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Results for “Patient Dropouts”

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PubMed2003

Promising outcome of a hip school for patients with hip dysfunction.

OBJECTIVE: To evaluate, in an exploratory study, a hip school led by physical therapists for patients with hip dysfunction including pain. METHODS: Physicians in primary care and orthopedic units consecutively recruited patients by residential area to a treatment group (T group; n = 77) and a control group (C group; n = 68), mean age 61.8 years, 59 men, 86 women. Ninety-nine of the 145 subjects had radiologic hip osteoarthritis. Outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Nottingham Health Profile (NHP). RESULTS: After hip school (6 months) the T group showed greater reduction on the subscales of pain and activity limitations (WOMAC) than the C group. The subscales sleep disturbances, pain, and physical mobility (NHP) showed improvement for the T group compared with at start. The results for the T group persisted after an additional 6 months. CONCLUSION: A hip school may reduce pain and activity limitations and improve health-related quality of life for patients with hip dysfunction including pain.

Adult↗
PubMed2005

Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus.

OBJECTIVE: The effectiveness of aggressive management of traditional risk factors for accelerated atherosclerosis in systemic lupus erythematosus (SLE) has been advocated but not proven. We conducted a pilot, randomized, controlled trial of known prevention medications (pravastatin, ramipril, aspirin, and a combination B vitamin) plus individualized cardiovascular prevention education. We describe our experience in recruiting and retaining patients with SLE in this trial. METHODS: Patients with SLE by American College of Rheumatology criteria who lived within 1 hour of the hospital and had visits within the past 3 years were screened. All eligible patients were contacted by the principal investigator who was not their physician. The reasons for nonparticipation were elicited in a nonjudgmental manner. RESULTS: A total of 662 patients met the selection criteria for the study. Of these, 295 patients (45%) with contraindications to study medications were excluded. Ninety-seven (40%) of 244 eligible patients refused to participate. More than 40% of those phoned were unwilling to participate and, among those, 19% felt they were too sick, too well, or taking too many medications already. A total of 41 patients were enrolled in the trial, and 22 dropped out within 4 months. CONCLUSION: SLE is a chronic disease, and the development and testing of interventions aimed at the prevention of long-term sequelae are of paramount importance. Prevention trials in SLE face serious challenges, including the recruitment and retention of participants. Our experience provides insights into the barriers to participation in randomized prevention trials in SLE.

Anticholesteremic Agents↗
PubMed2007

Effects of radiotherapy with or without chemotherapy on tongue strength and swallowing in patients with oral cancer.

BACKGROUND: Oral tongue strength and swallowing ability are reduced in patients treated with chemoradiotherapy for oral and oropharyngeal cancer. METHODS: Patients with oral or oropharyngeal cancer treated with high-dose chemoradiotherapy underwent tongue strength, swallowing, and dietary assessments at pretreatment and 1, 3, 6, and 12 months posttreatment. Tongue strength was assessed using the Iowa Oral Performance Instrument (IOPI). Oral and pharyngeal residue was evaluated utilizing videofluoroscopy. RESULTS: Mean maximum tongue strength dropped a nonsignificant amount immediately after treatment, and then increased significantly at 6- and 12-months posttreatment completion. Analyses were adjusted for patient dropout. Tongue strength was not significantly correlated with swallow observations of percentage oral and pharyngeal residue. Ability to eat various diet consistencies was reduced after treatment but improved over time at a rate similar to changes in oral intake and type of diet. CONCLUSIONS: Parallel but not significant changes in oral intake, diet, and tongue strength in the first year post chemoradiation therapy need further study in a larger population.

Adult↗
PubMed2003

Client and therapist reasons for termination: a conceptualization and preliminary validation.

While the comparison of client and therapist reasons for termination might shed light on their respective views of outcome and process, only one published study has examined directly the reasons given by therapist-client pairs. One barrier to such research is the absence of a systematic conceptualization of reasons for termination that incorporates both therapist and client perspectives. This article describes a comprehensive conceptualization, drawn from the existing literature, and applies a coding system based on that conceptualization to naturalistic clinical data from 123 therapist-client pairs in a psychology training clinic. Coders were able to categorize reliably open-ended client data into reasons for termination. For therapist and client data, the relationships between coding categories and participants' outcome ratings, generally were consistent with expectations, providing limited validation. Some support was found for concordance between therapist and client reasons, especially for those related to therapist or client departures, which were prominent in this setting. As expected, however, therapists were more likely than clients to endorse success as a reason for termination. Negative client feelings about therapy, including dissatisfaction, were reported infrequently as reasons for termination, and with little agreement between clients and therapists, but this may be due to methodological limitations.

Adolescent↗
PubMed2004

Drop-out rates of patients with hepatocellular cancer listed for liver transplantation: outcome with chemoembolization.

Patients with hepatocellular carcinoma (HCC) are assigned model for end stage liver disease (MELD) scores to provide access to liver transplantation (LT). An equitable policy would equate HCC progression beyond acceptable transplantation criteria with death on the waiting list. However, limited information is available regarding this issue. Thus, our aim was to analyze drop-out rates on the waiting list for patients with HCC. Between January 1994 and August 2001, 54 patients with HCC were listed for LT. Patients underwent chemoembolization prior to LT, and were assessed every three months for disease progression until LT. Two patients were stage T1, 45 patients were stage T2, and 7 patients were stage T3 at time of first chemoembolization. Median time was 211 days (range 28-1099 days) for patients that were eventually transplanted. Eight patients were removed from the list. Cumulative probability of drop out on the waiting list, assessed by Kaplan-Meier analysis, was 15% and 25% at 6 and 12 months, respectively. There were no significant differences in age, gender, initial tumor stage, or serum AFP levels in those who eventually underwent LT vs. those who dropped out. In conclusion, neoadjuvant chemoembolization for patients with HCC has a drop-out rate of 15% over 6 months.

Adult↗
PubMed2006

Split and whole liver transplantation outcomes: a comparative cohort study.

A specific split liver transplantation (SLT) program has been pursued in the North Italian Transplant program (NITp) since November 1997. After 5 yr, 1,449 liver transplants were performed in 7 transplant centers, using 1,304 cadaveric donors. Whole liver transplantation (WLT) and SLT were performed in 1,126 and 323 cases, respectively. SLTs were performed in situ as 147 left lateral segments (LLS), 154 right trisegment liver (RTL) grafts, and 22 modified split livers (MSL), used for couples of adult recipients. After a median posttransplant follow-up of 22 months, SLTs achieved a 3-yr patient and graft survival not significantly different from the entire series of transplants (79.4 and 72.2% vs. 80.6 and 74.9%, respectively). Recipients receiving a WLT or a LLS showed significantly better outcomes than patients receiving RTL and MSL (P < 0.03 for patients and P < 0.04 for graft survival). At the multivariate analysis, donor age of >60 yr, RTL transplant, <50 annual transplants volume, urgent transplantation (United Network for Organ Sharing (UNOS) status I and IIA), ischemia time of >7 hours, and retransplantation were factors independently related to graft failure and to significantly worst patient survival. Right grafts procured from RTL and either split procured as MSL had a similar outcome of marginal whole livers. In conclusion, in 5 yr, the increased number of pediatric transplants due to split liver donation reduced to 3% the in-list children mortality, and a decrease in the adult patient dropout rate from 27.2 to 16.2% was observed. Such results justify a more widespread adoption of SLT protocols, organizational difficulties not being a limit for the application of such technique.

Adult↗
PubMed2006

Measuring participation in a prevention trial with parents of young children.

This paper describes parent participation in a clinical trial of preventive parent training (PT) targeting low-income parents of young children. Participation encompassed enrollment, attendance, and engagement. Average enrollment rate was 34.9%, although enrollment rates were significantly higher in the control (39.1%) than in the intervention (30.6%) centers. Parents attended an average of 39% of the PT sessions. Higher attendance was associated with lower parenting self-efficacy, more parent-reported child behavior problems, and attending the first PT session. Level of engagement in the PT sessions was related to improvements in parent and child outcomes. Findings suggest that attendance is linked to parent perceived need for help and that resources should be focused on ensuring parent attendance at the first intervention session.

Adult↗
PubMed2006

Research with families facing cancer: the challenges of accrual and retention.

The purposes of this article are: (a) to describe and analyze the accrual and retention patterns in a longitudinal randomized clinical trial with prostate cancer patients and their partners, and (b) to discuss strategies that were used to overcome challenges in conducting this family-based study. Initially, 429 dyads were referred to the study. Of these, 166 were not enrolled due to refusal (n = 120) or ineligibility (n = 46), 21 of whom did not meet one or more of the inclusion criteria, and 25 of whom could not be reached within the 2-month window of eligibility. Of the 383 eligible dyads, 263 dyads were enrolled (enrollment rate of 68.7%). Accrual and retention patterns differed by research site, referral procedures, and phase of prostate cancer. The retention rate was very good with the majority of dyads (n = 218) completing all three follow-up assessments at 4, 8, and 12 months (82.9%).

Attitude to Health↗
PubMed2006

Methodological issues in the recruitment of cancer pain patients and their caregivers.

Published pain management guidelines recommend that caregivers of cancer pain patients be provided pain management education, but little is known about the utility of providing such information. This study examined recruitment and retention of cancer pain patients and caregivers for a randomized clinical trial that provided psychoeducation and stress management training to caregivers. Of 397 patient/caregiver dyads screened, only 22 (5.5%) were study eligible, consented to participate, and completed the study. A variety of problems hampered successful participation, including a high proportion of non-cancer-related pain syndromes among patients, a high proportion of patients without caregivers, and participants' perception of study burden. Results suggest that researchers should recruit from a broad patient base and limit study burden on participants.

Adult↗
PubMed2006

Community-based recruitment and enrollment for a clinical trial on the sensitive issue of fecal incontinence: the Fiber study.

The recruitment of community-living participants for clinical trials of sensitive topics, when the population is largely hidden and reluctant to self-identify, and the study protocols and procedures intensive, creates significant challenges to researchers. The Fiber Study is an ongoing randomized controlled clinical trial conducted to compare the effectiveness of three dietary fibers with different levels of fermentability for symptom management in community-living adults with fecal incontinence. The researchers developed a staged approach to recruitment using three primary recruitment methods and a three-phase approach to the enrollment process. We have been successful in reaching, recruiting, and enrolling participants in a clinical trial, as well as in effectively managing study resources and staff time.

Adult↗
PubMed2006

Enacting a theory of caring to recruit and retain vulnerable participants for sensitive research.

The recruitment and retention of research participants always presents challenges to researchers. This process is made more complicated when the research being undertaken is socially sensitive and the populations of interest are considered vulnerable. The purpose of this article is to illustrate how Swanson's middle-range theory of caring can be used as a framework for recruitment and retention for studies on sensitive topics that involve vulnerable participants. We provide an overview of the theory as well as illustrations from three separate studies that involved in-depth interviews with vulnerable participants. These studies included parents who had either experienced the death of their infant or were involved in life support decisions because of potentially giving birth to an extremely premature infant (22-25 weeks gestation).

Adaptation, Psychological↗
PubMed2006

Recruitment of African American women to a walking program: eligibility, ineligibility, and attrition during screening.

The purposes of this study were to identify strategies successful in the recruitment of African American (AA) women to a home-based walking program and to examine factors that contribute to attrition, eligibility, and ineligibility during the recruitment screening protocol. Of the 696 women who contacted the researchers, 281 (40.4%) women enrolled in the study, 227 (32.6%) were lost to attrition, and 188 (27%) were ineligible. Those not enrolled due to attrition during screening or ineligibility reported more family risk for cardiovascular disease (CVD) and lived in neighborhoods with higher poverty. Although our recruitment strategies may have been successful in attracting low-income AA women, we were not as successful in preventing their attrition during the screening protocol, particularly for those living in poorer neighborhoods.

Adult↗
PubMed2002

Study control, violators, inclusion criteria and defining explanatory and pragmatic trials.

Important differences between explanatory and pragmatic studies were originally argued by Schwartz and Lellouch. Three important differences between the two types of study involve study control, study violators and inclusion criteria. It was originally argued that explanatory studies are highly controlled, and pragmatic studies may be looser and more like 'real life'. It was argued that an explanatory study should only analyse those receiving treatment, and a pragmatic study would analyse all randomized patients. Explanatory trials are said to use homogeneous groups, and pragmatic studies have less selection (better generalizability). Some suggestions are put forward to update the original distinctions between these two attitudes for future study design. Poor study control is undesirable (but might be necessary) and should not be welcomed as pragmatic. The intention-to-treat strategy is now considered as standard for nearly all trials. Homogeneity is a red herring for studies in humans. Inclusion criteria should be minimized and they should not be used to justify claims of representativeness. Routine criticism of randomized controlled trials for being unrepresentative is unwarranted. We should accept that most trials in humans are 'explanatory'. The division line should be moved, so that pragmatic studies are in the domain of non-therapeutics and complex treatments.

Humans↗
PubMed2003

Last observation carry-forward and last observation analysis.

Drop-out often occurs in clinical trials with multiple visits and drop-out is often informative in the sense that the population of patients who dropped out is different from the population of patients who completed the study. To handle data with informative drop-out, an intention-to-treat analysis, which evaluates treatment effects over the population of all randomized patients with at least one post-treatment evaluation, is often required by the regulatory agencies. As a popular and simple intention-to-treat analysis, the last observation carry-forward (LOCF) analysis of variance (ANOVA) performs a statistical test for treatment effects by treating the last observation prior to drop-out as the observation from the last visit. Although discussions, examples and limited empirical results about the LOCF analysis can be found, its theoretical property is unclear. We find that the LOCF one-way ANOVA test is actually asymptotically valid (that is, its asymptotic size is equal to the nominal size) in the special but important case where only two treatments are compared and the two treatment groups have the same number of patients, regardless of whether drop-out is informative or not. In other cases, however, the asymptotic size of the LOCF test is different from the nominal size and is often too small when drop-out is informative, which results in a loss in power of detecting treatment effects, a disadvantage to drug companies. We propose an asymptotically valid test for comparing the global means over subpopulations, where each subpopulation contains patients dropping out after a particular visit. Some simulation results are presented to study the finite sample performance of the LOCF test and our proposed test.

Analysis of Variance↗
PubMed2005

Verification bias-corrected estimators of the relative true and false positive rates of two binary screening tests.

The relative accuracy of two binary screening tests can be quantified by estimating the relative true positive rate (rTPR) and relative false positive rate (rFPR) between the two tests. Ideally all study subjects are administered both screening tests as well as a gold standard to determine disease status. In practice, however, often the gold standard is so invasive or costly that only a percentage of study subjects receive disease verification and the percentage differs depending on the results of the two screening tests. This is known as verification-biased sampling and may be by design or due to differential patient dropout or refusal to have the gold standard test administered. In this paper, maximum likelihood estimators of rTPR and rFPR and corresponding confidence intervals are developed for studies with verification-biased sampling assuming that disease status is missing at random (MAR). Simulation studies are used to show that if the MAR assumption holds, then the verification bias-corrected point estimators have little small sample bias and the confidence intervals have good coverage probabilities. Simulation studies also demonstrate that the verification bias-corrected point estimators may not be robust to violation of the MAR assumption. The proposed methods are illustrated using data from a study comparing the accuracy of Papanicolaou and human papillomavirus tests for detecting cervical cancer.

Adolescent↗
PubMed2001

Using observational data to estimate prognosis: an example using a coronary artery disease registry.

With the proliferation of clinical data registries and the rising expense of clinical trials, observational data sources are increasingly providing evidence for clinical decision making. These data are viewed as complementary to randomized clinical trials (RCT). While not as rigorous a methodological design, observational studies yield important information about effectiveness of treatment, as compared with the efficacy results of RCTs. In addition, these studies often have the advantage of providing longer-term follow-up, beyond that of clinical trials. Hence, they are useful for assessing and comparing patients' long-term prognosis under different treatment strategies. For patients with coronary artery disease, many observational comparisons have focused on medical therapy versus interventional procedures. In addition to the well-studied problem of treatment selection bias (which is not the focus of the present study), three significant methodological problems must be addressed in the analysis of these data: (i) designation of the therapeutic arms in the presence of early deaths, withdrawals, and treatment cross-overs; (ii) identification of an equitable starting point for attributing survival time; (iii) site to site variability in short-term mortality. This paper discusses these issues and suggests strategies to deal with them. A proposed methodology is developed, applied and evaluated on a large observational database that has long-term follow-up on nearly 10 000 patients.

Analysis of Variance↗