scholarly journals Pediatric Weight Management Through mHealth Compared to Face-to-Face Care: Cost Analysis of a Randomized Control Trial (Preprint)

2021 ◽  
Author(s):  
Louise Tully ◽  
Jan Sorensen ◽  
Grace O'Malley

BACKGROUND Mobile health (mHealth) may improve pediatric weight management capacity and the geographical reach of services, and overcome barriers to attending physical appointments using ubiquitous devices such as smartphones and tablets. This field remains an emerging research area with some evidence of its effectiveness; however, there is a scarcity of literature describing economic evaluations of mHealth interventions. OBJECTIVE We aimed to assess the economic viability of using an mHealth approach as an alternative to standard multidisciplinary care by evaluating the direct costs incurred within treatment arms during a noninferiority randomized controlled trial (RCT). METHODS A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidence-based approaches. We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant. RESULTS In total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.1), with variations depending on the number of weeks of treatment completion. The conversion rate for the reference year 2013 was $1=€0.7525. The costs incurred for those who withdrew from the study ranged from €35 to €681, depending on the point of dropout and study arm. The main driver of the costs in the mHealth arm was the need for health professional monitoring and support for patients on a weekly basis. The budget impact for offering the mHealth intervention to all newly referred patients in a 1-year period was estimated at €59,046 using the assessed approach. CONCLUSIONS This mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs. The need for monitoring and support from health care professionals (HCPs) was not eliminated using this delivery model. Further research is needed to explore the cost-effectiveness and economic impact on families and from a wider societal perspective. CLINICALTRIAL ClinicalTrials.gov NCT01804855; https://clinicaltrials.gov/ct2/show/NCT01804855

10.2196/31621 ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. e31621
Author(s):  
Louise Tully ◽  
Jan Sorensen ◽  
Grace O'Malley

Background Mobile health (mHealth) may improve pediatric weight management capacity and the geographical reach of services, and overcome barriers to attending physical appointments using ubiquitous devices such as smartphones and tablets. This field remains an emerging research area with some evidence of its effectiveness; however, there is a scarcity of literature describing economic evaluations of mHealth interventions. Objective We aimed to assess the economic viability of using an mHealth approach as an alternative to standard multidisciplinary care by evaluating the direct costs incurred within treatment arms during a noninferiority randomized controlled trial (RCT). Methods A digitally delivered (via a smartphone app) maintenance phase of a pediatric weight management program was developed iteratively with patients and families using evidence-based approaches. We undertook a microcosting exercise and budget impact analysis to assess the costs of delivery from the perspective of the publicly funded health care system. Resource use was analyzed alongside the RCT, and we estimated the costs associated with the staff time and resources for service delivery per participant. Results In total, 109 adolescents participated in the trial, and 84 participants completed the trial (25 withdrew from the trial). We estimated the mean direct cost per adolescent attending usual care at €142 (SD 23.7), whereas the cost per adolescent in the mHealth group was €722 (SD 221.1), with variations depending on the number of weeks of treatment completion. The conversion rate for the reference year 2013 was $1=€0.7525. The costs incurred for those who withdrew from the study ranged from €35 to €681, depending on the point of dropout and study arm. The main driver of the costs in the mHealth arm was the need for health professional monitoring and support for patients on a weekly basis. The budget impact for offering the mHealth intervention to all newly referred patients in a 1-year period was estimated at €59,046 using the assessed approach. Conclusions This mHealth approach was substantially more expensive than usual care, although modifications to the intervention may offer opportunities to reduce the mHealth costs. The need for monitoring and support from health care professionals (HCPs) was not eliminated using this delivery model. Further research is needed to explore the cost-effectiveness and economic impact on families and from a wider societal perspective. Trial Registration ClinicalTrials.gov NCT01804855; https://clinicaltrials.gov/ct2/show/NCT01804855


2019 ◽  
Vol 120 (02) ◽  
pp. 216-228 ◽  
Author(s):  
Paolo Angelo Cortesi ◽  
Giancarlo Castaman ◽  
Gianluca Trifirò ◽  
Simona Serao Creazzola ◽  
Giovanni Improta ◽  
...  

AbstractRecent evidence demonstrated that weekly prophylaxis with subcutaneous bispecific antibody (emicizumab) has shown higher efficacy in adolescent and adults patients affected by haemophilia A (HA) with inhibitor, compared with patients treated on demand or on prophylaxis with bypassing agents (BPAs). However, no economic evaluations assessing the value and sustainability of emicizumab prophylaxis have been performed in Europe. This study assessed the cost-effectiveness of emicizumab prophylaxis compared with BPA prophylaxis and its possible budget impact from the Italian National Health Service (NHS) perspective. A Markov model and a budget impact model were developed to estimate the cost-effectiveness and budget impact of emicizumab prophylaxis in HA patients with inhibitors. The model was populated using treatment efficacy from clinical trials and key clinical, cost and epidemiological data retrieved through an extensive literature review. Compared with BPAs prophylaxis, emicizumab prophylaxis was found to be more effective (0.94 quality adjusted life-years) and cost saving (–€19.4/–€24.4 million per patient lifetime) in a cohort of 4-year-old patients with HA and inhibitors who failed immune tolerance induction. In the probabilistic sensitivity analysis, emicizumab prophylaxis had always 100% probability of being cost-effective at any threshold. Further, the use of emicizumab prophylaxis was associated to an overall budget reduction of €45.4 million in the next 3 years. In conclusion, the clinically effective emicizumab prophylaxis can be considered a cost-saving treatment for HA with inhibitor patients. Furthermore, emicizumab treatment is also associated to a significant reduction of the health care budget, making this new treatment a sustainable and convenient health care option for Italian NHS.


2021 ◽  
Vol 12 ◽  
pp. 215013272110002
Author(s):  
William Uribe-Arango ◽  
Juan Manuel Reyes Sánchez ◽  
Natalia Castaño Gamboa

Objectives To assess budget impact of the implementation of an anticoagulation clinic (AC) compared to usual care (UC), in patients with non-valvular atrial fibrillation (NVAF). Method A decision tree was designed to analyze the cost and events rates over a 1-year horizon. The patients were distributed according to treatment, 30% Direct Oral Anticoagulant (DOAC) regimens and the rest to warfarin. The thromboembolism and bleeding were derived from observational studies which demonstrated that ACs had important impact in reducing the frequency of these events compared with UC, due to higher adherence with DOACs and proportion of time in therapeutic range (TTR) with warfarin. Costs were derived from the transactional platform of Colombian government, healthcare authority reimbursement and published studies. The values were expressed in American dollars (USD). The exchanged rate used was COP $3.693 per dollar. Results During 1 year of follow-up, in a cohort of 228 patients there were estimated 48 bleedings, 6 thromboembolisms in AC group versus 84 bleedings, and 12 thromboembolisms events in patients receiving UC. Total costs related to AC were $126 522 compared with $141 514 in UC. The AC had an important reduction in the cost of clinical events versus UC ($52 085 vs $110 749) despite a higher cost of care facilities ($74 436 vs $30 765). A sensibility analysis suggested that in the 83% of estimations, the AC produced savings varied between $27 078 and $135 391. Conclusions This study demonstrated that AC compared with UC, produced an important savings in the oral anticoagulation therapy for patients with NVAF.


2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.


PEDIATRICS ◽  
1987 ◽  
Vol 79 (5) ◽  
pp. 835-835
Author(s):  

Pressures generated by a constellation of professional consumer, legislative, and health care provider vider groups in this era of increasing health care costs have led to enactment of generic substitution laws in 50 states. The general acceptance of this concept, despite conflicting evidence that it has reduced the cost of prescription items to the consumer, has led to the concept of therapeutic substitution. Considerable confusion exists among health care professionals regarding the precise meaning of these concepts. Generic prescribing is the prescribing of a drug by a physician using the generic name. This leaves the choice of brand to the dispensing pharmacist. Generic substitution is a pharmacist-initiated act by which a different brand or an unbranded drug product is dispensed instead of a drug brand that was prescribed by the physician. This means substituting the same chemical entity in the same dosage form for one marketed by a different company. Therapeutic substitution is a pharmacist-initiated act by which a pharmaceutical or therapeutic alternate for the physician-prescribed drug is dispensed without consulting the physician. This denotes replacement of the prescribed drug with a chemically different drug within the same therapeutic category, eg, hydrochlorothiazide for furosemide; ranitidine for cimetidine; chloramphenicol for erythromycin. In 1976, the AAP Committee on Drugs published a commentary in Pediatrics (1976;57:275-277) on generic prescribing and concluded that "the lack of data on bioavailability and bioequivalence in children precludes blanket support of generic prescribing for infants and children." The Committee recently reviewed this issue and concluded that the situation has changed little during the past decade.


2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022


2021 ◽  
pp. 096452842110557
Author(s):  
Trygve Skonnord ◽  
Arne Fetveit ◽  
Holgeir Skjeie ◽  
Mette Brekke ◽  
Margreth Grotle ◽  
...  

Objective: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). Methods: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. Results: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. Conclusion: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. Trial registration number: NCT01439412 (ClinicalTrials.gov).


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