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Infertility treatment dropout and insurance coverage.

OBJECTIVE: To assess early patient dropout rates during infertility treatment as a potential measure of wasted resources. METHODS: The study involved multifaceted population cohorts, including a prospectively observed captive health maintenance organization (HMO) population and retrospectively selected preferred provider organization (PPO) patients. One hundred twenty-eight HMO couples were followed prospectively for 6 months. The insurance carrier retroactively selected 96 couples from their PPO population who were believed to be infertility patients. They were matched by date, age, and time of hysterosalpingography to infertility patients in the carrier's HMO population. Patients were considered treatment dropouts if they either requested their provider to abandon further work-up or treatment, or if they failed to return for an appointment for 3 months. RESULTS: Forty-six of 128 (36%) HMO patients followed prospectively discontinued care within 180 days, with only eight (6.3%) providing defined reasons. Preferred provider organization patients uniformly demonstrated significantly higher dropout rates than HMO patients, a finding already apparent at 60 days (P < .002; odds ratio [OR] 3.67, 95% confidence interval [CI] 1.47-9.97) and 120 days of treatment (P = .002; OR 2.87, 95% CI 1.39-6.06). Among PPO patients, dropout rates were especially pronounced if infertility care was provided by generalists. At billing levels of at least $2000, HMO patients also demonstrated less dropout than PPO patients (P < .001; OR 6.14, 95% CI 2.72-14.79), with generalists again demonstrating a significantly larger patient loss than infertility specialists (P < .001; OR 0.18, 95% CI 0.66-0.49). CONCLUSION: Infertility patients demonstrate a surprisingly large early dropout rate, which is significantly larger if patients receive infertility care from generalists rather than specialists. Newly presenting infertility patients should be carefully evaluated, especially in indemnity situations, before expensive diagnostic and therapeutic interventions are ordered.

Adult↗

A prospective randomized comparison of the Swan neck, coiled, and straight Tenckhoff catheters in patients on CAPD.

Our objective was to study the impact of peritoneal catheter configuration on continuous ambulatory peritoneal dialysis (CAPD)-related infections, mechanical complications, and patient dropout in a prospective randomized trial. Forty consecutive patients who were commencing CAPD were randomized to receive either a double-cuff, Swan neck coiled catheter or a double-cuff, straight Tenckhoff catheter, implanted by surgical technique. There was no significant difference in the peritonitis rate between the two groups. There was a lower rate of exit-site infection in the Swan neck group compared to the straight catheter group (0.29 vs 0.60 episodes/patient-year, p < 0.05). Catheter-tip migration occurred in 3 patients with the straight catheters compared to one patient with the Swan neck catheter. No patient had to discontinue CAPD because of mechanical complications. The number of CAPD patient dropouts was not significantly different between the two groups. The Swan neck configuration resulted in a significant reduction in the rate of exit-site infections. The coiled component of the catheter may lead to fewer episodes of catheter-tip migration. However, catheter configuration did not influence the number of technique failures.

Aged↗

Effect of cause and time of dropout on the residual GFR: a comparative analysis of the decline of GFR on dialysis.

BACKGROUND: The decline of residual renal function (RRF) on dialysis has been reported to be slower in peritoneal dialysis (PD) then hemodialysis (HD). However, some clinicians have questioned whether this reported difference might not be caused by selection bias. In particular, if continuous ambulatory PD (CAPD) delivers only marginally adequate therapy as some clinicians speculate, then perhaps those patients on CAPD with low glomerular filtration rate (GFR) are purposefully switched to HD. If true, transferring CAPD patients with low GFR to HD could create a selection bias that very well may account for the differences in GFR between PD and HD. This is particularly problematic if one then censors patients at the time of transfer from PD to HD from analysis (that is, patients are no longer followed in the study once they have switched treatment modalities). When this occurs, the data are said to be informatively censored, a term used by statisticians to describe any kind of systematic bias associated with censored or incomplete data. In particular, informative censoring occurs when patients who die or transfer to another modality very early have an associated lower starting GFR or higher rate of decline of GFR than patients who either complete the study or who die or transfer much later. If patient dropout is indeed related to the rate of decline in GFR and if this relationship differs between PD and HD but is ignored in the analysis, then the results of such analysis may be biased. METHODS: This article analyzes the decline in GFR among 141 incident dialysis patients (39 HD and 102 PD) undergoing either HD or PD at the University of Missouri-Columbia. The decline in GFR was modeled as a nonlinear function of time, taking into account the possibility that missing values of GFR may be associated with patient dropout (death, transfer to another modality, or transplantation). To safeguard against this possibility, we utilized a conditional nonlinear mixed-effects model. The model was used to fit and compare each patient's GFR data to time adjusting for the patient's treatment modality (HD vs. PD), cause of dropout (death, transfer, transplant, lost to follow-up/study ended), and time to dropout. The model allowed a comparison of the starting GFR and the rate of decline in GFR between PD and HD adjusting for these three factors. RESULTS AND CONCLUSIONS: The results of our analysis suggest that such informative censoring is independent of treatment modality and that even after correcting for dropout caused by death or transfer to another modality, patients starting on PD have a lower rate of decline in GFR (that is, better preservation of GFR) than patients starting on HD.

Aged↗

Health-related quality of life predicts outcomes but is not affected by peritoneal clearance: The ADEMEX trial.

BACKGROUND: We hypothesized that increasing small solute clearance in peritoneal dialysis (PD) would lead to improvements in patient health-related quality of life (HRQOL). METHODS: Patients were randomized to a control group [standard 4 x 2 L continuous ambulatory peritoneal dialysis (CAPD)] and an intervention group (CAPD with a target creatinine clearance >/=60 L/week/1.73 m(2)). The Kidney Disease Quality of Life Short Form was obtained at baseline and at 6, 12, and 24 months. Physical (PCS), mental (MCS), and kidney disease component summary (KDCS) scores were computed. RESULTS: The two groups were comparable at baseline with respect to HRQOL. Baseline variables highly predictive of better QOL included absence of diabetes, younger age, higher starting GFR, and serum albumin. Baseline values of QOL were highly predictive of survival and hospitalizations. An unadjusted comparison revealed that patients in the intervention group had significantly higher PCS and KDCS scores at six months. However, there were no significant differences between the intervention and control patients at 12 or 24 months. When similar analyses were carried out adjusting for different patterns of patient dropout, there were no significant differences between the two groups at any time point in terms of PCS, MCS, and KDCS scores. CONCLUSION: We found no evidence of a long-term benefit in HRQOL of CAPD patients by increasing peritoneal small-solute clearances when HRQOL parameters were adjusted for patient dropout. Measures of HRQOL have a significant predictive value for patient survival and hospitalizations.

Adult↗

Estimation of the treatment difference in multicenter trials.

The three fixed effects estimators of a treatment,difference are compared under conditions of random enrollment in a multicenter clinical trial. These comparisons are performed by assuming five different enrollment schemes. The estimators are compared via simulation using their expected mean squared errors. Unlike previous discussions of these three estimators, we take explicit account of the effect of centers that fail to enroll patients to one or both treatment arms. Within each center, we assume enrollment follows a Poisson process and consider the two situations in which the mean rate of this process is the same in every center and in which the mean rates are sampled from a gamma distribution. The effect of patient dropout is studied as well as the effect of increasing the number of centers. Simulations show that for many sound scenarios, the simpler estimator corresponding to the simplest model works better, even for the cases when data are generated by more complex models.

Algorithms↗

[Combination chemotherapy with adriamycin, carboquone and 5-Fu for bladder cancer].

We treated 25 bladder cancer patients with combined cytotoxic chemotherapy of adriamycin (10--20 mg/day administration on days 1, 2 and 3), carboquone (4 mg/day administration on day 1 of weeks 3, 4 and 5 and 5-Fu (200 mg/day for 5 weeks) or futraful suppositories (750 mg/day for 5 weeks) as one course. According to the Koyama - Saitoh criteria, CR + PR was observed in 4 (17.4%) of 23 patients excluding the 2 dropout patients. According to Karnofsky's criteria, an effect with chemotherapy was observed in 9 (39.1%) of the 23 patients. There was a relatively good response rate in a group of 12 patients with the superficial tumors as compared with a group of 11 patients with the deep tumors. There were no severe adverse reactions.

Aged↗

Contrast sensitivity loss is coupled with capillary dropout in patients with diabetes.

PURPOSE: To assess the relationship of foveal microcirculation to contrast sensitivity function in early diabetes mellitus. METHODS: Twenty patients with diabetes with visual acuity of 20/25 or better without clinically significant macular edema were evaluated. Measurements of contrast sensitivity at four spatial frequencies (3, 6, 12, and 18 cycles/degree [c/deg]), macular capillary blood velocity (CBV), capillary density (PIA: perifoveal intercapillary area), foveal avascular zone (FAZ), and microaneurysm count were performed. Contrast sensitivity data collected from age-matched normal subjects and previously published normal angiographic data were used for comparison with our cohort with diabetes. RESULTS: The CBV was significantly reduced (P < 0.0001) and PIA and FAZ were significantly enlarged (P < 0.0001) when compared with healthy subjects. Contrast sensitivity was significantly lower in the group with diabetes at 6 (P = 0.01) and 12 (P = 0.002) c/deg as compared with healthy control values. FAZ and PIA correlated significantly (FAZ; r = -0.60, P = 0.005; PIA; r = -0.54, P = 0.02) with contrast sensitivity at 12 c/deg. CONCLUSIONS: The alterations of the perifoveal network are related to selective disturbances of central visual function as measured by contrast sensitivity. In patients with diabetes measurement of contrast sensitivity may provide a clinical adjunct in further identifying early ischemic diabetic maculopathy.

Adult↗

[Utilization of psychiatric treatment. Who drops out, who comes back and who stays?].

OBJECTIVE: The aim of this study is the prediction of specific factors associated with utilization patterns of mental health care. METHOD: Course of treatment of 272 out-patients and in-patients was observed for one year. Patients were asked five times (baseline, 1 month, 3, 6, and 12 months) about their utilization behavior. RESULTS: 71% of the patients continued treatment, 6% ended treatment in agreement with their therapists, and 23% dropped out of treatment. 24 patients of those who dropped out, i.e. 38% of this subgroup, returned to treatment during the one year period. Multivariate analyses indicate that continuity of treatment is associated with referrals from other institutions, male gender, the diagnosis of functional psychosis, high subjective well-being, and poor social functioning. First-time use of the corresponding institution, in-patient status, and living alone are predictors of treatment-dropout. Patients who ended treatment in agreement with their therapists are the best socially integrated group. Drop-outs who returned to treatment during the one year period have more unfavorable clinical premises, and are less well integrated socially than drop-outs who do not take up their treatment again. CONCLUSIONS: Therapeutic interventions, such as permanent efforts towards the maintenance of a supportive therapeutic relationship, motivate psychiatric patients to keep a continuing treatment-alliance. Well functioning communication between, or rather coordination of out-patient and in-patient treatment increases the chance of a continuous course of treatment.

Adult↗

Comparison of alternative strategies for analysis of longitudinal trials with dropouts.

PROBLEM: Patients may withdraw from longitudinal clinical trials for many reasons. Methods for handling the problem presented by missing data of patients who withdraw before reaching the time point of the primary measurement include carrying the last observation forward (LOCF), data as observed analysis (DAO), mixed model approaches, and pattern mixture models. METHOD: We evaluate a multiple imputation (MI) approach that has the flexibility to adjust inferences about the treatment effect for the withdrawn patients relative to currently used alternatives. Sensitivity analyses are performed under a collection of scenarios that include many circumstances that may arise in practice, including different assumptions about treatment effects post-withdrawal and about the missing data mechanism. Simulations are used to compare the results of analyses based on the MI approach with those based on the LOCF, DAO, and the mixed model approaches. RESULTS: The LOCF and DAO approaches cannot be recommended as strategies for handling missing responses, at least for these scenarios, because they provide biased estimates of treatment effects and biased tests of the null hypothesis of no treatment effect. Application of the various approaches to the analysis of clinical data from a longitudinal trial confirms the underestimation of the variability when the LOCF approach is used.

Analysis of Variance↗

Dropout from 12-step self-help groups: prevalence, predictors, and counteracting treatment influences.

Attendance at 12-step self-help groups is frequently recommended as an adjunct to professional substance use disorder (SUD) treatment, yet patient dropout from these groups is common. This study assessed the prevalence, predictors, and treatment-related factors affecting dropout in the first year following treatment for 2,778 male patients. Of these, 91% (2,518) were identified as having attended 12-step groups either in the 90 days prior to, or during, treatment. At 1-year followup 40% had dropped out. A number of baseline factors predicted dropout. Importantly, patients who initiated 12-step behaviors during treatment were less likely to drop out. Further findings suggest patients at highest risk for dropout may be at lower risk if treated in a more supportive environment. Clinicians may decrease the likelihood of dropout directly, by screening for risk factors and focusing facilitation efforts accordingly, and indirectly, by increasing the supportiveness of the treatment environment, and facilitating 12-step involvement during treatment.

Adult↗

Interferon beta treatment in relapsing-remitting multiple sclerosis: a post-marketing study in Lombardia, Italy. Multiple Sclerosis Centers of Lombardia, Italy.

The aim of the study was to evaluate the efficacy of interferon beta-1a (IFN-beta-1a) and beta-1b (IFN-beta-1b) in clinical practice for the treatment of relapsing-remitting multiple sclerosis (RR MS). Patients were selected and prospectively monitored according to a predefined protocol. An appropriate form was prepared to collect clinical data of multiple sclerosis patients attending the MS Centers of Lombardia, Italy. On 30 June 1998, 317 patients were treated with IFN-beta-1b and 156 with IFN-beta-1a. Basal expanded disability status scale (EDSS) and relapse frequency were similar in both groups of patients. The annual relapse rate consistently decreased from 1.76 to 0.63 at 1 year and to 0.51 at 2 years for the IFN-beta-1b group and from 1.6 to 1.0 at 1 year for the IFN-beta-1a group. Disability remained stable in most patients. Dropouts (20.5%) were affected by more active disease compared to patients who continued to be treated. This study confirms the efficacy of both treatments, showing a more marked effect than expected from the clinical trials' results, probably due to differences in selection criteria and exclusion of dropouts.

Adjuvants, Immunologic↗

Suprofen. An overview of long-term safety.

Suprofen, a new oral peripherally acting analgesic agent, has been shown to be effective in the relief of acute and chronic pain. This paper reviews data relative to long-term safety from more than 800 patients who received suprofen. Some of these patients were followed up to 2 years. Suprofen was generally found to be at least as safe and as well tolerated as reference drugs of aspirin, propoxyphene and propoxyphene combination. The discontinuance rate because of side effects was 17.7% for patients receiving suprofen and 23.9% for patients receiving reference drugs. Gastrointestinal side effects were the most frequently reported reasons for all patient dropout in all treatment groups. Fewer patients receiving suprofen discontinued due to gastrointestinal side effects (10.9%) than with reference drugs (17.2%).

Adult↗

Retention in psychosocial treatment of cocaine dependence: predictors and impact on outcome.

This report describes retention in treatment in the National Institute on Drug Abuse Collaborative Cocaine Treatment Study (CCTS), a multi-site trial of four psychosocial treatments for 487 cocaine dependent patients. Younger, African-American, and unemployed patients were retained in treatment for fewer days than their counterparts. African-American patients who lived with a partner were retained in treatment for less time than if they lived alone. Higher psychiatric severity kept men in treatment longer but put women at risk for dropping out sooner. Patients who completed the full treatment used drugs less often than patients who dropped out, but outcome did not differ at each month. Patients in the drug counseling condition stayed in treatment for fewer days than patients in psychotherapy, but they were more likely to be abstinent after dropout. Patients with higher psychiatric severity were more at risk for continuing to use drugs after dropout.

Adult↗

Reasons for dropout from exercise programs in post-coronary patients.

The dropout rate in the 7-yr Ontario Exercise Heart Collaborative Study of post-coronary men engaged in exercise programs was examined in order to determine possible contributing factors. A questionnaire pertaining to psychosocial and program-related variables was distributed to 728 subjects who were previously assigned randomly on the basis of four prognostic risk factors (occupation, personality, hypertension, and angina) into exercise groups: low intensity exercise (LIE), and high intensity exercise (HIE). Comparisons of answers by the 639 respondents (266 dropouts; 373 compliers) were made initially by chi-square analysis to determine significant categories of questions and, subsequently, by a logistic transform to determine the specific questions which related significantly to the dropout rate. It was found that three main categories were associated with a high dropout rate: convenience aspects of the exercise center, perceptions of the exercise program, and family/lifestyle factors. These three main categories should be carefully considered when designing and implementing potential compliance-improving strategies for secondary prevention exercise programs entailing long-term adherence.

Angina Pectoris↗