OBJECTIVES:This is a systematic review of evidence on issues in managing small cell lung cancer (SCLC). Key questions addressed are: the sequence, timing, and dosing characteristics of primary thoracic radiotherapy (TRTx) for limited-stage disease; primary TRTx for extensive-stage disease; effect of prophylactic cranial irradiation (PCI); positron emission tomography (PET) for staging; treatment of mixed histology tumors; surgery; and second- and subsequent-line treatment for relapsed/progressive disease.DATA SOURCES:MEDLINE, EMBASE, and the Cochrane RegisterREVIEW METHODS:The review methods were defined prospectively in a written protocol. We sought randomized controlled trials that compared the interventions of interest. Where randomized trials were limited or nonexistent, we sought additional studies. We performed meta-analysis of studies that compared early and late TRTx.RESULTS:The strongest evidence available for this report is a patient-level meta-analysis showing that PCI improves survival of SCLC patients who achieved complete response following primary therapy from 15.3 percent to 20.7 percent (p=0.01). No other question yielded evidence so robust. The case for concurrent over sequential radiation delivery rests largely on a single multicenter trial. Support for early concurrent therapy comes from one multicenter trial, but two other multicenter trials found no advantage. Our meta-analysis did not find significant reductions in 2- and 3-year mortality for early TRTx. Favorable results from a single-center trial on TRTx for extensive stage disease need replication in a multicenter setting. For other questions (i.e., management of mixed histology disease; surgery for early limited SCLC), relevant comparative studies were nonexistent. PET may be more sensitive in detecting disease outside the brain than conventional staging modalities, but studies were of poor quality and reliable estimates of performance are not possible.CONCLUSIONS:PCI improves survival among those with a complete response to primary therapy. A research agenda is needed to optimize the effectiveness of TRTx and its components. PET for staging may be useful, but its role awaits clarification by rigorous studies. No relevant evidence was available to address management of mixed histology disease or surgery for early limited SCLC.
OBJECTIVES To assess the evidence for using heparin in the treatment of burn injury or the complications of burn injury in adults and children. DATA SOURCES The following databases were searched: MEDLINE (1966-current), EMBASE (1980-current), Cumulative Index to Nursing & Allied Health (CINAHL) (1982-current), The Cochrane Central Database of Controlled Trials (1995-current), Web of Science (1976-current), and BIOSIS (1976-current). Additional data sources included the U.S. and European Patent Offices, technical experts, the partner organization, and reference lists. REVIEW METHODS Studies identified from the data sources went through two levels of title and abstract screening. Passing studies advanced to full text screening. Studies that met the full text screening criteria were abstracted. Criteria for abstraction included publication in any language, human patients of any age, and burns of any type, grade, or total body surface area. All formulations of heparin, and all application methods (e.g., topical, subcutaneous), were eligible for inclusion in the report. Abstracted studies required a comparison group. Outcomes of interest included mortality, pain, length of stay in hospital, thrombosis and emboli, psychiatric adjustment, and adverse effects (e.g., bleeding). RESULTS Nineteen articles from 18 unique studies were abstracted and included in this report. In these articles, there were multiple uses of heparin to treat burns (e.g., wound healing, inhalation injury, sepsis, pain). However, the overall quality of the articles was weak. Examples of weakness included unclear or inappropriate treatment allocation, no blinding, no control of confounding, poorly defined burn characteristics (e.g., thickness), unclear duration of treatment, incomplete description of heparin treatment, and use of inadequately described or invalid outcome measures. Overall, the evidence from these weak articles was insufficient to determine whether the effectiveness of heparin to treat burn injury was different from the effectiveness of other treatments, or whether treatment effectiveness varied according to (a) the method of applying heparin to (b) burn etiology. Four studies mentioned contraindications to using heparin to treat burns. These contraindications were bleeding diathesis, bleeding history, active bleeding or associated trauma with potential bleeding, active intestinal ulcer, thrombocytopenia, liver disease, renal disorders, or allergy to heparin. CONCLUSIONS There is no strong evidence in the 19 abstracted articles to suggest that heparin should be used in the treatment of burn injury on account of its non-anticoagulant properties.
OBJECTIVES To identify measures that are currently available to assess the quality of care provided to patients with colorectal cancer (CRC), and to assess the extent to which these measures have been developed and tested. DATA SOURCES Published and unpublished measures identified through a computerized search of English-language citations in MEDLINE (1966-January 2005), the Cochrane Database of Systematic Reviews, and the National Guideline Clearinghouse; through review of reference lists contained in seed articles, all included articles, and relevant review articles; and through searches of the grey literature (institutional or government reports, professional society documents, research papers, and other literature, in print or electronic format, not controlled by commercial publishing interests). Sources for grey literature included professional organization websites and the Internet. REVIEW METHODS Measures were selected by reviewers according to standardized criteria relating to each question, and were then rated according to their importance and usability, scientific acceptability, and extent of testing; each domain was rated from 1 (poor) to 5 (ideal). RESULTS We identified a number of well-developed and well-tested CRC-related quality-of-care measures, both general process-of-care measures (on a broader scale) and technical measures (pertaining to specific details of a procedure). At least some process measures are available for diagnostic imaging, staging, surgical therapy, adjuvant chemotherapy, adjuvant radiation therapy, and colonoscopic surveillance. Various technical measures were identified for quality of colonoscopy (e.g., cecal intubation rate, complications) and staging (adequate lymph node retrieval and evaluation). These technical measures were guideline-based and well developed, but less well tested, and the linkage between them and patient outcomes, although intuitive, was not always explicitly provided. For some elements of the care pathway, such as operative reports and chemotherapy reports, no technical measures were found. CONCLUSIONS Some general process measures have a stronger evidence base than others. Those based on guidelines have the strongest evidence base; those derived from basic first principles supported by some research findings are relatively weaker, but are often sufficient for the task at hand. A consistent source of tension is the distinction between the clinically derived fine-tuning of the definition of a quality measure and the limitations of available data sources (which often do not contain sufficient information to act on such distinctions). Although some excellent technical measures were found, the overall development of technical measures seems less advanced than that of the general process measures.
OBJECTIVES:The objectives of this report are to determine the following: (1) the effectiveness of the toilet training methods, (2) which factors modify the effectiveness of toilet training, (3) if the toilet training methods are risk factor for adverse outcomes, and (4) the optimal toilet training method for achieving bowel and bladder control among patients with special needs.DATA SOURCES:MEDLINE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid OLDMEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, PsycINFO, ERIC, EBM Reviews, HealthSTAR, AMED, Web of Science, Biological Abstracts, Sociological Abstracts, OCLC ProceedingsFirst, OCLC PapersFirst, Dissertation Abstracts, Index to Theses, National Research Register's Projects Database, and trials registers.REVIEW METHODS:Two reviewers assessed the studies for inclusion. Studies were included if they met the following criteria:STUDY DESIGN:RCT, CCT, prospective or retrospective cohort, case-control, cross-sectional or case-series;POPULATION:infants, toddlers, or children with or without co-morbidities, neuromuscular, cognitive, or behavioral handicaps disabilities;INTERVENTION:at least one toilet training method; andOUTCOME:bladder and/or bowel control, successes, failures, adverse outcomes. Methodological quality was assessed independently by two reviewers. Data were extracted by one reviewer and a second checked for accuracy and completeness. Due to substantial heterogeneity, meta-analysis was not possible.RESULTS:Twenty-six observational studies and eight controlled trials were included. Approximately half of the studies examined healthy children while the remaining studies assessed toilet training of mentally or physically handicapped children. For healthy children, the Azrin and Foxx method performed better than the Spock method, while child-oriented combined with negative term avoidance proved better than without. For mentally handicapped children, individual training was superior to group methods; relaxation techniques proved more efficacious than standard methods; operant conditioning was better than conventional treatment, and the Azrin and Foxx and a behavior modification method fared better than no training. The child-oriented approach was not assessed among mentally handicapped children. For children with Hirschsprung's disease or anal atresia, a multi-disciplinary behavior treatment was more efficacious than no treatment.CONCLUSIONS:Both the Azrin and Foxx method and the child-oriented approach resulted in quick, successful toilet training, but there was limited information about the sustainability of the training. The two methods were not directly compared, thus it is difficult to draw definitive conclusions regarding the superiority of one method over the other. In general, both programs may be used to teach toilet training to healthy children. The Azrin and Foxx method and operant conditioning methods were consistently effective for toilet training mentally handicapped children. Programs that were adapted to physically handicapped children also resulted in successful toilet training. A lack of data precluded conclusions regarding the development of adverse outcomes.
The aims of this evidence report are to summarize the current evidence on the health effects of soy and its isoflavones on the following: cardiovascular diseases, menopausal symptoms, endocrine function, cancer, bone health, reproductive health, kidney diseases, cognitive function, and glucose metabolism. In addition, safety issues and drug interactions of using soy and its isoflavones, as reported in the literature, are summarized. This report also summarizes the formulations of soy products and/or soy food used in clinical trials. The report was requested and funded by the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements at the National Institutes of Health (NIH) and was conducted through the Evidence-based Practice Center (EPC) program at the Agency for Healthcare Research and Quality (AHRQ).
Stroke defines an acute vascular event in the brain and is a leading cause of death and disability. Ischemic stroke results from decreased blood flow to a portion of the brain with consequent cell death. Hemorrhagic stroke, on the other hand, is a result of bleeding into the brain. Ischemic stroke is far more common and is potentially treatable with thrombolytic therapy. While effective, the wide application of this therapy has been hampered by restrictive selection criteria based on time since onset of symptoms. Successful treatment requires a system capable of rapidly identifying and evaluating prospective candidates. In this context, use of community education, specific ED protocols and designated treatment centers may demonstrate some advantages. Evidence is emerging that patient selection by time since stroke onset, imaging characteristics, and intra-arterial treatment may increase the probability of recanalisation of occluded vessels. Normalization of serum glucose, acute blood pressure management and surgical extraction of intracerebral clot may be of benefit in some circumstances.
Chronic Obstructive Pulmonary Disease (COPD) is manifested by chronic cough, sputum production, wheezing and, in later stages, dyspnea, poor exercise tolerance, and signs/symptoms of right-sided heart failure. Symptomatic COPD affects more than 5 percent of the adult population, is the fourth leading cause of death, and the twelfth leading cause of morbidity in the United States. In more than 80 percent of cases, cigarette smoking is causally linked to the development of COPD. Smoking status should be assessed in all adults, and smokers should be advised to abstain from tobacco.
Authors' objectives The purpose of this study was to conduct a systematic review of the scientific medical literature to identify, appraise and synthesize the evidence of omega-3 fatty acids in child and maternal health. Evidence was sought to investigate a series of questions regarding the influence of the omega-3 fatty acid intake (supplemented during pregnancy) on the duration of gestation, incidence of preeclampsia, eclapmsia or gestational hypertension (GHT), and incidence of infants small for gestational age (SGA), as well as the association between the maternal biomarkers during pregnancy and the pregnancy outcomes outlined above. The influence of the omega-3 fatty acid intake (supplemented or breast milk) on the developmental outcomes in preterm and term infants, such was growth, neurocognitive development and visual function, were also investigated, as well as the association between the maternal, fetal or childs biomarkers and these clinical outcomes. The impact of effect modifiers was also examined, as well as the safety profile. The results will be used to inform a research agenda.
Insomnia, or inability to sleep, is the most commonly reported sleep problem in the industrialized world. Estimates suggest that between 40 and 70 million Americans are affected by either intermittent or chronic sleep problems, representing approximately 20 percent of the population. The Sleep in America Poll, conducted by the National Sleep Foundation, revealed that almost 50 percent of people surveyed had complaints of frequent insomnia, but only 6 percent were formally diagnosed. Moreover, approximately, 30 to 35 percent of respondents complained of nightly insomnia. The most prevalent symptoms of insomnia, experienced at least a few nights a week by people with insomnia, include waking up feeling unrefreshed (34 percent) and being awake often during the night (32 percent). The symptoms of difficulty falling asleep and waking up too early are less common, but still experienced at least a few nights a week by about one-fourth of adults with insomnia (23 to 24 percent).
The burden of cancer falls disproportionately upon the medically underserved, and research studies are essential to improving health care in general, including for medically underserved populations. Clinical trials are used to evaluate efficacious prevention and treatment interventions; however, studies often fail to recruit the planned number of participants. Trials often do not include an adequately diverse population to ensure broad generalizability of results. Recent studies of patients enrolled in cancer treatment trials sponsored by the National Cancer Institute (NCI) have demonstrated that the following populations are underrepresented in terms of their participation in cancer treatment trials: the elderly, those of low socio-economic status, those living in rural areas and Latino/Hispanic, Asian /Pacific Islander and American Indian/Alaska native men and women, as well as AfricanAmerican men. Since the 1980s cancer prevention trials have been conducted with participants at highest risk for disease to reduce the cancer burden, and as in treatment trials, adequate representation of underserved populations in prevention trials is desirable. Questions remain regarding the appropriate level of inclusion, i.e., whether it might depend on the prevalence of the condition/disease studied in the overall population. This issue has not been addressed adequately in the literature. Moreover, there is substantial uncertainty about what are important barriers and promoters of recruitment of underrepresented populations, and what evidence-based interventions would address them. At the request of and with the financial support of NCI, AHRQ commissioned a systematic review of the existing evidence on the recruitment of underrepresented populations into cancer clinical trials, to be performed by the Johns Hopkins University EPC. Specifically, the EPC investigators were asked to consider six key questions: • Key Question 1: What methods (e.g., survey studies, focus groups) have been used to study strategies to recruit underrepresented populations into cancer prevention and treatment trials? We defined underrepresented populations as including the elderly, adolescents, those of low socioeconomic status, those living in rural areas, African Americans, Hispanics/Latinos, Asian Americans, and American Indians. • Key Question 2: What measures of success (e.g., proportional representation relative to the U.S. population; proportional representation relative to incidence in a specified population) have been used to evaluate the efficacy and/or effectiveness of strategies for recruitment of underrepresented populations into cancer prevention and treatment trials? • Key Questions 3 and 4: Which recruitment strategies (e.g., media appeals, incentives, etc.) have been shown to be efficacious and/or effective in increasing participation of Evidence Report/Technology Assessment Number 122
This is an update of the original evidence report, Diagnosis and Treatment of Acute Bacterial Rhinosinusitis, published in March 1999 by the Agency for Health Care Policy and Research. Our objective is to summarize and analyze comparative studies on the antibiotic efficacies in the treatment of acute bacterial sinusitis. The research questions in this evidence report are: 1. Given a clinical diagnosis of acute bacterial rhinosinusitis, what are the comparative efficacies of the antibiotics in resolving symptoms and preventing complications or recurrence? 1a. Is there evidence that duration of antibiotic treatment in acute bacterial rhinosinusitis affects efficacy? 2. What adverse effects are reported for antibiotics used for acute bacterial rhinosinusitis? 3. How does the introduction of the pneumococcal vaccine affect the resistance patterns of pneumococcus and the treatment decisions in acute bacterial rhinosinusitis?
Authors' objectives This study addresses five key questions (KQs): 1. Does the practice of liberal or routine episiotomy, compared to more selective use of episiotomy, influence maternal postpartum outcomes? 2. Does episiotomy incision type (i.e., midline or mediolateral), influence maternal postpartum outcomes? 3. Does the repair of the perineal defect (i.e., suture type and repair approach) influence maternal postpartum outcomes? 4. Does episiotomy have a long-term influence on urinary incontinence, fecal incontinence, or pelvic floor defects? 5. Does episiotomy or incision type, or both, influence future sexual function?
Citation Details Nelson HD, Haney E, Humphrey L, Miller J, Nedrow A, Nicolaidis C, Vesco K, Walker M, Bougatsos C, Nygren P. Management of Menopause-Related Symptoms. Summary, Evidence Report/Technology Assessment No. 120. (Prepared by the Oregon Evidence-based Practice Center, under Contract No. 290-02-0024.) AHRQ Publication No. 05-E016-1. Rockville, MD: Agency for Healthcare Research and Quality. March 2005.
This evidence report has been prepared by the Tufts-New England Medical Center (TuftsNEMC) Evidence-based Practice Center (EPC) concerning the health benefits of omega-3 fatty acids on organ transplantation. These reports are among several that address topics related to omega-3 fatty acids, and that were requested and funded by the Office of Dietary Supplements, National Institutes of Health (NIH), through the EPC program at the Agency for Healthcare Research and Quality (AHRQ). Three EPCs— the Tufts-NEMC EPC, the Southern California EPC (SCEPC), based at RAND, and the University of Ottawa EPC—each produced evidence reports. To ensure consistency of approach, the three EPCs collaborated on selected methodological elements, including literature search strategies, rating of evidence, and data table design. The aim of the reports is to summarize the current evidence on the health effects of omega-3 fatty acids (eicosapentaenoic acid [EPA; chemical abbreviation: 20:5 n-3], docosahexaenoic acid [DHA; 22:6 n-3], alpha-linolenic acid [ALA, 18:3 n-3], and docosapentaenoic acid [DPA, 22:5 n-3]) on the following: cardiovascular disease, cancer, child and maternal health, eye health, gastrointestinal diseases, kidney diseases, asthma, autoimmune diseases, immune-mediated diseases, organ transplantation, mental health, and neurological diseases and conditions. In addition to informing the research community and the public on the effects of omega-3 fatty acids on various health conditions, it is anticipated that the findings of the reports will also be used to help define the agenda for future research.
This report was requested by the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH) Office of Dietary Supplements, and several NIH Institutes. It is one of several reports focusing on the role of omega-3 fatty acids (FA) in the prevention or treatment of various diseases. Three Evidencebased Practice Centers (EPCs) produced this series of reports: the Southern California EPC ([SCEPC], based at RAND), the Tufts-New England Medical Center EPC, and the University of Ottawa EPC. This particular report focuses on the effects of omega-3 FA on cognitive function with aging, dementia, and neurological diseases. Over the past 40 years, an increasing number of physiological functions have been attributed to omega-3 FA, including movement of calcium and other substances into and out of cells; relaxation and contraction of muscles; regulation of clotting and of secretion of substances that include digestive enzymes and hormones; and control of fertility, cell division, and growth. In addition, omega-3 FA may play an important role in brain development and function. Docosahexaneoic acid (DHA; 22:6n-3) is the precursor to a newlydescribed metabolite called 10,17S-docosatriene, which is part of a family of compounds called resolvins. They are released in the brain in response to an ischemic insult and counteract the pro-inflammatory actions of infiltrating leukocytes by blocking interleukin 1-beta-induced NF-kappaB activation and cyclooxygenase-2 expression. DHA also plays a role in retinal rod outer segments by influencing membrane fluidity so as to optimize G protein coupled signaling. 4,5 The major dietary sources of omega-3 FA in the U.S. population are fish, fish oil, vegetable oils (principally canola and soybean), walnuts, wheat germ, and some dietary supplements.
ContextOmega-3 fatty acids are purported to reduce the risk of cancer. Studies have reported mixed results.ObjectiveTo synthesize published and unpublished evidence to determine estimates of the effect of omega-3 fatty acids on cancer risk in prospective cohort studies.Data SourcesArticles published from 1966 to October 2005 identified through MEDLINE, PREMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and CAB Health; unpublished literature sought through letters to experts in the neutraceutical industry.Study SelectionA total of 38 articles with a description of effects of consumption of omega-3 fatty acids on tumor incidence, prospective cohort study design, human study population; and description of effect of omega-3 among groups with different levels of exposure in the cohort were included. Two reviewers independently reviewed articles using structured abstraction forms; disagreements were resolved by consensus.Data ExtractionTwo reviewers independently abstracted detailed data about the incidence of cancer, the type of cancer, the number and characteristics of the patients, details on the exposure to omega-3 fatty acids, and the elapsed time between the intervention and outcome measurements. Data about the methodological quality of the study were also abstracted.Data SynthesisAcross 20 cohorts from 7 countries for 11 different types of cancer and using up to 6 different ways to categorize omega-3 fatty acid consumption, 65 estimates of the association between omega-3 fatty acid consumption were reported. Among these, only 8 were statistically significant. The high degree of heterogeneity across these studies precluded pooling of data. For breast cancer 1 significant estimate was for increased risk (incidence risk ratio [IRR], 1.47; 95% confidence interval [CI], 1.10-1.98) and 3 were for decreased risk (RR, 0.68-0.72); 7 other estimates did not show a significant association. For colorectal cancer, there was 1 estimate of decreased risk (RR, 0.49; 95% CI, 0.27-0.89) and 17 estimates without association. For lung cancer one of the significant associations was for increased cancer risk (IRR, 3.0; 95% CI, 1.2-7.3), the other was for decreased risk (RR, 0.32; 95% CI, 0.13-0.76), and 4 other estimates were not significant. For prostate cancer, there was 1 estimate of decreased risk (RR, 0.43; 95% CI, 0.22-0.83) and 1 of increased risk (RR, 1.98; 95% CI, 1.34-2.93) for advanced prostate cancer; 15 other estimates did not show a significant association. The study that assessed skin cancer found an increased risk (RR, 1.13; 95% CI, 1.01-1.27). No significant associations between omega-3 fatty acid consumption and cancer incidence were found for aerodigestive cancer, bladder cancer, lymphoma, ovarian cancer, pancreatic cancer, or stomach cancer.ConclusionsA large body of literature spanning numerous cohorts from many countries and with different demographic characteristics does not provide evidence to suggest a significant association between omega-3 fatty acids and cancer incidence. Dietary supplementation with omega-3 fatty acids is unlikely to prevent cancer.
