Smart continence care for people with profound intellectual and multiple disabilities:Protocol for a cluster randomized trial and trial-based economic evaluation

Background: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. Objective: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. Methods: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. Results: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. Conclusions: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD

Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial

Purpose This randomized clinical equivalence trial was designed to evaluate health-related quality of life (HRQoL) after fast-track treatment for low-risk coronary artery bypass (CABG) patients. Methods Four hundred and ten CABG patients were randomly assigned to undergo either short-stay intensive care treatment (SSIC, 8 h of intensive care stay) or control treatment (care as usual, overnight intensive care stay). HRQoL was measured at baseline and 1 month, and one year after surgery using the multidimensional index of life quality (MILQ), the EQ-5D, the Beck Depression Inventory and the State-Trait Anxiety Inventory. Results At one month after surgery, no statistically significant difference in overall HRQoL was found (MILQ-score P-value = .508, overall MILQ-index P-value = .543, EQ-5D VAS P-value = .593). The scores on the MILQ-domains, physical, and social functioning were significantly higher at one month postoperatively in the SSIC group compared to the control group (P-value = .049; 95% CI: 0.01-2.50 and P-value =.014, 95% CI:0.24-2.06, respectively). However, these differences were no longer observed at long-term follow-up. Conclusions According to our definition of clinical equivalence, the HRQoL of SSIC patients is similar to patients receiving care as usual. Since safety and the financial benefits of this intervention were demonstrated in a previously reported analysis, SSIC can be considered as an adequate fast-track intensive care treatment option for low-risk CABG patients

Economic evaluation of nurse-led stroke aftercare addressing long-term psychosocial outcome: a comparison to care-as-usual

Objective To examine the cost-effectiveness of nurse-led stroke aftercare addressing psychosocial outcome at 6 months post stroke, compared with care-as-usual.Design Economic evaluation within a comparative effectiveness research design.Setting Primary care (2016–2017) and community settings (2011–2013) in the Netherlands.Participants Persons who suffered from ischaemic or haemorrhagic stroke, or a transient ischaemic attack and were discharged home after visiting the emergency department, hospitalisation or inpatient rehabilitation.Interventions Nurse-led stroke aftercare at 6 months post stroke addressing psychosocial functioning by providing screening, psycho-education, emotional support and referral to specialist care when needed. Care-as-usual concerned routine follow-up care including secondary prevention programmes and a consultation with the neurologist at 6 weeks post stroke.Primary and secondary outcome measures Main outcome measure of cost-effectiveness was quality-adjusted life years (QALYs) estimated by the quality of life measured by the five-dimensional, three-level EuroQol. Costs were assessed using a cost-questionnaire. Secondary outcomes were mood (Hospital Anxiety and Depression Scale) and social participation (Utrecht Scale for Evaluation of Rehabilitation-Participation) restrictions subscale.Results Health outcomes were significantly better in stroke aftercare for QALYs (Δ=0.05; 95% CI 0.01 to 0.09) and social participation (Δ=4.91; 95% CI 1.89 to 7.93) compared with care-as-usual. Total societal costs were €1208 higher in stroke aftercare than in care-as-usual (95% CI −€3881 to €6057). Healthcare costs were in total €1208 higher in stroke aftercare than in care-as-usual (95% CI −€3881 to €6057). Average costs of stroke aftercare were €91 (SD=€3.20) per person. Base case cost-effectiveness analyses showed an incremental cost-effectiveness ratio of €24 679 per QALY gained. Probability of stroke aftercare being cost-effective was 64% on a €50 000 willingness-to-pay level.Conclusions Nurse-led stroke aftercare addressing psychosocial functioning showed to be a low-cost intervention and is likely to be a cost-effective addition to care-as-usual. It plays an important role by screening and addressing psychosocial problem, not covered by usual care

A qualitative study on the views of experts regarding the incorporation of non-health outcomes into the economic evaluations of public health interventions

Background: Public health interventions can impact a broad number of outcomes, including both health and non-health outcomes (NHOs). However, although it is often acknowledged that it's important to take NHOs into account in economic evaluation studies, in practice these are often neglected. To address this issue, our study investigated expert views regarding the incorporation of NHOs into the economic evaluations of public health interventions, by means of a qualitative study. Methods: A purposive sampling method was used to recruit the experts in the field of health economics and/or public health for this study. Twenty-two semi-structured interviews were held. After recording, the interviews were transcribed verbatim and entered in Nvivo. The data was analyzed using a thematic analysis to identify all important themes mentioned by the experts. Data collection and analysis was continued until saturation was reached. Multiple coding and validity checks were performed to further strengthen the rigour of our methodology. Results: Based on the expert interviews, the following overarching themes were identified; Theme 1: NHOs on the individual level, direct social level and societal level. Theme 2: Pros and Cons regarding the development of a new instrument to measure NHOs. Theme 3: The most important requirements for a new questionnaire to be developed for measuring broader outcomes. Theme 4: Alternative methods which could be used for measuring and valuating NHOs in economic evaluations for public health. Discussion: Our research findings indicate that the importance of NHOs and the need to measure them are universally accepted. Most of the experts acknowledge the importance of measuring broader outcomes and support the development of a new instrument to measure these. The experts, who do not support the development of a new instrument, question its usefulness and feasibility; i.e., they are not sure whether it is possible to valuate NHOs. Furthermore, experts have strong and sometimes conflicting views on the specific requirements of a new instrument to be developed for measuring NHOs. They did not identify a single preferred alternative method for measurement and valuation. Conclusions: Most experts find a wide range of NHOs important and are in favor of developing a new instrument for identifying and measuring NHOs. Hence, an open discussion needs to be initiated with experts and other stakeholders about which steps need to be taken to move forward

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation

Background: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. Objective: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. Methods: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. Results: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. Conclusions: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. Trial Registration: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840 International Registered Report Identifier (IRRID): DERR1-10.2196/4255

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555

Does sinus rhythm conversion after cardiac surgery affect postoperative health- related quality of life?

BACKGROUND: We investigated the impact and the predictive value of sinus rhythm at 12 months (SR(12)) on subscales of three different HrQoL questionnaires: SF-36., EuroQoL and MFI 20. METHODS: Data of 125 cardiac surgery patients with pre-operative AF from our previous randomized trial were used. Based on their rhythm outcome patients were divided in two groups: SR(12) or AF at 12 months follow up (non-SR(12)). All questionnaires were self-administered pre-operatively and at 3 months, 6 months and 12 months after surgery. RESULTS: Synus rhytm at 12 months was predictive of improvement of SF36- mental score (MS, p = 0.021), Euro-QoL-MS (p = 0.009), VAS (p = 0.006), and MFI 20-MS (p = 0.009). We failed to find any significant interactions between SR(12) and any of the other significant risk factors: age <65 years, paroxysmal type of AF and preoperative AF duration <12 months. In contrast, SR(12) was not significant in predicting physical score (PS) subscales of any of the questionnaires (all, p > 0.05) which were predicted by age <65 years (SF36-PS, p = 0.029) by paroxysmal type of AF and age <65 years (Euro-QoL-PS, p = 0.017 and p = 0.04, respectively) and by AF duration <12 months, paroxysmal type of AF and age < 65 years (MFI 20-PS, p = 0.019, p = 0.020 and p = 0.015, respectively). CONCLUSIONS: Specific mental-related HrQoL scales are much more sensitive to sinus rhythm conversion. Sinus rithm mantainance shows significant effects on mental scores independently of other cofactors. Successful conversion to sinus rhythm after surgical ablation during cardiac surgery does not significantly affect phisical health related quality of life during 1 year follow up