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Studies will be included if they measured frequency diflucan 150mg with visa, severity order diflucan 200 mg free shipping, presence versus absence buy diflucan 150 mg with amex, or a combination measure of frequency and severity as either primary or secondary outcomes at baseline, 3 months, and/or the end of the study. Safety Outcomes • Withdrawals • Withdrawals due to adverse effects • Withdrawals due to specific adverse effects For short-term use • Atypical bleeding; endometrial hypertrophy • Nausea and vomiting • Breast tenderness • Headaches • Weight changes • Dizziness • Thrombosis (including relationship to estradiol levels) • Cardiovascular events • Rash and pruritus • Cholecystitis • Effects on the liver For long-term use • Cardiovascular events • Breast cancer • Thrombosis • Cholecystitis • Ovarian cancer • Endometrial cancer Study Designs 1. Symptoms: Double-blind, randomized controlled trials of at least 3 months duration of one hormone therapy preparation versus another hormone therapy preparation or versus placebo. Prevention of osteoporosis: Double-blind or open, randomized controlled trials of postmenopausal women who are treated for at least 1 year versus another hormone therapy preparation or versus placebo. Hormone therapy Page 12 of 110 Final Report Update 3 Drug Effectiveness Review Project METHODS Literature Search To identify articles relevant to each key question, we searched the Cochrane Database of Systematic Reviews and Cochrane Controlled Trials Registry (2007, Issue 1), MEDLINE (1966 through March Week 1, 2007), Embase (1980 through April, 2004), PreMEDLINE (through March Week 1, 2007), reference lists of review articles, and dossiers submitted by pharmaceutical companies (see Appendix A for complete search strategies). All citations were imported into an electronic database (EndNote 9. Study Selection We included English-language randomized controlled trials and systematic evidence reviews of estrogen and treatment of menopausal symptoms or prevention of low bone density and fractures that used one or more of the estrogen preparations identified as eligible (listed above). Systematic reviews were included if they conducted literature searches in 2004 or later. Data Abstraction One reviewer abstracted the following data from included trials: study design, population characteristics (including age, ethnicity, setting, peri- vs. We recorded intention-to-treat results if available. Withdrawals due to adverse effects were characterized by type of specific adverse effect. Abbreviations and acronyms related to this review are listed in Appendix B. Validity Assessment 7, 8 For trials not included in either of two recently published Cochrane reviews, we assessed the internal validity (quality) based on the pre-defined criteria listed in Appendix C. These criteria are based on those developed by the U. Preventive Services Task Force and the 9-11 Center for Reviews and Dissemination (UK). We rated the internal validity based on the methods used for randomization, allocation concealment, and blinding; the similarity of compared groups at baseline; maintenance of comparable groups; adequate reporting of dropouts, attrition, crossover, adherence, and contamination; loss to follow-up; and the use of intention-to-treat analysis. Trials with a major limitation in one or more categories were rated poor quality; trials meeting all criteria were rated good quality; the remainder were rated fair quality. The “fair quality” category is broad and studies with this rating vary in their strengths and weaknesses: the results of some fair-quality studies are likely to be valid, while others are only probably valid. A “poor quality” trial is not valid—the results are at least as likely to reflect flaws in the study design as the true difference between the compared drugs. All trials included in the Cochrane reviews appeared to be of at least fair quality by these criteria and were not rated in this review. Quality ratings for studies 8 included in the Cochrane review on hot flashes or flushes are in Appendix D. External validity of trials was assessed based on whether the publication adequately described the study population, how similar patients were to the target population in whom the Hormone therapy Page 13 of 110 Final Report Update 3 Drug Effectiveness Review Project intervention will be applied, and whether the treatment received by the control group was reasonably representative of standard practice. Overall quality ratings for individual studies were based on ratings of the internal and external validity of the trial. The overall strength of evidence for a particular key question reflects the quality, consistency, and precision of the relevant studies and their estimates of effect. Data Synthesis Treatment effects were defined as the difference in outcomes between the estrogen and placebo groups, or between estrogen groups for head-to-head comparisons. For crossover trials, only results from the end of the first phase were used because of the potential for carry-over effects. We conducted a meta-analysis of trials reporting hot flash or flush outcomes in order to provide a more precise and more broadly applicable measure of treatment effect. This outcome was the most uniformly reported among studies of symptoms.
Intermediate outcome: An outcome not of direct practical importance but believed to reflect outcomes that are important purchase 200mg diflucan visa. For example purchase 50mg diflucan with visa, blood pressure is not directly important to patients but it is often used as an outcome in clinical trials because it is a risk factor for stroke and myocardial infarction (hear attack) discount diflucan 150 mg without prescription. Masking: See Blinding Mean difference: A method used to combine measures on continuous scales (such as weight) where the mean, standard deviation, and sample size are known for each group. Meta-analysis: The use of statistical techniques in a systematic review to integrate the results of included studies. Although the terms are sometimes used interchangeably, meta-analysis is not synonymous with systematic review. However, systematic reviews often include meta-analyses. Meta-regression: A technique used to explore the relationship between study characteristics (for example, baseline risk, concealment of allocation, timing of the intervention) and study results (the magnitude of effect observed in each study) in a systematic review. Mixed treatment comparison meta analysis: A meta-analytic technique that simultaneously compares multiple treatments (typical 3 or more) using both direct and indirect evidence. The multiple treatments form a network of treatment comparisons. Also called multiple treatment comparisons, network analysis, or umbrella reviews. Multivariate analysis: Measuring the impact of more than one variable at a time while analyzing a set of data. N-of-1 trial: A randomized trial in an individual to determine the optimum treatment for that individual. Noninferiority trial: A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a prespecified amount. Nonrandomized study: Any study estimating the effectiveness (harm or benefit) of an intervention that does not use randomization to allocate patients to comparison groups. There are many types of nonrandomized studies, including cohort studies, case-control studies, and before- after studies. Null hypothesis: The statistical hypothesis that one variable (for example, treatment to which a participant was allocated) has no association with another variable or set of variables. Triptans Page 59 of 80 Final Report Update 4 Drug Effectiveness Review Project Number needed to harm: The number of people who would need to be treated over a specific period of time before one bad outcome of the treatment will occur. The number needed to harm (NNH) for a treatment can be known only if clinical trials of the treatment have been performed. Number needed to treat: An estimate of how many persons need to receive a treatment before one person would experience a beneficial outcome. Observational study: A type of nonrandomized study in which the investigators do not seek to intervene, instead simply observing the course of events. Odds ratio: The ratio of the odds of an event in one group to the odds of an event in another group. Off-label use: When a drug or device is prescribed outside its specific FDA-approved indication, to treat a condition or disease for which it is not specifically licensed. Outcome: The result of care and treatment and/ or rehabilitation. In other words, the change in health, functional ability, symptoms or situation of a person, which can be used to measure the effectiveness of care/treatment/rehabilitation. Researchers should decide what outcomes to measure before a study begins; outcomes are then assessed at the end of the study. Outcome measure: Is the way in which an outcome is evaluated---the device (scale) used for measuring. One-tailed test (one-sided test): A hypothesis test in which the values that reject the null hypothesis are located entirely in one tail of the probability distribution. For example, testing whether one treatment is better than another (rather than testing whether one treatment is either better or worse than another). Open-label trial: A clinical trial in which the investigator and participant are aware which intervention is being used for which participant (that is, not blinded). Random allocation may or may not be used in open-label trials. Per protocol: The subset of participants from a randomized controlled trial who complied with the protocol sufficiently to ensure that their data would be likely to exhibit the effect of treatment.
The database did not record the formulation of methylphenidate involved cheap diflucan 150 mg free shipping, although they report that the number of calls regarding methylphenidate had reduced during 1998 to 2000 cheap diflucan 200mg overnight delivery, then increased during 2001 to 2004 discount diflucan 50mg amex. In looking at the evidence on diversion of these stimulants, the systematic review found that among children up through high school aged, 15% to 24% gave them away, 7% to 19% sold them, and 4% to 6% had them stolen at some time in the past. Among college students, 3 studies reported rates of diversion with widely varying rates reported. The lowest rate found in the systematic review, 23% to 29% had been asked to give, to trade, or to sell their ADHD 333 medications to another student. A web-based survey tool used to study students at Duke University and the University of North Carolina on various aspects of drug and alcohol misuse included questions on ADHD medication diversion, and rates of diversion among 115 students who had a drug prescribed to treat their ADHD were found to be higher. Fifty-six percent had been asked to sell their ADHD medications and 26% reported either giving or selling their 336 medications to another student. Another survey study of college students evaluated responses of 483 students with a prescription for any medication. This group of students had the highest rate of diverting ADHD medication at 61. The highest rate of diversion was reported with amphetamine/dextroamphetamine (70. Rates did not differ much between methylphenidate and extended-release methylphenidate (no formulation specified, 37% compared with 39. Data on sharing compared with selling medications were not stratified by type. In a small study of 66 adults prescribed methylphenidate, 44% reported diverting their medication to someone else, 334 with 97% giving it away, 17% selling it, and 14% doing both. Regression analyses indicated that diversion was associated with younger age both at the time of the survey and at the time methylphenidate was first prescribed. This was a very small study, however, and such regression analyses should be interpreted with caution. Attention deficit hyperactivity disorder 100 of 200 Final Update 4 Report Drug Effectiveness Review Project Reinforcing effects of ADHD medications We found 2 very small studies (1 in 5 children with ADHD, 1 in 10 adults with ADHD) that used 339, 340 a choice procedure as a proxy measurement of abuse potential. The logic behind this is that choice of 1 treatment over another may be reflective of the reinforcing effects of a drug, which is often considered to be predictive of abuse potential. The trials involved short-term administration of blinded drug (sampling days) and then allowing them to choose their preferred condition on other days (choice days). In the adult study, ADHD symptom improvement was self-assessed using a 5-point scale (1=“not effective” and 5=“extremely effective”). The main findings were that Immediate-release methylphenidate was chosen significantly more often than placebo (50% compared with 32. Based on these findings, authors concluded that the higher methylphenidate preference demonstrated by these patients was more reflective of therapeutic efficacy rather than abuse potential. In the study of children, effectiveness was measured in a variety of ways, none of which were standard ADHD rating scales. While the study found a higher rate of preference with immediate-release methylphenidate, the findings are not conclusive because the effectiveness data either showed no effect of methylphenidate or what was called an idiosyncratic response (no pattern identifiable). In addition, for both of these studies we feel that because the order of condition was not randomized and the sample sizes were so small, the studies should be considered exploratory only. Are there subgroups of patients based on demographics (age, racial groups, gender, and ethnicity), other medications, or comorbidities for which one pharmacologic treatment is more effective or associated with fewer adverse events? ADHD subtypes, comorbidities, and race or ethnicity were not recorded in most randomized controlled trials and observational studies. For example, only one-quarter of all studies of school- aged children reported ADHD subtype prevalence rates. Importantly, of those that did record demographic information, only 1 poor-quality trial reported results of a subgroup analysis of 341 Black children with ADHD. While the data available from the studies that do report this information can be useful in determining the generalizability of results, the lack of attention to assessing the impact of these factors means there is almost no evidence on potential differences in response or adverse events. Race or Ethnicity Only one-half of all studies of elementary school-aged children reported race or ethnicity among the baseline characteristics. Study populations were made up primarily of White participants, with a few exceptions.
It is the rate of events (such as breast cancer) in the total population of people who could have the event (such as women of a certain age) purchase 50mg diflucan visa. Risk difference: The difference in size of risk between two groups order diflucan 200mg on-line. In intervention studies discount diflucan 150mg visa, it is the ratio of the risk in the intervention group to the risk in the control group. A risk ratio of 1 indicates no difference between comparison groups. For undesirable outcomes, a risk ratio that is <1 indicates that the intervention was effective in reducing the risk of that outcome. Antihistamines Page 53 of 72 Final Report Update 2 Drug Effectiveness Review Project Run-in period: Run in period: A period before randomization when participants are monitored but receive no treatment (or they sometimes all receive one of the study treatments, possibly in a blind fashion). The data from this stage of a trial are only occasionally of value but can serve a valuable role in screening out ineligible or non-compliant participants, in ensuring that participants are in a stable condition, and in providing baseline observations. A run-in period is sometimes called a washout period if treatments that participants were using before entering the trial are discontinued. This term (or the term ‘‘safe’’) should not be used when evidence on harms is simply absent or is insufficient. Sample size: The number of people included in a study. In research reports, sample size is usually expressed as "n. Larger sample sizes also increase the chance that rare events (such as adverse effects of drugs) will be detected. Sensitivity analysis: An analysis used to determine how sensitive the results of a study or systematic review are to changes in how it was done. Sensitivity analyses are used to assess how robust the results are to uncertain decisions or assumptions about the data and the methods that were used. Side effect: Any unintended effect of an intervention. Side effects are most commonly associated with pharmaceutical products, in which case they are related to the pharmacological properties of the drug at doses normally used for therapeutic purposes in humans. Standard deviation (SD): A measure of the spread or dispersion of a set of observations, calculated as the average difference from the mean value in the sample. Standard error (SE): A measure of the variation in the sample statistic over all possible samples of the same size. The standard error decreases as the sample size increases. Standard treatment: The treatment or procedure that is most commonly used to treat a disease or condition. In clinical trials, new or experimental treatments sometimes are compared to standard treatments to measure whether the new treatment is better. Statistically significant: A result that is unlikely to have happened by chance. Study: A research process in which information is recorded for a group of people. The data are used to answer questions about a health care problem. Study population: The group of people participating in a clinical research study. The study population often includes people with a particular problem or disease. It may also include people who have no known diseases. Subgroup analysis: An analysis in which an intervention is evaluated in a defined subset of the participants in a trial, such as all females or adults older than 65 years.
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