Evidence report/technology assessment最新文献

Objectives: This systematic review aimed to evaluate, within unselected populations: the (1) performance of family history (FHx)-based models in predicting cancer risk; (2) overall benefits and harms associated with established cancer prevention interventions; (3) impact of FHx-based risk information on the uptake of preventive interventions; and (4) potential for harms associated with collecting cancer FHx.

Data sources: MEDLINE, EMBASE, CINAHL, Cochrane Central, Cochrane Database of Systematic Reviews, and PsycINFO were searched from 1990 to June 2008 inclusive. Cancer guidelines and recommendations were searched from 2002 forward and systematic reviews from 2003 to June 2008.

Review methods: Standard systematic review methodology was employed. Eligibility criteria included English studies evaluating breast, colorectal, ovarian, or prostate cancers. Study designs were restricted to systematic review, experimental and diagnostic types. Populations were limited to those unselected for cancer risk. Interventions were limited to collection of cancer FHx; primary and/or secondary prevention interventions for breast, colorectal, ovarian, and prostate cancers.

Results: Accuracy of models. Seven eligible studies evaluated systems based on the Gail model, and on the Harvard Cancer Risk Index. No evaluations demonstrated more than modest discriminatory accuracy at an individual level. No evaluations were identified relevant to ovarian or prostate cancer risk. Efficacy of preventive interventions. From 29 eligible systematic reviews, seven found no experimental studies evaluating interventions of interest. Of the remaining 22, none addressed ovarian cancer prevention. The reviews were generally based on limited numbers of randomized or controlled clinical trials. There was no evidence either to support or refute the use of selected chemoprevention interventions, there was some evidence of effectiveness for mammography and fecal occult blood testing. Uptake of intervention. Three studies evaluated the impact of FHx-based risk information on uptake of clinical preventive interventions for breast cancer. The evidence is insufficient to draw conclusions on the effect of FHx-based risk information on change in preventive behavior. Potential harms of FHx taking. One uncontrolled trial evaluated the impact of FHx-based breast cancer risk information on psychological outcomes and found no evidence of significant harm.

Conclusions: Our review indicates a very limited evidence base with which to address all four of the research questions: 1) the few evaluations of cancer risk prediction models do not suggest useful individual predictive accuracy; 2) the experimental evidence base for primary and secondary cancer prevention is very limited; 3) there is insufficient evidence to assess the effect of FHx-based risk assessment on preventive behaviors; 4) there

Background: Induction of labor is on the rise in the U.S., increasing from 9.5 percent in 1990 to 22.1 percent in 2004. Although, it is not entirely clear what proportion of these inductions are elective (i.e. without a medical indication), the overall rate of induction of labor is rising faster than the rate of pregnancy complications that would lead to a medically indicated induction. However, the maternal and neonatal effects of induction of labor are unclear. Many studies compare women with induction of labor to those in spontaneous labor. This is problematic, because at any point in the management of the woman with a term gestation, the clinician has the choice between induction of labor and expectant management, not spontaneous labor. Expectant management of the pregnancy involves nonintervention at any particular point in time and allowing the pregnancy to progress to a future gestational age. Thus, women undergoing expectant management may go into spontaneous labor or may require indicated induction of labor at a future gestational age.

Objectives: The Stanford-UCSF Evidence-Based Practice Center examined the evidence regarding four Key Questions: What evidence describes the maternal risks of elective induction versus expectant management? What evidence describes the fetal/neonatal risks of elective induction versus expectant management? What is the evidence that certain physical conditions/patient characteristics are predictive of a successful induction of labor? How is a failed induction defined?

Methods: We performed a systematic review to answer the Key Questions. We searched MEDLINE(1966-2007) and bibliographies of prior systematic reviews and the included studies for English language studies of maternal and fetal outcomes after elective induction of labor. We evaluated the quality of included studies. When possible, we synthesized study data using random effects models. We also evaluated the potential clinical outcomes and cost-effectiveness of elective induction of labor versus expectant management of pregnancy labor at 41, 40, and 39 weeks' gestation using decision-analytic models.

Results: Our searches identified 3,722 potentially relevant articles, of which 76 articles met inclusion criteria. Nine RCTs compared expectant management with elective induction of labor. We found that overall, expectant management of pregnancy was associated with an approximately 22 percent higher odds of cesarean delivery than elective induction of labor (OR 1.22, 95 percent CI 1.07-1.39; absolute risk difference 1.9, 95 percent CI: 0.2-3.7 percent). The majority of these studies were in women at or beyond 41 weeks of gestation (OR 1.21, 95 percent CI 1.01-1.46). In studies of women at or beyond 41 weeks of gestation, the evidence was rated as moderate because of the size and number of studies and consistency of the findings. Among women less than 41 weeks of ges

Objectives: This systematic review was undertaken to evaluate which complementary and alternative medicine (CAM) therapies are being used for persons with back pain in the United States.

Data sources: MEDLINE, CINHAHL, EMBASE, and Cochrane Central, and a variety of CAM specific databases were searched from 1990 to November 2007. A grey literature search was also undertaken, particularly for clinical practice guidelines (CPG) related to CAM.

Review methods: Standard systematic review methodology was employed. Eligibility criteria included English studies of adults with back pain, and a predefined list of CAM therapies.

Results: A total of 103 publications were evaluated; of these 29 did not present CAM therapy use stratified for back pain. There were a total of 65 utilization studies, 43 of which were American. Four publications evaluated the concurrent use of four or more CAM therapies and these suggest that chiropractic/manipulation is the most frequently used modality followed by massage and acupuncture. A limited number of publications evaluated utilization rates within multiple regions of the back and show that CAM was used least for treating the thoracic spine and most for the low back. However, rates of the use of massage were similar for neck and lower back regions. Concurrent use of different CAM or conventional therapies was not well reported. From 11 eligible CPG, only one (for electro-acupuncture) provided recommendations for frequency of use for low back pain of all acuity levels. Eighteen cost publications were reviewed and all but one publication (cost-effectiveness) were cost identification studies. There is limited information on the impact of insurance coverage on costs and utilization specific to back pain.

Conclusions: There are a few studies evaluating the relative utilization of various CAM therapies for back pain. For those studies evaluating utilization of individual CAM therapies, the specific characteristics of the therapy, the providers, and the clinical presentation of the back pain patients were not adequately detailed; nor was the overlap with other CAM or conventional treatments.

Context: The use of bariatric surgery for treating severe obesity has increased dramatically over the past 10 years; about half of patients who undergo these procedures are women of reproductive age. This report was commissioned to measure the incidence of bariatric surgery in this population and review the evidence on the impact of bariatric surgery on fertility and subsequent pregnancy.

Objectives: To measure the incidence of contemporary bariatric surgery procedures in women age 18-45 and to assess its impact on fertility, contraception, prepregnancy risk factors, and pregnancy outcomes, including those of neonates.

Data sources and study selection: Nationwide Inpatient Sample (NIS), a national sample of over 1,000 hospitals, to measure the trend in the number of women of reproductive age who underwent bariatric procedures from 1998-2005. We searched numerous electronic databases, including MEDLINE and Embase, for potentially relevant studies involving bariatric surgery (gastric bypass, laparoscopic adjustable gastric band, vertical-banded gastroplasty, biliopancreatic diversion), and consequent fertility, contraception, pregnancy, weight management, maternal and neonatal outcomes, and nutritional deficiencies. We scanned reference lists for additional relevant articles and contacted experts in the fields of bariatric surgery and obstetrics/gynecology (OB/GYN). Of 223 screened articles, we accepted 57 that reported on fertility following surgery (19 articles), contraception use/recommendations (11), maternal weight or nutrition management (28), maternal outcomes including morbidity and mortality (48), cesarean-section rates (16), and neonatal outcomes (44). These articles included reports on gastric bypass, both open and laparoscopic (27 articles), laparoscopic adjustable band (15), biliopancreatic diversion (16), and vertical-banded gastroplasty (6). Studies could contribute to one or more analyses. We found one case-control study and the observational data accepted included 12 cohort studies, 21 case series, and 23 individual case reports.

Data extraction: We abstracted information about study design, fertility history, fertility outcomes, prepregnancy weight loss, nutritional management, outcomes following pregnancy, and adverse events (during pregnancy) related to surgery.

Data synthesis: Nationally representative data showed a six-fold increase in bariatric surgery inpatient procedures from 1998 to 2005. Women age 18-45 accounted for about half of the patients undergoing bariatric surgery; over 50,000 have these procedures as inpatients annually. An unknown number have outpatient bariatric procedures. We identified one case-control study that directly addressed some of the key questions, but no randomized controlled trials or prospective cohort studies, which would be the strongest study designs to answer questions about effecti

Objectives: To describe models of integrated care used in the United States, assess how integration of mental health services into primary care settings or primary health care into specialty outpatient settings impacts patient outcomes and describe barriers to sustainable programs, use of health information technology (IT), and reimbursement structures of integrated care programs within the United States.

Data sources: MEDLINE, CINAHL, Cochrane databases, and PsychINFO databases, the internet, and expert consultants for relevant trials and other literature that does not traditionally appear in peer reviewed journals.

Review methods: Randomized controlled trials and high quality quasi-experimental design studies were reviewed for integrated care model design components. For trials of mental health services in primary care settings, levels of integration codes were constructed and assigned for provider integration, integrated processes of care, and their interaction. Forest plots of patient symptom severity, treatment response, and remission were constructed to examine associations between level of integration and outcomes.

Results: Integrated care programs have been tested for depression, anxiety, at-risk alcohol, and ADHD in primary care settings and for alcohol disorders and persons with severe mental illness in specialty care settings. Although most interventions in either setting are effective, there is no discernible effect of integration level, processes of care, or combination, on patient outcomes for mental health services in primary care settings. Organizational and financial barriers persist to successfully implement sustainable integrated care programs. Health IT remains a mostly undocumented but promising tool. No reimbursement system has been subjected to experiment; no evidence exists as to which reimbursement system may most effectively support integrated care. Case studies will add to our understanding of their implementation and sustainability.

Conclusions: In general, integrated care achieved positive outcomes. However, it is not possible to distinguish the effects of increased attention to mental health problems from the effects of specific strategies, evidenced by the lack of correlation between measures of integration or a systematic approach to care processes and the various outcomes. Efforts to implement integrated care will have to address financial barriers. There is a reasonably strong body of evidence to encourage integrated care, at least for depression. Encouragement can include removing obstacles, creating incentives, or mandating integrated care. Encouragement will likely differ between fee-for-service care and managed care. However, without evidence for a clearly superior model, there is legitimate reason to worry about premature orthodoxy.

Objectives: We reviewed the evidence on the barriers and drivers to the use of interactive consumer health information technology (health IT) by specific populations, namely the elderly, those with chronic conditions or disabilities, and the underserved.

Data sources: We searched MEDLINE, CINHAHL, PsycINFO the Cochrane Controlled Trials Register and Database of Systematic Reviews, ERIC, and the American Association of Retired Persons (AARP) AgeLine databases. We focused on literature 1990 to present.

Methods: We included studies of all designs that described the direct use of interactive consumer health IT by at least one of the populations of interest. We then assessed the quality and abstracted and summarized data from these studies with regard to the level of use, the usefulness and usability, the barriers and drivers of use, and the effectiveness of the interactive consumer health IT applications.

Results: We identified and reviewed 563 full-text articles and included 129 articles for abstraction. Few of the studies were specifically designed to compare the elderly, chronically ill, or underserved with the general population. We did find that several types of interactive consumer health IT were usable and effective in multiple settings and with all of our populations of interest. Of the studies that reported the impact of interactive consumer health IT on health outcomes, a consistent finding of our review was that these systems tended to have a positive effect when they provided a complete feedback loop that included: Monitoring of current patient status. Interpretation of this data in light of established, often individualized, treatment goals. Adjustment of the management plan as needed. Communication back to the patient with tailored recommendations or advice. Repetition of this cycle at appropriate intervals. Systems that provided only one or a subset of these functions were less consistently effective. The barriers and drivers to use were most often reported as secondary outcomes. Many studies were hampered by usability problems and unreliable technology, primarily due to the research being performed on early stage system prototypes. However, the most common factor influencing the successful use of the interactive technology by these specific populations was that the consumers' perceived a benefit from using the system. Convenience was an important factor. It was critical that data entry not be cumbersome and that the intervention fit into the user's daily routine. Usage was more successful if the intervention could be delivered on technology consumers used every day for other purposes. Finally, rapid and frequent interactions from a clinician improved use and user satisfaction.

Conclusions: The systems described in the studies we examined depended on the active engagement of consumers and patients and the involvement of healt

Objectives: Systematic review of trastuzumab outcomes among breast cancer patients who have negative, equivocal, or discordant HER2 assay results; use of HER2 assay results to predict outcomes of chemotherapy or hormonal therapy regimen for breast cancer; use of serum HER2 to monitor treatment response or disease progression in breast cancer patients; and use of HER2 testing to manage patients with lung, ovarian, prostate, or head and neck tumors. Also, narrative review of concordance of HER2 assays.

Data sources: We abstracted data from: three articles plus one conference abstract on negative, equivocal, or discordant HER2 results; 26 studies on selection of chemotherapy or hormonal therapy; 15 studies on serum HER2; and 26 studies on ovarian, lung, prostate, or head and neck tumors. Foreign-language studies were included.

Review methods: We sought randomized trials or single-arm series (prospective or retrospective) of identically treated patients that presented relevant outcome data associated with HER2 status.

Results: HER2 assay results are influenced by multiple biologic, technical, and performance factors. Many aspects of HER2 assays were standardized only recently, so inconsistencies confound the literature comparing different methods. The evidence is weak on outcomes of trastuzumab added to chemotherapy for HER2-equivocal, -discordant, or -negative patients. Evidence comparing chemotherapy outcomes in HER2-positive and HER2-negative patient subgroups may generate hypotheses, but is too weak to test hypotheses. Only a rigorous test can resolve whether HER2-positive patients (but not HER2-negative patients) benefit from an anthracycline regimen. Evidence is available only from uncontrolled series on whether HER2 status predicts complete pathologic response to neoadjuvant chemotherapy. Evidence also is weak regarding differences by HER2 status for outcomes of chemotherapy for advanced or metastatic disease; with most studies lacking statistical power. Data from studies of tamoxifen and aromatase inhibitors suggest that future studies should examine whether HER2 status predicts response to specific hormonal therapies among estrogen-receptor-positive patients. The evidence is weak on whether serum HER2 predicts outcome after treatment with any regimens in any setting, as is the evidence on use of serum or tissue HER2 testing for malignancies of lung, ovary, head and neck, or prostate.

Conclusions: Overall, few studies directly investigated the key questions of this systematic review. Going forward, cancer therapy trial protocols should incorporate elements to facilitate robust analyses of the use of HER2 status and other biomarkers for managing treatment.

Objectives: Synthesize evidence of the natural history of chronic hepatitis B (CHB) and effects and harms of antiviral drugs on clinical, virological, histological, and biochemical outcomes.

Data sources: MEDLINE, electronic databases, and manual searches of systematic reviews.

Review methods: We included original observational studies to assess natural history and randomized controlled trials (RCTs) of adults with CHB published in English to assess treatment effects and harms if they reported mortality, incidence of hepato-cellular carcinoma (HCC), cirrhosis or failure, HBeAg or HBsAg, viral load (HBV DNA), alanine aminotransferase (ALT) levels, histological necroinflammatory and fibrosis scores, and adverse events after interferon alfa-2b, pegylated interferon alfa 2-a, lamivudine, adefovir, entecavir, tenovir or telbivudine. We excluded pregnant women, transplant patients, and individuals undergoing cancer chemotherapy. We calculated relative risk or absolute risk differences at end of treatment and post-treatment.

Results: Observational studies (41 publications) suggested that male gender, coinfection with hepatitis C, D, or HIV, increased HBV DNA, and cirrhosis were associated with increased risk of HCC and death. Drugs did not reduce death, liver failure, or HCC in 16 RCTs not designed to test long-term clinical outcomes. Evidence from 93 publications of 60 RCTs suggested drug effects on viral load or replication, liver enzymes, and histology at end of treatment and lasting from 3 to 6 months off treatment. No one treatment improved all outcomes and there was limited evidence on comparative effects. Two RCTs suggested interferon alfa-2b increased CHB solution versus placebo. Interferon alfa-2b or lamivudine improved off treatment HBV DNA and HBeAg clearance and seroconversion and ALT normalization. Adefovir improved off treatment ALT normalization and HBV DNA clearance. Pegylated interferon alfa 2-a versus lamivudine improved off-treatment HBV DNA and HBeAg clearance and seroconversion, ALT normalization and liver histology. Lamivudine combined with interferon alfa-2b versus lamivudine improved off treatment HBV DNA clearance and HBeAg seroconversion and reduced HBV DNA mutations. Pegylated interferon alfa 2-a plus lamivudine improved off treatment HBV DNA and HBeAg clearance and seroconversion and ALT normalization compared to lamivudine but not pegylated interferon alfa 2-a monotherapy. Adverse events were common but generally mild and did not result in increased treatment discontinuation. Longer hepatitis duration, male gender, baseline viral load and genotype, HBeAg, and histological status may modify treatment effect on intermediate outcomes. Adefovir and pegylated interferon alfa 2-a with lamivudine improved off treatment viral clearance in HBeAg negative patients. There was insufficient evidence to determine if biochemical, viral, or histological

Objectives: To examine available behavioral, pharmacological, and surgical weight management interventions for overweight (defined as BMI > 85th to 94th percentile of age and sex-specific norms) and/or obese (BMI > 95th percentile) children and adolescents in clinical and nonclinical community settings.

Data sources: We identified two good quality recent systematic reviews that addressed our research questions. We searched Ovid MEDLINE, PsycINFO, Database of Abstracts of Reviews of Effects, the Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Education Resources Information Center from 2005 (2003 for pharmacological studies) to December 11, 2007, to identify literature that was published after the search dates of prior relevant systematic reviews; we also examined reference lists of five other good-quality systematic reviews and of included trials, and considered experts' recommendations. We identified two good quality systematic reviews and 2,355 abstracts from which we identified 45 primary studies and trials that addressed our research questions.

Review methods: After review by two investigators against pre-determined inclusion/exclusion criteria, we included existing good-quality systematic reviews, fair-to-good quality trials, and case series (for bariatric surgeries only) to evaluate the effects of treatment on weight and weight-related co-morbidities; we would have included large comparative cohort studies to evaluate longer term followup and harms of behavioral and pharmaceutical treatment and noncomparative cohort studies for surgical treatments if they had been available. Investigators abstracted data into standard evidence tables with abstraction checked by a second investigator. Studies were quality-rated by two investigators using established criteria.

Results: Available research primarily enrolled obese (but not overweight) children and adolescents aged 5 to 18 years and no studies targeted those less than 5 years of age. Behavioral interventions in schools or specialty health care settings can result in small to moderate short-term improvements. Absolute or relative weight change associated with behavioral interventions in these settings is generally modest and varies by treatment intensity and setting. More limited evidence suggests that these improvements can be maintained completely (or somewhat) over the 12 months following the end of treatments and that there are few harms with behavioral interventions. Two medications (sibutramine, orlistat) combined with behavioral interventions can result in small to moderate short-term weight loss in obese adolescents with potential side effects that range in severity. Among highly selected morbidly obese adolescents, very limited data from case series suggest bariatric surgical interventions can lead to moderate to substantial weight loss in the short term a