Additional file 3: Levels of evidence and Summary tables literature review. Levels of Evidence ac... more Additional file 3: Levels of evidence and Summary tables literature review. Levels of Evidence according to The Oxford Centre for Evidence-based Medicine. Level 6 was added to take the input from patients and caregivers into account. Summary table of reviewed full texts.
Background Metachromatic Leukodystrophy (MLD) is a rare lysosomal disorder. Patients suffer from ... more Background Metachromatic Leukodystrophy (MLD) is a rare lysosomal disorder. Patients suffer from relentless neurological deterioration leading to premature death. Recently, new treatment modalities, including gene therapy and enzyme replacement therapy, have been developed. Those advances increase the need for high-quality research infrastructure to adequately compare treatments, execute post-marketing surveillance, and perform health technology assessments (HTA). To facilitate this, a group of MLD experts started the MLD initiative (MLDi) and initiated an academia-led European MLD registry: the MLDi. An expert-based consensus procedure, namely a modified Delphi procedure, was used to determine the data elements required to answer academic, regulatory, and HTA research questions. Results Three distinct sets of data elements were defined by the 13-member expert panel. The minimal set (n = 13) contained demographics and basic disease characteristics. The core set (n = 55) included fun...
ABSTRACT OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-... more ABSTRACT OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventable adverse drug reactions (ADRs) as well as the determinants of both pADEs and ADRs. METHODS: Adverse events experienced by patients admitted to two Dutch hospitals with functioning computerized physician order entry (CPOE) systems were prospectively identified through chart review. For both pADEs and non-preventable ADRs a causal relationship between adverse events and patients' drugs was established using the simplified Yale algorithm. RESULTS: pADEs and non-preventable ADRs were experienced by 349 (58%) patients, of whom 307 (88%) had non-preventable ADRs. Multi-morbidity (adjusted odds ratio [ORadj] 1.90 and 1.28 respectively), length of stay (OR adj 1.13 and 1.11), admission to the geriatric ward (ORadj 7.78 and 3.82) and number of medication orders (ORadj 1.25 and 1.13) were significantly associated with pADEs and ADRs. Admission to the gastroenterology/rheumatology ward (ORadj 0.22 and 0.40) was inversely related to both pADEs and ADRs. Other determinants for ADRs only were female sex (ORadj 1.77) and use of drugs affecting the nervous system (ORadj 1.83). Age was a significant determinant for pADEs only (ORadj 1.07). CONCLUSIONS: More than half of the patients admitted to the hospitals are harmed by drugs, of which most are non-serious, non-preventable ADRs. Determinants of both pADEs and ADRs overlap to a large extent. Our results imply the need for signalling early potential adverse events during the normal use of drugs in multimorbid patients or those in geriatric wards. Subsequent therapeutic interventions may improve their well-being more than focusing on errors in the medication process only.
Aim: This study aimed to identify from different stakeholders the benefits and obstacles of imple... more Aim: This study aimed to identify from different stakeholders the benefits and obstacles of implementing precision medicine in diabetic kidney disease (DKD) and to build consensus about a way forward in order to treat, prevent, or even reverse this disease.Methods: As part of an ongoing effort of moving implementation of precision medicine in DKD forward, a two-day consensus-building meeting was organized with different stakeholders involved in drug development and patient care in DKD, including patients, patient representatives, pharmaceutical industry, regulatory agencies representatives, health technology assessors, healthcare professionals, basic scientists, and clinical academic researchers. The meeting consisted of plenary presentations and discussions, and small group break-out sessions. Discussion topics were based on a symposium, focus groups and literature search. Benefits, obstacles and potential solutions toward implementing precision medicine were discussed. Results fro...
De recent geregistreerde PCSK9-remmers evolocumab en alirocumab behoren tot een nieuwe klasse van... more De recent geregistreerde PCSK9-remmers evolocumab en alirocumab behoren tot een nieuwe klasse van cholesterolverlagers. Ze zijn geregistreerd voor de behandeling van familiaire en niet-familiaire hypercholesterolemie en van gemengde dyslipidemie, maar ze zijn nu – in afwachting van cardiovasculaire uitkomststudies – vooral geschikt voor hoogrisicopatienten.
Background Direct Healthcare Professional Communications (DHPCs) are letters that are distributed... more Background Direct Healthcare Professional Communications (DHPCs) are letters that are distributed by pharmaceutical companies to inform healthcare professionals (HCPs) about new safety information. HCPs do not always act on such information. This study aimed to assess whether HCP characteristics and their perceptions towards safety information are associated with the extent of action taking in response to DHPCs in Europe. Methods In the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action, general practitioners (GPs), cardiologists and pharmacists from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, the Netherlands, Norway, Sweden, and the UK) completed a web-based survey. HCPs were asked how often they take action in response to DHPCs (VAS 0%-100%). This outcome measure was dichotomized on the median per country. Associations between HCP characteristics (gender, profession, years of accreditation) and their perc...
International journal of medical informatics, 2014
Prescribing medication is an important aspect of almost all in-hospital treatment regimes. Beside... more Prescribing medication is an important aspect of almost all in-hospital treatment regimes. Besides their obviously beneficial effects, medicines can also cause adverse drug events (ADE), which increase morbidity, mortality and health care costs. Partially, these ADEs arise from medication errors, e.g. at the prescribing stage. ADEs caused by medication errors are preventable ADEs. Until now, medication ordering was primarily a paper-based process and consequently, it was error prone. Computerized Physician Order Entry, combined with basic Clinical Decision Support System (CPOE/CDSS) is considered to enhance patient safety. Limited information is available on the balance between the health gains and the costs that need to be invested in order to achieve these positive effects. Aim of this study was to study the balance between the effects and costs of CPOE/CDSS compared to the traditional paper-based medication ordering. The economic evaluation was performed alongside a clinical stud...
Aims: Cardiovascular outcome trials with anti-diabetic drugs suggest that additional cardiovascul... more Aims: Cardiovascular outcome trials with anti-diabetic drugs suggest that additional cardiovascular benefit can be achieved independent of improving glycaemic control. Nonetheless, dose selection of anti-diabetic drugs is typically based solely on glycaemic effects. We evaluated whether off-target drug effects are currently considered for dose justification to regulatory agencies. Methods: In the European Union, anti-diabetic drugs are registered by the European Medicines Agency. We extracted available information regarding dose selection from public assessment reports and marketing application dossiers. Descriptive statistics were used to summarise the extracted information. Results: In total, 14 drugs of three drug classes were included; sodium-glucose co-transporter-2 inhibitors (n = 4), dipeptidyl peptidase-4 inhibitors (n = 4) and glucagon-like peptide-1 receptor agonists (n = 6). For these drugs, 21 dose-finding trials were submitted including results of multiple off-target ef...
OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventab... more OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventable adverse drug reactions (ADRs) as well as the determinants of both pADEs and ADRs. METHODS: Adverse events experienced by patients admitted to two Dutch hospitals with functioning computerized physician order entry (CPOE) systems were prospectively identifed through chart review. For both pADEs and non-preventable ADRs a causal relationship between adverse events and patients' drugs was established using the simplifed Yale algorithm. RESULTS: pADEs and non-preventable ADRs were experienced by 349 (58%) patients, of whom 307 (88%) had non-preventable ADRs. Multi-morbidity (adjusted odds ratio [ORadj] 1.90 and 1.28 respec tively), length of stay (ORadj1.13 and 1.11), admission to the geriatric ward (ORadj7.78 and 3.82) and number of medication orders (ORadj1.25 and 1.13) were signifcantly associated with pADEs and ADRs. Admission to the gastroenterology/rheumatology ward (ORadj0.22 a...
Additional file 3: Levels of evidence and Summary tables literature review. Levels of Evidence ac... more Additional file 3: Levels of evidence and Summary tables literature review. Levels of Evidence according to The Oxford Centre for Evidence-based Medicine. Level 6 was added to take the input from patients and caregivers into account. Summary table of reviewed full texts.
Background Metachromatic Leukodystrophy (MLD) is a rare lysosomal disorder. Patients suffer from ... more Background Metachromatic Leukodystrophy (MLD) is a rare lysosomal disorder. Patients suffer from relentless neurological deterioration leading to premature death. Recently, new treatment modalities, including gene therapy and enzyme replacement therapy, have been developed. Those advances increase the need for high-quality research infrastructure to adequately compare treatments, execute post-marketing surveillance, and perform health technology assessments (HTA). To facilitate this, a group of MLD experts started the MLD initiative (MLDi) and initiated an academia-led European MLD registry: the MLDi. An expert-based consensus procedure, namely a modified Delphi procedure, was used to determine the data elements required to answer academic, regulatory, and HTA research questions. Results Three distinct sets of data elements were defined by the 13-member expert panel. The minimal set (n = 13) contained demographics and basic disease characteristics. The core set (n = 55) included fun...
ABSTRACT OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-... more ABSTRACT OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventable adverse drug reactions (ADRs) as well as the determinants of both pADEs and ADRs. METHODS: Adverse events experienced by patients admitted to two Dutch hospitals with functioning computerized physician order entry (CPOE) systems were prospectively identified through chart review. For both pADEs and non-preventable ADRs a causal relationship between adverse events and patients' drugs was established using the simplified Yale algorithm. RESULTS: pADEs and non-preventable ADRs were experienced by 349 (58%) patients, of whom 307 (88%) had non-preventable ADRs. Multi-morbidity (adjusted odds ratio [ORadj] 1.90 and 1.28 respectively), length of stay (OR adj 1.13 and 1.11), admission to the geriatric ward (ORadj 7.78 and 3.82) and number of medication orders (ORadj 1.25 and 1.13) were significantly associated with pADEs and ADRs. Admission to the gastroenterology/rheumatology ward (ORadj 0.22 and 0.40) was inversely related to both pADEs and ADRs. Other determinants for ADRs only were female sex (ORadj 1.77) and use of drugs affecting the nervous system (ORadj 1.83). Age was a significant determinant for pADEs only (ORadj 1.07). CONCLUSIONS: More than half of the patients admitted to the hospitals are harmed by drugs, of which most are non-serious, non-preventable ADRs. Determinants of both pADEs and ADRs overlap to a large extent. Our results imply the need for signalling early potential adverse events during the normal use of drugs in multimorbid patients or those in geriatric wards. Subsequent therapeutic interventions may improve their well-being more than focusing on errors in the medication process only.
Aim: This study aimed to identify from different stakeholders the benefits and obstacles of imple... more Aim: This study aimed to identify from different stakeholders the benefits and obstacles of implementing precision medicine in diabetic kidney disease (DKD) and to build consensus about a way forward in order to treat, prevent, or even reverse this disease.Methods: As part of an ongoing effort of moving implementation of precision medicine in DKD forward, a two-day consensus-building meeting was organized with different stakeholders involved in drug development and patient care in DKD, including patients, patient representatives, pharmaceutical industry, regulatory agencies representatives, health technology assessors, healthcare professionals, basic scientists, and clinical academic researchers. The meeting consisted of plenary presentations and discussions, and small group break-out sessions. Discussion topics were based on a symposium, focus groups and literature search. Benefits, obstacles and potential solutions toward implementing precision medicine were discussed. Results fro...
De recent geregistreerde PCSK9-remmers evolocumab en alirocumab behoren tot een nieuwe klasse van... more De recent geregistreerde PCSK9-remmers evolocumab en alirocumab behoren tot een nieuwe klasse van cholesterolverlagers. Ze zijn geregistreerd voor de behandeling van familiaire en niet-familiaire hypercholesterolemie en van gemengde dyslipidemie, maar ze zijn nu – in afwachting van cardiovasculaire uitkomststudies – vooral geschikt voor hoogrisicopatienten.
Background Direct Healthcare Professional Communications (DHPCs) are letters that are distributed... more Background Direct Healthcare Professional Communications (DHPCs) are letters that are distributed by pharmaceutical companies to inform healthcare professionals (HCPs) about new safety information. HCPs do not always act on such information. This study aimed to assess whether HCP characteristics and their perceptions towards safety information are associated with the extent of action taking in response to DHPCs in Europe. Methods In the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action, general practitioners (GPs), cardiologists and pharmacists from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, the Netherlands, Norway, Sweden, and the UK) completed a web-based survey. HCPs were asked how often they take action in response to DHPCs (VAS 0%-100%). This outcome measure was dichotomized on the median per country. Associations between HCP characteristics (gender, profession, years of accreditation) and their perc...
International journal of medical informatics, 2014
Prescribing medication is an important aspect of almost all in-hospital treatment regimes. Beside... more Prescribing medication is an important aspect of almost all in-hospital treatment regimes. Besides their obviously beneficial effects, medicines can also cause adverse drug events (ADE), which increase morbidity, mortality and health care costs. Partially, these ADEs arise from medication errors, e.g. at the prescribing stage. ADEs caused by medication errors are preventable ADEs. Until now, medication ordering was primarily a paper-based process and consequently, it was error prone. Computerized Physician Order Entry, combined with basic Clinical Decision Support System (CPOE/CDSS) is considered to enhance patient safety. Limited information is available on the balance between the health gains and the costs that need to be invested in order to achieve these positive effects. Aim of this study was to study the balance between the effects and costs of CPOE/CDSS compared to the traditional paper-based medication ordering. The economic evaluation was performed alongside a clinical stud...
Aims: Cardiovascular outcome trials with anti-diabetic drugs suggest that additional cardiovascul... more Aims: Cardiovascular outcome trials with anti-diabetic drugs suggest that additional cardiovascular benefit can be achieved independent of improving glycaemic control. Nonetheless, dose selection of anti-diabetic drugs is typically based solely on glycaemic effects. We evaluated whether off-target drug effects are currently considered for dose justification to regulatory agencies. Methods: In the European Union, anti-diabetic drugs are registered by the European Medicines Agency. We extracted available information regarding dose selection from public assessment reports and marketing application dossiers. Descriptive statistics were used to summarise the extracted information. Results: In total, 14 drugs of three drug classes were included; sodium-glucose co-transporter-2 inhibitors (n = 4), dipeptidyl peptidase-4 inhibitors (n = 4) and glucagon-like peptide-1 receptor agonists (n = 6). For these drugs, 21 dose-finding trials were submitted including results of multiple off-target ef...
OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventab... more OBJECTIVE: To analyse the prevalence of preventable adverse drug events (pADEs) and non-preventable adverse drug reactions (ADRs) as well as the determinants of both pADEs and ADRs. METHODS: Adverse events experienced by patients admitted to two Dutch hospitals with functioning computerized physician order entry (CPOE) systems were prospectively identifed through chart review. For both pADEs and non-preventable ADRs a causal relationship between adverse events and patients' drugs was established using the simplifed Yale algorithm. RESULTS: pADEs and non-preventable ADRs were experienced by 349 (58%) patients, of whom 307 (88%) had non-preventable ADRs. Multi-morbidity (adjusted odds ratio [ORadj] 1.90 and 1.28 respec tively), length of stay (ORadj1.13 and 1.11), admission to the geriatric ward (ORadj7.78 and 3.82) and number of medication orders (ORadj1.25 and 1.13) were signifcantly associated with pADEs and ADRs. Admission to the gastroenterology/rheumatology ward (ORadj0.22 a...
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