Cost-utility analysis of a structured medication review compared to usual care in Parkinson's disease.

PURPOSE: For controlling symptoms in Parkinson's disease (PD) together with treating additional comorbidities, patients often face complex medication regimens, with suboptimal adherence, drug-related problems, and diminished therapy efficacy as a common consequence. A medication review could potentially tackle these issues, among others by optimizing drug treatment. Even if no change in clinical outcomes is observed, this intervention might decrease health care costs by reducing drug-related problems and hospital admissions. This study aimed to gain more insight in the health benefits and costs of a structured medication review (SMR) in PD. METHODS: A cost-utility analysis was performed, based on a multicenter randomized controlled trial with 202 PD patients with polypharmacy. The intervention group received an SMR, whereas the control group received usual care. The intervention effect after 6 months of follow-up was presented as incremental quality-adjusted life years (QALY) using the EQ-5D-5L questionnaire. Costs were based on real-world data. Missing data was imputed using multiple imputation techniques. Bootstrapping was used to estimate the uncertainty in all health and economic outcomes. RESULTS: The QALY gain in the intervention group compared to the control group was - 0.011 (95% CI - 0.043; 0.020). Incremental costs were €433 (95% CI - 873; 1687). When adapting a willingness-to-pay threshold of €20,000/QALY and €80,000/QALY, the probability of SMRs being cost-effective was 18% and 30%, respectively. CONCLUSION: A community pharmacist-led SMR in PD patients in the current setting shows no apparent benefit and is not cost-effective after 6 months, compared to usual care. TRIAL REGISTRATION: Netherlands Trial Register, NL4360. Registered 17 March 2014.

A randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure : Design and rationale of the MONITOR HF multicentre randomised clinical trial.

BACKGROUND: Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands. AIMS: To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system. METHODS: The current study is a prospective, multi-centre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis. CONCLUSION: The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672.

Effects of training physicians in electronic prescribing in the outpatient setting on clinical, learning and behavioural outcomes: a cluster randomized trial.

AIMS: Electronic prescribing systems may improve medication safety, but only when used appropriately. The effects of task analysis-based training on clinical, learning and behavioural outcomes were evaluated in the outpatient setting, compared with the usual educational approach. METHODS: This was a multicentre, cluster randomized trial [EDUCATional intervention for IT-mediated MEDication management (MEDUCATE trial)], with physicians as the unit of analysis. It took place in the outpatient clinics of two academic hospitals. Participants comprised specialists and residents (specialty trainees, in the UK) and their patients. Training took the form of a small-group session and an e-learning. The primary outcome was the proportion of medication discrepancies per physician, measured as discrepancies between medications registered by physicians in the electronic prescribing system and those reported by patients. Clinical consequences were estimated by the proportion of patients per physician with at least one missed drug-drug interaction with the potential for causing adverse drug events. A questionnaire assessed physicians' knowledge and skills. RESULTS: Among 124 participating physicians, primary outcome data for 115 (93%) were available. A total of 1094 patients were included. A mean of 48% of registered medications per physician were discrepant with the medications that their patients reported in both groups (P = 0.14). Due to registration omissions, a mean of 4% of patients per physician had one or more missed drug-drug interactions with the potential to cause a clinically relevant adverse drug event in the intervention group, and 7% in controls (P = 0.11). The percentages of correct answers on the knowledge and skills test were higher in the intervention group (57%) compared with controls (51%; P = 0.01). CONCLUSION: The training equipped outpatient physicians with the knowledge and skills for appropriate use of electronic prescribing systems, but had no effect on medication discrepancies.

Prediction of the anti-RhD donor population size for managerial decision-making.

BACKGROUND: Rhesus D (RhD)-negative women pregnant with a RhD-positive child receive prophylactic injections to prevent haemolytic disease of the newborn. Because of the success of the prophylaxis, the number of naturally immunized women has decreased, thereby also decreasing the number of potential donors who provide the plasma from which the prophylaxis is made. As the current donor pool is ageing, the availability of the prophylaxis is threatened. OBJECTIVES: Objectives are to investigate whether the anti-D population and the changes therein can be described by a relatively simple model, to determine the impact of ageing of the anti-D donors on the decline of the population and how many new donors should be recruited to meet future supply demand. METHODS: Data on Dutch anti-D donors in 1994-2013 were used to simulate the donor population size and age composition for various donor recruitment scenarios. RESULTS: With a continuous influx of 27 new donors per year and a donor stopping rate of 10% per year, the population size will stabilize at 195 donors, with 2·3% of donors stopping annually due to reaching the donor age limit. A formula is derived to estimate which donor recruitment and retention efforts are required to maintain a prespecified donor pool. CONCLUSION: A relatively simple model can already describe and predict the size of the anti-D donor population and the impact of ageing accurately.

Personalised treatment using serum drug levels of adalimumab in patients with rheumatoid arthritis: an evaluation of costs and effects.

OBJECTIVE: To evaluate the cost-effectiveness of personalised treatment for rheumatoid arthritis (RA) using clinical response and serum adalimumab levels. METHODS: A personalised treatment algorithm defined, based on clinical (European League Against Rheumatism) response and drug levels at 6 months, whether adalimumab treatment should be continued in a specific dose or discontinued and/or switched to a next biological. Outcomes were simulated using a patient level Markov model, with 3 months cycles, based on a cohort of 272 adalimumab-treated patients with RA for 3 years and data of patients from the Utrecht Rheumatoid Arthritis Cohort. Costs, clinical effectiveness and quality adjusted life years (QALYs) were compared with outcomes as observed in usual care and incremental cost-effectiveness ratios were calculated. Analyses were performed probabilistically. RESULTS: Clinical effectiveness was higher for the cohort simulated to receive personalised care compared with usual care; the average difference in QALYs was 3.84 (95 percentile range -8.39 to 16.20). Costs were saved on drugs: €2 314 354. Testing costs amounted to €10 872. Mean total savings were €2 561 648 (95 percentile range -3 252 529 to -1 898 087), resulting in an incremental cost-effectiveness ratio of €666 500 or €646 266 saved per QALY gained from a societal or healthcare perspective, respectively. In 72% of simulations personalised care saved costs and resulted in more QALYs, in 28% it was cost saving with lower QALYs. Scenario analyses showed cost saving along with QALYs gain or limited loss. CONCLUSIONS: Tailoring biological treatment to individual patients with RA starting adalimumab using drug levels and short-term outcome is cost-effective. Results underscore the potential merit of personalised biological treatment in RA.

Common carotid intima-media thickness does not add to Framingham risk score in individuals with diabetes mellitus: the USE-IMT initiative.

AIMS/HYPOTHESIS: The aim of this work was to investigate whether measurement of the mean common carotid intima-media thickness (CIMT) improves cardiovascular risk prediction in individuals with diabetes. METHODS: We performed a subanalysis among 4,220 individuals with diabetes in a large ongoing individual participant data meta-analysis involving 56,194 subjects from 17 population-based cohorts worldwide. We first refitted the risk factors of the Framingham heart risk score on the individuals without previous cardiovascular disease (baseline model) and then expanded this model with the mean common CIMT (CIMT model). The absolute 10 year risk for developing a myocardial infarction or stroke was estimated from both models. In individuals with diabetes we compared discrimination and calibration of the two models. Reclassification of individuals with diabetes was based on allocation to another cardiovascular risk category when mean common CIMT was added. RESULTS: During a median follow-up of 8.7 years, 684 first-time cardiovascular events occurred among the population with diabetes. The C statistic was 0.67 for the Framingham model and 0.68 for the CIMT model. The absolute 10 year risk for developing a myocardial infarction or stroke was 16% in both models. There was no net reclassification improvement with the addition of mean common CIMT (1.7%; 95% CI -1.8, 3.8). There were no differences in the results between men and women. CONCLUSIONS/INTERPRETATION: There is no improvement in risk prediction in individuals with diabetes when measurement of the mean common CIMT is added to the Framingham risk score. Therefore, this measurement is not recommended for improving individual cardiovascular risk stratification in individuals with diabetes.

Cost-effectiveness of radioguided occult lesion localization (ROLL) versus wire-guided localization (WGL) in breast conserving surgery for nonpalpable breast cancer: results from a randomized controlled multicenter trial.

BACKGROUND: Accurate preoperative localization of nonpalpable breast cancer is essential to achieve complete resection. Radioguided occult lesion localization (ROLL) has been introduced as an alternative for wire-guided localization (WGL). Although efficacy of ROLL has been established in a randomized controlled trial, cost-effectiveness of ROLL compared with WGL is not yet known. The objective of this study was to determine whether ROLL has acceptable cost-effectiveness compared with WGL. METHODS: An economic evaluation was performed along with a randomized controlled trial (ClinicalTrials.gov, No. NCT00539474). Women (>18 years) with histologically proven nonpalpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomized to ROLL (n = 162) or WGL (n = 152). Empirical data on direct medical costs were collected, and changes in quality of life were measured over a 6-month period. Bootstrapping was used to assess uncertainty in cost-effectiveness estimates, and sensitivity of the results to the missing data approach was investigated. RESULTS: In total, 314 patients with 316 invasive breast cancers were enrolled. On average ROLL required the same time as WGL for the surgical procedure (119 vs 118 min), resulted in a 7 % higher reinterventions risk, and 13 % more complications. Quality of life effects were similar (difference 0.00 QALYs 95 % CI (-0.04-0.05). Total costs were also similar for ROLL and WGL (+26 per patient 95 % CI -250-311). CONCLUSION: ROLL is comparable to WGL with respect to both costs and quality of life effects as measured with the EQ5D and will therefore not lead to more cost-effective medical care.

Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis.

BACKGROUND: In the diagnostic work-up of deep vein thrombosis (DVT), the use of point-of-care-test (POCT) D-dimer assays is emerging as a promising patient-friendly alternative to regular D-dimer assays, but their cost-effectiveness is unknown. We compared the cost-effectiveness of two POCT-based approaches to the most common, laboratory-based, situation. METHODS: A patient-level simulation model was developed to simulate the diagnostic trajectory of patients presenting with symptoms of DVT at the general practitioner (GP). Three strategies were defined for further diagnostic work-up: one based on current guidelines ('regular strategy') and two alternative approaches where a POCT for D-dimer is implemented at the 1) phlebotomy service ('DVT care pathway') and 2) GP practice ('fast-POCT strategy'). Probabilities, costs and health outcomes were obtained from the literature. Costs and effects were determined from a societal perspective over a time horizon of 6 months. Uncertainty in model outcomes was assessed with a one-way sensitivity analysis. RESULTS: The Quality-Adjusted Life Years (QALYs) scores for the three DVT diagnostic work-up strategies were all around 0.43 across a 6 month-time horizon. Cost-savings of the two POCT-based strategies compared to the regular strategy were €103/patient for the DVT care pathway (95% CI: -€117-89), and €87/patient for the fast-POCT strategy (95% CI: -€113-67). CONCLUSIONS: Point-of-care-based approaches result in similar health outcomes compared with regular strategy. Given their expected cost-savings and patient-friendly nature, we recommend implementing a D-dimer POCT device in the diagnostic DVT work-up.

Are the latest point-of-care D-dimer devices ready for use in general practice? A prospective clinical evaluation of five test systems with a capillary blood feature for suspected venous thromboembolism.

INTRODUCTION: We evaluated clinical performance of five novel point-of-care (POC) D-dimer devices with a capillary finger stick feature for predicting venous thromboembolism (VTE) in general practice: Exdia TRF Plus (E), AFIAS-1® (A), Standard F200® (S), LumiraDx™ (L) and Hipro AFS/1® (H). MATERIALS AND METHODS: Primary care patients with a low suspicion of a VTE were asked to consent to (i) draw additional venous blood samples, (ii) perform a capillary POC D-dimer test, (iii) approach their general practitioner afterwards for clinical outcomes. Venous plasma samples were processed on all POC devices and a laboratory-based assay (STA-Liatest®D-Di PLUS assay). Results were compared with clinical outcomes to generate performance characteristics. Capillary and venous blood results were used for a matrix comparison. RESULTS: Venous plasma samples from 511 participants, of whom 57 had VTE, were used for clinical performance analyses. Areas under Receiving Operating Characteristic Curves ranged from 0.90 (95 % CI: 0.86-0.94) (H) to 0.93 (0.90-0.96) (E). All false-negative rates were below 1.4 % (95 % CI: 0.5 %-3.4 %). Matrix comparison demonstrated correlation coefficients ranging from r = 0.11 (95 % CI: -0.15-0.36) (H) to r = 0.94 (0.90-0.97) (A) with concordance percentages ranging from 71.4 % (applying a D-dimer cutoff of 500 ng/mL) (H) to 100 % (applying an age-dependent D-dimer cutoff) (A). CONCLUSIONS: Clinical performance of the POC D-dimer devices for predicting a VTE in low-risk patients was comparable to that of a laboratory-based assay. However, our results indicate that the finger stick feature of certain devices should be further improved. (NL71809.028.19.).

Can artificial intelligence separate the wheat from the chaff in systematic reviews of health economic articles?

OBJECTIVES: Artificial intelligence-powered tools, such as ASReview, could reduce the burden of title and abstract screening. This study aimed to assess the accuracy and efficiency of using ASReview in a health economic context. METHODS: A sample from a previous systematic literature review containing 4,994 articles was used. Previous manual screening resulted in 134 articles included for full-text screening (FT) and 50 for data extraction (DE). Here, accuracy and efficiency was evaluated by comparing the number of identified relevant articles with ASReview versus manual screening. Pre-defined stopping rules using sampling criteria and heuristic criteria were tested. Robustness of the AI-tool's performance was determined using 1,000 simulations. RESULTS: Considering included stopping rules, median accuracy for FT articles remained below 85%, but reached 100% for DE articles. To identify all relevant articles, a median of 89.9% of FT articles needed to be screened, compared to 7.7% for DE articles. Potential time savings between 49 and 59 hours could be achieved, depending on the stopping rule. CONCLUSIONS: In our case study, all DE articles were identified after screening 7.7% of the sample, allowing for substantial time savings. ASReview likely has the potential to substantially reduce screening time in systematic reviews of health economic articles.

The effectiveness of motivational interviewing on adherence to wearing orthopedic shoes in people with diabetes at low-to-high risk of foot ulceration: A multicenter cluster-randomized controlled trial.

AIM: To evaluate the effectiveness of motivational interviewing (MI) performed by MI-trained podiatrists in improving adherence to wearing orthopedic shoes in comparison to usual care in people with diabetes at low-to-high risk of ulceration. METHODS: People with diabetes with loss of protective sensation and/or peripheral artery disease, and with orthopedic shoes prescription were allocated to receive one MI-consultation by a podiatrist randomized to MI training (n = 53) or usual care only (n = 68). Adherence was measured as the percentage of steps taken while wearing orthopedic shoes, determined using an insole temperature microsensor and wrist-worn activity tracker during one week at 3 and 6 months. RESULTS: The proportion of participants ≥80 % adherent to wearing their orthopedic shoes was higher in the control group than in the MI-intervention group at 3 months (30.9 % versus 15.1 %; p = 0.044), and not significantly different at 6 months (22.1 % versus 13.2 %; p = 0.210). Average adherence was also higher in the control group than the intervention group at both 3 months (60.9 % versus 50.9 %; p = 0.029) and 6 months (59.9 % versus 49.5 %; p = 0.025). CONCLUSIONS: One podiatrist-led MI-consultation in its current form did not result in higher adherence to wearing orthopedic shoes in people with diabetes 3 and 6 months after inclusion. TRIAL REGISTRATION: Netherlands Trial Register NL7710 (available on the International Clinical Trials Registry Platform).

Prognosis and prognostic factors of patients with mesothelioma: a population-based study.

BACKGROUND: It is important to regularly update survival estimates of patients with malignant mesothelioma as prognosis may vary according to epidemiologic factors and diagnostic and therapeutic management. METHODS: We assessed overall (baseline) survival as well as related prognostic variables in a large cohort of 1353 patients with a confirmed diagnosis of malignant mesothelioma between 2005 and 2008. RESULTS: About 50% of the patients were 70 years or older at diagnosis and the median latency time since start of asbestos exposure was 49 years. One year after diagnosis, 47% of the patients were alive, 20% after 2 years and 15% after 3 years. Prognostic variables independently associated with worse survival were: older age (HR=1.04 per year 95% CI (1.03-1.06)), sarcomatoid subtype (HR=2.45 95% CI (2.06-2.90)) and non-pleural localisation (HR=1.67 95% CI (1.26-2.22)). CONCLUSION: Survival of patients with malignant mesothelioma is still limited and depends highly on patient age, mesothelioma subtype and localisation. In addition, a substantial part of the patients had a long latency time between asbestos exposure and diagnosis.

E-health in caring for patients with atopic dermatitis: a randomized controlled cost-effectiveness study of internet-guided monitoring and online self-management training.

BACKGROUND: The Dermatology Department of the University Medical Centre Utrecht, the Netherlands, developed an e-health portal for patients with atopic dermatitis (AD), consisting of e-consultation, a patient-tailored website, monitoring and self-management training. OBJECTIVES: To determine the cost-effectiveness of individualized e-health compared with usual face-to-face care for children and adults with AD. METHODS: A randomized controlled cost-effectiveness study from a societal perspective in adults and parents of children with moderate AD. Outcomes were quality of life, severity of AD, itching and direct and indirect costs. Data were collected at baseline and at 3 and 12 months after randomization. Linear mixed models were used to analyse clinical outcomes. After multiple imputation of missing data, costs and differences in costs were calculated over a period of 1 year. RESULTS: In total, 199 patients were included. There were no significant differences in disease-specific quality of life, severity of AD and intensity of itching between both groups at the three time points. The difference in direct costs between the intervention and control groups was €24 [95% confidence interval (CI) -360 to 383], whereas this difference was -€618 (95% CI -2502 to 1143) for indirect costs. Overall, individual e-health was expected to save €594 (95% CI -2545 to 1227) per patient in the first year of treatment, mainly through a reduction in work absenteeism. Uncertainty analyses revealed that the probability of e-health reducing costs was estimated to be ≥ 73%. CONCLUSIONS: E-health during follow-up of patients with AD is, after initial diagnosis and treatment during face-to-face contact, just as effective as usual face-to-face care with regard to quality of life and severity of disease. However, when costs are considered, e-health is likely to result in substantial cost savings. Therefore, e-health is a valuable service for patients with AD.

Attitudes and experiences towards the application of motivational interviewing by podiatrists working with people with diabetes at high-risk of developing foot ulcers: a mixed-methods study.

BACKGROUND: Podiatrists are key professionals in promoting adequate foot self-care for people with diabetes at high-risk of developing foot ulcers. However, merely informing patients about the advantages of foot self-care is insufficient to realise behavioural change. Motivational interviewing (MI) is a promising person-centred communication style that could help to create a working alliance between healthcare providers and patient to improve foot self-care. This study aims to observe and analyse the application of MI in consultations carried out by MI-trained and non-MI-trained podiatrists with their patients, and explore podiatrists' attitudes and experiences towards MI. METHODS: Eighteen podiatrists (median age: 28.5 years, 10 female and 8 male) followed a three-day basic training in MI and 4 podiatrists (median age: 38.5 years, 4 female) were not trained in MI. To observe and rate the MI-fidelity in daily clinical practice, audio recordings from the MI-trained and non-MI-trained podiatrists were scored with the Motivational Interviewing Treatment Integrity code. Individual, semi-structed, in-depth interviews were conducted with the MI-trained podiatrists to explore their attitudes towards and experiences with MI. These data sources were triangulated to describe the effect of training podiatrists in MI for their clinical practice. RESULTS: The MI-trained podiatrists scored significantly higher than the non-MI-trained podiatrists on two of four global MI-related communication skills (empathy, p = 0.008 and change talk, p = 0.008), on one of five core MI-adherent behaviours (affirmation, p = 0.041) and on one of the other behaviour counts (simple reflections, p = 0.008). The podiatrists mainly reported their attitudes and experiences regarding partnership and cultivating change talk, during the interviews. In addition, they also mentioned facilitators and barriers to using MI and indicated whether they experienced MI as having added value. CONCLUSIONS: The MI-trained podiatrists used the principles of MI at a solid beginner proficiency level in their clinical practice in comparison to the non-MI-trained podiatrists, who did not reach this level. This achievement is in accordance with the basic MI-training they received. This multi-method study reveals that podiatrists can be effectively trained in applying MI in daily clinical practice. TRIAL REGISTRATION: Netherlands Trial Register NL7710. Registered: 6 May 2019.

Markers for the non-invasive diagnosis of mesothelioma: a systematic review.

BACKGROUND: Numerous markers have been evaluated to facilitate the non-invasive diagnostic work-up of mesothelioma. The purpose of this study was to conduct a structured review of the diagnostic performance of non-invasive marker tests for the detection of mesothelioma in patients with suspected mesothelioma. METHODS: Studies on the diagnostic accuracy of serum and cytological markers published till 31 December 2009, available in either PUBMED or Embase, to detect or exclude the presence of mesothelioma were extracted. Study quality was assessed with use of the Quadas criteria. RESULTS: In total, 82 articles were included in this systemic review. Overall, quality of the incorporated studies to address our objective was poor. The most frequently studied immunohistochemical markers for cytological analysis were EMA, Ber-Ep4, CEA, and calretinin. The most frequently investigated serum marker was soluble mesothelin-related protein (SMRP). The markers CEA, Ber-EP4, and calretinin were most valuable in discriminating mesothelioma from other malignant diseases. Markers EMA and SMRP were most valuable in discriminating mesothelioma from non-malignant diseases. No marker performed well in discriminating between mesothelioma and all other diseases. CONCLUSION: Currently, there is only limited evidence to properly assess the value of non-invasive marker tests in the diagnosis of mesothelioma. Studies were of limited value to address our objective and results showed considerable unexplained study heterogeneity.

Aneurysm occlusion in elderly patients with aneurysmal subarachnoid haemorrhage: a cost-utility analysis.

BACKGROUND: Aneurysm occlusion after subarachnoid haemorrhage (SAH) aims to improve outcome by reducing the rebleeding risk. With increasing age, overall prognosis decreases, and the complications of aneurysm occlusion increase. The balance of risks for aneurysm occlusion in elderly SAH patients in different age categories and clinical conditions is unknown. METHODS: A Markov model was used to evaluate quality-adjusted life years (QALY), additional costs and incremental cost-effectiveness ratios (ICER) of aneurysm occlusion in 192 patient subgroups, based on age, gender, neurological condition at admission, time since SAH, and aneurysm size and location. Probabilistic sensitivity analyses were performed. RESULTS: For patients admitted in poor condition ≥ 10 days after SAH, and patients older than 80 years, admitted in poor condition admitted ≥ 4 days after SAH, occlusion implied QALY loss and increased costs. Only for women younger than 79 and men younger than 74 years admitted in good condition within 4 days did the ICER of occlusion fall below €50,000 per QALY. Occlusion was beneficial and cost-saving in women aged 74 years or younger admitted in good condition within 4 days with a small posterior circulation aneurysm. Conclusions Aneurysm occlusion is harmful in some subgroups of elderly patients and beneficial in others. It is cost-effective only in specific subgroups that comprise a large part of the patients encountered in clinical practice. Beyond the age of 80 years, the balance between risks and benefits is often no longer positive for occlusion, and it should only be considered if the predicted life expectancy leaves margin for benefit.

Using motivational interviewing combined with digital shoe-fitting to improve adherence to wearing orthopedic shoes in people with diabetes at risk of foot ulceration: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic shoes are considered essential. However, adherence to wearing the orthopedic shoes is low, and improving adherence was not successful in the past. We propose a novel care approach that combines motivational interviewing (MI) with a digital shoe-fitting procedure to improve adherence to orthopedic shoes. The aim of this trial is to assess the (cost-)effectiveness of this novel care approach compared to usual care (no MI and casting-based shoe-fitting) in promoting footwear adherence and ulcer prevention. METHODS: The trial will include people with diabetes, with IWGDF Risk categories 1-3, who have been prescribed orthopedic shoes. Participants will be randomized at the level of the podiatrist to the novel care approach or usual care. The primary outcome is the proportion of participants who adhere to the use of their orthopedic shoes, that is, who take at least 80% of their total daily steps with orthopedic shoes. A temperature microsensor will be built into the participants' orthopedic shoes to measure wearing time continuously over 12 months. In addition, daily activity will be measured periodically using log data with an activity monitor. Data from the temperature microsensor and activity monitor will be combined to calculate adherence. (Re-)experienced complications after receiving orthopedic shoes will be registered. Questionnaires and interviews will measure the experiences of participants regarding orthopedic shoes, experiences of podiatrists regarding motivational interviewing, care consumption, and quality of life. Differences in costs and quality of life will be determined in a cost-effectiveness analysis. DISCUSSION: This trial will generate novel insights into the socio-economic and well-being impact and the clinical effectiveness of the novel care approach on adherence to wearing orthopedic shoes. TRIAL REGISTRATION: Netherlands Trial Register NL7710 . Registered on 6 May 2019.

Impact of preventive screening and lifestyle interventions in women with a history of preeclampsia: A micro-simulation study.

BACKGROUND: Preeclampsia is a female-specific risk factor for the development of future cardiovascular disease. Whether early preventive cardiovascular disease risk screenings combined with risk-based lifestyle interventions in women with previous preeclampsia are beneficial and cost-effective is unknown. METHODS: A micro-simulation model was developed to assess the life-long impact of preventive cardiovascular screening strategies initiated after women experienced preeclampsia during pregnancy. Screening was started at the age of 30 or 40 years and repeated every five years. Data (initial and follow-up) from women with a history of preeclampsia was used to calculate 10-year cardiovascular disease risk estimates according to Framingham Risk Score. An absolute risk threshold of 2% was evaluated for treatment selection, i.e. lifestyle interventions (e.g. increasing physical activity). Screening benefits were assessed in terms of costs and quality-adjusted-life-years, and incremental cost-effectiveness ratios compared with no screening. RESULTS: Expected health outcomes for no screening are 27.35 quality-adjusted-life-years and increase to 27.43 quality-adjusted-life-years (screening at 30 years with 2% threshold). The expected costs for no screening are €9426 and around €13,881 for screening at 30 years (for a 2% threshold). Preventive screening at 40 years with a 2% threshold has the most favourable incremental cost-effectiveness ratio, i.e. €34,996/quality-adjusted-life-year, compared with other screening scenarios and no screening. CONCLUSIONS: Early cardiovascular disease risk screening followed by risk-based lifestyle interventions may lead to small long-term health benefits in women with a history of preeclampsia. However, the cost-effectiveness of a lifelong cardiovascular prevention programme starting early after preeclampsia with risk-based lifestyle advice alone is relatively unfavourable. A combination of risk-based lifestyle advice plus medical therapy may be more beneficial.