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A. Killian. Mississippi Valley State University.
DASH scores at 1 year in the PRP and corticosteroid groups in the Peerbooms et al study levitra extra dosage 60mg with visa. The primary outcome measure was 8 weeks; however order cheap levitra extra dosage line, by 12 weeks buy discount levitra extra dosage 60mg online, the scores were nearly identical purchase levitra extra dosage overnight, the percentage of patients who rated their treatment as “good or after which time the corticosteroid group returned to near baseline excellent” as measured by the modiﬁed Blazina scale and an but the PRP group continued to improve. This cohort was followed improvement on the Victorian Institute Sport Assessment-Patella for an additional year and there was continued improvement in the (VISA-P), a validated pain and functional activity scale for patellar PRP group without similar improvement in the corticosteroid group tendon injury analogous to that used for the Achilles. The third randomized controlled trial was by Krogh et al comparing PRP (n 20), saline (n 20), and corticosteroid (n 20). There are 4 for 25 months; however, the PRP and saline group had only had randomized controlled studies but their numbers are small. Three of symptoms for 17 months whereas the corticosteroid group had these studies show beneﬁt from PRP and one did not have an end symptoms for 36 months. The primary outcome measure was the point long enough to assess whether PRP was effective. Conclu- Patient Rated Tennis Elbow Evaluation (PRTEE) score, a validated sions that can be drawn at this point are that PRP should be pain and function score for the elbow. This study was initially considered after other conservative treatments have failed, in designed to look at outcomes at 6 months and 1 year; however, more particular eccentric exercises. In addition, if effective, PRP takes 3 than half of the study participants in all groups had dropped out by 6 to 6 months to show beneﬁt, but healing can continue out to 2 years. At 1 month, the corticosteroid group had better PRTEE activity modiﬁcation, which may adversely affect both physical and scores than the other groups; however, at 3 months, all groups had mental health. More research is needed, such as studies that include statistically equivalent scores. At the time the study was ended, the corticosteroid group was returning toward its baseline and the PRP group was trending toward improvement. It is PRP in arthritis unfortunate that 6- and 12-month data were not available as in other OA is a degenerative disease of the joints that affects the articular 6,12,14,25 cartilage, synovium, and subchondral bone. The complex The fourth randomized controlled study examined PRP versus balance of growth factors and cytokines involved in the regula- ESWT for chronic patellar tendinopathy. The average age in but PRP has been proposed as a physiologic combination of this study was 26 years, with an average duration of symptoms of 18 growth factors that can favorably affect the joint milieu in months. A 22-ga needle was used to inject LR-PRP with ultrasound osteoarthritic joints, thus halting or reversing the process. The ESWT group had 3 sessions 48 to 72 signiﬁcant impact on quality of life have sought out alternative hours apart. One week after the last treatment session, a standard and emerging treatments and have embraced the concept of a stretching and strengthening protocol was started, with a return to biologic treatment for this disease. Hematology 2013 623 PRP and other biologics have long been used in race horses with OA, and there are basic science studies suggesting why it use may be efﬁcacious; however, there are currently only 8 studies on the clinical use of PRP in OA in humans28-35 (Table 3) and all these studies have examined the effect of PRP in the osteoarthritic knee. None has reported any major adverse effect with the use of PRP and all have reported modest beneﬁt on validated functional outcome scales. It is difﬁcult to compare studies because they use different injection protocols and different types of PRP; however, Patel et al recently published a randomized, double-blind, placebo-controlled study supporting the use of PRP in OA of the knee. The 1 injection of LP-PRP was a higher platelet concentration, 10 baseline, than the 2 injection protocol, which was 4 baseline. Patients were followed at 6 weeks after the last injection at 3 and 6 months. There was a signiﬁcant improvement in all subscales of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores, as well as signiﬁcant improvements in the visual analog pain score. The scores were best at 3 months and regressed slightly at 6 months, but were still well above baseline compared with the saline group, which worsened over the 6 months from the initial baseline scores. Although the literature on the use of PRP is limited, initial clinical studies suggest a beneﬁt in knee OA. Its mechanism of action is also unknown, that is, whether it is purely pain relieving or if it stops or slows progression of further cartilage degradation or could reverse damage. More studies are needed in this area, including quantitative measurements of pre- and posttreatment articular cartilage on MRI and measurements of synovial and joint ﬂuid growth factors and cytokines. The possibili- ties of new treatments for this common and debilitating disease are intriguing. IL-1RA in OA Whereas it is not truly PRP, treatments with IL-1RA are being sought out for OA. IL-1 is thought to be a primary mediator of the breakdown of articular cartilage in degenerative joints. IL-1RA is theorized to mitigate this damage by blocking its actions. IL-1RA is produced by incubating whole blood for 24 hours with glass beads and then centrifuging it. This is considered to be “more than minimally manipulated” by the Food and Drug Administration and is therefore subject to different regulatory laws than PRP and is generally not available for human use in the United States. The typical protocol for this treatment is 6 injections several days apart. There are 2 randomized controlled trials on this treatment, both in knee OA. The second, in 376 knees, found that IL-1RA was a more effective treatment than either hyaluronic acid or saline based on WOMAC scores. The reasons for these contradictory results are unclear and more research is needed. Summary The use of PRP and other biologics is an exciting new development with potential to treat injuries such as chronic tendinopathy and OA. PRP is a heterogeneous term and should be further characterized as far as platelet concentration and other blood elements such as leukocytes that may also be present. There is currently no clear 624 American Society of Hematology evidence that one type of PRP is superior to another. Platelet-rich plasma versus focused shock waves in reasonable evidence that PRP may be effective in chronic degenera- the treatment of jumper’s knee in athletes. Krogh TP, Fredberg U, Stengaard-Pedersen K, Christensen R, ﬁrst-line treatment. It takes 4 to 6 months to synthesize new tendon, Jensen P, Ellingsen T. Treatment of lateral epicondylitis with so in sports settings, PRP should not to be considered an “in-season” platelet-rich plasma, glucocorticoid, or saline: a randomized, treatment for chronic tendinopathy. Initial studies in the use of PRP double-blind, placebo-controlled trial. Platelet-rich plasma other biologics at this point has outpaced the science behind the injection for chronic achilles tendinopathy: A randomized practice, there is reason to hope. Positive effect Disclosures of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: Platelet-rich plasma Conﬂict-of-interest disclosure: The authors declare no competing versus corticosteroid injection with a 1-year follow-up. A treatment algorithm for managing Correspondence achilles tendinopathy: New treatment options. Kimberly Harmon, MD, University of Washington, 4060 E Stevens 2007;41:211-216. Circle, Seattle, WA 98116; Phone: 206-616-2495; Fax: 206-598- 17. Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss injuries. Oral Surg Oral Med Oral Pathol Oral naire: A valid and reliable index of the clinical severity of Radiol Endod. Eccentric loading, gous conditioned serum: The comparative cytokine proﬁles of shock-wave treatment, or a wait-and-see policy for tendinopa- two commercial methods (irap and irap ii) using equine blood. Sonographically guided pathology model to explain the clinical presentation of load- percutaneous needle tenotomy for the treatment of chronic induced tendinopathy. Filardo G, Kon E, Della Villa S, Vincentelli F, Fornasari PM, 22. Use of platelet-rich plasma for the treatment of percutaneous needle tenotomy for treatment of common extensor refractory jumper’s knee.
Although the terms are sometimes used interchangeably 60 mg levitra extra dosage overnight delivery, meta-analysis is not synonymous with systematic review 40mg levitra extra dosage amex. However discount levitra extra dosage online, systematic reviews often include meta-analyses cheap levitra extra dosage. 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. Monotherapy: the use of a single drug to treat a particular disorder or disease. 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 Statins Page 109 of 128 Final Report Update 5 Drug Effectiveness Review Project 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. 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. Per protocol analyses are sometimes misidentified in published trials as intention-to- treat analyses. Pharmacokinetics: the characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism, and excretion. Placebo: An inactive substance commonly called a "sugar pill. It does not contain anything that could harm a person. It is not necessarily true that a placebo has no effect on the person taking it. Statins Page 110 of 128 Final Report Update 5 Drug Effectiveness Review Project Placebo controlled trial: A study in which the effect of a drug is compared with the effect of a placebo (an inactive substance designed to resemble the drug). In placebo controlled clinical trials, participants receive either the drug being studied or a placebo. The results of the drug and placebo groups are then compared to see if the drug is more effective in treating the condition than the placebo is. A confidence interval is a measure of the uncertainty (due to the play of chance) associated with that estimate. Pooling: The practice of combing data from several studies to draw conclusions about treatment effects. Power: The probability that a trial will detect statistically significant differences among intervention effects. Studies with small sample sizes can frequently be underpowered to detect difference. Precision: The likelihood of random errors in the results of a study, meta-analysis, or measurement. The greater the precision, the less the random error. Confidence intervals around the estimate of effect are one way of expressing precision, with a narrower confidence interval meaning more precision. Prospective study: A study in which participants are identified according to current risk status or exposure and followed forward through time to observe outcome. Prevalence: How often or how frequently a disease or condition occurs in a group of people. Prevalence is calculated by dividing the number of people who have the disease or condition by the total number of people in the group. Probability: The likelihood (or chance) that an event will occur. In a clinical research study, it is the number of times a condition or event occurs in a study group divided by the number of people being studied. Publication bias: A bias caused by only a subset of the relevant data being available. The publication of research can depend on the nature and direction of the study results. Studies in which an intervention is not found to be effective are sometimes not published. Because of this, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention. In addition, a published report might present a biased set of results (for example, only outcomes or subgroups for which a statistically significant difference was found). P value: The probability (ranging from zero to one) that the results observed in a study could have occurred by chance if the null hypothesis was true. Q-statistic: A measure of statistical heterogeneity of the estimates of effect from studies. It is calculated as the weighted sum of the squared difference of each estimate from the mean estimate. Random-effects model: A statistical model in which both within-study sampling error (variance) and between-studies variation are included in the assessment of the uncertainty (confidence interval) of the results of a meta-analysis. When there is heterogeneity among the results of the Statins Page 111 of 128 Final Report Update 5 Drug Effectiveness Review Project included studies beyond chance, random-effects models will give wider confidence intervals than fixed-effect models.
ADAS-cog raters were blinded to treatment allocation 40 mg levitra extra dosage amex, but unblinded clinicians administered the MMSE buy levitra extra dosage 60 mg low price. At 12 weeks no statistically significant differences in ADAS-cog or MMSE were reported for the two treatment groups order levitra extra dosage 40 mg line. These investigators also administered an unidentified measure of clinician and caregiver satisfaction buy cheap levitra extra dosage online. Placebo-controlled trials We identified 8 systematic reviews or meta-analyses of placebo-controlled trials and 23 RCTs that met the inclusion criteria for our review of placebo-controlled evidence. When good-rated systematic reviews provided comprehensive evidence for a specific drug-placebo comparison, we did not include individual trials already covered in the systematic review. However, in cases where individual trials were too heterogeneous or not adequately described by existing systematic reviews (i. Placebo (Meta-Analysis) 30, 31 Two methodologically sound meta-analysis evaluated placebo-controlled evidence for donepezil, galantamine, and rivastigmine. These reviews cannot be used to compare one drug to another directly, but quantitative analyses from these studies are relevant to the question of the general effectiveness of 31 ChEIs as a class. The most recently published review included 22 trials. The authors defined “global responders” as subjects rated as minimally to very much improved on the CGIC or CIBIC-plus; “cognitive responders” were defined as patients with a 4-point or greater improvement (decrease) from baseline on the ADAS-cog. Compared to placebo the pooled number needed to treat (NNT) to yield one additional ChEI global responder was 12 (95% CI 9-16); the NNT to yield one additional cognitive responder was 10 (95% CI 8-15). These pooled NNT calculations should be interpreted cautiously, as some heterogeneity exists among trials included in this analysis. Pooled rates of dropouts and adverse events were not reported for each drug. However, adverse event rates in excess of those for placebo were lowest for donepezil (6%; 95% CI 2%- 9%), followed by rivastigmine (8%; 95% CI 1%-10%), and galantamine (12%; 95% CI 7%-18%). Drop out rates due to adverse events demonstrated a similar trend. A good meta- 32 analysis pooled data from 13 trials lasting 12 or more weeks and involving 4,365 participants. Pooled results demonstrated statistically significantly better ratings for 5mg/day and 10mg/day donepezil on all outcomes measures at 24 weeks. For 10mg/day doses, the global assessment with CIBIC-plus, dichotomized into those showing no change or decline and those showing improvement yielded an odds ratio (OR) of 2. The size of the effect was dose-related and did not differ by severity of the disease. Furthermore, pooled data from two trials assessing activities of daily living (DAD, IADL, PSMS, CMCS) presented a statistically significant benefit for 5mg/day and 10mg/day donepezil treatment at week 12 and week 24. No difference was reported on a patient-rated Quality of Life Scale between donepezil and placebo. These findings were consistent with those of a fair-rated meta-analysis 33 using individual patient data of placebo-controlled trials. Because some of these included trials provide specific results on quality of life and 38, 40, 44 activities of daily living we summarize results in Table 4. The only effectiveness study we identified was the only trial on donepezil that was not funded by the 38 pharmaceutical industry. This UK study enrolled 565 patients and assessed the effectiveness of long- term (3 years and 36 weeks) donepezil treatment in community-residents with mild to moderate AD with or without concomitant vascular dementia. Primary outcome measures were rate of institutionalism and functional capacity (Bristol ADL). No significant differences could be observed in the rates of institutionalism between donepezil and placebo at 1 year (9% vs. After 12 weeks until the end of the trial, the Bristol ADL scores of donepezil-treated patients were statistically significantly better, though the difference was modest (average +1. Similarly, MMSE scores were modestly but statistically significantly higher in donepezil- than in placebo-treated patients (average 0. No significant differences were detected in progression of disability (Bristol ADL) or behavioral and psychological symptoms (NPI). The primary endpoint was time to clinically evident decline in function (defined in study protocol). A higher proportion of placebo than of donepezil- treated patients reached the primary endpoint (56% vs. The median time to clinically evident functional decline was significantly shorter for placebo than for donepezil-treated patients on donepezil (208 vs. The placebo-controlled study not included in any meta-analysis assessed the efficacy of donepezil on 46 cognitive outcomes. Findings are consistent with results from meta-analyses. Results reported significantly better outcomes for the donepezil than for placebo groups after 24 weeks of treatment. We focus the majority of our discussion on the updated 62 systematic review because it provides a comprehensive summary of four of the five RCTs identified in our search. However, for measures of behavior and functional capacity we focus our discussion on individual trials because data in these domains were not pooled in the systematic review. The most frequent galantamine dose tested was 24mg/day; in most trials patients began at 8 mg/day and increased over time to the daily maximum. Patients reached their maximum daily dose 2 to 8 weeks into the respective trials. All trials used the ADAS-cog to assess cognitive change; other measures of symptomatic change included the European adaptation of the ADAS scale, the expanded ADAS-cog, and the Digit Symbol Substitution Test. Most trials used global rating scales such as the CIBIC-plus or the ADCS-CGIC. Changes in behavior were assessed by the NPI and functional status was assessed using the PDS, DAD, and ADCS-ADL. Overall, galantamine was significantly better than placebo for improving intermediate outcome measures 34 of cognitive symptoms and global rating scales. Pooled analyses of ADAS-cog scores from trials lasting 5 to 6 months revealed statistically significant differences for all doses of galantamine compared to placebo (8mg: WMD -1. Results from trials of 3 months’ duration were similar. Pooled ITT analyses for global rating scales also favored galantamine over placebo. Trials lasting 5 to 6 months demonstrated similar differences (16mg/day: OR 2. Trials lasting 3 months demonstrated statistically significant differences between galantamine and placebo on global rating scales for doses of 18mg/day (OR 2. The good-rated trial not included in the systematic review provided consistent results. The LOCF mean change in ADAS-cog from baseline to 26 weeks was -1. Both galantamine and galantamine PRC were numerically superior to placebo in CIBIC-plus scores, but differences failed to reach statistical significance at 26 weeks. Although most trials assessed behavior or functional status, the authors of the systematic review did not pool these data, presumably because of differences in study design and reporting. Two good-rated trials assessed activities of daily living with the ADCS-ADL 49, 53 scale; ITT results statistically favored galantamine over placebo at 26 weeks in both trials. Another trial that assessed activities of daily living using the PDS found no significant differences between 54 galantamine and placebo. Three trials measured disability using the DAD scale; one reported statistically significant differences between galantamine and placebo for doses of 24mg/day and 51 32mg/day, one reported statistically significant differences for doses of 32mg/day but not for 53 50 24mg/day, and one reported no differences for doses of 24mg/day or 32mg/day. One trial assessed sleep quality using the NPI sleep score and the PSQ1; no differences were found between galantamine 63 and placebo on either measure. Three trials assessed behavioral symptoms using the NPI; two reported 49, 51 no statistically significant differences in NPI scores at 26 weeks and the other reported statistically 52 significant differences at 22 weeks for doses of 16mg/day and 24mg/day. This study reported the caregiver distress component of the NPI in a 22 week trial comparing galantamine 16mg/day and 24mg/day to placebo. At endpoint, only the 24mg/day dose was significantly better than placebo (P = 0.
It may also include people who have no known diseases order 60mg levitra extra dosage amex. Subgroup analysis: An analysis in which an intervention is evaluated in a defined subset of the participants in a trial buy 40mg levitra extra dosage otc, such as all females or adults older than 65 years discount 40mg levitra extra dosage. Superiority trial: A trial designed to test whether one intervention is superior to another discount levitra extra dosage 60 mg otc. Surrogate outcome: Outcome measures that are not of direct practical importance but are believed to reflect outcomes that are important; for example, 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 heart attacks. Surrogate endpoints are often physiological or biochemical markers that can be relatively quickly and easily measured, and that are taken as being predictive of important clinical outcomes. They are often used when observation of clinical outcomes requires long follow-up. Beta blockers Page 82 of 122 Final Report Update 4 Drug Effectiveness Review Project Survival analysis: Analysis of data that correspond to the time from a well-defined time origin until the occurrence of some particular event or end-point; same as time-to-event analysis. Systematic review: A review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research and to collect and analyze data from the studies that are included in the review. The extent to which a drug’s adverse effects impact the patient’s ability or willingness to continue taking the drug as prescribed. These adverse effects are often referred to as nuisance side effects, because they are generally considered to not have long-term effects but can seriously impact compliance and adherence to a medication regimen. Treatment regimen: The magnitude of effect of a treatment versus no treatment or placebo; similar to “effect size”. Can be calculated in terms of relative risk (or risk ratio), odds ratio, or risk difference. Two-tailed test (two-sided test): A hypothesis test in which the values that reject the null hypothesis are located in both tails of the probability distribution. For example, testing whether one treatment is different than another (rather than testing whether one treatment is either better than another). Type I error: A conclusion that there is evidence that a treatment works, when it actually does not work (false-positive). Type II error: A conclusion that there is no evidence that a treatment works, when it actually does work (false-negative). Validity: The degree to which a result (of a measurement or study) is likely to be true and free of bias (systematic errors). Variable: A measurable attribute that varies over time or between individuals. Variables can be • Discrete: taking values from a finite set of possible values (e. Washout period: [In a cross-over trial] The stage after the first treatment is withdrawn, but before the second treatment is started. The washout period aims to allow time for any active effects of the first treatment to wear off before the new one gets started. Beta blockers Page 83 of 122 Final Report Update 4 Drug Effectiveness Review Project Appendix B. Search strategies for Update 4 First searches: November 2008 Database: Ovid MEDLINE(R) <1996 to October Week 5 2008> Search Strategy: -------------------------------------------------------------------------------- 1 acebutolol. Quality assessment for the Drug Effectiveness Review Project Study quality is objectively assessed using predetermined criteria for internal validity, based on the combination of the US Preventive Services Task Force and the National Health Service Centre for Reviews and Dissemination criteria. This appendix lists questions that are posed for each included study in order to assess study quality. These quality-assessment questions differ for systematic reviews, controlled trials, and nonrandomized trials. Regardless of design, all studies that are included are assessed for quality and assigned a rating of “good,” “fair,” or “poor. A fatal flaw is failure to meet combinations of criteria that may indicate the presence of bias. An example would be inadequate procedure for randomization or allocation concealment combined with important differences in prognostic factors at baseline. Studies that meet all criteria are rated good quality, and the remainder is rated fair quality. As the fair-quality category is broad, 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 a true difference between the compared drugs. Does the review report a clear review question and inclusion/exclusion criteria that relate to the primary studies? A good-quality review should focus on a well-defined question or set of questions. These questions ideally are reflected in the inclusion/exclusion criteria, which guide the decision of whether to include or exclude specific primary studies. The criteria should relate to the 4 components of study design: indications (patient populations), interventions (drugs), and outcomes of interest. In addition, details should be reported relating to the process of decision-making, such as how many reviewers were involved, whether the studies were examined independently, and how disagreements between reviewers were resolved. Is there evidence of a substantial effort to search for all relevant research? If details of electronic database searches and other identification strategies are given, the answer to this question usually is yes. Ideally, search terms, dates, and language restrictions should be presented. In addition, descriptions of hand searching, attempts to identify unpublished material, and any contact with authors, industry, and research institutes should be provided. The appropriateness of the database(s) searched by the authors should also be considered. For example, if only Medline was searched for a review looking at proton pump inhibitors then it is unlikely that all relevant studies were located. Is the validity of included studies adequately assessed? A systematic assessment of the quality of primary studies should include an explanation of the criteria used (for example, how randomization was done, whether outcome Beta blockers Page 88 of 122 Final Report Update 4 Drug Effectiveness Review Project assessment was blinded, whether analysis was on an intention-to-treat basis). Authors may use a published checklist or scale or one that they have designed specifically for their review. Again, the process relating to the assessment should be explained (how many reviewers were involved, whether the assessment was independent, and how discrepancies between reviewers were resolved). Is sufficient detail of the individual studies presented? The review should demonstrate that the studies included are suitable to answer the question posed and that a judgment on the appropriateness of the authors’ conclusions can be made. If a paper includes a table giving information on the design and results of the individual studies or includes a narrative description of the studies within the text, this criterion is usually fulfilled. If relevant, the tables or text should include information on study design, sample sizes, patient characteristics, interventions, settings, outcome measures, follow-up periods, drop-out rates (withdrawals), effectiveness results, and adverse events. The authors should attempt to synthesize the results from individual studies. In all cases, there should be a narrative summary of results, which may or may not be accompanied by a quantitative summary (meta-analysis). For reviews that provide a meta-analysis, heterogeneity between studies should be assessed using statistical techniques. If heterogeneity is present, the possible reasons (including chance) should be investigated. In addition, the individual studies should be weighted in some way (for example, according to sample size or inverse of the variance) so that studies that are considered to provide the most reliable data have greater impact on the summary statistic. Controlled Trials Assessment of internal validity 1. Was the assignment to treatment groups really random?
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