Browsing by Subject "systematic review"
Now showing items 1-7 of 7
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(2018)This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.
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(2019)Despite the long history of skin grafting, there is no standardized treatment for split-thickness skin graft donor sites. These sites cause a notable amount of pain and discomfort to the patients and open wounds also introduce a risk for infection. There is an extensive need for treatment options promoting the fastest and least painful healing possible while also being infection-free. The treatment of split-thickness skin graft donor sites is constantly studied and there is plenty of scientific literature available about this topic. In the theory section of this Master’s thesis, the structure of skin, the process of wound healing, skin grafting surgery and wound care products for split-thickness skin graft donor sites are briefly introduced. Additionally, the method of systematic review is described. In the empirical section, a systematic review is performed to compare animal- and non-animal-based wound care products in the treatment of split skin graft donor sites. The methodological quality of the included studies is reviewed. In the literature search, 3552 references were found. In this systematic review a total of 23 articles were included comprising of 21 comparative clinical studies and two previous literature reviews. Of the original studies, 20 reviewed healing, 14 infection and 17 pain of the split-thickness skin graft donor sites. Based on the results of the systematic review, animal-based wound care products might promote healing and reduce pain experienced by patients in the treatment of split-thickness skin graft donor sites when compared with non-animal-based wound care products. The results concerning infection were inconsistent. Generally, the reporting of the clinical original studies was not comprehensive enough for proper evaluation of methodological quality. Some defects, mostly in the blinding of the patients, study personnel and the assessors of outcomes, were also found. Moreover, the studies were heterogeneous in their definitions and measuring of the reported outcomes. Therefore, there is substantial uncertainty in the results of this systematic review. The systematic and transparent way of conducting the literature search, the review of the methodological quality and the reporting of the outcomes can be considered as a strength of this thesis. The main weakness is, that only one person performed the critical steps of this study, which might increase the risk of bias and reduce the repeatability of the study.
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(2017)The economic burden of adverse events (AEs) is substantial and in direct relation to current increasing drug utilisation. According to previous research, the annual cost of AEs in the U.S. may be as high as 22.9 billion euros. In Europe AEs are considered to contribute to 3.6 percent of hospital admissions, have an impact on 10 percent of inpatients during their hospital admission and are responsible for less than 0.5 percent of inpatient deaths. AEs thus clearly constitute a major clinical issue. Fluoroquinolones have been in clinical use since the 1980s and are globally among the most consumed antimicrobials. Fluoroquinolones are generally well tolerated antimicrobials. The most common AEs are mild and reversible, such as diarrhea, nausea and headaches. Nevertheless, fluoroquinolones are also associated with more serious AEs, including Clostridium difficile associated diarrhea (CDAD), rate-corrected electrocardiographic prolonged QT interval, tendinitis and tendon rupture, dysglycemia, hepatic toxicity, phototoxicity, acute renal failure and serious AEs involving the central nervous system, such as seizures. Health service use and costs specifically associated with fluoroquinolone-related AEs have not been evaluated previously. The theory section of this Marter's thesis considers adverse events and fluoroquinolones. The main principles of conducting a systematic review are also discussed. The empirical section is a systematic review. The aim of this study is to identify health care use and costs associated with ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin -related AEs. A literature search covering Medline, SCOPUS, Cinahl, Web of Science and Cochrane Library was performed in April 2017. Two independent reviewers systematically extracted the data and assessed the quality of the included studies. All costs were converted to 2016 euro in order to improve comparability. Of the 5,687 references found in the literature search, 19 observational studies, of which 5 were case-controlled, fulfilled the inclusion criteria. Hospitalization was an AE-related health care use outcome in 17 studies. Length of stay associated with AEs varied between <5 - 45 days. The estimated cost of an AE episode ranged between 140 and 18,252 €. CDAD was associated with the longest stays in hospital. However, a mere 10 studies reported AE-related length of stays and only 5 evaluated costs associated with AEs. Although rare, in particular serious fluoroquinolone-related AEs can have substantial economic implications, in addition to imposing potentially devastating health complications for patients. Further measures are required to prevent and reduce health service use and costs associated with fluoroquinolone-related AEs. Equally, better-quality reporting and additional published data on health service use and costs associated with AEs are essential. The strengths of this study are a comprehensive and systematic literature search and transparency of methodologies and reporting. The main weakness is the generalizability of the results.
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(2018)Medication-related events are a significant cause of in-hospital adverse events. Intravenous medication errors occur more frequently and are more likely to result in serious harm than other medication therapies. Closed loop medication management which seamlessly integrates automated and intelligent systems barriers, is used for reducing medication errors. The aim of this systematic review was to identify what kind of scientific studies exist regarding closed loop medication in intravenous medication therapy and barriers related to it. This study is part of a larger systematic review. The literature search indentified 2292 scientific papers. Of these, only 57 were included in the larger review since most of the references were excluded based on titles, abstracts or full-texts. Of these, 21 studies regarding closed loop medication management in intravenous medication therapy were included in this thesis. The studies conserned intelligent infusion devices, computerized physician order entries, clinical decision support systems, automated workflow management systems reducing compounding errors and bar-code confirmation of drugs and patients. According to this review, closed loop medication management potentially reduces medication errors related to intravenous medication therapy. It seems to be more effective to seamlessly integrate the closed loop medication management barriers to each other and to the medication management process than to implement the barriers separately. It’s important to plan the implementation carefully by a multidisciplinary team. In addition, the latest care guidelines need to be taken in to account. Significant resources must be allocated to training and engaging employees and to systematically maintaining and developing the process to manage the successful implementation of the process. This review provides valuable information for Finnish hospitals implementing the closed loop medication management since the concept is not yet well-known in Finland.
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(2016)Breast cancer is the most common cancer among women, about 25 % of all cancers in women. 15 - 20 % of them are HER2 positive. HER2 is a transmembrane protein receptor with tyrosine kinase activity. When the overexpressed receptor is activated it turns on a cascade which results to activation of genes coding for for the growth of the cancer cells. Drugs against HER2 protein have significantly improved the survival of patients with HER2 positive breast cancer. In this systematic review the epidemiology, diagnostics and the principles of treatment is reviewed with focus on the treatment of HER2 positive breast cancer and anti-HER2 medications. Endpoints of clinical trials and handling the data are also reviewed. The aim of this study is to collect data of lapatinib, pertuzumab and trastuzumab emtansine in randomized clinical trials studying progression free survival, overall survival and adverse effects of patients with metastatic HER2 positive breast cancer. As a result of the literature search 22 whole text articles were found. There were 14 of randomized clinical trials, 2 of previous systematic reviews and 6 of meta-analysis. The facts and results of the selected studies were collected in tables. The quality of the studies was evaluated with CONSORT and PRISMA guidance. Lapaninib is used mainly for treatment of patients with resistanse to trastuzumab. Lapatinib improves the progression free survival and overall survival but the effect has not been as goog as expected. Lapatinib is better than chemotherapy but worse than trastuzumab in the treatment of metastatic HER2 positive breast cancer. Combinaition therapy is better than none of these alone. Lapatinib is a small molecule tyrosine kinase inhibitor. Pertuzumab and trastuzumab emtansine are monoclonal antibodies targeting HER2 receptor. In trastuzumab emtansine there is also a cytotoxic drug which is delivered into the cancer cell. Pertuzumab is effective in the treatment of metastatic HER2 positive breast cancer and it improves the survival also after treatment with trastuzumab. Pertuzumab is now approved also as neoadjuvant. Promising results has been published with trastuzmab emtansine in the treatment of heavily medicated patients with progressive disease. Adverse effects were abundant but usually manageable and reversible. The quality of the studies was mainly good. Some limitations were noticed, especially in reporting methods. Cancer therapy with targeted medication improves the effect of the treatment and decrease systemic adverse effects. It seems that the use of lapatinib is going to be mostly complementary when more promising pertuzumab and trastuzumab emtansine turned up to be more effective in the treatment of metastatic HER2 positive breast cancer. In the future there should be more clinical experience with the use of lapatinib, pertuzumab and trastuzumab emtansine. That would guarantee a cancer patient the most effective treatment, hopefully at the early stage of cancer.
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(2014)Various cardiovascular diseases cause a significant portion of the direct healthcare costs. For this reason it is important to develop effective treatment strategies. In the treatment of heart failure maintaining healthy lifestyle is an important issue in addition to medical treatment. The aim of this study is to find out whether multidisciplinary interventions in the treatment of heart failure have had better patient outcomes and/or cost savings compared to the standard care and has a certain intervention method proved itself to be more effective than another. The study focuses on the published material in the last ten years, which is compared with prior systematic review about the same topic. The study was conducted as a systematic review. The literature search was performed on Medline (Ovid), CINAHL and Scopus databases. MeSH-terms and other keywords were used in the search. Search was limited to English-language studies. The article selection was made after 06.01.2004 published studies based on the inclusion and exclusion criteria. A quality assessment was made to the selected articles. Only valid articles exceeding 60 % of the maximum points were selected to this review. Literature search found 848 references, of which quality assessment was carried out for 17 articles. 12 articles were selected to this review. Based on statistical significance mortality rate was reduced only rarely. There were lots of heterogeneity in the results for reducing hospitalizations or improving the quality of life. Hospital or clinic-based interventions seemed to be slightly more effective than other intervention methods. There have been no major changes in the intervention methods, only the methods using mailed materials have been left out. Also the outcomes used are similar to those in the past, although validated instruments in different areas of determining the effectiveness have not been developed. This study found no clear evidence about the effectiveness of the treatment programs. Hospital or clinic-based interventions might be more effective than other intervention methods. There is a lot of research about the issue, but high-quality cost-effectiveness studies are lagging. The results from different studies are hard to integrate because the ways to measure vary. The effectiveness of the intervention depends on many factors, and the sheer increase in the knowledge does not seem to be crucial. For assessing the profitability of multidisciplinary interventions there is a need for a high-quality research about the cost-effectiveness of the treatment programs.
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(2017)Hepatitis C virus disease is transmitted through blood. Chronic hepatitis C causes liver damages such as liver fibrosis, liver cirrhosis, and hepatocellular carcinoma. It is estimated that there are approximately 20 000 - 30 000 patients infected with hepatitis C virus in Finland. For many years pegylated interferon and ribavirin has been standard of care. However standard of care causes side effects and an adequate treatment response can't be achieved with it. There have been effective direct-acting antivirals available on market which are directed against structural proteins and enzymes of the virus from 2014 onward. These second generation direct-acting antivirals are effective, safe and well tolerated. The only disadvantage is the high price of these medicines which restricts them for severe liver damage patients. More information about cost-effectiveness of second generation direct-acting antivirals is needed to support the decision making. The aim of this master thesis is to describe current care, guidelines, and costs of hepatitis C in Finland. Thesis also describes the principles of economic evaluation and systematic literature review. The purpose of the thesis is to assess cost-effectiveness of second generation direct-acting antivirals versus standard of care in treating of hepatitis C by means of systematic literature review and evaluate the quality of cost-effectiveness analyses. Previously published studies were used to analyze the cost-effectiveness of second generation direct-acting antivirals. In total of 435 references were found through systematic literature search. In addition, two studies were found from the bibliographies of already included studies. Altogether 26 studies were included in the systematic review of which 25 were original studies and one was previously published systematic literature review. The most relevant data of the studies was gathered and analyzed. The quality of the studies was assessed by using three checklists. It is difficult to make conclusions about cost-effectiveness of second generation direct-acting antivirals based on previously published reviews because only one review was found through systematic literature search. The incremental cost-effectiveness ratio (ICER) of second generation direct-acting antivirals varied between dominance and 1 135 655 € /QALY compared to standard of care. When compared to another second generation direct-acting antiviral, ICER of second generation direct-acting antivirals varied between dominance and 65 281 € /QALY. It was also analyzed how stage of liver damage affects the incremental costeffectiveness of second generation direct-acting antivirals. The ICER of second generation direct-acting antivirals was between 299 € - 85 195 € /QALY when treating patients with cirrhosis. When treating non-cirrhotic patients, the ICER of second generation direct-acting antivirals was between 2182 € - 177 679 € /QALY.The connection between funder of the study and the ICER of second generation direct-acting antivirals was also analyzed. The ICER was 1717 € - 86 056 € /QALY in studies funded by pharmaceutical company. The ICER was 299 € - 1 135 655 € /QALY in studies funded by other party. Based on the results of the thesis second generation direct-acting antivirals might be cost-effective compared to current standard of care in treating hepatitis C. The cost-effectiveness ratio of second generation direct-acting antivirals is lower in cirrhotic patients than in non-cirrhotic patients. The incremental cost-effectiveness ratio is lower when pharmaceutical company funds a study. The quality of the cost-effectiveness analyses included in the thesis varied greatly which makes it difficult to draw conclusions and interpretate the results. This study has several strengths. First, literature search was conducted systematically and transparently. Second, quality of the reviewed studies included was assessed by care. Finally, reporting of the results is transparent and repeatable. The study has also some limitations. Selection of the reviewed studies, data extraction and quality assessment of the studies was conducted by one person which may increase the possibility of human error.
Now showing items 1-7 of 7