Search

Contains fulltext : 306672.pdf (Publisher’s version ) (Open Access), Radboud University, 25 juni 2024, Promotores : Hoogerbrugge-van der Linden, N., Ligtenberg, M.J.L. Co-promotor : Voer, R.M. de, 201 p.

Contains fulltext : 306295.pdf (Publisher’s version ) (Open Access), PTEN hamartoma tumor syndrome (PHTS) might be associated with a distinct cognitive and psychological profile. However, previous studies are limited, predominantly based on small and pediatric cohorts, likely affected by selection bias, and show a broad range of findings. We aimed to characterize the neuropsychological functioning of adults with PHTS. A total of 40 participants, with intellectual disability as exclusion criterium, completed an extensive clinical neuropsychological assessment including cognitive tasks, questionnaires, and a clinical diagnostic interview. The cognitive tasks and questionnaire data were categorized as below and above average based on 1.5 SD. About 80% of participants showed an average level of intelligence. In addition, 30% and 24% of participants scored below average on immediate memory recall and speed of information processing, respectively. Furthermore, about 25% reported above average scores on the majority of the questionnaires, indicating psychological distress, signs of alexithymia, and cognitive complaints. Personality of participants was characterized by inflexibility, social withdrawal, and difficulties in recognizing and describing their own emotions. Adults with PHTS demonstrate a heterogeneous yet distinct neuropsychological profile that is characterized by slower information processing, psychological problems, and specific personality traits. These findings provide directions on how to optimize the care and daily lives of adults with PHTS., 15 mei 2024, 11 p.

Radboud University, 14 februari 2023, Promotores : Nagtegaal, I.D., Hoogerbrugge-van der Linden, N. Co-promotores : Dutilh, B.E., Boleij, J.M., Contains fulltext : 288677.pdf (Publisher’s version ) (Closed access)

Radboud University, 22 november 2023, Promotores : Hullu, J.A. de, Hermens, R.P.M.G., Hoogerbrugge-van der Linden, N. Co-promotor : Steenbeek, M.P., Item does not contain fulltext

BACKGROUND: In patients with chest pain who arrive at the emergency department (ED) by ambulance, venous access is frequently established prehospital, and could be utilized to sample blood. Prehospital blood sampling may save time in the diagnostic process. In this study, the association of prehospital blood draw with blood sample arrival times, troponin turnaround times, and ED length of stay (LOS), number of blood sample mix-ups and blood sample quality were assessed. METHODS: The study was conducted from October 1, 2019 to February 29, 2020. In patients who were transported to the ED with acute chest pain with low suspicion for acute coronary syndrome (ACS), outcomes were compared between cases, in whom prehospital blood draw was performed, and controls, in whom blood was drawn at the ED. Regression analyses were used to assess the association of prehospital blood draw with the time intervals. RESULTS: Prehospital blood draw was performed in 100 patients. In 406 patients, blood draw was performed at the ED. Prehospital blood draw was independently associated with shorter blood sample arrival times, shorter troponin turnaround times and decreased LOS (P<0.001). No differences in the number of blood sample mix-ups and quality were observed (P>0.05). CONCLUSION: For patients with acute chest pain with low suspicion for ACS, prehospital blood sampling is associated with shorter time intervals, while there were no significant differences between the two groups in the validity of the blood samples., Policy Analysis

Radboud University, 20 januari 2022, Promotores : Drenth, J.P.H., Hoogerbrugge-van der Linden, N., Nagtegaal, I.D. Co-promotor : Bisseling, T.M., Contains fulltext : 241561.pdf (Publisher’s version ) (Open Access)

Radboud University, 29 april 2022, Promotores : Hullu, J.A. de, Hoogerbrugge-van der Linden, N., Massuger, L.F.A.G. Co-promotor : Hermens, R.P.M.G., Item does not contain fulltext

BACKGROUND: Crusted scabies is a debilitating dermatological condition. Although still relatively rare in the urban areas of Australia, rates of crusted scabies in remote Aboriginal communities in the Northern Territory (NT) are reported to be among the highest in the world. OBJECTIVE: To estimate the health system costs associated with diagnosing, treating and managing crusted scabies. METHODS: A disease pathway model was developed to identify the major phases of managing crusted scabies. In recognition of the higher resource use required to treat more severe cases, the pathway differentiates between crusted scabies severity grades. The disease pathway model was populated with data from a clinical audit of 42 crusted scabies patients diagnosed in the Top-End of Australia's Northern Territory between July 1, 2016 and May 1, 2018. These data were combined with standard Australian unit costs to calculate the expected costs per patient over a 12-month period, as well as the overall population cost for treating crusted scabies. FINDINGS: The expected health care cost per patient diagnosed with crusted scabies is $35,418 Australian dollars (AUD) (95% CI: $27,000 to $43,800), resulting in an overall cost of $1,558,392AUD (95% CI: $1,188,000 to $1,927,200) for managing all patients diagnosed in the Northern Territory in a given year (2018). By far, the biggest component of the health care costs falls on the hospital system. DISCUSSION: This is the first cost-of-illness analysis for treating crusted scabies. Such analysis will be of value to policy makers and researchers by informing future evaluations of crusted scabies prevention programs and resource allocation decisions. Further research is needed on the wider costs of crusted scabies including non-financial impacts such as the loss in quality of life as well as the burden of care and loss of well-being for patients, families and communities.

BACKGROUND: Crusted scabies is a debilitating dermatological condition. Although still relatively rare in the urban areas of Australia, rates of crusted scabies in remote Aboriginal communities in the Northern Territory (NT) are reported to be among the highest in the world. OBJECTIVE: To estimate the health system costs associated with diagnosing, treating and managing crusted scabies. METHODS: A disease pathway model was developed to identify the major phases of managing crusted scabies. In recognition of the higher resource use required to treat more severe cases, the pathway differentiates between crusted scabies severity grades. The disease pathway model was populated with data from a clinical audit of 42 crusted scabies patients diagnosed in the Top-End of Australia's Northern Territory between July 1, 2016 and May 1, 2018. These data were combined with standard Australian unit costs to calculate the expected costs per patient over a 12-month period, as well as the overall population cost for treating crusted scabies. FINDINGS: The expected health care cost per patient diagnosed with crusted scabies is $35,418 Australian dollars (AUD) (95% CI: $27,000 to $43,800), resulting in an overall cost of $1,558,392AUD (95% CI: $1,188,000 to $1,927,200) for managing all patients diagnosed in the Northern Territory in a given year (2018). By far, the biggest component of the health care costs falls on the hospital system. DISCUSSION: This is the first cost-of-illness analysis for treating crusted scabies. Such analysis will be of value to policy makers and researchers by informing future evaluations of crusted scabies prevention programs and resource allocation decisions. Further research is needed on the wider costs of crusted scabies including non-financial impacts such as the loss in quality of life as well as the burden of care and loss of well-being for patients, families and communities.

Radboud University, 10 september 2021, Promotor : Hoogerbrugge-van der Linden, N. Co-promotores : Jongmans, M.C.J., Kuiper, R.P., Contains fulltext : 216546.pdf (Publisher’s version ) (Open Access)

Radboud University, 09 november 2021, Promotores : Hoogerbrugge-van der Linden, N., Ligtenberg, M.J.L. Co-promotores : Voer, R.M. de, Kuiper, R.P., Contains fulltext : 239215.pdf (Publisher’s version ) (Open Access)

Over the past 10 years, Oosterhof and Todorov's valence-dominance model has emerged as the most prominent account of how people evaluate faces on social dimensions. In this model, two dimensions (valence and dominance) underpin social judgements of faces. Because this model has primarily been developed and tested in Western regions, it is unclear whether these findings apply to other regions. We addressed this question by replicating Oosterhof and Todorov's methodology across 11 world regions, 41 countries and 11,570 participants. When we used Oosterhof and Todorov's original analysis strategy, the valence-dominance model generalized across regions. When we used an alternative methodology to allow for correlated dimensions, we observed much less generalization. Collectively, these results suggest that, while the valence-dominance model generalizes very well across regions when dimensions are forced to be orthogonal, regional differences are revealed when we use different extraction methods and correlate and rotate the dimension reduction solution. PROTOCOL REGISTRATION: The stage 1 protocol for this Registered Report was accepted in principle on 5 November 2018. The protocol, as accepted by the journal, can be found at https://doi.org/10.6084/m9.figshare.7611443.v1 .

BACKGROUND: Scabies is a common dermatological condition, affecting more than 130 million people at any time. To evaluate and/or predict the effectiveness and cost-effectiveness of scabies interventions, disease transmission modelling can be used. OBJECTIVE: To review published scabies models and data to inform the design of a comprehensive scabies transmission modelling framework to evaluate the cost-effectiveness of scabies interventions. METHODS: Systematic literature search in PubMed, Medline, Embase, CINAHL, and the Cochrane Library identified scabies studies published since the year 2000. Selected papers included modelling studies and studies on the life cycle of scabies mites, patient quality of life and resource use. Reference lists of reviews were used to identify any papers missed through the search strategy. Strengths and limitations of identified scabies models were evaluated and used to design a modelling framework. Potential model inputs were identified and discussed. FINDINGS: Four scabies models were published: a Markov decision tree, two compartmental models, and an agent-based, network-dependent Monte Carlo model. None of the models specifically addressed crusted scabies, which is associated with high morbidity, mortality, and increased transmission. There is a lack of reliable, comprehensive information about scabies biology and the impact this disease has on patients and society. DISCUSSION: Clinicians and health economists working in the field of scabies are encouraged to use the current review to inform disease transmission modelling and economic evaluations on interventions against scabies.

Objective: The objective of this study is to assess the impact of a multimodal intervention on emergency department (ED) crowding and patient flow in a Dutch level 1 trauma center. Methods: In this cross-sectional study, we compare ED crowding and patient flow between a 9-month pre-intervention period and a 9-month intervention period, during peak hours and overall (24/7). The multimodal intervention included (1) adding an emergency nurse practitioner (ENP) and (2) five medical specialists during peak hours to the 24/7 available emergency physicians (EPs), (3) a Lean programme to improve radiology turnaround times, and (4) extending the admission offices' openings hours. Crowding is measured with the modified National ED OverCrowding Score (mNEDOCS). Furthermore, radiology turnaround times, patients' length of stay (LOS), proportion of patients leaving without being seen (LWBS) by a medical provider, and unscheduled representations are assessed. Results: The number of ED visits were grossly similar in the two periods during peak hours (15,558 ED visits in the pre-intervention period and 15,550 in the intervention period) and overall (31,891 ED visits in the pre-intervention period vs. 32,121 in the intervention period). During peak hours, ED crowding fell from 18.6% (pre-intervention period) to 3.5% (intervention period), radiology turnaround times decreased from an average of 91 min (interquartile range 45-256 min) to 50 min (IQR 30-106 min., p < 0.001) and LOS reduced with 13 min per patient from 167 to 154 min (p < 0.001). For surgery, neurology and cardiology patients, LOS reduced significantly (with 17 min, 25 min, and 8 min. respectively), while not changing for internal medicine patients. Overall, crowding, radiology turnaround times and LOS also decreased. Less patients LWBS in the intervention period (270 patients vs. 348 patients, p < 0.001) and less patients represented unscheduled within 1 week after the initial ED visit: 864 (2.7%) in the pr

© 2019, Springer Nature Switzerland AG. New health technologies often yield health benefits, but often at a high cost. In Australia, the processes for public reimbursement of high-cost pharmaceuticals and medical devices are different, potentially resulting in inequity in support for new therapies. We explore how reimbursement is different for medical devices compared with pharmaceuticals, including whether higher cost-effectiveness thresholds are accepted for pharmaceuticals. A literature review identified the challenges of economic evaluations for medical devices compared with pharmaceuticals. We used the ventricular assist device as a case study to highlight specific features of medical device funding in Australia. We used existing guidelines to evaluate whether ventricular assist devices would fulfil the requirements for the “Life-Saving Drugs Program”, which is usually reserved for expensive life–extending pharmaceutical treatments of serious and rare medical conditions. The challenges in conducting economic evaluations of medical devices include limited data to support effectiveness, device-operator interaction (surgical experience) and incremental innovations (miniaturisation). However, whilst high-cost pharmaceuticals may be funded by a single source (federal government), the funding of high-cost devices is complex and may be funded via a combination of federal, state and private health insurance. Based on the Life-Saving Drugs Program criteria, we found that ventricular assist devices could be funded by a similar mechanism to that which funds high-cost life-extending pharmaceuticals. This article highlights the complexities of medical device reimbursement. Whilst differences in available evidence affect the evaluation process, differences in funding methods contribute to inequitable reimbursement decisions between medical devices and pharmaceuticals.

© 2019 Cutler et al. Background: Scarcity of prospective medication non-adherence cost measurements for the Australian population with no directly measured estimates makes determining the burden medication non-adherence places on the Australian health care system difficult. This study aims to indirectly estimate the national cost of medication non-adherence in Australia comparing the cost prior to and following a community pharmacy-led intervention. Methods: Retrospective observational study. A de-identified database of dispensing data from 20,335 patients (n=11,257 on rosuvastatin, n=6,797 on irbesartan and n=2,281 on desvenlafaxine) was analyzed and average adherence rate determined through calculation of PDC. Included patients received a pharmacist-led medication adherence intervention and had twelve months dispensing records; six months before and six months after the intervention. The national cost estimate of medication non-adherence in hypertension, dyslipidemia and depression pre-and post-intervention was determined through utilization of disease prevalence and comorbidity, non-adherence rates and per patient disease-specific adherence-related costs. Results: The total national cost of medication non-adherence across three prevalent conditions, hypertension, dyslipidemia and depression was $10.4 billion equating to $517 per adult. Following enrollment in the pharmacist-led intervention medication non-adherence costs per adult decreased $95 saving the Australian health care system and patients $1.9 billion annually. Conclusion: In the absence of a directly measured national cost of medication non-adherence, this estimate demonstrates that pharmacists are ideally placed to improve patient adherence and reduce financial burden placed on the health care system due to non-adherence. Funding of medication adherence programs should be considered by policy and decision makers to ease the current burden and improve patient health outcomes moving forward.

© 2019 ISPOR–The Professional Society for Health Economics and Outcomes Research Background: Risk-sharing arrangements (RSAs) can be used to mitigate uncertainty about the value of a drug by sharing the financial risk between payer and pharmaceutical company. We evaluated the projected impact of alternative RSAs for non–small cell lung cancer (NSCLC) therapies based on real-world data. Methods: Data on treatment patterns of Dutch NSCLC patients from four different hospitals were used to perform “what-if” analyses, evaluating the costs and benefits likely associated with various RSAs. In the scenarios, drug costs or refunds were based on response evaluation criteria in solid tumors (RECIST) response, survival compared to the pivotal trial, treatment duration, or a fixed cost per patient. Analyses were done for erlotinib, gemcitabine/cisplatin, and pemetrexed/platinum for metastatic NSCLC, and gemcitabine/cisplatin, pemetrexed/cisplatin, and vinorelbine/cisplatin for nonmetastatic NSCLC. Results: Money-back guarantees led to moderate cost reductions to the payer. For conditional treatment continuation schemes, costs and outcomes associated with the different treatments were dispersed. When price was linked to the outcome, the payer's drug costs reduced by 2.5% to 26.7%. Discounted treatment initiation schemes yielded large cost reductions. Utilization caps mainly reduced the costs of erlotinib treatment (by 16%). Given a fixed cost per patient based on projected average use of the drug, risk sharing was unfavorable to the payer because of the lower than projected use. The impact of RSAs on a national scale was dispersed. Conclusions: For erlotinib and pemetrexed/platinum, large cost reductions were observed with risk sharing. RSAs can mitigate uncertainty around the incremental cost-effectiveness or budget impact of drugs, but only when the type of arrangement matches the setting and type of uncertainty.

© 2019 van der Linden et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Background Heatwaves have been linked to increased risk of mortality and morbidity and are projected to increase in frequency and intensity due to climate change. The current study uses emergency department (ED) data from Australia, Botswana, Netherlands, Pakistan, and the United States of America to evaluate the impact of heatwaves on ED attendances, admissions and mortality. Methods Routinely collected time series data were obtained from 18 hospitals. Two separate thresholds (4 and 7) of the acclimatisation excess heat index (EHIaccl) were used to define “hot days”. Analyses included descriptive statistics, independent samples T-tests to determine differences in case mix between hot days and other days, and threshold regression to determine which temperature thresholds correspond to large increases in ED attendances. Findings In all regions, increases in temperature that did not coincide with time to acclimatise resulted in increases in ED attendances, and the EHIaccl performed in a similar manner. During hot days in California and The Netherlands, significantly more children ended up in the ED, while in Pakistan more elderly people attended. Hot days were associated with more patient admissions in the ages 5–11 in California, 65–74 in Karachi, and 75–84 in The Hague. During hot days in The Hague, patients with psychiatric symptoms were more likely to die. The current study did not identify a threshold temperature associated with particularly large increases in ED demand. Interpretation The association between heat and ED demand differs between regions. A limitation of the current study is that it does not consider delayed effects or influences of other environmental factors. Given the association betwee

© 2019, Springer Nature Switzerland AG. Background: In 2009, mandatory folic acid fortification of bread-making flour was introduced in Australia to reduce the birth prevalence of preventable neural tube defects (NTDs) such as spina bifida. Before the introduction of the policy, modelling predicted a reduction of 14–49 NTDs each year. Objective: Using real-world data, this study provides the first ex-post evaluation of the cost effectiveness of mandatory folic acid fortification of bread-making flour in Australia. Methods: We developed a decision tree model to compare different fortification strategies and used registry data to quantify the change in NTD rates due to the policy. We adopted a societal perspective that included costs to industry and government as well as healthcare and broader societal costs. Results: We found 32 fewer NTDs per year in the post-mandatory folic acid fortification period. Mandatory folic acid fortification improved health outcomes and was highly cost effective because of the low intervention cost. The policy demonstrated improved equity in outcomes, particularly in birth prevalence of NTDs in births from teenage and indigenous mothers. Conclusions: This study calculated the value of mandatory folic acid fortification using real-world registry data and demonstrated that the attained benefit was comparable to the modelled expected benefits. Mandatory folic acid fortification (in addition to policies including advice on supplementation and education) improved equity in certain populations and was effective and highly cost effective for the Australian population.

Contains fulltext : 190195.pdf (publisher's version ) (Open Access), Introduction: Demoralization is a relatively neglected issue in which low morale and poor coping result from a stressor such as familial cancer risk. Female BRCA1/2 mutation carriers are highly susceptible for developing breast and ovarian cancer. The aim of this study was to evaluate demoralization in oophorectomized BRCA1/2 mutation carriers and its relation to quality of life. Methods: This cross-sectional study examined 288 oophorectomized BRCA1/2 mutation carriers using the following standardized self-report measures: Demoralization Scale, EORTC Quality of Life Questionnaire-C30, State-Trait Anxiety Inventory and the Cancer Worry Scale. Results: The mean score on the Demoralization Scale was 17.8 (SD 14.0). A clinically significant level of demoralization, defined as a score >=30, was found in 45 BRCA1/2 mutation carriers (16%). Being highly demoralized was associated with a significantly lower quality of life, and higher levels of physical problems, anxiety and cancer worries. No demographic or clinical factors could predict higher levels of demoralization. Conclusions: Our findings established that a clear proportion of oophorectomized BRCA1/2 mutation carriers experience demoralization impacting on their well-being. Further research is needed to explore the natural trajectory of demoralization and the resultant need for support in these women.

21 maart 2018, Promotores : Massuger, L.F.A.G., Hoogerbrugge-van der Linden, N., Maas, A.H.E.M. Co-promotores : Hullu, J.A. de, Hermens, R.P.M.G., Radboud University, 21 maart 2018, Contains fulltext : 183429.pdf (publisher's version ) (Open Access)

Background: Scabies is a common dermatological condition, affecting more than 130 million people at any time. To evaluate and/or predict the effectiveness and cost-effectiveness of scabies interventions, disease transmission modelling can be used. Objective: To review published scabies models and data to inform the design of a comprehensive scabies transmission modelling framework to evaluate the cost-effectiveness of scabies interventions. Methods: Systematic literature search in PubMed, Medline, Embase, CINAHL, and the Cochrane Library identified scabies studies published since the year 2000. Selected papers included modelling studies and studies on the life cycle of scabies mites, patient quality of life and resource use. Reference lists of reviews were used to identify any papers missed through the search strategy. Strengths and limitations of identified scabies models were evaluated and used to design a modelling framework. Potential model inputs were identified and discussed. Findings: Four scabies models were published: a Markov decision tree, two compartmental models, and an agent-based, network-dependent Monte Carlo model. None of the models specifically addressed crusted scabies, which is associated with high morbidity, mortality, and increased transmission. There is a lack of reliable, comprehensive information about scabies biology and the impact this disease has on patients and society. Discussion: Clinicians and health economists working in the field of scabies are encouraged to use the current review to inform disease transmission modelling and economic evaluations on interventions against scabies.

© 2018 Elsevier B.V. Background: : In Australia, the Pharmaceutical Benefits Advisory Committee (PBAC) advises on the reimbursement of drugs to be subsidised through the Pharmaceutical Benefits Scheme (PBS). This study aims to provide insights into the PBAC process and key considerations regarding the reimbursement of MS drugs in Australia. Methods: : The factors considered by the PBAC and its advice on whether to reimburse a drug are documented in public summary documents (PSDs). Qualitative content analysis of PSDs was conducted for all MS drugs considered by the PBAC between January 2006 and January 2018. Key issues identified by the PBAC were extracted and categorised. Common issues were identified and compared between drugs indicated for MS. Results: : A total of 23 submissions were evaluated relating to 13 MS drugs. Eight were recommended for reimbursement; an approval rate of 35% per submission and 62% per drug. Approval rates were higher for disease modifying treatments (73% per drug) than for symptomatic drugs (0% for nabiximols and fampridine submissions). The most frequently discussed issues in PSDs, irrespective of PBAC decision, were: (1) the validity of the indirect comparisons formed (n = 11); (2) the validity of the approach to obtain utilities (n = 6); (3) the lack of appropriate/long-term safety data (n = 8); and (4) the time horizon used in the economic models (n = 3). Conclusion: : A small but important number of issues have been consistently identified by the PBAC in relation to submissions for reimbursement of MS drugs. Drug developers and clinical trial investigators who are aware of these issues will be able to anticipate data requirements for reimbursement decision-making and thus potentially improve the evidence submitted for listing of MS drugs in Australia.

Radboud University, 22 juni 2017, Promotores : Massuger, L.F.A.G., Hoogerbrugge-van der Linden, N. Co-promotores : Hullu, J.A. de, Hermens, R.P.M.G., Contains fulltext : 173261.pdf (publisher's version ) (Open Access)

© 2017 Elsevier Ltd Introduction Emergency department (ED) crowding is a worldwide public health issue. In this study, patient flow and staff perceptions of crowding were assessed in Pakistan (Aga Khan University Hospital (AKUH)) and in the Netherlands (Haaglanden Medical Centre Westeinde (HMCW)). Bottlenecks affecting ED patient flow were identified. Methods First, a one-year review of patient visits was performed. Second, staff perceptions about ED crowding were collected using face-to-face interviews. Non-participant observation and document review were used to interpret the findings. Results At AKUH 58,839 (160 visits/day) and at HMCW 50,802 visits (140 visits/day) were registered. Length of stay (LOS) at AKUH was significantly longer than at HMCW (279 min (IQR 357) vs. 100 min (IQR 152)). There were major differences in patient acuities, admission and mortality rates, indicating a sicker population at AKUH. Respondents from both departments experienced hampered patient flow on a daily basis, and perceived similar causes for crowding: increased patients’ complexity, long treatment times, and poor availability of inpatient beds. Conclusion Despite differences in environment, demographics, and ED patient flow, respondents perceived similar bottlenecks in patient flow. Interventions should be tailored to specific ED and hospital needs. For both EDs, improving the outflow of boarded patients is essential.

© 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Objectives The aim of this article was to provide practical guidance in setting up patient registries to facilitate real-world data collection for health care decision making. Methods This guidance was based on our experiences and involvement in setting up patient registries in oncology in the Netherlands. All aspects were structured according to 1) mission and goals (“the Why”), 2) stakeholders and funding (“the Who”), 3) type and content (“the What”), and 4) identification and recruitment of patients, data handling, and pharmacovigilance (“the How”). Results The mission of most patient registries is improving patient health by improving the quality of patient care; monitoring and evaluating patient care is often the primary goal (“the Why”). It is important to align the objectives of the registry and agree on a clear and functional governance structure with all stakeholders (“the Who”). There is often a trade off between reliability, validity, and specificity of data elements and feasibility of data collection (“the What”). Patient privacy should be carefully protected, and address (inter-)national and local regulations. Patient registries can reveal unique safety information, but it can be challenging to comply with pharmacovigilance guidelines (“the How”). Conclusions It is crucial to set up an efficient patient registry that serves its aims by collecting the right data of the right patient in the right way. It can be expected that patient registries will become the new standard alongside randomized controlled trials due to their unique value.

© 2017 Kanters et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Objectives: Dutch health economic guidelines include a costing manual, which describes preferred research methodology for costing studies and reference prices to ensure high quality studies and comparability between study outcomes. This paper describes the most important revisions of the costing manual compared to the previous version. Methods: An online survey was sent out to potential users of the costing manual to identify topics for improvement. The costing manual was aligned with contemporary health economic guidelines. All methodology sections and parameter values needed for costing studies, particularly reference prices, were updated. An expert panel of health economists was consulted several times during the review process. The revised manual was reviewed by two members of the expert panel and by reviewers of the Dutch Health Care Institute. Results: The majority of survey respondents was satisfied with content and usability of the existing costing manual. Respondents recommended updating reference prices and adding some particular commonly needed reference prices. Costs categories were adjusted to the international standard: 1) costs within the health care sector; 2) patient and family costs; and 3) costs in other sectors. Reference prices were updated to reflect 2014 values. The methodology chapter was rewritten to match the requirements of the costing manual and preferences of the users. Reference prices for nursing days of specific wards, for diagnostic procedures and nurse practitioners were added. Conclusions: The usability of the costing manual was increased and parameter values were updated. The costing manual became integrated in the new health economic guidelines.

RU Radboud Universiteit, 6 april 2016, Promotores : Geurts van Kessel, A.H.M., Hoogerbrugge-van der Linden, N. Co-promotores : Kuiper, R.P., Ligtenberg, M.J.L., Contains fulltext : 156501.pdf (publisher's version ) (Open Access)