Two Days Versus Five Days of Postoperative Antibiotics for Complex Appendicitis: Cost Analysis of a Randomized, Noninferiority Trial.

OBJECTIVE: To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored. METHODS: This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019. RESULTS: In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - €625 (95% CI: -€ 958 to -€ 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of €31,117 per additional infectious complication. CONCLUSIONS: Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.

Cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy for traumatic meniscal tears in patients aged under 45 years.

Aims: The aim of this study was to evaluate the cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy plus optional delayed arthroscopic partial meniscectomy in young patients aged under 45 years with traumatic meniscal tears. Methods: We conducted a multicentre, open-labelled, randomized controlled trial in patients aged 18 to 45 years, with a recent onset, traumatic, MRI-verified, isolated meniscal tear without knee osteoarthritis. Patients were randomized to arthroscopic partial meniscectomy or standardized physical therapy with an optional delayed arthroscopic partial meniscectomy after three months of follow-up. We performed a cost-utility analysis on the randomization groups to compare both treatments over a 24-month follow-up period. Cost utility was calculated as incremental costs per quality-adjusted life year (QALY) gained of arthroscopic partial meniscectomy compared to physical therapy. Calculations were performed from a healthcare system perspective and a societal perspective. Results: A total of 100 patients were included: 49 were randomized to arthroscopic partial meniscectomy and 51 to physical therapy. In the physical therapy group, 21 patients (41%) received delayed arthroscopic partial meniscectomy during follow-up. Over 24 months, patients in the arthroscopic partial meniscectomy group had a mean 0.005 QALYs lower quality of life (95% confidence interval -0.13 to 0.14). The cost-utility ratio was €-160,000/QALY from the healthcare perspective and €-223,372/QALY from the societal perspective, indicating that arthroscopic partial meniscectomy incurs additional costs without any added health benefit. Conclusion: Arthroscopic partial meniscectomy is arthroscopic partial meniscectomy is unlikely to be cost-effective in treating young patients with isolated traumatic meniscal tears compared to physical therapy as a primary health intervention. Arthroscopic partial meniscectomy leads to a similar quality of life, but higher costs, compared to physical therapy plus optional delayed arthroscopic partial meniscectomy.

No Added Value of Duloxetine in Patients With Chronic Pain due to Hip or Knee Osteoarthritis: A Cluster-Randomized Trial.

OBJECTIVE: To assess the effectiveness of duloxetine in addition to usual care in patients with chronic osteoarthritis (OA) pain. The cost-effectiveness and whether the presence of symptoms of centralized pain alters the response to duloxetine were secondary objectives. METHODS: We conducted an open-label, cluster-randomized trial. Patients with chronic hip or knee OA pain who had an insufficient response to acetaminophen and nonsteroidal antiinflammatory drugs were included. Randomization took place at the general practice level, and patients received duloxetine (60 mg/day) in addition to usual care or usual care alone. The presence of centralized pain was defined as a modified PainDETECT Questionnaire score >12. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores (scale 0-20) at 3 months after the initiation of treatment. Our aim was to detect a difference between the groups of a clinically relevant effect of 1.9 points (effect size 0.4). We used a linear mixed model with repeated measurements to analyze the data. RESULTS: In total, 133 patients were included, and 132 patients were randomized into treatment groups. A total of 66 patients (at 31 practices) were randomized to receive duloxetine in addition to usual care, and 66 patients (at 35 practices) were randomized to receive usual care alone. We found no differences in WOMAC pain scores between the groups at 3 months (adjusted difference -0.58 [95% confidence interval (95% CI) -1.80, 0.63]) or at 12 months (adjusted difference -0.26 [95% CI -1.86, 1.34]). In the subgroup of patients with centralized pain symptoms, we also found no effect of duloxetine compared to usual care alone (adjusted difference -0.32 [95% CI -2.32, 1.67]). CONCLUSION: We found no effect of duloxetine added to usual care compared to usual care alone in patients with chronic knee or hip OA pain. Another trial including patients with centralized pain symptoms should be conducted to validate our results.

Socioeconomic differences in healthcare expenditure and utilization in The Netherlands.

BACKGROUND: Worldwide, socioeconomic differences in health and use of healthcare resources have been reported, even in countries providing universal healthcare coverage. However, it is unclear how large these socioeconomic differences are for different types of care and to what extent health status plays a role. Therefore, our aim was to examine to what extent healthcare expenditure and utilization differ according to educational level and income, and whether these differences can be explained by health inequalities. METHODS: Data from 18,936 participants aged 25-79 years of the Dutch Health Interview Survey were linked at the individual level to nationwide claims data that included healthcare expenditure covered in 2017. For healthcare utilization, participants reported use of different types of healthcare in the past 12 months. The association of education/income with healthcare expenditure/utilization was studied separately for different types of healthcare such as GP and hospital care. Subsequently, analyses were adjusted for general health, physical limitations, and mental health. RESULTS: For most types of healthcare, participants with lower educational and income levels had higher healthcare expenditure and used more healthcare compared to participants with the highest educational and income levels. Total healthcare expenditure was approximately between 50 and 150 % higher (depending on age group) among people in the lowest educational and income levels. These differences generally disappeared or decreased after including health covariates in the analyses. After adjustment for health, socioeconomic differences in total healthcare expenditure were reduced by 74-91 %. CONCLUSIONS: In this study among Dutch adults, lower socioeconomic status was associated with increased healthcare expenditure and utilization. These socioeconomic differences largely disappeared after taking into account health status, which implies that, within the universal Dutch healthcare system, resources are being spent where they are most needed. Improving health among lower socioeconomic groups may contribute to decreasing health inequalities and healthcare spending.

Clinical and cost effectiveness of a corticosteroid injection versus exercise therapy for shoulder pain in general practice: protocol for a randomised controlled trial (SIX Study).

INTRODUCTION: Shoulder pain is common and the prognosis is often unfavourable. Dutch guidelines on the treatment of shoulder pain in primary care recommend a corticosteroid injection or a referral to exercise therapy, if initial pain management fails and pain persists. However, evidence of the effectiveness of a corticosteroid injection compared with exercise therapy, especially in the long term, is limited. This trial will assess the clinical effectiveness and cost effectiveness of a corticosteroid injection compared with physiotherapist-led exercise therapy over 12 months follow-up in patients with shoulder pain in primary care. METHODS AND ANALYSIS: The SIX Study is a multicentre, pragmatic randomised clinical trial in primary care. A total of 213 patients with shoulder pain, aged ≥18 years presenting in general practice will be included. Patients will be randomised (1:1) into two groups: a corticosteroid injection or 12 sessions of physiotherapist-led exercise therapy. The effect of the allocated treatment will be assessed through questionnaires at 6 weeks and after 3, 6, 9 and 12 months. The primary outcome is patient's reported shoulder pain-intensity and function, measured with the Shoulder Pain and Disability Index, over 12 months follow-up. Secondary outcomes include cost effectiveness, pain-intensity, function, health-related quality of life, sleep quality, patient's global perceived effect, work absence, healthcare utilisation and adverse events. Between group differences will be evaluated using a repeated measurements analysis with linear effects models. A cost-utility analysis will be performed to assess the cost effectiveness using quality-adjusted life years from a medical and societal perspective. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of Erasmus MC University Medical Center Rotterdam (MEC 2020-0300). All participants will give written informed consent prior to data collection. The results from this study will be disseminated in international journals and implemented in the primary care guidelines on shoulder pain. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NL8854).

Clinically SUspected ScaPhoid fracturE: treatment with supportive bandage or CasT? 'Study protocol of a multicenter randomized controlled trial' (SUSPECT study).

INTRODUCTION: Some scaphoid fractures become visible on radiographs weeks after a trauma which makes normal radiographs directly after trauma unreliable. Untreated scaphoid fractures can lead to scaphoid non-union progressing to osteoarthritis. Therefore, the general treatment for patients with a clinically suspected scaphoid fracture and normal initial radiographs is immobilisation with below-elbow cast for 2 weeks. However, most of these patients are treated unnecessarily because eventually less than 10% of them are diagnosed with an occult scaphoid fracture. To reduce overtreatment and costs as a result of unnecessary cast treatment in patients with a clinically suspected scaphoid fracture and normal initial radiographs, we designed a study to compare below-elbow cast treatment with supportive bandage treatment. We hypothesise that the functional outcome after 3 months is not inferior in patients treated with supportive bandage compared to patients treated with below-elbow cast, but with lower costs in the supportive bandage group. METHODS AND ANALYSIS: The SUSPECT study is an open-labelled multicentre randomised controlled trial with non-inferiority design. A total of 180 adult patients with a clinically suspected scaphoid fracture and normal initial radiographs are randomised between two groups: 3 days of supportive bandage or 2 weeks of below-elbow cast. We aim to evaluate the functional outcome and cost-effectiveness of both treatments. The primary outcome is the functional outcome after 3 months, assessed with the Quick Disability of the Arm, Shoulder and Hand score. Secondary outcomes include functional outcome, recovery of function, pain, patient satisfaction, quality of life and cost-effectiveness measured by medical consumption, absence from work or decreased productivity. ETHICS AND DISSEMINATION: The Medical Ethics Committee of the Erasmus MC Medical Centre, Rotterdam, approved the study protocol (MEC-2017-504). We plan to present the results after completion of the study at (inter)national conferences and publish in general peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL6976.

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial.

BACKGROUND: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. METHODS: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed. DISCUSSION: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. TRIAL REGISTRATION: Dutch Trial Register, NTR6128 . Registered on 20 December 2016.

The costs of disease related malnutrition in hospitalized children.

INTRODUCTION: Disease related malnutrition (DRM) is a serious medical condition which is associated with an increase in morbidity and mortality, augmenting resource use and associated costs. DRM can be detected by actively and fully assessing the nutritional status. Studies in adult malnourished patients have shown that the additional health care costs are about € 2 billion (€ 2000 million) per year. The objective of the current study was to estimate the annual additional costs of DRM for pediatric patients as was done for adults. METHODS: A cost-of-illness analysis was performed to calculate the annual additional costs of DRM in 2015 pediatric patients (aged 1 month up to and including 17 years) admitted to non-academic hospitals in The Netherlands. DRM was assessed with weight-for-age, weight-for-height and height-for-age. Input variables in the formula used were length of stay and prevalence of DRM. The costs were estimated per disease as classified in the International Classification of Diseases by the WHO (ICD-10), per gender and age group. The results were expressed as an absolute monetary value as well as a percentage of the Dutch national health expenditure. Robustness of the results was checked by a sensitivity analysis. RESULTS: The total additional direct medical costs of DRM in pediatric patients in 2013 were estimated to be € 51 million for acute malnutrition, € 46 million when focused on chronic malnutrition and € 80 million in case of overall malnourished children. This equals 5.6% of the total Dutch hospital costs for these hospitalized children. CONCLUSIONS: This study has shown that DRM in hospitalized children is associated with an increase in annual hospital costs with an additional amount of € 80 million, of which acute malnutrition account for the largest part.

Cost-Utility Analysis of High Molecular Weight Hyaluronic Acid for Knee Osteoarthritis in Everyday Clinical Care in Patients at a Working Age: An Economic Evaluation of a Randomized Clinical Trial.

OBJECTIVE: Knee osteoarthritis (OA) is associated with high medical costs and especially with high productivity costs, in particular in patients in their working years. High molecular weight (HMW) hyaluronic acid (HA) is an alternative treatment for nonsteroidal antiinflammatory drugs, which are known for their serious side-effects. The cost-utility of intraarticular HMW-HA treatment in these patients is unknown, however, and was assessed in this study. METHODS: Secondary care patients ages 18-65 years with knee OA were randomized to usual care plus HMW-HA (intervention group) or to usual care only (control group). A cost-utility analysis over 52 weeks from the societal and health care perspective was performed. Uncertainty for costs, effects, and cost-utility ratio was analyzed by nonparametric bootstrapping. Baseline imbalance adjustment was done by inverse probability of treatment weighting. RESULTS: In total, 156 subjects were included (intervention group n = 77, control group n = 79). The total of productivity and medical costs was €475 higher in the intervention group at €7,754 (95% confidence interval [95% CI] 5,426, 10,436) versus €7,270 (95% CI 5,453, 9,262). The amount of quality-adjusted life years (QALYs) gained during followup was also higher in the intervention group (0.779 versus 0.727). This variation resulted in an incremental cost-effectiveness ratio of €9,100/QALY from a societal perspective and €8,700/QALY from a health care perspective. When the maximum willingness to pay for conditions similar to knee OA is considered, the probability on cost-effectiveness is 64% and 86%, respectively. CONCLUSION: Intraarticular HMW-HA added to usual care for knee OA is probably cost-effective in the treatment of knee OA.

Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intraocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.

INTRODUCTION: Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients' mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive-behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner. METHODS AND ANALYSIS: An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: http://www.trialregister.nl, identifier: NTR6337.

Effectiveness and cost-effectiveness of duloxetine added to usual care for patients with chronic pain due to hip or knee osteoarthritis: protocol of a pragmatic open-label cluster randomised trial (the DUO trial).

INTRODUCTION: Osteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed. Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice. METHODS AND ANALYSIS: A pragmatic open, cluster randomised trial is conducted. Patients with pain due to hip or knee OA on most days of the past 3 months with insufficient benefit of non-steroidal anti-inflammatory drugs or contraindications or intolerable side effects are included. General practices are randomised to either (1) duloxetine and usual care or (2) usual care only. Primary outcome is pain at 3 months measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes at 3 months and 1 year are pain (WOMAC, at 1 year), function (WOMAC), adverse reactions, quality of life and modification of the response to treatment by the presence of centrally sensitised pain (modified PainDETECT). At 1 year, medical and productivity costs will be assessed. Analyses will be performed following the intention-to-treat principle taking the cluster design into account. ETHICS AND DISSEMINATION: The study is approved by the local Medical Ethics Committee (2015-293). Results will be published in a scientific peer-reviewed journal and will be communicated at conferences. TRIAL REGISTRATION NUMBER: Dutch Trial Registry(ntr4798); Pre-results.

Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial.

PURPOSE: Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. PATIENTS AND METHODS: This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma specialists. In the glaucoma follow-up unit group (n=405), patients visited the glaucoma follow-up unit twice followed by a visit to a glaucoma specialist. The main outcome measures were: compliance to the working protocol by glaucoma follow-up unit employees; difference in intraocular pressure between baseline and at ≥18 months; and patient satisfaction. RESULTS: Glaucoma follow-up unit employees closely adhered to the working protocol for the measurement of intraocular pressure, visual acuity and GDx (≥97.5% of all visits). Humphrey Field Analyzer examinations were not performed as frequently as prescribed by the working protocol, but more often than in the Usual Care group. In a small minority of patients that required back-referral, the protocol was disregarded, notably when criteria were only slightly exceeded. There was no statistically significant difference in changes in intraocular pressure between the 2 treatment groups (P=0.854). Patients were slightly more satisfied with the glaucoma follow-up unit employees than with the glaucoma specialists (scores: 8.56 vs. 8.40; P=0.006). CONCLUSIONS: In general, the hospital-based shared care glaucoma follow-up closely observed its working protocol and patients preferred it slightly over the usual care provided by medical doctors. The glaucoma follow-up unit operated satisfactorily and might serve as a model for shared care strategies elsewhere.

Evaluation of the Prevention and Reactivation Care Program (PreCaP) for the hospitalized elderly: a prospective nonrandomized controlled trial.

BACKGROUND: The hospitalized elderly are at risk of functional decline. We evaluated the effects and care costs of a specialized geriatric rehabilitation program aimed at preventing functional decline among at-risk hospitalized elderly. METHODS: The prospective nonrandomized controlled trial reported here was performed in three hospitals in the Netherlands. One hospital implemented the Prevention and Reactivation Care Program (PReCaP), while two other hospitals providing usual care served as control settings. Within the PReCaP hospital we compared patients pre-implementation with patients post-implementation of the PReCaP ("within-hospital analysis"), while our nonrandomized controlled trial compared patients of the PReCaP hospital post-implementation with patients from the two control hospitals providing usual care ("between-hospital analysis"). Hospitalized patients 65 years or older and at risk of functional decline were interviewed at baseline and at 3 and 12 months using validated questionnaires to score functioning, depression, and health-related quality of life (HRQoL). We estimated costs per unit of care from hospital information systems and national data sources. We used adjusted general linear mixed models to analyze functioning and HRQoL. RESULTS: Between-hospital analysis showed no difference in activities of daily living (ADL) or instrumental activities of daily living (IADL) between PReCaP patients and control groups. PReCaP patients did have slightly better cognitive functioning (Mini Mental State Examination; 0.4 [95% confidence interval (CI) 0.2-0.6]), lower depression (Geriatric Depression Scale 15; -0.9 [95% -1.1 to -0.6]) and higher perceived health (Short-Form 20; 5.6 [95% CI 2.8-8.4]) than control patients. Analyses within the PReCaP hospital comparing patients pre-and post-implementation of the PReCaP showed no improvement over time in functioning, depression, and HRQoL. One-year health care costs were higher for PReCaP patients, both for the within-hospital analysis (+€7,000) and the between-hospital analysis (+€2,500). CONCLUSION: We did not find any effect of the PReCaP on ADL and IADL. The PReCaP may possibly provide some benefits to hospitalized patients at risk of functional decline with respect to cognitive functioning, depression, and perceived health. Further evaluations of integrated intervention programs to limit functional decline are therefore required.

Epidemiology of adverse drug reactions in Europe: a review of recent observational studies.

Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Included studies assessed the number of patients who were admitted to hospital due to an ADR, studies that assessed the number of patients who developed an ADR during hospitalization, and studies that measured ADRs in the outpatient setting. In total, 47 articles were included in the final review. The median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. Only five studies were found that assessed ADRs occurring in the outpatient setting. These results indicate that the occurrence of ADRs in the European hospital setting-both ADRs that result in hospitalization and ADRs that occur during the hospital stay-is significant. Furthermore, the limited number of studies that were performed in the outpatient setting identify a lack of information regarding the epidemiology of ADRs in this setting.

Formal and informal care costs of hospitalized older people at risk of poor functioning: A prospective cohort study.

Hospitalized older people are at risk of poor functioning after hospital discharge. We aimed to relate formal and informal care costs to level of risk for low functioning of hospitalized older people up to one year after admission. We studied 460 patients 65 years or older who were admitted to a 450-bed hospital in the Netherlands between June 2010 and October 2010. Participants were classified into five risk groups at hospital admission using the Identification Seniors At Risk-Hospitalized Patients (ISAR-HP). Patients were interviewed at hospital admission and at three and twelve months after admission using validated questionnaires to measure health care utilization. Informal caregivers were interviewed by mailed paper questionnaires at the same time as patients. We estimated costs per unit from hospital information systems and nationally representative research. Mean healthcare costs were €30k euro per person per year, with one third for initial hospital stay (€9,8k), one third for formal healthcare costs between hospital discharge and twelve month follow up (€10,3k), and one third for informal healthcare costs between hospital discharge and twelve month follow up (€9,5k). Informal and formal healthcare costs were almost double for people with the highest risk score compared to people not at risk (p<0.001). Older patients with high risk scores at hospital admission have substantially higher formal and informal care costs in the year after initial hospital admission than people with low risk scores. This implies that substantial investments may be made in preventive interventions for at-risk hospitalized older people.

Quality of life instruments for economic evaluations in health and social care for older people: a systematic review.

Gaining health may not be the main goal of healthcare services aimed at older people, which may (also) seek to improve wellbeing. This emphasizes the need of finding appropriate outcome measures for economic evaluation of such services, particularly in long-term care, capturing more than only health-related quality of life (HrQol). This review assesses the usefulness of HrQol and wellbeing instruments for economic evaluations specifically aimed at older people, focusing on generic and preference-based questionnaires measuring wellbeing in particular. We systematically searched six databases and extracted instruments used to assess HrQol and wellbeing outcomes. Instruments were compared based on their usefulness for economic evaluation of services aimed at older people (dimensions measured, availability of utility scores, extent of validation). We identified 487 articles using 34 generic instruments: 22 wellbeing (two of which were preference-based) and 11 HrQol instruments. While standard HrQol instruments measure physical, social and psychological dimensions, wellbeing instruments contain additional dimensions such as purpose in life and achievement, security, and freedom. We found four promising wellbeing instruments for inclusion in economic evaluation: Ferrans and Powers QLI and the WHO-Qol OLD, ICECAP-O and the ASCOT. Ferrans and Powers QLI and the WHO-Qol OLD are widely validated but lack preference-weights while for ICECAP-O and the ASCOT preference-weights are available, but are less widely validated. Until preference-weights are available for the first two instruments, the ICECAP-O and the ASCOT currently appear to be the most useful instruments for economic evaluations in services aimed at older people. Their limitations are that (1) health dimensions may be captured only partially and (2) the instruments require further validation. Therefore, we currently recommend using the ICECAP-O or the ASCOT alongside the EQ-5D or SF-6D when evaluating interventions aimed at older people.

Do reassessments reduce the uncertainty of decision making? Reviewing reimbursement reports and economic evaluations of three expensive drugs over time.

OBJECTIVE: To investigate the desirability and feasibility of a cyclic reimbursement process to address uncertainty accompanying initial decision making. METHODS: We performed desk research for three expensive outpatient drugs: imatinib, pegfilgrastim, and adalimumab. We analysed the evidence base at the time of decision making (T=0) and May 2011 (T=1). For T=0, public reports of the Dutch reimbursement agency were investigated regarding available clinical and economic evidence, and a systematic review was performed to retrieve additional economic evidence. For T=1, the systematic review was extended till May 2011. RESULTS: The evidence base at T=0 lacked information on clinically relevant outcomes such as mortality, morbidity, and quality of life (5/8 reports), (long-term) adverse events (2/8 reports) and experience in use (1/8 reports). One budget impact analysis and one economic evaluation were available but no pharmacoeconomic dossiers. The systematic review identified 39 cost-utility studies (of 52 economic evaluations) for T=1, characterised by methodological heterogeneity. CONCLUSIONS: Given the considerable uncertainty accompanying initial decision-making, a more cyclic reimbursement process seems feasible to reduce uncertainty regarding the therapeutical and economical value of expensive drugs. A mandatory evidence development requirement seems desirable to sufficiently meet decision makers' needs.

A validation of the ICECAP-O in a population of post-hospitalized older people in the Netherlands.

BACKGROUND: Various healthcare and social services may impact not only health, but wellbeing as well. Such effects may be more fully captured by capability-wellbeing instruments than with Health-related Quality of Life (HrQol) instruments. The aim of this study is to validate the ICEpop (Investigating Choice Experiments for the Preferences of Older People) CAPability measure for Older people (ICECAP-O) capability wellbeing instrument in a population of post-hospitalized older people admitted to a hospital 3 months earlier. METHODS: 296 post-hospitalized older people in the Netherlands were interviewed 3 months after admission between September 2010 and January 2011. We investigated the convergent validity of the ICECAP-O and overall wellbeing measures (Cantril's ladder and Social Production Function: Instrument for Level of Well-being (SPF-IL)), as well as with various health measures (EQ5D, Katz-15 Instrumental Activities of Daily Living (IADL) scale, Geriatric Depression Scale (GDS) and the Medical Outcomes Study Short form (SF-20) social functioning dimension). Additionally, we assessed discriminant validity by comparing several relevant subgroups in our sample (based on age, depression, IADL dependency, living situation, etc.). We also investigated the relationship between overall wellbeing and the ICECAP-O, controlling for HrQol and background characteristics. RESULTS: This study suggests that the ICECAP-O has good convergent validity with wellbeing measures as well as health measures and discriminates between various groups of post-hospitalized older people. Wellbeing measured by both Cantril's ladder and SPF-IL is associated with the ICECAP-O in a multivariate analysis controlling for HRQoL as well. CONCLUSION: The ICECAP-O seems to be a valid instrument of capability-wellbeing in older, post-hospitalized people, showing good convergent validity with health and wellbeing instruments, and is able to discriminate between elderly with various health profiles. The ICECAP-O measure seems to capture both health and wellbeing. Therefore it is a promising instrument for assessing the outcomes of health and social services aimed at older people.

Why a successful task substitution in glaucoma care could not be transferred from a hospital setting to a primary care setting: a qualitative study.

BACKGROUND: Healthcare systems are challenged by a demand that exceeds available resources. One policy to meet this challenge is task substitution-transferring tasks to other professions and settings. Our study aimed to explore stakeholders' perceived feasibility of transferring hospital-based monitoring of stable glaucoma patients to primary care optometrists. METHODS: A case study was undertaken in the Rotterdam Eye Hospital (REH) using semi-structured interviews and document reviews. They were inductively analysed using three implementation related theoretical perspectives: sociological theories on professionalism, management theories, and applied political analysis. RESULTS: Currently it is not feasible to use primary care optometrists as substitutes for optometrists and ophthalmic technicians working in a hospital-based glaucoma follow-up unit (GFU). Respondents' narratives revealed that: the glaucoma specialists' sense of urgency for task substitution outside the hospital diminished after establishing a GFU that satisfied their professionalization needs; the return on investments were unclear; and reluctant key stakeholders with strong power positions blocked implementation. The window of opportunity that existed for task substitution in person and setting in 1999 closed with the institutionalization of the GFU. CONCLUSIONS: Transferring the monitoring of stable glaucoma patients to primary care optometrists in Rotterdam did not seem feasible. The main reasons were the lack of agreement on professional boundaries and work domains, the institutionalization of the GFU in the REH, and the absence of an appropriate reimbursement system. Policy makers considering substituting tasks to other professionals should carefully think about the implementation process, especially in a two-step implementation process (substitution in person and in setting) such as this case. Involving the substituting professionals early on to ensure all stakeholders see the change as a normal step in the professionalization of the substituting professionals is essential, as is implementing the task substitution within the window of opportunity.