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PubMed2003

Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery.

Even the best-designed, randomized controlled trials suffer when patients are lost to follow-up. Incomplete follow-up biases the results of a trial when patients who drop out are different from those who complete follow-up. This is exaggerated further when there are differential dropout rates between study groups. Previous randomized controlled trials in orthopedic trauma have reported up to 28% loss to follow-up. Only by striving to achieve a 0% loss to follow-up rate can we be certain that this type of bias does not affect our results. In our ongoing multicenter, randomized controlled trial comparing reamed and nonreamed intramedullary nailing of tibial shaft fractures, we have implemented several innovative strategies to minimize loss to follow-up. The exclusion criteria and consent process are designed to minimize losses. Study staff are carefully trained in communication and negotiation with patients. Additionally, a central methods center monitors all patient follow-up and aids in finding lost patients. Through these primary, secondary, and tertiary interventions, we have achieved 94% complete 1-year follow-up for the first 440 patients enrolled in the trial. Eleven patients withdrew consent, and we are unable to locate 17 patients. We have successfully minimized the loss to follow-up rate in our trial by incorporating innovative prevention and retention strategies into its design and conduct. Through planning, organization, and committing time and resources to minimizing loss to follow-up, other orthopedic trauma trials can hope to achieve the same high rates of follow-up.

Bias↗
PubMed2003

Use of a single global assessment to reduce missing data in a clinical trial with follow-up at one year.

We conducted a randomized controlled trial (ISRCTN96537534) to assess the effects of acupuncture on migraine and chronic tension headache. Patients (n=401) completed a diary of headache severity four times a day for 4 weeks at baseline, immediately following a 3-month treatment period and 1 year after randomization. During the trial, it appeared that dropout might be higher than expected. We therefore obtained a rapid global assessment of headache from participants to aid imputation of missing data. Patients were contacted by telephone and asked to rate current and baseline headache on a 0-10 scale. Use of global assessment reduced the number of patients from whom we obtained no follow-up headache data from 69 (17%) to 24 (6%). Analysis of patients who provided both a diary and a global assessment demonstrated excellent properties of global assessment, with very similar results to the full diary. We therefore used the global assessment to help impute missing 1-year diary scores. Rapid global assessment can be easily implemented in any trial and aids imputation of missing data, though it should not be used instead of more intensive methods of assessment. Further research might usefully examine the value of global assessment for imputation of missing data in a variety of different settings.

Acupuncture↗
PubMed2005

Accuracy and precision of estimating intervention efficacy when the timing of observed events differ by treatment arm.

Randomization in clinical trials minimizes differences between treatment arms, allowing observed treatment differences to be attributable to an intervention. For prospective clinical trials, we examine the effects on inference when other specified treatment arm differences are also present. These differences are imposed using three measures: time between the unobserved failure event (e.g., HIV infection) and its detection, visit schedule adherence and dropout. Our context of interest is trials with non-recurrent time-to-event outcomes and fixed visit intervals, where treatment efficacy is measured either by a hazard ratio or by a ratio of cumulative incidence functions. Moderate treatment differences in visit adherence, either through missed visits or additional unscheduled visits, were not found to cause substantial bias or to reduce power. However, both differential loss to follow-up (when coincidentally dependent on risk of failure) and differential time between event and detection should be of concern in designing clinical trials. Efforts to re-capture subjects at the end of study for failure assessment are helpful in some contexts, and may be considered in study planning.

Biometry↗
PubMed2006

Including multiple imputation in a sensitivity analysis for clinical trials with treatment failures.

When treatment failures occur during the course of a clinical trial, the treatment regimen following failure may be changed. This change in therapy complicates comparisons among the original treatment arms. As in some clinical trials with dropouts, intent-to-treat analysis can yield a large bias. We examine the use of multiple imputation to replace observations after treatment failure has occurred. As a sensitivity analysis, this approach is compared to existing methods for handling treatment failures - removing treatment failure subjects, removing data after the onset of treatment failure, and imputation the last observation prior to treatment failure for all subsequent observations - in addition to an analysis of all collected data based on randomized treatment assignment. A data set from the Asthma Clinical Research Network is used to demonstrate the methods.

Algorithms↗
PubMed2005

Concentration of depot medroxyprogesterone acetate and pain scores in adolescents: a randomized clinical trial.

A prospective, single-blinded, randomized trial was initiated to determine whether injection site pain differed in adolescents receiving two concentrations of 150 mg of depot medroxyprogesterone acetate (DMPA). Ninety-five adolescents seeking injectable contraception were randomized to receive 150 mg of DMPA as follows: a deltoid injection of 1.0 mL from a single-unit-dose vial containing 150 mg/mL or 0.38 mL from a multidose vial containing 400 mg/mL of DMPA. A visual analogue scale was measured at each visit and cumulatively compared between the groups. Continuation rates were tabulated. The report of pain for the multidose vial group was significantly higher than for the unit-dose vial group (p<.003). The dropout rates for both groups were high at 1 year and were not statistically different (multidose group=64% and unit-dose group=77%). Twenty percent of the subjects in the multidose group vs. 22% in the unit-dose group discontinued due to bleeding irregularities. The concentrated form of DMPA led to greater pain at the injection site than did the less concentrated form, but this did not lead to higher discontinuation rates among adolescents.

Adolescent↗
PubMed2006

Relative efficacy of psychotherapy and combined therapy in the treatment of depression: a meta-analysis.

BACKGROUND: Reviews of the relative efficacy of psychotherapy and combined therapy (psychotherapy with pharmacotherapy) for depression have yielded contradicting conclusions. This may be explained by the clinical heterogeneity of the studies reviewed. AIMS: To conduct a meta-analysis with an acceptable level of homogeneity in order to investigate the relative efficacy of psychotherapy and combined therapy in the acute treatment of depression. METHOD: A systematic search was performed for RCTs published between 1980 and 2005 comparing psychotherapy and combined therapy in adult psychiatric outpatients with non-psychotic unipolar major depressive disorder. The studies were classified according to the chronicity and severity of the depression. Data were pooled by means of meta-analysis and statistical tests were conducted to measure heterogeneity. RESULTS: The meta-analysis included seven studies looking at a total of 903 patients. None of the heterogeneity tests established significance. This indicates a lack of evidence for the heterogeneity of the results. The dropout rates did not differ significantly between the two treatment modalities (25% in combined therapy and 24% in psychotherapy, p=0.77). At treatment termination, the intention-to-treat remission rate for combined therapy (46%) was better than for psychotherapy (34%) (p=0.0007); Relative Risk 1.32 (95% CI: 1.12-1.56), Odds Ratio 1.59 (95% CI: 1.22-2.09). In moderate depression, the difference between the remission rate for combined therapy and psychotherapy was statistically significant (47% compared to 34% respectively, p=0.001). This was not the case in mild major depression (42% compared to 37% respectively, p=0.29). The difference was also statistically significant in chronic major depression (48% compared to 32%, p<0.001), but not in non-chronic major depression (43% compared to 37%, p=0.22). On a more specific level, no differences were found in the remission rates for the treatment modalities in mild or moderate non-chronic depression. Combined therapy led to significantly better results than psychotherapy in moderate chronic depression only (48% compared to 32%, p<0.001). CONCLUSIONS: In the acute treatment of adult psychiatric outpatients with major depressive disorder, patient compliance with combined therapy matches compliance with psychotherapy alone. Combined therapy is more efficacious than psychotherapy alone. However, these results depend on severity and chronicity. Combined therapy outperformed psychotherapy in moderate chronic depression only. No differences were found in mild and moderate non-chronic depression. No data were found for mild chronic depression and for severe depression.

Chronic Disease↗
PubMed2004

Predictors of attrition from a pediatric weight management program.

OBJECTIVE: The current study examined characteristics of families who initiated weight management treatment for their obese child/adolescent and withdrew prematurely. STUDY DESIGN: Participants (body mass index > or =95(th) percentile) were enrolled in a pediatric interdisciplinary weight management clinic. Retrospective chart review revealed noncompleters (n=116) completed > or =1 visit(s) but withdrew before completion of the initial 4-month treatment phase. Completers (n=96) completed the initial treatment phase. Completers and noncompleters were compared on baseline demographic, psychological, clinical, and laboratory measures. Regression analyses assessed the degree to which these factors predicted attrition. RESULTS: Fifty-five percent of patients withdrew prematurely from treatment. Noncompleters were more likely to be Medicaid recipients, black, older, and self-report greater depressive symptomatology and lower self-concept. CONCLUSIONS: These data have implications for the design of pediatric weight management intervention models that improve the rate of completion for economically disadvantaged and minority youth. Screening for depressive symptomatology may identify patients at risk for treatment dropout who could be targeted for increased support and retention strategies.

Adolescent↗
PubMed2006

Heroin and cocaine craving and use during treatment: measurement validation and potential relationships.

Although commonly assessed with unidimensional scales, craving has been suggested to be multifaceted and to have a complex relationship with drug use and relapse. This study assessed the consistency and predictive validity of unidimensional and multidimensional craving scales. At the beginning of a 12-week outpatient treatment trial, opiate users (n = 101) and cocaine users (n = 72) completed unidimensional visual analog scales (VASs) assessing "want," "need," and "craving" and multidimensional 14- and 45-item versions of the Cocaine Craving Questionnaire (CCQ) or Heroin Craving Questionnaire (HCQ). Spearman correlations between the VASs and the first-order factors from the 45-item CCQ/HCQ were .20-.40, suggesting that the two types of assessment were not redundant. Treatment dropout and in-treatment drug use were more frequently predicted by scores on the 14- or 45-item CCQ than by VAS ratings. Results suggest that the CCQ/HCQ and the 14-item CCQ provide information that unidimensional VASs do not.

Adult↗
PubMed2004

Nefazodone in primary insomnia: an open pilot study.

The present study is the first to investigate the effect of the antidepressant nefazodone on sleep in patients with primary (psychophysiological) insomnia. Following baseline assessment of sleep (polysomnography and subjective sleep parameters), 32 patients received initially 100 mg nefazodone in a single dose at bedtime; according to efficacy and tolerability, the dose could be increased up to 400 mg. Polysomnography and assessment of subjective sleep parameters were repeated after 4 weeks' administration. 12 patients dropped out, 11 of them due to lack of efficiency or intolerable side effects. In 20 patients who completed, the authors observed a lengthened sleep onset latency, decreases in stage 1 and slow wave sleep, and increases in stages 2 and REM under nefazodone. Subjective measures of sleep mirrored a clearer improvement: there was a significant reduction of the PSQI total score and all subscores except sleep latency. We suppose that the dose range chosen was too high for this patient population, thus accounting for the high proportion of dropouts and the partly unfavorable effects on objective sleep parameters. For a definite evaluation of the possible role of nefazodone in the treatment of primary (psychophysiological) insomnia, double-blind, placebo-controlled, randomized studies with lower doses are needed.

Adult↗
PubMed2006

A pilot study of adherence with light treatment for seasonal affective disorder.

Non-adherence with antidepressant medication regimens is now recognised as a substantial problem when evaluating depression outcome. Given the behavioural demands of light treatment (LT), it might be expected that non-adherence would be even more pronounced in LT, a form of intervention for seasonal affective disorder (SAD). However, little research has focused upon the extent to which patients in light treatment protocols adhere to set regimens. Nineteen patients with SAD were allocated to either treatment with bright white light (intervention) or dim red light (control condition) in a four-week protocol. Light exposure was estimated automatically (without participants' knowledge) with elapsed time meters built into the light box. Daily diaries were also used to measure self-reported light box use. Participants were instructed to use the light box for 30 min each day during week 1, 45 during week 2 and one hour during weeks 3 and 4 (total duration of prescribed light exposure 1365 min). The results indicated that mean duration of light box operation for the entire sample was 59.3% of the prescribed 1365 min. Six of nineteen (31.6%) patients dropped out of treatment. Amongst those completing treatment, adherence to the prescribed duration of exposure averaged 83.3% (S.D.=31.4). A trend was found for the intervention condition to generate a lower dropout rate, as well as a trend for the degree of adherence to be greater in the intervention condition. Importantly, there was no association between adherence as measured automatically and the higher rates of self-reported adherence as measured in diaries. In summary, the results of this pilot study suggest that adherence with light treatment is of a similar order of magnitude to antidepressant medication adherence. Patient self-report was found to be unrelated to objectively estimated duration of light box use, a finding with significant research and clinical implications. Future research studies should routinely measure and evaluate adherence with light therapy and evidence-based techniques for maximising treatment adherence should be incorporated into routine clinical practice.

Adult↗
PubMed2003

Antidepressive treatment in patients with temporal lobe epilepsy and major depression: a prospective study with three different antidepressants.

Major depression (MD) is underdiagnosed and undertreated in patients with temporal lobe epilepsy (TLE). Side effects of some antidepressants, like increased risk of seizures and drug-drug interactions with anticonvulsants, contribute to undertreatment of MD in patients with TLE. We analyzed post hoc the data from 2 years of treatment of inpatients with MD and TLE. Seventy-five patients received standard treatment with citalopram, mirtazapine, or reboxetine, respectively, at recommended dosage. Examinations were done with the Hamilton Rating Scale for Depression at admission and after 4 and 20-30 weeks. Plasma levels of anticonvulsants were examined at admission and discharge. Seizures were documented. The antidepressive treatment was efficacious in all antidepressant groups. No case of serious adverse event or drug interaction occurred. There was no increase in frequency or severity of seizures. At endpoint the dropout rate for mirtazapine was significantly higher than that for reboxetine or citalopram. Reboxetine showed a trend to be more efficacious than citalopram but not mirtazapine at Week 4.

Adult↗
PubMed2002

Cumulative probability of live birth after three in vitro fertilization/intracytoplasmic sperm injection cycles.

OBJECTIVE: To assess the probability of live birth after three available in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycles. DESIGN: Retrospective, observational study. SETTING: University hospital. PATIENT(S): Nine hundred seventy-four couples who started their first conventional IVF or ICSI cycle between January 1996 and December 1997. A total of 1985 stimulated cycles were initiated. INTERVENTION(S): Analysis of the cumulative live birth rate using the life-table approach with and without taking dropouts into account. MAIN OUTCOME MEASURE(S): Cumulative live birth rate. RESULT(S): The overall cumulative live birth rate after three completed stimulated cycles (including freezing/thawing cycles) was 65.5% with an "optimistic" approach. For the "realistic" and "pessimistic" approaches the corresponding figures were 63.1% and 55.5%, respectively. Unexpectedly, 65% of couples not achieving a live birth interrupted the full treatment program of three cycles. CONCLUSION(S): The cumulative live birth rate gives the couple a more accurate prognosis of achieving a live birth after IVF/ICSI than the statistics usually provided. With the "realistic" estimation, 63% of the couples achieved childbirth after three available conventional IVF or ICSI cycles. Further studies are required to investigate the high drop-out rate.

Adult↗
PubMedDate not supplied

A double-blind, randomized, fixed-dose trial of fluoxetine vs. amitriptyline in the treatment of major depression complicating Alzheimer's disease.

The objective of this study was to determine the relative efficacy and safety of fluoxetine and amitriptyline in the treatment of major depression complicating Alzheimer's disease (AD). The sample included 37 patients with AD and major depression. The study design was a double-blind, fixed-dose, randomized clinical trial with 45 days of follow-up. The outcome measures were the Hamilton Depression Rating Scale (Ham-D), the Mini-Mental State Exam (MMSE), and the number of dropouts from each arm of the study. Efficacy was similar for fluoxetine and amitriptyline. At Day 45, there was a mean 9.4-point reduction in Ham-D scores (t[df,62] = 9.68, P < 0.0001) and a 2.4-point mean increase in MMSE scores as compared to baseline (t[df,2] = 2.69, P = 0.009). Eleven (58%) of the amitriptyline-treated patients dropped out, compared with 4 (22%) of the fluoxetine-treated patients (chi 2[df,2] = 8.9, P = 0.017). The authors conclude that antidepressant treatment for major depression complicating AD is effective. While fluoxetine and amitriptyline are equally effective, fluoxetine is better tolerated.

Aged↗
PubMed2003

Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up.

OBJECTIVES: To evaluate the long-term effect and safety of sildenafil citrate for the treatment of erectile dysfunction after radical prostatectomy (RP). METHODS: The study consisted of 91 patients with erectile dysfunction from our institution who received oral sildenafil citrate after RP. We surveyed these patients using a self-administered questionnaire during the first year of sildenafil citrate use to determine treatment satisfaction, patient compliance, and safety. Those who had responded positively to the drug were surveyed again 3 years later (n = 48). Sildenafil citrate was prescribed at a dose of 50 mg and increased to 100 mg if needed. Data were collected from a self-administered questionnaire using the abridged five-item version of the International Index of Erectile Function questionnaire, referred to as the Sexual Health Inventory of Men, and the Erectile Dysfunction Inventory of Treatment Satisfaction. The patients were stratified according to the type of nerve-sparing (NS) RP procedure they underwent: bilateral NS, unilateral NS, and non-NS. RESULTS: At 3 years, 31 (71%) of the 43 patients who had returned the second surveys were still responding to sildenafil. Of these 31 respondents, 10 (31%) had augmented their dose from 50 to 100 mg. The dropout rate was 27%; 6 of 12 had discontinued because of the return of natural erections, 5 because of a loss of efficacy, and 1 because his spouse had died. No differences were found in the 1-year and 3-year five-item International Index of Erectile Function (Sexual Health Inventory of Men) and Erectile Dysfunction Inventory of Treatment Satisfaction scores between the NS groups. The most common side effects at 3 years were headache (12%), flushing (10%), and blue or blurred vision (2%). No patient discontinued the drug at 3 years because of side effects. CONCLUSIONS: The results of this study indicate that the vast majority of patients with erectile dysfunction after RP who initially respond to sildenafil continue to do so at 3 years and are satisfied and compliant with the treatment regimen.

3',5'-Cyclic-GMP Phosphodiesterases↗
PubMed2002

Treatment of generalised anxiety disorder with a short course of psychological therapy, combined with buspirone or placebo.

BACKGROUND: Very few studies have examined the combination of drug and psychological treatment in generalised anxiety disorder (GAD). Theoretically, buspirone should be a useful drug to combine with a learning-based therapy. METHODS: Sixty patients with GAD were randomly assigned to treatment with buspirone or placebo, combined with anxiety management training or non-directive therapy for a period of 8 weeks. RESULTS: Forty-four patients with a mean Hamilton Anxiety Scale score of 28 completed treatment. There were no significant differences between treatment groups. All groups showed significant improvement after 8 weeks compared to baseline. There were no baseline differences between those who completed the trial and those who did not but patients given buspirone were more likely to drop out. CONCLUSIONS: A short course of psychological therapy, whether or not accompanied by active medication, was an effective treatment for patients diagnosed as having quite severe symptoms of GAD. CLINICAL IMPLICATIONS AND LIMITATIONS: Dropouts led to a sample size which may have been too small to detect group differences. Cognitive therapy may have been more effective.

Adolescent↗
PubMed1997

The efficacy, safety and tolerability of antidepressants in late life depression: a meta-analysis.

BACKGROUND: To determine the efficacy, safety and tolerability of antidepressants in depressed elderly patients. METHODS: Search for randomized controlled double-blind studies evaluating atypical antidepressants (ATYPs), reversible inhibitors of monoamine oxidase-A, selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants in moderate/severe depressed patients > or = 60 years for > or = four weeks. The random effects model (single-arm; comparative) was used to aggregate efficacy, safety and dropout. RESULTS: No difference in single-arm aggregation of outcomes for four antidepressant classes. Comparative analyses showed no statistical difference between outcomes, except SSRIs had a higher response rate than ATYPs. CONCLUSION: Elderly show no differences in antidepressant class outcomes. LIMITATIONS: Heterogeneity and lack of power. CLINICAL RELEVANCE: There is little advantage for antidepressant classes over another in the aged.

Age Factors↗
PubMed1998

Problems in recruiting patients to controlled trials on children with secretory otitis media: a demographic comparison of excluded versus included patients.

One thousand one hundred and sixty-four patients formed the pool of patients from which we intended to recruit children to a controlled trial evaluating the efficacy of amoxicillin-clavulanate and penicillin-V in the treatment of secretory otitis media (SOM). Only 360 patients ended up to be evaluated, consisting only 30% of the primarily involved patients. The spontaneous improvement of the tympanometric condition was the major course of pre-trial dropouts. The demographic composition of included and excluded patients did not differ, as one might have expected. Very little has previously been published about this great number of excluded patients even though other authors must have had the same experience. It is concluded that a 3-month duration of SOM, evaluated by tympanometry by the investigators, is required as a minimum to qualify for entering a trial evaluating SOM.

Acoustic Impedance Tests↗