Effectiveness of the Assessment of Burden of Chronic Conditions (ABCC)-tool in patients with asthma, COPD, type 2 diabetes mellitus, and heart failure: A pragmatic clustered quasi-experimental study in the Netherlands.

BACKGROUND: The Assessment of Burden of Chronic Conditions (ABCC)-tool was developed to optimise chronic care. OBJECTIVES: This study aimed to assess the effectiveness of the ABCC-tool in patients with COPD, asthma, type 2 diabetes, and/or heart failure in primary care in the Netherlands. METHODS: The study had a pragmatic, clustered, two-armed, quasi-experimental design. The intervention group (41 general practices; 176 patients) used the ABCC-tool during routine consultations and the control group (14 general practices; 61 patients) received usual care. The primary outcome was a change in perceived quality of care (PACIC; Patient Assessment of Chronic Illness Care) after 18 months. Secondary outcomes included change in the PACIC after 6 and 12 months, and in quality of life (EQ-5D-5L; EuroQol-5D-5L), capability well-being (ICECAP-A; ICEpop CAPability measure for Adults), and patients' activation (PAM; Patient Activation Measure) after 6, 12, and 18 months for the total group and conditions separately. RESULTS: We observed a significant difference in the PACIC after 6, 12, and 18 months (18 months: 0.388 points; 95%CI: 0.089-0.687; p = 0.011) for the total group and after 6 and 12 months for type 2 diabetes. After 18 months, we observed a significant difference in the PAM for the total group but not at 6 and 12 months, and not for type 2 diabetes. All significant effects were in favour of the intervention group. No significant differences were found for the EQ-5D-5L and the ICECAP-A. CONCLUSION: Use of the ABCC-tool has a positive effect on perceived quality of care and patients' activation, which makes the tool ready for use in clinical practice. Healthcare providers (e.g. general practitioners and practice nurses) can use the tool to provide person-centred care.Trial registration number: ClinicalTrials.gov Registry (NCT04127383).

The Assessment of Burden of Chronic Conditions (ABCC)-tool aims to support disease management for one or multiple chronic condition(s), currently COPD, asthma, type 2 diabetes, and heart failure.Statistically significant differences in patients' perceived quality of care and patient activation were found between the group that used the ABCC-tool and the care-as-usual group. No effect was found on generic quality of life or capability well-being.Healthcare providers can use the ABCC-tool in primary care.

Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial.

BACKGROUND: In an ageing population, efficiency improvements are required to assure future accessibility of cataract care. We aim to address remaining knowledge gaps by evaluating the safety, effectiveness, and cost-effectiveness of immediate sequential bilateral cataract surgery (ISBCS) versus delayed sequential bilateral cataract surgery (DSBCS). We hypothesised that ISBCS is non-inferior to DSBCS, regarding safety and effectiveness, and being superior in cost-effectiveness. METHODS: We did a multicentre, non-inferiority, randomised controlled trial, which included participants from ten Dutch hospitals. Eligible participants were 18 years or older, underwent expected uncomplicated surgery, and had no increased risk of endophthalmitis or refractive surprise. Participants were randomly assigned (1:1) to either the ISBCS (intervention) group or DSBCS (conventional procedure) group, using a web-based system stratified by centre and axial length. Participants and outcome assessors were not masked to the treatment groups because of the nature of the intervention. The primary outcome was the proportion of second eyes with a target refractive outcome of 1·0 dioptre (D) or less 4 weeks postoperatively, with a non-inferiority margin of -5% for ISBCS versus DSBCS. For the trial-based economic evaluation, the primary endpoint was the incremental societal costs per quality-adjusted life-year. All analyses were done by a modified intention-to-treat principle. Costs were calculated by multiplying volumes of resource use with unit cost prices and converted to 2020 Euros (€) and US$. This study was registered with ClinicalTrials.gov, number NCT03400124, and is now closed for recruitment. FINDINGS: Between Sept 4, 2018, and July 10, 2020, a total of 865 patients were randomly assigned to either the ISBCS group (427 [49%] patients; 854 eyes) or DSBCS group (438 [51%] patients; 876 eyes). In the modified intention-to-treat analysis, the proportion of second eyes with a target refraction of 1·0 D or less was 97% (404 of 417 patients) in the ISBCS group versus 98% (407 of 417) in the DSBCS group. The percentage difference was -1% (90% CI -3 to 1; p=0·526), thereby establishing non-inferiority for ISBCS compared with DSBCS. Endophthalmitis was not observed or reported in either group. Adverse events were comparable between groups, with only a significant difference in disturbing anisometropia (p=0·0001). Societal costs were €403 (US$507) lower with ISBCS than with DSBCS. The cost-effectiveness probability of ISBCS versus DSBCS was 100% across the willingness-to-pay range of €2500-80 000 (US$3145-100 629) per quality-adjusted life-year. INTERPRETATION: Our results showed non-inferiority of ISBCS versus DSBCS regarding effectiveness outcomes, comparable safety, and superior cost-effectiveness of ISBCS. National cost savings could amount to €27·4 million (US$34·5 million) annually, advocating for ISBCS if strict inclusion criteria are applied. FUNDING: Research grant from The Netherlands Organization for Health Research and Development (ZonMw) and Dutch Ophthalmological Society.

Validity and Reliability of the Assessment of Burden of Chronic Conditions Scale in the Netherlands.

PURPOSE: The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to improve care by facilitating shared decision making and self-management. It assesses and visualizes the experienced burden of 1 or multiple chronic conditions and integrates it in daily care. The aim of this study is to evaluate whether the ABCC scale is valid and reliable in people with chronic obstructive pulmonary disease (COPD), asthma, or type 2 diabetes (T2D). METHODS: The Saint George Respiratory Questionnaire (SGRQ), the Standardized Asthma Quality of Life Questionnaire (AQLQ-S), and the Audit of Diabetes Dependent Quality of Life Questionnaire (ADDQoL19) were compared with the ABCC scale to assess convergent validity. The internal consistency was evaluated using Cronbach's α. Test-retest reliability was evaluated at a 2-week interval. RESULTS: A total of 65 people with COPD, 62 with asthma, and 60 with T2D were included. The ABCC scale correlated, in accordance with hypotheses, with the SGRQ (75% of correlations ≥0.7), AQLQ-S (100%), and ADDQoL19 (75%). The ABCC scale was internally consistent with a Cronbach's α of 0.90, 0.92, and 0.91 for the total score for people with COPD, asthma, and T2D, respectively. The ABCC scale had a good test-retest reliability with an intraclass correlation coefficient of 0.95, 0.93, and 0.95 for people with COPD, asthma, and T2D, respectively. CONCLUSIONS: The ABCC scale is a valid and reliable questionnaire that can be used within the ABCC tool for people with COPD, asthma, or T2D. Future research should indicate whether this applies to people with multimorbidity, and what the effects and experiences are upon clinical use.

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease.

BACKGROUND: Immunomodulators and biologics are cornerstones in the management of inflammatory bowel disease [IBD], but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the prevalence of mild and moderate infections are scarce. We developed and validated a remote monitoring tool for real-world assessment of infections in IBD patients. METHODS: A 7-item Patient-Reported Infections Questionnaire [PRIQ] covering 15 infection categories was developed with a 3-month recall period. Infection severity was defined as mild [self-limiting or topical treatment], moderate [oral antibiotics, antivirals, or antifungals], or severe [hospitalisation or intravenous treatment]. Comprehensiveness and comprehensibility were ascertained through cognitive interviewing of 36 IBD outpatients. After implementation in the telemedicine platform myIBDcoach, a prospective, multicentre cohort study was performed between June 2020 and June 2021 in 584 patients, to assess diagnostic accuracy. Events were cross-checked with general practitioner and pharmacy data [gold standard]. Agreement was evaluated using linear-weighted kappa with cluster-bootstrapping to account for within-patient level correlation. RESULTS: Patient understanding was good and interviews did not result in reduction of PRIQ items. During validation, 584 IBD patients {57.8% female, mean age 48.6 (standard deviaton [SD]: 14.8), disease duration 12.6 years [SD: 10.9]} completed 1386 periodic assessments, reporting 1626 events. Linear-weighted kappa for agreement between PRIQ and gold standard was 0.92 (95% confidence interval [CI] 0.89-0.94). Sensitivity and specificity for infection [yes/no] were 93.9% [95% CI 91.8-96.0] and 98.5% [95% CI 97.5-99.4], respectively. CONCLUSIONS: The PRIQ is a valid and accurate remote monitoring tool to assess infections in IBD patients, providing means to personalise medicine based on adequate benefit-risk assessments.

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.

BACKGROUND: Trabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. METHODS: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. DISCUSSION: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019.

Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts.

BACKGROUND: Age-related cataract affects both eyes in most cases. Most people undergo cataract surgery in both eyes on separate days, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating on both eyes on the same day, but as two separate procedures, known as immediate sequential bilateral cataract surgery (ISBCS). Potential advantages of ISBCS include fewer hospital visits for the patient, faster visual recovery, and lower healthcare costs. Nevertheless, concerns exist about possible bilateral, postoperative, sight-threatening adverse effects with ISBCS. Therefore, there is a clear need for evaluating evidence regarding the safety, effectiveness, and cost-effectiveness of ISBCS versus DSBCS. OBJECTIVES: To assess the safety of ISBCS compared to DSBCS in people with bilateral age-related cataracts and to summarise current evidence for the incremental resource use, utilities, costs, and cost-effectiveness associated with the use of ISBCS compared to DSBCS in people with bilateral age-related cataracts (primary objectives). The secondary objective was to assess visual and patient-reported outcomes of ISBCS compared to DSBCS in people with bilateral age-related cataracts. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 5); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; the WHO ICTRP; and DARE and NHS EED on the CRD Database on 11 May 2021. There were no language restrictions. We limited the searches to a date range of 2007 onwards. SELECTION CRITERIA: We included randomised controlled trials (RCTs) to assess complications, refractive outcomes, best-corrected distance visual acuity (BCDVA) and patient-reported outcome measures (PROMs) with ISBCS compared to DSBCS. We included non-randomised (NRSs), prospective, and retrospective cohort studies comparing ISBCS and DSBCS for safety assessment, because of the rare incidence of important adverse events. To assess cost-effectiveness of ISBCS compared to DSBCS, we included both full and partial economic evaluations, and both trial-based and model-based economic evaluations. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures and assessed risk of bias for NRSs using the ROBINS-I tool. For cost-evaluations, we used the CHEC-list, the CHEERS-checklist, and the NICE-checklist to investigate risk of bias. We assessed the certainty of evidence with the GRADE tool. We reported results for economic evaluations narratively. MAIN RESULTS: We included 14 studies in the review; two RCTs, seven NRSs, and six economic evaluations (one study was both an NRS and economic evaluation). The studies reported on 276,260 participants (7384 for ISBCS and 268,876 for DSBCS) and were conducted in Canada, the Czech Republic, Finland, Iran, (South) Korea, Spain (Canary Islands), Sweden, the UK, and the USA. Overall, we considered the included RCTs to be at 'high to some concerns' risk of bias for complications, 'some concerns' risk of bias for refractive outcomes and visual acuity, and 'high' risk of bias for PROMs. The overall risk of bias for NRSs was graded 'serious' regarding complications and 'serious to critical' regarding refractive outcomes.  With regard to endophthalmitis, we found that relative effects were estimated imprecisely and with low certainty, so that relative estimates were not reliable. Nonetheless, we found a very low risk of endophthalmitis in both ISBCS (1/14,076 participants) and DSBCS (55/556,246 participants) groups. Based on descriptive evidence and partially weak statistical evidence we found no evidence of an increased risk of endophthalmitis with ISBCS. Regarding refractive outcomes, we found moderate-certainty (RCTs) and low-certainty (NRSs) evidence there was no difference in the percentage of eyes that did not achieve refraction within 1.0 dioptre of target one to three months after surgery (RCTs: risk ratio (RR) 0.84, 95% confidence interval (CI) 0.57 to 1.26; NRSs: RR 1.02, 95% CI 0.60 to 1.75). Similarly, postoperative complications did not differ between groups (RCTs: RR 1.33, 95% CI 0.52 to 3.40; NRSs: 1.04, 95% CI 0.47 to 2.29), although the certainty of this evidence was very low for both RCTs and NRSs. Furthermore, we found low-certainty (RCTs) to very low-certainty (NRSs) evidence that total costs per participant were lower for ISBCS compared to DSBCS, although results of individual studies could not be pooled. Only one study reported on cost-effectiveness. This study found that ISBCS is cost-effective compared to DSBCS, but did not measure quality-adjusted life years using preferred methods and calculated costs erroneously. Finally, regarding secondary outcomes, we found limited evidence on BCDVA (data of two RCTs could not be pooled, although both studies individually found no difference between groups (very low-certainty evidence)). Regarding PROMs, we found moderate-certainty evidence (RCTs only) that there was no difference between groups one to three months after surgery (standardised mean difference -0.08, 95% CI -0.19 to 0.03). AUTHORS' CONCLUSIONS: Current evidence supports there are probably no clinically important differences in outcomes between ISBCS and DSBCS, but with lower costs for ISBCS. However, the amount of evidence is limited, and the certainty of the evidence was graded moderate to very low. In addition, there is a need for well-designed cost-effectiveness studies.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. SETTING: 7 ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.

Correction: Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study.

[This corrects the article DOI: 10.2196/19696.].

[Effects and costs of The Healthy Primary School of the Future]. / De effecten en kosten van de Gezonde Basisschool van de Toekomst.

OBJECTIVE: To study school lifestyle interventions for elementary school children (The Healthy Primary School of the Future). RESEARCH QUESTION: What are the effects of the introduction of increased physical activity with or without healthy nutrition on health behaviour and BMI of young children and what are the costs of this program? DESIGN: Prospective controlled non-randomized study with nearly 1700 children in Parkstad (South-East Netherlands). RESULTS: Preliminary results after two years show that the combination of increased physical activity and healthy nutrition result in a decreased BMIz-score (-0.036), increased physical activity alone in hardly any change (-0.10) while in the control group the BMIz-score increased (0.052). The net societal costs of the combination of physical activity and health nutrition costs were 1 euro per child per day. CONCLUSION: The study contributes to the increasing amount of evidence proving that lifestyle interventions are effective in reducing the obesity epidemic. Future studies will show whether a weight reduction in children will result in the prevention of chronic disease later on in life and what the cost reduction related to this result will be.

How Financial Incentives Increase Smoking Cessation: A Two-Level Path Analysis.

INTRODUCTION: Financial incentives effectively increase smoking cessation rates, but it is unclear via which psychological mechanisms incentives influence quit behavior. The current study examines how receiving financial incentives for smoking cessation leads to quitting smoking and investigates several mediators and moderators of that relationship. AIMS AND METHODS: The study sample consisted of 604 tobacco-smoking employees from 61 companies in the Netherlands who completed a baseline and follow-up questionnaire. The current study is a secondary analysis from a cluster randomized trial where employees received smoking cessation group counseling at the workplace. Participants in the intervention group additionally received financial incentives of €350 in total for 12-month continuous smoking abstinence. We used a two-level path analysis to test a model that assesses the effects of financial incentives through smoking cessation program evaluation, medication use, nicotine replacement use, attitudes, self-efficacy, and social influences on quit success. We additionally tested whether an individual's reward responsiveness moderated the influence of incentives on quit success. RESULTS: The effect of financial incentives on quit success was mediated by a higher self-efficacy. Financial incentives were also associated with a higher use of cessation medication. A more positive program evaluation was related to higher self-efficacy, more social influence to quit, and more positive attitudes about quitting. The results did not differ significantly by individual reward responsiveness. CONCLUSIONS: The results of the current study suggest that financial incentives may be used to increase medication use and self-efficacy for quitting smoking, which offers an indirect way to increase successful smoking cessation. IMPLICATIONS: (1) This is the first study investigating via which psychological pathways financial incentives for quitting smoking can lead to long-term quit success. (2) The results showed a path between financial incentives and a higher likelihood of medication use. Incentives may encourage smokers to use medication in order to increase their chance of quitting smoking and receive the reward. (3) There was a path from financial incentives to quit success via a higher self-efficacy. (4) The effects of financial incentives did not depend on individual reward responsiveness.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in patients without diabetes: ESCRS PREMED study report 4.

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in patients without diabetes. SETTING: Seven ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective cost-effectiveness analysis using data from a European multicenter randomized clinical trial (ESCRS PREMED). METHODS: Patients without diabetes planned for expected uneventful cataract surgery were randomized to topical bromfenac (Yellox, n = 242), topical dexamethasone (n = 242), or a combination treatment (n = 238). All relevant resources from a healthcare perspective were included in the cost analysis within a time horizon of 12 weeks postoperatively. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) based on the cost per QALY. RESULTS: The study comprised 722 patients without diabetes. Total healthcare costs and QALYs were € 447 (US $562) and 0.174 in the bromfenac group, €421 (US $529) and 0.179 in the dexamethasone group, and €442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was €6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is € 20 000 (US $25 126) per QALY, the cost-effectiveness probability was 3%, 32%, and 65% in the bromfenac, dexamethasone, and combination groups, respectively. CONCLUSIONS: In patients without diabetes, combination treatment with topical bromfenac and dexamethasone was effective and cost-effective in preventing CME after cataract surgery compared with treatment with either drug alone.

Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study.

INTRODUCTION: The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure. METHODS AND ANALYSIS: The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04127383).

Smart Data Collection for the Assessment of Treatment Effects in Irritable Bowel Syndrome: Observational Study.

BACKGROUND: End-of-day symptom diaries are recommended by drug regulatory authorities to assess treatment response in patients with irritable bowel syndrome. We developed a smartphone app to measure treatment response. OBJECTIVE: Because the employment of an app to measure treatment response in irritable bowel syndrome is relatively new, we aimed to explore patients' adherence to diary use and characteristics associated with adherence. METHODS: A smartphone app was developed to serve as a symptom diary. Patients with irritable bowel syndrome (based on Rome IV criteria) were instructed to fill out end-of-day diary questionnaires during an 8-week treatment. Additional online questionnaires assessed demographics, irritable bowel syndrome symptom severity, and psychosocial comorbidities. Adherence rate to the diary was defined as the percentage of days completed out of total days. Adherence to the additional web-based questionnaires was also assessed. RESULTS: Overall, 189 patients were included (age: mean 34.0 years, SD 13.3 years; female: 147/189, 77.8%; male: 42/189, 22.2%). The mean adherence rate was 87.9% (SD 9.4%). However, adherence to the diary decreased over time (P<.001). No significant association was found between adherence and gender (P=.84), age (P=.22), or education level (lower education level: P=.58, middle education level: P=.46, versus high education level), while higher anxiety scores were associated with lower adherence (P=.03). Adherence to the online questionnaires was also high (>99%). Missing data due to technical issues were limited. CONCLUSIONS: The use of a smartphone app as a symptom diary to assess treatment response resulted in high patient adherence. The data-collection framework described led to standardized data collection with excellent completeness and can be used for future randomized controlled trials. Due to the slight decrease in adherence to diary use throughout the study, this method might be less suitable for longer trials.

The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg.

BACKGROUND: Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied. METHODS: In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. INCLUSION CRITERIA: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. EXCLUSION CRITERIA: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods. DISCUSSION: NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study. Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643 .

The Short-Term Value of the "Healthy Primary School of the Future" Initiative: A Social Return on Investment Analysis.

Background: This study examines the social return on investment (SROI) of the "Healthy Primary School of the Future" initiative after 2 years. Methods: Healthy Primary Schools of the Future (HPSF) provide a healthy lunch and daily structured physical activity sessions, whereas Physical Activity Schools (PAS) focus on physical activity only. We evaluated the 2-years investments and effects (N = 1,676 children) of both school environments (four schools) compared to control schools (four schools). Investments and outcomes were grouped within the healthcare, education, household & leisure, and labor & social security sector. Outcomes that could be expressed in monetary terms were used for the calculation of social return on investment. Results: HPSF and PAS created outcomes for the healthcare sector by favorable changes in health behaviors, body mass index [both significant], and medical resource use [not significant]. Outcomes for the education sector included a favorable impact on perceived social behaviors and school satisfaction, and absenteeism from school [latter not significant], and more engagement with the community was experienced. The per child investments, €859 (HPSF) and €1017 (PAS), generated a benefit of €8 (HPSF) and €49 (PAS) due to reduced school absenteeism and medical resource use. Conclusions: Within 2 years of intervention implementation, the HPSF initiative created outcomes in several sectors, but the benefits did not outweigh the investments. Follow-up assessments as well as modeling long-term outcomes are needed to assess the total value of the interventions. Until then, the SROI framework can inform strategies for obtaining stakeholder support and intervention implementation. Trial registration: The study was registered in the ClinicalTrials.gov database on 14 June 2016 (NCT02800616).

Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial.

BACKGROUND & AIMS: Telemedicine can be used to monitor determinants and outcomes of patients with chronic diseases, possibly increasing the quality and value of care. Telemedicine was found to reduce outpatient visits and hospital admissions for patients with inflammatory bowel diseases (IBD). We performed a full economic evaluation of telemedicine interventions in patients with IBD, comparing the cost-utility of telemedicine vs standard care. METHODS: We performed a randomized trial of 909 patients with IBD at 2 academic and 2 non-academic hospitals in The Netherlands. Patients were randomly assigned to groups that received telemedicine (myIBDcoach; n = 465) or standard outpatient care (n = 444) and followed for 12 months. Costs were measured from a societal perspective. Direct healthcare costs were based on actual resource use. Indirect costs comprised self-reported hours sick leave from work, intervention costs (annual license fee of €40 per patient [$45]), and utility costs (assessed using EQ5D). Cost-utility and uncertainty were estimated using the non-parametric bootstrapping method. RESULTS: Telemedicine resulted in lower mean annual costs of €547/patient [$612] (95% CI, €1029-2143 [$1150-2393]; mean costs of €9481 [$10,587] for standard care and €8924 [$9965] for telemedicine) without changing quality adjusted life years. At the Dutch threshold of €80,000 [$89,335] per quality adjusted life year, the intervention had increased incremental cost-effectiveness over standard care in 83% of replications and an incremental net monetary benefit of €707/patient [$790] (95% CI, €1241-2544 [$1386-2841]). CONCLUSIONS: Telemedicine with myIBDcoach is cost saving and has a high probability of being cost effective for patients with IBD. This self-management tool enables continuous registration of quality indicators and (patient-reported) outcomes and might help reorganize IBD care toward value-based healthcare. ClinicalTrials.gov no: NCT02173002.

Cost-effectiveness and cost-utility analysis of a work-place smoking cessation intervention with and without financial incentives.

AIMS: To perform an economic evaluation of a work-place smoking cessation group training programme with incentives compared with a training programme without incentives. DESIGN: A trial-based cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal perspective and an employer's perspective. SETTING: Sixty-one companies in the Netherlands. PARTICIPANTS: A total of 604 tobacco-smoking employees. INTERVENTION AND COMPARATOR: A 7-week work-place smoking cessation group training programme. The intervention group earned gift vouchers of €350 for 12 months' continuous abstinence. The comparator group received no incentives. MEASUREMENTS: Online questionnaires were administered to assess quality of life (EQ-5D-5 L) and resource use during the 14-month follow-up period (2-month training period plus 12-month abstinence period). For the CEA the primary outcome measure was carbon monoxide (CO)-validated continuous abstinence; for the CUA the primary outcome was quality-adjusted life years (QALY). Bootstrapping and sensitivity analyses were performed to account for uncertainty. Incremental cost-effectiveness ratio (ICER) tables were used to determine cost-effectiveness from a life-time perspective. FINDINGS: Of the participants in the intervention group, 41.1% had quit smoking compared with 26.4% in the control group. From a societal perspective with a 14-month follow-up period, the ICER per quitter for an intervention with financial incentives compared with no incentives was €11 546. From an employer's perspective, the ICER was €5686. There was no significant difference in QALYs between the intervention and control group within the 14-month follow-up period. The intervention was dominated by the comparator in the primary analysis at a threshold of €20 000 per QALY. In the sensitivity analysis, these results were uncertain. A life-time perspective showed an ICER of €1249 (95% confidence interval = €850-2387) per QALY. CONCLUSIONS: Financial incentives may be cost-effective in increasing quitting smoking, particularly from a life-time perspective.

Longitudinal analysis of health disparities in childhood.

OBJECTIVE: Combatting disparities in health outcomes among children is a major public health concern. This study focuses on two questions: (1) To what extent does socioeconomic status (SES) contribute to disparities in health outcomes? and (2) To what extent can social inequalities in health outcomes be explained by differences in children's health behaviours? DESIGN: This study included 2-year follow-up data of 1259 children (4-12 years of age) who participated in the 'Healthy Primary School of the Future' project (ClinicalTrials.gov NCT02800616). SES was measured by maternal and paternal education and household income (adjusted for family size). Health outcomes were body mass index (BMI) z-score, health resource use, school absenteeism, health-related quality of life and psychosocial health, measured over 2 years of follow-up (2015-2017). Health behaviours included physical activity, and consumption of fruits, vegetables and sweetened beverages. Associations between SES and baseline health behaviours were examined, and mixed models for repeated measures were used to assess associations between SES and health outcomes over 2 years of follow-up. RESULTS: A high socioeconomic background was significantly associated with better health outcomes (all outcomes). For example, children with a low SES had higher BMI z-scores (beta coefficient: 0.42, 95% CI 0.22 to 0.62) and higher consumption healthcare costs (ratio of mean costs: 2.21, 95% CI 1.57 to 3.10). Effects of SES changed very little after controlling for health behaviours. DISCUSSION: Our findings strongly suggest that socioeconomic background has a pervasive impact on disparities in child health, but gives little support to the idea that social inequalities in child health can be tackled by means of lifestyle interventions.

Effect of a workplace-based group training programme combined with financial incentives on smoking cessation: a cluster-randomised controlled trial.

BACKGROUND: Financial incentives are potentially useful tools to aid smoking cessation, but robust evidence to support their efficacy, particularly in combination with other interventions (eg, group counselling), has not been reported. We aimed to investigate whether financial incentives combined with a smoking cessation group training programme (compared with a training programme with no incentives) organised at the workplace would increase 12-month abstinence rates in tobacco-smoking employees with different education and income levels. METHODS: This cluster-randomised controlled trial was done in the Netherlands with companies that offer a smoking cessation group training programme to all of their smoking employees. Eligible participants were tobacco-smoking employees and spouses of employees who were at least 18 years of age. Participants in the control group received a weekly 90-min session of smoking cessation group training for 7 weeks at the workplace; in addition to the group training, participants in the intervention group received vouchers for being abstinent (€50 at the end of the training programme, €50 3 months after completion of the programme, €50 after 6 months, and €200 after 12 months). Companies were randomly assigned by an independent research assistant to the intervention group or the control group with a digital randomisation programme, using a biased urn method. The primary outcome was carbon monoxide-validated continuous abstinence at 12 months. All randomised participants were included in the modified intention-to-treat analyses, with the exception of unavoidable loss (participants who had died or moved to an untraceable address (according to the Russell Standard), and in the sensitivity analyses, except the complete case analysis, which included only participants for whom all variables included in the model were not missing. This study is registered with the Dutch Trial Register, number NTR5657. FINDINGS: Between March 1, 2016, and March 1, 2017, 61 companies with 604 participating smokers were enrolled. 31 companies (319 smokers) were randomly assigned to the intervention group and 30 companies (285 smokers) to the control group. 12 months after finishing the smoking cessation programme, the proportion of individuals abstaining from smoking in the intervention group was significantly higher than that in the control group (131 [41%] of 319 vs 75 [26%] of 284; adjusted odds ratio 1·93, 95% CI 1·31-2·85, p=0·0009; adjusted for education level, income level, and Fagerström score). INTERPRETATION: Financial incentives in addition to a smoking cessation group training programme can significantly increase long-term smoking abstinence. The results of the current study could motivate employers to facilitate a workplace smoking cessation programme with financial incentives to help employees to quit smoking. FUNDING: Dutch Cancer Society.

PsyScan e-tool to support diagnosis and management of psychological problems in general practice: a randomised controlled trial.

BACKGROUND: GPs are crucial in adequately diagnosing and initiating appropriate management for patients with psychological problems, but face many challenges and require support. AIM: To determine the effects of the e-tool PsyScan. DESIGN AND SETTING: A randomised controlled trial with a 1-year follow-up, comparing care using PsyScan with usual care for psychological problems, was undertaken in 10 multidisciplinary primary healthcare centres in Eindhoven, the Netherlands. METHOD: Between consultations with their GP, participants in the intervention group could complete PsyScan. The e-tool consists of a distress screener and Four-Dimensional Symptom Questionnaire to differentiate between stress, depression, anxiety, and somatisation symptoms, and to explore symptom severity. PsyScan generated diagnostic and therapeutic advice for GPs and participants that was automatically transferred to each patient's electronic medical record. The primary outcome was the proportion of participants that achieved a successful treatment result; namely, a decrease of ≥50% on the Symptom Checklist-90-Revised, after 1 year. RESULTS: There were 176 participants in the intervention group and 160 in the control group. After multiple imputation, the participants in the intervention group had higher chances of achieving a successful treatment result compared with those in the control group (odds ratio [OR] 2.7, 95% confidence interval [CI] = 1.5 to 4.8, P = 0.002). Quality of life was higher in the intervention group at 12 months (mean difference in EuroQol 5 Dimensions 5 Levels index values was 0.076, 95% CI = 0.015 to 0.136, P = 0.01). The mean 1-year costs per participant were similar (€13 622 in intervention group, €12 487 in control group [ß = -0.03, P = 0.71, R2 = 0.05]). CONCLUSION: PsyScan generated clinically relevant and statistically significant effects, and could be useful in offering effective individualised care to patients.