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Noncompliance
Selected AbstractsBehavioral Facilitation of Medical Treatment of Headache: Implications of Noncompliance and Strategies for Improving AdherenceHEADACHE, Issue 2006Jeanetta C. Rains PhD Clinical recommendations were gleaned from a review of treatment adherence published in the regular issue of Headache (released in tandem with this supplement). The recommendations include: (1) Nonadherence is prevalent among headache patients, undermines treatment efficacy, and should be considered as a treatment variable; (2) Calling patients to remind them of appointments and recalling those who miss a scheduled appointment are fundamentally the most cost-effective adherence-enhancing strategies, insofar as failed appointment-keeping acts as a ceiling on all future treatment and adherence efforts; (3) Simplified and tailored medication regimens improve adherence (eg, minimized number of medications and dosings, fixed-dose combinations, cue-dose training, stimulus control); (4) Screening and management of psychiatric comorbidities, especially depression and anxiety, is encouraged; (5) The concept of self-efficacy as a modifiable psychological process often can be employed to predict and improve adherence. [source] The economic consequences of noncompliance in cardiovascular disease and related conditions: a literature reviewINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2008N. Muszbek Summary Objectives:, To review studies on the cost consequences of compliance and/or persistence in cardiovascular disease (CVD) and related conditions (hypertension, dyslipidaemia, diabetes and heart failure) published since 1995, and to evaluate the effects of noncompliance on healthcare expenditure and the cost-effectiveness of pharmaceutical interventions. Methods:, English language papers published between January 1995 and February 2007 that examined compliance/persistence with medication for CVD or related conditions, provided an economic evaluation of pharmacological interventions or cost analysis, and quantified the cost consequences of noncompliance, were identified through database searches. The cost consequences of noncompliance were compared across studies descriptively. Results:, Of the 23 studies identified, 10 focused on hypertension, seven on diabetes, one on dyslipidaemia, one on coronary heart disease, one on heart failure and three covered multiple diseases. In studies assessing drug costs only, increased compliance/persistence led to increased drug costs. However, increased compliance/persistence increased the effectiveness of treatment, leading to a decrease in medical events and non-drug costs. This offset the higher drug costs, leading to savings in overall treatment costs. In studies evaluating the effect of compliance/persistence on the cost-effectiveness of pharmacological interventions, increased compliance/persistence appeared to reduce cost-effectiveness ratios, but the extent of this effect was not quantified. Conclusions:, Noncompliance with cardiovascular and antidiabetic medication is a significant problem. Increased compliance/persistence leads to increased drug costs, but these are offset by reduced non-drug costs, leading to overall cost savings. The effect of noncompliance on the cost-effectiveness of pharmacological interventions is inconclusive and further research is needed to resolve the issue. [source] Improving homework compliance in the treatment of generalized anxiety disorderJOURNAL OF CLINICAL PSYCHOLOGY, Issue 5 2002Robert L. Leahy Generalized anxiety disorder is a chronic condition characterized by beliefs that worry prepares and protects, but that excessive worry is out of control. In this article, I review the cognitive-behavioral model of generalized anxiety, focusing specifically on problems related to excessive worrying. Noncompliance in self-help homework is reflected in the patient's excessive focus on negative feelings, difficulty identifying automatic thoughts, demand for immediate results, and the belief that worries are realistic. Interventions for these problems are illustrated in the case of the treatment of a patient characterized by persistent worries, low self-confidence, procrastination, and avoidance. © 2002 Wiley Periodicals, Inc. J Clin Psychol/In Session 58: 499,511, 2002. [source] Malaria in Brazilian Military Personnel Deployed to AngolaJOURNAL OF TRAVEL MEDICINE, Issue 5 2000COL L. Jose Sanchez Background: Malaria represents one of the most important infectious disease threats to deployed military forces; most personnel from developed countries are nonimmune personnel and are at high risk of infection and clinical malaria. This is especially true for forces deployed to highly-endemic areas in Africa and Southeast Asia where drug-resistant malaria is common. Methods: We conducted an outbreak investigation of malaria cases in Angola where a total of 439 nonimmune Brazilian troops were deployed for a 6-month period in 1995,1996. A post-travel medical evaluation was also performed on 338 (77%) of the 439 soldiers upon return to Brazil. Questionnaire, medical record, thick/thin smear, and serum anti- Plasmodium falciparum antibody titer (by IFA) data were obtained. Peak serum mefloquine (M) and methylmefloquine (MM) metabolite levels were measured in a subsample of 66 soldiers (42 cases, 24 nonmalaria controls) who were taking weekly mefloquine prophylaxis (250 mg). Results: Seventy-eight cases of malaria occurred among the 439 personnel initially interviewed in Angola (attack rate = 18%). Four soldiers were hospitalized, and 3 subsequently died of cerebral malaria. Upon return to Brazil, 63 (19%) of 338 soldiers evaluated were documented to have had clinical symptoms and a diagnosis of malaria while in Angola. In addition, 37 (11%) asymptomatically infected individuals were detected upon return (< 1% parasitemia). Elevated, post-travel anti- P. falciparum IFA titers (, 1:64) were seen in 101 (35%) of 292 soldiers tested, and was associated with a prior history of malaria in-country (OR = 3.67, 95% CI 1.98,6.82, p < .001). Noncompliance with weekly mefloquine prophylaxis (250 mg) was associated with a malaria diagnosis in Angola (OR = 3.75, 95% CI 0.97,17.41, p = .03) but not with recent P. falciparum infection (by IFA titer). Mean peak levels (and ratios) of serum M and MM were also found to be lower in those who gave a history of malaria while in Angola. Conclusions: Malaria was a significant cause of morbidity among Brazilian Army military personnel deployed to Angola. Mefloquine prophylaxis appeared to protect soldiers from clinical, but not subclinical, P. falciparum infections. Mefloquine noncompliance and an erratic chemoprophylaxis prevention policy contributed to this large outbreak in nonimmune personnel. This report highlights the pressing need for development of newer, more efficacious and practical, prophylactic drug regimens that will reduce the malaria threat to military forces and travelers. [source] How to improve compliance with antiepileptic drugsPRESCRIBER, Issue 3 2009Bruce Packham MB BS, DRCOG Noncompliance with treatment is a significant problem in patients with epilepsy. Dr Packham describes how compliance can be improved by taking a concordant approach to medicine taking and by considering the use of once-daily formulations of sodium valproate. Copyright © 2009 Wiley Interface Ltd [source] Poor radiotherapy compliance predicts persistent regional disease in advanced head/neck cancer,THE LARYNGOSCOPE, Issue 3 2009Urjeet A. Patel MD Abstract Objective: To determine if poor compliance to chemoradiation results in an increased rate of persistent neck disease. Study Design: Retrospective, cohort study in an urban, tertiary-care medical center. Methods: The study included patients with N+ stage III/IV squamous cell carcinoma of the upper aerodigestive tract treated with curative-intent chemoradiation, who underwent subsequent planned neck dissection. Main outcome measure was persistent regional disease evidenced by identifiable carcinoma in neck dissection specimens. Variables including age, gender, race, primary site, initial T, N staging, imaging results, and treatment compliance were assessed and correlated to positive neck dissection pathology. Results: Of 40 patients, 18 (45%) had persistent carcinoma in neck dissection specimens while 22 (55%) demonstrated complete response in the neck. There were 14 patients (35%) who were poorly compliant to radiotherapy (,14 days treatment interruption) and the remaining 26 patients (65%) were considered compliant (<14 missed days). Only 23% of compliant patients had positive pathology while 79% of noncompliant patients had positive pathology (hazard ratio: 9.9). Noncompliance was the only variable that had a statistically significant correlation to positive pathology results (P = .002). Multivariate logistic regression showed all other variables to be insignificant in predicting pathology. Conclusions: This study found that poorly compliant patients are at significantly higher risk of persistent neck disease. Poor compliance may help identify patients who will most benefit from neck dissection after chemoradiation. This variable was more predictive than pretreatment variables and posttreatment CT scan. Further studies investigating patterns of failure after chemoradiotherapy in the poorly compliant patient population are warranted. Laryngoscope, 2009 [source] Transplant Outcomes and Economic Costs Associated with Patient Noncompliance to ImmunosuppressionAMERICAN JOURNAL OF TRANSPLANTATION, Issue 11 2009B. W. Pinsky We describe factors associated with immunosuppression compliance after kidney transplantation and examine relationships between compliance with allograft outcomes and costs. Medicare claims for immunosuppression in 15 525 renal transplant recipients with at least 1 year of graft function were used to calculate compliance as medication possession ratio. Compliance was categorized by quartiles as poor, fair, good and excellent. We modeled adjusted associations of clinical factors with the likelihood of persistent compliance by multiple logistic regressions (aOR), and estimated associations of compliance with subsequent graft and patient survival with Cox proportional hazards (aHR). Adolescent recipients aged 19,24 years were more likely to be persistently noncompliant compared to patients aged 24,44 years (aOR 1.49 [1.06,2.10]). Poor (aHR 1.80 [1.52,2.13]) and fair (aHR 1.63[1.37,1.93]) compliant recipients were associated with increased risks of allograft loss compared to the excellent compliant recipients. Persistent low compliance was associated with a $12 840 increase in individual 3-year medical costs. Immunosuppression medication possession ratios indicative of less than the highest quartile of compliance predicted increased risk of graft loss and elevated costs. These findings suggest that interventions to improve medication compliance among kidney transplant recipients should emphasize the benefits of maximal compliance, rather than discourage low compliance. [source] Identifiability and Estimation of Causal Effects in Randomized Trials with Noncompliance and Completely Nonignorable Missing DataBIOMETRICS, Issue 3 2009Hua Chen Summary In this article, we first study parameter identifiability in randomized clinical trials with noncompliance and missing outcomes. We show that under certain conditions the parameters of interest are identifiable even under different types of completely nonignorable missing data: that is, the missing mechanism depends on the outcome. We then derive their maximum likelihood and moment estimators and evaluate their finite-sample properties in simulation studies in terms of bias, efficiency, and robustness. Our sensitivity analysis shows that the assumed nonignorable missing-data model has an important impact on the estimated complier average causal effect (CACE) parameter. Our new method provides some new and useful alternative nonignorable missing-data models over the existing latent ignorable model, which guarantees parameter identifiability, for estimating the CACE in a randomized clinical trial with noncompliance and missing data. [source] Discussion of "Identifiability and Estimation of Causal Effects in Randomized Trials with Noncompliance and Completely Nonignorable Missing Data"BIOMETRICS, Issue 3 2009Dylan S. Small First page of article [source] Nested Markov Compliance Class Model in the Presence of Time-Varying NoncomplianceBIOMETRICS, Issue 2 2009Julia Y. Lin Summary We consider a Markov structure for partially unobserved time-varying compliance classes in the Imbens,Rubin (1997, The Annals of Statistics25, 305,327) compliance model framework. The context is a longitudinal randomized intervention study where subjects are randomized once at baseline, outcomes and patient adherence are measured at multiple follow-ups, and patient adherence to their randomized treatment could vary over time. We propose a nested latent compliance class model where we use time-invariant subject-specific compliance principal strata to summarize longitudinal trends of subject-specific time-varying compliance patterns. The principal strata are formed using Markov models that relate current compliance behavior to compliance history. Treatment effects are estimated as intent-to-treat effects within the compliance principal strata. [source] A Comparison of Methods for Estimating the Causal Effect of a Treatment in Randomized Clinical Trials Subject to NoncomplianceBIOMETRICS, Issue 2 2009Roderick J. Little Summary We consider the analysis of clinical trials that involve randomization to an active treatment (T,=,1) or a control treatment (T,=,0), when the active treatment is subject to all-or-nothing compliance. We compare three approaches to estimating treatment efficacy in this situation: as-treated analysis, per-protocol analysis, and instrumental variable (IV) estimation, where the treatment effect is estimated using the randomization indicator as an IV. Both model- and method-of-moment based IV estimators are considered. The assumptions underlying these estimators are assessed, standard errors and mean squared errors of the estimates are compared, and design implications of the three methods are examined. Extensions of the methods to include observed covariates are then discussed, emphasizing the role of compliance propensity methods and the contrasting role of covariates in these extensions. Methods are illustrated on data from the Women Take Pride study, an assessment of behavioral treatments for women with heart disease. [source] Multiple Imputation Methods for Treatment Noncompliance and Nonresponse in Randomized Clinical TrialsBIOMETRICS, Issue 1 2009L. Taylor Summary Randomized clinical trials are a powerful tool for investigating causal treatment effects, but in human trials there are oftentimes problems of noncompliance which standard analyses, such as the intention-to-treat or as-treated analysis, either ignore or incorporate in such a way that the resulting estimand is no longer a causal effect. One alternative to these analyses is the complier average causal effect (CACE) which estimates the average causal treatment effect among a subpopulation that would comply under any treatment assigned. We focus on the setting of a randomized clinical trial with crossover treatment noncompliance (e.g., control subjects could receive the intervention and intervention subjects could receive the control) and outcome nonresponse. In this article, we develop estimators for the CACE using multiple imputation methods, which have been successfully applied to a wide variety of missing data problems, but have not yet been applied to the potential outcomes setting of causal inference. Using simulated data we investigate the finite sample properties of these estimators as well as of competing procedures in a simple setting. Finally we illustrate our methods using a real randomized encouragement design study on the effectiveness of the influenza vaccine. [source] Likelihood Methods for Treatment Noncompliance and Subsequent Nonresponse in Randomized TrialsBIOMETRICS, Issue 2 2005A. James O'Malley Summary While several new methods that account for noncompliance or missing data in randomized trials have been proposed, the dual effects of noncompliance and nonresponse are rarely dealt with simultaneously. We construct a maximum likelihood estimator (MLE) of the causal effect of treatment assignment for a two-armed randomized trial assuming all-or-none treatment noncompliance and allowing for subsequent nonresponse. The EM algorithm is used for parameter estimation. Our likelihood procedure relies on a latent compliance state covariate that describes the behavior of a subject under all possible treatment assignments and characterizes the missing data mechanism as in Frangakis and Rubin (1999, Biometrika86, 365,379). Using simulated data, we show that the MLE for normal outcomes compares favorably to the method-of-moments (MOM) and the standard intention-to-treat (ITT) estimators under (1) both normal and nonnormal data, and (2) departures from the latent ignorability and compound exclusion restriction assumptions. We illustrate methods using data from a trial to compare the efficacy of two antipsychotics for adults with refractory schizophrenia. [source] Analysis of Times to Repeated Events in Two-Arm Randomized Trials with Noncompliance and Dependent CensoringBIOMETRICS, Issue 4 2004Shigeyuki Matsui Summary This article develops randomization-based methods for times to repeated events in two-arm randomized trials with noncompliance and dependent censoring. Structural accelerated failure time models are assumed to capture causal effects on repeated event times and dependent censoring time, but the dependence structure among repeated event times and dependent censoring time is unspecified. Artificial censoring techniques to accommodate nonrandom noncompliance and dependent censoring are proposed. Estimation of the acceleration parameters are based on rank-based estimating functions. A simulation study is conducted to evaluate the performance of the developed methods. An illustration of the methods using data from an acute myeloid leukemia trial is provided. [source] Penile rehabilitation protocol after robot-assisted radical prostatectomy: assessment of compliance with phosphodiesterase type 5 inhibitor therapy and effect on early potencyBJU INTERNATIONAL, Issue 3 2010Daniel J. Lee Study Type , Therapy (case series) Level of Evidence 4 OBJECTIVE To evaluate factors that affect compliance in men who enrol in a phosphodiesterase type 5 inhibitor (PDE5I) protocol after nerve-sparing robot-assisted prostatectomy (RAP), and report on short-term outcomes, as PDE5Is may help restore erectile function after RAP and patient adherence to the regimen is a factor that potentially can affect outcome. PATIENT AND METHODS We prospectively followed 77 men who had nerve-sparing RAP and enrolled in a postoperative penile rehabilitation protocol. The men received either sildenafil citrate or tadalafil three times weekly. The minimum follow-up was 8 weeks. Potency was defined as erection adequate for penetration and complete intercourse. Compliance was defined as men adhering to the regimen for ,2 months. RESULTS The mean age of the cohort was 57.8 years and the median follow-up was 8 months. In all, 32% of the men discontinued the therapy <2 months after RAP and were deemed noncompliant with an additional 39% discontinuing therapy by 6 months, with the high cost of medication being the primary reason (65%). Long-term compliance and preoperative erectile dysfunction were independent predictors of potency return after adjusting for age and nerve sparing. CONCLUSIONS The high cost of medication remains a significant barrier to maintaining therapy. Noncompliance to PDE5I therapy in a tertiary care centre was much higher than reported in clinical trial settings. With longer-term follow-up, we need to further define the factors that improve overall recovery of sexual function after RAP. [source] The Diffusion of Rights: From Law on the Books to Organizational Rights PracticesLAW & SOCIETY REVIEW, Issue 3 2006Jeb Barnes How does law change society? To gain new leverage on this long-standing question, this article draws on two lines of research that often ignore each other: political science research on the mobilization of law, and sociological research on the diffusion of organizational practices. Our insights stem from six case studies of diverse organizations' responses to the accommodation provisions in the Americans with Disabilities Act and related state laws. We found that different modes of exposure to the law combined with organizational attributes to produce distinct "rights practices",styles of standard operating procedures and informal routines that reflect the understanding of legal requirements within an organization. The diversity of the organizational responses challenges simple dichotomies between compliance/noncompliance, change through deterrence/change through norms, and mobilization/nonmobilization, and it underscores the importance of combining political science and sociological perspectives on law and social change. [source] Advanced Heart Failure: Prognosis, Uncertainty, and Decision MakingCONGESTIVE HEART FAILURE, Issue 5 2007Jane G. Zapka ScD Heart failure is a serious clinical management challenge for both patients and primary care physicians. The authors studied the perceptions and practices of internal medicine residents and faculty at an academic medical center in the Southeast to guide design of strategies to improve heart failure care. Data were collected via a self-administered survey. Eighty-nine faculty and resident physicians in general internal medicine and geriatrics participated (74% response rate). Items measured perceived skills and barriers, adherence to guidelines, and physician understanding of patient prognosis. Case studies explored practice approaches. Clinical knowledge and related scales were generally good and comparable between physician groups. Palliative care and prognostic skills were self-rated with wide variance. Physicians rated patient noncompliance and low lifestyle change motivation as major barriers. Given the complexities of caring for elderly persons with heart failure and comorbid conditions, there are significant opportunities for improving physician skills in decision making, patient-centered counseling, and palliative care. [source] New Insights into the Clinical Management of Partial EpilepsiesEPILEPSIA, Issue S5 2000Prof. Edouard Hirsch Summary The diagnosis, treatment, and prognosis of seizure disorders depend on the correct identification of epileptic syndromes. Partial epilepsies are heterogeneous and can be divided into idiopathic, cryptogenic, and symptomatic epilepsies. The most common of the idiopathic localization-related epilepsies is benign epilepsy with rolandic or centrotemporal spikes (BECTS). Seizures remain rare and the use of antiepileptic drug (AED) treatment in all patients does not appear justified. Children who present with some of the electroclinical characteristics of BECTS may also display severe unusual neurologic, neuropsychological, or atypical symptoms. In some cases, carbamazepine has been implicated as a triggering factor. Primary reading epilepsy and idiopathic occipital lobe epilepsies with photosensitivity are examples of an overlap between idiopathic localization-related and generalized epilepsies and respond well to sodium valproate. Autosomal dominant nocturnal frontal lobe epilepsy and benign familial infantile convulsions are recently described syndromes, differing in several ways from classical idiopathic localization-related epileptic syndromes. In cryptogenic or symptomatic epilepsy, the topography of the epileptogenic zone might influence drug efficacy. An individualized approach to AED selection, tailored to each patient's needs, should be used. Resistance of seizures to antiepileptic therapy may be due to diagnostic and/or treatment error or may be the result of noncompliance. Increasing the dosage, discontinuation or replacement of a drug, or addition of a second drug is indicated in truly resistant cases. The use of more than two AEDs rarely optimizes seizure control, and in some cases reduction of treatment may improve seizure control while lessening side effects. EEG-video assessment of patients with refractory epilepsy is important. Indications for and timing of epilepsy surgery should be reconsidered. Surgical therapy should probably be used more often and earlier than it is at present. [source] Emergency Medicine Resident Documentation: Results of the 1999 American Board of Emergency Medicine In-Training Examination SurveyACADEMIC EMERGENCY MEDICINE, Issue 10 2000John Howell MD Abstract. Objectives: To assess how emergency medicine (EM) residents perform medical record documentation, and how well they comply with Health Care Financing Administration (HCFA) Medicare charting guidelines. In addition, the study investigated their abilities and confidence with billing and coding of patient care visits and procedures performed in the emergency department (ED). Finally, the study assessed their exposure to both online faculty instruction and formal didactic experience with this component of their curriculum. Methods: A survey was conducted consisting of closed-ended questions investigating medical record documentation in the ED. The survey was distributed to all EM residents, EM,internal medicine, and EM,pediatrics residents taking the 1999 American Board of Emergency Medicine (ABEM) In-Training examination. Five EM residents and the Society for Academic Emergency Medicine (SAEM) board of directors prevalidated the survey. Summary statistics were calculated and resident levels were compared for each question using either chi-square or Fisher's exact test. Alpha was 0.05 for all comparisons. Results: Completed surveys were returned from 88.5% of the respondents. A small minority of the residents code their own charts (6%). Patient encounters are most frequently documented on free-form handwritten charts (38%), and a total of 76% of the respondents reported using handwritten forms as a portion of the patient's final chart. Twenty-nine percent reported delays of more than 30 minutes to access medical record information for a patient evaluated in their ED within the previous 72 hours. Twenty-five percent "never" record their supervising faculty's involvement in patient care, and another 25% record that information "1-25%" of the time. Seventy-nine percent are "never" or "rarely" requested by their faculty to clarify or add to medical records for billing purposes. Only 4% of the EM residents were "extremely confident" in their ability to perform billing and coding, and more than 80% reported not knowing the physician charges for services or procedures performed in the ED. Conclusions: The handwritten chart is the most widely used method of patient care documentation, either entirely or as a component of a templated chart. Most EM residents do not document their faculty's participation in the care of patients. This could lead to overestimation of faculty noncompliance with HCFA billing guidelines. Emergency medicine residents are not confident in their knowledge of medical record documentation and coding procedures, nor of charges for services rendered in the ED. [source] Behavioral Facilitation of Medical Treatment for Headache,Part II: Theoretical Models and Behavioral Strategies for Improving AdherenceHEADACHE, Issue 9 2006Jeanetta C. Rains PhD This is the second of 2 articles addressing the problem of noncompliance in medical practice and, more specifically, compliance with headache treatment. The companion paper describes the problem of noncompliance in medical practice and reviews literature addressing compliance in headache care (Behavioral Facilitation of Medical Treatment for Headache,Part I: Review of Headache Treatment Compliance). The present paper first summarizes relevant health behavior theory to help account for the myriad biopsychosocial determinants of adherence, as well as patient's shifting responsiveness or "readiness for change" over time. Appreciation of health behavior models may assist in optimally tailoring interventions to patient needs through instructional, motivational, and behavioral treatment strategies. A wide range of specific cognitive and behavioral compliance-enhancing interventions are described, which may facilitate treatment adherence among headache patients. Strategies address patient education, patient/provider interaction, dosing regimens, psychiatric comorbidities, self-efficacy enhancement, and other behavioral interventions. [source] An Incenter Nocturnal Hemodialysis Program,Three Years ExperienceHEMODIALYSIS INTERNATIONAL, Issue 1 2003M. Gene Radford We report our experience with a program of long, slow, overnight hemodialysis (HD) performed 3 times a week in an existing dialysis facility. Beginning in April 1999, 14 chairs in one bay of our facility were replaced with beds, subdued lighting was installed, and machine alarms were decreased to minimum volume. Fresenius F60 dialyzers were selected with a QB of 220,300 ml/min and a QD of 400,500 ml/min. Patients dialyze for 7,8 hrs overnight. Staffing is with 1 nurse and 1 PCT for 10 patients. Standard dialysate is used, and heparin is dosed 100 U/kg at treatment initiation and again at mid-treatment. All access types are utilized. The program is open to all patients in our area. A total of 65 patients have participated, with a current census of 20 patients. Participants have tried nocturnal dialysis for a variety of reasons including work/school schedules, excessive interdialytic weight gains, inadequate dialysis (due to poor access function or large body mass), and hemodynamic instability with standard daytime HD. Blood pressure control has improved among the participants in the program, perhaps due to more gentle ultrafiltration and improvement in maintenance of dry weight. Among 31 patients who remained on nocturnal dialysis for over 6 months, 21 started the program on an average of 2.5 antihypertensive agents (AHA). After 6 months, 9 patients no longer needed AHA while 12 patients remain on an average of 1.3 AHA. URR also improved by an average of 4.35 among 13 patients who transferred from standard incenter HD to the nocturnal program. In all, 45 patients have left the program, for reasons which include insomnia/social (15), death (9), transfer to home HD (8), renal transplantation (6), noncompliance (3), moved away (2), and other (2). In conclusion, long overnight HD can be performed in an existing dialysis facility, providing patients with another HD option. Patients who may benefit from this modality include those with daytime jobs, patients with inadequate clearance on standard HD, patients with excessive interdialytic weight gains, and those who poorly tolerate standard HD. [source] Rates of adherence to pharmacological treatment among children and adolescents with attention deficit hyperactivity disorderHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2002El Sheikh R. Ibrahim Abstract Pharmacological intervention, mainly with psychostimulants, alone or with psychotherapy or behavioural modification, was found to be effective in increasing sustained attention span, improving concentration, reducing hyperactive behaviour and improving areas of academic deficits in children and adolescents with the diagnosis of attention deficit-hyperactivity disorder (ADHD). Despite their proven efficacy, noncompliance of the children and adolescents to the prescribed medication presents serious problems to patients and health care providers alike. Objective To investigate the rate of adherence to prescribed medication in a clinically referred sample of children and adolescents diagnosed as having ADHD. In addition, the stability of reports of adherence over a 3 month period was explored. Method Fifty-one children and adolescents (males: n,=,42; females: n,=,9) between the age of 7 years and 16.6 years diagnosed with ADHD and their parents were administered a children behaviour checklist, a teacher report form scale and a compliance with treatement opinion and attitude scale. Results There were very high reports of adherence by children to prescribed medications for ADHD with rates of compliance greater than 70%. Correlation between the children and adolescents' reports and the parents' reports revealed high agreement both at the end of week 1 and at the end of the study (week 12). There were also findings of stability of adherence reports over a 3 month period. Conclusion The results of this study documented high rates of adherence to medication prescribed for symptoms of attention deficit hyperactivity disorder in a sample of children and adolescents. Their reports of adherence were well correlated with parents' reports. Several factors were found to be related to the high level of adherence. Copyright © 2002 John Wiley & Sons, Ltd. [source] Evaluation of effluent toxicity as an indicator of aquatic life condition in effluent-dominated streams: A pilot studyINTEGRATED ENVIRONMENTAL ASSESSMENT AND MANAGEMENT, Issue 4 2008Jerry Diamond Abstract The types and quality of data needed to determine relationships between chronic whole effluent toxicity (WET) test results and in-stream biological condition were evaluated using information collected over a 1.5-y period from 6 different sites across the United States. A data-quality-objectives approach was used that included several proposed measurement quality objectives (MQOs) that specified desired precision, bias, and sensitivity of methods used. The 6 facilities used in this study (4 eastern and 2 western United States) all had design effluent concentrations >60% of the stream flow. In addition to at least quarterly chronic Ceriodaphnia dubia, Pimephales promelas (fathead minnow), and Selenastrum capricornutum (green algae) WET tests, other tests were conducted to address MQOs, including splits, duplicates, and blind positive and negative controls. Macroinvertebrate, fish, and periphyton bioassessments were conducted at multiple locations upstream and downstream of each facility. The test acceptance criteria of the US Environmental Protection Agency (USEPA) were met for most WET tests; however, this study demonstrated the need to incorporate other MQOs (minimum and maximum percent significant difference and performance on blind samples) to ensure accurate interpretation of effluent toxicity. More false positives, higher toxicity, and more "failed" (noncompliant) tests were observed using no-observed-effect concentration (NOEC) as compared to the IC25 endpoint (concentration causing ,25% decrease in organism response compared to controls). Algae tests often indicated the most effluent toxicity in this study; however, this test was most susceptible to false positives and high interlaboratory variability. Overall, WET test results exhibited few relationships with bioassessment results even when accounting for actual effluent dilution. In general, neither frequency of WET noncompliance nor magnitude of toxicity in tests were significantly related to differences in biological condition upstream and downstream of a discharge. Periphyton assessments were most able to discriminate small changes downstream of the effluent, followed by macroinvertebrates and fish. Although sampling methods were robust, more replicate samples collected upstream and downstream of each facility were needed to increase detection power. In general, macroinvertebrate and periphyton assessments together appeared to be sufficient to address project objectives. [source] Effect of the correction for noncompliance and contamination on the estimated reduction of metastatic prostate cancer within a randomized screening trial (ERSPC section Rotterdam)INTERNATIONAL JOURNAL OF CANCER, Issue 11 2010Melissa Kerkhof Abstract The European Randomized study of Screening for Prostate Cancer (ERSPC) has recently reported a 20% reduction in death from prostate cancer in a population-based prostate cancer screening (core age group: 55,69 years of age). The effect of screening may be diluted by noncompliance in the screening arm and contamination by PSA testing in the control arm. The purpose is to analyze the effect of prostate cancer screening on the incidence of metastatic prostate cancer, both with and without adjustment for noncompliance and contamination. We analyzed the occurrence of metastases in 42,376 men aged 55,75 years who were randomized in the Rotterdam section of the ERSPC between 1993 and 1999. Contamination adjustment was based on follow-up findings and questionnaire data from all men in the control group who developed prostate cancer and from a random sample of 291 men without cancer who had a PSA test. Prostate cancer screening significantly reduced the occurrence of metastatic prostate cancer in the intention-to-screen analysis [RR 0.75, 95% CI 0.59,0.95, p = 0.02] and more so in adjusted analyses; contamination adjusted RR 0.73, 95% CI 0.56,0.96; noncompliance adjusted RR 0.72, 95% CI 0.55,0.95 and fully adjusted analysis RR 0.68, 95% CI 0.49,0.94, p = 0.02. In the population of ERSPC Rotterdam (N = 42,376 men), screening reduces the risk to be diagnosed with metastatic prostate cancer considerably on population level, an effect which is even more pronounced in men who are in fact screened. [source] The economic consequences of noncompliance in cardiovascular disease and related conditions: a literature reviewINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2008N. Muszbek Summary Objectives:, To review studies on the cost consequences of compliance and/or persistence in cardiovascular disease (CVD) and related conditions (hypertension, dyslipidaemia, diabetes and heart failure) published since 1995, and to evaluate the effects of noncompliance on healthcare expenditure and the cost-effectiveness of pharmaceutical interventions. Methods:, English language papers published between January 1995 and February 2007 that examined compliance/persistence with medication for CVD or related conditions, provided an economic evaluation of pharmacological interventions or cost analysis, and quantified the cost consequences of noncompliance, were identified through database searches. The cost consequences of noncompliance were compared across studies descriptively. Results:, Of the 23 studies identified, 10 focused on hypertension, seven on diabetes, one on dyslipidaemia, one on coronary heart disease, one on heart failure and three covered multiple diseases. In studies assessing drug costs only, increased compliance/persistence led to increased drug costs. However, increased compliance/persistence increased the effectiveness of treatment, leading to a decrease in medical events and non-drug costs. This offset the higher drug costs, leading to savings in overall treatment costs. In studies evaluating the effect of compliance/persistence on the cost-effectiveness of pharmacological interventions, increased compliance/persistence appeared to reduce cost-effectiveness ratios, but the extent of this effect was not quantified. Conclusions:, Noncompliance with cardiovascular and antidiabetic medication is a significant problem. Increased compliance/persistence leads to increased drug costs, but these are offset by reduced non-drug costs, leading to overall cost savings. The effect of noncompliance on the cost-effectiveness of pharmacological interventions is inconclusive and further research is needed to resolve the issue. [source] Evaluation of Nationally Mandated Drug Use Reviews to Improve Patient Safety in Nursing Homes: A Natural ExperimentJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2005Becky Briesacher PhD Objectives: To test whether nationally required drug use reviews reduce exposure to inappropriate medications in nursing homes. Design: Quasi-experimental, longitudinal study. Setting: Data source is the 1997,2000 Medicare Current Beneficiary Survey, a nationally representative survey of Medicare beneficiaries. Participants: Nationally representative population sample of 8 million nursing home (NH) residents (unweighted n=2,242) and a comparative group of 2 million assisted living facility (ALF) residents (unweighted n=664). Measurements: Prevalence and incident use of 38 potentially inappropriate medications compared before and after the policy: 32 restricted for all NH residents and six for residents with certain conditions. Inappropriate medications were stratified by potential for legitimate exceptions: always avoid, rarely appropriate, or some acceptable indications. Results: In July 1999, the Centers for Medicare and Medicaid Services (CMS) mandated expansions to the drug use review policy for nursing home certification. Using explicit criteria, surveyors and consultant pharmacists must evaluate resident records for potentially inappropriate medication exposures and related adverse drug reactions. Nursing homes in noncompliance may receive citations for deficient care. Before the CMS policy, 28.8% (95% confidence interval (CI)=27.3,30.3) of Medicare beneficiaries in NHs and 22.4% (95% CI=19.8,25.0) in ALFs received potentially inappropriate medications. Nearly all prepolicy use came from medications with some acceptable indications: 23.4% in NHs (95% CI=20.4,26.4) and 18.0% in ALFs (95% CI=15.6,20.4). After the policy, exposures in NHs declined to 25.6% (95% CI=24.1,27.1, P<.05), but similar declines occurred in ALFs (19.0%, 95% CI=16.7,21.3, nonsignificant). Postpolicy use of inappropriate medications with exempted indications remained high, and more than half was incident use: 20.6% of NH residents (95% CI=19.0,22.0) and 15.6% of ALF residents (95% CI=15.2,15.7). Use of drugs that are restricted with certain diseases increased 33% in NHs between 1997 and 2000 (from 9.3% to 13.2%; P<.05). Multivariate results detected no postpolicy differences in inappropriate drug use between long-term care facilities with mandatory drug use reviews and those without. Conclusion: Some postpolicy declines were noted in NH use of potentially inappropriate medications, but the decrease was uneven and could not be attributed to the national drug use reviews. This study is the first evaluation of the CMS policy, and it highlights the unclear effectiveness of drug use reviews to improve patient safety in NHs even though state and federal agencies have widely adopted this strategy. [source] Prescription Duration After Drug Copay Changes in Older People: Methodological AspectsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 3 2002Sebastian Schneeweiss MD OBJECTIVES: Impact assessment of drug benefits policies is a growing field of research that is increasingly relevant to healthcare planning for older people. Some cost-containment policies are thought to increase noncompliance. This paper examines mechanisms that can produce spurious reductions in drug utilization measures after drug policy changes when relying on pharmacy dispensing data. Reference pricing, a copayment for expensive medications above a fixed limit, for angiotensin-converting enzyme (ACE) inhibitors in older British Columbia residents, is used as a case example. DESIGN: Time series of 36 months of individual claims data. Longitudinal data analysis, adjusting for autoregressive data. SETTING: Pharmacare, the drug benefits program covering all patients aged 65 and older in the province of British Columbia, Canada. PARTICIPANTS: All noninstitutionalized Pharmacare beneficiaries aged 65 and older who used ACE inhibitors between 1995 and 1997 (N = 119,074). INTERVENTION: The introduction of reference drug pricing for ACE inhibitors for patients aged 65 and older. MEASUREMENTS: Timing and quantity of drug use from a claims database. RESULTS: We observed a transitional sharp decline of 11%± a standard error of 3% (P = .02) in the overall utilization rate of all ACE inhibitors after the policy implementation; five months later, utilization rates had increased, but remained under the predicted prepolicy trend. Coinciding with the sharp decrease, we observed a reduction in prescription duration by 31% in patients switching to no-cost drugs. This reduction may be attributed to increased monitoring for intolerance or treatment failure in switchers, which in turn led to a spurious reduction in total drug utilization. We ruled out the extension of medication use over the prescribed duration through reduced daily doses (prescription stretching) by a quantity-adjusted analysis of prescription duration. CONCLUSION: The analysis of prescription duration after drug policy interventions may provide alternative explanations to apparent short-term reductions in drug utilization and adds important insights to time trend analyses of drug utilization data in the evaluation of drug benefit policy changes. J Am Geriatr Soc 50:521,525, 2002. [source] Beyond the Usual Strategies for Blood Pressure Reduction: Therapeutic Considerations and Combination TherapiesJOURNAL OF CLINICAL HYPERTENSION, Issue 6 2001Thomas D. Giles MD Rapidly accumulating clinical data have repeatedly demonstrated not only the critical importance of even small increases in blood pressure as a pathophysiologic factor in the development of cardiovascular disease, particularly in individuals with diabetes mellitus, but also the therapeutic necessity of more aggressive blood pressure reduction and the achievement of progressively lower blood pressure targets in reducing cardiovascular event rates. JNC VI has defined optimal blood pressure as ,120/80 mm Hg, and Stage 1 hypertension as ,140/80 mm Hg. Target blood pressures are now ,130/80 mm Hg in patients with diabetes and <125/75 mm Hg for patients with hypertensive renal disease with proteinuria of>1 gm/24 hours. Achieving such target pressures is increasingly difficult, particularly in diabetic patients with chronic renal disease, who require complex multidrug antihypertensive regimens. This review attempts to provide some suggestions for constructing such antihypertensive regimens, and provides considerations for the appropriate use of diuretics and the most effective drug combinations. Factors potentially contributing to drug resistant hypertension include such problems as failure to maximize drug dosing, suboptimal diuretic use, noncompliance, and possible confounding effects of such concomitant medications as nonsteroidal and anti-inflammatory drugs or decongestants. The issues underlying drug-resistant hypertension are listed, together with strategies for overcoming this problem. [source] Guidelines to Practice Gap in the Use of Glycoprotein IIb/IIIa Inhibitors: From ISAR-REACT to Overreact?JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2009G. VISWANATHAN M.R.C.P. Adjunctive use of glycoprotein IIb/IIIa inhibitors (GPI) is associated with favorable outcomes following percutaneous coronary intervention (PCI). Guidelines for use of GPI have been published by various national societies including National Institute of Clinical Excellence (NICE), United Kingdom. The latter has not been updated since publication. The impact of contemporary trials such as ISAR-REACT (which showed no benefit of abciximab and 600 mg of clopidogrel compared with 600 mg of clopidogrel alone, in elective patients) on adherence to NICE guidelines is unknown. Methods: We audited use of GPI against NICE guidelines following publication in May 2002. Data were collected from 1,685 patients between September and November in years 2002, 2003, 2004, and 2007. Results: In 2002 and 2003, only 10.2% and 11.8%, respectively, of patients were noncompliant to NICE guidelines. Over time, there was an increase in patients not given GPI despite meeting NICE criteria. After publication of ISAR-REACT, the comparative figures for noncompliance in 2004 and 2007 were 40.0% and 44.5%. A similar pattern was seen in patients with diabetes; in 2002 and 2003 noncompliance was 16.7% and 11.1%, respectively, and in 2004 and 2007 noncompliance was 38.0% and 44.7%, respectively. Qualitatively, similar findings were recorded in patients with NSTE-ACS. The overall noncompliance to NICE guidelines increased from 11.0% to 42.1% (P < 0.0001) after the ISAR-REACT study. Conclusions: We found a decline in compliance to NICE guidelines on GPI usage during PCI. This was likely influenced by contemporary trials demonstrating little or no benefit of GPI in patients undergoing elective PCI who are adequately pretreated with clopidogrel. Our findings suggest the need for a mechanism whereby regular updates to guidelines can be disseminated following new trial evidence. [source] Feasibility of Using Interactive Voice Response to Monitor Daily Drinking, Moods, and Relationship Processes on a Daily Basis in Alcoholic CouplesALCOHOLISM, Issue 3 2010James A. Cranford Background:, Daily process research on alcohol involvement has used paper-and-pencil and electronic data collection methods, but no studies have yet tested the feasibility of using Interactive Voice Response (IVR) technology to monitor drinking, affective, and social interactional processes among alcoholic (ALC) couples. This study tested the feasibility of using IVR with n = 54 ALC couples. Methods:, Participants were n = 54 couples (probands who met criteria for a past 1-year alcohol use disorder and their partners) recruited from a substance abuse treatment center and the local community. Probands and their partners reported on their daily drinking, marital interactions, and moods once a day for 14 consecutive days using an IVR system. Probands and partners were on average 43.4 and 43.0 years old, respectively. Results:, Participants completed a total of 1,418 out of a possible 1,512 diary days for an overall compliance rate of 93.8%. ALC probands completed an average of 13.3 (1.0) diary reports, and partners completed an average of 13.2 (1.0) diary reports. On average, daily IVR calls lasted 7.8 (3.0) minutes for ALC probands and 7.6 (3.0) minutes for partners. Compliance was significantly lower on weekend days (Fridays and Saturdays) compared to other weekdays for probands and spouses. Although today's intoxication predicted tomorrow's noncompliance for probands but not spouses, the strongest predictor of proband's compliance was their spouse's compliance. Daily anxiety and marital conflict were associated with daily IVR nonresponse, which triggered automated reminder calls. Conclusions:, Findings supported that IVR is a useful method for collecting daily drinking, mood, and relationship process data from alcoholic couples. Probands' compliance is strongly associated with their partners' compliance, and automated IVR calls may facilitate compliance on high anxiety, high conflict days. 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