Lower Likelihood Of Improvement Research Articles

Prospective transitions in hemoglobin A1c following gestational diabetes using Multistate Markov Models.

We characterized the state-to-state transitions in postpartum A1c levels after gestational diabetes, including remaining in a state of normoglycemia or transitions between prediabetes or diabetes states of varying severity. We used data from the APPLE Cohort, a postpartum population-based cohort of individuals with gestational diabetes between 2009-2011and linked HbA1c data with up to 9 years follow-up (N=34,171). We examined maternal sociodemographic and perinatal characteristics as predictors of transitions in A1c progression using Markov multistate models. In the first-year postpartum following gestational diabetes, 45.1% of people had no-diabetes, 43.1% had prediabetes, 4.6% had controlled diabetes and 7.2% had uncontrolled diabetes. Roughly two-thirds of individuals remained in same state in the next year. Black individuals were more likely to transition from pre-diabetes to uncontrolled diabetes (aHR: 2.32 95% CI: 1.21 ,4.47) than White persons. Perinatal risk factors were associated with disease progression and lower likelihood of improvement. For example, hypertensive disorders of pregnancy were associated with a stronger transition (aHR: 2.06 95% CI: 1.39, 3.05) from prediabetes to uncontrolled diabetes. We illustrate factors associated with adverse transitions in incremental A1c stages and describe patient profiles who may warrant enhanced postpartum monitoring.

Abstract 11871: Left Ventricular End Diastolic Diameter as a Predictor of Severe Functional Mitral Regurgitation Persistence Following Acute Heart Failure Hospitalization

Introduction: The phenotype of patients with functional mitral regurgitation (fMR) is broad. We sought to study the relationship of left-ventricular end-diastolic diameter (LVIDd) with severe fMR persistence after acute heart failure hospitalization. Methods/Results: We conducted a retrospective chart review of consecutively admitted patients to Montefiore Medical Center between 2012-2017 for acute-decompensated heart-failure (ADHF) who also had a severe fMR on index transthoracic-echocardiogram (TTE), and had follow-up TTE available within 1-6 months of hospital discharge. Patients were categorized into two subgroups based on whether their follow-up TTE showed improvement in fMR severity to moderate/less vs. persistence of severe fMR and compared for baseline characteristics. Relationship between LVIDd quartiles based on LVIDd on index TTE, and rates of persistent severe fMR on follow-up TTE were also evaluated. A total of 134 patients met our study criteria, n= 53(40%) with improved fMR and n=81(60%) with persistent severe fMR on follow-up TTE. The two groups were similar including guideline-directed-medical-therapy (GDMT) and diuretic use (Table-1). Patients in the highest LVIDd quartile (≥6.4cm) were less likely to have fMR improvement on follow-up TTE than patients in the 1 st -3 rd quartiles (19% vs 46%,p=0.007, Figure 1). Conclusions: LVIDd on index TTE at time of ADHF-hospitalization was associated with severe fMR persistence post-discharge. In our cohort, LVIDd ≥6.4cm was associated with lower likelihood of improvement in severe fMR with pharmacotherapy alone, and may help to identify patients who may benefit from interventional therapies.

Baseline SARS-CoV-2 Viral Load Is Associated with Disease Severity and Clinical Outcomes in Hospitalised Patients with COVID-19: Post-Hoc Analyses of a Phase 2/3 Multicentre Trial

Background: Elucidating the relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load and clinical outcomes is critical for understanding COVID-19.Methods: SARS-CoV-2 levels were analysed by quantitative real-time polymerase chain reaction (RT-qPCR) of naso- or oro-pharyngeal swab specimens collected at baseline and clinical outcomes were recorded over 60 days from 1362 COVID-19 hospitalised patients enrolled in a multi-center, randomized, placebo-controlled phase II/III trial of sarilumab for COVID-19 (NCT04315298).Findings: In post-hoc analyses, higher baseline viral load, measured by both RT-qPCR cycle threshold (Ct) and log10 copies/mL, was associated with greater supplemental oxygenation requirements and disease severity at study entry. Higher baseline viral load was associated with higher mortality, lower likelihood of improvement in clinical status and supplemental oxygenation requirements, and lower rates of hospital discharge. Viral load was not impacted by sarilumab treatment over time compared with placebo.Interpretation: These data support viral load as an important determinant of clinical outcomes in hospitalized patients with COVID-19 requiring supplemental oxygen or assisted ventilation.Trial Registration: NCT04315298Funding Statement: Supported by Regeneron Pharmaceuticals, Inc. and Sanofi. Certain aspects of this project have been funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under OT number: HHSO100201700020C.Declaration of Interests: All authors are employees or employees and shareholders of Regeneron Pharmaceuticals, Inc.Ethics Approval Statement: The local institutional review board or ethics committee at each centre oversaw trial conduct and documentation. All patients provided written informed consent before participation. Ethics approval was obtained from the following ethics review boards: WCG IRB, Puyallup, WA (IRB00000533); Oregon Health & Science University, Portland, OR (MOD00027616); Institutional Review Board University of Florida, Gainesville, FL (IRB202000779); Columbia University, Human Research Protection Office and IRBs, New York, NY (IRB-AAAS9615); Johns Hopkins Medicine, Office of Human Subjects Research, IRB, Baltimore, MD (IRB00246576/CIR00058074); NYU School Of Medicine, New York, NY (I20-00351_MOD03); Northwestern University IRB, Chicago, IL (STU00212239-MOD0012); Westchester Medical Center, NY Medical College, Office of Research Administration, Valhalla, NY (IRBReg#00000428); Portland Health and Services IRB Providence – St. Johns, Portland, OR (MOD2020001024); Cornell Weill Medicine IRB, New York, NY (IRB00009419); Providence St. Joseph IRB, Renton, WA (MOD2020001029); Providence Health and Services IRB, Portland, OR (MOD2020000519); Ascension St. John Hospital, Tulsa, OK (IRB#00001980); Geisinger IRB, Danville, PA (IRB#0008345).

Correlates of 1-Year Change in Quality of Life in Patients with Urologic Chronic Pelvic Pain Syndrome: Findings from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network.

We evaluated and identified baseline factors associated with change in health related quality of life among patients with interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome. A total of 191 men and 233 women with interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome (collectively referred to as urologic chronic pelvic pain syndrome) were followed for 12 months with bimonthly completion of the Short Form 12 to assess general mental and physical health related quality of life, and with biweekly assessment of condition specific health related quality of life using the Genitourinary Pain Index. A functional clustering algorithm was used to classify participants as improved, stable or worsened for each health related quality of life measure. Ordinal logistic regression was used to determine baseline factors associated with change. Physical health related quality of life improved in 22% of the participants, mental health related quality of life improved in 25% and condition specific health related quality of life improved in 47%. Better baseline physical health related quality of life, older age and the presence of nonurological symptoms were associated with lower likelihood of improvement in physical health related quality of life. Better baseline mental health related quality of life, female sex, and greater baseline depression and stress were associated with a lower likelihood of improvement in mental health related quality of life. Better baseline condition specific health related quality of life and more severe baseline urologic chronic pelvic pain syndrome pain symptoms were associated with a lower likelihood of improvement in condition specific health related quality of life. While several nonurologic chronic pelvic pain syndrome factors influenced the trajectory of general health related quality of life over time, only condition specific baseline health related quality of life and urologic chronic pelvic pain syndrome symptoms were associated with urologic chronic pelvic pain syndrome specific health related quality of life change. Significant differences in how urologic chronic pelvic pain syndrome impacts various aspects of health related quality of life suggest a multidisciplinary approach to assessment and treatment of these patients.

Fate and long-term prognostic implications of mitral regurgitation in patients undergoing transcatheter aortic valve replacement

BackgroundThe management of patients with mitral regurgitation (MR) undergoing transcatheter aortic valve replacement (TAVR) is challenging. We sought to investigate the evolution and long-term prognostic impact of residual post-TAVR MR. MethodsThe severity of MR was assessed at baseline and at 30 days and six months post-TAVR. Left ventricular mass and volumes were assessed by magnetic resonance imaging at two weeks and six months post-TAVR. ResultsThe study included 970 patients (age, 80.6 ± 6.2 years; female, 53.2%; Society of Thoracic Surgeons score, 5.2 ± 4.6). Moderate-severe MR at baseline improved at 30-day post-TAVR in 60% of cases, and TAVR with the Medtronic CoreValve (OR: 0.44 [0.23–0.86]) was associated with a lower likelihood of improvement. Further MR improvement continued beyond 30 days post-TAVR especially in patients with a significant improvement of left ventricular volume and mass.Stratified by the severity of MR at 30 days post-TAVR, the 5-year cumulative incidence of the composite of cardiovascular mortality or heart failure hospitalization was 37.5%, 40.0%, and 58.2% in patients with none-mild, moderate, and severe MR, respectively (log rank p < .001; adjusted hazard ratio of severe vs. none-mild MR: 4.83 [2.49–9.38]. ConclusionsMR improves in a majority of patients early after TAVR, and its evolution continues thereafter in line with reverse cardiac remodeling. Residual post-TAVR severe MR is associated with adverse long-term outcome. Therefore, intervention to treat severe MR persisting after TAVR should be considered by the heart team.

Antifibrinolytics for heavy menstrual bleeding.

Antifibrinolytics for heavy menstrual bleeding.

Patterns and Predictors of Frailty Transitions in Older Men: The Osteoporotic Fractures in Men Study.

To describe the natural history of frailty transitions in a large cohort of community-dwelling older men and identify predictors associated with progression to or improvement from states of greater frailty. Prospective cohort study. Six U.S. sites. Community-dwelling men aged 65 and older (N = 5,086). Frailty was measured at baseline and an average of 4.6 years later. Frailty was defined as having three or more of the following components (low lean mass, weakness, self-reported exhaustion, low activity level, and slow walking speed); prefrailty was defined as having one or two components. Separate multivariable logistic regression models were analyzed for progression and improvement in frailty status. Of the 5,086 men, 8% were frail, 46% were prefrail, and 46% were robust at baseline. Between baseline and follow-up, 35% progressed in frailty status or died, 56% had no change in frailty status, and 15% of prefrail or frail participants improved, although only 0.5% improved across two levels, from frail to robust. In multivariable models, factors associated with improvement in frailty status included greater leg power, being married, and good or excellent self-reported health, whereas presence of any instrumental activity of daily living (IADL) limitations, low albumin levels, high interleukin-6 levels, and presence of chronic obstructive pulmonary disease or diabetes mellitus were associated with lower likelihood of improvement in frailty status. Improvement in frailty status was possible in this cohort of community-dwelling older men, but improvement from frail to robust was rare. Several predictors were identified as possible targets for intervention, including prevention and management of comorbid medical conditions, prevention of IADL disability, physical exercise, and nutritional and social support.

Predictors of Improvements in Pain Intensity in a National Cohort of Older Veterans With Chronic Pain.

Little is known about the factors associated with pain-related outcomes in older adults. In this observational study, we sought to identify patient factors associated with improvements in pain intensity in a national cohort of older veterans with chronic pain. We included 12,924 veterans receiving treatment from the Veterans Health Administration with persistently elevated numeric rating scale scores in 2010 who had not been prescribed opioids in the previous 12months. We examined: 1) percentage decrease over 12months in average pain intensity scores relative to average baseline pain intensity score; and 2) time to sustained improvement in average pain intensity scores, defined as a 30% reduction in 3-month scores compared with baseline. Average relative improvement in pain intensity scores from baseline ranged from 25% to 29%; almost two-thirds met criteria for sustained improvement during the 12-month follow-up period. In models, higher baseline pain intensity and older age were associated with greater likelihood of improvement in pain intensity, whereas Veterans Affairs service-connected disability, mental health, and certain pain-related diagnoses were associated with lower likelihood of improvement. Opioid prescription initiation during follow-up was associated with lower likelihood of sustained improvement. The findings call for further characterization of heterogeneity in pain outcomes in older adults as well as further analysis of the relationship between prescription opioids and treatment outcomes. This study identified factors associated with improvements in pain intensity in a national cohort of older veterans with chronic pain. We found that older veterans frequently show improvements in pain intensity over time, and that opioid prescriptions, mental health, and certain pain diagnoses are associated with lower likelihood of improvement.

Socioeconomic status influences time to surgery and surgical outcome in pediatric epilepsy surgery.

The aims of this study were to evaluate the influence of socioeconomic status (SES) on time-to-surgery (TTS) and surgical outcome in children with treatment-resistant epilepsy in a universal health care system. The cohort consisted of children who had undergone resective epilepsy surgery between 2001 and 2013 in Canada. The patients' postal codes were linked to Statistics Canada National Household Survey data to obtain dissemination area income, which was used to infer SES. Time-to-surgery was defined as the interval from date of epilepsy onset to date of surgery. Seizure outcome was classified using ILAE classification. The associations between SES and TTS, as well as SES and surgical outcome, were assessed. Two hundred eighty-four children who had epilepsy surgery were included. Patients in the lowest income quintile had a significantly higher TTS relative to the highest income quintile (β=0.121, p=0.044). There were no significant associations between income quintiles and seizure-free surgical outcome (odds ratio (OR)=0.746-1.494, all p>0.05). However, patients in the lowest income quintile had a significantly lower odds of an improvement in seizure frequency relative to the highest income quintile (OR=0.262, p=0.046). The TTS was not uniform across SES in spite of the existence of a universal health care system. This finding highlights the need to address social and economic barriers for epilepsy surgery to improve access to this potentially curative treatment. Those with lower SES had lower likelihood of improvement in seizure control following epilepsy surgery and may require additional support including social and financial support to mitigate the discrepancies in seizure control following surgery between SES levels.

Olfactory Improvement and Decline in Patients with Posttraumatic Olfactory Dysfunction

Objectives: Identify the prognosis for patients with post-traumatic olfactory dysfunction. Methods: From 2007 to 2013, patients with posttraumatic olfactory dysfunction were enrolled. The threshold, discrimination, and identification (TDI) score of Sniffin’ Sticks test was ≤15 for anosmia, ≥30 for normosmia, and between these values for hyposmia. Olfactory improvement/decline was defined as an increase/decrease in TDI score ≥ 6 points. The cumulative incidence rates of olfactory improvement and decline were calculated using the Kaplan-Meier method. Variables with a potential impact on olfactory changes were entered into Cox regression analysis. The correlation between the TDI scores of the first and last visit was evaluated. Results: We included 80 patients with an average 9.4-month follow-up period (range, 1-52 months). The 12-month cumulative rates of olfactory improvement and decline were 8.4% and 11.8%, respectively. Anosmia, hyposmia, and normosmia were noted in 71.2%, 27.5%, and 1.2% of the patients at the first visit and 72.5%, 23.8%, and 3.8% at the last visit (Fisher’s exact, P = .583). Multivariate analysis revealed no associations between clinical predictors and olfactory changes (all P &gt; .05). A positive correlation between the TDI scores of first and last visit (Spearman test, Rho = 0.532, P &lt; .001) confirmed the absence of significant changes in olfaction. Conclusions: Posttraumatic olfactory dysfunction was associated with a lower risk of decline in olfaction and a lower likelihood of improvement. Although most patients maintained a stable disease status, anosmia in the majority of patients may reflect a poor prognosis in olfactory recovery for patients with head trauma.

Non-operative outcomes in Chiari I malformation patients

While postoperative outcomes of Chiari I malformation patients have been well-reported, there is a paucity of literature concerning non-operative management in these patients. We retrospectively identified patients with Chiari I malformation who were not recommended for surgery based on lack of clinical objective findings or inconsistent cough headaches and conducted patient follow-up with a prospective telephone survey. Of the 68 patients (mean age at diagnosis 30.1±17.4years), 72% were female and 31% were pediatric patients (age at diagnosis ⩽18years). Average follow up was 4.9±2.9years. Typical presenting symptoms included cough headache, non-specific headache, nausea, ataxia, dysphagia and paresthesias. Overall, 40% of patients who had cough headaches and 61.5% of patients with non-specific headaches reported improvement. The presence of subjective sensory symptoms was significantly associated with less likelihood of cough headache improvement while the presence of a cough headache was also associated with a lower likelihood of improvement in all non-cough symptoms. The pediatric subgroup had a greater rate of improvement with all cases of nausea/emesis and paresthesias improved or resolved at follow-up. Overall 67% of pediatric patients had improved cough headache and 71% had improvement of migraines/diffuse headaches. We found that many symptoms of Chiari I patients from our conservatively managed cohort either improved or remained unchanged over time. However, the presence of cough headaches was a significant negative predictor of concomitant symptom improvement. This further validates the view that patients with cough headaches should be considered for surgical intervention and provides useful information to counsel patients.

Reduction of exposure in the management of occupational asthma

The management of immunologically mediated occupational asthma may be difficult in clinical practice since complete avoidance of exposure to the sensitizing agent is associated with a substantial adverse socio-economic impact. The purpose of this review was to critically analyze the available information on the effectiveness of reducing exposure as an alternative to complete avoidance. Short-term exposure studies showed that respiratory protective devices can reduce bronchial responses to sensitizing agents in patients with occupational asthma, but do not provide complete protection. Recent systematic reviews of long-term follow-up studies of workers with occupational asthma indicated that reduction of exposure to the causal agent is associated with a lower likelihood of improvement in asthma symptoms and a higher risk of worsening of symptoms and nonspecific bronchial hyper-responsiveness. There are insufficient data to compare the socio-economic consequences related to both of these management options. Available data indicate that a reduction of exposure to the agents causing occupational asthma cannot be routinely recommended as an alternative to complete avoidance. However, due to the methodological weaknesses of the published studies, further investigations are required to determine the evidence-based cost-effectiveness of the occupational asthma management strategies.

Management of occupational asthma: cessation or reduction of exposure? A systematic review of available evidence

Reduction of exposure to sensitising agents causing occupational asthma has been proposed as an alternative to total avoidance in order to minimise the adverse socio-economic impact of the condition. The aim of this systematic review was to compare the effects of these two management options on asthma and socio-economic outcomes. A bibliographic search was conducted to identify studies examining the outcome of workers with occupational asthma after reduction or cessation of exposure to the causal agent. The changes in asthma symptoms and nonspecific bronchial hyperresponsiveness after reduction or cessation of exposure were described in nine and five studies, respectively. The meta-analysis of pooled data showed that a reduction of exposure was associated with a lower likelihood of improvement (OR 0.16, 95% CI 0.03-0.91) and recovery (OR 0.30, 95% CI 0.11-0.84) of asthma symptoms and a higher risk of worsening of the symptoms (OR 10.23, 95% CI 2.97-35.28) and nonspecific bronchial hyperresponsiveness (OR 5.65, 95% CI 1.11-28.82), compared with complete avoidance of exposure. This systematic review indicates that reduction of exposure cannot be routinely recommended as an alternative to cessation of exposure in the management of occupational asthma. However, further investigations are required before drawing evidence-based conclusions on the cost-effectiveness of this approach.

Interaction between two predictors of functional outcome after revascularization in ischemic cardiomyopathy: Left ventricular volume and amount of viable myocardium

In patients with ischemic cardiomyopathy and substantial amounts of dysfunctional but viable myocardium, revascularization cannot always improve the left ventricular ejection fraction. We sought to investigate the interaction between the left ventricular volume and the amount of viable myocardium to predict the left ventricular ejection fraction increase after revascularization. Eighty-five consecutive patients with a depressed left ventricular ejection fraction (mean: 27.3% +/- 5.2%) underwent coronary artery bypass grafting after a dobutamine stress echocardiography had determined that they had at least 4 viable segments. Six months after coronary artery bypass grafting, left ventricular ejection fraction and regional wall motion were reassessed. Although the left ventricular ejection fraction was expected to recover more than 5% in all 85 patients after coronary artery bypass grafting, it did not improve in 15 patients (17.6%) despite the presence of viable segments. The likelihood of the left ventricular ejection fraction recovery decreased proportionally with an increase in the left ventricular end-systolic volume. The nonimprovers had a higher left ventricular end-systolic volume (164.2 +/- 22.4 mL vs 125.6 +/- 23.4 mL, P = .0001). In addition, the number of viable segments during the dobutamine stress echocardiography had a significant correlation with the ejection fraction increase after 6 months (P < .0001). Patients with 6 viable segments showed a good outcome irrespective of their left ventricular end-systolic volume. In patients with fewer than 6 viable segments, left ventricular end-systolic volume was a major factor in the prognosis: Patients with left ventricular end-systolic volume of 145 or more had a poor left ventricular ejection fraction increase and vice versa. The extent of left ventricular remodeling determines the rate of functional improvement after coronary artery bypass grafting. Patients with a high left ventricular end-systolic volume and fewer than 6 viable segments have a lower likelihood of improvement.

The impact of surgical wait time on patient-based outcomes in posterior lumbar spine surgery (by J. Braybrooke et al.)

The hazards of waiting lists are all too well known. Dabke et al. [2] studied 101 patients undergoing surgery for scoliosis. The mean waiting time between listing and surgery was 8 months. Whilst on the waiting list, significant curve progression occurred in 50/101 (50%) patients and ultimately 29/101 (29%) patients required more surgery than originally planned increasing complexity, morbidity and cost of surgery. Here at last we have a prospective observational study assessing the influence of waiting time on patient-derived functional outcome measures for those undergoing posterior lumbar spinal surgery. Policy-makers should sit up and take note! The authors studied 70 consecutive patients undergoing spinal decompression or fusion for degenerative conditions of the lumbar spine. Follow-up was available for 53/70 (76%) patients at 12 months. Of these 53 patients, 30 underwent spinal decompression and 23 underwent spinal fusion. The authors used a well-validated generic health status measure, the short form 36 (SF-36) and a disease-specific questionnaire, the Oswestry disability index (ODI). Data was collected by an independent evaluator who was blinded to the treatment. The operating surgeon was blinded to baseline outcome measures. The relationship between wait time and surgical outcome was tested using a Cox proportional hazards regression model. As a whole the group demonstrated both clinically relevant and statistically significant improvements in six of eight domains from the SF-36. The mean ODI improved by 16.6% points over the study period. Patients who had a longer wait for surgery had a lower likelihood of improvement in functional outcome scores. On average those patients requiring spinal fusion had a longer wait time compared to those waiting for spinal decompression. However, the authors controlled for surgery type as a covariate in the statistical analysis. Forty percent of patients believed waiting time had a negative impact on their perceived clinical condition, physical and mental well being. This study does have limitations: 76% follow-up at 1 year is a short-term follow up, particularly for those undergoing spinal fusion. Administering the questionnaire relating to the patient’s wait for assessment and investigations at the final follow-up introduces the possibility of recall bias. Interestingly the ‘short waiters’ (those who waited less or equal to the median surgical wait time of the study cohort) had pre-operative ODI scores (mean 50.3) that were higher that the ‘long waiters’ (mean 40.3). This raises the possibility of selection bias, whereby surgeons were inadvertently prioritizing patients with higher disability. We are not given the post-operative outcome measures of these two cohorts to further assess this. Nevertheless the authors have shown that a longer wait time for surgery negatively influences the functional outcome measures following surgery. Airaksinen et al. [1] in the European guidelines for the management of chronic non-specific low back pain (CLBP) state, ‘We cannot recommend fusion surgery for CLBP unless 2 years of all other recommended conservative treatments have failed’. Taking into account the above, this ‘imposed sentence’ of 2 years for patients seems harsh and may serve only to reduce the chances of successful outcomes following surgery. Hansson et al. [3] estimated the societal costs of having patients on paid sick-leave whilst on a waiting list for elective procedures including lumbar discectomy and lumbar spinal decompression. The costs for paid sick leave together with future costs for those granted permanent disability were 90 million SEK (almost 90 million USD), corresponding to an equivalent cost of more than 2,000 disc operations. The authors have further consolidated the view that, ‘Waiting lists are bad for your health’. Decision makers should work not only to reduce waiting times for spinal surgery, but also to investigate ways of preventing patient deterioration whilst on such waiting lists.