Risk Factors For Withdrawal Research Articles

Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study

BackgroundIdiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world...

Predictors of participants’ retention—socioeconomic factors or nonadherence: insights from a urological clinical prospective study

BackgroundTo investigate various patient-level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigated a non-interventional prospective study assessing the role of novel imaging as a biomarker for cancer upgradation in prostate cancer for this objective.MethodsIn this retrospective analysis, we assessed the association between various patient-level factors including clinic-demographic factors, socioeconomic status, and the number of non-adherences with the participants’ retention or withdrawal from the study. For socioeconomic status (SES), we used the zip code–based Economic Innovation Group Distressed Community Index (DCI) which classifies into five even distress tiers: prosperous, comfortable, mid-tier, at-risk, or distressed. Low SES was defined as those with a DCI Distress tier of at-risk or distressed. We compared values between the two retention and withdrawal groups using t-test, chi-square test, and logistic regression analysis.ResultsOf 273 men screened, 123 men were enrolled. Among them, 86.2% (106/123) retained through the study whereas 13.8% (17/123) withdrew from the study. The mean (SD) age was 64 (6.4) years. Overall, 31.7% (39/123) were Hispanics and 24.3% (30/123) were African Americans. The median (IQR) DCI score was 34 (10.3, 68.1) and 30.8% (38/123) of patients belonged to low SES. The median DCI score in participants who retained in the study was statistically similar to those who withdrew from the study (p=0.4). Neither the DCI tiers (p=0.7) nor the low SES (p=0.9) were associated with participants’ retention or withdrawal of the study. In terms of non-adherence, all participants in the withdrawn group had at least one non-adherent event compared to 48.1% in the retained group (p<0.001). Repetitive non-adherence was significantly higher in participants who withdrew from the study vs those who retained in the study [88.2% vs 16.9%, p <0.001]. On multivariate logistic regression analysis, the number of non-adherences (OR=12.5, p<0.001) and not DCI (OR=0.99, p=0.7) appeared to be an independent predictor for participants’ retention or withdrawal from the study.ConclusionsExpanding diverse inclusion and limiting withdrawal with real-time non-adherence monitoring will lead to more efficient clinical research and greater generalizability of results.

Causes and risk factors for peritoneal dialysis withdrawal.

This study intends to investigate the causes and risk factors for withdrawal from peritoneal dialysis (PD) in patients with end stage renal disease (ESRD). Two hundred ninety-three patients admitted to the peritoneal dialysis center in nephrology department for PD treatment were divided into 175 cases in group A (continuous treatment group) and 118 cases in group B (withdrawal group). The proportion of patients in group B whose primary disease was glomerulonephritis was significantly lower than that in group A (p <0.05), whereas the proportion of patients with diabetic nephropathy was significantly higher in group B than in group A (p <0.05). Group A received better emotional support and care services from family members than group B. Family care was mostly severely impaired in patients who died and were lost to follow-up. Diabetes mellitus, level of knowledge regarding PD, depression, and family care are risk factors for withdrawal from PD.

Amantadine withdrawal syndrome masquerading as COVID-19 encephalopathy: a case report and review of the literature

ABSTRACTAmantadine withdrawal syndrome (AWS) is a rare but recognized cause of severe and persistent altered mental status sometimes with co-occurring extrapyramidal symptoms. First described in a case series from 1987, its clinical manifestations have been characterized along a spectrum ranging from profound hypoactive delirium to hyperactive delirium with hallucinations. Risk factors for withdrawal include abrupt medication discontinuation, prolonged use, older age and underlying dementia.Herein we describe a case of a 52-year-old woman who presented with confusion, hallucinations, and coronavirus disease-2019 infection. She subsequently developed a prolonged hypoactive delirium after her amantadine was tapered and held. Her hypoactive delirium entirely resolved with resumption of amantadine confirming the diagnosis of AWS. This case illustrates the importance of slowly tapering dopaminergic medications and being aware of rare pharmacologic side effects.

What I have learnt from helping thousands of people taper off antidepressants and other psychotropic medications.

Although psychiatric drug withdrawal syndromes have been recognized since the 1950s – recent studies confirm antidepressant withdrawal syndrome incidence upwards of 40% – medical information about how to safely go off the drugs has been lacking. To fill this gap, over the last 25 years, patients have developed a robust Internet-based subculture of peer support for tapering off psychiatric drugs and recovering from withdrawal syndrome. This account from the founder of such an online community covers lessons learned from thousands of patients regarding common experiences with medical providers, identification of adverse drug reactions, risk factors for withdrawal, tapering techniques, withdrawal symptoms, protracted withdrawal syndrome, and strategies to cope with symptoms, in the context of the existing scientific literature.

End of Life, Withdrawal, and Palliative Care Utilization among Patients Receiving Maintenance Hemodialysis Therapy.

Withdrawal from maintenance hemodialysis before death has become more common because of high disease and treatment burden. The study objective was to identify patient factors and examine the terminal course associated with hemodialysis withdrawal, and assess patterns of palliative care involvement before death among patients on maintenance hemodialysis. We designed an observational cohort study of adult patients on incident hemodialysis in a midwestern United States tertiary center, from January 2001 to November 2013, with death events through to November 2015. Logistic regression models evaluated associations between patient characteristics and withdrawal status and palliative care service utilization. Among 1226 patients, 536 died and 262 (49% of 536) withdrew. A random sample (10%; 52 out of 536) review of Death Notification Forms revealed 73% sensitivity for withdrawal. Risk factors for withdrawal before death included older age, white race, palliative care consultation within 6 months, hospitalization within 30 days, cerebrovascular disease, and no coronary artery disease. Most withdrawal decisions were made by patients (60%) or a family member (33%; surrogates). The majority withdrew either because of acute medical complications (51%) or failure to thrive/frailty (22%). After withdrawal, median time to death was 7 days (interquartile range, 4-11). In-hospital deaths were less common in the withdrawal group (34% versus 46% nonwithdrawal, P=0.003). A third (34%; 90 out of 262) of those that withdrew received palliative care services. Palliative care consultation in the withdrawal group was associated with longer hemodialysis duration (odds ratio, 1.19 per year; 95% confidence interval, 1.10 to 1.3; P<0.001), hospitalization within 30 days of death (odds ratio, 5.78; 95% confidence interval, 2.62 to 12.73; P<0.001), and death in hospital (odds ratio, 1.92; 95% confidence interval, 1.13 to 3.27; P=0.02). In this single-center study, the rate of hemodialysis withdrawals were twice the frequency previously described. Acute medical complications and frailty appeared to be driving factors. However, palliative care services were used in only a minority of patients.

Dexmedetomidine as Single Continuous Sedative During Noninvasive Ventilation: Typical Usage, Hemodynamic Effects, and Withdrawal.

Dexmedetomidine use in pediatric critical care is increasing. Its prolonged effects as a single continuous agent for sedation are not well described. The aim of the current study was to describe prolonged dexmedetomidine therapy without other continuous sedation, specifically the hemodynamic effects, discontinuation strategies, and risk factors for withdrawal. Retrospective chart review. Large, single-center, quaternary care pediatric academic institution. Data from 382 children, less than 18 years old admitted to the PICU who received dexmedetomidine for more than 24 hours without other infusions for sedation during noninvasive positive pressure ventilation. Usual care practices for dexmedetomidine use were described. Discontinuation strategies were categorized as abrupt discontinuation, wean from dexmedetomidine infusion, and transition to enteral clonidine. Median peak and cumulative doses with interquartile range were 1 µg/kg/hr (0.6-1.2 µg/kg/hr) and 30 µg/kg (20-50 µg/kg), respectively, and median duration was 45 hours (34-66 hr). Four hours after reaching peak dose, we observed a decrease in heart rate (p < 0.01) with 28% prevalence of bradycardia and an increase in systolic blood pressure (p < 0.01) with 33% prevalence of hypertension and 2% hypotension. During the escalation phase, the prevalence of bradycardia and hypotension were 75% and a 30%, respectively. Three-hundred thirty-six patients (88%) had abrupt discontinuation, 37 (10%) were weaned, and nine (2%) were transitioned to clonidine. Nineteen patients (5%) experienced withdrawal. Univariate risk of withdrawal was most associated with duration: odds ratio equal to 1.5 (1.3-1.7) for each 12-hour period (p < 0.01). By multivariate analysis including age, discontinuation group, dexmedetomidine cumulative dose, and peak dose, only cumulative dose remained significant with an odds ratio equal to 1.3 (1.1-1.5) for each 10 μg/kg (p < 0.01). Dexmedetomidine use for noninvasive positive pressure ventilation sedation in pediatric critical care has predictable hemodynamic effects including bradycardia and hypertension. Although withdrawal was associated with higher cumulative dose, these symptoms were effectively managed with short-term enteral clonidine.

Prolonged dexmedetomidine infusion and drug withdrawal in critically ill children

We investigated the incidence, symptoms and risk factors for withdrawal associated with prolonged dexmedetomidine use. Dexmedetomidine is an α2-adrenergic receptor agonist, with anxiolytic, analgesic and sedative properties. Intended for short-term use, there is increasing literature describing prolonged use for sedation. However, this raises the potential of withdrawal syndrome and there is no recommendation for the discontinuation of dexmedetomidine. Other goals included determining the hemodynamic effects of discontinuation of dexmedetomidine and role of clonidine in patients with prolonged dexmedetomidine use.

Perinatal Risk Factors for the Neonatal Abstinence Syndrome in Infants Born to Women on Methadone Maintenance Therapy

More than 50% of newborn infants whose mothers are on methadone maintenance therapy during pregnancy for opiate addiction develop neonatal withdrawal or neonatal abstinence syndrome (NAS). Although a large number of studies have investigated strategies that could predict the occurrence of NAS requiring pharmacological treatment, these studies have had conflicting results and identified no useful strategies. Maternal methadone dosing has been studied as a possible predictive risk factor for occurrence of NAS requiring treatment. Several studies have reported that methadone dosing may influence the onset of NAS. Other studies, however, found no correlation between the amount of methadone and NAS requiring treatment. In one study, the cumulative maternal methadone dose during pregnancy was predictive for the development of NAS. Gestational age and mode of delivery have also been reported to be associated with increased risk of NAS; the interaction between these 2 parameters and the last methadone dose has not been adequately investigated. This study was a retrospective review designed to investigate and correlate maternal methadone dose and other potential risk factors with the development of NAS requiring pharmacological treatment using clinical parameters easily accessible to clinicians. The study population was 228 methadone-maintained pregnant women who delivered 232 live-born infants between 2001 and 2006. A statistical model based on multiple logistic regression was developed to identify parameters predictive of subsequent need for treatment for NAS. External validation of the prediction model was provided by the use of a separate independent cohort of 188 infants born to methadone-maintained women. A total of 172 (74%) of the 232 infants were treated for NAS. The risk of withdrawal was associated with a higher last methadone dose and a higher cumulative dose (P < 0.001 for both). Infants delivered at a lower gestational age or by cesarean section were overall less likely to require NAS treatment. Gestational age, mode of delivery, and last methadone dose were identified as risk factors for withdrawal. External validation of the model developed from the original cohort was demonstrated in the validation cohort. These findings suggest that significant risk factors associated with the development of NAS requiring treatment are timing, mode of delivery, and the last maternal methadone dose. The statistical robustness of the data was demonstrated using internal and external validation methods.

Perinatal risk factors for the neonatal abstinence syndrome in infants born to women on methadone maintenance therapy

Neonatal abstinence syndrome (NAS) occurs in more than 50% of infants exposed to intrauterine opiates. Maternal opiate dosing has been investigated with conflicting results. The aims of this study were to correlate maternal methadone dose and other risk factors with the development of NAS requiring pharmacological treatment by using easily accessible clinical parameters. Retrospective medical record review of data from 228 opioid dependent pregnant women who delivered 232 live-born infants. Logistic regression analysis was performed on maternal, perinatal and neonatal parameters to identify risk factors for NAS requiring treatment. A prediction model was developed and validated on a separate independent cohort of 188 infants. Of the 232 infants, 172 (74%) infants were treated for NAS. The risk of withdrawal increased by 17% per 5 mg increment of the last maternal methadone dose. The risk was lower for younger gestational ages and for those delivered by Caesarean section compared to those delivered by normal vaginal delivery. Through predictive modeling, gestational age, mode of delivery and last methadone dose were established as risk factors for withdrawal. The model was validated by other statistical measures and its diagnostic performance confirmed on the separate independent cohort. Our data suggests that timing and mode of delivery as well as last maternal methadone dose are significant risk factors for the development of NAS requiring treatment. Based on these clinical parameters, risk stratification for perinatal management of pregnancies associated with opioid dependency and risk prediction for the neonate might now be possible.