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Selection biases during recruitment of patients and relatives for a family study in the elderly.

The aim of the present study was to examine selection effects during recruitment of patients, controls and relatives for a family study in the elderly. The primary sample consisted of 368 in-patients (aged above 60 years) admitted in the years 1992 and 1993. One-hundred and eighty-four subjects (50%) suffering from dementia of Alzheimer type or major depression fulfilled the diagnostic inclusion criteria. Finally, 100 subjects participated in the family study. Demographic data of participants, ineligible subjects, uncooperative candidates, and control subjects from the general population was examined. Demographic parameters, reasons for refusal of personal interviews, and family history information were compared in first-degree relatives of participants and of 40 control subjects. According to demographic data, participants were representative for the whole sample of demented or depressed patients, and were comparable with the control sample. Demographic parameters of relatives were also equivalent in both groups. Rates of psychiatric disorders were equal in interviewed and unavailable relatives of patients (18.0% and 18.8%, respectively). However, interviewed relatives of controls had significantly fewer psychiatric disorders than unavailable relatives (7.8% vs 20%). This selection effect indicates the need for family history information on unavailable relatives in family studies on geriatric patients. Equivalence of demographic data alone was not a sufficient indicator of sample comparability. A second hospitalized comparison group might serve to increase the validity of conclusions resulting from comparative family studies.

Aged↗

Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation.

Patients who agree and those who refuse clinical trial entry may differ in attitudes towards decision control and the benefits associated with the trial arms. These differences, if they exist, have implications for the process of obtaining informed consent and for the generalization of the results of a clinical trial. This paper describes the development and initial application of methods designed to detect such differences. Developmental work involved creating an inventory of instruments designed to determine patients' attitudes towards participating in treatment decision making, permitting random selection of treatment, and undertaking the risks and benefits associated with the various treatments in a trial. Initial application involved modifying these instruments in terms of an actual chemotherapeutic trial for colonic adenocarcinoma, seeking responses to these measures from 60 non-eligible colorectal cancer patients, then determining whether those who would agree to trial entry differed systematically on these measures from those who indicated that they would refuse such a trial. Twenty-five of the respondents reported that, if faced with the actual decision, they would agree to trial entry: 35 would refuse. Refusers demanded more participation in decision making (Chi-square; P = 0.01) and a greater increment in treatment benefit (t-test; P = 0.0001). Twenty-two of the 35 refusers reported aversion to randomization as their primary reason for trial refusal. Since their particular content can be modified, these measures may be applicable to all clinical trials. They could be used to study the reasons patients accept or refuse trial entry and to determine if agreer-refuser attitude differences undermine the generalizability of a trials results.

Clinical Trials as Topic↗

Perception and social consequences of tuberculosis: a focus group study of tuberculosis patients in Sialkot, Pakistan.

Treatment defaulting is one of the major causes of the failure of TB control programs. In Bethania Hospital, Sialkot, defaulting rates are high: 72% for the standard 12 months course and 56% for the 8 months course. Attrition is especially important in the first weeks of treatment: < 70% of the patients start the 10th week of treatment. A focus group discussion study has been carried out to gain a better understanding of the impact of social stigmatization, treatment cost and pregnancy on defaulting. The study population consisted of 3 male and 3 female groups each with 8 hospitalized TB patients. The study shows that TB is perceived as a very dangerous, infectious and incurable disease. This perception has many social consequences: stigmatization and social isolation of TB patients and their families: diminished marriage prospects for young TB patients, and even for their family members: TB in one of the partners may lead to divorce. Due to fear patients often deny the diagnosis and reject the treatment. While both male and female TB patients face many social and economical problems, female patients are more affected. Divorce and broken engagements seem to occur more often in female patients. Females are usually economically dependent on their husbands and family in law, and need their cooperation to avail of treatment. The belief that pregnancy enhances the risk for relapse decreases their marriage prospects. Pregnancy is also a reason for stopping TB treatment as both are considered as incompatible. The findings of this study reveal the urgent need for a health education campaign to convince the general population that tuberculosis is curable. All health care providers should act as destigmatizers.

Adolescent↗

Five-year study of Class II restorations in permanent teeth using amalgam, glass polyalkenoate (ionomer) cerment and resin-based composite materials.

The aim of this study was to compare the clinical performance of an amalgam, a glass polyalkenoate (ionomer) cerment material and a resin-based composite material used in small Class II cavities in permanent teeth. All restorations were inserted under rubber dam. They were examined yearly for 3 years. One clinician continued the study up to 5 years. The clinical examination focused on two criteria: clinically acceptable and failure. In addition, impressions were taken of the prepared cavities immediately before restoration and at each clinical examination using an elastomeric material. The study comprised 274 Class II restorations (88 amalgams, 95 cerments and 91 resin composites) placed in 142 adolescent patients. One hundred and sixty-seven restorations were in molar and 107 in premolar teeth. Patient dropout after 5 years resulted in the loss of 161 restorations, evenly distributed for restorative material and type of tooth involved. Four amalgam restorations, 22 glass ionomer cerment and nine resin composite restorations failed. The glass ionomer cerment and amalgam restorations failed primarily due to bulk fractures, while the resin composite restorations failed due to secondary caries and bulk fractures.

Analysis of Variance↗

Correlates of methadone patients' lengths of stay for first and second admissions.

Product moment correlations were calculated between 17 psychosocial characteristics of 216 heroin addicts and their lengths of stay for first and second admissions to the dame methadone maintenance program. None of the variables which were related to retention during the first admission was associated with retention during the second admission. The conclusion was drawn that the relationships between addict characteristics and length of stay vary according to admission, and it would be unwise to use addicts' former treatment experiences to predict latter responses.

Adult↗

Substance abuse treatment entry, retention and effectiveness: out-of-treatment opiate injection drug users.

This study was designed to assess the effect of client characteristics and community interventions on treatment entry and retention, and to evaluate the relative effectiveness of treatment, compared to other interventions, in reducing drug use and crime among out-of-treatment opiate injectors. Subjects (N = 2973) from 15 cities were randomly assigned to: standard intervention (SI)-HIV testing and counseling; or enhanced intervention (EI)-SI plus additional educational sessions stressing responsible drug use. EI in some cities included staff assistance with treatment admission (i.e. "active' referral). All locations provided intervention by community outreach workers. Factors positively associated with treatment entry included: prior treatment, intervention by community workers, assignment to the EI, not injecting cocaine, injecting opiates, and fewer program interventions received. Sites where the EI included active referral achieved significantly higher treatment entry rates than sites where the EI did not. Findings supported the efficacy of treatment over other interventions in reducing drug use and arrests, the addition of staff assistance to facilitate clients' entry into treatment, and the involvement of community outreach workers in achieving treatment entry.

Adult↗

Health education to improve repeat participation in the Dutch breast cancer screening programme: evaluation of a leaflet tailored to previous participants.

Participation in breast cancer screening programmes often declines in the course of the programme. The purpose of the present study was to examine whether health education could diminish the amount of drop-outs between two screening rounds. The health education was tailored to women who previously underwent mammography. Based on the Elaboration Likelihood Model two versions of the tailored leaflet were made: a simple version and a version with additional peripheral cues. In an experimental study among 2961 women the effects of the tailored leaflets on reparticipation were tested against a standard leaflet. Re-participation rates were high (> 90%) and did not differ between the 3 groups. No significant differences regarding beliefs about re-participating were found between the 3 groups. Results indicate that the tailored information leaflets did not enhance re-participation. Therefore, the required additional efforts and costs do not seem to be justified. The results of the study provide indications that less painful mammograms and friendly staff might improve re-participation.

Aged↗

Effects of an appointment reminder call on patient show rates.

A pilot study (N = 80) was conducted to determine if (1) prospective substance-dependent patients randomly selected to be reminded (TC) of their scheduled intake evaluation the day before their first appointment would have a higher show rate than those not contacted (NC); and (2) if TC subjects administered a satisfaction questionnaire 1-3 days after intake would exhibit higher treatment retention rates at one week and one month posttreatment entry than NC subjects not exposed to the questionnaire. The findings suggest that reminding prospective patients of their initial scheduled appointments and following up with phone calls to those who fail to show can improve the rate at which patients will initiate treatment, provided initial appointments are scheduled in a timely manner (7 days or less). Similarly, the combination of the reminder call and the satisfaction questionnaire were associated with higher treatment retention rates for those whose initial appointments were scheduled in a timely manner.

Adult↗

Recruitment for phase II of the Trials of Hypertension Prevention. Effective strategies and predictors of randomization. Trials of Hypertension Prevention (TOHP) Collaborative Research Group.

Phase II of the Trials of Hypertension Prevention is a multicenter, randomized, controlled trial designed to determine the efficacy of weight loss and reduction of sodium intake for lowering blood pressure and incidence of hypertension among persons with high-normal levels of blood pressure. The 2 x 2 factorial study design includes weight loss alone, restricted sodium intake alone, the combination of weight loss and sodium restriction, and a control group. Nine clinical centers used a variety of recruitment strategies to enroll 2382 participants over 17 months, which exceeded the sample size goal of 2250. Among randomized participants, 21% were minorities and 34% were women. Overall, direct mail generated the most randomized participants (73%), followed by community screening (12%) and media advertisement (11%). Referrals from community health care providers yielded few participants. Prescreening improved overall efficiency and reduced costs. Participants who were more likely to drop out voluntarily during the three-visit screening regimen tended to be younger, single, male, smokers, and less educated.

Adult↗

Is a history of alcohol problems or of psychiatric disorder associated with attrition at 11-year follow-up?

Although rarely available, detailed analyses of attrition in psychiatric surveys are important because surveys of this type might be more vulnerable to follow-up losses. In this report the demographic characteristics, as well as history of alcohol problems and psychiatric disorders of responders were compared to nonresponders in an 11-year follow-up study. Data revealed few differences between responders and nonresponders. Men, those less educated, and low users of medical care were more likely to be nonresponders, as were those reporting driving trouble when drinking or a history of barbiturate abuse or dependence. A history of other psychiatric disorders was not associated with nonresponse. Refusal conversion did not change the findings; those who were converted (25% of initial refusals) had demographic characteristics, symptoms of alcohol abuse, and psychiatric histories comparable to those who resisted conversion. These findings suggest that efforts to convert refusals to responders might not be necessary. The results also support community psychiatric research by providing evidence that those with a history of psychiatric disorder are not more difficult to recruit than their unaffected counterparts.

Adolescent↗

Fast Track: one hospital's journey.

This paper is the first of two articles discussing the implementation and evaluation of an innovative Fast Track process. This current paper explains how one metropolitan hospital identified the need to establish Fast Track in their Emergency Department and the journey that was taken to implement the initiative. The other paper presents the findings of the evaluation of the Fast Track process over a twelve month time frame. Fast Track is the treatment of minor injuries and illnesses by designated clinicians within the Emergency Department. The model was based upon the available literature from studies on Fast Track and "See and Treat" conducted in the United Kingdom, North America and Australia, and was adapted to address the type of presentations arriving at the hospital's Emergency Department. The initial change management process lasted twelve months and as a result Fast Track has revolutionised the way many patients are treated in the Emergency Department. Furthermore, Fast Track has provided nurses with the opportunity to achieve advanced skills in the areas of suturing and plastering.

Attitude of Health Personnel↗

Recruitment and retention of economically underserved women to a cervical cancer prevention trial.

This review contrasts the planned and actual recruitment and retention efforts for a cervical cancer prevention study within a predominantly underserved population. Recruitment was a primary obstacle to trial progression and multiple strategies to improve recruitment were implemented to meet objectives. The actual recruitment strategies were expansion to five geographically distinct clinical sites, use of nurse practitioners focused primarily on patient issues, extremely flexible study hours and location, honorariums, support for transportation and child care, and creativity in maintaining contact with study participants. With these strategies, 90% of eligible patients consented to participate in the study.

Adult↗

Recruitment and retention in a longitudinal palliative care study.

A longitudinal feasibility study regarding quality of life and interventions for patients with advanced cancer or AIDS and their family caregivers was conducted to determine issues related to their recruitment and retention and to obtain pilot data relevant to the development of a larger study. At the completion of the study, a focus group consisting of the members of the palliative care research team was convened to identify barriers to and facilitators of the research process based on their research experience. The purpose of this article is to (1) describe recruitment, mortality rates, attrition rates, and compliance with data collection of patients and family caregivers experiencing an advanced illness and to (2) examine the researchers' perspectives regarding barriers to and facilitators of the research process that relate to patients and family caregivers, institutions, the data collection process, and their personal experiences. Implications for palliative care research are discussed.

Acquired Immunodeficiency Syndrome↗

Cognitive-behaviour therapy for chronic fatigue syndrome: comparison of outcomes within and outside the confines of a randomised controlled trial.

Outcomes for cognitive-behaviour therapy (CBT) in randomised controlled trials (RCTs) have rarely been compared to those in routine clinical practice. Taking the case of CBT for chronic fatigue syndrome (CFS), we evaluated the results of a successful RCT against those of the same treatment given in the same setting as part of routine practice. Fatigue and social adjustment scores were compared for patients who received CBT for CFS as part of a RCT (N=30) and patients who received CBT as part of everyday clinical practice (N=384). The results in the RCT were superior to those in routine clinical practice. Between pre-treatment and 6-month follow-up, the RCT showed a larger reduction in fatigue and greater improvement in social adjustment than those in routine treatment. The changes in fatigue scores were similar for both groups during treatment but were greater in the RCT between post-treatment and follow-up. Potential reasons for the superior results of the RCT include patient selection, therapist factors and the use of a manualised treatment protocol. Practitioners need to pay particular attention to relapse prevention and ensuring adequate follow-up in addition to encouraging patients to continue with cognitive-behavioural strategies once treatment has ended.

Adaptation, Psychological↗

Quality improvement methods as applied to a multicenter effectiveness trial--STAR*D.

In multicenter clinical trials, important aspects of trial performance (e.g., the number of participants who enter the trial within the required time frame, the number of participants who remain in the trial, and/or the completeness of the outcome data collected) directly affect the extent to which the study can achieve its aims. Obtaining the maximum amount of data from the maximum number of participants at each step in the trial increases the likelihood of identifying real differences in outcome. These aspects of trial performance can, therefore, be considered intermediate performance goals of the study since success in achieving each of them is directly related to success in achieving study aims. A quality improvement system was introduced to improve efficiency and performance in the multicenter Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. Four intermediate performance goals were targeted for quality improvement efforts: (1) initial enrollment of subjects, (2) collection of entry/exit primary outcome data, (3) retention of subjects to enter subsequent "levels" of the trial, and (4) collection of blood samples for genetics studies. The identification of numerical targets for these goals provides a basis for monitoring performance and for implementing attempts to improve performance, since success in achieving each goal is directly related to success in achieving the study aims. This paper describes the background, rationale, development, and potential utility of implementing a quality improvement system to improve the performance and efficiency of the trial.

Adolescent↗

PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.

BACKGROUND: Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. METHODS: The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. RESULTS: We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. CONCLUSIONS: The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.

Adult↗

Predictors of retention in methadone programs: a signal detection analysis.

Retention in Opioid Agonist Therapy (OAT) is associated with reductions in substance use, HIV risk behavior, and criminal activities in opioid dependent patients. To improve the effectiveness of treatment for opioid dependence, it is important to identify predisposing characteristics and provider-related variables that predict retention in OAT. Participants include 258 veterans enrolled in 8 outpatient methadone/l-alpha-acetylmethadol (LAAM) treatment programs. Signal detection analysis was utilized to identify variables predictive of 1-year retention and to identify the optimal cut-offs for significant predictors. Provider-related variables play a vital role in predicting retention in OAT programs, as higher methadone dose (> or =59 mg/day) and greater treatment satisfaction were among the strongest predictors of retention at 1-year follow-up.

Adult↗