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Studies in which an intervention is not found to be effective are sometimes not published purchase cheap viagra gold line. Because of this generic 800 mg viagra gold, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention purchase viagra gold without prescription. 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. Randomization: The process by which study participants are allocated to treatment groups in a trial. Adequate (that is, unbiased) methods of randomization include computer generated schedules and random-numbers tables. Randomized controlled trial: A trial in which two or more interventions are compared through random allocation of participants. Regression analysis: A statistical modeling technique used to estimate or predict the influence of one or more independent variables on a dependent variable, for example, the effect of age, sex, or confounding disease on the effectiveness of an intervention. Relative risk: The ratio of risks in two groups; same as a risk ratio. Retrospective study: A study in which the outcomes have occurred prior to study entry. Risk: A way of expressing the chance that something will happen. It is a measure of the association between exposure to something and what happens (the outcome). Risk is the same as probability, but it usually is used to describe the probability of an adverse event. 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). Risk difference: The difference in size of risk between two groups. In intervention studies, 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. Run-in period: Run in period: A period before randomisation 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. Statins Page 112 of 128 Final Report Update 5 Drug Effectiveness Review Project 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. Superiority trial: A trial designed to test whether one intervention is superior to another. 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. 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.

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Comparing time to sustained progression curves (the primary outcome) while the glatiramer acetate curve showed slower progression generic 800mg viagra gold visa, no significant difference was found between the groups over a 2-year period purchase 800 mg viagra gold mastercard. This study did not conduct a sample size calculation order 800mg viagra gold, and with 106 patients may have been underpowered to show a difference of this magnitude. Further, subgroup analyses indicated that patients enrolled at the 2 centers responded differently while on study, and that overall patient disease activity differed on trial compared with the pre-trial assessment period. Analysis of secondary outcomes indicated that statistically significant differences in proportions with progression (defined as an increase on Expanded Disability Status Scale of ≥ 1 if baseline ≥ 5, and 1. The authors also explored a definition of progression of an increase of only 0. Using this definition, the probability of progression was significantly lower with glatiramer acetate compared with placebo only at the 24-month time point (44. Do disease-modifying treatments for multiple sclerosis differ in their effects on the development or recurrence of interferon beta neutralizing antibodies? Summary of the Evidence ® • Interferon beta-1a IM (Avonex ) appeared to have the lowest immunogenicity, with rates of development of neutralizing antibodies of 2% to 8. Disease-modifying drugs for multiple sclerosis Page 46 of 120 Final Report Update 1 Drug Effectiveness Review Project Detailed Assessment Neutralizing antibodies are known to develop in some patients taking beta interferons, potentially interfering with effectiveness. Two systematic reviews summarized the current state of understanding about the impact 98, 99 of these antibodies on relapse and disease progression, and how the products differ. There were several factors that can impact the prevalence of such antibodies, including assay method (varying sensitivity/specificity), dose (conflicting evidence), host cell source (Escherichia coli more antigenic than mammalian source), definition of positive status, and route of administration (subcutaneous more antigenic than intramuscular). Because there is no standardized universal assay, comparisons across studies of the beta interferons is fraught with uncertainty. It appears that the rate of antibody development occurs earlier and in greater frequency with interferon ® beta-1b SC (Betaseron ), appearing as early as 3 months into treatment in approximately 30% to 99 40% of patients. Evidence reported in the Namaka review indicated that antibodies occur ® somewhat later (9 months) with interferon beta-1a SC (Rebif ), with rates as low as 12% and as ® high as 46% (see Table 18). Interferon beta-1a IM (Avonex ) appeared to have the lowest immunogenicity with rates of 2% to 8. Importantly, 40% to 50% of antibody-positive patients will become antibody-negative over time, while small numbers of patients will become antibody-positive into the second year of treatment. Comparison of neutralizing antibodies in beta interferon products Avonex Betaseron Rebif Percent developing neutralizing 2% to 6% 30% to 40% 12% to 25% antibodies First 3-6 months, can Time to appear First 9-15 months First 9-15 months occur up to month 18 Data from 9 comparative observational studies reporting the presence of neutralizing 100-108 antibodies in patients taking beta interferons are shown in Table 19 below. The proportion ® of patients developing antibodies was lower for interferon beta-1a IM (Avonex ), 0% to 14%, ® compared with 11% to 44% with interferon beta-1a SC (Rebif ) and 15% to 44% with interferon ® beta-1b SC (Betaseron ), consistent with findings from the Namaka systematic review. The usefulness of these studies in making comparisons across drugs was limited because most did not study patients on therapy for more than 2 years. Disease-modifying drugs for multiple sclerosis Page 47 of 120 Final Report Update 1 Drug Effectiveness Review Project Table 19. Proportion of patients testing neutralizing antibody-positive after beta interferon therapy reported in comparative observational studies Association of clinical Author, Duration of outcomes with neutralizing ® ® ® year treatment Avonex Betaseron Rebif antibody status More relapses in neutralizing 16/131 Boz, 2007 >3 years 0/12 (0%) 18/119 (15%) antibody-positive patients in (12. Relapse rates higher in Farrell, 24/292 neutralizing antibody-positive >3 years 4/242 (6%) 11/115 (28%) 2008 (30%) groups, risk greater in those with higher titres Median 26 No significant association Dubois, 10/23 months, range 0/18 (0%) 12/32 (38%) between antibody status and 2006 (44%) 2-85 months outcomes. Kivisakk, No effect of neutralizing 1-46 months 1/20 (5%) 21/48 (44%) 2000 antibodies on clinical outcome Koch- 21,963 Effect of neutralizing antibody N=417 N=892 Henriksen months of status on relapses did not differ 33. They are not discussed in detail here because 80, 107, they provided no additional evidence beyond the Namaka and Goodin systematic reviews. What is the evidence that interferon beta neutralizing antibody status has an impact on clinical outcomes (relapse and disease progression) in patients with multiple sclerosis? Summary of the Evidence ® ® • Evidence for interferon beta-1b SC (Betaseron ) and interferon beta-1a SC (Rebif ) indicated that consistent positive neutralizing antibody status with high titer adversely affected the impact of these drugs on relapse rates, by one-half to two-thirds, during longer periods of follow-up. Detailed Assessment The duration of many studies was not adequate to assess the impact of antibody status on progression clearly. Namaka et al found that in the first 2 years of treatment a difference in outcome based on antibody status could not be identified, but that relapse rates were lower in years 3 and 4 among patients who were antibody-positive (Table 20). The review by Goodin et 98 al also found that relapse rates were affected by positive neutralizing antibody status of high titer only in studies of 2 years or longer in duration. The evidence for the impact on disease progression was less compelling, with only 2 of 8 studies showing a significant increase in progression among those with neutralizing antibodies. Duration of treatment and clinical impact of antibody status Interferon β-1b SC Interferon β-1a SC ® ® ® Duration (Betaseron ) (Rebif ) Interferon β-1a IM (Avonex ) nd “correlation not 1. Two trials published subsequent to the Goodin and Namaka systematic reviews reported rates of interferon beta neutralizing antibodies occurring in enrolled patients. Most of these may not have been of sufficient duration to show clinical effects of antibody development, however. In the EVIDENCE trial, which compared interferon high-dose, high-frequency interferon beta-1a ® ® (Rebif ) 44 mcg to low-dose interferon beta-1a IM (Avonex ) 30 mcg over 2 years, neutralizing ® antibodies were detected at least once in 26% of patients receiving high-dose Rebif and in 3% ® of those receiving low dose Avonex (P<0. Neutralizing antibodies developed earlier with high-dose treatment (58% by week 24, compared with 14% in the low-dose group). Relapse rates 45 were similar in antibody-positive and antibody-negative patients. The proportion of patients developing neutralizing antibodies was reported in the ® REGARD study of interferon beta-1a (Rebif ). The rate was 60/138 (16%) at 24 weeks, 93/355 Disease-modifying drugs for multiple sclerosis Page 49 of 120 Final Report Update 1 Drug Effectiveness Review Project (26%) at 48 weeks, 91/319 (29%) at 72 weeks, and 102/374 (27%) at 96 weeks or last observation carried forward. Neutralizing antibodies had no effect on clinical efficacy: there was no difference in time to first relapse for those positive at any time and those negative (hazard ratio, 1. Although there was an association between neutralizing antibody status and clinical outcome shown in several studies, none found the detrimental effect of positive antibody status to be greater with one of the beta interferons than another. The conclusions that could be drawn from these studies were limited for several reasons: most were not of sufficient duration to show an effect of neutralizing antibodies on clinical status, the numbers of patients taking each drug may not have been sufficient to show a difference between treatments, and lack of control for confounding factors limited the validity of their results. Evidence correlating comparative clinical outcomes to the antibody status of the individual beta interferons was incomplete and inadequate to make conclusions. Longer-term trials will be needed to clarify the role of this difference in antigenicity and its correlation of clinical outcomes over longer periods of time. Development of antibodies to natalizumab An analysis of the AFFIRM and SENTINEL trials reported the incidence and clinical effects of 117 antibodies to natalizumab that developed over 2 years of therapy. In AFFIRM, 57 of 625 patients (9%) tested positive for antibodies at any time during the study; 3% were transiently positive and 6% were persistently positive throughout the study. Most (88%) patients developed antibodies by week 12 of treatment. Results were similar in SENTINEL, in which natalizumab was added to interferon beta-1a therapy, with 12% of patients testing positive for antibodies to natalizumab during the 2-year study, 5% transiently positive, and 96% showing antibodies by week 12 of treatment. In AFFIRM, 34% of patients who were persistently antibody-positive had sustained disability progression, compared with 17% of patients who were antibody-negative.

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Keep both incisions open with a glove tion and trauma) cheap 800 mg viagra gold with visa. Explain about the benign nature drain of the syndrome discount viagra gold 800 mg with amex. Advise use of a firm bra and the 307 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS (a) use of non-steroidal anti-inflammatory drugs (NSAIDs) in case of severe pain (e viagra gold 800 mg on line. Local application of progest- erone (gel) may help where it is available. In cases where contraceptives are used this may reduce symptoms. Contraceptives with higher gestagens, including injectables, may decrease symptoms after an initial (around 3 months) phase of increasing symptoms4. Benign tumors The most common benign tumors in premeno- pausal patients (mostly around the age of 20 years) are fibroadenoma. Fibroadenoma usually grow slowly, are firm and mobile on palpation and often multiple in appearance. Growth is accelerated in (b) adolescence, during pregnancy and before meno- pause. Breast cancer or phyllodes tumor must be considered as a differential diagnosis but there is no risk of developing cancer from a fibroadenoma. In cases of rapid growth, large size (>4 cm) or concern of the patient, surgical removal is indicated. Fibro- adenoma may be larger (>5 cm) in the African pop- ulation. The excision can usually be done under local anesthesia. Extirpation should be in toto; histo- logy will confirm the diagnosis. An operation on a fibroadenoma in a young women is illustrated in Figure 8. The patient complained of a mobile mass in the right breast. On clinical examination, no axillary lymph nodes were present (Figure 8a, b). On ultra- sound, fibroadenoma was strongly suspected with (c) no signs of malignancy. The surgical technique of fibroadenoma extirpation is as follows: position the patient’s arm outwards at a 90º angle. If the mass is located at the lower quadrants, a submammary in- cision may be chosen. Otherwise a semicircular para-alveolar incision gives better cosmetic results. Identify and incise the submammary fold (Figure 8c). As fibroadenoma are usually very mobile, fix the tumor with your fingers or let your assistant do this. Dissect the fatty tissue and breast tissue on top of the fibroadenoma with dissecting scissors until you reach the capsule of the tumor (Figure 8d). Dissect the thin layers of the capsule carefully with dissecting scissors or bluntly by using your index finger to avoid removing too much normal breast tissue (Figure 8e). The fibroadenoma is Figure 7 Patient with tuberculosis of the left breast. Usually a 308 Benign Disease of the Breast (a) (d) (e) (b) (f) (c) Figure 8 See caption on following page pedicle is found at one end of the fibroadenoma. Breast tissue in premenopausal women Lipoma may also appear in the breast. Take great care in hemostasis are soft on palpation, may grow considerably and to avoid hematoma. A postoperative bandage can lead to asymmetric breast volume. The fibro- surgery one should carefully identify the margins of 309 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS (g) (i) (h) (j) Figure 8 An operation on a fibroadenoma in a young woman. Courtesy of: (a–g, j) Erik Erichsen, Ethiopia; (h) Regina Grosse, Germany; (i) Joerg Buchmann, Germany the lesion in order to avoid removal of too much or lesions, the pathologist should identify non- too little tissue since the fat of the breast is similar proliferative lesions, proliferative lesions without to the fat of the lipoma. Around 4% of benign palpable lesions will have proliferative disease. Women with proliferative dis- Fibrocystic changes ease, especially with atypia, have a greater risk of This is a remodeling of the breast tissue that takes developing breast cancer (up to five times higher place in women 20–50 years of age. Due to excessive than the general population, a higher risk for pre- estrogen levels compared to progesterone fibrotic menopausal women, a higher risk with a first- changes, epithelial proliferation, widening of milk- degree relative with breast cancer; the risk will ducts and formation of cysts may occur. This may decline after the discovery of the lesion). This is the follow-up of the patient (especially the young pa- most common benign disease of the breast. Otherwise including adenosis, epithelial hyperplasia with or routine follow-up is recommended (CBE) – there without atypia, apocrine metaplasia, radial scar or is no detailed evidence on the frequency, 6–12 papilloma. In cases of histologically confirmed months seems feasible. Unilateral, sometimes bilateral (in cases of bilateral papilloma) bloody or serous secre- tions from the nipple are seen. Be aware that papil- loma may have proliferative epithelium and become malignant. Cytology should be done before any intervention (see Chapter 30 on how to do that). An excision of the duct should be done in cases of suspicious cytology or persistent bloody secre- tion. When the patient is under general anesthesia, a few milliliters of methylene-blue are injected into the duct opening in the areola where the secretion is coming from to mark the correct duct. Take care that the dye stays for 20–30 min inside the duct! Therefore the skin incision should be performed in a semicircular manner parallel to the areola (e. Carefully explore the area behind the nipple to identify the blue milk duct. The structure is fragile directing to one of the breast quadrants. The small papilloma (most likely not visible as such) is sitting at the end of the occluded duct.

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