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PubMed2001

Loss to follow-up in a longitudinal study on aging in Spain.

The objectives of this study were to describe follow-up dynamics in a longitudinal study on aging conducted in Spain between 1993 and 1997, and to identify the demographic, behavioral and health characteristics of persons who would later refuse to continue participating, move out of the area or be hard to locate (i.e., become lost to follow-up subjects). Data from the 1993 baseline survey were used to predict the probabilities of being lost to follow-up in the 1995 and 1997 waves. Structural multiple logistic regressions were fitted and mean probabilities were estimated to identify patterns of loss to follow-up. After 4 years, 52% of baseline participants remained in the study, 24% had died, 17% refused to continue participating, and 8.7% were impossible to locate. In the multivariate analysis, advanced age and living alone were independent predictors of loss to follow-up, and none of the health status variables remained significant. However, participation status in previous waves and the number of nonresponse items were strong independent predictors of further non-participation. Our results suggest that an attitude against participation in surveys may be an independent predictor of losses to follow-up and efforts should be made to retain this subgroup of the population in the study. Further research on reasons why people are unwilling to participate in surveys and strategies to retain people in longitudinal studies is needed.

Aged↗
PubMed2001

Screening for eligibility in the study of antihypertensive medication in children: experience from the Ziac Pediatric Hypertension Study.

BACKGROUND: The FDA Modernization Act has resulted in an increase in pediatric trials of antihypertensive medications. As experience is limited in children to guide the planning of these studies, we reviewed data from the Ziac Pediatric Hypertension Study to determine patterns of early study termination to help future studies. METHODS: For inclusion, subjects aged 6 to 17 years were required to have an average systolic blood pressure (SBP) or diastolic blood pressure (DBP) above the 95th percentile at the last of three visits during 2 weeks of single-blind placebo screening. Early study termination was defined as early termination for any reason. Screening termination was defined as normalization of blood pressure (BP) during the placebo screening phase. RESULTS: Early study termination rate was 27% (38 of 140 subjects). The most common reason was screening termination due to normalization of BP, accounting for 63% of all early study terminations. Among screening termination subjects who completed three screening visits, SBP was higher (P < .001) at visit 1 (129+/-8 mm Hg) than at visit 2 (123+/-7 mm Hg) or visit 3 (121+/-8 mm Hg), but did not differ between visits 2 and 3. Screening termination occurred in 15% with isolated SBP hypertension, and 21% with isolated DBP hypertension. At randomization, 83% had SBP hypertension and 53% had DBP hypertension. CONCLUSIONS: These data suggest that SBP hypertension should be part of inclusion criteria to increase enrollment and reduce the rate of screening termination, and that 1-week placebo screening is necessary and sufficient to minimize inclusion of transiently hypertensive subjects.

Adolescent↗
PubMed2002

African American smokers interested and eligible for a smoking cessation clinical trial: predictors of not returning for randomization.

PURPOSE: Recruitment is often the rate-limiting step in conducting clinical trials among ethnic minorities. Little is known about participants who consent and enroll into a trial, but do not return for randomization. Why participants fail to return for randomization is largely unknown. METHODS: We compared 287 enrolled African American smokers who did not return for randomization, to the 500 who returned and were randomized to participate in a clinical trial for smoking cessation in African Americans. Analyses were conducted to identify variables associated with not returning for randomization. RESULTS: Univariate comparisons found the nonrandomized group to be significantly different from those randomized. Logistic regression showed younger age, less readiness to quit, having been proactively recruited, lacking a regular source of health care, believing that they will be smoking in 6 months, less church attendance, and a lower literacy level to be jointly related with not returning for randomization. CONCLUSIONS: African American participants who did not return for randomization into a clinical trial were different from those who did. Better understanding of these factors may allow researchers to target recruitment efforts resulting in enhanced accrual in clinical trials and increased efficiency.

Adult↗
PubMed2003

Recruitment and retention of adolescent participants in HIV research: findings from the REACH (Reaching for Excellence in Adolescent Care and Health) Project.

PURPOSE: To evaluate the importance of 13 items in the recruitment and retention of HIV-positive and HIV-negative adolescent participants in a longitudinal study (REACH study). METHODS: A confidential, self-administered, visual analog, cross-sectional survey was offered to active participants (November 1999-August 2000) with 438 subjects (86%) participating. Sixty-six percent of the cohort were HIV-positive and 34% were HIV-negative with a mean age of 17 years, and 76% were female. Subjects were asked to recall the importance they placed on 13 items in deciding to join the REACH study (recruitment) and to remain on study (retention). Factors that might explain the judgment placed on the items were analyzed using the nonparametric Wilcoxon Rank-Sum test or the Kruskall-Wallis test. RESULTS: The five most important factors for study recruitment were identical to those chosen for retention by participants. The factors were: (a) quality medical care, (b) caring staff, (c) health education, (d) privacy/confidentiality, and (e) altruism. Items judged least important were social activities, compensation, transportation, and food/meals. Subject characteristics (gender, age, HIV status) were not associated with statistically different mean judgment scores at recruitment and retention, although clinical site showed significant variation. Factors that could render subjects vulnerable (health insurance, family finances) were not associated with related items. CONCLUSIONS: Adolescents found quality health care and care team characteristics critically important in considering research participation. Attention to privacy and the opportunity to be altruistic were also important. Compensation for participation was not a significant factor for recruitment and retention of this adolescent cohort. This study demonstrates that adolescents apply sound criteria in evaluating research participation and do not appear to be unduly affected by compensation.

Adolescent↗
PubMed2006

Implementation of an asthma intervention in the inner city.

BACKGROUND: Despite availability of asthma self-management interventions for children, few have been implemented in community-based settings. OBJECTIVE: To describe implementation of the Inner-City Asthma Intervention and factors associated with higher rates of program completion by enrollees. METHODS: Descriptive analyses of data from multiple data sources. Two-tailed Pearson correlation coefficients and analyses of variance were used to calculate associations of descriptive variables with the retention rate (percentage of enrolled children who completed the core intervention and had more than 1 follow-up visit) and with the percentage who had allergy testing done. RESULTS: A total of 4,174 children were enrolled at 22 sites; 2,153 (52%) completed the core intervention and had more than 1 follow-up visit. A total of 2,014 enrolled children (48%) were tested for allergies. Retention was related to type and location of site, ease of obtaining written plans, language and ethnicity of asthma counselor, and on-site allergy testing. Higher rates of allergy testing were associated with the same factors, as well as flexibility in scheduling and selective enrollment of participants. CONCLUSIONS: Inner-city children with asthma can be enrolled in the Inner-City Asthma Intervention outside a controlled research setting. However, completion of all intervention components is difficult to achieve. We identify having an asthma counselor who is representative of the community, access to asthma action plans, and on-site allergy testing as factors that facilitate the implementation of this intervention in community-based settings.

Asthma↗
PubMed2003

What is the best way to schedule patient follow-up appointments?

BACKGROUND: What is the best way to schedule follow-up appointments? The most popular model requires the patient to negotiate a follow-up appointment time on leaving the office. This process accounts for the majority of follow-up patient scheduling. There are circumstances when this immediate appointment arrangement is not possible, however. The two common processes used to contact patients for follow-up appointments after they have left the office are the postcard reminder method and the prescheduled appointment method. METHODS: In 2001 the two methods used to contact patients for follow-up appointments after they had left the clinic were used for all 2,116 reappointment patients at an ophthalmology practice at Dartmouth-Hitchcock Medical Center. The number of completed successful appointments, the no-show rate, and patient satisfaction for each method were calculated. RESULTS: A larger number of patient reappointments were completed using the prescheduled appointment procedure than the postcard reminder system (74% vs 54%). The difference between completed and pending appointments (minus no-shows) of the two methods equaled 163 patients per quarter, or 652 patients per year. Additional revenues associated with use of the prescheduled appointment letter method were estimated at $594,600 for 3 years. SUMMARY: Using the prescheduled appointment method with a patient notification letter is advised when patients do not schedule their appointments on the way out of the office.

Academic Medical Centers↗
PubMed1999

Factors contributing to delayed diagnosis in nasopharyngeal carcinoma.

Nasopharyngeal carcinoma (NPC) can be difficult to diagnose. Not only is the post-nasal space (PNS) inaccessible to examination, it is frequently occupied by normal lympho-epithelium which can make differentiation from NPC difficult. Together with its frequent atypical presentation, it is not surprising that the diagnosis is missed or delayed. This is undesirable as the treatment of early NPC carries an excellent prognosis. The aim of this study is to ascertain the extent of the problem of missed or delayed diagnosis and to study the factors responsible. This was a retrospective study of all newly diagnosed patients with NPC from the Singapore General Hospital and treated in the Department of Therapeutic Radiology in the year 1996 (1 January-31 December). A total of 126 patients were studied. Eighteen patients (14.3 per cent) were found to have delayed diagnosis of more than a month. The delay ranged from 1.2 to 25 months (mean 7.2 months). Factors identified which contributed to delayed diagnosis included i) Clinicians not considering a diagnosis of NPC ii) Clinicians suspecting NPC but misled by the results of investigations iii) Patients refusing investigation or defaulting follow-up. Nearly a fifth of patients with NPC had delayed diagnosis. Many of the factors responsible for the delays appear to be preventable by better patient education and counselling, doctors having sharper clinical acumen and skills in NPC diagnosis and the hospital administration having a system of tracking down high risk patients who default.

Clinical Competence↗
PubMed2002

Inter-episodic morbidity and drop-out under carbamazepine and lithium in the maintenance treatment of bipolar disorder.

BACKGROUND: Evaluation of mood-stabilizing treatment strategies usually focuses on their efficacy in preventing recurrences. The aim of this study is to supplement evaluation by two important aspects: inter-episodic morbidity and drop-out. METHODS: Using a global outcome measure, response to prophylactic lithium and carbamazepine was evaluated in N = 171 bipolar patients (DSM-IV) participating in a randomized controlled trial with an observation period of 2 1/2 years (MAP study). RESULTS: The rates of re-hospitalization were similar for both treatments. However, the percentage of good clinical response (i.e. patients with a low score of inter-episodic morbidity and without both re-hospitalization and drop-out during the observation period) was significantly higher in patients randomized to lithium (40% v. 24%). This superiority of lithium resulted essentially from a lower drop-out rate in patients without re-hospitalization (17% v. 42%). Regarding severity of inter-episodic morbidity, no clear difference between the drugs was found. For both medications the predominant symptomatology was minor depressive (but not manic, mixed or schizoaffective) symptoms. In the lithium group, inter-episodic morbidity in patients without re-hospitalization significantly decreased during the first 10 months and remained on the lower level for the rest of the observation period. For carbamazepine, reduction of inter-episodic morbidity over time did not reach statistical significance. Inter-episodic morbidity was significantly related to drop-out and to re-hospitalization for both medications. CONCLUSION: Taking inter-episodic morbidity, drop-out and re-hospitalization into consideration, the response rate in bipolar patients (DSM-IV) was higher for prophylactic lithium than for carbamazepine. The global outcome parameter used appears to be a valuable measure of clinical response to mood stabilizing drugs.

Adult↗
PubMed2005

Are palliative cancer patients willing and able to participate in a physical exercise program?

OBJECTIVE: The primary aim of the present article was to identify palliative care patient populations who are willing to participate in and able to complete a group exercise/physical training program designed specifically for the individual patient. METHOD: We conducted a prospective phase II intervention study examining the willingness and ability of palliative care cancer patients to participate in a group exercise physical training program. Patients who were diagnosed with incurable cancer and had a life expectancy of less than 1 year at two outpatient clinics were invited to participate in an exercise program in the hospitals. The groups met twice a week over a 6-week period. RESULTS: One hundred one consecutive patients were asked for inclusion. Sixty-three patients agreed to participate. Sixteen (25%) of the 63 patients dropped out after consent was given, but before the program started due to medical problems, social reasons, or death. Thus, 47 patients started the exercise program. Thirteen patients withdrew during the program due to sudden death, medical problems, or social reasons. The most frequent reasons for withdrawal were increased pain or other symptoms. Thirty-four patients completed the exercise program. SIGNIFICANCE OF RESULTS: A high proportion of incurable cancer patients were willing to participate (63%) in a structured exercise program. The attrition rate was high, but despite being severely ill, 54% of the patients completed the exercise period. This shows that a physical exercise program tailored to the individual patient is feasible in this population.

Activities of Daily Living↗
PubMed2001

The role of patient training in the management of seasonal rhinitis and asthma: clinical implications.

BACKGROUND: Allergic rhinitis is an inflammatory disease often associated with bronchial asthma. Intranasal corticosteroids and oral antihistamines are the first-choice drugs. Patient training is relevant to asthma management, but little is known about its impact on rhinitis. We evaluated the role of patient training in the treatment of allergic rhinitis and its effects on nasal and bronchial symptoms. METHODS: One hundred and one patients (M/F = 62/39, age range 12-62 years) with pollen-induced rhinitis (32 with concomitant mild asthma) were enrolled. They were randomized into three groups: A (n = 30) with drug therapy alone, B (n = 35) with drug therapy plus training on the use of nasal spray, and C (n = 36) the same as B plus a lesson on rhinitis and asthma. All patients received mometasone furoate nasal spray for 8 weeks as regular therapy, plus rescue medications on demand. Symptoms and drug consumption were evaluated during the pollen season. RESULTS: The rate of noncompliance/dropout was highest in the untrained patients (P = 0.001). No difference in nasal symptoms was seen among the three groups. On the other hand, group C had significantly fewer asthma symptoms (P = 0.02) and less albuterol use (P = 0.005) than group A. Moreover, the trained group globally used less rescue medication than the other groups (P = 0.02). CONCLUSIONS: Detailed training of patients seems to improve compliance with treatment, reduce concomitant asthma symptoms, and reduce the use of symptomatic drugs.

Administration, Intranasal↗
PubMed1994

Predictors of attrition in health intervention research among older subjects with osteoarthritis.

Attrition in an experimental osteoarthritis intervention was studied among 364 (130 male) volunteers (ages 60-87). Subjects were randomly assigned to control, social support, education, or combined treatment groups. A series of discriminant function analyses showed that the final intervention groups were more homogeneous than the original samples. The most robust predictor of attrition was having either high or very low depression scores. Social support variables were predictors of poor attendance in the social support group, indicating possible attrition bias in evaluating this treatment. The results indicate that psychosocial variables may be the best predictors of attrition in health intervention research among older subjects, and that variables related to attrition can be related to the content of the intervention.

Aged↗
PubMed1981

Protecting the scientific integrity of a clinical trial: some ethical dilemmas.

Physicians who participate in clinical trials are mandated or encouraged to adhere to fundamental conditions than enhance the scientific validity of medical research. In some situations compliance with the study protocol may threaten the delivery of optimal care and raise ethical dilemmas among the staff. Moral conflicts may occur with respect to recruitment, control groups, randomization, blind assignments, patient withdrawals, and the use of supplementary therapies that could weaken statistical power. In designing and managing clinical trials, steps can be taken to reduce the likelihood of conflict between scientific inquiry and medical practice. Special means of protecting patients in the study can be introduced. Recognizing the existence of ethical dilemmas is a necessary prelude to the quest for objective solutions.

Clinical Trials as Topic↗
PubMed1993

An open-access dental practice.

The DoH funded a drop-in dental practice in inner-city Salford for 12 months. Its aim was to increase accessibility and availability of dental services to people not registered with a dentist. It operated on a no-appointment basis and priority was given to those in pain and/or on their initial visit.

Adult↗
PubMed1998

The impact of marital satisfaction and psychological counselling on the outcome of ICI-treatment in men with ED.

We investigated the relationship between marital satisfaction and choice of and compliance with treatment in 195 consecutive men with erectile dysfunction (ED). Marital satisfaction as measured by means of the Maudsley Marital Questionnaire (MMQ), was compared between four groups: (1) patients on intracavernous injection (ICI) treatment after the trial-dose phase (32%); (2) patients dropped out ICI in the trial-dose phase (12%); (3) patients on other treatment (31%); and (4) patients following first counselling renounced treatment (25%). Above, in a small group of 15 patients the effect of ICI treatment in combination with short-term psychological counselling (ICI + treatment) was assessed. No significant differences were found in marital satisfaction between the four groups. In the ICI + treatment group we experienced that providing information about factors that contribute to erectile function and enabling couples to communicate about sexual problems were the most important factors to increase efficacy of ICI treatment.

Erectile Dysfunction↗
PubMedDate not supplied

Safety and efficacy of citalopram in the treatment of premature ejaculation: a double-blind placebo-controlled, fixed dose, randomized study.

We evaluate the efficacy and safety of citalopram, a potent and highly selective serotonin reuptake inhibitor (SSRI) antidepressant, in patients with premature ejaculation (PE). In total, 58 potent men with PE were included in the study. Patients were randomly assigned to receive 20 mg oral daily citalopram (group 1, n = 29) or placebo (group 2, n = 29), during a 12-week period for each agent. Pretreatment evaluation included history and physical examination, intravaginal ejaculatory latency time (IVELT) evaluation, International Index of Erectile Function (IIEF) and Meares-Stamey test. The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of study and in 3- and 6-month follow-up after cessation of treatment, using responses to IIEF, IVELT evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. The trial was completed by 51 (88%) men. Analysis revealed a difference in the evolution of IVELT delay over time (P < 0.001). The IVELT after citalopram and placebo gradually increased from 32 and 28 s to approximately 268 and 38 s, respectively. The mean weekly intercourse episodes increased from pretreatment values of 1.3 and 1.2 to 2.4 and 1.4, for citalopram and placebo, respectively (P < 0.05). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 16 and 10 at 12-week treatment in groups 1 and 2, respectively (P < 0.05). Mean IVELT in group 1 was 210 and 198 s at 3- and 6-month follow-up, while in group 2 it was 27 and 25 s (P < 0.001), respectively. At 3- and six-month intercourse satisfaction domain values of IIEF were 15 and 14 in group 1 and 10 and 10 (P < 0.05) in group 2, respectively. Group 1 patients reported a significantly higher number of intercourse episodes per week (P < 0.05). Mean number of adverse events was 12 for citalopram and 4 for placebo (P < 0.05). In conclusion, these results indicate that citalopram has significantly better results in terms of IVELT and intercourse satisfaction versus placebo. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in PE and to prolong the efficacy.

Adult↗
PubMed2005

Comparison of recruitment, retention, and compliance results for three children's exposure monitoring studies.

The School Health Initiative: Environment, Learning, Disease (SHIELD) study, the Minnesota Children's Pesticide Exposure Study (MNCPES), and the National Cooperative Inner-City Asthma Study (NCICAS) are three of the most intensive and invasive exposure-monitoring projects ever undertaken in children. An intrinsic facet of each study was the need to recruit children and their families, retain them for the duration of the project, and ensure that they completed monitoring protocols successfully. All of the studies used fiscal incentives to encourage participation, retention, and compliance. Recruitment rates varied from 40% in MNCPES, to 57% in SHIELD, to 64% in NCICAS, while retention rates varied from 85% in SHIELD, to 94% in MNCPES, to 95% in NCICAS. Rates of compliance with exposure sampling procedures were typically >80% for each study. For example, > or =85% of the enrolled children provided all requested urine samples (1 for NCICAS, 2 for SHIELD, 3 for MNCPES), and 82% of the children in SHIELD provided two out of two blood samples (optional in MNCPES and NCICAS). However, compliance rates were substantially lower (34% SHIELD, 40% NCICAS, not applicable to MNCPES) for the more complex and time-consuming protocol used to collect peak flow data. Overall, results demonstrate that it is practical and affordable to conduct demanding exposure-monitoring studies in children, including children from poor minority communities.

Adolescent↗