Evidence report/technology assessment最新文献

Objectives: We reviewed the evidence regarding the outcomes of interventions used in ovulation induction, superovulation, and in vitro fertilization (IVF) for the treatment of infertility. Short-term outcomes included pregnancy, live birth, multiple gestation, and complications. Long-term outcomes included pregnancy and post-pregnancy complications for both mothers and infants.

Data sources: MEDLINE and Cochrane Collaboration resources.

Review methods: We included studies published in English from January 2000 through January 2008. For short-term outcomes, we excluded non-randomized studies and studies where a pregnancy or live birth rate per subject could not be calculated. For long-term outcomes, we excluded studies with fewer than 100 subjects and those without a control group. Articles were abstracted for relevant details, and relative risks or odds ratios, with 95 percent confidence intervals, were calculated for outcomes of interest for each study.

Results: We identified 5294 abstracts and (for the three questions discussed in this draft report) reviewed 1210 full-text articles and included 478 articles for abstraction. Approximately 80 percent of the included studies were performed outside the United States. The majority of randomized trials were not designed to detect differences in pregnancy and live birth rates; reporting of delivery rates and obstetric outcomes was unusual. Most did not have sufficient power to detect clinically meaningful differences in live birth rates, and had still lower power to detect differences in less frequent outcomes such as multiple births and complications. Interventions for which there was sufficient evidence to demonstrate improved pregnancy or live birth rates included: (a) administration of clomiphene citrate in women with polycystic ovarian syndrome, (b) metformin plus clomiphene in women who fail to respond to clomiphene alone; (c) ultrasound-guided embryo transfer, and transfer on day 5 post-fertilization, in couples with a good prognosis; and (d) assisted hatching in couples with previous IVF failure. There was insufficient evidence regarding other interventions. Infertility itself is associated with most of the adverse longer-term outcomes. Consistently, infants born after infertility treatments are at risk for complications associated with abnormal implantation or placentation; the degree to which this is due to the underlying infertility, treatment, or both is unclear. Infertility, but not infertility treatment, is associated with an increased risk of breast and ovarian cancer.

Conclusions: Despite the large emotional and economic burden resulting from infertility, there is relatively little high-quality evidence to support the choice of specific interventions. Removing barriers to conducting appropriately designed studies should be a major policy goal.

Objectives: The RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically reviewed evidence on outcomes of gestational weight gain and their confounders and effect modifiers, outcomes of weight gain within or outside the 1990 Institute of Medicine (IOM) guidelines, risks and benefits of weight gain recommendations, and anthropometric measures of weight gain.

Data sources: We searched MEDLINE Cochrane Collaboration resources, Cumulative Index to Nursing & Allied Health Literature, and Embase.

Review methods: We included studies published in English from 1990 through October 2007. We excluded studies with low sample size (based on study design: case series <100 subjects and cohorts <40 subjects).

Results: Overall, strong evidence supported an association between gestational weight gains and the following outcomes: preterm birth, total birthweight, low birthweight (<2,500 g), macrosomia, large-for-gestational-age (LGA) infants, and small-for-gestational-age (SGA) infants; moderate evidence supported an association for cesarean delivery and intermediate-term weight retention (3 months to 3 years postpartum). The studies reviewed provided strong evidence for the independent association of pregravid weight status and outcomes, moderate evidence for age and parity, and weak evidence for race. Regarding outcomes of weight gain within or outside 1990 IOM guidelines, moderate to strong evidence suggests an association between weight gain below IOM recommendations and preterm birth, low birthweight, SGA birthweights, and failure to initiate breastfeeding, and strong evidence for the association between weight gain above IOM recommendations and high birthweight, macrosomia, and LGA birthweights. Moderate evidence supports an association between weight gain above IOM guidelines and cesarean delivery and postpartum weight retention in the short, intermediate, and long term. Included research is inadequate for objective assessments of the range of harms and benefits of providing all women, irrespective of age, race or ethnicity, or pregravid body mass index (BMI), with the same recommendation for weight gain in pregnancy.

Conclusions: Gestational weight gain is associated with some infant and maternal outcomes. One weight gain recommendation for all women is not supported by the evidence identified in this review. To understand fully the impact of gestational weight gain on short- and long-term outcomes for women and their offspring will require that researchers use consistent definitions of weight gain during pregnancy, better address confounders in their analyses, improve study designs and statistical models, and conduct studies with longer followup.

Objectives: To determine the effectiveness of diabetes education on metabolic control, diabetes-related hospitalizations, complications, and knowledge, quality of life and other psychosocial outcomes for children with type 1 diabetes and their families.

Data sources: A systematic and comprehensive literature review was conducted in 21 electronic databases of medical and health education literature to identify randomized controlled trials (RCTs) and observational studies evaluating the effectiveness of diabetes education.

Review methods: Study selection, quality assessment, and data extraction were conducted independently by several investigators in duplicate. A descriptive analysis is presented.

Results: From 12,756 citations, 80 studies were identified and included in the review (53 RCTs or CCTs, 27 observational studies). The methodological quality of studies was generally low. Most studies (35/52) that examined the effect of educational interventions on HbA1c found no evidence of increased effectiveness of the interventions over the education provided as part of standard care. Successful interventions were heterogeneous and included cognitive behavioral therapy, family therapy, skills training and general diabetes education. Most studies reported a positive effect on health service utilization (i.e., reduced use), although less than half were statistically significant. There was no clear evidence that educational interventions had an effect on short-term complications. The effect of educational interventions on diabetes knowledge was unclear with 12/30 studies reporting a significant improvement. Interventions which had varying effects on knowledge scores included diabetes camp, general diabetes education, and cognitive behavioral therapy. In the area of self management/regimen adherence, 10/21 studies reported improving this outcome significantly. Successful interventions included general diabetes education and cognitive behavioral therapy. Educational interventions were successful in improving various psychosocial outcomes. The results of two studies examining refinements to intensive therapy education suggest that educational interventions may enhance the effects of intensive diabetes management in reducing HbA1c. CONCLUSIONS Due to the heterogeneity of reported diabetes education interventions, outcome measures, and duration of followup, there is insufficient evidence to identify a particular intervention that is more effective than standard care to improve diabetes control or quality of life or to reduce short-term complications.

Objectives: We focused on four questions: What are the risks and benefits of an oral diabetes agent (i.e., glyburide), as compared to all types of insulin, for gestational diabetes? What is the evidence that elective labor induction, cesarean delivery, or timing of induction is associated with benefits or harm to the mother and neonate? What risk factors are associated with the development of type 2 diabetes after gestational diabetes? What are the performance characteristics of diagnostic tests for type 2 diabetes in women with gestational diabetes?

Data sources: We searched electronic databases for studies published through January 2007. Additional articles were identified by searching the table of contents of 13 journals for relevant citations from August 2006 to January 2007 and reviewing the references in eligible articles and selected review articles.

Review methods: Paired investigators reviewed abstracts and full articles. We included studies that were written in English, reported on human subjects, contained original data, and evaluated women with appropriately diagnosed gestational diabetes. Paired reviewers performed serial abstraction of data from each eligible study. Study quality was assessed independently by each reviewer.

Results: The search identified 45 relevant articles. The evidence indicated that: Maternal glucose levels do not differ substantially in those treated with insulin versus insulin analogues or oral agents. Average infant birth weight may be lower in mothers treated with insulin than with glyburide. Induction at 38 weeks may reduce the macrosomia rate, with no increase in cesarean delivery rates. Anthropometric measures, fasting blood glucose (FBG), and 2-hour glucose value are the strongest risk factors associated with development of type 2 diabetes. FBG had high specificity, but variable sensitivity, when compared to the 75-gm oral glucose tolerance test (OGTT) in the diagnosis of type 2 diabetes after delivery.

Conclusions: The evidence suggests that benefits and a low likelihood of harm are associated with the treatment of gestational diabetes with an oral diabetes agent or insulin. The effect of induction or elective cesarean on outcomes is unclear. The evidence is consistent that anthropometry identifies women at risk of developing subsequent type 2 diabetes; however, no evidence suggested the FBG out-performs the 75-gm OGTT in diagnosing type 2 diabetes after delivery.

Objectives: To synthesize the published literature on the efficacy, effectiveness, and toxicity of hydroxyurea (HU) when used for treatment of sickle cell disease (SCD); and to review the evidence regarding barriers to its use.

Data sources: Articles cited in MEDLlNE, EMBASE, TOXLine, and CINAHL through June 30, 2007.

Review methods: Paired reviewers reviewed each title, abstract, and article to assess eligibility. They abstracted data sequentially and then independently graded the evidence.

Results: In one small, randomized trial of HU in children with SCD; the yearly hospitalization rate was lower with HU than placebo (1.1 versus 2.8, p=0.002). The absolute increase in fetal hemoglobin (Hb F%) was 10.7 percent. Twenty observational studies of HU in children reported similar increases in Hb F%, while hemoglobin concentration increased by roughly 1 g/dl. One large randomized trial tested the efficacy of HU in adults with SCD and found that after 2 years of treatment, Hb F% increased by 3.2 percent and hemoglobin increased by 0.6 g/dl, The median number of painful crises was 44 percent (p<0.001) lower among patients treated with HU. The 12 observational studies of HU enrolling adults with SCD supported these findings. Panelists from the Center for the Evaluation of Risks to Human Reproduction reviewed the literature for potential toxicities of HU. They concluded that HU does not cause a growth delay in children 5-15 years old. There were no data on the effects on subsequent generations following exposure of developing germ cells to HU in utero. Some evidence supported impaired spermatogenesis with use of HU. Although we identified six patients taking HU who developed leukemia, the evidence did not support causality. Similarly, the evidence suggested no association between HU and leg ulcers in patients with SCD, although there was in patients with other illnesses. The literature supported neutropenia, skin rashes and nail changes associated with use of HU, but was sparse regarding skin neoplasms or other secondary malignancies in SCD. Only two studies investigated barriers to use of HU. Perceived efficacy and perceived safety of HU had the largest influence on patients' (or parents' ) choice to use HU. Providers reported barriers to be patient concerns about side effects; and their own concerns about HU in older patients, patient compliance, lack of contraception, side effects and carcinogenic potential, doubts about effectiveness, and concern about costs.

Conclusions: HU is efficacious in children and adults with SCD; with an increase in Hb F%, and reduction in hospitalizations and pain crises. However, few studies have measured the effectiveness of HU for SCD in usual practice. The paucity of long-term studies limits conclusions about toxicities and about mortality. Future studies of interventions to overcome the barriers to use of HU i

Objectives: To investigate whether monitoring concentrations of mycophenolic acid (MPA) in the serum or plasma of persons who receive a solid organ transplant will result in a lower incidence of transplant rejections and adverse events versus no monitoring of MPA. To investigate whether the incidence of rejection or adverse events differs according to MPA dose or frequency, type of MPA, the form of MPA monitored, the method of MPA monitoring, or sample characteristics. To assess whether monitoring is cost-effective versus no monitoring.

Data sources: The following databases were searched from their dates of inception (in brackets) until October 2007: MEDLINE (1966); BIOSIS Previews (1976); EMBASE (1980); Cochrane Database of Systematic Reviews (1995); and Cochrane Central Register of Controlled Trials (1995).

Review methods: Studies identified from the data sources went through two levels of screening (i.e., title and abstract, full text) and the ones that passed were abstracted. Criteria for abstraction included publication in the English language, study design (i.e., randomized controlled trial [RCT], observational study with comparison group, case series), and patient receipt of allograft solid organ transplant. Additionally, any form of MPA had to be measured at least once in the plasma or serum using any method of measurement (e.g., AUC0-12, C0). Furthermore, these measures had to be linked to a health outcome (e.g., transplant rejection). Certain biomarkers (e.g., serum creatinine, glomular filtration rate) and all adverse events were also considered health outcomes.

Results: The published evidence on MPA monitoring is inconclusive. Direct, head-to-head comparison of monitoring versus no monitoring is limited to one RCT in adult, kidney transplant patients. Inferences about monitoring can be made from some observational studies, although the evidence is equivocal for MPA dose and dose frequency, nonexistent for type of MPA, inconclusive for form of MPA monitored or method of monitoring, and nonexistent for cost-effectiveness. Some studies suggest gender and concomitant use of calcineurin inhibitors will affect pharmacokinetic parameters, but the impact of these findings has not been assessed in relation to monitoring versus no monitoring.

Conclusions: The state of knowledge about therapeutic drug monitoring of MPA in solid organ transplants is still in its infancy. Until there is more evidence on the utility of routine MPA monitoring in solid organ transplant recipients, patients, clinicians, and other stakeholders (e.g., public and private insurers) will have to decide on a case by case basis whether the possible but uncertain benefits are worth the extra time and expense of monitoring.

Objectives: To assess the prevalence of carbohydrate and lipid disorders in adults with chronic spinal cord injury and evaluate their risk contribution to cardiovascular diseases and the potential impact of exercise and pharmacologic and dietary therapies to alter these disorders and reduce cardiovascular disease risk.

Data sources: MEDLINE (PubMed), Cochrane Database and Web sites of the American Spinal Injury Association, American Paraplegia Society, Paralyzed Veterans of America, Consortium of Spinal Cord Medicine, and WorldCat through August 2007.

Review methods: English language observational studies addressing prevalence of carbohydrate and lipid disorders were included if they evaluated at least 100 adults with chronic spinal cord injury or a total of 100 subjects if using a control group. Epidemiologic investigations of more than 50 adults with spinal cord injury that were published in English after 1990 and reported cardiovascular morbidity and mortality were abstracted. Intervention studies from 1996-2007 were included regardless of design or size if they assessed exercise, diet, or pharmacologic therapies and reported carbohydrate, lipid, or cardiovascular outcomes.

Results: The quality of evidence regarding the prevalence, impact, and outcomes of carbohydrate and lipid disorders in adults with chronic spinal cord injuries is weak. Evidence is limited by relatively few studies, small sample size, lack of appropriate control groups, failure to adjust for known confounding variables, and variation in reported outcomes. However, the existing evidence does not indicate that adults with spinal cord injuries are at markedly greater risk for carbohydrate and lipid disorders or subsequent cardiovascular morbidity and mortality than able-bodied adults. Body mass index is not reliable for assessing body composition, especially percent body fat, in adults with spinal cord injury. There are no high quality studies evaluating the impact of exercise, diet, or pharmacologic therapies on these disorders.

Conclusions: The available evidence does not support incorporating SCI status as an independent variable to assess risk of cardiovascular morbidity and mortality or to alter diagnostic/treatment thresholds compared to able-bodied adults. Furthermore, individuals with SCI may have unique physiologic differences compared to able-bodied individuals. As a result, it is uncertain that findings from studies conducted in able-bodied adults evaluating efficacy and harms of interventions to improve carbohydrate, lipid disorders, and subsequent CVD can be extrapolated to individuals with SCI. The role of exercise in individuals with spinal cord injuries represents a unique challenge and requires further exploration into the benefits, harms, and resource implications of broad-based spinal cord injury exercise programs.

Objectives: To assess the prevalence of and risk factors for urinary (UI) and fecal (FI) incontinence in adults in long-term care (LTC) settings and in the community, the effectiveness of diagnostic methods to identify adults at risk and patients with incontinence, and to review the effectiveness of clinical interventions to reduce the risk of incontinence.

Data sources: MEDLINE (PubMed), CINAHL, and Cochrane Databases.

Review methods: Observational studies were reviewed to examine the prevalence and incidence of UI and FI and the association with risk factors. The effects of treatments on patient outcomes were analyzed from randomized controlled and multicenter clinical trials. The diagnostic values of the tests were compared from the original epidemiologic studies of different designs. Of the 6,097 articles identified, 1,077 articles were eligible for analysis.

Results: The prevalence of UI, FI, and combined incontinence increased with age and functional dependency. Cognitive impairment, limitations in daily activities, and prolonged institutionalization in nursing homes were associated with a higher risk of incontinence. Stroke, diabetes, obesity, poor general health, and comorbidities were associated with UI and FI in community dwelling adults. Parity, anal trauma, and vaginal prolapse in women and urological surgery and radiation for prostate cancer in men are risk factors for UI and FI. Intensive individualized management and rehabilitation programs improved continence status in nursing home residents and adults after stroke. Self-administered behavioral interventions including pelvic floor muscle training with biofeedback and bladder training resolved UI in incontinent women. Electrical stimulation and sacral neuromodulation improved urge UI, but improvement for FI was inconsistent. Tension-free vaginal tape procedures and modified surgical techniques for prolapse to support the bladder neck resolved stress UI in the majority of treated women. Behavioral treatments of FI resulted in small improvements in severity and quality of life related to incontinence. The effects on FI of surgical techniques for hemorrhoids, rectal prolapse, rectal cancer, and anal fissures are not consistent across studies. Surgical interventions in patients with ulcerative colitis resulted in the same rates of fecal continence when compared to each other. The few clinical interventions to treat FI that were tested in well-designed trials had no clear evidence of better effects of the compared treatments. Instrumental outcomes to evaluate the effectiveness of treatments did not correlate with patient outcomes. Epidemiologic surveys to detect persons at risk and patients with undiagnosed UI have the same diagnostic value and less cost compared to professional examinations and diagnostic tests. Self-reported questionnaires and scales have unsatisfactory validity to diagnose FI.