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Background: Several approaches to medication optimisation by identifying drug-related problems in older people have been described. Although some interventions have shown reductions in drug-related problems (DRPs), evidence supporting the effectiveness of medication reviews on clinical and economic outcomes is lacking. Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy. Therefore, application of STOPP/START criteria during a medication review is likely to be beneficial. Incorporation of explicit screening tools into clinical decision support systems (CDSS) has gained traction as a means to improve both quality and efficiency in the rather time-consuming medication review process. Although CDSS can generate more potential inappropriate medication recommendations, some of these have been shown to be less clinically relevant, resulting in alert fatigue. Moreover, explicit tools such as STOPP/START do not cover all relevant DRPs on an individual patient level. The OPERAM study aims to assess the impact of a structured drug review on the quality of pharmacotherapy in older people with multi-morbidity and polypharmacy. The aim of this paper is to describe the structured, multi-component intervention of the OPERAM trial and compare it with the approach in the comparator arm.Method: This paper describes a multi-component intervention, integrating interventions that have demonstrated effectiveness in defining DRPs. The intervention involves a structured history-taking of medication (SHiM), a medication review according to the systemic tool to reduce inappropriate prescribing (STRIP) method, assisted by a clinical decision support system (STRIP Assistant, STRIPA) with integrated STOPP/START criteria (version 2), followed by shared decision-making with both patient and attending physician. The developed method integrates patient input, patient data, involvement from other healthcare professionals and CDSS-assistance into one structured intervention.Discussion: The clinical and economical effectiveness of this experimental intervention will be evaluated in a cohort of hospitalised, older patients with multi-morbidity and polypharmacy in the multicentre, randomized controlled OPERAM trial (OPtimising thERapy to prevent Avoidable hospital admissions in the Multi-morbid elderly), which will be completed in the last quarter of 2019.Trial Registration: Universal Trial Number: U1111-1181-9400 Clinicaltrials.gov: NCT02986425, Registered 08 December 2016. FOPH (Swiss national portal): SNCTP000002183. Netherlands Trial Register: NTR6012 (07-10-2016). [ABSTRACT FROM AUTHOR]

Simple Summary: This nationwide cohort study evaluated the incidence and severity of immune-related adverse events (irAEs) in melanoma patients receiving adjuvant versus advanced anti-PD-1 therapy. A total of 1465 advanced melanoma patients and 908 adjuvant-treated patients were included. Patients in the adjuvant group were younger, had superior ECOG performance status, and had fewer comorbidities compared to those in the advanced group. No significant difference was observed in the incidence of grade III-IV irAEs between the two groups. However, higher ECOG status (>1) and the presence of any comorbidities were independently associated with an increased risk of irAE development across both treatment settings. Although adjuvant therapy was not linked to a heightened risk of severe irAEs compared to advanced therapy, it was more frequently discontinued due to toxicity in the adjuvant group. These findings provide critical insights for informing patient consultations regarding adjuvant anti-PD-1 treatment. Introduction: The difference in incidence and severity of anti-PD-1 therapy-related adverse events (irAEs) between adjuvant and advanced treated melanoma patients remains unclear, as no head-to-head studies have compared these groups. Methods: This multi-center cohort study analyzed melanoma patients treated with anti-PD-1 in adjuvant or advanced settings between 2015 and 2021. Comorbidities and ECOG performance status were assessed before treatment, and grade III-IV irAEs were monitored during treatment. Univariate and multivariate regression analyses were conducted to identify factors associated with irAE development. Results: A total of 1465 advanced melanoma patients and 908 resected melanoma patients received anti-PD-1 therapy. Adjuvant-treated patients were younger, with a median age of 63 years compared to 69 years in the advanced group (p < 0.01), and had a better ECOG performance status (p < 0.01). Comorbidities were seen more frequently in advanced melanoma patients than in those receiving adjuvant treatment, 76% versus 68% (p < 0.01). Grade III-IV irAEs occurred in 214 (15%) advanced treated patients and in 119 (13%) adjuvant-treated patients. Multivariate analysis showed an increased risk of severe irAE development with the presence of any comorbidity (adjusted OR 1.22, 95% CI 1.02–1.44) and ECOG status greater than 1 (adjusted OR 2.00, 95% CI 1.20–3.32). Adjuvant therapy was not associated with an increased risk of irAE development compared to advanced treatment (adjusted OR 0.95, 95% CI 0.74–1.21) after correcting for comorbidities and ECOG performance score. Anti-PD-1 therapy was halted due to toxicity (any grade irAE) more often in the adjuvant setting than in the advanced setting, 20% versus 15% (p < 0.01). Conclusions: Higher ECOG performance status and presence of any comorbidity were independently associated with an increased risk of Grade III-IV irAE in adjuvant and advanced treated melanoma patients. Patients treated in the adjuvant setting did not have an increased risk of developing severe irAEs compared to advanced melanoma patients. These findings are of clinical significance in consulting patients for adjuvant anti-PD-1 treatment. [ABSTRACT FROM AUTHOR]

Background: Various international studies have shown that a substantial number of patients suffer from injuries or even die as a result of care delivered in hospitals. The occurrence of injuries among patients caused by health care management in Dutch hospitals has never been studied systematically. Therefore, an epidemiological study was initiated to determine the incidence, type and impact of adverse events among discharged and deceased patients in Dutch hospitals. Methods/Design: Three stage retrospective patient record review study in 21 hospitals of 8400 patient records of discharged or deceased patients in 2004. The records were reviewed by trained nurses and physicians between August 2005 and October 2006. In addition to the determination of presence, the degree of preventability, and causes of adverse events, also location, timing, classification, and most responsible specialty of the adverse events were measured. Moreover, patient and admission characteristics and the quality of the patient records were recorded. Discussion: In this paper we report on the design of the retrospective patient record study on the occurrence of adverse events in Dutch hospitals. Attention is paid to the strengths and limitations of the study design. Furthermore, alterations made in the original research protocol in comparison with former international studies are described in detail. [ABSTRACT FROM AUTHOR]

Background: Compliance with perioperative anticoagulation guidelines is essential to minimize bleeding and thromboembolic risks in patients undergoing surgery. Compared to vitamin-K antagonists (VKAs), perioperative management of direct oral anticoagulants (DOACs) contains fewer steps. Therefore, we hypothesized that noncompliance with guidelines in VKA users is higher than in DOAC users. The primary aim of our study was to investigate the difference in noncompliance to perioperative anticoagulant management guidelines between elderly patients using VKAs versus those using DOACs. The secondary aim was to determine the difference in occurrence of conflicting information communicated to the patients and the difference in incidence of coagulation-related adverse events. Methods: This retrospective non-controlled observational cohort study examined elderly patients undergoing elective orthopedic surgery in a teaching hospital in the Netherlands. All patients undergoing elective orthopedic surgery between 1 May 2016 and 1 January 2020, aged 70 years and over, using VKAs or DOACs were selected. Nonelective surgeries were excluded. The primary outcome was the noncompliance to perioperative anticoagulant management guidelines. Secondary outcomes were missing or conflicting information on anticoagulation management communicated to the patient and coagulation-related adverse events. For continuous data, the unpaired T-test was used and for categorical data, the chi-square test. Results: In patients using VKAs, noncompliance to one of the steps of perioperative anticoagulation management was 81%, compared to 55% in patients using DOACs (p < 0.001). In most cases, VKAs or DOACs were interrupted for longer than recommended. In 13% of patients using a VKA with perioperative bridging, bridging was not conducted as recommended in the guidelines. In 13% of patients using a DOAC, a low-molecular-weight heparin (LMWH) was prescribed while a DOAC had already been restarted postoperatively. VKA users received conflicting information about perioperative anticoagulation management more often than DOAC users (33% versus 20%; p < 0.001). No difference was seen in postoperative coagulation-related complications. Conclusion: Guidelines compliance in DOAC users is higher than in VKA users. Clinical decision support to help in selecting the right interruption interval in DOAC users, simplified standardized perioperative management, good coordination of instructions given to patients, and familiarity with updated guidelines are important in reducing noncompliance. [ABSTRACT FROM AUTHOR]

Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of "poor", "moderate", and "good" knowledge, as well as "positive" and "negative" attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting. [ABSTRACT FROM AUTHOR]

Background: This study was designed to investigate the impact of age on the effectiveness and immune-related adverse events (irAEs) of programmed death-(ligand)1 [PD-(L)1] inhibitors in patients with non-small cell lung cancer (NSCLC) using a novel text-mining technique. Methods: This retrospective study included patients with stage III/IV NSCLC treated with a PD-(L)1 inhibitor (nivolumab, pembrolizumab, atezolizumab and durvalumab) at Leiden University Medical Centre and Haga Teaching hospital, (both in The Netherlands) from September 2016 to May 2021. All the relevant data was extracted from the structured and unstructured fields of the Electronic Health Records using a novel text-mining tool. Effectiveness [progression-free survival (PFS) and overall survival (OS)] and safety (the incidence of nine potentially fatal irAEs and systemic corticosteroid requirement) outcomes were compared across age subgroups (young: < 65 years, Middle-aged: 65–74 years, and old: ≥ 75 years) after adjustment for confounding. Results: Of 689 patients, 310 patients (45.0%) were < 65 years, 275 patients (39.9%) were aged between 65 and 74 years, and 104 patients (15.1%) were ≥ 75 years. There was no significant difference between younger and older patients regarding PFS (median PFS 12, 8, 13 months respectively; Hazard ratio (HR)middle-aged = 1.14, 95% CI 0.92–1.41; HRold = 1.10, 95% CI 0.78–1.42). This was also the case for OS (median OS 19, 14, 18 months respectively; HRmiddle-aged = 1.22, 95% CI 0.96–1.53; HRold = 1.10, 95% CI 0.79–1.52). Safety analysis demonstrated a higher incidence of pneumonitis among patients aged 65–74. When all the investigated irAEs were pooled, there was no statistically significant difference found between age and the incidence of potentially fatal irAEs. Conclusions: The use of PD-(L)1 inhibitors is not associated with age related decrease of PFS and OS, nor with increased incidence of serious irAEs compared to younger patients receiving these treatments. Chronological age must therefore not be used as a predictor for the effectiveness or safety of ICIs. [ABSTRACT FROM AUTHOR]

Background: Guidelines recommend to prescribe a laxative with an opioid to prevent constipation. We aimed to determine the adherence by general practitioners (GPs) to this recommendation and to explore which GP- and patient related factors were associated with it from the perspective of the GP. Methods: We conducted an observational study using GPs' prescription data from the Nivel Primary Care Database combined with a questionnaire asking for reasons of non-adherence. The proportion of first opioid prescriptions prescribed together with a laxative was determined as primary outcome. Possible explanatory factors such as the quality of registration, the level of collaboration with the pharmacy, familiarity with the recommendation and use of a clinical decision support system were explored, as were the self-reported reasons for non-adherence (classified as either GP-related or patient-related). We assessed the association of factors with the primary outcome using univariable multilevel logistic regression analysis. Results: The recommendation was measured in 195 general practices. The median proportion of first opioid prescriptions prescribed together with a laxative in these practices was 54% (practice range 18–88%). None of the determinants was consistently associated with the primary outcome. GPs from 211 practices filled out the questionnaire and the most frequently mentioned reason not to prescribe a laxative was that the patient has laxatives in stock, followed by that the patient doesn't want a laxative; both were patient-related factors. Conclusion: There was room for improvement in following the guideline on laxative prescribing in opioid use. A main reason seemed to be that the patient refuses a laxative. Improvement measures should therefore focus on communication between GPs and patients on the relevance of co-using a laxative with opioids. Future studies need to establish the effect of such improvement measures, and determine whether reasons for non-adherence to the guideline changed over time. [ABSTRACT FROM AUTHOR]

Background: Older patients using antihypertensive medication may experience Adverse Drug Events (ADEs), and thus benefit from deprescribing. The lack of a practical protocol may hamper deprescribing. Therefore, we aimed to develop a deprescribing protocol, based on a review of literature, combined with a feasibility test in a small number of patients. Methods: A deprescribing protocol for general practitioners was drafted and tested in older patients using multiple antihypertensive medication in a single arm intervention. Patients were included if they were 75 years or older, were using two or more antihypertensives, had at least one ADE linked to antihypertensive medication and deprescribing was considered to be safe by their general practitioner. The primary outcome was the percentage of patients for whom one or more antihypertensive drugs were stopped or reduced in dose after 12 months of follow up while maintaining safe blood pressures. Secondary outcomes were the proportion of patients reporting no ADEs after 12 months and the number of deprescribed antihypertensives. Patient's opinions on deprescribing and enablers and barriers for study participation were also collected. Results: Nine general practitioners included 14 patients to deprescribe antihypertensive medication using the deprescribing protocol. After 12 months antihypertensive drug use was lowered in 11 patients (79%). These patients had a mean systolic blood pressure increase of 16 mmHg and a mean diastolic blood pressure increase of 8 mmHg. Nine patients (64%) reported experiencing no ADEs anymore after twelve months. The mean number of deprescribed antihypertensives was 1.1 in all patients and 1.4 (range: 0.5 to 3.5) in patients who successfully lowered their medication. At baseline, being able to use less medication was the most frequently mentioned enabler to participate in this study. The most frequently mentioned positive experience at the end of the study was using less medication, which was in line with the most mentioned enabler to participate in this study. Conclusion: A protocol for deprescribing antihypertensives in older patients was considered feasible, as it resulted in a substantial degree of safe deprescribing in this pilot study. Larger studies are needed to demonstrate the effect and safety of deprescribing antihypertensives in older patients. [ABSTRACT FROM AUTHOR]

Background: To support patients in shared decision‐making about treatment options, patient decision aids (PtDAs) usually provide benefit/harm information and value clarification methods (VCMs). Recently, personalized risk information from prediction models is also being integrated into PtDAs. This study aimed to design decision‐relevant information (i.e., personalized survival rates, harm information and VCMs) about adjuvant breast cancer treatment in cocreation with patients, in a way that suits their needs and is easily understandable. Methods: Three cocreation sessions with breast cancer patients (N = 7–10; of whom N = 5 low health literate) were performed. Participants completed creative assignments and evaluated prototypes of benefit/harm information and VCMs. Prototypes were further explored through user testing with patients (N = 10) and healthcare providers (N = 10). The researchers interpreted the collected data, for example, creative and homework assignments, and participants' presentations, to identify key themes. User tests were transcribed and analysed using ATLAS.ti to assess the understanding of the prototypes. Results: Important information needs were: (a) need for overview/structure of information directly after diagnosis and; (b) need for transparent benefit/harm information for all treatment options, including detailed harm information. Regarding VCMs, patients stressed the importance of a summary/conclusion. A bar graph seemed the most appropriate way of displaying personalized survival rates; the impact of most other formats was perceived as too distressful. The concept of 'personalization' was not understood by multiple patients. Conclusions: A PtDA about adjuvant breast cancer treatment should provide patients with an overview of the steps and treatment options, with layers for detailed information. Transparent information about the likelihood of benefits and harm should be provided. Given the current lack of information on the likelihood of side effects/late effects, efforts should be made to collect and share these data with patients. Further quantitative studies are needed to validate the results and to investigate how the concept of 'personalization' can be communicated. Patient or Public Contribution: Ten breast cancer patients participated in three cocreation sessions to develop decision‐relevant information. Subsequent user testing included 10 patients. The Dutch Breast Cancer Association (BVN) was involved as an advisor in the general study design. [ABSTRACT FROM AUTHOR]

Aims: Prescribing medication is a complex process that, when done inappropriately, can lead to adverse drug events, resulting in patient harm and hospital admissions. Worldwide cost is estimated at 42 billion USD each year. Despite several efforts in the past years, medication‐related harm has not declined. The aim was to determine whether a prescriber‐focussed participatory action intervention, initiated by a multidisciplinary pharmacotherapy team, is able to reduce the number of in‐hospital prescriptions containing ≥1 prescribing error (PE), by identifying and reducing challenges in appropriate prescribing. Methods: A prospective single‐centre before‐ and after study was conducted in an academic hospital in the Netherlands. Twelve clinical wards (medical, surgical, mixed and paediatric) were recruited. Results: Overall, 321 patients with a total of 2978 prescriptions at baseline were compared with 201 patients with 2438 prescriptions postintervention. Of these, m456 prescriptions contained ≥1 PE (15.3%) at baseline and 357 prescriptions contained ≥1 PEs (14.6%) postintervention. PEs were determined in multidisciplinary consensus. On some study wards, a trend toward a decreasing number of PEs was observed. The intervention was associated with a nonsignificant difference in PEs (incidence rate ratio 0.96, 95% confidence interval 0.83–1.10), which was unaltered after correction. The most important identified challenges were insufficient knowledge beyond own expertise, unawareness of guidelines and a heavy workload. Conclusion: The tailored interventions developed with and implemented by stakeholders led to a statistically nonsignificant reduction in inappropriate in‐hospital prescribing after a 6‐month intervention period. Our prescriber‐focussed participatory action intervention identified challenges in appropriate in‐hospital prescribing on prescriber‐ and organizational level. [ABSTRACT FROM AUTHOR]

Background: Antibiotics are over-prescribed for lower respiratory tract infections (LRTI) in nursing home residents due to diagnostic uncertainty. Inappropriate antibiotic use is undesirable both on patient level, considering their exposure to side effects and drug interactions, and on societal level, given the development of antibiotic resistance. C-reactive protein (CRP) point-of-care testing (POCT) may be a promising diagnostic tool to reduce antibiotic prescribing for LRTI in nursing homes. The UPCARE study will evaluate whether the use of CRP POCT for suspected LRTI is (cost-) effective in reducing antibiotic prescribing in the nursing home setting.Methods/design: A cluster randomized controlled trial will be conducted in eleven nursing homes in the Netherlands, with the nursing home as the unit of randomization. Residents with suspected LRTI who reside at a psychogeriatric, somatic, or geriatric rehabilitation ward are eligible for study participation. Nursing homes in the intervention group will provide care as usual with the possibility to use CRP POCT, and the control group will provide care as usual without CRP POCT for residents with (suspected) LRTI. Data will be collected from September 2018 for approximately 1.5 year, using case report forms that are integrated in the electronic patient record system. The primary study outcome is antibiotic prescribing for suspected LRTI at index consultation (yes/no).Discussion: This is the first randomised trial to evaluate the effect of nursing home access to and training in the use of CRP POCT on antibiotic prescribing for LRTI, yielding high-level evidence and contributing to antibiotic stewardship in the nursing home setting. The relatively broad inclusion criteria and the pragmatic study design add to the applicability and generalizability of the study results.Trial Registration: Netherlands Trial Register, Trial NL5054. Registered 29 August 2018. [ABSTRACT FROM AUTHOR]

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Background: The need for physical cancer rehabilitation programmes (PCRPs), addressing adverse effects from cancer, is growing. Implementing these programmes into daily practice is still a challenge. Since barriers for successful implementation often arise at different levels in healthcare, multi-faceted strategies focusing on multiple levels are likely more effective than single-faceted strategies. Nevertheless, most studies implementing PCRPs used strategies directed at patients only. The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy. Methods/design: We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care. A stepwise approach will be followed: Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital). Step 2: Selection and development of interventions to create a PD and MF strategy during expert roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs. Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n = 50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital. Main outcome measures: % screened patients, % referrals to PCRPs, incremental costs and incremental cost-effectiveness ratios (ICERs). Trail registration: NCT02205853 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Background: Epidemiologic information on time trends of Adverse Drug Reactions (ADR) and ADR-related hospitalizations is scarce. Over time, pharmacotherapy has become increasingly complex. Because of raised awareness of ADR, a decrease in ADR might be expected. The aim of this study was to determine trends in ADR-related hospitalizations in the older Dutch population. Methodology and Principal Findings: Secular trend analysis of ADR-related hospital admissions in patients ⁄60 years between 1981 and 2007, using the National Hospital Discharge Registry of the Netherlands. Numbers, age-specific and ageadjusted incidence rates (per 10,000 persons) of ADR-related hospital admissions were used as outcome measures in each year of the study. Between 1981 and 2007, ADR-related hospital admissions in persons ⁄60 years increased by 143%. The overall standardized incidence rate increased from 23.3 to 38.3 per 10,000 older persons. The increase was larger in males than in females. Since 1997, the increase in incidence rates of ADR-related hospitalizations flattened (percentage annual change 0.65%), compared to the period 1981-1996 (percentage annual change 2.56%). Conclusion/Significance: ADR-related hospital admissions in older persons have shown a rapidly increasing trend in the Netherlands over the last three decades with a temporization since 1997. Although an encouraging flattening in the increasing trend of ADR-related admissions was found around 1997, the incidence is still rising, which warrants sustained attention to this problem. [ABSTRACT FROM AUTHOR]

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • More and more countries accept patient reporting in their spontaneous reporting systems. • Media exposure about drugs can influence patients and health professionals. • Evaluation of patient reporting of adverse drug reactions is needed to provide further evidence of its benefits. WHAT THIS STUDY ADDS • Patient reporting compared with reporting by health professionals after media attention about statins. • Patient reports provide additional insight into impact on daily life, the patient–health professional relationship and general worries next to health professionals' reports. AIMS To compare adverse drug reaction (ADR) reports from patients and health professionals after the broadcast of a Dutch television consumer programme about the benefits and risks of statins. METHODS We performed a quantitative and qualitative analysis on patients' and health professionals' reports of ADRs to statins. These reports were received by the Netherlands Pharmacovigilance Centre Lareb between March 2007 and August 2007. Quantitative data consisted of patient age and gender, number of received reports and characteristics of the report (most frequently reported ADRs, seriousness, drug discontinuation and outcome of the reported reaction). Open text fields in the ADR reporting form were categorized and a content analysis was carried out. RESULTS Media attention led to a peak in patient reporting of ADRs but not in reporting by health professionals. There were no differences between patient and health professional reports in seriousness of the ADRs and drug cessation. Patients reported nonrecovery more often than health professionals. The TV programme is mentioned as a reason for drug discontinuation in almost 30 reports. Patients often felt that they did not receive sufficient information and that their concerns were not adequately addressed by healthcare professionals. CONCLUSIONS Media attention affects drug use and ADR reporting by patients. Patient reports can provide additional information, making them a useful source of information next to health professional reports. Content analysis provides vital insights into the impact of statins on daily life, and patients' concerns about adverse reactions should be recognized in reports to national pharmacovigilance centres. [ABSTRACT FROM AUTHOR]

Background: Up to now, costs attributable to adverse events (AEs) and preventable AEs in the Netherlands were unknown. We assessed the total direct medical costs associated with AEs and preventable AEs in Dutch hospitals to gain insight in opportunities for cost savings. Methods: Trained nurses and physicians retrospectively reviewed 7926 patient records in 21 hospitals. Additional patient information of 7889 patients was received from the Dutch registration of hospital information. Direct medical costs attributable to AEs were assessed by measuring excess length of stay and additional medical procedures after an AE occurred. Costs were valued using Dutch standardized cost prices. Results: The annual direct medical costs in Dutch hospitals were estimated at a total of euro 355 million for all AEs and euro 161 million for preventable AEs in 2004. The total number of hospital admissions in which a preventable AE occurred was 30,000 (2.3% of all admissions) and more than 300,000 (over 3% of all bed days) bed days were attributable to preventable AEs in 2004. Multilevel analysis showed that variance in direct medical costs was not determined by differences between hospitals or hospital departments. Conclusion: The estimates of the total preventable direct medical costs of AEs indicate that they form a substantial part (1%) of the expenses of the national health care budget and are of importance to hospital management. The cost driver of the direct medical costs is the excess length of stay (including readmissions) in a hospital. Insight in which determinants are associated with high preventable costs will offer useful information for policymakers and hospital management to determine starting points for interventions to reduce the costs of preventable AEs. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare the importance that patients with type 2 diabetes mellitus from the Netherlands and Turkey attach to certain drug effects of oral anti-diabetic drugs. Methods: Data were collected through a cross-sectional survey containing demographic questions and a discrete choice experiment assessing preferences for oral anti-diabetic drugs. Adults from the Netherlands and Turkey were included if they had type 2 diabetes mellitus and had received a prescription of an oral anti-diabetic drug in the last 4 months. The oral anti-diabetic drugs in the discrete choice experiment were described in terms of six attributes: effects on HbA1c, cardiovascular diseases, weight change, gastrointestinal adverse drug events hypoglycemic events, and bladder cancer. Multinomial logit models with country as an interaction factor were fitted. Results: In total, 381 patients were included, 199 from the Netherlands and 182 from Turkey. Patients' preferences toward drug effects varied between the countries. Turkish patients attached the highest importance to reducing the risk of cardiovascular diseases (relative weight: 0.51, 95% CI 0.45–0.55), followed by reducing hypoglycemic events (relative weight: 0.16, 95% CI 0.11–0.22), and reducing gastrointestinal adverse drug events (relative weight: 0.11, 95% CI 0.07–0.18). Patients from the Netherlands attached the highest importance to gastrointestinal ADEs (relative weight: 0.22, 95% CI 0.14–0.39), followed by reducing hypoglycemic events (relative weight: 0.22, 95% CI 0.16–0.25), and reducing the risk of cardiovascular diseases (relative weight: 0.20, 95% CI 0.13–0.23). Conclusion: Patient preferences may differ across countries. Such differences should be acknowledged in regulatory decisions and clinical practice. [ABSTRACT FROM AUTHOR]