Symptom persistence in a community cohort of women with interstitial cystitis/bladder pain syndrome (IC/BPS): 3-, 6-, 9-, and 12-month follow-up from the RICE cohort.

INTRODUCTION AND HYPOTHESIS: The persistence of interstitial cystitis/bladder pain syndrome (IC/BPS) symptoms has been described in women seeking medical care. The purpose of this study was to determine whether symptoms persist among a population-based sample of women. METHODS: A probability sample of US women was identified through a two-stage telephone screening process using the Research and Development (RAND) Interstitial Cystitis Epidemiology (RICE) high-sensitivity case definition. A randomly selected subgroup (n = 508) was enrolled in a longitudinal study and interviewed about their symptoms at baseline, 3, 6, 9, and 12 months. Bivariate and multivariate linear regression analyses determined predictors of persistence of symptoms over the four waves. RESULTS: A total of 436 women with a mean age of 47.5 years responding to all waves were included in the analysis. Forty-one percent met the RICE high-sensitivity case definition at baseline and in all four waves; an additional 21 % met the definition at baseline and in three waves. Women with a college degree (+12 % vs. no college, p = 0.02) and who were younger (-5 % per decade of age, p < 0.01) had higher chances of symptom persistence at each wave. Scoring one standard deviation higher on the continuity of symptoms and the O'Leary-Sant Interstitial Cystitis Symptom index increased the chances of symptom persistence by 4 % and 2 %, respectively (both p < 0.01). CONCLUSIONS: The majority of women demonstrated symptom persistence across at least three of four waves over 12 months. These women tended to be younger, college-educated, and to have reported a history of greater continuity of symptoms and higher severity of symptoms at baseline.

WITHDRAWN: Spinal manipulative therapy for low-back pain.

BACKGROUND: Low-back pain is a costly illness for which spinal manipulative therapy is commonly recommended. Previous systematic reviews and practice guidelines have reached discordant results on the effectiveness of this therapy for low-back pain. OBJECTIVES: To resolve the discrepancies related to the use of spinal manipulative therapy and to update previous estimates of effectiveness, by comparing spinal manipulative therapy with other therapies and then incorporating data from recent high-quality randomized, controlled trials (RCTs) into the analysis. SEARCH METHODS: The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and CINAHL were electronically searched from their respective beginning to January 2000, using the Back Group search strategy; references from previous systematic reviews were also screened. SELECTION CRITERIA: Randomized, controlled trials (RCT) that evaluated spinal manipulative therapy for patients with low-back pain, with at least one day of follow-up, and at least one clinically-relevant outcome measure. DATA COLLECTION AND ANALYSIS: Two authors, who served as the authors for all stages of the meta-analysis, independently extracted data from unmasked articles. Comparison treatments were classified into the following seven categories: sham, conventional general practitioner care, analgesics, physical therapy, exercises, back school, or a collection of therapies judged to be ineffective or even harmful (traction, corset, bed rest, home care, topical gel, no treatment, diathermy, and minimal massage). MAIN RESULTS: Thirty-nine RCTs were identified. Meta-regression models were developed for acute or chronic pain and short-term and long-term pain and function. For patients with acute low-back pain, spinal manipulative therapy was superior only to sham therapy (10-mm difference [95% CI, 2 to 17 mm] on a 100-mm visual analogue scale) or therapies judged to be ineffective or even harmful. Spinal manipulative therapy had no statistically or clinically significant advantage over general practitioner care, analgesics, physical therapy, exercises, or back school. Results for patients with chronic low-back pain were similar. Radiation of pain, study quality, profession of manipulator, and use of manipulation alone or in combination with other therapies did not affect these results. AUTHORS' CONCLUSIONS: There is no evidence that spinal manipulative therapy is superior to other standard treatments for patients with acute or chronic low-back pain.

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities.

PURPOSE: To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores. RESULTS: Mean patient age was 45.1 (SD 15.9) years, and 83% of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: -8 points on the PCS (p < 0.001) and -6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores. CONCLUSIONS: In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.

The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study.

PURPOSE: As part of the RICE (RAND Interstitial Cystitis Epidemiology) study, we developed validated case definitions to identify interstitial cystitis/bladder pain syndrome in women and chronic prostatitis/chronic pelvic pain syndrome in men. Using population based screening methods, we applied these case definitions to determine the prevalence of these conditions in men. MATERIALS AND METHODS: A total of 6,072 households were contacted by telephone to screen for men who had symptoms of interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome. An initial 296 men screened positive, of whom 149 met the inclusionary criteria and completed the telephone interview. For interstitial cystitis/bladder pain syndrome 2 case definitions were applied (1 with high sensitivity and 1 with high specificity), while for chronic prostatitis/chronic pelvic pain syndrome a single case definition (with high sensitivity and specificity) was used. These case definitions were used to classify subjects into groups based on diagnosis. RESULTS: The interstitial cystitis/bladder pain syndrome weighted prevalence estimates for the high sensitivity and high specificity definitions were 4.2% (3.1-5.3) and 1.9% (1.1-2.7), respectively. The chronic prostatitis/chronic pelvic pain syndrome weighted prevalence estimate was 1.8% (0.9-2.7). These values equate to 1,986,972 (95% CI 966,042-2,996,924) men with chronic prostatitis/chronic pelvic pain syndrome and 2,107,727 (95% CI 1,240,485-2,974,969) men with the high specificity definition of interstitial cystitis/bladder pain syndrome in the United States. The overlap between men who met the high specificity interstitial cystitis/bladder pain syndrome case definition or the chronic prostatitis/chronic pelvic pain syndrome case definition was 17%. CONCLUSIONS: Symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome are widespread among men in the United States. The prevalence of interstitial cystitis/bladder pain syndrome symptoms in men approaches that in women, suggesting that this condition may be underdiagnosed in the male population.

The effectiveness of community-based delivery of an evidence-based treatment for adolescent substance use.

This study evaluates the effectiveness of motivational enhancement therapy/cognitive behavioral therapy-5 (MET/CBT-5) when delivered in community practice settings relative to standard community-based adolescent treatment. A quasi-experimental strategy was used to adjust for pretreatment differences between the MET/CBT-5 sample (n = 2,293) and those who received standard care (n = 458). Results suggest that youth who received MET/CBT-5 fared better than comparable youth in the control group on five of six 12-month outcomes. A low follow-up rate (54%) in the MET/CBT-5 sample raised concerns about nonresponse bias in the treatment effect estimates. Sensitivity analyses suggest that although modest differences in outcomes between the MET/CBT-5 nonrespondents and respondents would yield no significant differences between the two groups on two of the six outcomes, very large differences in outcomes between responders and nonresponders would be required for youth receiving MET/CBT-5 to have fared better had they received standard outpatient care.

Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study.

PURPOSE: The RAND Interstitial Cystitis Epidemiology survey estimated that 2.7% to 6.5% of United States women have urinary symptoms consistent with a diagnosis of interstitial cystitis/bladder pain syndrome. We describe the demographic and clinical characteristics of the symptomatic community based RAND Interstitial Cystitis Epidemiology cohort, and compare them with those of a clinically based interstitial cystitis/bladder pain syndrome cohort. MATERIALS AND METHODS: Subjects included 3,397 community women who met the criteria for the RAND Interstitial Cystitis Epidemiology high sensitivity case definition, and 277 women with an interstitial cystitis/bladder pain syndrome diagnosis recruited from specialist practices across the United States (clinical cohort). Questions focused on demographic information, symptom severity, quality of life indicators, concomitant diagnoses and treatment. RESULTS: Average symptom duration for both groups was approximately 14 years. Women in the clinical cohort reported worse baseline pain and maximum pain, although the absolute differences were small. Mean Interstitial Cystitis Symptom Index scores were approximately 11 for both groups, but mean Interstitial Cystitis Problem Index scores were 9.9 and 13.2 for the clinical cohort and the RAND Interstitial Cystitis Epidemiology cohort, respectively (p <0.001). The RAND Interstitial Cystitis Epidemiology subjects were more likely to be uninsured. CONCLUSIONS: The RAND Interstitial Cystitis Epidemiology community cohort was remarkably similar to an interstitial cystitis/bladder pain syndrome clinical cohort with respect to demographics, symptoms and quality of life measures. In contrast to other chronic pain conditions for which clinical cohorts typically report worse symptoms and functional status than population based samples, our data suggest that many measures of symptom severity and functional impact are similar, and sometimes worse, in the RAND Interstitial Cystitis Epidemiology cohort. These findings suggest that interstitial cystitis/bladder pain syndrome is significantly burdensome, and likely to be underdiagnosed and undertreated in the United States.

Validation of a quality-of-life scale for women with bladder pain syndrome/interstitial cystitis.

PURPOSE: To validate a disease-specific scale to measure the impact of symptoms of bladder pain syndrome/interstitial cystitis (BPS/IC), a condition that affects up to 6.5% of U.S. women. METHODS: Participants were drawn from the RAND Interstitial Cystitis Epidemiology (RICE) Study, a telephone probability survey of 146,231 US households. Women who met RICE BPS/IC symptom criteria (n = 3,397) completed the 6-item RAND Bladder Symptom Impact scale (RICE BSI-6). The RICE BSI-6 was adapted from a scale used to assess the impact of diabetes on life and sexuality and modified based on expert input on face validity and focus group work; items specific to diabetic symptoms were eliminated. Validated scales of symptom severity, mental- and physical-health-related quality of life (QoL), depression, coping, and perceived control were used to assess convergent validity. RESULTS: The RICE BSI-6 (α = 0.92) was significantly related to greater symptom severity, worse general mental- and physical-health-related QoL, more severe depression symptoms, and lower perceived control over life in general and over BPS/IC symptoms (P values < .05). It was also associated with less use of distancing coping (P < .05). CONCLUSION: The RICE BSI-6 shows excellent internal consistency and strong convergent validity. It can be used to examine the effects of psychosocial and treatment interventions on QoL among women with BPS/IC.

Identifying continuous quality improvement publications: what makes an improvement intervention 'CQI'?

BACKGROUND: The term continuous quality improvement (CQI) is often used to refer to a method for improving care, but no consensus statement exists on the definition of CQI. Evidence reviews are critical for advancing science, and depend on reliable definitions for article selection. METHODS: As a preliminary step towards improving CQI evidence reviews, this study aimed to use expert panel methods to identify key CQI definitional features and develop and test a screening instrument for reliably identifying articles with the key features. We used a previously published method to identify 106 articles meeting the general definition of a quality improvement intervention (QII) from 9427 electronically identified articles from PubMed. Two raters then applied a six-item CQI screen to the 106 articles. RESULTS: Per cent agreement ranged from 55.7% to 75.5% for the six items, and reviewer-adjusted intra-class correlation ranged from 0.43 to 0.62. 'Feedback of systematically collected data' was the most common feature (64%), followed by being at least 'somewhat' adapted to local conditions (61%), feedback at meetings involving participant leaders (46%), using an iterative development process (40%), being at least 'somewhat' data driven (34%), and using a recognised change method (28%). All six features were present in 14.2% of QII articles. CONCLUSIONS: We conclude that CQI features can be extracted from QII articles with reasonable reliability, but only a small proportion of QII articles include all features. Further consensus development is needed to support meaningful use of the term CQI for scientific communication.

Depressive disorders and panic attacks in women with bladder pain syndrome/interstitial cystitis: a population-based sample.

OBJECTIVE: We report the population prevalence of probable depressive disorders and current panic attacks in women with bladder pain syndrome/interstitial cystitis (BPS/IC) symptoms and describe their characteristics and access care. METHOD: We conducted a telephone screening of 146,231 households and telephone interviews with women with BPS/IC symptoms. A weighted probability sample of 1469 women who met the criteria for BPS/IC was identified. Measures of BPS/IC severity, depressive symptoms, panic attacks and treatment utilization were administered. T and χ(2) tests were used to examine differences between groups. RESULTS: Over one third of the sample (n=536) had a probable diagnosis of depression, and 52% (n=776) reported recent panic attacks. Women with a probable diagnosis of depression or current panic attacks reported worse functioning and increased pain and were less likely to work because of bladder pain. CONCLUSIONS: In this community-based sample, rates of probable current depression and panic attacks are high, and there is considerable unmet need for treatment. These findings suggest that clinicians should be alert to complaints of bladder pain in patients seeking treatment for depressive or anxiety disorders and to complaints of emotional or personal problems in patients seeking treatment for painful bladder symptoms.

Prevalence and correlates of sexual dysfunction among women with bladder pain syndrome/interstitial cystitis.

OBJECTIVES: To examine the prevalence and correlates of general and bladder pain syndrome/interstitial cystitis (BPS/IC)-specific sexual dysfunction among women in the RAND Interstitial Cystitis Epidemiology study using a probability sample survey of U.S. households. Sexual dysfunction can contribute to a reduced quality of life for women with bladder pain syndrome/interstitial cystitis (BPS/IC). METHODS: We telephoned 146,231 households to identify women who reported bladder symptoms or a BPS/IC diagnosis. Those who reported either underwent a second-stage screening using the RAND Interstitial Cystitis Epidemiology study high-specificity symptom criteria. The criteria were pain, pressure, or discomfort in pelvic area; daytime urinary frequency ≥10 times or urgency due to pain, pressure, or discomfort (not fear of wetting); pain that worsened as the bladder filled; bladder symptoms did not resolve after antibiotic treatment; and patients never treated with hormone injections for endometriosis. Women who met the RAND Interstitial Cystitis Epidemiology criteria (n = 1469) completed measures of BPS/IC-specific and general sexual dysfunction symptoms, bladder symptom severity, general physical health, depression, medical care-seeking, and sociodemographic characteristics. RESULTS: Of those with a current sexual partner (75%), 88% reported ≥1 general sexual dysfunction symptom and 90% reported ≥1 BPS/IC-specific sexual dysfunction symptom in the past 4 weeks. In the multivariate models, BPS/IC-specific sexual dysfunction was significantly associated with more severe BPS/IC symptoms, younger age, worse depression symptoms, and worse perceived general health. Multivariate correlates of general sexual dysfunction included non-Latino race/ethnicity, being married, and having depression symptoms. CONCLUSIONS: The results of our study have shown that women with BPS/IC symptoms experience very high levels of sexual dysfunction. Also, sexual dysfunction covaries with symptoms.

Safety of probiotics used to reduce risk and prevent or treat disease.

OBJECTIVES: To catalog what is known about the safety of interventions containing Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus strains used as probiotic agents in research to reduce the risk of, prevent, or treat disease. DATA SOURCES: We searched 12 electronic databases, references of included studies, and pertinent reviews for studies addressing the safety of probiotics from database inception to August 2010 without language restriction. REVIEW METHODS: We identified intervention studies on probiotics that reported the presence or absence of adverse health outcomes in human participants, without restriction by study design, participant type, or clinical field. We investigated the quantity, quality, and nature of adverse events. RESULTS: The search identified 11,977 publications, of which 622 studies were included in the review. In 235 studies, only nonspecific safety statements were made ("well tolerated"); the remaining 387 studies reported the presence or absence of specific adverse events. Interventions and adverse events were poorly documented. A number of case studies described fungemia and some bacteremia potentially associated with administered probiotic organisms. Controlled trials did not monitor routinely for such infections and primarily reported on gastrointestinal adverse events. Based on reported adverse events, randomized controlled trials (RCTs) showed no statistically significantly increased relative risk (RR) of the overall number of experienced adverse events (RR 1.00; 95% confidence interval [CI]: 0.93, 1.07, p=0.999); gastrointestinal; infections; or other adverse events, including serious adverse events (RR 1.06; 95% CI: 0.97, 1.16; p=0.201), associated with short-term probiotic use compared to control group participants; long-term effects are largely unknown. Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium. Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further. Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants. CONCLUSIONS: There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence.

Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review.

CONTEXT: Acute otitis media (AOM) is the most common condition for which antibiotics are prescribed for US children; however, wide variation exists in diagnosis and treatment. OBJECTIVES: To perform a systematic review on AOM diagnosis, treatment, and the association of heptavalent pneumococcal conjugate vaccine (PCV7) use with AOM microbiology. DATA SOURCES: PubMed, Cochrane Databases, and Web of Science, searched to identify articles published from January 1999 through July 2010. STUDY SELECTION: Diagnostic studies with a criterion standard, observational studies and randomized controlled trials comparing AOM microbiology with and without PCV7, and randomized controlled trials assessing antibiotic treatment. DATA EXTRACTION: Independent article review and study quality assessment by 2 investigators with consensus resolution of discrepancies. RESULTS: Of 8945 citations screened, 135 were included. Meta-analysis was performed for comparisons with 3 or more trials. Few studies examined diagnosis; otoscopic findings of tympanic membrane bulging (positive likelihood ratio, 51 [95% confidence interval {CI}, 36-73]) and redness (positive likelihood ratio, 8.4 [95% CI, 7-11]) were associated with accurate diagnosis. In the few available studies, prevalence of Streptococcus pneumoniae decreased (eg, 33%-48% vs 23%-31% of AOM isolates), while that of Haemophilus influenzae increased (41%-43% vs 56%-57%) pre- vs post-PCV7. Short-term clinical success was higher for immediate use of ampicillin or amoxicillin vs placebo (73% vs 60%; pooled rate difference, 12% [95% CI, 5%-18%]; number needed to treat, 9 [95% CI, 6-20]), while increasing the rate of rash or diarrhea by 3% to 5%. Two of 4 studies showed greater clinical success for immediate vs delayed antibiotics (95% vs 80%; rate difference, 15% [95% CI, 6%-24%] and 86% vs 70%; rate difference, 16% [95% CI, 6%-26%]). Data are absent on long-term effects on antimicrobial resistance. Meta-analyses in general showed no significant differences in antibiotic comparative effectiveness. CONCLUSIONS: Otoscopic findings are critical to accurate AOM diagnosis. AOM microbiology has changed with use of PCV7. Antibiotics are modestly more effective than no treatment but cause adverse effects in 4% to 10% of children. Most antibiotics have comparable clinical success.

Diagnosing and managing common food allergies: a systematic review.

CONTEXT: There is heightened interest in food allergies but no clear consensus exists regarding the prevalence or most effective diagnostic and management approaches to food allergies. OBJECTIVE: To perform a systematic review of the available evidence on the prevalence, diagnosis, management, and prevention of food allergies. DATA SOURCES: Electronic searches of PubMed, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, and Cochrane Central Register of Controlled Trials. Searches were limited to English-language articles indexed between January 1988 and September 2009. STUDY SELECTION: Diagnostic tests were included if they had a prospective, defined study population, used food challenge as a criterion standard, and reported sufficient data to calculate sensitivity and specificity. Systematic reviews and randomized controlled trials (RCTs) for management and prevention outcomes were also used. For foods where anaphylaxis is common, cohort studies with a sample size of more than 100 participants were included. DATA EXTRACTION: Two investigators independently reviewed all titles and abstracts to identify potentially relevant articles and resolved discrepancies by repeated review and discussion. Quality of systematic reviews and meta-analyses was assessed using the AMSTAR criteria, the quality of diagnostic studies using the QUADAS criteria most relevant to food allergy, and the quality of RCTs using the Jadad criteria. DATA SYNTHESIS: A total of 12,378 citations were identified and 72 citations were included. Food allergy affects more than 1% to 2% but less than 10% of the population. It is unclear if the prevalence of food allergies is increasing. Summary receiver operating characteristic curves comparing skin prick tests (area under the curve [AUC], 0.87; 95% confidence interval [CI], 0.81-0.93) and serum food-specific IgE (AUC, 0.84; 95% CI, 0.78-0.91) to food challenge showed no statistical superiority for either test. Elimination diets are the mainstay of therapy but have been rarely studied. Immunotherapy is promising but data are insufficient to recommend use. In high-risk infants, hydrolyzed formulas may prevent cow's milk allergy but standardized definitions of high risk and hydrolyzed formula do not exist. CONCLUSION: The evidence for the prevalence and management of food allergy is greatly limited by a lack of uniformity for criteria for making a diagnosis.

Outcomes of intravesical botulinum toxin for idiopathic overactive bladder symptoms: a systematic review of the literature.

PURPOSE: We systematically reviewed the evidence for the efficacy and safety of botulinum toxin in the management of overactive bladder. MATERIALS AND METHODS: We performed a systematic review of the literature to identify articles published between 1985 and March 2009 on intravesical botulinum toxin-A injections for the treatment of refractory idiopathic overactive bladder in men and women. Databases searched included MEDLINE, CENTRAL and Embase. Data were tabulated from case series and from randomized controlled trials, and data were pooled where appropriate. RESULTS: Our literature search identified 432 titles and 23 full articles were included in the final review. Three randomized placebo controlled trials addressing the use of botulinum toxin-A were identified (99 patients total). The pooled random effects estimate of effect across all 3 studies was 3.88 (95% CI -6.15, -1.62), meaning that patients treated with botulinum toxin-A had 3.88 fewer incontinence episodes per day. Urogenital Distress Inventory data revealed significant improvements in quality of life compared with placebo with a standardized mean difference of -0.62 (CI -1.04, -0.21). Data from case series demonstrated significant improvements in overactive bladder symptoms and quality of life, despite heterogeneity in methodology and case mix. However, based on the randomized controlled trials there was a 9-fold increased odds of increased post-void residual after botulinum toxin-A compared with placebo (8.55; 95% CI 3.22, 22.71). CONCLUSIONS: Intravesical injection of botulinum toxin resulted in improvement in medication refractory overactive bladder symptoms. However, the risk of increased post-void residual and symptomatic urinary retention was significant. Several questions remain concerning the optimal administration of botulinum toxin-A for the patient with overactive bladder.

Management of Acute Otitis Media: update.

CONTEXT: Acute Otitis Media (AOM), a viral or bacterial infection of the ear, is the most common childhood infection for which antibiotics are prescribed in the United States. In 2001, the Southern California Evidence-based Practice Center conducted a systematic review of the evidence comparing treatments of AOM. OBJECTIVES: This review updates the 2001 review findings on diagnosis and treatment of uncomplicated AOM, assesses the evidence for treatment of recurrent AOM, and assesses the impact of the heptavalent pneumococcal conjugate (PCV7) vaccine on the microbiology of AOM. DATA SOURCES AND STUDY SELECTION: Searches of PubMed® and the Cochrane databases were conducted from January 1998 to July 2010 using the same search strategies used for the 2001 report, with the addition of terms not considered in the 2001 review. The Web of Science was also searched for citations of the 2001 report and its peer-reviewed publications. DATA EXTRACTION: After review by two investigators against pre-determined inclusion/exclusion criteria, we included existing systematic reviews and randomized controlled clinical trials for assessment of treatment efficacy and safety. Pooled analysis was performed for comparisons with three or more trials. RESULTS AND CONCLUSIONS: Few studies were found that examined the accuracy and precision of the diagnosis of AOM. Since PCV7's introduction, AOM microbiology has shifted significantly, with Streptococcus pneumoniae becoming less prevalent and Haemophilus influenzae (HF) increasing in importance. For uncomplicated AOM, pooled analysis indicates that nine children (95% CI: 6, 20) would need to be treated with ampicillin or amoxicillin rather than placebo to note a difference in the rate of clinical success. However, in four studies of delayed treatment approaches for uncomplicated AOM, two had higher rates of clinical success with immediate antibiotic therapy while two did not, and in three studies, a marked decrease in antibiotic utilization was noted. We are unable to draw definitive conclusions regarding the comparative effectiveness of different antibiotics for AOM in children with recurrent otitis media (ROM). For ROM, long-term antibiotic administration will decrease AOM episodes from 3 to 1.5 for every 12 months of treatment per otitis prone child during active treatment (95% CI: 1.2, 2.1); however, potential consequences of long-term treatment need to be considered. Data were insufficient to draw conclusions about comparative effectiveness of different treatment strategies in subgroups of children with uncomplicated AOM. Adverse events were generally more frequent for amoxicillin-clavulanate than for cefdinir, ceftriaxone, or azithromycin. Higher quality studies and improved reporting of study characteristics related to quality are needed to provide definitive conclusions for AOM and ROM treatment options.

Off-label prescribing to children in the United States outpatient setting.

OBJECTIVE: The aim of this study was to determine the frequency of off-label prescribing to children at United States outpatient visits and to determine how drug class, patient age, and physician specialty relate to off-label prescribing. METHODS: Data from the 2001 through 2004 National Ambulatory Medical Care Surveys (NAMCS) consisted of a sample of 7901 outpatient visits by children aged 0 through 17 years in which prescriptions were given, representative of an estimated 312 million visits. We compared FDA-approved age and indication to the child's age and diagnoses. We used multivariate logistic regression to determine adjusted differences in probabilities of off-label prescribing. RESULTS: Sixty-two percent of outpatient pediatric visits included off-label prescribing. Approximately 96% of cardiovascular-renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary and dermatologic medication prescriptions were off label. Visits by children aged <6 years had a higher probability of off-label prescribing (P < .01), especially visits by children aged <1 year (74% adjusted probability). Visits to specialists also involved a significantly increased probability (68% vs 59% for general pediatricians, P < .01) of off-label prescribing. CONCLUSIONS: Despite recent studies and labeling changes of pediatric medications, the majority of pediatric outpatient visits involve off-label prescribing across all medication categories. Off-label prescribing is more frequent for younger children and those receiving care from specialist pediatricians. Increased dissemination of pediatric studies and label information may be helpful to guide clinical practice. Further research should be prioritized for the medications most commonly prescribed off label and to determine outcomes, causes, and appropriateness of off-label prescribing to children.

Determinants of health insurance status for children of Latino immigrant and other US farm workers: findings from the National Agricultural Workers Survey.

OBJECTIVE: To characterize the health insurance status of farm workers' children, an understudied topic. DESIGN: A population-based multistage survey. SETTING: Employer-based study conducted in the continental United States from 2000 to 2002. PARTICIPANTS: A total of 3136 parents with children younger than 18 years and no children residing outside of the United States who participated in the US Department of Labor's National Agricultural Workers Survey, which is administered to a national probability sample of US farm workers. OUTCOME MEASURES: Children's parent-reported health insurance status. RESULTS: Of the farm workers who were parents, 87% were Latino, 81% were foreign born, 15% were migrant workers, 55% had less than a sixth-grade education, and 68% reported little to no English language proficiency. Thirty-two percent of all farm-worker parents, including 45% of migrant-worker parents, reported that their children were uninsured. In multivariate analyses, older parental age (odds ratio [OR] for parents aged 30-39 years, 1.71; 95% confidence interval [CI], 1.16-2.50; OR for parents aged >/=40 years, 3.07; 95% CI, 1.99-4.74), less parental education (OR, 1.52; 95% CI, 1.09-2.10), less time in the United States (OR, 0.68; 95% CI, 0.56-0.91 per 10 years in the United States), being a migrant worker (OR, 1.96; 95% CI, 1.31-2.93), and living in the Southeast (OR, 3.17; 95% CI, 2.00-5.02) or Southwest (OR, 3.91; 95% CI, 2.32-6.57) were significantly associated with having uninsured children. CONCLUSIONS: Farm workers' children were uninsured at roughly 3 times the rate of all other children and almost twice the rate of those at or near the federal poverty level. Programs aimed at extending insurance coverage for children should consider the unique social barriers that characterize this vulnerable population of US children. Moreover, there is significant regional variation that may reflect varying levels of insurance resources and eligibility from state to state.

Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis.

OBJECTIVE: To perform a meta-analysis of randomized controlled trials (RCTs) and systematic reviews evaluating the efficacy of self-monitoring of blood glucose (SMBG) levels among patients with diabetes mellitus (DM). STUDY DESIGN: Meta-analysis of RCTs among patients with DM not taking insulin comparing patients with SMBG versus those without SMBG and reporting results as change in glycosylated hemoglobin (A1C) values. METHODS: Prior systematic reviews and a PubMed search were used to identify studies. Data were extracted by trained physician reviewers working in duplicate. Trials were classified according to duration of the intervention, and random-effects meta-analysis was used to pool results. RESULTS: Three trials of SMBG of 3 months' duration were too heterogeneous to pool. Nine other trials were identified. Five trials of SMBG of 6 months' duration yielded a pooled effect estimate of a decrease in mean A1C values of -0.21% (95% confidence interval [CI], -0.38% to -0.04%). Four trials that reported outcomes of 1 year or longer yielded a pooled effect estimate of a decrease in mean A1C values of -0.16% (95% CI, -0.38% to 0.05%). Three trials reported hypoglycemic outcomes, which were increased in the patients using SMBG, although this mostly involved asymptomatic or mild episodes. CONCLUSIONS: At most, SMBG produces a statistically significant but clinically modest effect in controlling blood glucose levels in patients with DM not taking insulin. It is of questionable value in helping meet target values of glucose control.

Psychosocial correlates of unprotected sex without disclosure of HIV-positivity among African-American, Latino, and White men who have sex with men and women.

African-American, Latino, and White men who have sex with men and women (MSMW) may be a bridge of HIV transmission from men to women. Very little research has directly compared culturally specific correlates of the likelihood of unprotected sex among MSMW. The present study examined psychosocial correlates of unprotected sex without disclosure of HIV status with male and female partners among 50 African American, 50 Latino, and 50 White HIV-positive MSMW recruited from AIDS service organizations in Los Angeles County. Multivariate logistic regressions were conducted to examine relationships of race/ethnicity and psychosocial variables (e.g., condom attitudes, self-efficacy for HIV disclosure, sexual identification) to unprotected sex without disclosure of HIV status, for male and female partners separately. For female partners, different effects emerged by race/ethnicity. Among African-Americans, less exclusively homosexual identification and low self-efficacy for disclosure of HIV status to female partners were associated with unprotected sex without disclosure; among Latinos, less exclusively homosexual identification and negative attitudes about condoms were significant. Participants who were more exclusively homosexually identified, who held less positive condom attitudes, and who had low self-efficacy for disclosure to female partners were more likely to have unprotected sex without disclosure of HIV status to male partners. Culturally tailored community-level interventions may help to raise awareness about HIV and bisexuality, and decrease HIV and sexual orientation stigma, thereby increasing African-American and Latino MSMW's comfort in communicating with their female partners about sexuality, HIV and condoms. Addressing norms for condom use and disclosure between male partners is recommended, especially for homosexually identified MSMW.

Screening for osteoporosis in men: a systematic review for an American College of Physicians guideline.

BACKGROUND: Screening for low bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA) is the primary way to identify asymptomatic men who might benefit from osteoporosis treatment. Identifying men at risk for low BMD and fracture can help clinicians determine which men should be tested. PURPOSE: To identify which asymptomatic men should receive DXA BMD testing, this systematic review evaluates 1) risk factors for osteoporotic fracture in men that may be mediated through low BMD and 2) the performance of non-DXA tests in identifying men with low BMD. DATA SOURCES: Studies identified through the MEDLINE database (1990 to July 2007). STUDY SELECTION: Articles that assessed risk factors for osteoporotic fracture in men or evaluated a non-DXA screening test against a gold standard of DXA. DATA EXTRACTION: Researchers performed independent dual abstractions for each article, determined performance characteristics of screening tests, and assessed the quality of included articles. DATA SYNTHESIS: A published meta-analysis of 167 studies evaluating risk factors for low BMD-related fracture in men and women found high-risk factors to be increased age (>70 years), low body weight (body mass index <20 to 25 kg/m2), weight loss (>10%), physical inactivity, prolonged corticosteroid use, and previous osteoporotic fracture. An additional 102 studies assessing 15 other proposed risk factors were reviewed; most had insufficient evidence in men to draw conclusions. Twenty diagnostic study articles were reviewed. At a T-score threshold of -1.0, calcaneal ultrasonography had a sensitivity of 75% and specificity of 66% for identifying DXA-determined osteoporosis (DXA T-score, -2.5). At a risk score threshold of -1, the Osteoporosis Self-Assessment Screening Tool had a sensitivity of 81% and specificity of 68% to identify DXA-determined osteoporosis. LIMITATION: Data on other screening tests, including radiography, and bone geometry variables, were sparse. CONCLUSION: Key risk factors for low BMD-mediated fracture include increased age, low body weight, weight loss, physical inactivity, prolonged corticosteroid use, previous osteoporotic fracture, and androgen deprivation therapy. Non-DXA tests either are too insensitive or have insufficient data to reach conclusions.