Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were ... more Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were addressed synonymously by many healthcare authorities and practitioners. A deep understanding and clarification of these concepts are fundamental and a prerequisite for developing robust frameworks and practical guidelines to ensure the safety, efficacy, and effectiveness of DH solutions and AI-embedded technologies. Categorizing DH into technologies (DHTs) and services (DHSs) enables regulatory, HTA, and reimbursement bodies to develop category-specific frameworks and guidelines for evaluating these solutions effectively. DH is the key in generating real-world data, which is increasingly important in decision-making processes. The potential benefits of DHTs in improving health outcomes and reducing health system costs can position them alongside traditional health technologies in certain medical conditions. AI, one of the potential tools for DH, can be embedded in technologies, such as medical devices or applications, to enhance functionality and performance. AI excels at handling numerical and perceptual data. In the context of numerical data, machine learning algorithms enable prediction, classification, and clustering. In managing perceptual data, AI recognizes image/video, voice, and text. In recent years, generative AI, a form of AI that generates new content by employing a combination of a wide range of learning approaches, has become prominent in research and influences the health sector. A thorough understanding of DH and AI, along with accurate terminology use, would facilitate the timely generation of regulatory and HTA-grade evidence that helps improve health outcomes and decision-making certainty. Keywords Digital health (DH), digital health technologies (DHTs), digital health services (DHSs), artificial intelligence, real-world data (RWD), machine learning (ML)
Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were ... more Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were addressed synonymously by many healthcare authorities and practitioners. A deep understanding and clarification of these concepts are fundamental and a prerequisite for developing robust frameworks and practical guidelines to ensure the safety, efficacy, and effectiveness of DH solutions and AI-embedded technologies. Categorizing DH into technologies (DHTs) and services (DHSs) enables regulatory, HTA, and reimbursement bodies to develop category-specific frameworks and guidelines for evaluating these solutions effectively. DH is the key in generating real-world data, which is increasingly important in decision-making processes. The potential benefits of DHTs in improving health outcomes and reducing health system costs can position them alongside traditional health technologies in certain medical conditions. AI, one of the potential tools for DH, can be embedded in technologies, such as medical devices or applications, to enhance functionality and performance. AI excels at handling numerical and perceptual data. In the context of numerical data, machine learning algorithms enable prediction, classification, and clustering. In managing perceptual data, AI recognizes image/video, voice, and text. In recent years, generative AI, a form of AI that generates new content by employing a combination of a wide range of learning approaches, has become prominent in research and influences the health sector. A thorough understanding of DH and AI, along with accurate terminology use, would facilitate the timely generation of regulatory and HTA-grade evidence that helps improve health outcomes and decision-making certainty. Digital health (DH), digital health technologies (DHTs), digital health services (DHSs), artificial intelligence, real-world data (RWD), machine learning (ML)
Journal of Pharmacy and Pharmaceutical Sciences, Jul 17, 2023
Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in ... more Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process. RWE aims to fill the current evidence gaps, reduce the uncertainty around the benefits of medical technologies, and better understand the long-term impact of health technologies in real-world conditions. Despite the minimal use of RWE in some elements of HTA, there has been a larger push to further utilize RWE in the HTA processes. HTA bodies, as other stakeholders, work towards developing more robust means to leverage RWE from various data sources in the HTA processes. However, these agencies need to overcome important challenges before the broader incorporation of RWE into their routine practice. This paper aims to explore the extensive integration of RWE utilizing diverse sources of RWD. We discuss the utilization of RWE in HTA processes, considering aspects such as when, where, and how RWE can be effectively applied. Additionally, we seek the potential challenges and barriers associated with the utilization of different data sources. KEYWORDS real-world evidence, health technology, health technology assessment, real-world data, reassessment
Background: The incidence and prevalence of liver disease are increasing and contribute to signif... more Background: The incidence and prevalence of liver disease are increasing and contribute to significant morbidity and mortality. In Canada, more than 3 million people live with liver diseases, accounting for approximately 2% of all hospitalizations. However, it remains unclear how much liver hospitalizations cost the Canadian healthcare system. Thus, this study estimates the cost of liver-related hospitalization across Canada. Methods: We conducted a population-based, retrospective study using acute inpatient admission data for liver-related hospitalizations obtained from the Canadian Institute for Health Information. We calculated the total and the average nominal spending for liver hospitalizations nationally from April 1, 2004, to March 31, 2020, based on fiscal year (FY). In addition, we stratified the average liver hospitalization spending based on age and sex group. Results: Canada spent $947 million on liver-related hospitalizations in FY2019, a 145% growth in spending from FY...
Background&Objective: The ways of prevention of wound infections are too much, and some reference... more Background&Objective: The ways of prevention of wound infections are too much, and some references mentioned that one of those ways is dressing. Dressing can cause a sort of spiritual transquility for patients, too. In the other side, doing it causes some kinds of limitations such as preventing of taking a bath or spending expenses. So, we decided to consider the influence of continuation of dressing, on the rate of wound infection, after first 48 hours post operation. Materials&Methods: In this research, we studied on 150 patients who were under the same surgeries, So that in the half of them, after 48 hours dressing were removed, and in the half remaining, dressing were changed daily for one week. In both groups, in the third, seventh and thirtieth day after surgery were inspected and examined by surgeon, in the case for having or absence of symptoms and signs of infection. In subgrouping patients we considered some factors include age, sex, type of operation and predisposing dise...
In 2021, our group presented the first forecast of trends in the Canadian pharmaceutical market. ... more In 2021, our group presented the first forecast of trends in the Canadian pharmaceutical market. The goal was to identify factors that may influence future spending to support public and private decision-makers in predicting the growth of national drug purchases. This report is the first annual update of estimated pharmaceutical drug purchases in Canada for 2022–2023. We conducted a time series analysis of annual estimated pharmaceutical drug purchases across Canada between 2001 and 2021 using IQVIA’s Canadian Drugstore and Hospital Purchases Audit, calculated total estimated purchases and relative percentage change annually for the retail and hospital sectors, and forecasted annual spending to 2023. Total drug purchases for 2021 were approximately $35.4 billion, 8.3% higher than in 2020 (7.3% growth in the retail sector; 12.4% growth in the hospital sector). Spending for the top 25 drugs was 31.2% and 52.3% of total spending in the retail and hospital sectors, respectively. The for...
Purpose: This study was designed to assess different variables of thoracic benign and malignant m... more Purpose: This study was designed to assess different variables of thoracic benign and malignant masses on Computed tomography (CT) guided biopsy and to identify the complication rate of procedure. Materials and methods: We evaluated 757 CT-guided biopsies of thoracic lesions performed from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist. The CTs were assessed by a trained general practitioner for the size and location of lesions and pneumothorax diagnosis and then all CTs were double checked by the same radiologist. Lesions considered benign or malignant based on pathology reports. Results: Biopsy yielded sufficient tissue for pathologic examination in 612 cases (80.8%); 224 lesions (29.6%) were benign and 388 lesions (51.3%) were malignant (27 small cell and 233 non-small cell tumors). The most prevalent location of lesions was Right Upper Lobe (182 cases). 78 masses were located in mediastinum and 41 lesions in chest wall. 44.2% of benign lesions belonged to infectious (69.7% bacterial, 20.2% fungal, 6.1% hydatid cyst and 4% TB) and the rest were inflammatory masses (43.8%), granolomatus (5.8%) and neoplastic (6.2%) ones. The mean size of benign and malignant lesions were 6.011 and 7.481 cm, respectively (P.V. Conclusion: CT-guided needle biopsy seems to be a reliable diagnostic modality with low risk probability of complications for thoracic lesions.
Background: In recent years, CT-guided biopsy is going to be replaced with open biopsy for Lympho... more Background: In recent years, CT-guided biopsy is going to be replaced with open biopsy for Lymphoma diagnosis. Objectives: This study was designed to assess Lymphoma diagnosis on CT-guided biopsy and to identify the complication rate of procedure. Methods: We evaluated 78 CT-guided biopsies of mediastinal lesions performed from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist. The CTs were assessed by a trained general practitioner for the size and location of lesions and pneumothorax or pneumomediastinum diagnosis and then all CTs were double checked by the same radiologist. Lesions considered benign or malignant and lymphoma based on pathology reports. Results: Biopsy yielded sufficient tissue for pathologic examination in 63 cases (80.77%); 14 lesions (17.9%) were benign and 49 lesions (62.8%) were malignant. In malignant masses 15 Lymphoma (30.6%) and 20 other kinds of tumors (46.8%) were found. Moreover, 1 1malignant lesions had no differentiation. Among Lymphoma lesions, there were 7 (46.7%) Hodgkin, 5 (33.33%) Non-Hodgkin Lymphoma and 3 (20%) Lymphoma without differentiation. Pneumothorax or pneumomediastinum as complications did not present in any case. Conclusion: CT-guided needle biopsy seems to be reliable as a less invasive diagnostic modality with low risk probability of complications for Lymphoma.
Background: CT-guided biopsy provides results in a short period and can be applied on outpatient ... more Background: CT-guided biopsy provides results in a short period and can be applied on outpatient and even high risk patients however; some studies do not recommend it in lesions with benign histology probability. Objectives: To report our experience regarding hydatid cyst diagnosis on CT-guided biopsy and to identify the complication rate of procedure. Materials and methods: We evaluated 99 CT-guided biopsies of infected thoracic lesions performed to investigate hydatid cyst masses from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist by westcott needle number 20 and 18. The CT scans were assessed by a trained general practitioner for the size and location of lesions and pneumothorax or pneumomediastinum diagnosis and then all CT scans were double checked by the same radiologist. Lesions considered infection and their differentiations based on pathology reports. Results: During four year study 6 hydatid cysts (3 male and 3 female) were fou...
Objective: Primary major airway tumors are rare. A retrospective analysis of referral centers exp... more Objective: Primary major airway tumors are rare. A retrospective analysis of referral centers experience could be helpful for their management. Methods: Fifty-one patients, including 44 (86%) malignant and seven (14%) benign with primary tumors of subglottis, trachea, carina, and main stem bronchi, were managed in a 14-year period. Based on computed tomography (CT) scan and rigid bronchoscopy findings, those who evaluated as resectable underwent airway resection and reconstruction. The others were managed by one or a combination of these methods: core out, laser, chemotherapy, radiotherapy, and tracheostomy. Follow-up was completed in 88.2%, mean (35.2 AE 33.2 months). Results: Extraluminal extension of the tumor found in CT scan was significantly associated with unresectability ( p = 0.006). Thirty-two patients underwent resection with three complications (9%) and one mortality (3%). Nineteen were managed by non-resectional methods; of these, 15 were found unresectable, because of tumor length, extensive local invasion or diffuse distant metastases, and four due to risk-benefit ratio or patient preference. Among 18 patients with adenoid cystic carcinoma 13 (72%) were resected (seven with negative margins). Overall 1-, 2-, 5-, and 8-year survival was 90.9%, 90.9%, 77.9%, and 19.5%, respectively. In unresectable tumors with adenoid cystic carcinoma, overall 1-and 2-year survival was 60% and 40%, respectively. Data analysis found significant association of long-term survival with resection ( p = 0.005) but not with negative margins in adenoid cystic carcinoma. Among 15 patients with carcinoid tumors, all were alive at the end of follow-up, except one who died after surgery. Conclusions: Airway resection, if feasible, may extend survival and may even be curative, with low morbidity and mortality, in most patients with major airway tumors. #
Materials and Methods: 757 patients with thoracic lesions whom underwent CT-guided biopsy were ev... more Materials and Methods: 757 patients with thoracic lesions whom underwent CT-guided biopsy were evaluated retrospectively from March 2004 to December 2008. All biopsies were performed by one radiologist. The CTs were assessed by a trained general ...
Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were ... more Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were addressed synonymously by many healthcare authorities and practitioners. A deep understanding and clarification of these concepts are fundamental and a prerequisite for developing robust frameworks and practical guidelines to ensure the safety, efficacy, and effectiveness of DH solutions and AI-embedded technologies. Categorizing DH into technologies (DHTs) and services (DHSs) enables regulatory, HTA, and reimbursement bodies to develop category-specific frameworks and guidelines for evaluating these solutions effectively. DH is the key in generating real-world data, which is increasingly important in decision-making processes. The potential benefits of DHTs in improving health outcomes and reducing health system costs can position them alongside traditional health technologies in certain medical conditions. AI, one of the potential tools for DH, can be embedded in technologies, such as medical devices or applications, to enhance functionality and performance. AI excels at handling numerical and perceptual data. In the context of numerical data, machine learning algorithms enable prediction, classification, and clustering. In managing perceptual data, AI recognizes image/video, voice, and text. In recent years, generative AI, a form of AI that generates new content by employing a combination of a wide range of learning approaches, has become prominent in research and influences the health sector. A thorough understanding of DH and AI, along with accurate terminology use, would facilitate the timely generation of regulatory and HTA-grade evidence that helps improve health outcomes and decision-making certainty. Keywords Digital health (DH), digital health technologies (DHTs), digital health services (DHSs), artificial intelligence, real-world data (RWD), machine learning (ML)
Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were ... more Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were addressed synonymously by many healthcare authorities and practitioners. A deep understanding and clarification of these concepts are fundamental and a prerequisite for developing robust frameworks and practical guidelines to ensure the safety, efficacy, and effectiveness of DH solutions and AI-embedded technologies. Categorizing DH into technologies (DHTs) and services (DHSs) enables regulatory, HTA, and reimbursement bodies to develop category-specific frameworks and guidelines for evaluating these solutions effectively. DH is the key in generating real-world data, which is increasingly important in decision-making processes. The potential benefits of DHTs in improving health outcomes and reducing health system costs can position them alongside traditional health technologies in certain medical conditions. AI, one of the potential tools for DH, can be embedded in technologies, such as medical devices or applications, to enhance functionality and performance. AI excels at handling numerical and perceptual data. In the context of numerical data, machine learning algorithms enable prediction, classification, and clustering. In managing perceptual data, AI recognizes image/video, voice, and text. In recent years, generative AI, a form of AI that generates new content by employing a combination of a wide range of learning approaches, has become prominent in research and influences the health sector. A thorough understanding of DH and AI, along with accurate terminology use, would facilitate the timely generation of regulatory and HTA-grade evidence that helps improve health outcomes and decision-making certainty. Digital health (DH), digital health technologies (DHTs), digital health services (DHSs), artificial intelligence, real-world data (RWD), machine learning (ML)
Journal of Pharmacy and Pharmaceutical Sciences, Jul 17, 2023
Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in ... more Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process. RWE aims to fill the current evidence gaps, reduce the uncertainty around the benefits of medical technologies, and better understand the long-term impact of health technologies in real-world conditions. Despite the minimal use of RWE in some elements of HTA, there has been a larger push to further utilize RWE in the HTA processes. HTA bodies, as other stakeholders, work towards developing more robust means to leverage RWE from various data sources in the HTA processes. However, these agencies need to overcome important challenges before the broader incorporation of RWE into their routine practice. This paper aims to explore the extensive integration of RWE utilizing diverse sources of RWD. We discuss the utilization of RWE in HTA processes, considering aspects such as when, where, and how RWE can be effectively applied. Additionally, we seek the potential challenges and barriers associated with the utilization of different data sources. KEYWORDS real-world evidence, health technology, health technology assessment, real-world data, reassessment
Background: The incidence and prevalence of liver disease are increasing and contribute to signif... more Background: The incidence and prevalence of liver disease are increasing and contribute to significant morbidity and mortality. In Canada, more than 3 million people live with liver diseases, accounting for approximately 2% of all hospitalizations. However, it remains unclear how much liver hospitalizations cost the Canadian healthcare system. Thus, this study estimates the cost of liver-related hospitalization across Canada. Methods: We conducted a population-based, retrospective study using acute inpatient admission data for liver-related hospitalizations obtained from the Canadian Institute for Health Information. We calculated the total and the average nominal spending for liver hospitalizations nationally from April 1, 2004, to March 31, 2020, based on fiscal year (FY). In addition, we stratified the average liver hospitalization spending based on age and sex group. Results: Canada spent $947 million on liver-related hospitalizations in FY2019, a 145% growth in spending from FY...
Background&Objective: The ways of prevention of wound infections are too much, and some reference... more Background&Objective: The ways of prevention of wound infections are too much, and some references mentioned that one of those ways is dressing. Dressing can cause a sort of spiritual transquility for patients, too. In the other side, doing it causes some kinds of limitations such as preventing of taking a bath or spending expenses. So, we decided to consider the influence of continuation of dressing, on the rate of wound infection, after first 48 hours post operation. Materials&Methods: In this research, we studied on 150 patients who were under the same surgeries, So that in the half of them, after 48 hours dressing were removed, and in the half remaining, dressing were changed daily for one week. In both groups, in the third, seventh and thirtieth day after surgery were inspected and examined by surgeon, in the case for having or absence of symptoms and signs of infection. In subgrouping patients we considered some factors include age, sex, type of operation and predisposing dise...
In 2021, our group presented the first forecast of trends in the Canadian pharmaceutical market. ... more In 2021, our group presented the first forecast of trends in the Canadian pharmaceutical market. The goal was to identify factors that may influence future spending to support public and private decision-makers in predicting the growth of national drug purchases. This report is the first annual update of estimated pharmaceutical drug purchases in Canada for 2022–2023. We conducted a time series analysis of annual estimated pharmaceutical drug purchases across Canada between 2001 and 2021 using IQVIA’s Canadian Drugstore and Hospital Purchases Audit, calculated total estimated purchases and relative percentage change annually for the retail and hospital sectors, and forecasted annual spending to 2023. Total drug purchases for 2021 were approximately $35.4 billion, 8.3% higher than in 2020 (7.3% growth in the retail sector; 12.4% growth in the hospital sector). Spending for the top 25 drugs was 31.2% and 52.3% of total spending in the retail and hospital sectors, respectively. The for...
Purpose: This study was designed to assess different variables of thoracic benign and malignant m... more Purpose: This study was designed to assess different variables of thoracic benign and malignant masses on Computed tomography (CT) guided biopsy and to identify the complication rate of procedure. Materials and methods: We evaluated 757 CT-guided biopsies of thoracic lesions performed from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist. The CTs were assessed by a trained general practitioner for the size and location of lesions and pneumothorax diagnosis and then all CTs were double checked by the same radiologist. Lesions considered benign or malignant based on pathology reports. Results: Biopsy yielded sufficient tissue for pathologic examination in 612 cases (80.8%); 224 lesions (29.6%) were benign and 388 lesions (51.3%) were malignant (27 small cell and 233 non-small cell tumors). The most prevalent location of lesions was Right Upper Lobe (182 cases). 78 masses were located in mediastinum and 41 lesions in chest wall. 44.2% of benign lesions belonged to infectious (69.7% bacterial, 20.2% fungal, 6.1% hydatid cyst and 4% TB) and the rest were inflammatory masses (43.8%), granolomatus (5.8%) and neoplastic (6.2%) ones. The mean size of benign and malignant lesions were 6.011 and 7.481 cm, respectively (P.V. Conclusion: CT-guided needle biopsy seems to be a reliable diagnostic modality with low risk probability of complications for thoracic lesions.
Background: In recent years, CT-guided biopsy is going to be replaced with open biopsy for Lympho... more Background: In recent years, CT-guided biopsy is going to be replaced with open biopsy for Lymphoma diagnosis. Objectives: This study was designed to assess Lymphoma diagnosis on CT-guided biopsy and to identify the complication rate of procedure. Methods: We evaluated 78 CT-guided biopsies of mediastinal lesions performed from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist. The CTs were assessed by a trained general practitioner for the size and location of lesions and pneumothorax or pneumomediastinum diagnosis and then all CTs were double checked by the same radiologist. Lesions considered benign or malignant and lymphoma based on pathology reports. Results: Biopsy yielded sufficient tissue for pathologic examination in 63 cases (80.77%); 14 lesions (17.9%) were benign and 49 lesions (62.8%) were malignant. In malignant masses 15 Lymphoma (30.6%) and 20 other kinds of tumors (46.8%) were found. Moreover, 1 1malignant lesions had no differentiation. Among Lymphoma lesions, there were 7 (46.7%) Hodgkin, 5 (33.33%) Non-Hodgkin Lymphoma and 3 (20%) Lymphoma without differentiation. Pneumothorax or pneumomediastinum as complications did not present in any case. Conclusion: CT-guided needle biopsy seems to be reliable as a less invasive diagnostic modality with low risk probability of complications for Lymphoma.
Background: CT-guided biopsy provides results in a short period and can be applied on outpatient ... more Background: CT-guided biopsy provides results in a short period and can be applied on outpatient and even high risk patients however; some studies do not recommend it in lesions with benign histology probability. Objectives: To report our experience regarding hydatid cyst diagnosis on CT-guided biopsy and to identify the complication rate of procedure. Materials and methods: We evaluated 99 CT-guided biopsies of infected thoracic lesions performed to investigate hydatid cyst masses from March 2004 to December 2008, retrospectively. All biopsies were performed by one radiologist by westcott needle number 20 and 18. The CT scans were assessed by a trained general practitioner for the size and location of lesions and pneumothorax or pneumomediastinum diagnosis and then all CT scans were double checked by the same radiologist. Lesions considered infection and their differentiations based on pathology reports. Results: During four year study 6 hydatid cysts (3 male and 3 female) were fou...
Objective: Primary major airway tumors are rare. A retrospective analysis of referral centers exp... more Objective: Primary major airway tumors are rare. A retrospective analysis of referral centers experience could be helpful for their management. Methods: Fifty-one patients, including 44 (86%) malignant and seven (14%) benign with primary tumors of subglottis, trachea, carina, and main stem bronchi, were managed in a 14-year period. Based on computed tomography (CT) scan and rigid bronchoscopy findings, those who evaluated as resectable underwent airway resection and reconstruction. The others were managed by one or a combination of these methods: core out, laser, chemotherapy, radiotherapy, and tracheostomy. Follow-up was completed in 88.2%, mean (35.2 AE 33.2 months). Results: Extraluminal extension of the tumor found in CT scan was significantly associated with unresectability ( p = 0.006). Thirty-two patients underwent resection with three complications (9%) and one mortality (3%). Nineteen were managed by non-resectional methods; of these, 15 were found unresectable, because of tumor length, extensive local invasion or diffuse distant metastases, and four due to risk-benefit ratio or patient preference. Among 18 patients with adenoid cystic carcinoma 13 (72%) were resected (seven with negative margins). Overall 1-, 2-, 5-, and 8-year survival was 90.9%, 90.9%, 77.9%, and 19.5%, respectively. In unresectable tumors with adenoid cystic carcinoma, overall 1-and 2-year survival was 60% and 40%, respectively. Data analysis found significant association of long-term survival with resection ( p = 0.005) but not with negative margins in adenoid cystic carcinoma. Among 15 patients with carcinoid tumors, all were alive at the end of follow-up, except one who died after surgery. Conclusions: Airway resection, if feasible, may extend survival and may even be curative, with low morbidity and mortality, in most patients with major airway tumors. #
Materials and Methods: 757 patients with thoracic lesions whom underwent CT-guided biopsy were ev... more Materials and Methods: 757 patients with thoracic lesions whom underwent CT-guided biopsy were evaluated retrospectively from March 2004 to December 2008. All biopsies were performed by one radiologist. The CTs were assessed by a trained general ...
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