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1.  Severe Expressive-Language Delay Related to Duplication of the Williams–Beuren Locus 
The New England journal of medicine  2005;353(16):1694-1701.
SUMMARY
The Williams–Beuren syndrome (WBS) locus, at 7q11.23, is prone to recurrent chromosomal rearrangements, including the microdeletion that causes WBS, a multisystem condition with characteristic cardiovascular, cognitive, and behavioral features. It is hypothesized that reciprocal duplications of the WBS interval should also occur, and here we present such a case description. The most striking phenotype was a severe delay in expressive speech, in contrast to the normal articulation and fluent expressive language observed in persons with WBS. Our results suggest that specific genes at 7q11.23 are exquisitely sensitive to dosage alterations that can influence human language and visuospatial capabilities.
doi:10.1056/NEJMoa051962
PMCID: PMC2893213  PMID: 16236740 CAMSID: cams399
2.  US prevalence and treatment of mental disorders: 1990–2003 
The New England journal of medicine  2005;352(24):2515-2523.
Background
Although the 1990s saw enormous change in the US mental health care system, little is known about changes in prevalence or treatment of mental disorders.
Methods
We examined US trends in prevalence and treatment of mental health disorders for people age 18–54 over the past decade. Data were collected from face-to-face household interviews in 1990–2 (National Comorbidity Survey (NCS), n = 5388) and 2001–3 (National Comorbidity Survey Replication (NCS-R), n = 4319). Anxiety, mood, and substance use disorders in the 12 months before interview were diagnosed using the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Treatment for emotional problems was categorized by sector: psychiatry (PSY), other mental health (OMH), general medical (GM), human services (HS), and complementary-alternative medical (CAM).
Results
Disorder prevalence did not change over time (29.4% in 1990–2 and 30.5% in 2001–3, p = 0.52), but treatment increased. Of patients with a disorder, 20.3% received treatment in 1990–2 and 32.9% in 2001–3 (p < .001). Overall, 12.2% of the US population age 18–54 received treatment for emotional problems in 1990–2 and 20.1% in 2001–3 (p < .001). Only about half of people who received treatment met diagnostic criteria for a disorder. Significant treatment increases were limited to GM (159.1% increase), PSY (116.8%), and OMH (59.0%) and were independent of disorder severity and socio-demographics.
Conclusions
Despite increased treatment, most mental disorders remain untreated. Continued efforts are needed to obtain treatment effectiveness data and to increase use of effective treatments.
doi:10.1056/NEJMsa043266
PMCID: PMC2847367  PMID: 15958807
3.  Sex and Racial Differences in the Management of Acute Myocardial Infarction, 1994 through 2002 
The New England journal of medicine  2005;353(7):671-682.
BACKGROUND
Although increased attention has been paid to sex and racial differences in the management of myocardial infarction, it is unknown whether these differences have narrowed over time.
METHODS
With the use of data from the National Registry of Myocardial Infarction, we examined sex and racial differences in the treatment of patients who were deemed to be “ideal candidates” for particular treatments and in deaths among 598,911 patients hospitalized with myocardial infarction between 1994 and 2002.
RESULTS
In the unadjusted analysis, sex and racial differences were observed for rates of reperfusion therapy (for white men, white women, black men, and black women: 86.5, 83.3, 80.4, and 77.8 percent, respectively; P<0.001), use of aspirin (84.4, 78.7, 83.7, and 78.4 percent, respectively; P<0.001), use of beta-blockers (66.6, 62.9, 67.8, and 64.5 percent; P<0.001), and coronary angiography (69.1, 55.9, 64.0, and 55.0 percent; P<0.001). After multivariable adjustment, racial and sex differences persisted for rates of reperfusion therapy (risk ratio for white women, black men, and black women: 0.97, 0.91, and 0.89, respectively, as compared with white men) and coronary angiography (relative risk, 0.91, 0.82, and 0.76) but were attenuated for the use of aspirin (risk ratio, 0.97, 0.98, and 0.94) and beta-blockers (risk ratio, 0.98, 1.00, and 0.96); all risks were unchanged over time. Adjusted in-hospital mortality was similar among white women (risk ratio, 1.05; 95 percent confidence interval, 1.03 to 1.07) and black men (risk ratio, 0.95; 95 percent confidence interval, 0.89 to 1.00), as compared with white men, but was higher among black women (risk ratio, 1.11; 95 percent confidence interval, 1.06 to 1.16) and was unchanged over time.
CONCLUSIONS
Rates of reperfusion therapy, coronary angiography, and in-hospital death after myocardial infarction, but not the use of aspirin and beta-blockers, vary according to race and sex, with no evidence that the differences have narrowed in recent years.
doi:10.1056/NEJMsa032214
PMCID: PMC2805130  PMID: 16107620
5.  Intensive Diabetes Treatment and Cardiovascular Disease in Patients with Type 1 Diabetes 
The New England journal of medicine  2005;353(25):2643-2653.
BACKGROUND
Intensive diabetes therapy aimed at achieving near normoglycemia reduces the risk of microvascular and neurologic complications of type 1 diabetes. We studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term incidence of cardiovascular disease.
METHODS
The DCCT randomly assigned 1441 patients with type 1 diabetes to intensive or conventional therapy, treating them for a mean of 6.5 years between 1983 and 1993. Ninety-three percent were subsequently followed until February 1, 2005, during the observational Epidemiology of Diabetes Interventions and Complications study. Cardiovascular disease (defined as nonfatal myocardial infarction, stroke, death from cardiovascular disease, confirmed angina, or the need for coronary-artery revascularization) was assessed with standardized measures and classified by an independent committee.
RESULTS
During the mean 17 years of follow-up, 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment. Intensive treatment reduced the risk of any cardiovascular disease event by 42 percent (95 percent confidence interval, 9 to 63 percent; P = 0.02) and the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 57 percent (95 percent confidence interval, 12 to 79 percent; P = 0.02). The decrease in glycosylated hemoglobin values during the DCCT was significantly associated with most of the positive effects of intensive treatment on the risk of cardiovascular disease. Microalbuminuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease, but differences between treatment groups remained significant (P≤0.05) after adjusting for these factors.
CONCLUSIONS
Intensive diabetes therapy has long-term beneficial effects on the risk of cardiovascular disease in patients with type 1 diabetes.
doi:10.1056/NEJMoa052187
PMCID: PMC2637991  PMID: 16371630
6.  Trial Registration at ClinicalTrials.gov between May and October 2005 
The New England journal of medicine  2005;353(26):2779-2787.
BACKGROUND
Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication.
METHODS
We reviewed ClinicalTrials.gov records to determine patterns of completion of the “Intervention Name” and “Primary Outcome Measure” data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively.
RESULTS
During the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank.
CONCLUSIONS
During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement.
doi:10.1056/NEJMsa053234
PMCID: PMC1568386  PMID: 16382064
7.  Developmental Origins of Health and Disease 
The New England journal of medicine  2005;353(17):1848-1850.
doi:10.1056/NEJMe058187
PMCID: PMC1488726  PMID: 16251542
8.  Developmental Outcomes after Early or Delayed Insertion of Tympanostomy Tubes 
The New England journal of medicine  2005;353(6):576-586.
BACKGROUND
To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. We previously reported that prompt as compared with delayed insertion of tympanostomy tubes in children with persistent effusion who were younger than three years of age did not result in improved developmental outcomes at three or four years of age. However, the effect on the outcomes of school-age children is unknown.
METHODS
We enrolled 6350 healthy infants younger than 62 days of age and evaluated them regularly for middle-ear effusion. Before three years of age, 429 children with persistent middle-ear effusion were randomly assigned to have tympanostomy tubes inserted either promptly or up to nine months later if effusion persisted. We assessed developmental outcomes in 395 of these children at six years of age.
RESULTS
At six years of age, 85 percent of children in the early-treatment group and 41 percent in the delayed-treatment group had received tympanostomy tubes. There were no significant differences in mean (±SD) scores favoring early versus delayed treatment on any of 30 measures, including the Wechsler Full-Scale Intelligence Quotient (98±13 vs. 98±14); Number of Different Words test, a measure of word diversity (183±36 vs. 175±36); Percentage of Consonants Correct–Revised test, a measure of speech-sound production (96±2 vs. 96±3); the SCAN test, a measure of central auditory processing (95±15 vs. 96±14); and several measures of behavior and emotion.
CONCLUSIONS
In otherwise healthy children younger than three years of age who have persistent middle-ear effusion within the duration of effusion that we studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at six years of age.
doi:10.1056/NEJMoa050406
PMCID: PMC1201478  PMID: 16093466

Results 1-8 (8)