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Background: Eastern Norway Regional Health Authority asked The Norwegian Knowledge Centre for the Health Services to assess the documentation for six areas of intervention launched by the Institute for Healthcare Improvement (100K-Campaign). The six areas were:1. Deploy 'Rapid Response Team' 2. Improve Care for Acute Myocardial Infarction 3. Prevent Adverse Drug Events 4. Prevent Surgical Site Infection 5. Prevent Ventilator-Associated Pneumonia 6. Prevent Central Line-Associated Bloodstream Infection The objectives were: To identify and assess scientific documentation on the above mentioned six areas ofintervention and their effect on hospital mortality.To discuss the relevance for Norwegian hospitals. Working group A support group of clinicians has contributed to this work:1. Elisabeth Arntzen, Director of department, Helse Øst RHF 2. Anders Baalsrud, Senior adviser Sosial-og helsedirektoratet, Head of department, Rikshospitalet-Radiumhospitalet HF3. Mads Gilbert, Avdelingsoverlege, professor, Akuttmedisinsk avdeling, Universitetssykehuset Nord-Norge, Tromsø 4. Stein Tore Nilsen, Fagdirektør, professor, Stavanger Universitetssjukehus, Helse Stavanger HF 5. Bjarne Riis Strøm, Medisinsk fagdirektør i den Norske Legeforening, Oslo (two meetings) From the Knowledge centre: 1. Unni Krogstad, Senior researcher (prosjektleder) 2. Liv Rygh, Senior adviser 3. Sari Ormstad, Research librarian 4. Inger Norderhaug, Research director We searched the Cochrane, Medline, Cinahl and Embase databases for all systematic reviews, guidelines and review articles on documentation of effect of the six areas. Separate searches were done for each issue. Assessment of the retrieved literature was done stepwise by two persons independently. Agreement on the inclusion of studies was reached through discussions. Method All six areas in the 100K-campaign should be included. Database searches were restricted to secondary literature defined as systematic reviews, health technology assessments and other review studies presenting themselves as systematic. Each area was treated separately with individual strategy for searches. Where we could not find systematic reviews we opened for assessment of primary studies. Selection of relevant studies and assessment of retrieved literature were done stepwise by two persons. Results We found two systematic reviews on patient safety in general. A total of 1411 abstracts were retrieved. 40 articles were read in full text and 19 were included in the documentation. The amount of research literature on each of the six areas varied substantially. Results are summarised under the separate issues: Rapid response team The intervention is not much studied. No systematic reviews were found. We found two review articles of poor to moderate quality which were positive, but not conclusive. One 13 new cluster-randomised trial of 23 Australian hospitals concluded that the intervention was not cost-effective. Evidence based treatment of Acute Myocardial Infarction The literature on Acute Myocardial Infarction is large. The 100K-campaign suggest seven interventions: Aspirin given as initial treatment, Aspirin at discharge, Betablocker given within 24 hours, Betablocker by discharge, ACE-inhibitors or angiotensin-blockers by discharge, Thrombolysis within 30 minutes after admittance or PCI within 2 hours, advice on smoking cessation. All interventions are recommended by the American and the European cardiology guidelines. We found two studies reporting on practice and outcomes of the recommended interventions. Regional variation in the practice were found by register studies in the US. Whether implementation saves lives on a large scale is not documented. Prevent Adverse Drug Events by "medication reconciliation'' Medication reconciliation' is a complex process and this intervention is not much studied. One relevant review article was found that compared discrepancies between the medication history obtained by the physician and the comprehensive medication history at the time of admission. No conclusions can be drawn on this issue. Prevent Surgical Site Infection We found six Cochrane reviews and three relevant review articles on this issue. The main general conclusion is that Antibiotic prophylaxis is effective treatment in different kinds of surgery and should be recommended. We found no evidence of hair removal reducing surgical site infections. There is, however, documented that if hair removal is conducted clipping, not shaving should be used. Prevent Ventilator-Associated Pneumonia The field is scarcely studied due to difficulties with definition of the diagnosis. Two articles were included which support the elevation of head by 30-45 degrees, and daily assessment of possible extubation. Two other suggestions were not supported. Prevent Central Line-Associated Bloodstream Infection Two studies were included but none were conclusive on the suggested interventions. Both discuss the difficulty of deciding causal relationships of isolated intervention in complex patient situations. The six different areas and the suggested interventions vary considerably with regard to level of evidence. The seven advices for treatment of acute myocardial infarction are well documented as is the case for the recommendation of antibiotic prophylaxis for surgical site infections. There is not sufficient evidence in the cases of prevention of sepsis in relation to intra venous central lines catheters or ventilator associated pneumonia. Rapid response teams and "medication reconciliation" has not been much studied. These interventions also are deeply rooted in the organising of work, which may vary considerably across countries and health systems. Studies in these areas should probably 14 be related to the relevant health system setting. In general medical interventions are better documented than organisational interventions. The literature included in the review is from English speaking countries only. The studies are conducted in UK, Canada, USA and Australia. This may imply a bias which may be more related to financial, organisational or cultural aspects than to language in itself.
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Background During the past ten years the sale of snuff in Norway has increased, while the sale of smoking tobacco has declined. This has happened parallel to the introduction of smoking restrictions in public areas and growing concern about the health risks associated with smoking. Approximately 300,000 used snuff in 2003/2004. Of these about 140,000 used snuff every day. The majority of snuff users are men under 45 years. The age at starting is decreasing. Female users are still few, but the number is expected to rise. Situations where the consumption rises and the health effects are not clarified, generates new challenges. Objectives To systematically review, assess and summarize the epidemiological evidence concerning the health effects and dependency associated with snuff consumption, and the role of snuff in smoking initiation and smoking cessation. Search strategy Systematic search was undertaken in the Cochrane Library (Cochrane Database of Systematic Reviews, DARE, CENTRAL (earlier Cochrane Controlled Trials Register), HTA (INAHTA)), Medline, Embase, Psycinfo, Cinahl, Swemed, Current Controlled Trials, from 1872 to 7 February 2005. References of identified trials and relevant reviews were also screened. Selection criteria Epidemiological studies were selected if they were systematic reviews, randomised controlled trials, controlled trials, cohort studies or case-control trials, if they included users of snuff or smokeless tobacco, and measured one of the following: nicotine absorption, toxin exposure, mortality, cancer, cardiovascular effects, diabetes, pregnancy outcomes, oral health, dependence, smoking initiation, smoking cessation (or their synonyms). An evaluation was not performed of documentation from animal experiments with snuff or components of snuff. The member of the expert group Erik Dybing disagrees that documentation from animal experiments was not included as a basis for the group's conclusions. Data collection and analysis The literature search gave 1040 hits. Two authors independently screened the abstracts, reviewed 207 publications in full text, and assessed the methodological quality of 59 studies using the Norwegian Knowledge Centre for Health Services' checklists. 29 studies were excluded due to irrelevant problem formulation, outcome or study design. Because the study population, interventions and outcome measures were heterogeneous, a rating system with level of evidence was used. Scandinavian and American studies were assessed separately due to reported differences in some harmful constituents of snuff products sold in Scandinavia and USA. Main results A systematic review was carried out on the 30 studies that met the inclusion criteria. All the studies were of high or medium methodological quality. Many of the studies however 60 included few individuals who exclusively used smokeless tobacco, and combined use of smokeless tobacco and cigarettes appeared frequently. In addition, information about exposure duration and dose was often lacking. There was overall limited epidemiological evidence of health effects associated with smokeless tobacco. There was strong evidence that smokeless tobacco produces dependency. There was conflicting evidence about smokeless tobacco and its role in smoking initiation and smoking cessation. Conclusions1. Nicotine is absorbed rapidly into the bloodstream and to the same degree as when smoking.2. One study indicates that mean carcinogenic nitrosamine uptake into the bloodstream is lower for Scandinavian snuff compared to American snuff, but not in all individuals.3. Overall mortality is not increased in users of American smokeless tobacco according to one large cohort study. However, one study is not enough to draw conclusions regarding this issue.4. One study of high methodological quality indicates that American snuff increases the risks of oral cancer among white women. Other American studies are not congruent and have some methodological limitations.5. Studies of Scandinavian snuff have not found significantly increased risks for oral cancer but the studies lack statistical power to detect a moderately increased risk.6. Studies of pancreatic cancer have overall included few individuals exclusively using smokeless tobacco, and conclusions cannot be drawn on the basis of these results neither for American nor Scandinavian smokeless tobacco.7. One Norwegian study including combined users of smokeless tobacco and cigarettes suggest a connection between use of smokeless tobacco and risk for developing pancreatic cancer when controlling for cigarette smoking.8. There is limited evidence concerning use of American or Scandinavian smokeless tobacco and cancer of the oesophagus, larynx, stomach, lung, kidney, bladder or prostate.9. One Swedish study among construction workers exclusively using snuff, found an increased risk for myocardial infarction and cardiovascular death. None of the four following studies have found an increased risk for myocardial infarction or stroke among users of snuff in Sweden.10. A newly published population based study from the north of Sweden did not find an increased risk for diabetes among users of snuff. However, one study is not enough to draw conclusions regarding this issue.11. A recent Swedish study found an correlation between use of snuff and increased risk for preterm delivery, pre-eclampsia and reduced birth weight. However, one study is not enough to draw conclusions regarding this issue.12. Use of American or Scandinavian snuff induces oral mucosal changes (snuff dippers' lesion) located where the snuff is usually placed. The snuff dippers' lesions are reversible, while other changes in the oral mucosa caused by snuff use (gingival retractions) are irreversible. Portion packed snuff does not give the same oral mucosal changes as loose snuff.13. Frequent use of either American or Scandinavian snuff will, after cessation, be followed by withdrawal symptoms.14. Studies analysing American or Scandinavian smokeless tobacco use as a gateway for smoking initiation are not consistent. Conclusions cannot be drawn due to the conflicting evidence.15. Studies regarding the role of American or Scandinavian snuff in smoking cessation are not congruent. Due to the conflicting evidence conclusions cannot be drawn.16. One study indicated that use of Scandinavian snuff did not result in higher cessation rates compared to nicotine replacement therapy. However, one study is not enough to draw conclusions regarding this issue.
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Background During the past ten years the sale of snuff in Norway has increased, while the sale of smoking tobacco has declined. This has happened parallel to the introduction of smoking restrictions in public areas and growing concern about the health risks associated with smoking. Approximately 300,000 used snuff in 2003/2004. Of these about 140,000 used snuff every day. The majority of snuff users are men under 45 years. The age at starting is decreasing. Female users are still few, but the number is expected to rise. Situations where the consumption rises and the health effects are not clarified, generates new challenges. Objectives To systematically review, assess and summarize the epidemiological evidence concerning the health effects and dependency associated with snuff consumption, and the role of snuff in smoking initiation and smoking cessation. Search strategy Systematic search was undertaken in the Cochrane Library (Cochrane Database of Systematic Reviews, DARE, CENTRAL (earlier Cochrane Controlled Trials Register), HTA (INAHTA)), Medline, Embase, Psycinfo, Cinahl, Swemed, Current Controlled Trials, from 1872 to 7 February 2005. References of identified trials and relevant reviews were also screened. Selection criteria Epidemiological studies were selected if they were systematic reviews, randomised controlled trials, controlled trials, cohort studies or case-control trials, if they included users of snuff or smokeless tobacco, and measured one of the following: nicotine absorption, toxin exposure, mortality, cancer, cardiovascular effects, diabetes, pregnancy outcomes, oral health, dependence, smoking initiation, smoking cessation (or their synonyms). An evaluation was not performed of documentation from animal experiments with snuff or components of snuff. The member of the expert group Erik Dybing disagrees that documentation from animal experiments was not included as a basis for the group's conclusions. Data collection and analysis The literature search gave 1040 hits. Two authors independently screened the abstracts, reviewed 207 publications in full text, and assessed the methodological quality of 59 studies using the Norwegian Knowledge Centre for Health Services' checklists. 29 studies were excluded due to irrelevant problem formulation, outcome or study design. Because the study population, interventions and outcome measures were heterogeneous, a rating system with level of evidence was used. Scandinavian and American studies were assessed separately due to reported differences in some harmful constituents of snuff products sold in Scandinavia and USA. Main results A systematic review was carried out on the 30 studies that met the inclusion criteria. All the studies were of high or medium methodological quality. Many of the studies however 60 included few individuals who exclusively used smokeless tobacco, and combined use of smokeless tobacco and cigarettes appeared frequently. In addition, information about exposure duration and dose was often lacking. There was overall limited epidemiological evidence of health effects associated with smokeless tobacco. There was strong evidence that smokeless tobacco produces dependency. There was conflicting evidence about smokeless tobacco and its role in smoking initiation and smoking cessation. Conclusions1. Nicotine is absorbed rapidly into the bloodstream and to the same degree as when smoking.2. One study indicates that mean carcinogenic nitrosamine uptake into the bloodstream is lower for Scandinavian snuff compared to American snuff, but not in all individuals.3. Overall mortality is not increased in users of American smokeless tobacco according to one large cohort study. However, one study is not enough to draw conclusions regarding this issue.4. One study of high methodological quality indicates that American snuff increases the risks of oral cancer among white women. Other American studies are not congruent and have some methodological limitations.5. Studies of Scandinavian snuff have not found significantly increased risks for oral cancer but the studies lack statistical power to detect a moderately increased risk.6. Studies of pancreatic cancer have overall included few individuals exclusively using smokeless tobacco, and conclusions cannot be drawn on the basis of these results neither for American nor Scandinavian smokeless tobacco.7. One Norwegian study including combined users of smokeless tobacco and cigarettes suggest a connection between use of smokeless tobacco and risk for developing pancreatic cancer when controlling for cigarette smoking.8. There is limited evidence concerning use of American or Scandinavian smokeless tobacco and cancer of the oesophagus, larynx, stomach, lung, kidney, bladder or prostate.9. One Swedish study among construction workers exclusively using snuff, found an increased risk for myocardial infarction and cardiovascular death. None of the four following studies have found an increased risk for myocardial infarction or stroke among users of snuff in Sweden.10. A newly published population based study from the north of Sweden did not find an increased risk for diabetes among users of snuff. However, one study is not enough to draw conclusions regarding this issue.11. A recent Swedish study found an correlation between use of snuff and increased risk for preterm delivery, pre-eclampsia and reduced birth weight. However, one study is not enough to draw conclusions regarding this issue.12. Use of American or Scandinavian snuff induces oral mucosal changes (snuff dippers' lesion) located where the snuff is usually placed. The snuff dippers' lesions are reversible, while other changes in the oral mucosa caused by snuff use (gingival retractions) are irreversible. Portion packed snuff does not give the same oral mucosal changes as loose snuff.13. Frequent use of either American or Scandinavian snuff will, after cessation, be followed by withdrawal symptoms.14. Studies analysing American or Scandinavian smokeless tobacco use as a gateway for smoking initiation are not consistent. Conclusions cannot be drawn due to the conflicting evidence.15. Studies regarding the role of American or Scandinavian snuff in smoking cessation are not congruent. Due to the conflicting evidence conclusions cannot be drawn.16. One study indicated that use of Scandinavian snuff did not result in higher cessation rates compared to nicotine replacement therapy. However, one study is not enough to draw conclusions regarding this issue.
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Background: Eastern Norway Regional Health Authority asked The Norwegian Knowledge Centre for the Health Services to assess the documentation for six areas of intervention launched by the Institute for Healthcare Improvement (100K-Campaign). The six areas were:1. Deploy 'Rapid Response Team' 2. Improve Care for Acute Myocardial Infarction 3. Prevent Adverse Drug Events 4. Prevent Surgical Site Infection 5. Prevent Ventilator-Associated Pneumonia 6. Prevent Central Line-Associated Bloodstream Infection The objectives were: To identify and assess scientific documentation on the above mentioned six areas ofintervention and their effect on hospital mortality.To discuss the relevance for Norwegian hospitals. Working group A support group of clinicians has contributed to this work:1. Elisabeth Arntzen, Director of department, Helse Øst RHF 2. Anders Baalsrud, Senior adviser Sosial-og helsedirektoratet, Head of department, Rikshospitalet-Radiumhospitalet HF3. Mads Gilbert, Avdelingsoverlege, professor, Akuttmedisinsk avdeling, Universitetssykehuset Nord-Norge, Tromsø 4. Stein Tore Nilsen, Fagdirektør, professor, Stavanger Universitetssjukehus, Helse Stavanger HF 5. Bjarne Riis Strøm, Medisinsk fagdirektør i den Norske Legeforening, Oslo (two meetings) From the Knowledge centre: 1. Unni Krogstad, Senior researcher (prosjektleder) 2. Liv Rygh, Senior adviser 3. Sari Ormstad, Research librarian 4. Inger Norderhaug, Research director We searched the Cochrane, Medline, Cinahl and Embase databases for all systematic reviews, guidelines and review articles on documentation of effect of the six areas. Separate searches were done for each issue. Assessment of the retrieved literature was done stepwise by two persons independently. Agreement on the inclusion of studies was reached through discussions. Method All six areas in the 100K-campaign should be included. Database searches were restricted to secondary literature defined as systematic reviews, health technology assessments and other review studies presenting themselves as systematic. Each area was treated separately with individual strategy for searches. Where we could not find systematic reviews we opened for assessment of primary studies. Selection of relevant studies and assessment of retrieved literature were done stepwise by two persons. Results We found two systematic reviews on patient safety in general. A total of 1411 abstracts were retrieved. 40 articles were read in full text and 19 were included in the documentation. The amount of research literature on each of the six areas varied substantially. Results are summarised under the separate issues: Rapid response team The intervention is not much studied. No systematic reviews were found. We found two review articles of poor to moderate quality which were positive, but not conclusive. One 13 new cluster-randomised trial of 23 Australian hospitals concluded that the intervention was not cost-effective. Evidence based treatment of Acute Myocardial Infarction The literature on Acute Myocardial Infarction is large. The 100K-campaign suggest seven interventions: Aspirin given as initial treatment, Aspirin at discharge, Betablocker given within 24 hours, Betablocker by discharge, ACE-inhibitors or angiotensin-blockers by discharge, Thrombolysis within 30 minutes after admittance or PCI within 2 hours, advice on smoking cessation. All interventions are recommended by the American and the European cardiology guidelines. We found two studies reporting on practice and outcomes of the recommended interventions. Regional variation in the practice were found by register studies in the US. Whether implementation saves lives on a large scale is not documented. Prevent Adverse Drug Events by "medication reconciliation'' Medication reconciliation' is a complex process and this intervention is not much studied. One relevant review article was found that compared discrepancies between the medication history obtained by the physician and the comprehensive medication history at the time of admission. No conclusions can be drawn on this issue. Prevent Surgical Site Infection We found six Cochrane reviews and three relevant review articles on this issue. The main general conclusion is that Antibiotic prophylaxis is effective treatment in different kinds of surgery and should be recommended. We found no evidence of hair removal reducing surgical site infections. There is, however, documented that if hair removal is conducted clipping, not shaving should be used. Prevent Ventilator-Associated Pneumonia The field is scarcely studied due to difficulties with definition of the diagnosis. Two articles were included which support the elevation of head by 30-45 degrees, and daily assessment of possible extubation. Two other suggestions were not supported. Prevent Central Line-Associated Bloodstream Infection Two studies were included but none were conclusive on the suggested interventions. Both discuss the difficulty of deciding causal relationships of isolated intervention in complex patient situations. The six different areas and the suggested interventions vary considerably with regard to level of evidence. The seven advices for treatment of acute myocardial infarction are well documented as is the case for the recommendation of antibiotic prophylaxis for surgical site infections. There is not sufficient evidence in the cases of prevention of sepsis in relation to intra venous central lines catheters or ventilator associated pneumonia. Rapid response teams and "medication reconciliation" has not been much studied. These interventions also are deeply rooted in the organising of work, which may vary considerably across countries and health systems. Studies in these areas should probably 14 be related to the relevant health system setting. In general medical interventions are better documented than organisational interventions. The literature included in the review is from English speaking countries only. The studies are conducted in UK, Canada, USA and Australia. This may imply a bias which may be more related to financial, organisational or cultural aspects than to language in itself.
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Background Breast cancer is the most commonly diagnosed cancer in women. In 2005, there were about 3000 incident cases of breast cancer in Norway. Ovarian cancer is less common, with about 400 cases each year. Although breast cancer is relatively common, only about 5-10% of cases are due to inheritance of highly penetrant cancer susceptibility genes. The genes are also associated with an increased risk of ovarian cancer. The two main genes that confer susceptibility to breast and ovarian cancer are the BRCA1 gene and the BRCA2 gene. The mutations in these genes are associated with both hereditary breast cancer and hereditary ovarian cancer. One characteristic of inherited breast and ovarian cancer is that cancer usually appears at a younger age. There is a question if genetic testing can reduce the incidence and morbidity of cancer more than the existing strategy based on documenting families with an inherited predisposition to cancer. The Directorate for Health and Social Affairs has asked the Norwegian Knowledge Centre for the Health Services to summarize the documentation of the genetic testing of BRCA1 and BRCA2 and the clinical outcome of the testing. Methods We have performed a search for systematic reviews in Cochrane Library and Health technology Assessment databases until September 2007. Results Data has been gathered from four systematic reviews that have summarised published literature on genetic testing for BRCA1 and BRCA2 for breast and ovarian cancer. BRCA1 and BRCA2 are very large genes. Since the cloning of BRCA1 and BRCA2, more than a thousand mutations have been identified in these genes. From the published literature, there is no compelling evidence to suggest that one genetic test performs better than another. To ensure a full mutation screen, more than one method needs to be used. Different populations have different mutations. Hence, the type of mutation analysis required often depends on population or subpopulations. Individuals from families with known mutations can more easily be tested specifically for them. Populations where specific BRCA mutations are clustered because of a common ancestor are called founder populations. Cancer risk in family history risk groups are estimated by determining the prevalence of the mutation and its penetrance for breast and ovarian cancer. The prevalence of mutations varies according to the geographic and ethnic origin(s) of the population. Few direct measures of the prevalence of clinically important BRCA1 or BRCA2 mutations in a general population have been published. Models have estimated the prevalence to be about 1 in 397 in a general population. The systematic reviews find that many (up to 36 %) women with breast cancer who are mutation carriers report no family history of breast or ovarian cancer. A small number of clinically significant BRCA1 and BRCA2 mutations have been found repeatedly in different families, such as the four founder mutations most common in the Norwegian population. The prevalence of each mutation differs according to different parts of the country. The penetrance or cumulative lifetime risk of breast cancer in women who carry these inherited gene mutations is estimated to 65 % for BRCA1 and 45 % for BRCA2, and these cancers often occur at a younger age. The penetrance for ovarian cancer in women with BRCA1 mutations is estimated to be 39 % and is slightly lower, 11 %, in women who carry BRCA2 gene mutations. The cumulative lifetime risk of breast or ovarian cancer in Norwegian women who carry one of the four BRCA1 founder mutations is approximately 58 % (51-66 %). Increased surveillance, chemoprevention and prophylactic surgeries are standard options for the effective medical management of mutation carriers. Prophylactic surgery was associated with a reduced risk of breast and ovarian cancers in short term cohort studies. However, optimal management of female carriers who choose to undergo prophylactic surgeries is still poorly understood. International guidelines recommend testing for mutations only when an individual has personal or family history features suggestive of inherited cancer susceptibility, the test can be adequately interpreted, and results will aid in management. Genetic counselling is recommended prior to testing. Conclusion There exist several genetic tests for BRCA gene mutations; no test can detect all mutations in BRCA1 or BRCA2 genes. Testing primarily benefits families in which a BRCA1/2 mutation has been discovered. Individuals from Norwegian families with known mutations can easily be tested specifically for that mutation. There are still limited data on the appropriate medical management for BRCA mutation carriers, and more studies are needed to resolve this.
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Background Breast cancer is the most commonly diagnosed cancer in women. In 2005, there were about 3000 incident cases of breast cancer in Norway. Ovarian cancer is less common, with about 400 cases each year. Although breast cancer is relatively common, only about 5-10% of cases are due to inheritance of highly penetrant cancer susceptibility genes. The genes are also associated with an increased risk of ovarian cancer. The two main genes that confer susceptibility to breast and ovarian cancer are the BRCA1 gene and the BRCA2 gene. The mutations in these genes are associated with both hereditary breast cancer and hereditary ovarian cancer. One characteristic of inherited breast and ovarian cancer is that cancer usually appears at a younger age. There is a question if genetic testing can reduce the incidence and morbidity of cancer more than the existing strategy based on documenting families with an inherited predisposition to cancer. The Directorate for Health and Social Affairs has asked the Norwegian Knowledge Centre for the Health Services to summarize the documentation of the genetic testing of BRCA1 and BRCA2 and the clinical outcome of the testing. Methods We have performed a search for systematic reviews in Cochrane Library and Health technology Assessment databases until September 2007. Results Data has been gathered from four systematic reviews that have summarised published literature on genetic testing for BRCA1 and BRCA2 for breast and ovarian cancer. BRCA1 and BRCA2 are very large genes. Since the cloning of BRCA1 and BRCA2, more than a thousand mutations have been identified in these genes. From the published literature, there is no compelling evidence to suggest that one genetic test performs better than another. To ensure a full mutation screen, more than one method needs to be used. Different populations have different mutations. Hence, the type of mutation analysis required often depends on population or subpopulations. Individuals from families with known mutations can more easily be tested specifically for them. Populations where specific BRCA mutations are clustered because of a common ancestor are called founder populations. Cancer risk in family history risk groups are estimated by determining the prevalence of the mutation and its penetrance for breast and ovarian cancer. The prevalence of mutations varies according to the geographic and ethnic origin(s) of the population. Few direct measures of the prevalence of clinically important BRCA1 or BRCA2 mutations in a general population have been published. Models have estimated the prevalence to be about 1 in 397 in a general population. The systematic reviews find that many (up to 36 %) women with breast cancer who are mutation carriers report no family history of breast or ovarian cancer. A small number of clinically significant BRCA1 and BRCA2 mutations have been found repeatedly in different families, such as the four founder mutations most common in the Norwegian population. The prevalence of each mutation differs according to different parts of the country. The penetrance or cumulative lifetime risk of breast cancer in women who carry these inherited gene mutations is estimated to 65 % for BRCA1 and 45 % for BRCA2, and these cancers often occur at a younger age. The penetrance for ovarian cancer in women with BRCA1 mutations is estimated to be 39 % and is slightly lower, 11 %, in women who carry BRCA2 gene mutations. The cumulative lifetime risk of breast or ovarian cancer in Norwegian women who carry one of the four BRCA1 founder mutations is approximately 58 % (51-66 %). Increased surveillance, chemoprevention and prophylactic surgeries are standard options for the effective medical management of mutation carriers. Prophylactic surgery was associated with a reduced risk of breast and ovarian cancers in short term cohort studies. However, optimal management of female carriers who choose to undergo prophylactic surgeries is still poorly understood. International guidelines recommend testing for mutations only when an individual has personal or family history features suggestive of inherited cancer susceptibility, the test can be adequately interpreted, and results will aid in management. Genetic counselling is recommended prior to testing. Conclusion There exist several genetic tests for BRCA gene mutations; no test can detect all mutations in BRCA1 or BRCA2 genes. Testing primarily benefits families in which a BRCA1/2 mutation has been discovered. Individuals from Norwegian families with known mutations can easily be tested specifically for that mutation. There are still limited data on the appropriate medical management for BRCA mutation carriers, and more studies are needed to resolve this.
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Mini-HTA is a tool designed to support evidence-based processes when introducing new health technologies at the hospital level. Mini-HTA consists of a form or a checklist that is used to assess efficacy, safety, costs and organisational consequences before a new health technology is introduced into clinical practice or an existing health technology is phased out. The purpose of this work was to investigate various mini-HTA systems internationally. We identified eight mini-HTA systems from Australia, Canada, Denmark, Spain, Sweden and the United States. The comparison of the eight systems shows that it is important to consider the following elements when introducing a system of mini-HTA: 1. The system should be anchored in the management. 2. Should the use of mini-HTA be mandatory? 3. Who should prepare mini-HTAs (clinicians or a local HTA-unit)? 4. What kind of support services should be established? 5. In what cases should one conduct mini-HTA? 6. How to make decisions about the introduction of new health technologies? 7. System for monitoring the performance of new health technologies. 8. How broad should the mini-HTAs and decisions be made public? Experiences from the identified mini-HTA systems and evaluations of their function are used to develop a Norwegian mini-HTA version and to pilot a project for mini-HTA in the Western Norway Regional Health Authority.
Technology assessment. --- Biomedical engineering. --- Hospitals --- Administration.
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Background Cervical cancer is the second most common cancer in women world-wide and affects about 300 women in Norway each year. Cervical cancer develops through cellular abnormalities in the cervix that can be detected by cytological tests. With the introduction of organized cervical cytologic screening programs, the incidence of cervical cancer has been dramatically reduced. However, cytologic screening tests also have limitations, especially their limited sensitivity. Because infection with oncogenic human papillomavirus (HPV) has been identified as the underlying cause of cervical cancer, there is interest in the use of HPV testing as a screening test for cervical cancer. The overall prevalence of HPV among cervical cancers is more than 99%. We have evaluated HPV RNA testing for cervical pre cancer lesions by assessing the diagnostic accuracy of the HPV RNA tests compared with cytology and HPV DNA testing. Methods We have systematically searched the following databases for studies that fulfilled our criteria:1. Medline (Ovid) 1966 - 2007, September week 12. Embase (Ovid) 1980 - 2007 week 373. CRD databases (DARE, NHS EED, HTA) 2007, September Relevant topics and text words were combined. We also composed a search filter for diagnostic studies. NorChip AS who has developed a HPV mRNA test was invited to dispatch documentation. We included published literature based on the following criteria: Population: Women Index test: HPV RNA tests Comparators: HPV DNA tests or cytology for screening of cervical cancer Reference standard: Histology Study design: No limit Outcome: Test sensitivity and specificity, positive and negative predictive value or other values that describe diagnostic accuracy Development of cancer Test reliability Language: English and Scandinavian We did not include publications from conferences or abstracts. Relevance and quality was assessed according to our handbook. We used GRADE to assess the documentation for diagnostic accuracy. The results are presented in tables and in a descriptive summary. This work has been carried out by two researchers at NOKC and the report has been externally reviewed. We calculated diagnostic accuracy using 2 x 2 tables for each study. Results We identified 2498 references and assessed 31 full-text articles. Five studies were included in the report and results were extracted and pooled from three of them. Details of each study are presented in evidence tables. Two of the studies were sponsored by the producers of the tests. We have assessed the quality of the documentation of diagnostic accuracy using GRADE. For HPV RNA testing, the quality is very low which means that the results are very uncertain. It is not known whether HPV RNA testing give a better diagnostic accuracy than HPV DNA testing and cytology. In summary these results showed:1. The HPV RNA tests had slightly lower sensitivity compared with HPV DNA tests (77 % 95 % CI 73-81) versus 92 % (95 % CI 89-94), while cytology had lowest sensitivity (61 %). The sensitivity states the probability of a positive test result if you have the disease.2. The HPV RNA tests had slightly higher specificity compared with HPV DNA tests (64 % 95 % CI 60-68) versus 45 % (95 % CI 41-49), while cytology had highest specificity (81 %). The specificity states the probability of a negative test result if you are healthy.3. The HPV RNA tests had comparable positive predictive value with the HPV DNA tests (63 % 95 % CI 59-67) versus 57 % (95 % CI 53-60), while cytology had the highest positive predictive value (91 %). Positive predictive value states the probability of illness among people with a positive test.4. The HPV RNA tests had slightly lower negative predictive value compared with the HPV DNA tests (78 % 95 % CI 74-82) versus 87 % (95 % CI 83-91), while cytology had the lowest negative predictive value (39 %). Negative predictive value states the probability of illness among people with a negative test. Conclusions Due to spare and low quality documentation, we do not know if HPV RNA tests have a better diagnostic accuracy compared to HPV DNA tests and cytology for detection of cervical pre cancer lesions. Norwegian Knowledge Centre for the Health Services summarizes and disseminates evidence concerning the effect of treatments, methods, and interventions in health services, in addition to monitoring health service quality. Our goal is to support good decision making in order to provide patients in Norway with the best possible care. The Centre is organized under The Directorate for Health and Social Affairs, but is scientifically and professionally independent. The Centre has no authority to develop health policy or responsibility to implement policies.
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Background Different tools for performing 'evidence based' leadership have been implemented in hospitals to meet the challenges of modern hospital management. Balanced Scorecard (BSC) and EFQM Excellence-Model (EFQM) are among such tools. The key mission of these is to provide a system for evaluating the organisation from a number of predefined perspectives. The Norwegian Knowledge Centre for the Health Services was asked to conduct a systematic review to assess whether implementation of these tools provide better strategies, better management or better hospital quality. Methods A systematic literature review with a defined search strategy, and predefined criteria for selecting studies. Quality assessment, data extraction and summary of results were performed by two researchers independent of each other. Results We retrieved 639 possibly relevant publications; 71 articles were obtained in full text and five studies were finally included. Four studies reported experiences from implementing BSC and one study reported on EFQM. Included studies described that scorecards may be useful at a local level to define strategic aims, measure quality indicators, and define lower levels for quality action, compare departments over time or to evaluate implementation of new treatment options. We found no evidence that implementation of BSC or EFQM influenced hospital management or quality.1. Three studies reported results after implementing BSC at department level in hospitals in different areas: emergency unit, anaesthesia department and nephrological department. These studies described development of criteria and indicators for measuring, but are not able to relate results to implementation of BSC or EFQM.2. Two studies reported results on the institutional level. One study used EFQM to evaluate the implementation of evidence based treatment processes in an addiction centre in the Netherlands. Another study compared one hospital in Japan with a Chinese hospital with indicators within the BSC model. Both studies assessed the models as useful for measuring quality. Conclusion Research on the usefulness of scorecards is especially challenging due to the fact that scorecards may influence on different levels within a hospital and at different time points.1. There is no evidence that BSC or EFQM influence on hospital performance.2. There are descriptive reports on the usefulness for different purposes in local settings.3. Time series with several pre and post measurements would add to our understanding of the usefulness of scorecards.4. More research and development of suited methodology are needed.
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Background Different tools for performing 'evidence based' leadership have been implemented in hospitals to meet the challenges of modern hospital management. Balanced Scorecard (BSC) and EFQM Excellence-Model (EFQM) are among such tools. The key mission of these is to provide a system for evaluating the organisation from a number of predefined perspectives. The Norwegian Knowledge Centre for the Health Services was asked to conduct a systematic review to assess whether implementation of these tools provide better strategies, better management or better hospital quality. Methods A systematic literature review with a defined search strategy, and predefined criteria for selecting studies. Quality assessment, data extraction and summary of results were performed by two researchers independent of each other. Results We retrieved 639 possibly relevant publications; 71 articles were obtained in full text and five studies were finally included. Four studies reported experiences from implementing BSC and one study reported on EFQM. Included studies described that scorecards may be useful at a local level to define strategic aims, measure quality indicators, and define lower levels for quality action, compare departments over time or to evaluate implementation of new treatment options. We found no evidence that implementation of BSC or EFQM influenced hospital management or quality.1. Three studies reported results after implementing BSC at department level in hospitals in different areas: emergency unit, anaesthesia department and nephrological department. These studies described development of criteria and indicators for measuring, but are not able to relate results to implementation of BSC or EFQM.2. Two studies reported results on the institutional level. One study used EFQM to evaluate the implementation of evidence based treatment processes in an addiction centre in the Netherlands. Another study compared one hospital in Japan with a Chinese hospital with indicators within the BSC model. Both studies assessed the models as useful for measuring quality. Conclusion Research on the usefulness of scorecards is especially challenging due to the fact that scorecards may influence on different levels within a hospital and at different time points.1. There is no evidence that BSC or EFQM influence on hospital performance.2. There are descriptive reports on the usefulness for different purposes in local settings.3. Time series with several pre and post measurements would add to our understanding of the usefulness of scorecards.4. More research and development of suited methodology are needed.
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