Efficacy of isoniazid prophylactic therapy in prevention of tuberculosis in children: a meta-analysis.

BACKGROUND: Children are highly susceptible to tuberculosis; thus, there is need for safe and effective preventive interventions. Our objective was to evaluate the efficacy of isoniazid in prevention of tuberculosis morbidity and mortality in children aged 15 years or younger by performing a meta-analysis of randomized controlled trials. To our knowledge, this is the first meta-analysis evaluating efficacy of isoniazid prophylaxis in prevention of tuberculosis in children. METHODS: A systematic search of the literature was done to identify randomized controlled trials evaluating isoniazid prophylaxis efficacy among children. Each study was evaluated for relevance and validity for inclusion in the analysis. Subgroup analyses were conducted based on study quality, HIV status, tuberculosis endemicity, type of prophylaxis and age of participants. RESULTS: Eight studies comprising 10,320 participants were included in this analysis. Upon combining data from all eight studies, isoniazid prophylaxis was found to be efficacious in preventing development of tuberculosis, with a pooled RR of 0.65 (95% CI 0.47, 0.89) p = 0.004 , with confidence intervals adjusted for heterogeneity. Among the sub-group analyses conducted, only age of the participants yielded dramatic differences in the summary estimate of efficacy, suggesting that age might be an effect modifier of the efficacy of isoniazid among children, with no effect realised in children initiating isoniazid at four months of age or earlier and an effect being present in older children. Excluding studies in which isoniazid was initiated at four months of age or earlier yielded an even stronger effect (RR = 0.41 (95% CI 0.31, 0.55) p <0.001). Data on the effect of isoniazid on all-cause mortality, excluding studies in which isoniazid was initiated in infants, yielded an imprecise estimate of mortality benefit (RR = 0.58 (95% CI 0.31, 1.09) p = 0.092). CONCLUSION: Isoniazid prophylaxis reduces the risk of developing tuberculosis by 59% among children aged 15 years or younger excluding children initiated during early infancy for primary prophylaxis (RR = 0.41, 95% CI 0.31, 0.55 p < 0.001) . However, further studies are needed to assess effects on mortality and to determine prophylaxis effectiveness in very young children and among HIV-infected children.

A Qualitative Analysis of Physician Perspectives on Missed and Delayed Outpatient Diagnosis: The Focus on System-Related Factors.

BACKGROUND: Delayed and missed diagnoses lead to significant patient harm. Because physician actions are fundamental to the outpatient diagnostic process, a study was conducted to explore physician perspectives on diagnosis. METHODS: As part of a quality improvement initiative, an integrated health system conducted six physician focus groups in 2004 and 2005. The focus groups included questions about the process of diagnosis, specific factors contributing to missed diagnosis, use of guidelines, atypical vs. typical presentations of disease, diagnostic tools, and follow-up, all with regard to delays in the diagnostic process. The interviews were analyzed (1) deductively, with application of the Systems Engineering Initiative for Patient Safety (SEIPS) model, which addresses systems design, quality management, job design, and technology implementations that affect safety-related patient and organizational and/or staff outcomes, and (2) inductively, with identification of novel themes using content analysis. RESULTS: A total of 25 physicians participated in the six focus groups, which yielded 12 hours of discussion. Providers identified multiple barriers to timely and accurate diagnosis, including organizational culture, information availability, and communication factors. CONCLUSIONS: Multiple themes relating to each of the participants in the diagnostic process-health system, provider, and patient-emerged. Concerns about health system structure and providers' interactions with one another and with patients far exceeded discussion of the cognitive factors that might affect the diagnostic process. The results suggest that, at least in physicians' views, improving the diagnostic process requires attention to the organization of the health system in addition to the cognitive aspects of diagnosis.

Identifying women at risk of delayed breast cancer diagnosis.

BACKGROUND: Delays in breast cancer diagnosis contribute to increased morbidity and mortality. Factors related to the occurrence of delayed diagnosis have not been well studied. METHODS: A retrospective cohort study of 5,464 women newly diagnosed with breast cancer from 1999 through 2006 was conducted at a comprehensive cancer center in Boston. A delayed diagnosis was defined as an interval greater than 90 days between the patient's first breast-related problem that prompted seeking of medical care and the breast cancer diagnosis based on biopsy. RESULTS: 938 (17%) patients had a delayed breast cancer diagnosis. Non-white race or Hispanic ethnicity (adjusted odds ratio [OR] = 1.46, 95% confidence interval [CI] = 1.13-1.90), living more than 26 miles from Boston (OR 1.46, 95% CI = 1.25-1.71), and initial presentation with a lump found by the patient herself (OR = 2.89, 95% CI = 2.36-3.55) or another breast symptom (OR = 0.25, 95% CI = 1.79-2.82) compared to an abnormal mammogram were significantly associated with a delay in diagnosis. In contrast, the odds of a delay were lower for women who were older than 18-39 years of age and for women living with two or more household members (OR = 0.72, 95% CI = 0.59-0.87). The likelihood of experiencing a delayed breast cancer diagnosis increased markedly if a woman had multiple risk factors, with a nearly 12-fold increase among women with five or more risk factors (OR = 11.96, 95% CI = 6.32-22.61). CONCLUSIONS: Younger age, minority race, and self-identification of breast symptom affect the likelihood of delayed breast cancer diagnosis. Awareness of these issues could help focus efforts to develop algorithms that identify women at risk for a delay and build programs that facilitate their timely access to care.

Process of care failures in breast cancer diagnosis.

BACKGROUND: Process of care failures may contribute to diagnostic errors in breast cancer care. OBJECTIVE: To identify patient- and provider-related process of care failures in breast cancer screening and follow-up in a non-claims-based cohort. DESIGN: Retrospective chart review of a cohort of patients referred to two Boston cancer centers with new breast cancer diagnoses between January 1, 1999 and December 31, 2004. PARTICIPANTS: We identified 2,275 women who reported > or =90 days between symptom onset and breast cancer diagnosis or presentation with at least stage II disease. We then selected the 340 (14.9%) whose physicians shared an electronic medical record. We excluded 238 subjects whose records were insufficient for review, yielding a final cohort of 102 patients. INTERVENTIONS: None MEASUREMENTS: We tabulated the number and types of process of care failures and examined risk factors using bivariate analyses and multivariable Poisson regression. MAIN RESULTS: Twenty-six of 102 patients experienced > or =1 process of care failure. The most common failures occurred when physicians failed to perform an adequate physical examination, when patients failed to seek care, and when diagnostic or laboratory tests were ordered but patients failed to complete them. Failures were attributed in similar numbers to provider- and patient-related factors (n = 30 vs. n = 25, respectively). Process of care failures were more likely when the patient's primary care physician was male (IRR 2.8, 95% CI 1.2 to 6.5) and when the patient was non-white (IRR 2.8, 95% CI 1.4 to 5.7). CONCLUSIONS: Process failures were common in this patient cohort, with both clinicians and patients contributing to breakdowns in the diagnostic process.

The You CAN campaign: teamwork training for patients and families in ambulatory oncology.

BACKGROUND: Health care organizations have begun to adapt high-performance teamwork training techniques from aviation to clinical environments. Oncology care is often delivered in multispecialty teams and with the patient's and family's active involvement. To examine the potential value of a patient-oriented teamwork intervention, a teamwork training initiative for oncology patients and their families was developed at the Dana-Farber Cancer Institute. DEVELOPING THE CAMPAIGN: The content and format of the initiative evolved iteratively on the basis of several core team-training concepts derived from the research literature in health care and aviation. Initially a targeted intervention, the program evolved into a multifaceted campaign that included internal marketing, staff training, and one-on-one patient outreach by a group of volunteers. The You CAN campaign sought to convey a positive and empowering message that encouraged patients to (1) check for hazards in the environment, (2) ask questions of clinicians, and (3) notify staff of safety concerns. IMPLEMENTING THE CAMPAIGN: The You CAN campaignwas conducted from July through September 2007. To assess its progress, patients were surveyed at baseline and during the campaign. On the basis of the survey results, 32% (95% confidence interval [CI]: 25%-38%) of the ambulatory clinic population, or 1,145 patients, were exposed to the campaign. Although patients rated the quality of teamwork and communication favorably at both baseline and followup, there was no significant change in the self-reported use of teamwork techniques on a written survey. However, 39% (95% CI: 27%-51%) of those who were exposed to the campaign said that it changed their behavior. DISCUSSION: A training program for patients and their families is feasible in ambulatory oncology and may be applicable to other clinical settings.

Perceptions and experiences of patients receiving oral chemotherapy.

Although many patients prefer orally administered cancer therapy (including oral chemotherapy) because of its convenience, the shift from hospital to home-based administration creates concerns. This article explores the perceptions and experiences of oral chemotherapy users and their caregivers to assess vulnerabilities and improvement opportunities at each stage of the medication process: choosing oral chemotherapy, prescribing, dispensing, administering, and monitoring. The authors recruited 15 current and former oral chemotherapy users, as well as caregivers who administered the medications to children, to participate in one of two focus group sessions at a comprehensive cancer center. Participants largely were satisfied with oral cancer therapy but raised concerns regarding their lack of preparedness for side effects and their unfamiliarity with the possible techniques to mitigate drug toxicity. Participants also described difficulties obtaining medications through retail pharmacies. Parents of pediatric patients with cancer indicated concerns regarding their children's emotional health and correct medication administration. Participants believed that the initial prescribing encounter should have included more education, and they also wanted more frequent follow-up by healthcare practitioners. As oral cancer therapy is used more widely, oncology healthcare providers will need to create robust mechanisms to support their safe use.

An empirical model to estimate the potential impact of medication safety alerts on patient safety, health care utilization, and cost in ambulatory care.

BACKGROUND: Because ambulatory care clinicians override as many as 91% of drug interaction alerts, the potential benefit of electronic prescribing (e-prescribing) with decision support is uncertain. METHODS: We studied 279 476 alerted prescriptions written by 2321 Massachusetts ambulatory care clinicians using a single commercial e-prescribing system from January 1 through June 30, 2006. An expert panel reviewed a sample of common drug interaction alerts, estimating the likelihood and severity of adverse drug events (ADEs) associated with each alert, the likely injury to the patient, and the health care utilization required to address each ADE. We estimated the cost savings due to e-prescribing by using third-party-payer and publicly available information. RESULTS: Based on the expert panel's estimates, electronic drug alerts likely prevented 402 (interquartile range [IQR], 133-846) ADEs in 2006, including 49 (14-130) potentially serious, 125 (34-307) significant, and 228 (85-409) minor ADEs. Accepted alerts may have prevented a death in 3 (IQR, 2-13) cases, permanent disability in 14 (3-18), and temporary disability in 31 (10-97). Alerts potentially resulted in 39 (IQR, 14-100) fewer hospitalizations, 34 (6-74) fewer emergency department visits, and 267 (105-541) fewer office visits, for a cost savings of 402,619 USD (IQR, 141,012-1,012,386 USD). Based on the panel's estimates, 331 alerts were required to prevent 1 ADE, and a few alerts (10%) likely accounted for 60% of ADEs and 78% of cost savings. CONCLUSIONS: Electronic prescribing alerts in ambulatory care may prevent a substantial number of injuries and reduce health care costs in Massachusetts. Because a few alerts account for most of the benefit, e-prescribing systems should suppress low-value alerts.

Clinicians' assessments of electronic medication safety alerts in ambulatory care.

BACKGROUND: While electronic prescribing (e-prescribing) systems with drug interaction and allergy alerts promise to improve medication safety in ambulatory care, clinicians often override these safety features. We undertook a study of respondents' satisfaction with e-prescribing systems, their perceptions of alerts, and their perceptions of behavior changes resulting from alerts. METHODS: Random sample survey of 300 Massachusetts ambulatory care clinicians who used a commercial e-prescribing system. RESULTS: A total of 184 respondents completed the survey (61%). Respondents indicated that e-prescribing improved the quality of care delivered (78%), prevented medical errors (83%), and enhanced patient satisfaction (71%) and clinician efficiency (75%). In addition, 35% of prescribers said that electronic alerts caused them to modify a potentially dangerous prescription in the last 30 days. They suggested that alerts also led to other changes in clinical care: counseling patients about potential reactions (49% of respondents), looking up information in medical references (44%), and changing the way a patient was monitored (33%). Altogether, 63% of clinicians reported taking action other than discontinuing or modifying an alerted prescription in the previous month in response to alerts. Despite these benefits, fewer than half of respondents were satisfied with drug interaction and allergy alerts (47%). Problems included alerts triggered by discontinued medications (58%), alerts that failed to account for appropriate drug combinations (46%), and excessive volume of alerts (37%). CONCLUSION: Although clinicians were critical of the quality of e-prescribing alerts, alerts may lead to clinically significant modifications in patient management not readily apparent based on "acceptance" rates.