Showing papers on "Randomized controlled trial published in 2002"

Voriconazole versus Amphotericin B for Primary Therapy of Invasive Aspergillosis

Abstract: Background Voriconazole is a broad-spectrum triazole that is active against aspergillus species. We conducted a randomized trial to compare voriconazole with amphotericin B for primary therapy of invasive aspergillosis. Methods In this randomized, unblinded trial, patients received either intravenous voriconazole (two doses of 6 mg per kilogram of body weight on day 1, then 4 mg per kilogram twice daily for at least seven days) followed by 200 mg orally twice daily or intravenous amphotericin B deoxycholate (1 to 1.5 mg per kilogram per day). Other licensed antifungal treatments were allowed if the initial therapy failed or if the patient had an intolerance to the first drug used. A complete or partial response was considered to be a successful outcome. Results A total of 144 patients in the voriconazole group and 133 patients in the amphotericin B group with definite or probable aspergillosis received at least one dose of treatment. In most of the patients, the underlying condition was allogeneic hematop...

Mediators and Moderators of Treatment Effects in Randomized Clinical Trials

Abstract: Randomized clinical trials (RCTs) not only are the gold standard for evaluating the efficacy and effectiveness of psychiatric treatments but also can be valuable in revealing moderators and mediators of therapeutic change. Conceptually, moderators identify on whom and under what circumstances treatments have different effects. Mediators identify why and how treatments have effects. We describe an analytic framework to identify and distinguish between moderators and mediators in RCTs when outcomes are measured dimensionally. Rapid progress in identifying the most effective treatments and understanding on whom treatments work and do not work and why treatments work or do not work depends on efforts to identify moderators and mediators of treatment outcome. We recommend that RCTs routinely include and report such analyses.

A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee

Abstract: Background The efficacy of arthroscopic surgery for the treatment of osteoarthritis of the knee is unknown. Methods We conducted a single-center, randomized, controlled trial of arthroscopic surgery in patients with moderate-to-severe osteoarthritis of the knee. Patients were randomly assigned to surgical lavage and arthroscopic debridement together with optimized physical and medical therapy or to treatment with physical and medical therapy alone. The primary outcome was the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (range, 0 to 2400; higher scores indicate more severe symptoms) at 2 years of follow-up. Secondary outcomes included the Short Form-36 (SF-36) Physical Component Summary score (range, 0 to 100; higher scores indicate better quality of life). Results Of the 92 patients assigned to surgery, 6 did not undergo surgery. Of the 86 patients assigned to control treatment, all received only physical and medical therapy. After 2 years, the mean (±SD) WOMAC score for the surgery group was 874±624, as compared with 897±583 for the control group (absolute difference [surgery-group score minus control-group score], −23±605; 95% confidence interval [CI], −208 to 161; P = 0.22 after adjustment for baseline score and grade of severity). The SF-36 Physical Component Summary scores were 37.0±11.4 and 37.2±10.6, respectively (absolute difference, −0.2±11.1; 95% CI, −3.6 to 3.2; P = 0.93). Analyses of WOMAC scores at interim visits and other secondary outcomes also failed to show superiority of surgery.

Effects of Cognitive training interventions with older adults. A randomized controlled trial

Abstract: ContextCognitive function in older adults is related to independent living and need for care. However, few studies have addressed whether improving cognitive functions might have short- or long-term effects on activities related to living independently.ObjectiveTo evaluate whether 3 cognitive training interventions improve mental abilities and daily functioning in older, independent-living adults.DesignRandomized, controlled, single-blind trial with recruitment conducted from March 1998 to October 1999 and 2-year follow-up through December 2001.Setting and ParticipantsVolunteer sample of 2832 persons aged 65 to 94 years recruited from senior housing, community centers, and hospital/clinics in 6 metropolitan areas in the United States.InterventionsParticipants were randomly assigned to 1 of 4 groups: 10-session group training for memory (verbal episodic memory; n = 711), or reasoning (ability to solve problems that follow a serial pattern; n = 705), or speed of processing (visual search and identification; n = 712); or a no-contact control group (n = 704). For the 3 treatment groups, 4-session booster training was offered to a 60% random sample 11 months later.Main Outcome MeasuresCognitive function and cognitively demanding everyday functioning.ResultsThirty participants were incorrectly randomized and were excluded from the analysis. Each intervention improved the targeted cognitive ability compared with baseline, durable to 2 years (P<.001 for all). Eighty-seven percent of speed-, 74% of reasoning-, and 26% of memory-trained participants demonstrated reliable cognitive improvement immediately after the intervention period. Booster training enhanced training gains in speed (P<.001) and reasoning (P<.001) interventions (speed booster, 92%; no booster, 68%; reasoning booster, 72%; no booster, 49%), which were maintained at 2-year follow-up (P<.001 for both). No training effects on everyday functioning were detected at 2 years.ConclusionsResults support the effectiveness and durability of the cognitive training interventions in improving targeted cognitive abilities. Training effects were of a magnitude equivalent to the amount of decline expected in elderly persons without dementia over 7- to 14-year intervals. Because of minimal functional decline across all groups, longer follow-up is likely required to observe training effects on everyday function.

Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control

Abstract: Objective To evaluate the efficacy of self-management education on GHb in adults with type 2 diabetes. Research design and methods We searched for English language trials in Medline (1980-1999), Cinahl (1982-1999), and the Educational Resources Information Center database (ERIC) (1980-1999), and we manually searched review articles, journals with highest topic relevance, and reference lists of included articles. Studies were included if they were randomized controlled trials that were published in the English language, tested the effect of self-management education on adults with type 2 diabetes, and reported extractable data on the effect of treatment on GHb. A total of 31 studies of 463 initially identified articles met selection criteria. We computed net change in GHb, stratified by follow-up interval, tested for trial heterogeneity, and calculated pooled effects sizes using random effects models. We examined the effect of baseline GHb, follow-up interval, and intervention characteristics on GHb. Results On average, the intervention decreased GHb by 0.76% (95% CI 0.34-1.18) more than the control group at immediate follow-up; by 0.26% (0.21% increase - 0.73% decrease) at 1-3 months of follow-up; and by 0.26% (0.05-0.48) at > or = 4 months of follow-up. GHb decreased more with additional contact time between participant and educator; a decrease of 1% was noted for every additional 23.6 h (13.3-105.4) of contact. Conclusions Self-management education improves GHb levels at immediate follow-up, and increased contact time increases the effect. The benefit declines 1-3 months after the intervention ceases, however, suggesting that learned behaviors change over time. Further research is needed to develop interventions effective in maintaining long-term glycemic control.

Effect of aerobic exercise on blood pressure: a meta-analysis of randomized, controlled trials.

Abstract: Purpose Physical activity has been associated with reduced blood pressure in observational epidemiologic studies and individual clinical trials. This meta-analysis of randomized, controlled trials was conducted to determine the effect of aerobic exercise on blood pressure. Data sources English-language articles published before September 2001. Study selection 54 randomized, controlled trials (2419 participants) whose intervention and control groups differed only in aerobic exercise. Data extraction Using a standardized protocol and data extraction form, three of the investigators independently abstracted data on study design, sample size, participant characteristics, type of intervention, follow-up duration, and treatment outcomes. Data synthesis In a random-effects model, data from each trial were pooled and weighted by the inverse of the total variance. Aerobic exercise was associated with a significant reduction in mean systolic and diastolic blood pressure (-3.84 mm Hg [95% CI, -4.97 to -2.72 mm Hg] and -2.58 mm Hg [CI, -3.35 to -1.81 mm Hg], respectively). A reduction in blood pressure was associated with aerobic exercise in hypertensive participants and normotensive participants and in overweight participants and normal-weight participants. Conclusions Aerobic exercise reduces blood pressure in both hypertensive and normotensive persons. An increase in aerobic physical activity should be considered an important component of lifestyle modification for prevention and treatment of high blood pressure.

Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

Abstract: Background The effects of the dose of dialysis and the level of flux of the dialyzer membrane on mortality and morbidity among patients undergoing maintenance hemodialysis are uncertain. Methods We undertook a randomized clinical trial in 1846 patients undergoing thrice-weekly dialysis, using a two-by-two factorial design to assign patients randomly to a standard or high dose of dialysis and to a low-flux or high-flux dialyzer. Results In the standard-dose group, the mean (±SD) urea-reduction ratio was 66.3±2.5 percent, the single-pool Kt/V was 1.32±0.09, and the equilibrated Kt/V was 1.16±0.08; in the high-dose group, the values were 75.2±2.5 percent, 1.71±0.11, and 1.53±0.09, respectively. Flux, estimated on the basis of beta2-microglobulin clearance, was 3±7 ml per minute in the low-flux group and 34±11 ml per minute in the high-flux group. The primary outcome, death from any cause, was not significantly influenced by the dose or flux assignment: the relative risk of death in the high-dose group as com...

Meta-analyses involving cross-over trials: methodological issues

Abstract: Background Meta-analysis of randomized controlled trials (RCTs) is usually based on trials where patients are randomized individually into two different, parallel, treatment groups. This paper concentrates on RCTs of a different design—two-period, twotreatment cross-over trials. Methods The characteristics of these trials are outlined, with detailed examples of methods for analysis for both continuous and binary data. These case studies are then extended into the context of a meta-analysis. The Cochrane Library was surveyed to assess current practice for synthesis. Results Methods are described for continuous and binary data for use both when the necessary paired data are given and also when they need to be calculated or imputed, and some suggestions are provided to help people wishing to synthesize data from cross-over trials into meta-analyses. The survey suggested that about 8% of the trials in the Cochrane library were cross-over trials and 18% of the reviews referred to such trials, although there was no consistent approach to their inclusion into the reviews. Conclusions Methods do exist for including valuable information from two-period, twotreatment cross-over trials into quantitative reviews. However, poor reporting of cross-over trials will often impede attempts to perform a meta-analysis using the available methods.

INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy.

Abstract: PURPOSE: To compare the local/regional control, survival, and toxicity of combined-modality therapy using high-dose (64.8 Gy) versus standard-dose (50.4 Gy) radiation therapy for the treatment of p...

Early Protection Against Sudden Death by n-3 Polyunsaturated Fatty Acids After Myocardial Infarction Time-Course Analysis of the Results of the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico (GISSI)-Prevenzione

Abstract: Background— Our purpose was to assess the time course of the benefit of n-3 polyunsaturated fatty acids (PUFAs) on mortality documented by the GISSI-Prevenzione trial in patients surviving a recent (<3 months) myocardial infarction. Methods and Results— In this study, 11 323 patients were randomly assigned to supplements of n-3 PUFAs, vitamin E (300 mg/d), both, or no treatment (control) on top of optimal pharmacological treatment and lifestyle advice. Intention-to-treat analysis adjusted for interaction between treatments was carried out. Early efficacy of n-3 PUFA treatment for total, cardiovascular, cardiac, coronary, and sudden death; nonfatal myocardial infarction; total coronary heart disease; and cerebrovascular events was assessed by right-censoring follow-up data 12 times from the first month after randomization up to 12 months. Survival curves for n-3 PUFA treatment diverged early after randomization, and total mortality was significantly lowered after 3 months of treatment (relative risk [RR] 0...

Effect of Carvedilol on the Morbidity of Patients With Severe Chronic Heart Failure Results of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study

Abstract: Background— β-Blocking agents improve functional status and reduce morbidity in mild-to-moderate heart failure, but it is not known whether they produce such benefits in severe heart failure. Methods and Results— We randomly assigned 2289 patients with symptoms of heart failure at rest or on minimal exertion and with an ejection fraction <25% (but not volume-overloaded) to double-blind treatment with either placebo (n=1133) or carvedilol (n=1156) for an average of 10.4 months. Carvedilol reduced the combined risk of death or hospitalization for a cardiovascular reason by 27% (P=0.00002) and the combined risk of death or hospitalization for heart failure by 31% (P=0.000004). Patients in the carvedilol group also spent 27% fewer days in the hospital for any reason (P=0.0005) and 40% fewer days in the hospital for heart failure (P<0.0001). These differences were as a result of both a decrease in the number of hospitalizations and a shorter duration of each admission. More patients felt improved and fewer pat...

Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women's Health Initiative Randomized Controlled Trial. Writing Group for the Women's Health Initiative Investigators. JAMA 2002; 288(3): 321-333

Abstract: 221 The Journal of Family Planning and Reproductive Health Care 2002: 28(4) Evaluation results from the Portsmouth and Wirral pilots found that testing was a success with both patients and health care professionals and reached a high proportion of the target group. A total of 75% of those offered screening accepted and approximately 1 in 10 were found to be infected; 95% of those diagnosed with chlamydia returned for treatment. The two centres are currently investigating reinfection rates for chlamydia, in order to ascertain the frequency required for an effective national programme. Public Health Minister, Hazel Blears said: ‘We are committed to tackling the rising rates of all sexually transmitted infections and today’s announcement is an important step in the right direction. As we continue to implement the first ever National Strategy for Sexual Health and HIV we will deliver a range of measures to increase public awareness, improve access to GUM services and offer better treatment and care to those who need it.’ The first ten sites will primarily target women aged 16–24 years who access sexual health services. Young women, particularly those under 21 years, are at greatest risk of infection and the long-term complications of untreated chlamydia are more serious for women. However testing will be offered to both men and women presenting with symptoms, and greater uptake of testing among men will be promoted. Efforts will also be made to trace partners or ex-partners of those found to be infected to offer treatment. The increase in diagnosis of chlamydia over recent years is, in some part, due to improved awareness of the infection amongst both public and professionals and increased testing. However, continued efforts to increase awareness are needed – ongoing work will be supported by the Department of Health’s public information campaign to be launched in Autumn 2002. It will highlight the risk of contracting all STIs, including human immunodeficiency virus (HIV), and the importance of practising safe sex.

Interventions to enhance patient adherence to medication prescriptions: scientific review.

Abstract: ContextLow adherence with prescribed treatments is ubiquitous and undermines treatment benefits.ObjectiveTo systematically review published randomized controlled trials (RCTs) of interventions to assist patients' adherence to prescribed medications.Data SourcesA search of MEDLINE, CINAHL, PSYCHLIT, SOCIOFILE, IPA, EMBASE, The Cochrane Library databases, and bibliographies was performed for records from 1967 through August 2001 to identify relevant articles of all RCTs of interventions intended to improve adherence to self-administered medications.Study Selection and Data ExtractionStudies were included if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications for a medical or psychiatric disorder; both adherence and treatment outcome were measured; follow-up of at least 80% of each study group was reported; and the duration of follow-up for studies with positive initial findings was at least 6 months. Information on study design features, interventions, controls, and findings (adherence rates and patient outcomes) were extracted for each article.Data SynthesisStudies were too disparate to warrant meta-analysis. Forty-nine percent of the interventions tested (19 of 39 in 33 studies) were associated with statistically significant increases in medication adherence and only 17 reported statistically significant improvements in treatment outcomes. Almost all the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, counseling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention. Even the most effective interventions had modest effects.ConclusionsCurrent methods of improving medication adherence for chronic health problems are mostly complex, labor-intensive, and not predictably effective. The full benefits of medications cannot be realized at currently achievable levels of adherence; therefore, more studies of innovative approaches to assist patients to follow prescriptions for medications are needed.

Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial.

Abstract: Context Little randomized evidence is available to guide the in-hospital management of patients with an acute exacerbation of chronic heart failure. Although intravenous inotropic therapy usually produces beneficial hemodynamic effects and is labeled for use in the care of such patients, the effect of such therapy on intermediate-term clinical outcomes is uncertain. Objective To prospectively test whether a strategy that includes short-term use of milrinone in addition to standard therapy can improve clinical outcomes of patients hospitalized with an exacerbation of chronic heart failure. Design Prospective, randomized, double-blind, placebo-controlled trial conducted from July 1997 through November 1999. Setting Seventy-eight community and tertiary care hospitals in the United States. Participants A total of 951 patients admitted with an exacerbation of systolic heart failure not requiring intravenous inotropic support (mean age, 65 years; 92% with baseline New York Heart Association class III or IV; mean left ventricular ejection fraction, 23%). Intervention Patients were randomly assigned to receive a 48-hour infusion of either milrinone, 0.5 microg/kg per minute initially (n = 477), or saline placebo (n = 472). Main outcome measure Cumulative days of hospitalization for cardiovascular cause within 60 days following randomization. Results The median number of days hospitalized for cardiovascular causes within 60 days after randomization did not differ significantly between patients given milrinone (6 days) compared with placebo (7 days; P =.71). Sustained hypotension requiring intervention (10.7% vs 3.2%; P Conclusion These results do not support the routine use of intravenous milrinone as an adjunct to standard therapy in the treatment of patients hospitalized for an exacerbation of chronic heart failure.

Network meta-analysis for indirect treatment comparisons

Abstract: I present methods for assessing the relative effectiveness of two treatments when they have not been compared directly in a randomized trial but have each been compared to other treatments. These network meta-analysis techniques allow estimation of both heterogeneity in the effect of any given treatment and inconsistency ('incoherence') in the evidence from different pairs of treatments. A simple estimation procedure using linear mixed models is given and used in a meta-analysis of treatments for acute myocardial infarction.

Erythropoietin therapy for acute stroke is both safe and beneficial.

Abstract: Background: Erythropoietin (EPO) and its receptor play a major role in embryonic brain, are weakly expressed in normal postnatal/adult brain and up-regulated upon metabolic stress. EPO protects neurons from hypoxic/ ischemic injury. The objective of this trial is to study the safety and efficacy of recombinant human EPO (rhEPO) for treatment of ischemic stroke in man. Materials and Methods: The trial consisted of a safety part and an efficacy part. In the safety study, 13 patients received rhEPO intravenously (3.3 � 10 4 IU/50 ml/30 min) once daily for the first 3 days after stroke. In the double-blind randomized proof-of-concept trial, 40 patients received either rhEPO or saline. Inclusion criteria were age � 80 years, ischemic stroke within the middle cerebral artery territory confirmed by diffusion-weighted MRI, symptom onset � 8 hr before drug administration, and deficits on stroke scales. The study endpoints were functional outcome at day 30 (Barthel Index, modified Rankin scale), NIH and Scandinavian stroke scales, evolution of

Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT).

Abstract: Context Blood pressure control ( Objective To determine the success and predictors of blood pressure control in a large hypertension trial involving a multiethnic population in diverse practice settings. Design The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial is a randomized, double-blind, active-controlled clinical trial with a mean follow-up of 4.9 years. Participant enrollment began in February 1994 and follow-up was completed in March 2002. Setting A total of 623 centers in the United States, Canada, and the Caribbean. Participants A total of 33,357 participants (aged > or =55 years) with hypertension and at least one other coronary heart disease risk factor. Interventions Participants were randomly assigned to receive (double-blind) chlorthalidone, 12.5-25 mg/d (n=15,255), amlodipine 2.5-10 mg/d (n=9048), or lisinopril 10-40 mg/d (n=9054) after other medication was discontinued. Doses were increased within these ranges and additional drugs from other classes were added as needed to achieve blood pressure control ( Main outcome measures The outcome measures for this report are systolic and diastolic blood pressure, the proportion of participants achieving blood pressure control ( Results Mean age was 67 years, 47% were women, 35% black, 36% diabetic; 90% were on antihypertensive drug treatment at entry. At the first of two pre-randomization visits, blood pressure was or =2 drugs was 63%. Blood pressure control varied by geographic regions, practice settings, and demographic and clinical characteristics of participants. Conclusions These data demonstrate that blood pressure may be controlled in two thirds of a multiethnic hypertensive population in diverse practice settings. Systolic blood pressure is more difficult to control than diastolic blood pressure, and at least two antihypertensive medications are required for most patients to achieve blood pressure control. It is likely that the majority of people with hypertension could achieve a blood pressure

Randomized controlled trial of interventions designed to reduce the risk of progression to first-episode psychosis in a clinical sample with subthreshold symptoms.

Abstract: BACKGROUND: Most disability produced by psychotic illnesses, especially schizophrenia, develops during the prepsychotic period, creating a case for intervention during this period However, only recently has it been possible to engage people in treatment during this phase METHODS: A randomized controlled trial compared 2 interventions in 59 patients at incipient risk of progression to first-episode psychosis We termed this group ultra-high risk to emphasize the enhanced risk vs conventional genetic high-risk studies Needs-based intervention was compared with specific preventive intervention comprising low-dose risperidone therapy (mean dosage, 13 mg/d) and cognitive behavior therapy Treatment was provided for 6 months, after which all patients were offered ongoing needs-based intervention Assessments were performed at baseline, 6 months, and 12 months RESULTS: By the end of treatment, 10 of 28 people who received needs-based intervention progressed to first-episode psychosis vs 3 of 31 from the specific preventive intervention group (P=03) After 6-month follow-up, another 3 people in the specific preventive intervention group became psychotic, and with intention-to-treat analysis, the difference was no longer significant (P=24) However, for risperidone therapy-adherent patients in the specific preventive intervention group, protection against progression extended for 6 months after cessation of risperidone use CONCLUSIONS: More specific pharmacotherapy and psychotherapy reduces the risk of early transition to psychosis in young people at ultra-high risk, although their relative contributions could not be determined This represents at least delay in onset (prevalence reduction), and possibly some reduction in incidence

Effects of coenzyme Q10 in early Parkinson disease: evidence of slowing of the functional decline.

Abstract: Background Parkinson disease (PD) is a degenerative neurological disorder for which no treatment has been shown to slow the progression. Objective To determine whether a range of dosages of coenzyme Q10is safe and well tolerated and could slow the functional decline in PD. Design Multicenter, randomized, parallel-group, placebo-controlled, double-blind, dosage-ranging trial. Setting Academic movement disorders clinics. Patients Eighty subjects with early PD who did not require treatment for their disability. Interventions Random assignment to placebo or coenzyme Q10at dosages of 300, 600, or 1200 mg/d. Main Outcome Measure The subjects underwent evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) at the screening, baseline, and 1-, 4-, 8-, 12-, and 16-month visits. They were followed up for 16 months or until disability requiring treatment with levodopa had developed. The primary response variable was the change in the total score on the UPDRS from baseline to the last visit. Results The adjusted mean total UPDRS changes were +11.99 for the placebo group, +8.81 for the 300-mg/d group, +10.82 for the 600-mg/d group, and +6.69 for the 1200-mg/d group. ThePvalue for the primary analysis, a test for a linear trend between the dosage and the mean change in the total UPDRS score, was .09, which met our prespecified criteria for a positive trend for the trial. A prespecified, secondary analysis was the comparison of each treatment group with the placebo group, and the difference between the 1200-mg/d and placebo groups was significant (P= .04). Conclusions Coenzyme Q10was safe and well tolerated at dosages of up to 1200 mg/d. Less disability developed in subjects assigned to coenzyme Q10than in those assigned to placebo, and the benefit was greatest in subjects receiving the highest dosage. Coenzyme Q10appears to slow the progressive deterioration of function in PD, but these results need to be confirmed in a larger study.

Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial.

Abstract: ContextThere has been increasing interest in the use of health-related quality-of-life (HRQL) assessments in daily clinical practice, yet few empirical studies have been conducted to evaluate the usefulness of such assessments.ObjectiveTo evaluate the efficacy of standardized HRQL assessments in facilitating patient-physician communication and increasing physicians' awareness of their patients' HRQL-related problems.DesignProspective, randomized crossover trial.SettingOutpatient clinic of a cancer hospital in the Netherlands.ParticipantsTen physicians and 214 patients (76% women; mean age, 57 years) undergoing palliative chemotherapy who were invited to participate between June 1996 and June 1998.InterventionAt 3 successive outpatient visits, patients completed an HRQL questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). The responses were computer scored and transformed into a graphic summary. Physicians and patients received a copy of the summary before the consultation.Main Outcome MeasuresAudiotapes of the consultations were content analyzed to evaluate patient-physician communication. Physicians' awareness of their patients' health problems was assessed by comparing physicians' and patients' ratings on the Dartmouth Primary Care Cooperative Information Functional Health Assessment (COOP) and the World Organisation Project of National Colleges and Academics (WONCA) charts.ResultsThe HRQL-related issues were discussed significantly more frequently in the intervention than in the control group (mean [SD] communication composite scores: 4.5 [2.3] vs 3.7 [1.9], respectively (P = .01). Physicians in the intervention group identified a greater percentage of patients with moderate-to-severe health problems in several HRQL domains than did those in the control group. All physicians and 87% of the patients believed that the intervention facilitated communication and expressed interest in its continued use.ConclusionIncorporating standardized HRQL assessments in daily clinical oncology practice facilitates the discussion of HRQL issues and can heighten physicians' awareness of their patients' HRQL.

The International Index of Erectile Function (IIEF): a state-of-the-science review.

Abstract: The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity. The IIEF was developed in conjunction with the clinical trial program for sildenafil, and has since been adopted as the 'gold standard' measure for efficacy assessment in clinical trials of ED. It has been linguistically validated in 32 languages and used as a primary endpoint in more than 50 clinical trials. This review summarizes early stages in the psychometric validation of the instrument, its subsequent adoption in randomized clinical trials with sildenafil and other ED therapies, and its use in classifying ED severity and prevalence. The IIEF meets psychometric criteria for test reliability and validity, has a high degree of sensitivity and specificity, and correlates well with other measures of treatment outcome. It has demonstrated consistent and robust treatment responsiveness in studies in USA, Europe and Asia, as well as in a wide range of etiological subgroups. Although only one direct comparator trial has been performed to date, the IIEF is also sensitive to therapeutic effects with treatment agents other than sildenafil. A severity classification for ED has recently been developed, in addition to a brief screening version of the instrument. This review includes the strengths as well as limitations of the IIEF, along with some potential areas for future research.

Interventions for helping patients to follow prescriptions for medications

Abstract: Background People who are prescribed self-administered medications typically take less than half the prescribed doses. Efforts to assist patients with adherence to medications might improve the benefits and efficiency of health care, but also might increase its adverse effects. Objectives To update a review summarising the results of randomised controlled trials (RCTs) of interventions to help patients follow prescriptions for medications for medical problems, focusing on trials that measured both adherence and clinical outcomes. Search strategy Computerised searches to August 2001 in MEDLINE, CINAHL, The Cochrane Library, International Pharmaceutical Abstracts (IPA) PsychInfo, and Sociofile; bibliographies in articles on patient adherence; articles in the reviewers' personal collections; and contact with authors of original and review articles on the topic. Selection criteria Articles were selected if they reported an unconfounded RCT of an intervention to improve adherence with prescribed medications, measuring both medication adherence and treatment outcome, with at least 80% follow-up of each group studied and, for long-term treatments, at least six months follow-up for studies with positive initial findings. Data collection and analysis Information on study design features, interventions and controls, and results were extracted by one reviewer and confirmed by at least one other reviewer. The studies were too disparate to warrant meta-analysis. Main results For short-term treatments, one of three interventions reported in three RCTs showed an effect on both adherence and clinical outcome. Eighteen of 36 interventions for long-term treatments reported in 30 RCTs were associated with improvements in adherence, but only 16 interventions led to improvements in treatment outcomes. Almost all of the interventions that were effective for long-term care were complex, including combinations of more convenient care, information, reminders, self-monitoring, reinforcement, counselling, family therapy, and other forms of additional supervision or attention by a health care provider (physician, nurse, pharmacist or other). Even the most effective interventions did not lead to large improvements in adherence and treatment outcomes. Two studies showed that telling patients about adverse effects of treatment did not affect their adherence. Authors' conclusions The full benefits of medications cannot be realised at currently achievable levels of adherence. Current methods of improving adherence for chronic health problems are mostly complex and not very effective. Innovations to assist patients to follow medication prescriptions are needed.

Blood Pressure and Clinical Outcomes in the International Stroke Trial

Abstract: Background and Purpose— Among patients with acute stroke, high blood pressure is often associated with poor outcome, although the reason is unclear. We analyzed data from the International Stroke Trial (IST) to explore the relationship between systolic blood pressure (SBP), subsequent clinical events over the next 2 weeks, and functional outcome at 6 months in patients with acute stroke. Methods— We included in the analysis 17 398 patients from IST with confirmed ischemic stroke. A single measurement of SBP was made immediately before randomization. Clinical events within 14 days of randomization were recorded: recurrent ischemic stroke, symptomatic intracranial hemorrhage, death resulting from presumed cerebral edema, fatal coronary heart disease, and death. Survival and dependency were assessed at 6 months. Outcomes were adjusted for age, sex, clinical stroke syndrome, time to randomization, consciousness level, atrial fibrillation, and treatment allocation (aspirin, unfractionated heparin, both, or nei...

Psychological treatments in schizophrenia: I. Meta-analysis of family intervention and cognitive behaviour therapy

Abstract: Background. While there is a growing body of evidence on the efficacy of psychological interventions for schizophrenia, this meta-analysis improves upon previous systematic and meta-analytical reviews by including a wider range of randomized controlled trials and providing comparisons against both standard care and other active interventions. Method. Literature searches identified randomized controlled trials of four types of psychological interventions: family intervention, cognitive behavioural therapy (CBT), social skills training and cognitive remediation. These were then subjected to meta-analysis on a variety of outcome measures. This paper presents results relating to the first two. Results. Family therapy, in particular single family therapy, had clear preventative effects on the outcomes of psychotic relapse and readmission, in addition to benefits in medication compliance. CBT produced higher rates of 'important improvement' in mental state and demonstrated positive effects on continuous measures of mental state at follow-up. CBT also seems to be associated with low drop-out rates. Conclusions. Family intervention should be offered to people with schizophrenia who are in contact with carers. CBT may be useful for those with treatment resistant symptoms. Both treatments, in particular CBT, should be further investigated in large trials across a variety of patients, in various settings. The factors mediating treatment success in these interventions should be researched.