Sample sizes and withdrawals in clinical trials.
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Angina Pectoris↗
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Factors associated with unplanned discharge from psychiatric day treatment programs. A multicenter study.
This study describes and evaluates the adequacy of sociodemographic and clinical descriptors as potential predictors of unplanned discharge from and completion of psychiatric day treatment programs. A 2-year retrospective chart review was completed on all patients (N = 327) attending three university-affiliated day treatment programs. Statistical comparisons were made between those patients who completed and those who had unplanned discharge. Logistic regression was used to generate a predictive model of unplanned discharge using identified variables. The rate of unplanned discharge was 54%. Factors associated with program completion were diagnoses of major depression or posttraumatic stress disorder, a history of completing a prior day treatment program, and higher education levels. Active substance abuse and a history of three or more inpatient admissions were associated with unplanned discharge. The predictive model was able to correctly classify 71% of patients completing day treatment programs and 43% of patients with unplanned discharges. Traditional demographic and clinical variables contribute differentially to program completion/noncompletion. Given the relatively poor predictability of unplanned discharge in this study, patient selection practices based on these factors alone may be somewhat limiting. Interactive effects of patient and program characteristics need to be addressed to improve program outcome.
Adult↗
Rheumatic fever and rheumatic heart disease: clinical profile of 550 cases in India.
BACKGROUND: The aims and objectives of this paper were to analyze the clinical presentation of children with rheumatic fever (RF) and rheumatic heart disease (RHD), to determine the cardiac sequel of RF and valvular affection due to RF, and to study clinical manifestations in recurrences of RF. METHODS: Our study, a retrospective analysis, was conducted at a tertiary-care teaching hospital with specialty follow-up clinic for patients with RF/RHD. This retrospective study was conducted to include a period of 31 years (from January 1971 through December 2001). Pre-completed case protocols of patients with RF/RHD were analyzed to record the following information: demographic data; clinical features on admission/presentation; relevant investigations; recurrences; cardiac valvular affection, and outcome. Modified Jones' criteria were used for diagnosis of RF. RESULTS: The study included 550 patients. Mean age of presentation was 9.62 years and sex ratio was 1.15:1 favoring males. A total of 250 patients presented with initial/first attack of RF. Arthritis and carditis were seen in 169 (67.6%) and 105 cases (42%), respectively. Chorea was seen in 47 cases (18.8%) and erythema marginatum, in four. A total of 224 patients presented with recurrence of RF (with pre-existing RHD). Arthritis and carditis were seen in 109 (48.66%) and 178 cases (79.46%), respectively, in these patients; 76 cases presented with chronic RHD. Mitral regurgitation was the most common cardiac valvular lesion observed (150 cases) followed by a combination of mitral stenosis and mitral regurgitation (98 cases). Congestive cardiac failure was seen in 201 cases (36.54%) and infective endocarditis in 30 (5.45%). 2-D echocardiography and/or color Doppler was performed in 201 patients (36.54%). Average duration of follow-up was 3.19 years; 74.72% of cases were lost to follow-up. Benzathine penicillin prophylaxis was regular in 42.18% cases. Positive family history of RF/RHD was present in 2% of cases. Twenty three patients (4.18%) died. CONCLUSIONS: Arthritis was the most common manifestation in the initial attack of RF, while carditis was the most common manifestation in patients presenting with rheumatic recurrences (with pre-existing RHD) and mitral regurgitation was the most common valvular lesion. Rate of patient dropout from penicillin prophylaxis was high. Clinical manifestations in initial/first attack of RF have not significantly changed in the last 31 years.
Adolescent↗
Understanding and evaluating clinical trials.
In this review, we attempt to provide the basic knowledge necessary to understand and evaluate clinical trials because properly conducted, randomized clinical trials are the best sources for determining the best available treatment. Other commonly used sources rarely provide sufficient detail necessary to determine the efficacy and safety of any treatment, and they often contain biases or pitfalls that make them unacceptable or unreliable. Our method for reviewing clinical trials allows a busy clinician to use his or her time most efficiently by deciding not to read the majority of poorly conceived, designed, executed, or reported trials and those trials with insignificant results. It provides a means to determine the quality of the trials that one does decide to read and to retain and retrieve the information when it is needed. The method involves recognizing and evaluating the features that strengthen clinical trials and help validate their conclusions. These features include proper selection and allocation of patients, inclusion of an appropriate control group, randomization, prior selection of clinically and biologically important outcome variables, blinding of assessment, consideration of patient compliance and drop out, and proper presentation and statistical analysis of results.
Bias↗
Emergency department patients who leave without seeing a physician: the Toronto Hospital experience.
STUDY OBJECTIVES: To determine why emergency department patients leave without being seen by a physician and whether they receive alternate medical care. DESIGN: A prospective, cross-sectional study of patients who left without being seen. Charts were reviewed for population demographics, presenting complaints, and clinical acuity rating. Follow-up was achieved within 6 weeks through mailed survey questionnaires and telephone interviews. SETTING: Two inner-city EDs of the Toronto Hospital, a quaternary care facility. PARTICIPANTS: All 423 patients who registered for care and left without being seen during a 16-week period from January to May 1991. RESULTS: Of 23,933 registered patients, 423 (1.4%) left without being seen. Follow-up was achieved on 39% of patients (165 of 423). Sixty-seven percent of those who left (284 of 423) had low acuity ratings. Of the 165 survey respondents, 107 (65%) left between 30 minutes and 2 hours after registration. The major reasons cited for leaving included prolonged waiting time (99 of 165, 60%), perceived difficulties with hospital staff (46 of 165, 28%), and pressing commitments elsewhere (45 of 165, 27%). Ninety-two percent (152 of 165) believed they should be evaluated by a physician within 1 hour of presentation. Forty-eight percent (80 of 165) sought further medical attention within 24 hours. Personal physicians (65 of 165, 39%) and other EDs (29 of 165, 18%) were the most common sources of further medical care. CONCLUSION: The majority of survey respondents had a low acuity rating and left because of prolonged waiting times. Most of these patients sought alternate medical care through their personal physician or other EDs.
Adolescent↗
Enhancing adherence in randomized controlled clinical trials.
This paper identifies individual and systematic primary, secondary, and tertiary prevention approaches that can be used to enhance adherence in randomized controlled trials. Specifically, strategies such as these are discussed: careful screening during enrollment, use of a run-in period, fully informing participants of the study burden, explaining randomization, determining the participant's prior history with treatment interventions, establishing and using a tracking system, clearly specifying adherence measures, and staff training in communication and negotiation. These strategies have been gathered over time from our experiences working in multiple randomized controlled trials. Research on factors that promote or detract from adherence should be a standard part of randomized controlled trials. Control Clin Trials 2000;21:226S-232S
Aged↗
Use of a run-in period to decrease loss to follow-up in the Contact Lens and Myopia Progression (CLAMP) study.
Rigid gas permeable (RGP) contact lenses are initially less comfortable to wear than spectacles. In previous studies evaluating the use of RGP contact lenses to control myopia, more subjects randomly assigned to wear RGP contact lenses have been lost to follow-up than spectacle wearers. Previous rigid contact lens myopia control studies have lost 44% and 47% of the rigid contact lens wearers. This unequal loss to follow-up may compromise the results of the study, so we conducted a run-in period prior to randomized treatment-group assignment to ensure that all participants could adapt to RGP contact lens wear. We enrolled 147 children ages 8-11 years with myopia in the run-in period. Of the 147 subjects, 116 (78.9%) were able to wear RGP contact lenses for at least 40 hours per week and reported that they were "usually comfortable" or "always comfortable." After 3 years, no subjects were lost to follow-up. The run-in period greatly reduced the loss to follow-up suffered by previous RGP contact lens myopia progression studies and may help provide more definitive answers regarding myopia control with RGP contact lenses.
Child↗
Tracking and follow-up of 16,915 adolescents: minimizing attrition bias.
This paper reports a multi-dimensional approach to minimize drop-outs from a two-year follow-up of a clinical trial designed to reduce initiation of tobacco use in 16,915 adolescent orthodontic patients. A hierarchical approach to data collection and tracking was employed. Seventy percent of participants were reached and interviewed at home by telephone. Strategies used to survey remaining participants included calling parents' work numbers and directory assistance, reviewing orthodontists' charts, sending surveys by mail, offering incentives, and using reverse telephone directories. More than 92% of the participants completed follow-up surveys. Multivariate analyses showed that baseline tobacco and alcohol use predicted loss to follow-up. Similarly, the number of procedures used to track each participant predicted presence of risk behaviors at post-test, demonstrating that an organized tracking hierarchy curtailed even greater compromises to internal and external validity. Evaluation and costs of individual strategies are discussed.
Adolescent↗
Heat-killed microorganisms induce PAI-1 expression in human peritoneal mesothelial cells: role of interleukin-1alpha.
Human peritoneal mesothelial cells (HMCs) have a critical role in maintaining the intraperitoneal balance between fibrinolysis and coagulation by expressing the fibrinolytic enzyme, tissue-type plasminogen activator (tPA), as well as a specific plasminogen activator inhibitor (type 1; PAI-1). During bacterial peritonitis, the balance between intraperitoneal generation and degradation of fibrin is disturbed. As a consequence, severe peritoneal damage occurs, which is one of the leading causes of patient dropout from continuous ambulatory peritoneal dialysis (CAPD) therapy. Cultured HMCs isolated from omental biopsy specimens were used to study the effect of heat-killed strains (2 x 10(8)/mL) of Staphylococcus aureus, Staphylococcus epidermidis, and Escherichia coli on the synthesis of tPA and PAI-1. Conditioned media were obtained by incubating cells with the different bacterial strains. tPA and PAI-1 antigen concentrations were measured in the cell supernatants by enzyme-linked immunosorbent assay. Each of the three heat-killed microorganisms induced a time-dependent increase in PAI-1 synthesis. After a 48-hour incubation period, the strongest effect was seen in the presence of S aureus (3.5-fold versus control), followed by S epidermidis (2.5-fold versus control) and E coli (1.5-fold versus control). Under the same conditions, tPA antigen levels did not change after exposure to S aureus or E coli, whereas the addition of S epidermidis resulted in enhanced tPA antigen production (2-fold versus control). The increase in PAI-1 synthesis in the presence of the heat-killed microorganisms was preceded by similar changes in interleukin-1alpha (IL-1alpha) levels. Inhibiting the activity of IL-1alpha with a neutralizing antibody significantly reduced bacterial-induced PAI-1 production. Our results indicate that the fibrinolytic imbalance during bacterial peritonitis depends on the bacterial species. The increase in PAI-1 synthesis, not the decrease in the production of tPA, alters mesothelial fibrinolytic activity. Because the increase in PAI-1 expression is significantly quenched by blocking the activity of IL-1alpha, the mesothelial release of this cytokine is involved in bacterial-induced changes in the fibrinolytic system.
Bacterial Vaccines↗
Use of alternative medicines by allergic patients in Turkey.
BACKGROUND: Although complementary and alternative medicines are frequently used in Turkey, no studies with large series have yet been published. OBJECTIVE: Our aim was to determine the prevalences of the use of various types of complementary and alternative medicines in patients with asthma, seasonal allergic rhinitis (SAR) and chronic urticaria (CU) and the relationship between the use of these substances and patients' social, economic and demographic characteristics. METHODS: All patients completed a questionnaire about the use of complementary and alternative medicines, including herbal products, animal products, acupuncture, yoga, massage therapies, Turkish-baths, speleotherapy, and psychoreligious methods for curing their diseases. RESULTS: The overall use of complementary and alternative medicines was 38 %. The most common alternative therapy treatment was herbal therapy (30.5 %). The prevalence of the use of these therapies was higher in asthmatics than in patients with SAR and CU. In all patients, variables associated with the use of these therapies were older age and having asthma. Among asthmatics, the use of these therapies within the previous 12 months was higher in patients with hospitalization and acute attacks than in those without hospitalization or acute attacks. In this group important covariates in the use of complementary and alternative medicines were older age and severe disease. Approximately half of the patients and 41.2 % of asthmatics discontinued pharmacological therapy during alternative treatment or had not yet started it. CONCLUSION: Because of the high prevalence of the use of complementary and alternative medicines and the tendency to discontinue drug therapy during these treatments, patients should be educated about the importance of pharmacological therapies.
Acute Disease↗
Matching substance abuse aftercare treatments to client characteristics.
This study investigated matching client attributes to different aftercare treatments. A naturalistic sample of adults entering substance abuse treatment was randomized into either Structured Relapse Prevention (RP, n=61) or a 12-Step Facilitation (TSF, n=72) aftercare program. Four patient attributes were matched to treatment: age, gender, substance abuse profile, and psychological status. Substance use outcomes were assessed 3 and 6 months posttreatment. At 6 months, four significant matches were uncovered. Females and individuals with a multiple substance abuse profile reported better alcohol outcomes with TSF aftercare than their cohorts exposed to RP aftercare. Individuals with high psychological distress at treatment entry were able to maintain longer periods of posttreatment abstinence with TSF aftercare compared to their cohorts exposed to RP. Inversely, RP was found to maintain abstinence significantly longer for individuals reporting low distress compared to those with high distress. Finally, better outcomes were achieved when random assignment to aftercare was consistent with participant preference. Overall, an Alcoholics Anonymous approach to aftercare appears to provide the most favorable substance use outcomes for most groups of substance abusers. RP may be most suitable for clients whose psychological distress is low, especially where maintenance of abstinence is targeted. Where choice in aftercare program is possible, matching client preference with type of aftercare program can improve outcome.
Adult↗
Substance abuse treatment for pregnant women: a window of opportunity?
The use of substance abuse treatment services by pregnant and nonpregnant women was compared to explore the effects of pregnancy on treatment utilization and outcomes. Treatment service records for 227 pregnant drug- and alcohol-dependent women and a matched comparison group of 277 nonpregnant women were retrieved from the Massachusetts Bureau of Substance Abuse Services Management Information System. Treatment services received by the two groups of women during a 6-month period following an index detoxification were tabulated and compared. Treatment services for pregnant women differed quantitatively and qualitatively from the services received by nonpregnant women over the 6-month time period. After controlling for background characteristics and substance abuse history, pregnant women were 1.7 times more likely to be readmitted to detoxification, 2.8 times more likely to enter residential facilities, and 5.4 times more likely to enter methadone programs. For both groups, the use of outpatient and/or residential treatment services following discharge from detoxification significantly reduced the risk of subsequent detoxification admissions. The increased likelihood of admission to detoxification, residential, and methadone services suggests that treatment programs have improved access to care for pregnant women. Multiple detoxification admissions suggest, however, that some pregnant women have difficulty entering stable recovery. Given the brevity of the gestational period and the detrimental effects of drug and alcohol use on fetal outcomes, the use of continuing treatment services for pregnant women is strongly recommended.
Adolescent↗
A new recruiting strategy to allow estimates of response rates in studies with people who inject drugs.
A new method of recruiting people who inject drugs was employed in Adelaide in 1994 to attempt to obtain a response rate and demographic information about those who declined to participate. Numbered invitation cards were distributed to injecting drug users (IDUs). Those choosing not to participate were asked to complete 4 questions on the card and return them. 22.7%. Of all cards distributed resulted in an enquiry about the study and only 1.4% of the cards were returned from those who chose not to participate. This recruiting strategy is as successful as other strategies with the added advantage of estimating response rates.
Adolescent↗
Does reduced length of stay decrease the number of emergency department patients who leave without seeing a physician?
Previous studies have suggested that most emergency department (ED) patients who leave without being seen by a physician (LWBS) are nonurgent. Our institution developed a fast-track process to reduce length of stay (LOS) for these patients. The present study was conducted to determine the effect of reducing LOS on the number of ED patients who leave without seeing a physician and the acuity of this subset of ED patients. We retrospectively audited, at a tertiary care teaching hospital, the number of LWBS patients and their triage status over two 1-mo periods. These sampling periods corresponded to immediately before and after implementation of five solutions developed by a continuous quality improvement (CQI) process to facilitate patient flow through the triage and fast-track areas of our ED. Before the CQI process was begun, 2.4% of patients (110/4553) left without being seen in a 1-mo study period. Of these, 82 were nonurgent and 28 were urgent. After implementation of the CQI process, 1.1% of patients (51/4514) left without being seen. Of these, 35 were nonurgent and 16 were urgent. There was a significant decrease in the LWBS proportion after the CQI process was implemented. We conclude that (1) reducing LOS is associated with a decrease in the number of ED patients who leave without seeing a physician and (2) many patients who leave without being seen are classified as urgent at presentation.
Emergencies↗
Who cares about recruitment anyway?
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Humans↗
Outcome of two patient education methods on recruitment and compliance with ivermectin in the treatment of onchocerciasis.
Two patient education methods, Information Media (IM) and Social Network (SN), were compared to determine their relative effectiveness on recruitment and subsequent compliance behavior of people infected with onchocerciasis in respect of appointment keeping and ivermectin consumption in existing primary health care facilities in six communities in southwestern Nigeria. Two communities each were randomly assigned to the IM intervention group, two of the SN group, and two served as controls. A total of 1265 persons out of an estimated target population of 5033 infected individuals were enrolled in the study. Coverage rates were higher in the intervention communities (30.3% for SN and 29.9% for IM) than control (7.3%), but the differences between intervention groups was not significant. A drop-off was seen in attendance at the second round of ivermectin distribution. Nearly equal proportions of the intervention groups returned (43.3% for SN and 47.4% for IM), while few control patients came back for their second dose (12.3%). Factors responsible for the low turnout were thought to include the content of educational messages, mobility of community members and limited time available to collect the drugs. Cost considerations led to recommendations to maintain facility based distribution and the SN approach, with greater emphasis on mobilization to increase coverage and compliance.
Adolescent↗
Application of the Stages of Change Scale in a clinical drug trial.
The Stages of Change Scale (SOC: McConnaughy, Prochaska, & Velicer, 1983) was used to predict outcome among 131 outpatients with generalized anxiety disorder who were enrolled in a clinical drug trial. As predicted, subjects high on Precontemplation did not experience as much relief from anxiety as subjects low on Precontemplation, whereas subjects high on Contemplation or Action experienced more decrease in anxiety during the trial than subjects low on these stages. Contrary to our hypothesis, only Contemplation was related to illness severity changes, and scores on the Maintenance scale were not related to outcome. Of the four stage scores, only Maintenance was related to premature termination of treatment. There were no differences between drug (adinazolam) and placebo groups and only Action scores interacted with drug/placebo assignment in this study. Results suggest that the SOC may be useful in identifying individuals who are most likely to experience decreased anxiety while enrolled in a clinical drug trial.
Adult↗
How to deal with the drop-out in clinical follow-up studies: results of a long-term follow-up study of orthodontically treated patients.
The drop-out in a long-term follow-up study of former orthodontically treated patients was analyzed to avoid biased results. Since structural conformity of the responders (n = 299) and the potential study population (n = 1464) cannot be presumed on the basis of the clinical results, roentgenologic results, and questionnaires, analysis of the participating patients, the follow-up method was used. By means of questionnaires sent to all nonresponders, a comparison of responding and nonresponding patient characteristics was completed to find a presumed selectivity bias. The comparison of the participating patients (n = 299) and the total sample revealed that the responders live closer to the health center, had a longer treatment time, and a shorter posttreatment interval. Compared with nonresponders (n = 266), the responders were satisfied with the treatment result and had a higher dental Intelligence Quotient (IQ, concerning tooth and jaw position). Although a definite answer to the question of validity of the examined subsample was difficult to give, the description and evaluation of the parameters that might be reasons for missing at random respectively, not missing at random was recommended.
Adolescent↗