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PubMed2006

Birth spacing and risk of adverse perinatal outcomes: a meta-analysis.

CONTEXT: Both short and long interpregnancy intervals have been associated with an increased risk of adverse perinatal outcomes. However, whether this possible association is confounded by maternal characteristics or socioeconomic status is uncertain. OBJECTIVE: To examine the association between birth spacing and relative risk of adverse perinatal outcomes. DATA SOURCES: Studies published in any language were retrieved by searching MEDLINE (1966 through January 2006), EMBASE, ECLA, POPLINE, CINAHL, and LILACS, proceedings of meetings on birth spacing, and bibliographies of retrieved articles, and by contact with relevant researchers in the field. STUDY SELECTION: Included studies were cohort, cross-sectional, and case-control studies with results adjusted for at least maternal age and socioeconomic status, reporting risk estimates and 95% confidence intervals (or data to calculate them) of birth spacing and perinatal outcomes. Of 130 articles identified in the search, 67 (52%) were included. DATA EXTRACTION: Information on study design, participant characteristics, measure of birth spacing used, measures of outcome, control for potential confounding factors, and risk estimates was abstracted independently by 2 investigators using a standardized protocol. DATA SYNTHESIS: A random-effects model and meta-regression analyses were used to pool data from individual studies. Compared with interpregnancy intervals of 18 to 23 months, interpregnancy intervals shorter than 6 months were associated with increased risks of preterm birth, low birth weight, and small for gestational age (pooled adjusted odds ratios [95% confidence intervals]: 1.40 [1.24-1.58], 1.61 [1.39-1.86], and 1.26 [1.18-1.33], respectively). Intervals of 6 to 17 months and longer than 59 months were also associated with a significantly greater risk for the 3 adverse perinatal outcomes. CONCLUSIONS: Interpregnancy intervals shorter than 18 months and longer than 59 months are significantly associated with increased risk of adverse perinatal outcomes. These data suggest that spacing pregnancies appropriately could help prevent such adverse perinatal outcomes.

Birth Intervals↗
PubMed2006

Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

CONTEXT: Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial. OBJECTIVE: To assess the efficacy of surgery for lumbar intervertebral disk herniation. DESIGN, SETTING, AND PATIENTS: The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks. INTERVENTIONS: Standard open diskectomy vs nonoperative treatment individualized to the patient. MAIN OUTCOME MEASURES: Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status. RESULTS: Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes. CONCLUSIONS: Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000410.

Adult↗
PubMed1999

Outcome evaluation of the 1997 American Joint Committee on Cancer staging system for prostate carcinoma treated by radiation therapy.

BACKGROUND: The 1997 American Joint Committee on Cancer (AJCC) staging system condensed unilobular tumors into one entity and continues the use of both imaging and biopsy to alter classification status in T2 and T3 carcinomas. This study analyzes the biochemical freedom from disease recurrence (bNED) outcome in a large database to determine whether these changes reflect outcome differences. METHODS: Five hundred and thirty-seven patients with adenocarcinoma of the prostate were treated with radiation therapy to a median dose of 7180 centigrays (cGy) (range, 6316-8074 cGy) between November 1987 and November 1994. The median age of the patients was 70 years and the median follow-up was 51 months. The median pretreatment prostate specific antigen (PSA) was 11.0 ng/mL. Patients were analyzed using 1992 AJCC stage comparing bNED outcome after radiation therapy for T2a versus T2b versus T2c tumors using Kaplan-Meier estimation and the log rank test. Patients then were analyzed multivariately using Cox regression with the known prognostic variables of dose, pretreatment PSA, palpation stage, and grade in addition to palpation plus imaging stage and palpation plus biopsy stage. The prognostic endpoint was bNED with failure as defined by the 1997 American Society for Therapeutic Radiology and Oncology Consensus Panel. RESULTS: The 1992 AJCC palpation classifications T2a versus T2b versus T2c have a significantly different (P = 0.02) bNED outcome. Prognostic significance is lost by pooling these three classifications in the 1997 AJCC staging system. Adding imaging information to palpation did not improve the ability of palpation alone to assess bNED status (P = 0.33). However, the addition of biopsy information to palpation significantly (P = 0.02) increased the accuracy of palpation stage alone to predict for bNED outcome for T2 and T3 tumors. CONCLUSIONS: The subdivision of T2 tumors in the 1992 AJCC classification (T2a, T2b, and T2c) should be used in the next revision of the 1997 AJCC staging system. The addition of imaging data does not discriminate bNED outcome any better than palpation stage alone in T2 and T3 tumors and should not be used. The addition of biopsy information to palpation stage did significantly improve the predicted outcome compared with palpation alone and should continue to be used.

Adenocarcinoma↗
PubMed2000

A simplified urinary incontinence score for the evaluation of treatment outcomes.

There are no standardized definitions for anti-incontinence therapy outcomes. The present study was conducted to evaluate whether the incorporation of several non-invasive outcome measures into a new score may serve as a meaningful outcome instrument. Ninety-four consecutive sphincteric incontinent women who underwent a pubovaginal sling by a single surgeon were enrolled. All patients underwent a full clinical evaluation, including pre- and post-operative questionnaires, 24-hour voiding diary, and 24-hour pad test. Surgery outcomes were classified twice: First, by analyzing the patient questionnaire, voiding diary, and pad test separately, according to previously published criteria, and second, by combining the three outcome tools into a new response score. The new score was constructed in a simple, easy-to-remember format and divided into five categories: cure, good response, fair response, poor response, and failure. All patients were evaluated at least 1 year post-operatively. Comparison of the old and new classifications suggests that the new response score provides a more accurate evaluation of the surgical outcomes. Although 64 to 69% of the patients were originally classified as cure according to the old classification, only 44.7% were re-classified as cure by the strict criteria employed in the new score. Furthermore, the response score also differentiates between various degrees of clinical improvement (i.e., good, fair, or poor response). Twenty-five (26.6%) patients, most of whom were previously classified as cure, were re-classified as good response, whereas 20 others were re-classified as fair (13. 9%), or poor (7.4%) response. Seven (7.4%) patients were re-classified as surgical failures. All were diagnosed pre-operatively as having complex sphincteric incontinence. Specific failure rates were therefore 11.3% for complex and 0% for simple cases. In conclusion, the suggested post-operative response score incorporates in a user-friendly format three popular outcome tools (i.e., 24-hour diary, 24-hour pad test, and patient questionnaire) and seems to reflect the surgical results more accurately. Further studies are needed to assess its validity and reproducibility in other treatment modalities. Neurourol Urodynam. 19:127-135, 2000.

Adult↗
PubMed2000

Impact of definitions on the description and prediction of bulimia nervosa outcome.

OBJECTIVE: The authors sought to compare definitions of eating disorder outcome found in the bulimia nervosa literature and to determine the impact of definitions on the description and prediction of outcome. METHOD: Definitions of outcome were identified from studies involving a follow-up duration of at least 5 years. Definitions were applied to a sample of women (N = 173) assessed more than 10 years following presentation with bulimia nervosa. RESULTS: Across definitions, the percentage of women considered fully recovered ranged from 38% to 47% in the follow-up sample. Associations between eating disorder outcome and other measures of outcome were relatively unaffected by differences in definitions. Conversely, the significance of various prognostic variables differed substantially among definitions. DISCUSSION: Our findings suggest that differences in definitions influence the description and prediction of eating disorder outcome significantly. Consistency in defining recovery is needed in order to explore other areas of outcome such as relapse.

Adult↗
PubMed2006

Audit and feedback: effects on professional practice and health care outcomes.

BACKGROUND: Audit and feedback continues to be widely used as a strategy to improve professional practice. It appears logical that healthcare professionals would be prompted to modify their practice if given feedback that their clinical practice was inconsistent with that of their peers or accepted guidelines. Yet, audit and feedback has not consistently been found to be effective. OBJECTIVES: To assess the effects of audit and feedback on the practice of healthcare professionals and patient outcomes. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group's register and pending file up to January 2004. SELECTION CRITERIA: Randomised trials of audit and feedback (defined as any summary of clinical performance over a specified period of time) that reported objectively measured professional practice in a healthcare setting or healthcare outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. Quantitative (meta-regression), visual and qualitative analyses were undertaken. For each comparison we calculated the risk difference (RD) and risk ratio (RR), adjusted for baseline compliance when possible, for dichotomous outcomes and the percentage and the percent change relative to the control group average after the intervention, adjusted for baseline performance when possible, for continuous outcomes. We investigated the following factors as possible explanations for the variation in the effectiveness of interventions across comparisons: the type of intervention (audit and feedback alone, audit and feedback with educational meetings, or multifaceted interventions that included audit and feedback), the intensity of the audit and feedback, the complexity of the targeted behaviour, the seriousness of the outcome, baseline compliance and study quality. MAIN RESULTS: Thirty new studies were added to this update, and a total of 118 studies are included. In the primary analysis 88 comparisons from 72 studies were included that compared any intervention in which audit and feedback is a component compared to no intervention. For dichotomous outcomes the adjusted risk difference of compliance with desired practice varied from - 0.16 (a 16 % absolute decrease in compliance) to 0.70 (a 70% increase in compliance) (median = 0.05, inter-quartile range = 0.03 to 0.11) and the adjusted risk ratio varied from 0.71 to 18.3 (median = 1.08, inter-quartile range = 0.99 to 1.30). For continuous outcomes the adjusted percent change relative to control varied from -0.10 (a 10 % absolute decrease in compliance) to 0.68 (a 68% increase in compliance) (median = 0.16, inter-quartile range = 0.05 to 0.37). Low baseline compliance with recommended practice and higher intensity of audit and feedback were associated with larger adjusted risk ratios (greater effectiveness) across studies. AUTHORS' CONCLUSIONS: Audit and feedback can be effective in improving professional practice. When it is effective, the effects are generally small to moderate. The relative effectiveness of audit and feedback is likely to be greater when baseline adherence to recommended practice is low and when feedback is delivered more intensively.

Education, Medical, Continuing↗
PubMed1999

Fertility and pregnancy outcome in women with systemic sclerosis.

OBJECTIVE: To determine fertility and pregnancy outcome in women with systemic sclerosis (SSc; scleroderma) who had disease onset before age 45 years. METHODS: All living women with scleroderma who had first been evaluated at the University of Pittsburgh Scleroderma Clinic after January 1, 1972 were sent a detailed self-administered questionnaire in 1986 specifically concerning pregnancy outcomes and infertility. This group was compared with 2 race- and age-matched control groups, one comprising women with rheumatoid arthritis (RA) and one comprising healthy neighborhood women identified by random-digit dialing. We determined the number, history, treatment, and outcome of women who either had never been pregnant or had attempted to become pregnant unsuccessfully for more than 1 year. We also obtained data regarding pregnancy outcomes, including the frequency of miscarriage, premature births, small full-term infants, perinatal deaths, and births of live healthy infants. RESULTS: The study group comprised 214 women with SSc, 167 with RA, and 105 neighborhood controls. There were no significant differences in the overall rates of miscarriage, premature births, small full-term births, or neonatal deaths between the 3 groups. Women with SSc were more likely than those without SSc to have adverse outcomes of pregnancy after the onset of their rheumatic disease, particularly premature births (also seen in RA women after disease onset) and small full-term infants. Although a significantly greater number of women with SSc had never been pregnant, there were no significant differences in the frequency of never having been pregnant or of infertility in the 3 groups after adjustment for contributing factors. CONCLUSION: This study indicates that women with SSc have acceptable pregnancy outcomes compared with those of women with other rheumatic disease and healthy neighborhood controls. Infertility was not a frequent problem. We believe that there are no excessive pregnancy risks to women with SSc or their infants. However, a well-timed pregnancy with careful obstetric monitoring will maximize the likelihood of a successful outcome.

Adult↗
PubMed1995

Outcome assessment for epilepsy surgery: the impact of measuring health-related quality of life.

Epilepsy surgery is an increasingly common treatment for intractable epilepsy; yet there is no clear consensus among experts on how to report epilepsy surgery outcome. Most published outcome reporting systems focus on seizure frequency and type but differ in how they define clinically distinct outcome categories. We used a reliable and valid measure of self-reported health-related quality of life (HRQOL), the Epilepsy Surgery Inventory (ESI)-55, as an external standard by which to evaluate seven previously published, seizure-based outcome classification systems. The ESI-55 was administered to 133 adults who had previously undergone surgery for intractable epilepsy, and results were linked to data on their seizure occurrence before and after surgery (over the year prior to their HRQOL reports). These 133 patients were classified according to each seizure-based outcome system, and variation in HRQOL across outcome groups was evaluated using analysis of variance. Results reveal noteworthy variation in the extent to which different systems reflect patients' HRQOL at follow-up. We modified existing systems to derive a seizure-based surgery outcome system that most closely reflects HRQOL when applied over the latest 1-year postoperative interval.

Adolescent↗
PubMed2003

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

OBJECTIVE: Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. METHODS: We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. RESULTS: The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. CONCLUSION: The simulation studies demonstrate that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

Antirheumatic Agents↗
PubMed1997

The outcome of bacterial arthritis: a prospective community-based study.

OBJECTIVE: To assess the outcome and adverse prognostic factors of bacterial arthritis (BA). METHODS: In a prospective community survey of BA, data were collected at the time of diagnosis and at a mean of 2 years later. A poor patient outcome was defined as death due to BA or severe overall functional deterioration. A poor joint outcome was defined as amputation, arthrodesis, prosthetic surgery, or severe functional deterioration. Possible prognostic factors were analyzed by univariate analysis. RESULTS: BA was diagnosed in 154 patients, 121 adults and 33 children. One-half of the adults had a preexisting joint disease and 29% of the infected joints contained synthetic material. The patient outcome was poor in 21% of all patients, and the joint outcome was poor in 33% of the surviving patients. Adverse prognostic factors were an older age, preexisting joint disease, and an infected joint containing synthetic material. These factors were interrelated. There was no association between a poor outcome and young age, comorbidity, immunosuppressive medication, functional class, multiple infected joints, type of microorganism, or treatment delay. CONCLUSION: BA had a poor outcome in almost one-half of the patients. Patients who were older, had a preexisting joint disease, and/or had an infected joint containing synthetic material had the poorest prognosis.

Adult↗
PubMed2005

Pregnancy outcomes after maternal exposure to simvastatin and lovastatin.

BACKGROUND: Our objective was to determine the frequency of adverse outcomes after maternal exposure to simvastatin and/or lovastatin during pregnancy in postmarketing experience. METHODS: We reviewed the Merck & Co., Inc. (West Point, PA) pharmacovigilance database for reports of exposure to simvastatin or lovastatin during pregnancy. The reports were classified as prospective (reported prior to pregnancy outcome) or retrospective (reported after pregnancy outcome) and were evaluated for timing of exposure, outcome, congenital anomalies, and other events. Outcome rates were calculated for prospective pregnancies. RESULTS: We identified 477 reports (386 prospective and 91 retrospective) with 225 prospective outcomes reported: 154 live born infants, 49 elective abortions, 18 spontaneous abortions, and 4 fetal deaths. Six congenital anomalies were reported: chromosomal translocation, trisomy 18, hypospadias, duodenal atresia, cleft lip, and skin tag. The rate of congenital anomalies (congenital anomalies/live births plus fetal deaths) was 3.8%, which is similar to the background population rate (3.2%; relative ratio, 1.21; 95% 1-sided upper confidence interval [CI], 2.02). There were 13 retrospective reports describing a range of congenital anomalies. No specific pattern of anomalies was identified in either the prospective or retrospective reports. Rates for other outcomes were similar to background rates. CONCLUSIONS: Although the number of reports was relatively small, there was no evidence of a notable increase in congenital anomalies in women exposed to simvastatin or lovastatin versus the general population. Greater reporting of congenital abnormalities in the retrospective cohort is not unexpected and may reflect a reporting bias. Drugs should be used during pregnancy only if the benefits outweigh the risks. Simvastatin and lovastatin remain contraindicated during pregnancy.

Abnormalities, Drug-Induced↗
PubMed2002

Detrusor instability with equivocal obstruction: A predictor of unfavorable symptomatic outcomes after transurethral prostatectomy.

AIMS: To elucidate whether preoperative urodynamic findings can predict outcomes of transurethral resection of the prostate (TUR-P). METHODS: Sixty-two patients with symptomatic benign prostatic hyperplasia were categorized in three different ways based on findings of preoperative pressure-flow study (PFS) and cystometry: urodynamic obstruction (determined by the Abrams-Griffiths nomogram), detrusor instability (DI), and combination of both. Outcomes of TUR-P regarding symptom, function, and quality of life (QOL) were analyzed by changes in the International Prostate Symptom Score (I-PSS), maximum flow rate in uroflowmetry, and QOL index before and after TUR-P, respectively. Overall outcome was defined as success when all of the three categories showed successful improvement. RESULTS: Neither urodynamic obstruction alone nor DI alone predicted outcomes of TUR-P. However, symptomatic and overall outcomes were significantly worse in patients who were not obstructed but had DI. Postoperative persistent DI was more frequently noted in patients without clear obstruction (60%) than in those with obstruction (27%). Patients with equivocal obstruction showed less satisfactory symptomatic outcomes of TUR-P when DI was accompanied. Persistent DI might be the principle cause of unfavorable outcomes. CONCLUSIONS: Preoperative evaluation of DI is of benefit because it enhances predictive value of the PFS.

Aged↗
PubMed2002

Clinical outcomes research from the occupational therapist's perspective.

With increasing costs and scarcity of resources, occupational therapists need to embrace outcomes research to demonstrate the effectiveness of its clinical interventions. To explore clinicians' perspectives on clinical outcomes research a qualitative study was undertaken involving three in-depth group interviews with 15 occupational therapists from the South Western Sydney Area Health Service. Five broad themes permeated participants' perception: (a) defining the process, (b) factors that impact on participation in clinical outcomes research, (c) organizational influences, (d) the value of clinical outcomes research, and (e) potential partnerships with academics. Three conceptual categories are identified: knowledge and understanding about clinical outcomes research, clinicians' experience conducting or participating in clinical outcomes research and the relevance of clinical outcomes research to occupational therapy clinical practice. Similarity to findings in the international literature on occupational therapists' engagement in clinical research suggests that the findings from this small sample of Australian therapists are robust. The implications of the findings for continuing professional education programmes and clinical supervision are presented.

Attitude of Health Personnel↗
PubMed2007

Effect of race on outcome of white and black children with acute myeloid leukemia: the St. Jude experience.

BACKGROUND: The association between race and outcome of treatment for childhood acute myeloid leukemia (AML) has not been adequately studied. PROCEDURE: We compared the clinical characteristics, biological features, and outcomes between white and black children with AML who were treated on five consecutive clinical protocols (1980-2002) at St. Jude Children's Research Hospital. We used proportional hazards modeling to investigate the relation between race and outcome. RESULTS: We observed no statistically significant differences between the 229 white and 58 black patients in clinical characteristics, FAB subtype, cytogenetic features, or outcome. There were no significant differences in event-free survival (EFS) or overall survival (OS) between the two race groups in individual clinical trials or in all studies combined. For the study group as a whole, the 5-year survival estimate was 39.2% +/- 3.6% for white patients and 33.8% +/- 6.5% for black patients. However, on our most recent trial (AML-97), there was a trend towards inferior outcome among black patients: the 5-year survival estimates were 55.6% +/- 12.3% and 27.3% +/- 13.5% for whites and blacks, respectively. CONCLUSIONS: Although we detected no differences in treatment outcome between white and black children with AML over the entire study period, black children appear to have worse outcomes than white children during more recent studies. Improved treatment is needed for all children with AML.

Adolescent↗
PubMed2004

How do women of diverse backgrounds value prenatal testing outcomes?

OBJECTIVES: To describe women's preferences for prenatal testing outcomes and to explore their association with sociodemographic characteristics and attitudes. METHODS: We conducted a cross-sectional study of 584 racially/ethnically and socioeconomically diverse pregnant women aged 16 to 47 years recruited from 23 San Francisco Bay Area practices. We assessed preferences for 12 potential prenatal testing outcomes using the time trade-off metric for all outcomes and the standard gamble metric for two outcomes. Preferences were calculated on a scale of 0 (death) to 1 (perfect health). Participants also completed a sociodemographic and attitude survey. RESULTS: Highest preference scores were assigned to outcomes resulting in the birth of a chromosomally normal infant (mean = 0.91-0.93; median = 0.99-1.00). Lower scores were obtained for outcomes involving pregnancy loss (mean = 0.69-0.87; median = 0.76-0.92), which were correlated with attitudes regarding miscarriage, pregnancy termination, and Down syndrome. The lowest scores were assigned to Down syndrome-affected births (mean = 0.67-0.69; median = 0.73-0.75), which also were correlated with attitudes toward Down syndrome. We did not find a statistically significant relationship between participants' preference scores and age. CONCLUSION: Preferences for prenatal testing outcomes vary according to the pregnant women's underlying attitudes about pregnancy loss and Down syndrome, and not according to her age. Current age/risk-based guidelines should account for individual variation in patient preferences.

Abortion, Induced↗
PubMed2006

Population antibiotic susceptibility for Streptococcus pneumoniae and treatment outcomes in common respiratory tract infections.

PURPOSE: Antibiotic-resistant Streptococcus pneumoniae potentially threatens the successful treatment of common respiratory tract infections (RTIs); however, the relationship between antibiotic resistance and treatment outcomes remains unclear. We aimed to test the hypothesis that higher in vitro penicillin and erythromycin nonsusceptibility levels among clinical isolates of S. pneumoniae are associated with higher risk of treatment failure in suppurative acute otitis media (AOM), acute sinusitis, and acute exacerbation of chronic bronchitis (AECB). METHODS: We conducted a population-level analysis using treatment outcomes data from a national, managed-care claims database, and antibiotic susceptibility data from a national repository of antimicrobial susceptibility results between 1997 and 2000. Treatment outcomes in patients with suppurative AOM, acute sinusitis, or AECB receiving selected macrolides or beta-lactams were assessed. Associations between RTI-specific treatment outcomes and antibiotic nonsusceptibility were determined using Spearman correlation coefficients with condition-specific paired outcome and susceptibility data for each region and each year. RESULTS: There were 649 552 available RTI outcomes and 7252 susceptibility tests performed on S. pneumoniae isolates. There were no statistically significant trends across time for resolution proportions following treatment by either beta-lactams or macrolides among any of the RTIs. Correlation analyses found no statistically significant association between S. pneumoniae susceptibility and RTI treatment outcomes apart from a significant positive association between of erythromycin nonsusceptibility in ear isolates and macrolide treatment resolution for suppurative AOM. CONCLUSION: On the population level, in vitro S. pneumoniae nonsusceptibility to macrolide or beta-lactam antibiotics was not associated with treatment failure in conditions of probable S. pneumoniae etiology.

Acute Disease↗
PubMed2007

An evaluation of bivariate random-effects meta-analysis for the joint synthesis of two correlated outcomes.

Often multiple outcomes are of interest in each study identified by a systematic review, and in this situation a separate univariate meta-analysis is usually applied to synthesize the evidence for each outcome independently; an alternative approach is a single multivariate meta-analysis model that utilizes any correlation between outcomes and obtains all the pooled estimates jointly. Surprisingly, multivariate meta-analysis is rarely considered in practice, so in this paper we illustrate the benefits and limitations of the approach to provide helpful insight for practitioners. We compare a bivariate random-effects meta-analysis (BRMA) to two independent univariate random-effects meta-analyses (URMA), and show how and why a BRMA is able to 'borrow strength' across outcomes. Then, on application to two examples in healthcare, we show: (i) given complete data for both outcomes in each study, BRMA is likely to produce individual pooled estimates with very similar standard errors to those from URMA; (ii) given some studies where one of the outcomes is missing at random, the 'borrowing of strength' is likely to allow BRMA to produce individual pooled estimates with noticeably smaller standard errors than those from URMA; (iii) for either complete data or missing data, BRMA will produce a more appropriate standard error of the pooled difference between outcomes as it incorporates their correlation, which is not possible using URMA; and (iv) despite its advantages, BRMA may often not be possible due to the difficulty in obtaining the within-study correlations required to fit the model. Bivariate meta-regression and further research priorities are also discussed.

Analysis of Variance↗
PubMed1995

Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes.

We present a Bayesian approach for monitoring multiple outcomes in single-arm clinical trials. Each patient's response may include both adverse events and efficacy outcomes, possibly occurring at different study times. We use a Dirichlet-multinomial model to accommodate general discrete multivariate responses. We present Bayesian decision criteria and monitoring boundaries for early termination of studies with unacceptably high rates of adverse outcomes or with low rates of desirable outcomes. Each stopping rule is constructed either to maintain equivalence or to achieve a specified level of improvement of a particular event rate for the experimental treatment, compared with that of standard therapy. We avoid explicit specification of costs and a loss function. We evaluate the joint behaviour of the multiple decision rules using frequentist criteria. One chooses a design by considering several parameterizations under relevant fixed values of the multiple outcome probability vector. Applications include trials where response is the cross-product of multiple simultaneous binary outcomes, and hierarchical structures that reflect successive stages of treatment response, disease progression and survival. We illustrate the approach with a variety of single-arm cancer trials, including bio-chemotherapy acute leukaemia trials, bone marrow transplantation trials, and an anti-infection trial. The number of elementary patient outcomes in each of these trials varies from three to seven, with as many as four monitoring boundaries running simultaneously. We provide general guidelines for eliciting and parameterizing Dirichlet priors and for specifying design parameters.

Bayes Theorem↗