Browsing by Subject "effectiveness"
Now showing items 1-15 of 15
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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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(2020)Objective. The FRIENDS programme is a group cognitive behavioural therapy (CBT) programme, developed for the prevention and treatment of child and adolescent anxiety and depression. In the context of prevention, FRIENDS has been extensively researched; however, little research has been conducted on FRIENDS in a treatment setting and with different populations. To help fill this gap, the aim of the present study was to evaluate the effectiveness of the Finnish version of FRIENDS in reducing internalising symptoms in children diagnosed with psychiatric and neuropsychiatric disorders. Methods. The present study was conducted at Helsinki University Hospital (HUS) Child Psychiatry outpatient clinics in the Helsinki metropolitan area, Finland. The participating children (n = 99, mean age = 9.45 years, range 6–13 years, 68.7 % boys) were randomly assigned to either FRIENDS (n = 52) or a waitlist control group (n = 47), which received treatment as usual for a period of 3 months before the intervention. The children’s internalising symptoms were assessed using parent- and teacher-report questionnaires (Child Behavior Checklist and Teacher’s Report Form) at referral to treatment, pre-treatment, post-treatment, and six-month follow-up. Results and conclusions. In both groups, there was a medium-sized statistically significant decrease in parent-reported internalising symptoms immediately after the intervention; however, these improvements were not retained at six-month follow-up. Teacher-reported internalising symptoms followed a similar pattern of decrease during the intervention and increase during follow-up; however, these changes were smaller in magnitude and did not reach statistical significance, possibly due to loss of statistical power caused by missing data. Neither parent- or teacher-reports showed an intervention effect, with children’s internalising symptoms exhibiting similar changes regardless of whether they belonged to the intervention group or the waitlist control group, which received treatment as usual during the wait period. These results raise questions on the durability of treatment effects and the superiority of FRIENDS over active waitlist control conditions or treatment as usual when treating children diagnosed with diverse psychiatric and neuropsychiatric disorders in a community setting where treatment adherence and integrity may not be ideal.
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(2020)Objective. The FRIENDS programme is a group cognitive behavioural therapy (CBT) programme, developed for the prevention and treatment of child and adolescent anxiety and depression. In the context of prevention, FRIENDS has been extensively researched; however, little research has been conducted on FRIENDS in a treatment setting and with different populations. To help fill this gap, the aim of the present study was to evaluate the effectiveness of the Finnish version of FRIENDS in reducing internalising symptoms in children diagnosed with psychiatric and neuropsychiatric disorders. Methods. The present study was conducted at Helsinki University Hospital (HUS) Child Psychiatry outpatient clinics in the Helsinki metropolitan area, Finland. The participating children (n = 99, mean age = 9.45 years, range 6–13 years, 68.7 % boys) were randomly assigned to either FRIENDS (n = 52) or a waitlist control group (n = 47), which received treatment as usual for a period of 3 months before the intervention. The children’s internalising symptoms were assessed using parent- and teacher-report questionnaires (Child Behavior Checklist and Teacher’s Report Form) at referral to treatment, pre-treatment, post-treatment, and six-month follow-up. Results and conclusions. In both groups, there was a medium-sized statistically significant decrease in parent-reported internalising symptoms immediately after the intervention; however, these improvements were not retained at six-month follow-up. Teacher-reported internalising symptoms followed a similar pattern of decrease during the intervention and increase during follow-up; however, these changes were smaller in magnitude and did not reach statistical significance, possibly due to loss of statistical power caused by missing data. Neither parent- or teacher-reports showed an intervention effect, with children’s internalising symptoms exhibiting similar changes regardless of whether they belonged to the intervention group or the waitlist control group, which received treatment as usual during the wait period. These results raise questions on the durability of treatment effects and the superiority of FRIENDS over active waitlist control conditions or treatment as usual when treating children diagnosed with diverse psychiatric and neuropsychiatric disorders in a community setting where treatment adherence and integrity may not be ideal.
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(2019)Objective. Transdiagnostic models of psychopathology assume that the commonalities across disorders may outweigh their differences. While these models acknowledge that disorder-specific symptoms and features undoubtedly exist, the same underlying factors are perceived to cause and maintain various disorders. In recent years, this approach has received growing attention and several new forms of therapy have been developed based on it. These may be well-suited for the treatment of mixed-diagnosis groups or individuals with comorbid disorders, and as such, they hold the promise of being very cost-effective. One of the most established transdiagnostic treatments is the Unified Protocol (UP), designed to help patients suffering from depression and the full range of anxiety disorders. The purpose of the present study is to review the evidence regarding the efficacy and effectiveness of the UP for the transdiagnostic treatment of adult anxiety and depression. Methods. For this review, systematic literature searches were performed using the PsychInfo and PubMed online databases in October 2018. The search term used was “Unified Protocol”. The search yielded 114 results in PsychInfo and 138 in PubMed. Ten of these matched the following study selection criteria and were included in the current review: a) the study measured either the efficacy or effectiveness of the cognitive-behavioral UP therapy developed by Barlow (2011), b) treatment was delivered face-to-face in either individual or group setting, c) treatment followed the UP therapist guide without major modifications, d) participants suffered from an anxiety disorder or depression, e) participants were over 18 years of age, d) the study was published in 2015 or later, and f) the study was published in English in a peer-reviewed journal. Results and conclusions. The UP appeared both efficacious and efficient in reducing the severity of adult anxiety and depression as well as the number of comorbid diagnoses; however, there were some conflicting findings regarding recovery rates and effect sizes. The results achieved were comparable to those achieved using diagnosis-specific cognitive-behavioral therapy. The UP treatment had a positive impact on the patients’ functioning and quality of life and the amount of positive and negative affect they experienced. Treatment retention was generally high, particularly when treatment was delivered individually, and the UP received high ratings from those who participated in the studies. All in all, the current empiric evidence regarding the UP appears fairly promising. However, these results must be interpreted with caution, as the research concerning the UP is still in its infancy and a large part of it has been conducted by researchers affiliated with the treatment.
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(University of HelsinkiHelsingin yliopistoHelsingfors universitet, 2007)The Purpose of the Finnish Hygiene Act (The Act on Food Hygiene of Foodstuff of Animal Origin 1195/1996), which was in force until the beginning of March 2006, was to ensure the hygienic quality of foodstuffs of animal origin and prevent the spread of infections from animals to humans via foodstuffs. The Hygiene Act applied to handling, hygienic quality requirements and inspections prior to retail of foodstuff of animal origin. The aim of official food control is to ensure that establishments fulfil the requirements imposed on them by the legislation. According to The Hygiene Act, abattoirs and establishments connected to them were controlled by an official veterinarian working for The National Food Agency, and other establishments controlled by the municipal authorities. Each municipality or federation of municipality was responsible for the official control in its own region. The inspection frequencies depended on the type of establishment, but all establishments had to be inspected regularly. The purpose of this study was to investigate how official control was perceived in establishments covered by the Hygiene Act in terms of effects and congruence of the official control and guidance received from the authorities. The aim was also to investigate the influence of control frequency on perceptions on effects, congruence and guidance. The research was performed in spring 2006 using a questionnaire, which was issued to all establishments in meat branch, establishments handling fishery products, dairy plants, egg packing centres and warehouses of foodstuffs of animal origin registered as approved establishments by The National Food Agency in 2005. 459 answers were received, which was 36 % of the questionnaires sent. The results show that the food control had improved the hygiene of the establishments according to the perceptions of the establishments. Product safety was considered to be improved by the official control more in small and medium-sized establishments than in large establishments. EU-establishments in meat branch have made more changes to their production processes and line of production due to food control than other types of establishments. Approximately one half of the respondents were unable to provide a view on congruence of official control. Incongruence was experienced most frequently in low-capacity slaughterhouses. High inspection frequency was found to be connected to the experience of incongruence. The higher the inspection frequency, the higher was the perceived incongruence of official control. Most establishments were satisfied with the amount of guidance concerning the legislation they had been given by the official inspector. However, more guidance was needed on the planning of the own-check, construction of production facilities, expansion and repair of production facilities and correction of the shortcomings found during inspections. The frequency of inspections was also found to have an effect on perceived benefit of official control. The more frequent the control inspections performed by the municipal control authorities were, the higher was the perceived positive impact on hygiene.
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(2009)Sustainable forestry has been the primary principle of Finnish forest policy for decades. However the concept has extended to areas of ecological and socio-cultural sustainability alongside with the more usual economic sustainability. Goals for the use of forests have multiplied and made an impact on forest legislation and policy programmes. Timber production remains as the main objective of forest policy but other objectives, such as carbon sequestration and preservation of forest biodiversity, have also reached the policy agenda. The co-production of material and immaterial goods in forests is not straightforward and the conflicts can prevent a consistent implementation of sustainable forestry. The purpose of the study is to develop a comprehensive evaluation matrix (or table) in order to determine the logic and structure of forest policy instruments. The matrix comprises the evaluation of goals, motivation, effects and effectiveness of instruments. Theories considering process and impact evaluations are used in the analysis. Furthermore, the table is tested in practice by examining the following three policy instruments: 10§ of the Forest Act, public funding for tending of young stands and public forest planning. Content analysis was used in examining the data set of policy documents. The evaluation matrix enables a systematic assessment of policy instruments. It provides information on the consistency of the aim and effects of the instrument. Certain points in the table were sometimes difficult to fill in, but the reason can be in the structure of the instrument that public documents provide rather than in the structure of the matrix. In general, more detailed information on policy goals and motivation of the instruments would make public forest policy more transparent. In addition, the use of indicators that measure effectiveness should be further increased for easier evaluation of policy effectiveness.
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(2011)Objective The objective of this study was to learn about the psychosocial well-being and life management of Finnish adults with late deafness or hearing loss and to observe the effectiveness of the rehabilitation courses they participated in. Methods For my study I used indicators which were suitable for the evaluation of life management and psychosocial well-being of late-deafened adults. The first part of the study was conducted during 2009 as a questionnaire on three rehabilitation courses in Kopola, a course center of the Finnish Federation of Hard of Hearing. The follow-up study was done at the third period of the courses during 2009 2010. The questionnaire contained both open and structured questions. The questionnaire consisted of five areas concerning life management and psychosocial well-being: sense of coherence (life management), human relations and social support, mood, self-esteem and satisfaction with life. I also asked the participants to reflect on their experiences of group rehabilitation. Results and conclusions The participants consisted of seven women and three men. They were approximately 63 years old and were all retired. Loss of hearing was described to have affected their social life, free time, and in general made their lives more difficult. From the course the participants hoped to gain new skills such as signed speech and lip-reading, uplift their mood, accept their loss of hearing and experience peer support. After the courses they replied that they had more close relations with whom they also were a little more in contact with. More participants were satisfied with e.g. their ability to take care of themselves, their free time, financial situation, family life, mental resources and physical shape. Majority of the participants showed symptoms of depression when the courses started, but at the end of the courses these signs had moderated or disappeared for most of them. The participants felt that during the rehabilitation they had been heard, respected, accepted and been taken care of. The course provided the possibility for confiding, and the discussions gave the participants support and consolidation. In conclusion, the course affected positively on the acclimatization to the hearing loss and the empowerment of the participants. The results of this study can be utilized in disability services, the development of rehabilitation and in the social- and health services of senior citizens.
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(2020)The Forest Academy for Decision-makers is a well-known concept. It is necessary to evaluate the concept occasionally as it was created already in 1995. The goal of the Forest Academy is to increase dialogue between forest sector and rest of society by providing a forum to arouse interest towards forest issues and the possibilities that the field can provide for society, create new networks and provide stimulations for forest professionals from other sectors. Interaction, high-class presentations and attractions and the unique course spirit are in the core of the concept. I have evaluated the impact and effectiveness of the Forest Academy forums in this quality study. I have studied weather the concept has been able to affect in decision making or has something been achieved in the forest sector or wider in the society by utilizing networks or substance from the courses. I have interviewed course participants in 2016. Additionally, I have analyzed the course themes and how those have been changed during the past 20 years. I have used the previous evaluation study of the Forest Academy forums for planning this study and it is also valuable to compare results between these studies. The Forest Academy has improved the understanding of the Finnish forest sector among decision-makers. The acceptability of the forest sector and forest utilization and the national consensus in forest issues have strengthened by the Forest Academy. It has offered a memorable four-day-course experience for over thousand decision-makers. The concept has worked effectively as it has created new networks, added knowledge of the forest sector, and introduced how pervasive the forest and natural resource sector is. The results support the future demand for this kind of forum. At the same time, it is important to reach appropriate, effective, and committed participants for the upcoming courses. However, the concept needs developing as society and operational environment has become more hectic and global, forest sector is nowadays part of the bioeconomy and the whole natural resources and bioeconomy field faces strong expectations how to tackle the climate change and maintain biodiversity. The Forest Academy would need to answer more and more complex and wider topics. It demands development of the concept structure, encourage for interdisciplinary collaboration with various interest groups, even more interactive working during the courses, and bolder visions of the future role of forests. However, the basic knowledge of the forest related issues cannot be neglect. Forest Academy would need to consider, how to coordinate continuous and more determined developing, which takes into account the different operational environment than 20 years ago. The Forest Academy should still regard that the two-way communication really works in practice.
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(2021)Intercultural communication competence entails “effective,” “successful” and “appropriate” interaction across cultural contexts. Interpersonal communication competence is central in dyadic social interaction. In addition to these concepts, the central definitions in this study are concepts of effectiveness and appropriateness related to communication competence This study aims at shedding light in the perceptions of the scholars in Villa Karo of their interpersonal communication competence in collaborative interaction with the local residents in Grand Popo, Benin. The data was obtained via semi-structured interviews conducted in November – December 2020. Seven interviewees, who had spent time as scholars in Villa Karo, were recruited via Villa Karo office in Helsinki. The data was analysed by using thematic analyses. Through coding three themes were identified in the data: language use, relationship building as competence and reflections of perceived appropriateness. The results show that the scholars had little expectations and knowledge about the culture in advance, but yet reported managing communication well in relation to the goals of the project. They all reported perceiving their interpersonal communication in their collaborative interaction as effective, meaning achieving desired, preferred outcomes in communication. The accounts of being appropriate communicators, meaning that the scholars knew how to behave and communicate according to expectations and demands of the situation were more ambiguous. All interviewees reported that their project work was actualised as planned.
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(2021)Intercultural communication competence entails “effective,” “successful” and “appropriate” interaction across cultural contexts. Interpersonal communication competence is central in dyadic social interaction. In addition to these concepts, the central definitions in this study are concepts of effectiveness and appropriateness related to communication competence This study aims at shedding light in the perceptions of the scholars in Villa Karo of their interpersonal communication competence in collaborative interaction with the local residents in Grand Popo, Benin. The data was obtained via semi-structured interviews conducted in November – December 2020. Seven interviewees, who had spent time as scholars in Villa Karo, were recruited via Villa Karo office in Helsinki. The data was analysed by using thematic analyses. Through coding three themes were identified in the data: language use, relationship building as competence and reflections of perceived appropriateness. The results show that the scholars had little expectations and knowledge about the culture in advance, but yet reported managing communication well in relation to the goals of the project. They all reported perceiving their interpersonal communication in their collaborative interaction as effective, meaning achieving desired, preferred outcomes in communication. The accounts of being appropriate communicators, meaning that the scholars knew how to behave and communicate according to expectations and demands of the situation were more ambiguous. All interviewees reported that their project work was actualised as planned.
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(2023)Digitalization requires new legislative tools that can effectively address the issues that are specific to digital markets. In the European Union, cases concerning dominant platforms used to fall under EU competition law and Article 102 TFEU, but this legal framework was sometimes ineffective in regulating issues that exist in digital markets. For instance, the Google Shopping case illustrates one of the difficulties of Article 102 TFEU in relation to digital markets, which are the abuses that are specific to digital markets, such as self-favouring. Digital markets evolve rapidly, and thus they require quick and effective responses from legislators. In order to further regulate digital markets, the European Commission introduced the EU Digital Markets Act (DMA) in 2020 and the DMA rules start to apply in May 2023. The overall objective of the DMA is to increase contestability and fairness in digital markets while simultaneously creating a more effective legal framework. The DMA is a sector-specific EU regulation that regulates the actions of the biggest digital platforms that are called gatekeepers, which offer their services to business users and end users located in the European Union. When the Commission designates a platform as a gatekeeper, the platform must follow the obligations set out by the DMA within six months after the designation. The main goal of this thesis is analysing the effectiveness of the regulation of digital markets after the DMA. As this thesis is finalized in April 2023 and the DMA rules start to apply in May 2023, this thesis focuses on the elements of effectiveness that can be evaluated now. In order to illustrate the effectiveness of the DMA, one of the central elements is the application of the DMA rules to the Google Shopping case. By applying the new legal framework to a case that was judged under the Article 102 TFEU framework, improvements in effectiveness will be portrayed in a more concrete manner. Furthermore, this thesis also examines the potential shortcomings when it comes to the effectiveness of the DMA. One of the most significant issues of the DMA is its inflexibility towards future developments. This thesis argues that while the DMA provides an effective framework for addressing the current issues in digital markets, it is unable to address future developments in digital markets effectively.
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(2023)Digitalization requires new legislative tools that can effectively address the issues that are specific to digital markets. In the European Union, cases concerning dominant platforms used to fall under EU competition law and Article 102 TFEU, but this legal framework was sometimes ineffective in regulating issues that exist in digital markets. For instance, the Google Shopping case illustrates one of the difficulties of Article 102 TFEU in relation to digital markets, which are the abuses that are specific to digital markets, such as self-favouring. Digital markets evolve rapidly, and thus they require quick and effective responses from legislators. In order to further regulate digital markets, the European Commission introduced the EU Digital Markets Act (DMA) in 2020 and the DMA rules start to apply in May 2023. The overall objective of the DMA is to increase contestability and fairness in digital markets while simultaneously creating a more effective legal framework. The DMA is a sector-specific EU regulation that regulates the actions of the biggest digital platforms that are called gatekeepers, which offer their services to business users and end users located in the European Union. When the Commission designates a platform as a gatekeeper, the platform must follow the obligations set out by the DMA within six months after the designation. The main goal of this thesis is analysing the effectiveness of the regulation of digital markets after the DMA. As this thesis is finalized in April 2023 and the DMA rules start to apply in May 2023, this thesis focuses on the elements of effectiveness that can be evaluated now. In order to illustrate the effectiveness of the DMA, one of the central elements is the application of the DMA rules to the Google Shopping case. By applying the new legal framework to a case that was judged under the Article 102 TFEU framework, improvements in effectiveness will be portrayed in a more concrete manner. Furthermore, this thesis also examines the potential shortcomings when it comes to the effectiveness of the DMA. One of the most significant issues of the DMA is its inflexibility towards future developments. This thesis argues that while the DMA provides an effective framework for addressing the current issues in digital markets, it is unable to address future developments in digital markets effectively.
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Results, rights and effectiveness : complementarities, tensions and emerging alternative responses (2021)In spite of alleged complementarities between human rights and results and their programming approaches (HRBA and RBM), a number of criticisms have arisen on how the concept of results-based management can even undermine progress on human rights. This is the case especially if the potential explanations for the tensions are ignored. This puzzle is a point of my departure in exploring the relationship between human rights and result based management. The overall aim of this thesis is to contribute to the discussions and understanding of the relationship between human rights, results and effectiveness agendas and their theoretical and operational interplay. The aim is especially to highlight the complementarities between the agendas, but also address the limitations and tensions but also the ‘better fit’ solutions between the two approaches. My main method was an appraisal of theoretical and empirical literature. An important finding is, that there is no inherent conflict between rights and results initiatives, but that tensions arise rather when the narrow, technical interpretation of results management is adopted to transformative work. The mainstream results-based management assumes that change occurs in a linear fashion where a set of activities results in outputs, outcomes and ultimately impact. However, the transformative vision of both human rights and rights-based agendas in development described in this thesis, establishes a much more complex causal chain and therefore collides with some basics assumptions behind the traditional RBM assumptions. However, findings indicate that RBM can be used for a variety of practices, including by complexity theory and social change theory. But in order to work, RBM needs to occur in accordance with the particularities and nature of the activity to be implemented. Theories of change – a central tool of RBM models – are considered as a good tool to reframe the results artefacts and communicate the assumptions and particularities behind change of each sector involved in development cooperation. In conclusion chapter I propose alternatives to the most problematic assumptions behind RBM models and offering different assumptions behind social change from human rights perspective.
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(2021)In spite of alleged complementarities between human rights and results and their programming approaches (HRBA and RBM), a number of criticisms have arisen on how the concept of results-based management can even undermine progress on human rights. This is the case especially if the potential explanations for the tensions are ignored. This puzzle is a point of my departure in exploring the relationship between human rights and result based management. The overall aim of this thesis is to contribute to the discussions and understanding of the relationship between human rights, results and effectiveness agendas and their theoretical and operational interplay. The aim is especially to highlight the complementarities between the agendas, but also address the limitations and tensions but also the ‘better fit’ solutions between the two approaches. My main method was an appraisal of theoretical and empirical literature. An important finding is, that there is no inherent conflict between rights and results initiatives, but that tensions arise rather when the narrow, technical interpretation of results management is adopted to transformative work. The mainstream results-based management assumes that change occurs in a linear fashion where a set of activities results in outputs, outcomes and ultimately impact. However, the transformative vision of both human rights and rights-based agendas in development described in this thesis, establishes a much more complex causal chain and therefore collides with some basics assumptions behind the traditional RBM assumptions. However, findings indicate that RBM can be used for a variety of practices, including by complexity theory and social change theory. But in order to work, RBM needs to occur in accordance with the particularities and nature of the activity to be implemented. Theories of change – a central tool of RBM models – are considered as a good tool to reframe the results artefacts and communicate the assumptions and particularities behind change of each sector involved in development cooperation. In conclusion chapter I propose alternatives to the most problematic assumptions behind RBM models and offering different assumptions behind social change from human rights perspective.
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(2012)Inflammatory bowel diseases are among the fastest growing chronic disease of young people in Europe and they are increasing in Western countries for unknown reasons. Illness often occurs at a young age and the symptoms persist generally throughout life, Crohn's disease and ulcerative colitis are the most common diseases in this category. Inflammatory bowel diseases often cause persistent symptoms and require treatment usually for life, affect the quality of life and the ability to go to work. Conventional treatment usually consists of anti-inflammatory and immunosuppressive drug therapy or surgical intervention. In difficult cases, the biologic drug treatment is used. New biological drug products (TNF-blockers) have improved, in particular in Crohn's disease, a response to treatment. The aim of this study is to provide information about the effectiveness and the costs of the biological treatment in inflammatory bowel diseases. The main results presented are the changes of the quality of life during the observation period measured with the generic and disease-specific HRQoL instruments. The results are also reported on the matter of costs for quality-adjusted life-years gained during the follow-up period. The study consists of FinnIBDQ (inflammatory Bowel Disease Questionnaire) survey (n=2831) and the follow-up survey of the patients who used biologic drug products (n=189). Patients were selected into the follow-up if they reported using the biologic drugs to treat the illness. FinnIBDQ-survey was conducted in 2006/2008 and follow-up questionnaire in 2011. As a generic HRQoL instrument was the 15D-instrument used which is a standardized measure of the health related quality of life. 15D-instrument produces a single index number between 0-1. IBDQ is a disease-specific HRQoL instrument, which consists of 32 questions. The total number of points varies between 32 and 224 from the worst to the best. Patients' medical history, symptoms, medication and health care use were studied in their own partition on the questionnaire. Biological drug therapy group belonged at the baseline (n=148) improved the quality of life (p=0.004) during the follow-up. A disease-specific HRQoL instrument (IBDQ) shows the quality of life has changed in parallel (p=0.003)with the 15D-instrument. Dimensions, where progress was achieved (p<0.05) were the elimination, the usual activities, discomfort and symptoms, as well as vitality and sexual activity. In the research group (n=51), the average cost per patient per QALYs gained during the follow-up period proved to be very high, at over 5 million euro's. During this time, the patient gained an average of 0,01 quality adjusted additional years of life. The evidence of the long-term impact of the biologic drug treatment on the patient's quality of life is still scarce. In most of the research concerned with the benefits of biological treatment, the effectiveness data is derived from the pharmaceutical manufacturers' short-term clinical efficacy studies, or taken from any other quality of life studies.
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