low TPM reinsertion rate (0.0%-1.8%); earlier discharge was also feasible in 50.0%-65.5%, with a low 30-day postdischarge PPM rate (0.0%-2.8%) and no 30-day death. ConclusionsEarly TPM removal and discharge after TAVI appear safe and feasible in the majority of cases. These data may provide a framework for an early, streamlined hospital discharge plan for TAVI recipients, optimizing both cost savings and patient safety.

Follow-up of primary melanoma patients with high risk of recurrence: recommendations based on evidence and consensus.

In spite of the good prognosis of patients with early-stage melanoma, there is a substantial proportion of them that develop local or distant relapses. With the introduction of targeted and immune therapies for advanced melanoma, including at the adjuvant setting, early detection of recurrent melanoma and/or second primary lesions is crucial to improve clinical outcomes. However, there is a lack of universal guidelines regarding both frequency of surveillance visits and diagnostic imaging and/or laboratory evaluations. In this article, a multidisciplinary expert panel recommends, after careful review of relevant data in the field, a consensus- and experience-based follow-up strategy for melanoma patients, taking into account prognostic factors and biomarkers and the high-risk periods and patterns of recurrence in each (sub) stage of the disease. Apart from the surveillance intensity, healthcare professionals should focus on patients' education to perform regular self-examinations of the skin and palpation of lymph nodes.

Evolution of germline TP53 variant classification in children with cancer

Li-Fraumeni syndrome, caused by germline pathogenic variants in TP53, results in susceptibility to multiple cancers. Variants of uncertain significance (VUS) and reclassification of variants over time pose management concerns given improved survival with cancer surveillance for LFS patients. We describe the experience of TP53 variant reclassification at a pediatric cancer center. Methods: We reviewed medical records (2010–2019) of 756 patients seen in Texas Children's Cancer Genetics Clinic. We noted initial TP53 classification and any reclassifications. We then classified TP53 variants following ClinGen TP53 variant curation expert panel recommendations using data from ClinVar, medical literature and IARC database. Results: Of 234 patients tested for TP53, 27 (11.5%) reports contained pathogenic/likely pathogenic (P/LP) variants and 7 (3)% contained VUS. By January 2022, 4 of 6 unique VUS and 2 of 16 unique P/LP variants changed interpretations in ClinVar. Reinterpretation of these 4 VUS in ClinVar matched clinical decision at the time of initial report. Applying TP53 VCEP specifications classified 3 VUS to P/LP/benign, and one pathogenic variant to likely benign. Conclusions: Planned review of variant significance is essential, especially for patients with high probability of LFS.

117 Identifying Patient Specific Variables Influencing Decisions to Perform Fusion in Grade I Spondylolisthesis Based on Expert Panel Recommendations from SLIP II Study

INTRODUCTION: The role of fusion as an adjunct to decompression in patients with stenosis associated with spondylolisthesis remains an area of controversy. We recently reported significant variation in treatment recommendations regarding fusion from an expert panel using data from the SLIP II study. We found that this variability was due to both surgeon specific and patient specific variables METHODS: A pilot study using de-identified data from the SLIP II study was performed. Expert panel recommendations were examined and patients whose recommendations reflected a consensus for decompression alone or decompression and fusion were identified. A consensus was defined as >80% agreement among panelists. Five patients were identified where there was >80% consensus for decompression alone and ten patients were identified where there was >80% consensus for decompression and fusion. Each of these 15 cases was then carefully examined to determine which characteristics (from the clinical vignette, imaging, and other patient collected data) most consistently differed between the two cohorts. RESULTS: With regard to demographic factors, the fusion cohort was younger (60 years vs 67.2 years, p = 0.077), and had a lower health state based on EQ-5D scores (0.50 vs 0.68, p = 0.04). There was no difference in the ODI between the cohorts (37.2 vs 37, p = 0.49).With regard to imaging characteristics, we found that greater degree of spondylolisthesis (24% vs 12%, p < 0.001), greater facet angle from horizontal (54 vs 48 degrees p = 0.12), and movement on dynamic images all predicted a recommendation for fusion. CONCLUSION: In examining the subset of patients with consensus from the expert panel regarding the utility of fusion, it is apparent that younger age, lower EQ-5D, sagittally-oriented facets, mobile spondylolisthesis, and degree of anterolisthesis were all associated with recommendation for fusion. This information provides significant evidence that particular patient characteristics drive senior surgeon decision making regarding the utility of fusion as an adjunct to decompression in this patient population. This has important policy implications and may help to explain disparate results from contemporary clinical trials.

Addressing the role of edaravone in the management of amyotrophic lateral sclerosis and gaps in care and access: expert panel recommendations.

A virtual key opinion leader (KOL) and payer discussion was held on December 5, 2020. In attendance were 2 KOLs, both specialists in amyotrophic lateral sclerosis (ALS) at leading clinics in the United States, and 6 managed care executives from US regional health plans. The objective of this panel was to share opinions, ideas, and information around the treatment of ALS with edaravone, gaps in management and guidelines, and potential solutions. The panel concluded that coverage criteria for edaravone may need to be reassessed and treatment guidelines could be revisited to include a determination of place intherapy for edaravone.

American Society of Breast Surgeons' Practice Patterns for Patients at Risk and Affected by Breast Cancer-Related Lymphedema.

In 2017, the American Society of Breast Surgeons (ASBrS) published expert panel recommendations for patients at risk for breast cancer-related lymphedema (BCRL) and those affected by BCRL. This study sought to determine BCRL practice patterns. A survey was sent to 2975 ASBrS members. Questions evaluated members' clinical practice type, practice duration, and familiarity with BCRL recommendations. Descriptive statistics, the chi-square test, and Fisher's exact test were used. Of the ASBrS members surveyed, 390 (13.1%) responded. Most of the breast surgeons (58.5%, 228/390) indicated unfamiliarity with recommendations. Nearly all respondents (98.7%, 385/390) educate at-risk patients. Most (60.2%, 234/389) instruct patients to avoid venipuncture, injection or blood pressure measurements in the at-risk arm, and 35.6% (138/388) recommend prophylactic compression sleeve use during air travel. Nearly all (97.7%, 380/389) encourage those at-risk to exercise, including resistance exercise (86.2%, 331/384). Most do not perform axillary reverse mapping (ARM) (67.9%, 264/389) or a lymphatic preventive healing approach (LYMPHA) (84.9%, 331/390). Most (76.1%, 296/389) screen at-risk patients for BCRL. The most frequently used screening tools include self-reported symptoms (81%, 255/315), circumferential tape measure (54%, 170/315) and bioimpedance spectroscopy (27.3%, 86/315). After a BCRL diagnosis, most (90%, 351/390) refer management to a lymphedema-certified physical therapist. For affected patients, nearly all encourage exercise (98.7%, 384/389). Many (49%, 191/390) refer affected patients for consideration of lymphovenous bypass or lymph node transfer. Most respondents were unfamiliar with the ASBrS expert panel recommendations for patients at risk for BCRL and those affected by BCRL. Opportunities exist to increase awareness of best practices and to acquire ARM and LYMPHA technical expertise.

The landscape of systemic lupus erythematosus in Brazil: An expert panel review and recommendations.

PurposeThe objective of this review is to address the barriers limiting access to diagnosis and treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN) in Brazil, specifically for patients in the public healthcare system, arguably those with the least access to innovation.DesignA selected panel of Brazilian experts in SLE/LN were provided with a series of relevant questions to address in a multi-day conference. During the conference, responses were discussed and edited by the entire group through numerous drafts and rounds of discussion until a consensus was achieved.ResultsThe authors propose specific and realistic recommendations for implementing access to innovative diagnostic tools and treatment alternatives for SLE/LN in Brazil. Moreover, in creating these recommendations, the authors strived to address barriers and impediments for technology adoption. The multidisciplinary care required for SLE/LN necessitates the collective participation of all involved stakeholders.ConclusionA great need exists to expand the adoption of innovative diagnostic tools and treatments for SLE/LN not only in Brazil but also in most countries, as access issues remain an urgent demand. The recommendations presented in this article can serve as a strategy for new technology adoption in other countries in a similar situation.

HBV Reactivation During the Treatment of Non-Hodgkin Lymphoma and Management Strategies.

Hepatitis B virus reactivation (HBV-R), which can lead to HBV-related morbidity and mortality, is a common and well-known complication that occurs during the treatment of non-Hodgkin lymphoma (NHL) patients with current or past exposure to HBV infection. HBV-R is thought to be closely associated with chemotherapeutic or immunosuppressive therapies. However, immunosuppressive agents such as anti-CD20 antibodies (e.g., rituximab and ofatumumab), glucocorticoids, and hematopoietic stem cell transplantation (HSCT) administered to NHL patients during treatment can cause deep immunodepression and place them at high risk of HBV-R. In this review, we explore the current evidence, the guidelines of several national and international organizations, and the recommendations of expert panels relating to the definition, risk factors, screening and monitoring strategies, whether to use prophylaxis or pre-emptive therapy, and the optimal antiviral agent and duration of antiviral therapy for HBV-R.

Variant curation expert panel recommendations for RYR1 pathogenicity classifications in malignant hyperthermia susceptibility

PurposeAs a ClinGen Expert Panel (EP) we set out to adapt the American College of Medical Genetics and Genomics (ACMG)/Association for Molecular Pathology (AMP) pathogenicity criteria for classification of RYR1 variants as related to autosomal dominantly inherited malignant hyperthermia (MH). MethodsWe specified ACMG/AMP criteria for variant classification for RYR1 and MH. Proposed rules were piloted on 84 variants. We applied quantitative evidence calibration for several criteria using likelihood ratios based on the Bayesian framework. ResultsSeven ACMG/AMP criteria were adopted without changes, nine were adopted with RYR1-specific modifications, and ten were dropped. The in silico (PP3 and BP4) and hotspot criteria (PM1) were evaluated quantitatively. REVEL gave an odds ratio (OR) of 23:1 for PP3 and 14:1 for BP4 using trichotomized cutoffs of ≥0.85 (pathogenic) and ≤0.5 (benign). The PM1 hotspot criterion had an OR of 24:1. PP3 and PM1 were implemented at moderate strength. Applying the revised ACMG/AMP criteria to 44 recognized MH variants, 29 were classified as pathogenic, 13 as likely pathogenic, and 2 as variants of uncertain significance. ConclusionCuration of these variants will facilitate classification of RYR1/MH genomic testing results, which is especially important for secondary findings analyses. Our approach to quantitatively calibrating criteria is generalizable to other variant curation expert panels.

Sickle Cell Disease and the Adherence to Guidelines for Use of Blood Transfusions

▪Background:An expert panel convened by the NHLBI in 2014 provided guidelines and indications for blood transfusions in patients with sickle cell disease (SCD). These recommendations were to help conserve the use of blood transfusions in SCD in order to reduce the complications of iron overload, transmission of blood-borne pathogens and development of alloantibodies. We retrospectively reviewed the charts of SCD patients who received blood during inpatient admissions and evaluated the indications for transfusions in this population.Methods:The hospital database was screened for admissions of patients with the diagnosis of SCD (HbSS, HbSβ0, HbSβ+, HbSC) who were billed for a blood transfusion between 8/1/2015 to 8/31/2016. All patients were >18 years of age. Each chart was reviewed individually to assess the clinical setting and reasons for transfusion. The following parameters were documented: age, sex, length of hospital stay (LOS), hemoglobin (Hgb) at time of transfusion, baseline Hgb, reticulocyte count, total bilirubin, number of units transfused, documented reason for transfusion, immediate reaction to transfusion, presence of alloantibodies and ferritin level. We defined the infusion of blood as a transfused event which included single or multiple units of blood. We excluded transfusions given for acute bleeding.Results:There were a total of 200 decisions to transfuse blood for 87 patients between 8/1/2015 to 8/31/2016. 72% of the patients had HbSS disease. HbSB0, HbSB+, HbSC, and unknown genotype constituted 14%, 19%, 6% and 7% of the cohort, respectively. Mean age was 30.6 years and 76% were female. A total of 434 units were transfused. The most common reasons for transfusion that deviated from guidelines were uncomplicated pain crises and a fall in Hgb (> 2g/dl, >1.5 g/dl) which accounted for 65.5% (n = 237 units) of the transfusion events (Pain 27%, Hgb drop > 2 gm 20.5% and Hgb drop > 1.5 gm 17.5%). The most common indicated guideline reasons for transfusion were symptomatic anemia and acute chest syndrome and only accounted for 12.5% and 10%, respectively of transfusions in this cohort. The mean Hgb at which patients were transfused was 6.6 g/dl, with a median value of 6.5 g/dl. The mean Hgb of those transfused for drop in hemoglobin and symptomatic anemia were 5.9 g/dl and 5.7 g/dl, respectively. The mean level of ferritin in this cohort was 2483. 15/87(17%) of patients had allo-antibodies. There was a 2% occurrence of immediate allergic blood transfusion reaction. The average LOS for all patients was 9.0 days. The average LOS for patient who received blood for uncomplicated pain or drop in Hgb was 8.9 days.Conclusion:In this group of patients with SCD, the majority of the inpatient transfusions were not indicated by national guidelines. Only 34.5% of transfusion events met expert panel recommendations. There was significant iron overload and development of allo-antibodies noted in our cohort. It is possible that there was a lack of documentation of symptoms due to anemia in those who received blood for a drop in hemoglobin. Regardless, there appears to be a significant number of unnecessary transfusions in SCD patients. We plan to develop and implement an educational program for care providers as to increase adherence to guidelines for transfusions in SCD. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Low-value medical care in the pandemic—is this what the doctor ordered?

Low-value medical care in the pandemic—is this what the doctor ordered?

Accuracy of a single-lead mobile smartphone electrocardiogram for QT interval measurement in patients undergoing maintenance methadone therapy.

Methadone is associated with QT interval prolongation and torsades de pointes. Expert panel recommendations advocate a pre-methadone electrocardiogram (ECG) and another ECG at 30 days of therapy in patients with risk factors. Some guidelines recommend a pre-methadone ECG and routine ECG monitoring in all methadone patients, but this is controversial due to the resources required. Availability of a convenient, less resource-intensive method of ECG monitoring for patients taking methadone is desirable. The objective of this study was to assess the accuracy of a handheld smartphone ECG (iECG) for QT measurement in patients on maintenance methadone therapy in an urban opioid treatment program. Prospective study. Urban opioid treatment program. n = 115 patients in normal sinus rhythm who were on steady-state maintenance methadone therapy INTERVENTION: Patients (n = 115) underwent a simultaneous 12-lead ECG and a single-lead iECG. The first three QT and RR intervals from lead II of the 12-lead ECG and simulated lead I from the iECG were compared using the Bland-Altman analysis of measurement agreement. Mean [± standard deviation) age was 34 ± 11 years; 71% were female, 75% were white. Compared to the 12-lead ECG, the iECG was associated with a QTc bias of - 0.14 ms (SD = 12 ms, 95% CI = -2.4 to 2.1 ms). The absolute mean difference in QTc between the two methods was 9.5 ± 7.1 ms. For identification of patients with methadone-associated QTc prolongation, the iECG performed moderately well [c-statistic 0.97 (95% CI 0.91-0.99); sensitivity and specificity 75% (95% CI 43-95%) and 99% (95% CI 94-99%), respectively]. The positive and negative likelihood ratios of the iECG for identifying patients with methadone-associated QTc prolongation were 77.25 (95% CI 10.69 to 558.18) and 0.25 (95% CI 0.09 to 0.67), respectively, while the positive and negative predictive values were 90% (95% CI 56-99%) and 97% (95% CI 92-99%), respectively. The accuracy of the iECG for identifying patients with QTc prolongation was 97% (95% CI 91-99%). A handheld smartphone ECG is accurate for QT interval measurement in patients taking maintenance methadone therapy, and its performance is moderately good for identifying patients with methadone-associated QTc prolongation.

Glycemic Control and Prevention of Diabetic Complications in Low- and Middle-Income Countries: An Expert Opinion.

IntroductionTrends on glycemic control and diabetes complications are known for high-income countries, but comprehensive data from low- and middle-income countries (LMIC) are lacking.MethodsThis is an expert opinion based on two retrospective studies. Here we examine the recent subset analysis of relevant data from the IDMPS Wave 7 (International Diabetes Management-Practices Study, 2015–2016) and the GOAL study conducted in multiple LMICs.ResultsWave 7 sub-analysis was performed in 6113 people with type 2 diabetes from 24 LMIC. Poorly controlled diabetes (hemogloblin A1c [HbA1c] ≥ 7%) was found in 58.6, 73.0 and 78.3% of participants with diabetes duration of < 5, 5–12 and > 12 years, respectively (in association with a high prevalence of macro- and microvascular complications). Moreover, 37.7% of participants with diabetes duration of 5–12 years were treated only with oral antihyperglycemic drugs. The GOAL study investigated the efficacy of insulin in 2704 poorly controlled participants (mean HbA1c 9.7%; diabetes duration 10.1 ± 6.7 years; 10 LMIC). A significant 2% reduction in mean HbA1c levels was observed after 12 months of treatment. Only 7.2% of participants experienced a symptomatic episode of hypoglycemia (nocturnal or severe hypoglycemia events were infrequent).ConclusionThe rate of well-controlled participants (HbA1c < 7.0%) in the Wave 7 sub-analysis was lower than that observed in the USA (NHANES survey) or in European countries (GUIDANCE study), and the incidence of microvascular complications was higher. The GOAL study showed that insulin treatment improves glycemic control and reduces this gap. The Expert Panel recommends intensifying diabetes treatment as soon as possible, as well as patients’ education and other preventive measures, initiatives which require modest costs compared to hospitalization and treatment of diabetes complications.