Pub Date : 2015-09-20DOI: 10.4172/2167-1052.1000193
G. Vitale, G. Simonetti, F. Conti, G. Taruschio, C. Cursaro, A. Scuteri, L. Brodosi, R. Vukotic, E. Loggi, N. Gamal, L. Pirillo, A. Cicero, G. Boncompagni, P. Andreone
Pegylated-interferon-α (Peg-IFN) are part of chronic hepatitis C (CHC) treatment. Among several side effects, it can induce psychiatric symptoms (PS) which could require discontinuation. The aim of this study was to evaluate the incidence, onset and risk factors of PS and antiviral treatment adherence in CHC patients treated with Peg-IFN plus ribavirin (RBV). All consecutive patients who received antiviral therapy between 2005 and 2011 were subjected to a psychiatric assessment before and during treatment. Of them, 49.2% reported PS especially during the first 4 weeks. Irritability was the predominant symptom recorded. The baseline factors associated with a higher risk of developing PS were: age ≤ 50 years (OR=1.67, 95% CI=1.15-2.43), living in Northern Italy (OR=1.88, 95% CI=1.31-2.70), genotype 1 (OR=1.82, 95% CI=1.28-2.60), previous antiviral treatment (OR=1.53, 95% CI=1.07-2.19) and history of mental disorders (MD) (OR=2.32, 95%CI=1.50-3.58). There was no difference in terms of sustained virologic response (SVR) between patients with and those without a history of MD (p=0.129). On the contrary, SVR was lower in patients who developed PS compared to other ones (p<0.001) due to the higher prevalence of difficult-to-treat patients. Only 1.7% of patients dropped-out for PS. In conclusion, most of patients receiving Peg-IFN develop PS, in particular irritability, especially during the first 4 weeks. Age ≤ 50, living in Northern Italy, genotype 1 infection, previous antiviral treatment and history of MD are associated with a higher chance of developing PS.
{"title":"Development of Psychiatric Symptoms during Antiviral Therapy for Chronic Hepatitis C","authors":"G. Vitale, G. Simonetti, F. Conti, G. Taruschio, C. Cursaro, A. Scuteri, L. Brodosi, R. Vukotic, E. Loggi, N. Gamal, L. Pirillo, A. Cicero, G. Boncompagni, P. Andreone","doi":"10.4172/2167-1052.1000193","DOIUrl":"https://doi.org/10.4172/2167-1052.1000193","url":null,"abstract":"Pegylated-interferon-α (Peg-IFN) are part of chronic hepatitis C (CHC) treatment. Among several side effects, it can induce psychiatric symptoms (PS) which could require discontinuation. The aim of this study was to evaluate the incidence, onset and risk factors of PS and antiviral treatment adherence in CHC patients treated with Peg-IFN plus ribavirin (RBV). All consecutive patients who received antiviral therapy between 2005 and 2011 were subjected to a psychiatric assessment before and during treatment. Of them, 49.2% reported PS especially during the first 4 weeks. Irritability was the predominant symptom recorded. The baseline factors associated with a higher risk of developing PS were: age ≤ 50 years (OR=1.67, 95% CI=1.15-2.43), living in Northern Italy (OR=1.88, 95% CI=1.31-2.70), genotype 1 (OR=1.82, 95% CI=1.28-2.60), previous antiviral treatment (OR=1.53, 95% CI=1.07-2.19) and history of mental disorders (MD) (OR=2.32, 95%CI=1.50-3.58). There was no difference in terms of sustained virologic response (SVR) between patients with and those without a history of MD (p=0.129). On the contrary, SVR was lower in patients who developed PS compared to other ones (p<0.001) due to the higher prevalence of difficult-to-treat patients. Only 1.7% of patients dropped-out for PS. In conclusion, most of patients receiving Peg-IFN develop PS, in particular irritability, especially during the first 4 weeks. Age ≤ 50, living in Northern Italy, genotype 1 infection, previous antiviral treatment and history of MD are associated with a higher chance of developing PS.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"35 5 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78027421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-09-17DOI: 10.4172/2167-1052.1000E135
Patil Js
{"title":"Hydrogel System: An Approach for Drug Delivery Modulation","authors":"Patil Js","doi":"10.4172/2167-1052.1000E135","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E135","url":null,"abstract":"","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"110 1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78628732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-09-11DOI: 10.4172/2167-1052.1000192
T. Bc, Alrasheedy Aa, Hassali Ma, Tew Mm, Samsudin Ma
Objective: Reporting of medication errors in Malaysia is currently low. Consequently, the objective of the study is to explore the perceptions of doctors and pharmacists towards reporting of medication errors and to explore perceived factors that could cause or prevent medication errors. Method: The study was a cross-sectional mail survey. All eight primary outpatient care clinics under Kuala Muda District Health Office, Kedah, Malaysia were included. The study targeted all doctors and pharmacists working in these clinics. The survey questionnaire consisted of two domains — perceptions of medication errors reporting and exploration of perceived preventive factors of medication errors. The Rasch model was used in data analysis. Results: A total of sixty-seven questionnaires were received from the eight clinics, giving a response rate of 100%. Doctors believed that patients’ knowledge about their medications and counselling by pharmacists are the most important preventing factors of medication errors. Pharmacists believed that compliance with the standard operating procedures, decreasing the heavy workload and patients’ knowledge about their medications are the most important preventing factors. Regarding reporting of medication errors, both doctors and pharmacists had relatively the same perceptions. While they did not agree that their workload interferes with their ability to report medication errors, both pharmacists and doctors moderately agreed that individuals could be blamed when an error is reported in the department. Conclusion: The study findings showed that the workload was not a barrier to medication error reporting. Moreover, both doctors and pharmacists stated that prevention of medication errors is a high priority in their work place. However, the fear of blame could prevent some doctors and pharmacists from reporting medication errors.Consequently, reporting medication errors needs be encouraged in the Malaysian primary care setting building on the current initiatives and activities in Malaysia. This could further promote the culture of medication safety and error reporting.
{"title":"Perceptions of Doctors and Pharmacists towards Medication Error Reporting and Prevention in Kedah, Malaysia: A Rasch Model Analysis","authors":"T. Bc, Alrasheedy Aa, Hassali Ma, Tew Mm, Samsudin Ma","doi":"10.4172/2167-1052.1000192","DOIUrl":"https://doi.org/10.4172/2167-1052.1000192","url":null,"abstract":"Objective: Reporting of medication errors in Malaysia is currently low. Consequently, the objective of the study is to explore the perceptions of doctors and pharmacists towards reporting of medication errors and to explore perceived factors that could cause or prevent medication errors. \u0000Method: The study was a cross-sectional mail survey. All eight primary outpatient care clinics under Kuala Muda District Health Office, Kedah, Malaysia were included. The study targeted all doctors and pharmacists working in these clinics. The survey questionnaire consisted of two domains — perceptions of medication errors reporting and exploration of perceived preventive factors of medication errors. The Rasch model was used in data analysis. \u0000Results: A total of sixty-seven questionnaires were received from the eight clinics, giving a response rate of 100%. Doctors believed that patients’ knowledge about their medications and counselling by pharmacists are the most important preventing factors of medication errors. Pharmacists believed that compliance with the standard operating procedures, decreasing the heavy workload and patients’ knowledge about their medications are the most important preventing factors. Regarding reporting of medication errors, both doctors and pharmacists had relatively the same perceptions. While they did not agree that their workload interferes with their ability to report medication errors, both pharmacists and doctors moderately agreed that individuals could be blamed when an error is reported in the department. \u0000Conclusion: The study findings showed that the workload was not a barrier to medication error reporting. \u0000Moreover, both doctors and pharmacists stated that prevention of medication errors is a high priority in their work place. However, the fear of blame could prevent some doctors and pharmacists from reporting medication errors.Consequently, reporting medication errors needs be encouraged in the Malaysian primary care setting building on the current initiatives and activities in Malaysia. This could further promote the culture of medication safety and error reporting.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"25 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2015-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80807287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-09-10DOI: 10.4172/2167-1052.1000191
T. Obara, Hiroaki Yamaguchi, M. Satoh, Y. Iida, T. Sakai, Y. Aoki, Yuriko Murai, Masaki Matsuura, Mayumi Sato, T. Ohkubo, K. Iseki, N. Mano
Little is known about the potential of adverse drug reaction (ADR) non-reporting by Japanese pharmacists. The aim of the present study was to clarify the prevalence, determinants, and reasons for ADR non-reporting by pharmacists in the Miyagi and Hokkaido regions of Japan. In this cross-sectional, self-administered questionnaire-based study, we contacted 3,164 pharmacists who belonged to the Miyagi Prefecture Hospital Pharmacists Association or the Hokkaido Society of Hospital Pharmacists during the 3-month period between January to March 2013. Of the 1,795 respondents 22.4% were <30 years of age, 25.6% were ≥ 50 years of age, and 42.1% were female. A total of 77.6% of the respondents did not have a personal history of ADR reporting. The multivariate logistic regression analysis showed that female sex (odds ratio, 1.52; 95% confidence interval, 1.17-1.97), having <10 years of practical experience (2.59, 1.39-4.82 for 5-9 years; 7.03, 2.94-16.83 for <5 years), working at a community pharmacy or drugstore (1.90, 1.16-3.12), having <5 pharmacists in the workplace (2.01, 1.48-2.75), and not understanding the ADR reporting system (5.93, 4.23-8.33) were significantly and independently associated with not having a personal history of ADR reporting. The most common reason for ADR non-reporting was “It was a well-known adverse drug reaction” (43.0%) followed by “Association between the drug and adverse reaction was not clear” (38.0%), “It was a minor adverse drug reaction” (29.0%), “Did not know how to make a report” (17.4%), and “Never been consulted about ADRs” (17.2%). As an understanding the ADR reporting system was strongly associated with ADR reporting, a more aggressive promotion of the ADR reporting system among pharmacists is warranted.
{"title":"Prevalence, Determinants, and Reasons for the Non-Reporting of Adverse Drug Reactions by Pharmacists in the Miyagi and Hokkaido Regions of Japan","authors":"T. Obara, Hiroaki Yamaguchi, M. Satoh, Y. Iida, T. Sakai, Y. Aoki, Yuriko Murai, Masaki Matsuura, Mayumi Sato, T. Ohkubo, K. Iseki, N. Mano","doi":"10.4172/2167-1052.1000191","DOIUrl":"https://doi.org/10.4172/2167-1052.1000191","url":null,"abstract":"Little is known about the potential of adverse drug reaction (ADR) non-reporting by Japanese pharmacists. The aim of the present study was to clarify the prevalence, determinants, and reasons for ADR non-reporting by pharmacists in the Miyagi and Hokkaido regions of Japan. In this cross-sectional, self-administered questionnaire-based study, we contacted 3,164 pharmacists who belonged to the Miyagi Prefecture Hospital Pharmacists Association or the Hokkaido Society of Hospital Pharmacists during the 3-month period between January to March 2013. Of the 1,795 respondents 22.4% were <30 years of age, 25.6% were ≥ 50 years of age, and 42.1% were female. A total of 77.6% of the respondents did not have a personal history of ADR reporting. The multivariate logistic regression analysis showed that female sex (odds ratio, 1.52; 95% confidence interval, 1.17-1.97), having <10 years of practical experience (2.59, 1.39-4.82 for 5-9 years; 7.03, 2.94-16.83 for <5 years), working at a community pharmacy or drugstore (1.90, 1.16-3.12), having <5 pharmacists in the workplace (2.01, 1.48-2.75), and not understanding the ADR reporting system (5.93, 4.23-8.33) were significantly and independently associated with not having a personal history of ADR reporting. The most common reason for ADR non-reporting was “It was a well-known adverse drug reaction” (43.0%) followed by “Association between the drug and adverse reaction was not clear” (38.0%), “It was a minor adverse drug reaction” (29.0%), “Did not know how to make a report” (17.4%), and “Never been consulted about ADRs” (17.2%). As an understanding the ADR reporting system was strongly associated with ADR reporting, a more aggressive promotion of the ADR reporting system among pharmacists is warranted.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"181 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2015-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80222231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-08-12DOI: 10.4172/2167-1052.1000E133
D. Lu, Tingren Lu, Chen Xl, B. Xu, J. Ding
Many of patient’s deaths with solid tumors are caused by altered pathogenesis coagulation cascade components and processes in clinics. Therapeutic actions for inhibiting cancer coagulation complications in clinics are indispensable part of modern cancer therapies. This editorial discusses the relationship between plasma/solid tumor fibrinogen levels and mechanisms of action by anticoagulants and fibrinolytic agents. Revisit old theory with latest hypothetic and therapeutic options. Many updating clinical information between fibrinogen malformation and its specific therapy are highlighted herein.
{"title":"Plasma Fibrinogen Concentrations in Patients with Solid Tumors and Therapeutic Improvements by Combining Anticoagulants or FibrinolyticalAgents","authors":"D. Lu, Tingren Lu, Chen Xl, B. Xu, J. Ding","doi":"10.4172/2167-1052.1000E133","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E133","url":null,"abstract":"Many of patient’s deaths with solid tumors are caused by altered pathogenesis coagulation cascade components and processes in clinics. Therapeutic actions for inhibiting cancer coagulation complications in clinics are indispensable part of modern cancer therapies. This editorial discusses the relationship between plasma/solid tumor fibrinogen levels and mechanisms of action by anticoagulants and fibrinolytic agents. Revisit old theory with latest hypothetic and therapeutic options. Many updating clinical information between fibrinogen malformation and its specific therapy are highlighted herein.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"21 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2015-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85830082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-07-22DOI: 10.4172/2167-1052.1000E132
Patil Js
Tuberculosis (TB) is a ubiquitous, highly fatal contagious chronic granulomatous bacterial infection. It is mainly an infection of the lungs, but can affect almost any part of the body. Although TB is a preventable and treatable disease, yet it still poses a significant threat globally. Approximately, nine million new cases and one‐and‐a‐half million TB‐related deaths occur each year; the incidence may vary. In 2012, an estimated 8.6 million people developed TB and 1.3 million died from the disease.
{"title":"Epidemiology of Tuberculosis and Drug Resistance in Tuberculosis Treatment in Indian Patients","authors":"Patil Js","doi":"10.4172/2167-1052.1000E132","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E132","url":null,"abstract":"Tuberculosis (TB) is a ubiquitous, highly fatal contagious chronic granulomatous bacterial infection. It is mainly an infection of the lungs, but can affect almost any part of the body. Although TB is a preventable and treatable disease, yet it still poses a significant threat globally. Approximately, nine million new cases and one‐and‐a‐half million TB‐related deaths occur each year; the incidence may vary. In 2012, an estimated 8.6 million people developed TB and 1.3 million died from the disease.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74446870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-07-22DOI: 10.4172/2167-1052.1000189
Tobe Eh
Background: Modafinil has complex, and as yet unclear, pharmacodynamics mechanisms. The prescribing of modafinil to augment monoamine oxidase inhibitor (MAOI) therapy was investigated for 3 patients with major depressive disorder determined to be treatment-resistant depression. Methods: As a retrospective report from a private psychiatry practice, 2 men and 1 woman with major depressive disorder, aged from 55 to 60 years, were evaluated and treated. All patients met criteria for treatment-resistant depression, with failure of 3 or more trials of medication with augmentation; one patient failed electroconvulsive therapy and vagal nerve stimulation. All patients had reported feeling some improvement before the addition of modafinil to existing MAOI therapy. However, immobilizing exhaustion in the 2 male patients and fatigue in the female patient impaired daily function. All patients suffered multiple serious medical comorbidities. Mitigating the influence of cycling or placebo, a 2-year period of response approximated treatment outcome. Results: With the addition of modafinil to MAOI therapy, modafinil all 3 patients improved in mood and alertness modafinil without adverse events (e.g., blood pressure, cardiac rate, extrapyramidal symptoms). Limitations: Although treatment was effective, the sample size was 3 patients. Conclusion: The mechanism by which modafinil improved the function of the 3 patients is unclear. Although many medications are contraindicated with MAOIs, most contraindications are unsubstantiated. In the present series of patients, there were no adverse events with either higher-than-recommended doses of MAOI or the combination of modafinil or tianeptine modafinil with MAOI.
{"title":"Modafinil Enhances Two-Year Outcome from Monoamine Oxidase Inhibitor Therapy in 3 Patients with Treatment-Resistant Depression","authors":"Tobe Eh","doi":"10.4172/2167-1052.1000189","DOIUrl":"https://doi.org/10.4172/2167-1052.1000189","url":null,"abstract":"Background: Modafinil has complex, and as yet unclear, pharmacodynamics mechanisms. The prescribing of modafinil to augment monoamine oxidase inhibitor (MAOI) therapy was investigated for 3 patients with major depressive disorder determined to be treatment-resistant depression. \u0000Methods: As a retrospective report from a private psychiatry practice, 2 men and 1 woman with major depressive disorder, aged from 55 to 60 years, were evaluated and treated. All patients met criteria for treatment-resistant depression, with failure of 3 or more trials of medication with augmentation; one patient failed electroconvulsive therapy and vagal nerve stimulation. All patients had reported feeling some improvement before the addition of modafinil to existing MAOI therapy. However, immobilizing exhaustion in the 2 male patients and fatigue in the female patient impaired daily function. All patients suffered multiple serious medical comorbidities. Mitigating the influence of cycling or placebo, a 2-year period of response approximated treatment outcome. \u0000Results: With the addition of modafinil to MAOI therapy, modafinil all 3 patients improved in mood and alertness modafinil without adverse events (e.g., blood pressure, cardiac rate, extrapyramidal symptoms). \u0000Limitations: Although treatment was effective, the sample size was 3 patients. \u0000Conclusion: The mechanism by which modafinil improved the function of the 3 patients is unclear. Although many medications are contraindicated with MAOIs, most contraindications are unsubstantiated. In the present series of patients, there were no adverse events with either higher-than-recommended doses of MAOI or the combination of modafinil or tianeptine modafinil with MAOI.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"74 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2015-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79490833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-07-12DOI: 10.4172/2167-1052.1000187
B. Lilja, J. Miranda-Téllez, G. Ljunggren, S. Loov, B. Wettermark, A. Lissmats, R. Henriksson
Background: Data from clinical practice have only to a limited extent, been used routinely to monitor cancer patients initiated on new drugs. In this study of patients with cancer, focussing on prostate, breast, and skin cancer, two years of individual data from several registries was used to explore the possibilities to monitor patients with cancer. Methods: This study is based on a research database with more than 78 million records with person-linked diagnoses, drug treatment, and socioeconomic characteristics from eight national and regional registries, for patients with a recorded cancer diagnosis or treated with cancer drugs during 2001-2011. For this cross-sectional registry study 7,378 patients diagnosed with prostate, breast, or skin cancer during 2009-2010, were selected to assess patient characteristics, comorbidities and drug treatment. Results: Of the population selected from the Swedish Cancer Register with the three major diseases, 3,581 had prostate cancer, 2,760 had breast cancer, and 1,037 had skin cancer. The income was 70.1%, 62.9%, and 53.3% in the prostate, breast and skin cancer group, respectively. Urogenital- and cardiovascular diseases were common in both prostate (47.8% and 52.7%), and breast cancer (52.4% and 42.6%) patients. In skin cancer patients, other skin diagnoses were most common (50.7%) followed by cardiovascular disorders (48.3%). Cancer drugs, mainly mature, were received by 85.9% of patients with breast cancer, 32.4% of patients with prostate cancer, and 4.1% of patients with skin cancer. Additional tumour diagnoses for 5.2% of prostate cancer patients, 4.1% of breast cancer patients, and 17.3% of patients with skin cancer, were found in primary care data. Conclusion: Access to healthcare data, including primary care, and the opportunity to link records from multiple data sources by the Swedish personal identity number, allow the possibility to study treatment, disease pattern and characteristics in large cancer patient populations.
{"title":"A Study on Cancer Patients in the Region of Stockholm by Linking Data from Multiple Sources","authors":"B. Lilja, J. Miranda-Téllez, G. Ljunggren, S. Loov, B. Wettermark, A. Lissmats, R. Henriksson","doi":"10.4172/2167-1052.1000187","DOIUrl":"https://doi.org/10.4172/2167-1052.1000187","url":null,"abstract":"Background: Data from clinical practice have only to a limited extent, been used routinely to monitor cancer patients initiated on new drugs. In this study of patients with cancer, focussing on prostate, breast, and skin cancer, two years of individual data from several registries was used to explore the possibilities to monitor patients with cancer. \u0000Methods: This study is based on a research database with more than 78 million records with person-linked diagnoses, drug treatment, and socioeconomic characteristics from eight national and regional registries, for patients with a recorded cancer diagnosis or treated with cancer drugs during 2001-2011. For this cross-sectional registry study 7,378 patients diagnosed with prostate, breast, or skin cancer during 2009-2010, were selected to assess patient characteristics, comorbidities and drug treatment. \u0000Results: Of the population selected from the Swedish Cancer Register with the three major diseases, 3,581 had prostate cancer, 2,760 had breast cancer, and 1,037 had skin cancer. The income was 70.1%, 62.9%, and 53.3% in the prostate, breast and skin cancer group, respectively. Urogenital- and cardiovascular diseases were common in both prostate (47.8% and 52.7%), and breast cancer (52.4% and 42.6%) patients. In skin cancer patients, other skin diagnoses were most common (50.7%) followed by cardiovascular disorders (48.3%). Cancer drugs, mainly mature, were received by 85.9% of patients with breast cancer, 32.4% of patients with prostate cancer, and 4.1% of patients with skin cancer. Additional tumour diagnoses for 5.2% of prostate cancer patients, 4.1% of breast cancer patients, and 17.3% of patients with skin cancer, were found in primary care data. \u0000Conclusion: Access to healthcare data, including primary care, and the opportunity to link records from multiple data sources by the Swedish personal identity number, allow the possibility to study treatment, disease pattern and characteristics in large cancer patient populations.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"7 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2015-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82667626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-07-10DOI: 10.4172/2167-1052.1000188
A. Burden, A. Gruneir, J. M. Paterson, S. Cadarette
Introduction: Using pharmacy claims data we previously identified exposure misclassification in pharmacy claims data that underestimated oral bisphosphonate compliance, particularly in long-term care (LTC). In this study we examined the impact of exposure misclassification in pharmacy claims data on estimates of drug effectiveness using osteoporosis pharmacotherapy and hip fractures as a case example. Methods: We identified new users of oral bisphosphonates, aged 66 or more years, using Ontario claims data. Compliance was quantified by the proportion of days covered (PDC) and categorized into groups during a 365-day ascertainment period. PDC was calculated using observed and cleaned days supply values. Hip fracture rates were calculated using Cox proportional hazard models, adjusted for behavioral and fracture risk factors. Low compliance (PDC < 20%) was the referent. Analyses were completed overall and separately for patients in community and LTC settings. Results: The rate of hip fracture was higher in LTC (2.4/100 patient-years) than in the community (1.0/100 patient-years). Following data cleaning, to adjust for exposure misclassification, the estimated benefit of high compliance (PDC ≥ 80%) on fracture prevention (HRobserved = 0.74, 95% CI = 0.66-0.83; HRcleaned = 0.65, 95% CI = 0.57-0.74) increased. Risk estimates were similar among community-dwelling patients (HRobserved = 0.68, 95% CI = 0.60–0.77; HRcleaned = 0.65, 95% CI = 0.56–0.75), yet differed substantially in LTC (HRobserved = 0.96, 95% CI = 0.73–1.26; HRcleaned = 0.64, 95% CI = 0.46–0.91). Conclusion: Exposure misclassification can bias estimates of drug effectiveness. While minimal change was noted in the community setting where most studies are completed, large differences were noted in LTC where fracture risk was highest. These results highlight the importance of understanding and examining the potential for exposure misclassification prior to data analysis in pharmacoepidemiology, particularly when including LTC settings.
引言:利用药房索赔数据,我们先前发现药房索赔数据中的暴露错误分类低估了口服双膦酸盐的依从性,特别是在长期护理(LTC)中。在这项研究中,我们以骨质疏松症药物治疗和髋部骨折为例,研究了药房索赔数据中暴露错误分类对药物有效性估计的影响。方法:我们使用安大略省的索赔数据,确定66岁或以上的口服双膦酸盐新使用者。通过覆盖天数(PDC)的比例来量化依从性,并在365天的确定期内进行分组。PDC是根据观察到的和清洗过的天数来计算的。采用Cox比例风险模型计算髋部骨折发生率,并根据行为和骨折危险因素进行调整。参照低依从性(PDC < 20%)。对社区和LTC环境中的患者进行整体和单独的分析。结果:LTC患者髋部骨折发生率(2.4/100患者-年)高于社区患者(1.0/100患者-年)。在数据清洗后,为了校正暴露错误分类,估计高依从性(PDC≥80%)对预防骨折的益处(HRobserved = 0.74, 95% CI = 0.66-0.83;HRcleaned = 0.65, 95% CI = 0.57-0.74)增高。社区居住患者的风险估计相似(hrobserve = 0.68, 95% CI = 0.60-0.77;HRcleaned = 0.65, 95% CI = 0.56-0.75),但在LTC中差异很大(hrobserve = 0.96, 95% CI = 0.73-1.26;HRcleaned = 0.64, 95% CI = 0.46-0.91)。结论:暴露程度的错误分类可能导致药物有效性估计的偏差。虽然在大多数研究完成的社区环境中发现的变化很小,但在骨折风险最高的LTC中发现的差异很大。这些结果强调了在药物流行病学数据分析之前理解和检查暴露错误分类可能性的重要性,特别是在包括LTC设置时。
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Pub Date : 2015-06-25DOI: 10.4172/2167-1052.1000E131
Patil Js
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