Multiple sclerosis, the measurement of disability and access to clinical trial data

Background: Inferences about long-term effects of therapies in multiple sclerosis (MS) have been based on surrogate markers studied in short-term trials. Nevertheless, MS trials have been getting steadily shorter despite the lack of a consensus definition for the most important clinical outcome - unremitting progression of disability. Methods: We have examined widely used surrogate markers of disability progression in MS within a unique database of individual patient data from the placebo arms of 31 randomised clinical trials. Findings: Definitions of treatment failure used in secondary progressive MS trials include much change unrelated to the target of unremitting disability. In relapsing-remitting MS, disability progression by treatment failure definitions was no more likely than similarly defined improvement for these disability surrogates. Existing definitions of disease progression in relapsing-remitting trials encompass random variation, measurement error and remitting relapses and appear not to measure unremitting disability. Interpretation: Clinical surrogates of unremitting disability used in relapsing -remitting trials cannot be validated. Trials have been too short and/or degrees of disability change too small to evaluate unremitting disability outcomes. Important implications for trial design and reinterpretation of existing trial results have emerged long after regulatory approval and widespread use of therapies in MS, highlighting the necessity of having primary trial data in the public domain

Wide complex tachycardia differentiation: A reappraisal of the state-of-the-art

The primary goal of the initial ECG evaluation of every wide complex tachycardia is to determine whether the tachyarrhythmia has a ventricular or supraventricular origin. The answer to this question drives immediate patient care decisions, ensuing clinical workup, and long-term management strategies. Thus, the importance of arriving at the correct diagnosis cannot be understated and has naturally spurred rigorous research, which has brought forth an ever-expanding abundance of manually applied and automated methods to differentiate wide complex tachycardias. In this review, we provide an in-depth analysis of traditional and more contemporary methods to differentiate ventricular tachycardia and supraventricular wide complex tachycardia. In doing so, we: (1) review hallmark wide complex tachycardia differentiation criteria, (2) examine the conceptual and structural design of standard wide complex tachycardia differentiation methods, (3) discuss practical limitations of manually applied ECG interpretation approaches, and (4) highlight recently formulated methods designed to differentiate ventricular tachycardia and supraventricular wide complex tachycardia automatically

Differentiating wide complex tachycardias: A historical perspective

One of the most critical and challenging skills is the distinction of wide complex tachycardias into ventricular tachycardia or supraventricular wide complex tachycardia. Prompt and accurate differentiation of wide complex tachycardias naturally influences short- and long-term management decisions and may directly affect patient outcomes. Currently, there are many useful electrocardiographic criteria and algorithms designed to distinguish ventricular tachycardia and supraventricular wide complex tachycardia accurately; however, no single approach guarantees diagnostic certainty. In this review, we offer an in-depth analysis of available methods to differentiate wide complex tachycardias by retrospectively examining its rich literature base - one that spans several decades

Vision, mission, and values: From concept to execution at Mayo Clinic

Mayo Clinic displays steadfast commitment to patient care, referral relations, and health care quality through institutional examples of unique, value-add endeavors that are under way with the Mayo Clinic Patient Experience Subcommittee and the Referring Physician Office. In this article, we share the Mayo Model of Care and patient stories that embody the 8 Mayo Clinic values of respect, compassion, integrity, healing, teamwork, excellence, innovation, and stewardship. The Mayo founders imparted to their staff the passion for patient care by encouraging a fair and just culture for its employees. This culture allows the creation, maintenance, and improvement of clinical care, research studies, and educational curricula, which in turn propagate the mission–“To inspire hope and contribute to health and well-being by providing the best care to every patient through integrated clinical practice, education, and research.

Automatic wide complex tachycardia differentiation using mathematically synthesized vectorcardiogram signals

BACKGROUND: Automated wide complex tachycardia (WCT) differentiation into ventricular tachycardia (VT) and supraventricular wide complex tachycardia (SWCT) may be accomplished using novel calculations that quantify the extent of mean electrical vector changes between the WCT and baseline electrocardiogram (ECG). At present, it is unknown whether quantifying mean electrical vector changes within three orthogonal vectorcardiogram (VCG) leads (X, Y, and Z leads) can improve automated VT and SWCT classification. METHODS: A derivation cohort of paired WCT and baseline ECGs was used to derive five logistic regression models: (i) one novel WCT differentiation model (i.e., VCG Model), (ii) three previously developed WCT differentiation models (i.e., WCT Formula, VT Prediction Model, and WCT Formula II), and (iii) one all-inclusive model (i.e., Hybrid Model). A separate validation cohort of paired WCT and baseline ECGs was used to trial and compare each model\u27s performance. RESULTS: The VCG Model, composed of WCT QRS duration, baseline QRS duration, absolute change in QRS duration, X-lead QRS amplitude change, Y-lead QRS amplitude change, and Z-lead QRS amplitude change, demonstrated effective WCT differentiation (area under the curve [AUC] 0.94) for the derivation cohort. For the validation cohort, the diagnostic performance of the VCG Model (AUC 0.94) was similar to that achieved by the WCT Formula (AUC 0.95), VT Prediction Model (AUC 0.91), WCT Formula II (AUC 0.94), and Hybrid Model (AUC 0.95). CONCLUSION: Custom calculations derived from mathematically synthesized VCG signals may be used to formulate an effective means to differentiate WCTs automatically

Computerized electrocardiogram data transformation enables effective algorithmic differentiation of wide QRS complex tachycardias

BACKGROUND: Accurate automated wide QRS complex tachycardia (WCT) differentiation into ventricular tachycardia (VT) and supraventricular wide complex tachycardia (SWCT) can be accomplished using calculations derived from computerized electrocardiogram (ECG) data of paired WCT and baseline ECGs. OBJECTIVE: Develop and trial novel WCT differentiation approaches for patients with and without a corresponding baseline ECG. METHODS: We developed and trialed WCT differentiation models comprised of novel and previously described parameters derived from WCT and baseline ECG data. In Part 1, a derivation cohort was used to evaluate five different classification models: logistic regression (LR), artificial neural network (ANN), Random Forests [RF], support vector machine (SVM), and ensemble learning (EL). In Part 2, a separate validation cohort was used to prospectively evaluate the performance of two LR models using parameters generated from the WCT ECG alone (Solo Model) and paired WCT and baseline ECGs (Paired Model). RESULTS: Of the 421 patients of the derivation cohort (Part 1), a favorable area under the receiver operating characteristic curve (AUC) by all modeling subtypes: LR (0.96), ANN (0.96), RF (0.96), SVM (0.96), and EL (0.97). Of the 235 patients of the validation cohort (Part 2), the Solo Model and Paired Model achieved a favorable AUC for 103 patients with (Solo Model 0.87; Paired Model 0.95) and 132 patients without (Solo Model 0.84; Paired Model 0.95) a corroborating electrophysiology procedure or intracardiac device recording. CONCLUSION: Accurate WCT differentiation may be accomplished using computerized data of (i) the WCT ECG alone and (ii) paired WCT and baseline ECGs

Mobile Phones and Multiple Sclerosis – A Nationwide Cohort Study in Denmark

We investigated the risk of, prognosis of and symptoms of multiple sclerosis (MS) among all Danish residents who owned a mobile phone subscription before 1996. Using the Danish Multiple Sclerosis Registry and Civil Registration System, study subjects were followed up for MS through 2004. Poisson models were used to calculate incidence rate ratios (IRR, age range: 18–64 years) and mortality rate ratios (MRR, age range: 18+) and to compare presenting symptoms among subscribers and all non-subscribers. A total of 405 971 subscription holders accrued four million years of follow up, with men accounting for 86% of the observation time. Among subscription holding men, the IRR of MS was close to unity, overall as well as 13+ years after first subscription (IRR 1.02, 95% CI: 0.48–2.16). Among women, the IRR was 3.43 (95% CI: 0.86–13.72) 13+ years after first subscription, however, based on only two cases. Presenting symptoms of MS differed between subscribers and non-subscribers (p = 0.03), with slightly increased risk of diplopia in both genders (IRR: 1.38, 95% CI: 1.02–1.86), an increased risk of fatigue among women (IRR: 3.02, 95% CI: 1.45–6.28), and of optic neuritis among men (IRR: 1.38, 95% CI: 1.03–1.86). Overall the MRR was close to one (MRR: 0.91, 95%CI 0.70–1.19) among MS-patients with a subscription and although we observed some increased MRR estimates among women, these were based on small numbers. In conclusion, we found little evidence for a pronounced association between mobile phone use and risk of MS or mortality rate among MS patients. Symptoms of MS differed between subscribers and nonsubscribers for symptoms previously suggested to be associated with mobile phone use. This deserves further attention, as does the increased long-term risk of MS among female subscribers, although small numbers and lack of consistency between genders prevent causal interpretation

How do informal information sources influence women’s decision-making for birth? A meta-synthesis of qualitative studies

Background: Women approach birth using various methods of preparation drawing from conventional healthcare providers alongside informal information sources (IIS) outside the professional healthcare context. An investigation of the forms in which these informal information sources are accessed and negotiated by women, and how these disconnected and often conflicting elements influence women’s decision-making process for birth have yet to be evaluated. The level of antenatal preparedness women feel can have significant and long lasting implications on their birth experience and transition into motherhood and beyond. The aim of this study was to provide a deeper understanding of how informal information sources influence women’s preparation for birth. Methods: Seven electronic databases were searched with predetermined search terms. No limitations were imposed for year of publication. English language studies using qualitative methods exploring women’s experiences of informal information sources and their impact upon women’s birth preparation were included, subject to a quality appraisal framework. Searches were initiated in February 2016 and completed by March 2016. Studies were synthesised using an interpretive meta-ethnographic approach. Results: Fourteen studies were included for the final synthesis from Great Britain, Australia, Canada and the United States. Four main themes were identified: Menu Birth; Information Heaven/Hell; Spheres of Support; and Trust. It is evident that women do not enter pregnancy as empty vessels devoid of a conceptual framework, but rather have a pre-constructed embodied knowledge base upon which other information is superimposed. Allied to this, it is clear that informal information was sought to mitigate against the widespread experience of discordant information provided by maternity professionals. Conclusion: Women’s access to the deluge of informal information sources in mainstream media during pregnancy have significant impact on decision making for birth. These informal sources redefine the power dynamic between women and maternal healthcare providers, simultaneously increasing levels of anxiety and challenging women’s pre- existing ideations and aspirations of personal birth processes. A lack of awareness by some professionals of women’s information seeking behaviours generates barriers to women-centred support, leaving an experience expectation mismatch unchecked

Choice of psychological coping in laryngectomized, head and neck squamous cell carcinoma patients versus multiple sclerosis patients

To be treated for cancer must be a frightening experience. Yet quality of life (QoL) of successfully treated cancer patients seems to be relatively similar in comparison with QoL of a general population, with psychological coping partly responsible for this finding. When measuring choice of coping, the nature of coping score levels constituting appropriate scores, and whether score levels rely on the context of the disease has not been settled. We have studied the COPE coping responses as related to disease in successfully treated head and neck squamous cell carcinoma (HNSCC) patient groups (general and laryngectomized), as well as compared to multiple sclerosis (MS) patients. The COPE response patterns have also been compared to the Beck depression inventory (BDI) scores. Age and gender of patients were not directly associated with choice of coping. Within the problem-focused coping indexes, the coping index “active coping” was reported to be most utilized among HNSCC patients, whereas “coping by suppression” and “coping by social support” were most utilized among MS patients. Emotional-focused coping was most prevalent among HNSCC patients and lowest among the MS patients. Level of avoidance coping was similar between the groups. The coping of the general HNSCC patients differed most from the MS patients. An association was shown between increased coping efforts and lowered mood. In particular, avoidance coping was associated with lowered mood. These associations were stronger among the MS patients than HNSCC patients. Drinking to cope was most prevalent among the laryngectomized group, and was correlated with BDI scores in all groups. Furthermore, adequate coping seems to be to limit avoidance coping and promote coping by acceptance. The response pattern of the COPE inventory seems to be valid among HNSCC and MS patients