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.

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.

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.

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.

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.

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.

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.

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.

Challenges in systematic reviews of complementary and alternative medicine topics.

The use of complementary and alternative medicine (CAM) continues to grow in the United States. The Agency for Healthcare Research and Quality has devoted a substantial proportion of the Evidence-based Practice Center (EPC) program to systematic reviews of CAM. Such syntheses present different challenges from those conducted on western medicine topics, and in many ways are more difficult. We discuss 3 challenges: identifying evidence about CAM, assessing the quality of individual studies, and addressing rare serious adverse events. We use illustrations from EPC evidence reports to show readers approaches to the 3 areas and then present specific recommendations for each issue.

Meta-analysis: chronic disease self-management programs for older adults.

BACKGROUND: Although enthusiasm is growing for self-management programs for chronic conditions, there are conflicting data regarding their effectiveness and no agreement on their essential components. PURPOSE: To assess the effectiveness and essential components of self-management programs for hypertension, osteoarthritis, and diabetes mellitus. DATA SOURCES: The authors searched multiple sources dated through September 2004, including the Cochrane Library, MEDLINE, PsycINFO, and Nursing and Allied Health databases, and bibliographies of 87 previous reviews. STUDY SELECTION: Randomized trials that compared outcomes of self-management interventions with a control or with usual care for diabetes mellitus, osteoarthritis, or hypertension; outcomes included hemoglobin A1c level, fasting blood glucose level, weight, blood pressure, pain, or function. DATA EXTRACTION: Two reviewers independently identified trials and extracted data regarding whether the intervention used tailored adjustments to meet individual patient needs, a group setting, feedback, and psychological services, and whether the intervention was provided by the patient's usual physician. DATA SYNTHESIS: Of 780 studies screened, 53 studies contributed data to the random-effects meta-analysis (26 diabetes studies, 14 osteoarthritis studies, and 13 hypertension studies). Self-management interventions led to a statistically and clinically significant pooled effect size of -0.36 (95% CI, -0.52 to -0.21) for hemoglobin A1c, equivalent to a reduction in hemoglobin A1c level of about 0.81%. Self-management interventions decreased systolic blood pressure by 5 mm Hg (effect size, -0.39 [CI, -0.51 to -0.28]) and decreased diastolic blood pressure by 4.3 mm Hg (effect size, -0.51 [CI, -0.73 to -0.30]). Pooled effects of self-management interventions were statistically significant but clinically trivial for pain and function outcomes for osteoarthritis. No consistent results supported any of the 5 characteristics examined as essential for program success. LIMITATIONS: Studies had variable quality, and possible publication bias was evident. CONCLUSIONS: Self-management programs for diabetes mellitus and hypertension probably produce clinically important benefits. The elements of the programs most responsible for benefits cannot be determined from existing data, and this inhibits specification of optimally effective or cost-effective programs. Osteoarthritis self-management programs do not appear to have clinically beneficial effects on pain or function.

Effects of omega-3 fatty acids on cancer risk: a systematic review.

CONTEXT: Omega-3 fatty acids are purported to reduce the risk of cancer. Studies have reported mixed results. OBJECTIVE: To synthesize published and unpublished evidence to determine estimates of the effect of omega-3 fatty acids on cancer risk in prospective cohort studies. DATA SOURCES: Articles published from 1966 to October 2005 identified through MEDLINE, PREMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and CAB Health; unpublished literature sought through letters to experts in the neutraceutical industry. STUDY SELECTION: A total of 38 articles with a description of effects of consumption of omega-3 fatty acids on tumor incidence, prospective cohort study design, human study population; and description of effect of omega-3 among groups with different levels of exposure in the cohort were included. Two reviewers independently reviewed articles using structured abstraction forms; disagreements were resolved by consensus. DATA EXTRACTION: Two reviewers independently abstracted detailed data about the incidence of cancer, the type of cancer, the number and characteristics of the patients, details on the exposure to omega-3 fatty acids, and the elapsed time between the intervention and outcome measurements. Data about the methodological quality of the study were also abstracted. DATA SYNTHESIS: Across 20 cohorts from 7 countries for 11 different types of cancer and using up to 6 different ways to categorize omega-3 fatty acid consumption, 65 estimates of the association between omega-3 fatty acid consumption were reported. Among these, only 8 were statistically significant. The high degree of heterogeneity across these studies precluded pooling of data. For breast cancer 1 significant estimate was for increased risk (incidence risk ratio [IRR], 1.47; 95% confidence interval [CI], 1.10-1.98) and 3 were for decreased risk (RR, 0.68-0.72); 7 other estimates did not show a significant association. For colorectal cancer, there was 1 estimate of decreased risk (RR, 0.49; 95% CI, 0.27-0.89) and 17 estimates without association. For lung cancer one of the significant associations was for increased cancer risk (IRR, 3.0; 95% CI, 1.2-7.3), the other was for decreased risk (RR, 0.32; 95% CI, 0.13-0.76), and 4 other estimates were not significant. For prostate cancer, there was 1 estimate of decreased risk (RR, 0.43; 95% CI, 0.22-0.83) and 1 of increased risk (RR, 1.98; 95% CI, 1.34-2.93) for advanced prostate cancer; 15 other estimates did not show a significant association. The study that assessed skin cancer found an increased risk (RR, 1.13; 95% CI, 1.01-1.27). No significant associations between omega-3 fatty acid consumption and cancer incidence were found for aerodigestive cancer, bladder cancer, lymphoma, ovarian cancer, pancreatic cancer, or stomach cancer. CONCLUSIONS: A large body of literature spanning numerous cohorts from many countries and with different demographic characteristics does not provide evidence to suggest a significant association between omega-3 fatty acids and cancer incidence. Dietary supplementation with omega-3 fatty acids is unlikely to prevent cancer.

Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies.

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. PURPOSE: To resolve the discrepancies related to 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. DATA SOURCES: MEDLINE, EMBASE, CINAHL, the Cochrane Controlled Trials Register, and previous systematic reviews. STUDY SELECTION: Randomized, controlled trials of patients with low back pain that evaluated spinal manipulative therapy with at least 1 day of follow-up and at least one clinically relevant outcome measure. DATA EXTRACTION: Two authors, who served as the reviewers 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). DATA SYNTHESIS: 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. CONCLUSIONS: There is no evidence that spinal manipulative therapy is superior to other standard treatments for patients with acute or chronic low back pain.

Smoking-cessation interventions by type of provider: a meta-analysis.

OBJECTIVE: To synthesize the evidence on the effectiveness of smoking-cessation interventions by type of provider. METHODS: A random effects meta-regression was estimated to examine the effect of provider and whether the intervention contained nicotine replacement therapy (NRT), on the intervention's relative risk of quitting as compared to placebo or usual care from studies published in databases from inception to 2000. Thirty additional studies not included in the previous 1996 and 2000 U.S. Public Health Service clinical practice guidelines were used to provide the most comprehensive analysis to date of the comparative effectiveness of different types of providers in interventions for smoking cessation that have been published. RESULTS: The effectiveness without NRT follows: psychologist (1.94, 95% confidence interval [CI]: 1.04-3.62); physician (1.87, CI=1.42-2.45); counselor (1.82, CI=0.84-3.96); nurse (1.76, CI=1.21-2.57); unknown (1.27, CI=0.57-2.82); other (1.18, CI=0.67-2.10); and self-help (1.28, CI=0.89-1.82). Effectiveness of most providers increased by almost twofold with the use of NRT. CONCLUSIONS: Smoking-cessation interventions without NRT delivered by psychologists, physicians, or nurses are all effective. NRT increases the effectiveness of most providers.

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.

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.

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.

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.