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PubMed2002

Sildenafil for male erectile dysfunction: a systematic review and meta-analysis.

OBJECTIVE: To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction. DATA SOURCES: The MEDLINE, HealthSTAR, Current Contents, and Cochrane Library databases (January 1, 1995, through December 31, 2000); bibliographies of retrieved articles and review articles; conference proceedings abstracts; the Food and Drug Administration Web site; and the manufacturer. STUDY SELECTION: Trials were eligible if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were of at least 7 days' duration, and assessed clinically relevant outcomes. DATA EXTRACTION: Two reviewers independently evaluated study quality and extracted data in a standardized fashion. DATA SYNTHESIS: Twenty-seven trials (6659 men) met the inclusion criteria. In results pooled from 14 parallel-group, flexible as-needed dosing trials, sildenafil was more likely than placebo to lead to successful sexual intercourse, with a higher percentage of successful intercourse attempts (57% vs 21%; weighted mean difference, 33.7; 95% confidence interval [CI], 29.2-38.2; 2283 men) and a greater percentage of men experiencing at least 1 intercourse success during treatment (83% vs 45%; relative benefit increase, 1.8; 95% CI, 1.7-1.9; 2205 men). In data pooled from 6 parallel-group, fixed-dose trials, efficacy appeared slightly greater at higher doses. Treatment response appeared to vary between patient subgroups, although relative to placebo, sildenafil significantly improved erectile function in all evaluated subgroups. In trials with parallel-group design and flexible dosing, men randomized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality. Specific adverse events with sildenafil included flushing (12%), headache (11%), dyspepsia (5%), and visual disturbances (3%); all adverse events were significantly less likely to occur with placebo. Sildenafil was not significantly associated with serious cardiovascular events or death. CONCLUSIONS: Sildenafil improves erectile function and is generally well tolerated. Treatment response seems to vary between patient subgroups, although sildenafil has greater efficacy than placebo in all evaluated subgroups.

Age Factors↗
PubMed2005

Theophylline for prevention of contrast-induced nephropathy: a systematic review and meta-analysis.

BACKGROUND: Contrast-induced nephropathy (CIN) is an important cause of declines in kidney function and is related to greater morbidity, health care costs, and mortality. Adenosine has been proposed to contribute to the pathophysiological process of CIN. We performed a systematic review and meta-analysis of theophylline, an adenosine antagonist, for the prevention of CIN. DATA SOURCES: Studies were identified in all languages by search of MEDLINE (1966 through November 2003), EMBASE (1980 through week 44 [November] of 2003), and the Cochrane Controlled Clinical Trials Register (1996 through November 2003) databases and selected conference proceedings. STUDY SELECTION: We searched for randomized controlled trials comparing theophylline vs control in patients receiving radiocontrast media for angiography or computed tomography. DATA EXTRACTION: Our primary outcome measures were the risk of CIN, the difference in serum creatinine levels between theophylline and control groups at 48 hours and need for dialysis. DATA SYNTHESIS: Nine randomized controlled trials involving 585 patients were identified and included for analysis. Theophylline protocols and definitions of CIN varied across studies. There was evidence of heterogeneity of results across trials (Q = 9.77; P = .08); therefore, pooled values require cautious interpretation. The overall pooled odds ratio (OR) using a conservative random-effects model was 0.40 (95% confidence interval [CI], 0.14 to 1.16; P = .09) indicating a trend toward reduction in the incidence of CIN with theophylline use. The pooled estimate for the difference in 48-hour serum creatinine levels between the theophylline and control groups was -0.17 mg/dL (95% CI, -0.28 to -0.06 mg/dL) (-15.2 micromol/L [95% CI, -24.6 to -5.7 micromol/L]) (P = .002), indicating that theophylline may be protective in CIN. The incidence of CIN requiring dialysis was uncommon and reported in only 1 case. CONCLUSIONS: Theophylline may reduce the incidence of CIN with an efficacy that is perhaps comparable to that reported in studies of N-acetylcysteine. However, findings are inconsistent across studies. A large, well-designed trial that incorporates the evaluation of clinically relevant outcomes is required to more adequately assess the role for theophylline in CIN prevention.

Angiography↗
PubMed2003

Interventions to reduce sexual risk for the human immunodeficiency virus in adolescents, 1985-2000: a research synthesis.

OBJECTIVE: To summarize studies that have tested the efficacy of human immunodeficiency virus (HIV) sexual risk-reduction interventions in adolescents. DATA SOURCES: Reports were gathered from computerized databases, by contacting individual researchers, by searching conference proceedings and relevant journals, and by reviewing reference sections of obtained articles. STUDY SELECTION: Studies were included if they investigated any educational, psychosocial, or behavioral intervention advocating sexual risk reduction for HIV prevention; used experimental designs (or other designs with adequate comparison groups); had behavioral-dependent measures relevant to sexual risk; sampled adolescents (age range, 11-18 years); and had sufficient information to calculate effect size (ES) estimates. Data from 44 studies and 56 interventions (N = 35 282 participants) that were available as of January 2, 2001, were included. DATA EXTRACTION: Study information was coded, and individual ESs were calculated in SD units (the difference between the intervention and comparison condition means, divided by the pooled SD), with ESs coded so that positive signs indicated greater risk reduction. DATA SYNTHESIS: Across the studies, reductions in sexual risk were greater for adolescents who received the HIV risk-reduction intervention compared with those in the comparison conditions for 5 dimensions: condom use negotiation skills (mean ES, 0.50; 95% confidence interval [CI], 0.41-0.59), condom use skills (mean ES, 0.30; 95% CI, 0.09-0.51), communications with sexual partners (mean ES, 0.27; 95% CI, 0.19-0.36), condom use (mean ES, 0.07; 95% CI, 0.03-0.11), and sexual frequency (mean ES, 0.05; 95% CI, 0.02-0.09). Interventions achieved greater success with condom use (1) in noninstitutionalized populations, (2) when condoms were provided, (3) with more condom information and skills training, (4) when the comparison group received less HIV skills training, and (5) when the comparison group received more non-HIV-related sexual education. CONCLUSION: Intensive behavioral interventions reduced sexual HIV risk, especially because they increased skill acquisition, sexual communications, and condom use and decreased the onset of sexual intercourse or the number of sexual partners.

Adolescent↗
PubMed2005

Control group bias in randomized atypical antipsychotic medication trials for schizophrenia.

CONTEXT: It has been suggested that the need for concurrent placebo control groups in new schizophrenia studies might be minimized by making comparisons with external placebo. This strategy requires an assumption of constancy, that the novel medication will perform the same way in a study with only active controls as it would have in a placebo-controlled trial. OBJECTIVE: To test this constancy assumption in active- and low dose-controlled trials vs placebo-controlled trials of atypical antipsychotic medications. DATA SOURCES: A comprehensive search of bibliographic databases, conference proceedings, and Food and Drug Administration databases through November 24, 2003. STUDY SELECTION: English-language, randomized, double-blind clinical trials of newer atypical antipsychotic medications in otherwise unselected acutely ill adults with schizophrenia or schizoaffective disorder that reported baseline and intent-to-treat end point change values for the Brief Psychiatric Rating Scale. DATA EXTRACTION: Study number, sample size, reported dosage for each arm, trial duration, percentage of men, average age, trial arm treatment completion rate, baseline and within-arm end point change in the Brief Psychiatric Rating Scale, method of scoring the Brief Psychiatric Rating Scale, and date of publication were extracted from each study independently by 2 of us (S.W.W. and C.B.B.) each. DATA SYNTHESIS: There were 32 studies comprising 66 risperidone, olanzapine, quetiapine, and ziprasidone arms including 7264 patients. Random-effects analysis revealed that in atypical antipsychotic medication arms, the degree of improvement was nearly double in active-controlled trials than that seen with the same drugs and dosages in placebo-controlled studies. An effect of design was also observed in low dose-controlled studies vs placebo-controlled studies in ineffective and intermediate antipsychotic medication dose ranges. CONCLUSIONS: The observed control group bias indicates that the constancy assumption does not hold in recent antipsychotic medication trials. These results suggest that caution is indicated when considering active- or low dose-controlled studies requiring comparisons with external placebo as alternatives to placebo-controlled trials for establishing efficacy of new medications for schizophrenia.

Age Factors↗
PubMed1998

Sleepiness, driving, and motor vehicle crashes. Council on Scientific Affairs, American Medical Association.

OBJECTIVE: To assess the contribution of driver sleepiness to highway crashes and review recent recommendations to change federal hours-of-service regulations for commercial motor vehicle drivers. DATA SOURCES: Information was derived from a search of the MEDLINE, Transportation Research Information Service (TRIS), and Bibliographic Electronic Databases of Sleep (BEDS) databases from 1975 through 1997 and from manual review of the reference lists in relevant journal articles, government publications, conference proceedings, and textbooks. DATA SYNTHESIS: Driver sleepiness is a causative factor in 1% to 3% of all US motor vehicle crashes. Surveys of the prevalence of sleepy behavior in drivers suggest that sleepiness may be a more common cause of highway crashes than is reflected in these estimates. About 96% of sleep-related crashes involve passenger vehicle drivers and 3% involve drivers of large trucks. Risk factors include youth, shift work, alcohol and other drug use, over-the-counter and prescription medications, and sleep disorders. CONCLUSIONS: Increased awareness of the relationship between sleepiness and motor vehicle crashes will promote the health and safety of drivers and highway users. Physicians can contribute by encouraging good sleep habits, recognizing and treating sleep-related problems, and counseling patients about the risks of driving while sleepy. To protect public health and safety, the American Medical Association recommends continued research on devices and technologies to detect the signs of sleepiness and prevent the deterioration of driver alertness and performance. Educational programs about the risks of falling asleep while driving are needed for physicians, the public, and commercial truck drivers.

Accidents, Traffic↗
PubMed1998

Effects of computer-based clinical decision support systems on physician performance and patient outcomes: a systematic review.

CONTEXT: Many computer software developers and vendors claim that their systems can directly improve clinical decisions. As for other health care interventions, such claims should be based on careful trials that assess their effects on clinical performance and, preferably, patient outcomes. OBJECTIVE: To systematically review controlled clinical trials assessing the effects of computer-based clinical decision support systems (CDSSs) on physician performance and patient outcomes. DATA SOURCES: We updated earlier reviews covering 1974 to 1992 by searching the MEDLINE, EMBASE, INSPEC, SCISEARCH, and the Cochrane Library bibliographic databases from 1992 to March 1998. Reference lists and conference proceedings were reviewed and evaluators of CDSSs were contacted. STUDY SELECTION: Studies were included if they involved the use of a CDSS in a clinical setting by a health care practitioner and assessed the effects of the system prospectively with a concurrent control. DATA EXTRACTION: The validity of each relevant study (scored from 0-10) was evaluated in duplicate. Data on setting, subjects, computer systems, and outcomes were abstracted and a power analysis was done on studies with negative findings. DATA SYNTHESIS: A total of 68 controlled trials met our criteria, 40 of which were published since 1992. Quality scores ranged from 2 to 10, with more recent trials rating higher (mean, 7.7) than earlier studies (mean, 6.4) (P<.001). Effects on physician performance were assessed in 65 studies and 43 found a benefit (66%). These included 9 of 15 studies on drug dosing systems, 1 of 5 studies on diagnostic aids, 14 of 19 preventive care systems, and 19 of 26 studies evaluating CDSSs for other medical care. Six of 14 studies assessing patient outcomes found a benefit. Of the remaining 8 studies, only 3 had a power of greater than 80% to detect a clinically important effect. CONCLUSIONS: Published studies of CDSSs are increasing rapidly, and their quality is improving. The CDSSs can enhance clinical performance for drug dosing, preventive care, and other aspects of medical care, but not convincingly for diagnosis. The effects of CDSSs on patient outcomes have been insufficiently studied.

Clinical Competence↗
PubMed2000

Chorioamnionitis as a risk factor for cerebral palsy: A meta-analysis.

CONTEXT: Chorioamnionitis has been implicated in the pathogenesis of cerebral palsy, but most studies have not reported a significant association. Cystic periventricular leukomalacia (cPVL) is believed to be a precursor of cerebral palsy in preterm infants. OBJECTIVES: To determine whether chorioamnionitis is associated with cerebral palsy or cPVL and to examine factors that may explain differences in study results. DATA SOURCES: Searches of MEDLINE (1966-1999), Index Medicus (1960-1965), Doctoral Dissertation Abstracts On-Line (1861-1999), bibliographies, and online conference proceedings (1999) were performed for English-language studies with titles or abstracts that discussed prenatal risk factors for cerebral palsy or cPVL. STUDY SELECTION: Of 229 initially identified publications, meta-analyses were performed on studies that addressed the association between clinical (n = 19) or histologic (n = 7) chorioamnionitis and cerebral palsy or cPVL in both preterm and full-term infants. Inclusion criteria were: presence of appropriate exposure and outcome measures, case-control or cohort study design, and provision of sufficient data to calculate relative risks (RRs) or odds ratios with 95% confidence intervals (CIs). Studies evaluating risk of cerebral palsy following maternal fever, urinary tract infection, or other maternal infection were collected, but not included in the meta-analysis. DATA EXTRACTION: Information from individual studies was abstracted using standardized forms by 2 independent observers blinded to authors' names, journal titles, and funding sources. DATA SYNTHESIS: Using a random effects model, clinical chorioamnionitis was significantly associated with both cerebral palsy (RR, 1.9; 95% CI, 1.4-2.5) and cPVL (RR, 3.0; 95% CI, 2.2-4.0) in preterm infants. The RR of histologic chorioamnionitis and cerebral palsy was 1.6 (95% CI, 0.9-2.7) in preterm infants, and histologic chorioamnionitis was significantly associated with cPVL (RR, 2.1; 95% CI, 1.5-2.9). Among full-term infants, a positive association was found between clinical chorioamnionitis and cerebral palsy (RR, 4.7; 95% CI, 1.3-16.2). Factors explaining differences in study results included varying definitions of clinical chorioamnionitis, extent of blinding in determining exposure status, and whether individual studies adjusted for potential confounders. CONCLUSION: Our meta-analysis indicates that chorioamnionitis is a risk factor for both cerebral palsy and cPVL. JAMA. 2000;284:1417-1424.

Cerebral Palsy↗
PubMed2000

Effect of patient reminder/recall interventions on immunization rates: A review.

CONTEXT: Immunization rates for children and adults remain below national goals. While experts recommend that health care professionals remind patients of needed immunizations, few practitioners actually use reminders. Little is known about the effectiveness of reminders in different settings or patient populations. OBJECTIVES: To assess the effectiveness of patient reminder systems in improving immunization rates, and to compare the effectiveness of different types of reminders for a variety of patient populations. DATA SOURCES: A search was performed using MEDLINE, EMBASE, PsychINFO, Sociological Abstracts, and CAB Health Abstracts. Relevant articles, as well as published abstracts, conference proceedings, and files of study collaborators, were searched for relevant references. STUDY SELECTION AND DATA EXTRACTION: English-language studies involving patient reminder/recall interventions (using criteria established by the Cochrane Collaboration) were eligible for review if they involved randomized controlled trials, controlled before-after studies, or interrupted time series, and measured immunization rates. Of 109 studies identified, 41 met eligibility criteria. Studies were reviewed independently by 2 reviewers using a standardized checklist. Results of studies are expressed as absolute percentage-point changes in immunization rates and as odds ratios (ORs). Studies with similar characteristics of patients or interventions were pooled (random effects model). DATA SYNTHESIS: Patient reminder systems were effective in improving immunization rates in 33 (80%) of the 41 studies, irrespective of baseline immunization rates, patient age, setting, or vaccination type. Increases in immunization rates due to reminders ranged from 5 to 20 percentage points. Reminders were effective for childhood vaccinations (OR, 2.02; 95% confidence interval [CI], 1.49-2.72), childhood influenza vaccinations (OR, 4. 25; 95% CI, 2.10-8.60), adult pneumococcus or tetanus vaccinations (OR, 5.14; 95% CI, 1.21-21.78), and adult influenza vaccinations (OR, 2.29; 95% CI, 1.69-3.10). While reminders were most effective in academic settings (OR, 3.33; 95% CI, 1.98-5.58), they were also highly effective in private practice settings (OR, 1.79; 95% CI, 1. 45-2.22) and public health clinics (OR, 2.09; 95% CI, 1.42-3.07). All types of reminders were effective (postcards, letters, and telephone or autodialer calls), with telephone reminders being most effective but costliest. CONCLUSIONS: Patient reminder systems in primary care settings are effective in improving immunization rates. Primary care physicians should use patient reminders to improve immunization delivery. JAMA. 2000;284:1820-1827.

Adult↗
PubMedDate not supplied

Safety outcomes in meta-analyses of phase 2 vs phase 3 randomized trials: Intracranial hemorrhage in trials of bolus thrombolytic therapy.

CONTEXT: Recent studies have reported disagreement between meta-analysis of small trials and subsequent large trials addressing the same question. However, disagreement for uncommon but serious adverse safety outcomes has not been examined. OBJECTIVE: To explore disagreement for serious adverse safety (intracranial hemorrhage [ICH]) and efficacy outcomes between meta-analysis of phase 2 (small) vs meta-analysis of phase 3 (large) randomized controlled trials comparing the efficacy of bolus thrombolytic therapy with infusion for acute myocardial infarction (AMI). DATA SOURCES: Electronic databases (MEDLINE, Cochrane Database of Clinical Trials) between January 1980 and December 1999 using the search terms thrombolysis, thrombolytic therapy, and myocardial infarction; conference proceedings; and reference lists. STUDY SELECTION: Fifteen randomized trials comparing thrombolytic agents administered by bolus injection with standard infusion therapy in patients with AMI. DATA EXTRACTION: Data on ICH, other causes of stroke, total mortality, and reinfarction were independently extracted from each study by 2 observers. DATA SYNTHESIS: Meta-analysis of 9 phase 2 trials (n = 3956) revealed a lower risk of ICH with bolus thrombolytic therapy (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.27-1.01), which was not statistically significant. Meta-analysis of 6 phase 3 trials (n = 62 673) indicated a significant increase in risk of ICH (OR, 1.25; 95% CI, 1.06-1.49). These results were significantly different (P =.01). There was no disagreement for efficacy outcomes. Phase 2 trials included younger and heavier patients with lower baseline blood pressures, and were more often open-label. Subgroup analyses suggested that each of these factors was associated with a lower estimate of risk of ICH with bolus agents. CONCLUSIONS: Our results suggest that when therapeutic interventions are associated with a potential for uncommon but serious adverse safety outcomes, there may be differences between small phase 2 and large phase 3 trials that result in their disagreement for safety but not necessarily efficacy outcomes. Further investigation of the frequency and causes of disagreement between small and large trials for safety outcomes is warranted.

Clinical Trials, Phase II as Topic↗
PubMed2001

Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions: a meta-analysis.

CONTEXT: Focal pulmonary lesions are commonly encountered in clinical practice, and positron emission tomography (PET) with the glucose analog 18-fluorodeoxyglucose (FDG) may be an accurate test for identifying malignant lesions. OBJECTIVE: To estimate the diagnostic accuracy of FDG-PET for malignant focal pulmonary lesions. DATA SOURCES: Studies published between January 1966 and September 2000 in the MEDLINE and CANCERLIT databases; reference lists of identified studies; abstracts from recent conference proceedings; and direct contact with investigators. STUDY SELECTION: Studies that examined FDG-PET or FDG with a modified gamma camera in coincidence mode for diagnosis of focal pulmonary lesions; enrolled at least 10 participants with pulmonary nodules or masses, including at least 5 participants with malignant lesions; and presented sufficient data to permit calculation of sensitivity and specificity were included in the analysis. DATA EXTRACTION: Two reviewers independently assessed study quality and abstracted data regarding prevalence of malignancy and sensitivity and specificity of the imaging test. Disagreements were resolved by discussion. DATA SYNTHESIS: We used a meta-analytic method to construct summary receiver operating characteristic curves. Forty studies met inclusion criteria. Study methodological quality was fair. Sample sizes were small and blinding was often incomplete. For 1474 focal pulmonary lesions of any size, the maximum joint sensitivity and specificity (the upper left point on the receiver operating characteristic curve at which sensitivity and specificity are equal) of FDG-PET was 91.2% (95% confidence interval, 89.1%-92.9%). In current practice, FDG-PET operates at a point on the summary receiver operating characteristic curve that corresponds approximately to a sensitivity and specificity of 96.8% and 77.8%, respectively. There was no difference in diagnostic accuracy for pulmonary nodules compared with lesions of any size (P =.43), for semiquantitative methods of image interpretation compared with qualitative methods (P =.52), or for FDG-PET compared with FDG imaging with a modified gamma camera in coincidence mode (P =.19). CONCLUSIONS: Positron emission tomography with 18-fluorodeoxyglucose is an accurate noninvasive imaging test for diagnosis of pulmonary nodules and larger mass lesions, although few data exist for nodules smaller than 1 cm in diameter. In current practice, FDG-PET has high sensitivity and intermediate specificity for malignancy.

Glucose-6-Phosphate↗
PubMed2002

Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis.

CONTEXT: The effects of home visitation programs to prevent functional decline in elderly persons have been inconsistent, and the value of these programs is controversial. OBJECTIVE: To evaluate the effect of preventive home visits on functional status, nursing home admission, and mortality. DATA SOURCES: Studies published in English, French, German, Italian, or Spanish reporting randomized trials of the effects of preventive in-home visits in older people (mean age >70 years) living in the community were identified through searches of MEDLINE, PSYCHINFO, and EMBASE (January 1985--November 2001). We also searched the Cochrane Controlled Trials Register, checked reference lists of earlier reviews and book chapters, searched conference proceedings and specialty journals, and contacted experts. STUDY SELECTION: We screened 1349 abstracts and excluded those that did not test in-home interventions or in which the mean age of the study population was younger than 70 years. After further exclusions, 17 articles describing 18 trials were analyzed. DATA EXTRACTION: Two reviewers independently screened abstracts. Discrepancies were resolved by consensus with a third reviewer. For each included trial, we extracted data on the study population and the characteristics of the intervention. Two of us extracted information on 3 end points: nursing home admissions, mortality, and functional status. One of us assessed trial quality, including an examination of the method of randomization, blinding of caregivers and research staff ascertaining outcomes, and proportion of patients included in analyses of the 3 end points. DATA SYNTHESIS: The 18 trials included 13 447 individuals aged 65 years and older. The effect on nursing home admissions depended on the number of visits performed during follow-up. The pooled relative risk (RR) was 0.66 (95% confidence interval [CI], 0.48-0.92) for trials in the upper tertile (>9 visits) but was 1.05 (95% CI, 0.85-1.30) in the lower tertile (0-4 visits). Functional decline was reduced in trials that used multidimensional assessment with follow-up (RR, 0.76; 95% CI, 0.64-0.91) but not in other trials (RR, 1.01; 95% CI, 0.92-1.11). Functional decline was reduced (RR, 0.78; 95% CI, 0.64-0.95) in trials with a control group mortality rate in the lower tertile (3.4%-5.8%) but not (RR, 0.98; 95% CI, 0.84-1.13) in those with a control-group mortality rate in the upper tertile (8.3%-10.7%). A beneficial effect on mortality was evident in younger study populations (RR, 0.76; 95% CI, 0.65-0.88 for ages 72.7-77.5 years) but not in older study populations (RR, 1.09; 95% CI, 0.92-1.28 for ages 80.2-81.6 years). CONCLUSION: Preventive home visitation programs appear to be effective, provided the interventions are based on multidimensional geriatric assessment and include multiple follow-up home visits and target persons at lower risk for death. Benefits on survival were seen in young-old rather than old-old populations.

Activities of Daily Living↗
PubMed2003

Long-term renal prognosis of diarrhea-associated hemolytic uremic syndrome: a systematic review, meta-analysis, and meta-regression.

CONTEXT: The long-term renal prognosis of patients with diarrhea-associated hemolytic uremic syndrome (HUS) remains controversial. OBJECTIVES: To quantify the long-term renal prognosis of patients with diarrhea-associated HUS and to identify reasons for different estimates provided in the literature. DATA SOURCES: We searched MEDLINE and Experta Medica (EMBASE) bibliographic databases and conference proceedings, and we contacted experts until February 2003. We also searched the Institute for Scientific Information index and reference lists of all studies that fulfilled our eligibility criteria. The search strategy included the terms hemolytic-uremic syndrome, purpura, thrombotic thrombocytopenic, Escherichia coli O157, longitudinal studies, kidney diseases, hypertension, and proteinuria STUDY SELECTION: Any study that followed up 10 or more patients with primary diarrhea-associated HUS for at least 1 year for renal sequelae. DATA EXTRACTION: Two authors independently abstracted data on study and patient characteristics, renal measures, outcomes, and prognostic features. Disagreements were resolved by a third author or by consensus. DATA SYNTHESIS: Forty-nine studies of 3476 patients with a mean follow-up of 4.4 years (range, 1-22 years at last follow-up) from 18 countries, 1950 to 2001, were summarized. At the time of recruitment, patients were aged 1 month to 18 years. In the different studies, death or permanent end-stage renal disease (ESRD) ranged from 0% to 30%, with a pooled incidence of 12% (95% confidence interval [CI], 10%-15%). A glomerular filtration rate lower than 80 mL/min per 1.73 m2, hypertension, or proteinuria was extremely variable and ranged from 0% to 64%, with a pooled incidence of 25% (95% CI, 20%-30%). A higher severity of acute illness was strongly associated with worse long-term prognosis. Studies with a higher proportion of patients with central nervous system symptoms (coma, seizures, or stroke) had a higher proportion of patients who died or developed permanent ESRD at follow-up (explaining 44% of the between-study variability, P =.01). Studies with a greater proportion of patients lost to follow-up also described a worse prognosis (P =.001) because these patients were typically healthier than those followed up. One or more years after diarrhea-associated HUS, patients with a predicted creatinine clearance higher than 80 mL/min per 1.73 m2, no overt proteinuria, and no hypertension appeared to have an excellent prognosis. CONCLUSIONS: Death or ESRD occurs in about 12% of patients with diarrhea-associated HUS, and 25% of survivors demonstrate long-term renal sequelae. Patients lost to follow-up contribute to worse estimates in some studies. The severity of acute illness, particularly central nervous system symptoms and the need for initial dialysis, is strongly associated with a worse long-term prognosis.

Diarrhea↗
PubMed2003

Emerging risk factors for atherosclerotic vascular disease: a critical review of the evidence.

CONTEXT: Atherosclerotic vascular disease is an enormous public health problem. A number of emerging risk factors for atherosclerosis have recently been proposed to help identify high-risk individuals. OBJECTIVE: To review the epidemiological, basic science, and clinical trial evidence concerning 4 emerging risk factors: C-reactive protein, lipoprotein(a), fibrinogen, and homocysteine. DATA SOURCES: Using the terms atherosclerosis, cardiovascular disease, risk factors, prevention, screening, C-reactive protein, lipoprotein(a), fibrinogen, and homocysteine, we searched the MEDLINE database from January 1990 to January 2003. Conference proceedings, abstract booklets, bibliographies of pertinent articles and books, and personal files were hand searched to identify additional articles. STUDY SELECTION: Original investigations and reviews of the epidemiology of atherosclerosis and the association of conventional and novel risk factors with vascular risk were selected. On the basis of the search strategy, 373 relevant studies were identified. DATA EXTRACTION: A diverse array of studies were examined, including randomized controlled trials, prospective cohort studies, systematic overviews, case-control, cross-sectional, and mechanistic studies. Data extraction was performed by one of the authors. DATA SYNTHESIS: The available epidemiological and basic science evidence supports, to varying degrees, independent associations between these 4 candidate risk factors and atherosclerotic vascular disease. However, there is relatively little data regarding the additive yield of screening for these factors over that of validated global risk assessment strategies currently in use. Furthermore, controlled intervention studies targeting individuals with these factors for proven risk-reduction therapies, or specifically treating these factors with available therapies, are few. The explanatory power of the major, established cardiovascular risk factors has been systematically underestimated. CONCLUSIONS: Although C-reactive protein, lipoprotein(a), fibrinogen, and homocysteine are associated with vascular disease risk, their optimal use in routine screening and risk stratification remains to be determined.

Arteriosclerosis↗
PubMed2004

Travel medicine considerations for North American immigrants visiting friends and relatives.

CONTEXT: In the United States, 10% of the population was born outside of its borders. Immigrants and their children frequently return to visit their homeland, referred to as visiting friends and relatives (VFRs). They account for a disproportionately high volume of international travel. EVIDENCE ACQUISITION: Searches of MEDLINE, World Health Organization, Centers for Disease Control and Prevention, International Society of Travel Medicine, and American Society of Tropical Medicine computerized databases, conference proceedings and abstracts, US Census Bureau, bibliographies of pertinent articles, and travel medicine texts. Priority was given to recent (1996-2003) evidence, addressing VFR travelers. General sources including travel medicine and immigrant health were also used. EVIDENCE SYNTHESIS: Immigrants visiting friends and relatives experience excessive rates of travel-related morbidity and mortality. Lack of pretravel care is common due to patient and clinician barriers to care, preexisting health beliefs, and incomplete childhood vaccinations. Travel patterns increase risk with VFRs traveling to high-risk destinations. Susceptibility to infectious and noninfectious illnesses is often increased because of multiple preexisting medical problems and extremes of age. Infectious diseases differ in etiology and magnitude from those of traditional travelers. For example with malaria, VFRs are frequently prescribed inappropriate prophylaxis or take none at all, have longer stays, spend time in high-risk areas, and do not appropriately adhere to chemoprophylaxis regimens. Effective pretravel health advice, guidelines, and services for this high-risk population are essential. There are already a number of useful and readily available databases that may aid clinicians in providing optimal travel-related preventive and therapeutic care. CONCLUSIONS: Immigrants who are visitors of friends and relatives in other countries account for a high volume of international travelers and are at markedly increased risk of travel-related illness. New strategies are needed to properly address the needs of VFR travelers. Pretravel services should be convenient, accessible, affordable, culturally competent, and if possible, located within clinics serving immigrant populations. Clinicians caring for VFRs should be knowledgeable about their travel-related risks and have access to regularly updated, detailed pretravel health information.

Emigration and Immigration↗
PubMed2004

Highly active antiretroviral therapy and sexual risk behavior: a meta-analytic review.

CONTEXT: Evidence suggests that since highly active antiretroviral therapy (HAART) became available, the prevalence of unprotected sex and the incidence of sexually transmitted infections (STIs) have increased. OBJECTIVE: To conduct 3 meta-analyses to determine whether (1) being treated with HAART, (2) having an undetectable viral load, or (3) holding specific beliefs about HAART and viral load are associated with increased likelihood of engaging in unprotected sex. DATA SOURCES: A comprehensive search included electronic bibliographic databases, including AIDSLINE, MEDLINE, PubMed, CINHAL, PsycInfo, ERIC, EMBASE, and Sociofile, from January 1996 to August 2003, conference proceedings, hand searches of journals, reference lists of articles, and contacts with researchers. STUDY SELECTION: Twenty-five English-language studies (some contributing >1 finding) met the selection criteria and examined the association of unprotected sexual intercourse or STIs with receiving HAART (21 findings), having an undetectable viral load (13 findings), or beliefs about HAART and viral load (18 findings). DATA EXTRACTION: Reports were screened and information from eligible studies was abstracted independently by pairs of reviewers using a standardized spreadsheet. DATA SYNTHESIS: Random-effects models were used to aggregate data. The prevalence of unprotected sex was not higher among persons with the human immunodeficiency virus (HIV) receiving HAART (prevalence range, 9%-56%; median, 33%) vs those not receiving HAART (range, 11%-77%; median, 44%; odds ratio [OR], 0.92; 95% confidence interval [CI], 0.65-1.31) or among HIV-positive persons with an undetectable viral load (range, 10%-68%; median, 39%) vs those with a detectable viral load (range, 14%-70%; median, 42%; OR, 0.99; 95% CI, 0.82-1.21). The prevalence of unprotected sex was elevated (OR, 1.82; 95% CI, 1.52-2.17) in HIV-positive, HIV-negative, and unknown serostatus persons who believed that receiving HAART or having an undetectable viral load protects against transmitting HIV or who had reduced concerns about engaging in unsafe sex given the availability of HAART (range, 17%-81% [median, 49%] vs 9%-68% [median, 38%] for counterparts). CONCLUSIONS: In the studies reviewed, HIV-positive patients receiving HAART did not exhibit increased sexual risk behavior, even when therapy achieved an undetectable viral load. However, people's beliefs about HAART and viral load may promote unprotected sex and may be amenable to change through prevention messages.

Antiretroviral Therapy, Highly Active↗
PubMed2004

Benefits of adding a drug to a single-agent or a 2-agent chemotherapy regimen in advanced non-small-cell lung cancer: a meta-analysis.

CONTEXT: Randomized trials have demonstrated that adding a drug to a single-agent or to a 2-agent regimen increased the tumor response rate in patients with advanced non-small-cell lung cancer (NSCLC), although its impact on survival remains controversial. OBJECTIVE: To evaluate the clinical benefit of adding a drug to a single-agent or 2-agent chemotherapy regimen in terms of tumor response rate, survival, and toxicity in patients with advanced NSCLC. DATA SOURCES AND STUDY SELECTION: Data from all randomized controlled trials performed between 1980 and 2001 (published between January 1980 and October 2003) comparing a doublet regimen with a single-agent regimen or comparing a triplet regimen with a doublet regimen in patients with advanced NSCLC. There were no language restrictions. Searches of MEDLINE and EMBASE were performed using the search terms non-small-cell lung carcinoma/drug therapy, adenocarcinoma, large-cell carcinoma, squamous-cell carcinoma, lung, neoplasms, clinical trial phase III, and randomized trial. Manual searches were also performed to find conference proceedings published between January 1982 and October 2003. DATA EXTRACTION: Two independent investigators reviewed the publications and extracted the data. Pooled odds ratios (ORs) for the objective tumor response rate, 1-year survival rate, and toxicity rate were calculated using the fixed-effect model. Pooled median ratios (MRs) for median survival also were calculated using the fixed-effect model. ORs and MRs lower than unity (<1.0) indicate a benefit of a doublet regimen compared with a single-agent regimen (or a triplet regimen compared with a doublet regimen). DATA SYNTHESIS: Sixty-five trials (13 601 patients) were eligible. In the trials comparing a doublet regimen with a single-agent regimen, a significant increase was observed in tumor response (OR, 0.42; 95% confidence interval [CI], 0.37-0.47; P<.001) and 1-year survival (OR, 0.80; 95% CI, 0.70-0.91; P<.001) in favor of the doublet regimen. The median survival ratio was 0.83 (95% CI, 0.79-0.89; P<.001). An increase also was observed in the tumor response rate (OR, 0.66; 95% CI, 0.58-0.75; P<.001) in favor of the triplet regimen, but not for 1-year survival (OR, 1.01; 95% CI, 0.85-1.21; P =.88). The median survival ratio was 1.00 (95% CI, 0.94-1.06; P =.97). CONCLUSION: Adding a second drug improved tumor response and survival rate. Adding a third drug had a weaker effect on tumor response and no effect on survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2005

Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials.

CONTEXT: Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear. OBJECTIVE: To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. DATA SOURCES: PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005. STUDY SELECTION: Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months. DATA EXTRACTION: Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest. DATA SYNTHESIS: Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23). CONCLUSIONS: Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.

Angioplasty, Balloon, Coronary↗
PubMed2000

Randomized controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention.

The improved prognosis of cystic fibrosis (CF) over the last three decades has been associated with an increased use of a range of treatments, but it is important that the use of an individual treatment is based on evidence. Well-designed randomized controlled trials (RCTs) are a robust method for evaluating the effectiveness of such treatments. We have developed a register of RCTs in CF and have studied when they were performed, their design, and what interventions were investigated. We identified 506 RCTs; 37.5% were identified solely as abstract reports in conference proceedings. There has been about a 30-fold increase in the number of RCTs in CF since 1966. A high proportion of the RCTs (72.7%) had a sample size of 30 or less, and only 8.7% were multicenter trials. Reporting of study design was poor: in 51.4% the report did not state whether there was any blinding in the trial design; 53.6% of studies were of crossover design. The most common interventions studied were antibiotic treatments and physiotherapy, but a number of commonly used therapies had been evaluated only in a small number of patients. Although the number of RCTs of interventions in CF patients has increased over the last 25 years, the sample sizes of these trials are generally too small to indicate whether the intervention was effective, and very few were multicenter. Future RCTs in CF are more likely to provide clinically useful answers if higher numbers of patients are recruited into large, well-designed multicenter trials. This should be a priority of the organization of future research in CF.

Cystic Fibrosis↗