Use of the single subject design for practice based primary care research.

The use of a single subject research design is proposed for practice based primary care research. An overview of the rationale of the design, an introduction to the methodology, strengths, limitations, a sample of recent literature citations, a working example, and possible clinical applications are presented.

Anticoagulation and incidence of late cerebrovascular accidents following the Fontan procedure.

Thromboembolic events are a well-reported complication following the Fontan procedure, but no previous studies have compared the incidence of thromboembolic events relative to the prophylactic anticoagulation strategy utilized. We examined the time-adjusted incidence of late thromboembolic events relative to chronic anticoagulation strategy. All patients who have undergone Fontan palliation and are followed at our institution were reviewed. All thromboembolic and major bleeding events were recorded and compared among different subgroups (anticoagulant medication utilized, Fontan variant, and the presence of a residual right-to-left shunt). The incidence of late cerebrovascular accidents (CVAs) per patient-year was calculated for each subgroup. The records of 132 patients were analyzed (median follow-up, 7.6 years; 1066.5 total patient-years). There were no major bleeding complications. One patient receiving no anticoagulation therapy developed a symptomatic thrombus 6 months after Fontan. Three patients suffered late CVAs (range, 3-7 years); 2 were receiving aspirin, and the other received no anticoagulation therapy. All 3 had lateral tunnel Fontan and a residual right-to-left shunt. The overall incidence of late CVA was 2.3%, with an event rate of 0.28% per patient-year. Late CVA was not related to anticoagulation strategy or time from Fontan procedure but was associated with a residual right-to-left shunt and lateral tunnel-type Fontan palliation (p < 0.001). Regardless of anticoagulation strategy utilized, symptomatic CVA is a rare long-term complication following the Fontan procedure.

Increased corticotropin-releasing hormone immunoreactivity in monoamine-containing pontine nuclei of depressed suicide men.

A number of clinical investigations and postmortem brain studies have provided evidence that excessive corticotropin-releasing hormone (CRH) secretion and neurotransmission is involved in the pathophysiology of depressive illness, and several studies have suggested that the hyperactivity in CRH neurotransmission extends beyond the hypothalamus involving several extra-hypothalamic brain regions. The present study was designed to test the hypothesis that CRH levels are increased in specific brainstem regions of suicide victims with a diagnosis of major depression. Frozen tissue sections of the pons containing the locus coeruleus and caudal raphe nuclei from 11 matched pairs of depressed suicide and control male subjects were processed for radioimmunocytochemistry using a primary antiserum to CRH and a ([125])I-IgG secondary antibody. The optical density corresponding to the level of CRH-immunoreactivity (IR) was quantified in specific pontine regions from the film autoradiographic images. The level of CRH-IR was increased by 30% in the locus coeruleus, 39% in the median raphe and 45% in the caudal dorsal raphe in the depressed suicide subjects compared to controls. No difference in CRH-IR was found in the dorsal tegmentum or medial parabrachial nucleus between the subject groups. These findings reveal that CRH-IR levels are specifically increased in norepinephrine- and serotonin-containing pontine nuclei of depressed suicide men, and thus they are consistent with the hypothesis that CRH neurotransmission is elevated in extra-hypothalamic brain regions of depressed subjects.

Localized decrease in serotonin transporter-immunoreactive axons in the prefrontal cortex of depressed subjects committing suicide.

A variety of postmortem brain studies and clinical investigations have provided evidence that reduced serotonin neurotransmission is associated with suicidal behavior and depression, and several serotonergic parameters have been found to be altered in the prefrontal cortex of suicide victims. However, the integrity of the serotonin innervation of the prefrontal cortex in mood disorders has not been directly investigated. The present study used immunocytochemical methods and an antibody against the serotonin transporter to examine the relative density of serotonin axons in the dorsolateral prefrontal cortex of suicide victims with a diagnosis of major depression. The mean total length of serotonin transporter-immunoreactive axons per unit area was unchanged in layers 2 and 4 of area 46 in the depressed suicide subjects compared to controls, but was significantly (P < 0.01) decreased by 24% in layer 6 in the depressed suicide group. The total length of serotonin transporter-positive axons in layer 6 was reduced in eight of the 12 depressed suicide subjects compared to their matched control subjects. These findings reveal that depressed subjects who have committed suicide exhibit a lamina-specific reduction in a marker of serotonin axons in the dorsolateral prefrontal cortex that may reflect an alteration in cortical serotonin neurotransmission.

A comprehensive investigation of barriers to adult immunization: a methods paper.

OBJECTIVE: Immunization rates for influenza and pneumococcal vaccines among the elderly (especially minority elderly) are below desired levels. We sought to answer 4 questions: (1) What factors explain most missed immunizations? (2) How are patient beliefs and practices regarding adult immunization affected by racial or cultural factors? (3) How are immunizations and patient beliefs affected by physician, organizational, and operational factors? and (4) Based on the relationships identified, can typologies be created that foster the tailoring of interventions to improve immunization rates? STUDY DESIGN: A multidisciplinary team chose the PRECEDE-PROCEED framework, the Awareness-to-Adherence model of clinician response to guidelines, and the Triandis model of consumer decision making as the best models to assess barriers to and facilitators of immunization. Our data collection methods included focus groups, face-to-face and telephone interviews, self-administered surveys, site visits, participant observation, and medical record review. POPULATION: To encounter a broad spectrum of patients, facilities, systems, and interventions, we sampled from 4 strata: inner-city neighborhood health centers, clinics in Veterans Administration facilities, rural practices in a network, and urban/suburban practices in a network. In stage 1, a stratified random cluster sample of 60 primary care clinicians was selected, 15 in each of the strata. In stage 2, a random sample of 15 patients was selected from each clinician's list of patients, aiming for 900 total interviews. CONCLUSIONS: This multicomponent approach is well suited to identifying barriers to and facilitators of adult immunizations among a variety of populations, including the disadvantaged.

Behavioral risk factors for disease and preventive health practices among lesbians.

OBJECTIVES: This study compared the prevalence of health behaviors among lesbians and in the general population of women. METHODS: We used a cross-sectional community-based survey of 1010 self-identified lesbians 18 years or older. RESULTS: Compared with the general population of women, lesbians were more likely to report cigarette use, alcohol use, and heavy alcohol use. A higher percentage of lesbians were categorized as overweight, and lesbians were more likely to participate in vigorous physical activity. They were less likely to report having had a Papanicolaou test within the past 2 years but more likely to report ever having had a mammogram. CONCLUSIONS: While there may be differences in health behaviors between lesbians and the general population of women, how these differences influence the risk of subsequent disease is unknown.

Measurement of pediatric illness severity using simple pretransport variables.

OBJECTIVE: To test the hypothesis that pretransport variables can predict in-hospital mortality that will correlate with major interventions and unplanned events during interfacility transport. METHODS: A cohort of children (n = 2,253) transported by a specialized pediatric team to a children's hospital were studied. At the time of referral, data collected included age (months), heart rate, systolic blood pressure, respiratory rate, retractions, stridor or wheezing, seizures, skin perfusion, oxygen requirement, and mental status. Using univariate and stepwise logistic regression, variables predictive of in-hospital mortality were selected from a training set (n = 1,111) and assigned integers based on their computed coefficients. Probability of in-hospital mortality was calculated using the total integer score and age. The risk of mortality derived from the training set was validated in the remaining patients (n = 1,142) by comparing the observed and predicted mortalities. Major interventions performed and unplanned events were determined for each of five predetermined mortality risk groups. RESULTS: Variables (integers) predicting in-hospital mortality included systolic blood pressure (11), respiratory rate (6), oxygen requirement (11), and altered mental status (11). Observed mortality was similar to predicted mortality in all risk categories for the validation sample. As risk of mortality increased, so did the performance of major interventions and the occurrence of unplanned events. CONCLUSION: Four pretransport variables predicted in-hospital mortality. Risk of mortality correlated with the incidence of major patient interventions, and the occurrence of unplanned events increased as well. This model might be useful in comparing different transport systems using severity-adjusted assessment of children requiring interfacility transport.

Association of susceptibility locus for inflammatory bowel disease on chromosome 16 with both ulcerative colitis and Crohn's disease.

A susceptibility locus for inflammatory bowel disease (IBD) on chromosome 16 (IBD1) has been linked to Crohn's disease in genome-wide linkage studies. We performed a case-control study with two markers for this locus using leukocyte DNA from 127 Crohn's patients, 83 ulcerative colitis patients, and 74 control patients. Allele, genotype, and haplotype frequencies of the polymerase chain reaction products were determined using autoradiography. Haplotype frequencies differed for ulcerative colitis and Crohn's disease, particularly for haplotype CC (22% ulcerative colitis vs 10% Crohn's disease, P = 0.002 Chi2 = 10.0) and haplotype CD (18% Crohn's disease vs 9% ulcerative colitis, P = 0.025 Chi2 = 5.02). These data demonstrate the association of the IBD1 locus with both ulcerative colitis and Crohn's disease in a group of unrelated IBD patients. The use of such microsatellite markers when combined with others, might help distinguish ulcerative colitis from Crohn's disease in patients with ambiguous clinical and histological features.

Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years.

BACKGROUND: A main indication for the insertion of tympanostomy tubes in infants and young children is persistent otitis media with effusion, reflecting concern that this condition may cause lasting impairments of speech, language, cognitive, and psychosocial development. However, evidence of such relations is inconclusive, and evidence is lacking that the insertion of tympanostomy tubes prevents developmental impairment. METHODS: We enrolled 6350 healthy infants from 2 to 61 days of age and evaluated them regularly for middle-ear effusion. Before the age of three years 429 children with persistent effusion were randomly assigned to have tympanostomy tubes inserted either as soon as possible or up to nine months later if effusion persisted. In 402 of these children we assessed speech, language, cognition, and psychosocial development at the age of three years. RESULTS: By the age of three years, 169 children in the early-treatment group (82 percent) and 66 children in the late-treatment group (34 percent) had received tympanostomy tubes. There were no significant differences between the early-treatment group and the late-treatment group at the age of three years in the mean (+/-SD) scores on the Number of Different Words test, a measure of word diversity (124+/-32 and 126+/-30, respectively); the Percentage of Consonants Correct-Revised test, a measure of speech-sound production (85+/-7 vs. 86+/-7); the General Cognitive Index of McCarthy Scales of Children's Abilities (99+/-14 vs. 101+/-13); or on measures of receptive language, sentence length, grammatical complexity, parent-child stress, and behavior. CONCLUSIONS: In children younger than three years of age who have persistent otitis media, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at the age of three years.

The importance of diagnostic accuracy in colonic inflammatory bowel disease.

OBJECTIVE: Crohn's disease (CD) and ulcerative colitis (UC) may both affect the colon. However, in approximately 10-20% of these cases, it is impossible to distinguish between these two entities either clinically or histologically, and a diagnosis of indeterminate colitis (IC) is made. Correct diagnosis is important because surgical treatment and long-term prognosis differ for UC and CD. The purpose of this study was to determine the extent of interobserver agreement among board-certified pathologists and a specialist gastrointestinal (GI) pathologist regarding the histological diagnosis of colonic inflammatory bowel disease (IBD). METHODS: A total of 24 university medical center pathologists from eight institutions evaluated 84 colectomy specimens and 35 sets of biopsy specimens from 119 consecutive patients with colonic IBD. A specialist GI pathologist subsequently reviewed all cases without knowledge of clinical data and prior diagnosis. RESULTS: The GI pathologist's diagnoses differed from the initial diagnoses in 45% of surgical specimens and 54% of biopsy specimens. Of 70 cases initially diagnosed as UC, 30 (43%) were changed to CD or IC, whereas 4 of 23 cases (17%) initially diagnosed as CD were changed to UC or IC. The kappa coefficient for the overall agreement of initial diagnoses with the specialist GI pathologist's diagnoses was -0.01 (p = 0.98). CONCLUSIONS: There is significant interobserver variation in the histological diagnosis of colonic IBD. This may have a profound effect on clinical patient care and, especially, on the choice of operation. More accurate diagnostic criteria are needed to facilitate patient care and to optimize treatment outcome.

Measurement properties of the MacArthur communicative development inventories at ages one and two years.

In a prospective study of child development in relation to early-life otitis media, we administered the MacArthur Communicative Development Inventories (CDI) to a large (N = 2,156), sociodemographically diverse sample of 1- and 2-year-old children. As a prerequisite for interpreting the CDI scores, we studied selected measurement properties of the inventories. Scores on the CDI/Words and Gestures (CDI-WG), designed for children 8 to 16 months old, and on the CDI/Words and Sentences (CDI-WS), designed for children 16 to 30 months old, increased significantly with months of age. On several scales of both CDI-WG and CDI-WS, standard deviations approximated or exceeded mean values, reflecting wide variability in results. Statistically significant differences in mean scores were found according to race, maternal education, and health insurance status as an indirect measure of income, but the directionality of differences was not consistent across inventories or across scales of the CDI-WS. Correlations between CDI-WG and CDI-WS ranged from .18 to .39. Our findings suggest that the CDI reflects the progress of language development within the age range 10 to 27 months. However, researchers and clinicians should exercise caution in using results of the CDI to identify individual children at risk for language deficits, to compare groups of children with different sociodemographic profiles, or to evaluate the effects of interventions.

Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life.

OBJECTIVE: As part of a prospective study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between children's cumulative duration of middle ear effusion (MEE) in their first 3 years of life and their scores on measures of language, speech sound production, and cognition at 3 years of age. METHODS: We enrolled 6350 healthy infants by 2 months of age who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small town/rural and 4 suburban private pediatric practices. We intensively monitored the children's middle ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. Children who met specified minimum criteria regarding the persistence of MEE became eligible for a clinical trial in which they were assigned randomly to undergo tympanostomy tube placement either promptly or after a defined extended period if MEE remained present. From among those remaining, we selected randomly, within sociodemographic strata, a sample of 241 children who represented a spectrum of MEE experience from having no MEE to having MEE whose cumulative duration fell just short of meeting randomization criteria. In subjects so selected, the estimated duration of MEE ranged from none to 65.6% of the first year of life and 44.8% of the first 3 years of life. In these 241 children we assessed language development, speech sound production, and cognition at 3 years of age, using both formal tests and conversational samples. RESULTS: We found weak to moderate, statistically significant negative correlations between children's cumulative durations of MEE in their first year of life or in age periods that included their first year of life, and their scores on formal tests of receptive vocabulary and verbal aspects of cognition at 3 years of age. However, the percent of variance in these scores explained by time with MEE in the first year of life beyond that explained by sociodemographic variables ranged only from 1.2% to 2.9%, and the negative correlations were concentrated in the subgroup of children whose families had private health insurance (rather than Medicaid). We found no significant correlations in the study population as a whole or in any subgroup between time with MEE during antecedent periods and children's scores on measures of spontaneous expressive language, speech sound production, or other measured aspects of cognition. In contrast, by wide margins, scores on all measures were consistently highest among the most socioeconomically advantaged children and lowest among the most socioeconomically disadvantaged children. CONCLUSIONS: Our findings suggest either that persistent early-life MEE actually causes later small, circumscribed impairments of receptive language and verbal aspects of cognition in certain groups of children or that unidentified, confounding factors predispose children both to early-life otitis media and to certain types of developmental impairment. Findings in the randomized clinical trial component of the larger study should help distinguish between causality and confounding as explanations for our findings.language, speech, cognition, development, otitis media, middle ear effusion.

Maternal education and measures of early speech and language.

The present study was designed to determine whether 4 measures of children's spontaneous speech and language differed according to the educational level of the children's mothers. Spontaneous language samples from 240 three-year-old children were analyzed to determine mean length of utterance in morphemes (MLUm), number of different words (NDW), total number of words (TNW), and percentage of consonants correct (PCC). A norm-referenced, knowledge-dependent measure of language comprehension, the Peabody Picture Vocabulary Test-Revised (PPVT-R), was also included for purposes of comparison with the spontaneous measures. Three levels of maternal education were compared: less than high school graduate, high school graduate, and college graduate. Trend analyses showed statistically significant linear trends across educational levels for MLUm, NDW, TNW, and PPVT-R; the trend for PCC was not significant. The relationship of maternal education and other sociodemographic variables to measures of children's language should be examined before using such measures to identify children with language disorders.

Parental stress and parent-rated child behavior in relation to otitis media in the first three years of life.

OBJECTIVE: As part of a long-term study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between parents' ratings of parent-child stress at ages 1, 2, and 3 years, and of their children's behavior problems at ages 2 and 3 years, and the children's cumulative duration of middle-ear effusion (MEE) in their first 3 years of life. METHODS: We enrolled healthy infants by age 2 months who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric practices. We obtained standardized baseline measures of parental stress; we intensively monitored the children's middle-ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. We obtained parent ratings of parental stress using the Parenting Stress Index/Short Form when the children reached ages 1, 2, and 3 years, and parent ratings of children's behavior using the Child Behavior Checklist when the children reached ages 2 and 3 years. RESULTS: In 2278 children we found no substantial relationships between parents' ratings of parent-child stress when the children reached ages 1, 2, and 3 years, or of their children's behavior problems at ages 2 and 3 years, and the cumulative duration of the children's MEE during antecedent periods. On the other hand, ratings both of parent-child stress and of behavior problems were consistently highest among the most socioeconomically disadvantaged children and lowest among the most socioeconomically advantaged children. Ratings also tended to be highest among children whose parents' baseline stress scores were highest. CONCLUSIONS: Parent-child stress and children's behavior problems in the first 3 years of life, as rated by parents, bear little or no relationship to the children's previous cumulative duration of MEE.

Parent-reported language and communication skills at one and two years of age in relation to otitis media in the first two years of life.

OBJECTIVE: As part of a study of possible effects of early life otitis media on children's development, we attempted to determine whether levels of language and communication skills at 1 and 2 years of age are associated with the cumulative duration of middle ear effusion (MEE) in the first 2 years of life. METHODS: Subjects (N = 2156) were followed at one of eight study sites in the Pittsburgh area. Middle ear status was monitored closely throughout the first 2 years of life. For each child, the cumulative percentage of days with MEE was estimated based on diagnoses at visits and interpolations for intervals between visits. For each child also, 1 or both parents completed the MacArthur Communicative Development Inventory-Words and Gestures (CDI-WG) when the child was 1 year of age and the MacArthur Communicative Development Inventory-Words and Sentences (CDI-WS) when the child was 2 years of age. RESULTS: Unadjusted correlations between scores on the CDI-WG and percentage of days with MEE in the first year of life were close to zero, and there were no statistically significant negative correlations. Unadjusted correlations between scores on the CDI-WS and the cumulative percentage of days with MEE in year 2 and in years 1 and 2 combined were generally negative and statistically significant, but the magnitudes of those correlations were no higher than 0.09. After adjustment for sociodemographic variables, only the Vocabulary Production Scale of the CDI-WS remained correlated significantly with the percentage of days with MEE, and the percentage of days with MEE accounted for only a negligible percentage of the variance in scores on this scale. CONCLUSIONS: In this diverse sample of children, parent-reported levels of language skills at 1 and 2 years of age were correlated negligibly with the cumulative percentage of days with MEE in the children's first and second years of life. otitis media, otitis media with effusion, language, communication.

Oral versus initial intravenous therapy for urinary tract infections in young febrile children.

BACKGROUND: The standard recommendation for treatment of young, febrile children with urinary tract infection has been hospitalization for intravenous antimicrobials. The availability of potent, oral, third-generation cephalosporins as well as interest in cost containment and avoidance of nosocomial risks prompted evaluation of the safety and efficacy of outpatient therapy. METHODS: In a multicenter, randomized clinical trial, we evaluated the efficacy of oral versus initial intravenous therapy in 306 children 1 to 24 months old with fever and urinary tract infection, in terms of short-term clinical outcomes (sterilization of the urine and defervescence) and long-term morbidity (incidence of reinfection and incidence and extent of renal scarring documented at 6 months by 99mTc-dimercaptosuccinic acid renal scans). Children received either oral cefixime for 14 days (double dose on day 1) or initial intravenous cefotaxime for 3 days followed by oral cefixime for 11 days. RESULTS: Treatment groups were comparable regarding demographic, clinical, and laboratory characteristics. Bacteremia was present in 3.4% of children treated orally and 5.3% of children treated intravenously. Of the short-term outcomes, 1) repeat urine cultures were sterile within 24 hours in all children, and 2) mean time to defervescence was 25 and 24 hours for children treated orally and intravenously, respectively. Of the long-term outcomes, 1) symptomatic reinfections occurred in 4.6% of children treated orally and 7.2% of children treated intravenously, 2) renal scarring at 6 months was noted in 9.8% children treated orally versus 7.2% of children treated intravenously, and 3) mean extent of scarring was approximately 8% in both treatment groups. Mean costs were at least twofold higher for children treated intravenously ($3577 vs $1473) compared with those treated orally. CONCLUSIONS: Oral cefixime can be recommended as a safe and effective treatment for children with fever and urinary tract infection. Use of cefixime will result in substantial reductions of health care expenditures.

Leptin in African-American children.

Leptin, the protein product of the obesity gene, produced by adipose tissue, regulates body weight and energy expenditure through CNS feedback mechanisms. In obesity, leptin levels are elevated suggestive of leptin resistance. Because of increased prevalence of obesity in African-Americans, the aim of this study was to assess leptin and its relationship to adiposity in African-American children. We measured plasma leptin levels in 42 African-American children (23 M, 19 F), age 11.8 +/- 0.3 yr, and compared them with 30 American-White children matched for age, body composition and puberty. Body composition was assessed by bioelectrical impedance and plasma leptin by RIA. Data are presented as means +/- SEM and statistical significance is implied by p < 0.05. There was no racial difference in plasma leptin levels (Blacks: 9.8 +/- 1.6, Whites 9.8 +/- 1.9 ng/ml). Leptin correlated with %BF in Black (r = 0.75, p = 0.005) and White (r = 0.79, p = 0.005) children. There were no gender or puberty related differences in leptin levels in African-American children. We concluded that leptin levels are comparable between African-American and American White children of similar body composition. The major determinant of serum leptin levels in these children is degree of adiposity with no gender or puberty related differences. Longitudinal studies are needed to assess leptin's role during puberty in both genders.

The effect of full-time faculty hospitalists on the efficiency of care at a community teaching hospital.

BACKGROUND: Hospitalists are increasingly being used for inpatient care. OBJECTIVE: To investigate whether the use of hospitalists is beneficial. DESIGN: Retrospective cohort study. SETTING: Inpatient medical service of a 500-bed community teaching hospital. PARTICIPANTS: 1620 patients in the study group, seen during the hospitalist year; 1679 patients from the same outpatient practice as the study group, seen during the previous year (prehospitalist year); an unselected comparison group of 3413 patients seen during the prehospitalist year and 3223 patients seen during the hospitalist year; and a subset of the unselected comparison group, cared for by outpatient practices, who had a prehospitalist length of stay similar to that of the study group (743 patients in the prehospitalist year and 786 in the hospitalist year). INTERVENTIONS: Full-time faculty hospitalists cared for the study group, were in the hospital during normal working hours, and made decisions throughout the day. In the prehospitalist year and in the comparison groups, primary care physicians managed their own hospitalized patients. MEASUREMENTS: Length of stay; cost of care; costs of hematology and chemistry evaluation, pharmacy, and radiology; and readmissions were determined for the prehospitalist and hospitalist years. RESULTS: In the study group, median length of stay decreased from 6.01 to 5.01 days (P < 0.001). Median cost of care decreased from $4139 to $3552 (P < 0.001), and the 14-day readmission rate decreased from 9.9 to 4.64 readmissions per 100 admissions (P < 0.001). In the comparison groups, length of stay decreased but both cost of care and readmission rates increased. CONCLUSION: Hospitalists may improve the efficiency of inpatient care. Further study in various settings is needed to verify these findings.

Assessment of adenoidal obstruction in children: clinical signs versus roentgenographic findings.

OBJECTIVE: As part of a comprehensive study of indications for tonsillectomy and adenoidectomy, we investigated the reliability of standardized clinical assessments and standardized roentgenographic assessments of adenoidal obstruction of the nasopharynx, and the degree of correlation between clinical assessments and roentgenographic assessments. METHODS: We rated the degree of patients' mouth breathing and patients' speech hyponasality on a 4-point scale (none = 1; mild = 2; moderate = 3; marked = 4), we averaged the ratings for each child to obtain a Nasal Obstruction Index, and we determined levels of interobserver agreement concerning the ratings. We classified lateral soft-tissue roentgenograms of the nasopharynx, based on assessments of adenoid size and of nasopharyngeal airway patency, as showing either no obstruction, borderline obstruction, or obstruction, and we determined levels of inter- and intraobserver agreement concerning the classifications. Finally, we determined correlations in individual patients between clinical ratings and roentgenographic ratings of nasal/nasopharyngeal obstruction, and calculated the predictive values of clinical ratings based on roentgenographic ratings as the gold standard. RESULTS: In sets of paired examinations, weighted kappa values for interobserver agreement concerning mouth breathing (total, 235 children) and speech hyponasality (total, 648 children) ranged from 0.84 to 0.91. The value for interobserver agreement concerning roentgenographic assessment of nasopharyngeal airway status (207 children) was 0.92, and for intraobserver agreement (191 children) 0.88. The Kendall's tau b value for concordance between Nasal Obstruction Index values and roentgenographic ratings (1033 children) was 0.51. Nasal Obstruction Index values at the lower and upper extremes--i.e., 1.0 and > or = 3.5, respectively--were highly predictive of concordant roentgenographic ratings. CONCLUSIONS: We conclude that standardized clinical ratings of the degree of children's mouth breathing and speech hyponasality provide reliable and reasonably valid assessments of the presence and degree of adenoidal obstruction of the nasopharyngeal airway. These clinical assessments are particularly valid at the extremes of either marked obstruction or no obstruction. Clinical assessment alone may be insufficient to establish the presence of adenoidal obstruction, but clinical assessment alone when findings are unequivocally negative can suffice to rule out adenoidal obstruction with a high degree of confidence.