Six-year follow-up study of residential displacement and health outcomes following the 2011 Japan Earthquake and Tsunami.

Studies examining the long-term health consequences of residential displacement following large-scale disasters remain sparse. Following the 2011 Japan Earthquake and Tsunami, victims who lost their homes were resettled by two primary means: 1) group relocation to public housing or 2) individual relocation, in which victims moved into public housing by lottery or arranged for their own accommodation. Little is known about how the specific method of residential relocation affects survivors' health. We examined the association between residential relocation and long-term changes in mental and physical well-being. Our baseline assessment predated the disaster by 7 mo. Two follow-up surveys were conducted ∼2.5 y and 5.5 y after the disaster to ascertain the long-term association between housing arrangement and health status. Group relocation was associated with increased body mass index and depressive symptoms at 2.5-y follow-up but was no longer significantly associated with these outcomes at 5.5-y follow-up. Individual relocation at each follow-up survey was associated with lower instrumental activities of daily living as well as higher risk of cognitive impairment. Our findings underscore the potential complexity of long-term outcomes associated with residential displacement, indicating both positive and negative impacts on mental versus physical dimensions of health.

What Is Value in Health and Healthcare? A Systematic Literature Review of Value Assessment Frameworks.

OBJECTIVES: This study aimed to investigate how value is defined and measured in existing value assessment frameworks (VAFs) in healthcare. METHODS: We searched PubMed, Embase, the Cochrane Library, and Centre for Reviews and Dissemination from 2008 to 2019. We also performed backward citation chaining of included studies and previously published systematic reviews. Studies reporting the development of a VAF in healthcare were included. For each included framework, we extracted and compared the context, target users, intended use, methods used to identify value attributes, description of the attributes, and attribute scoring approaches. RESULTS: Of the 8151 articles screened, 57 VAFs were included. The value attributes included in 55 VAFs were grouped into 9 categories: health benefits (n = 53, 96%), affordability (n = 45, 82%), societal impact (n = 42, 76%), burden of disease (n = 36, 65%), quality of evidence (n = 32, 58%), cost-effectiveness (n = 31, 56%), ethics and equity (n = 27, 49%), unmet needs (n = 21, 38%), and innovation (n = 15, 27%). The remaining 2 VAFs used broad attributes or user-defined attributes. Literature review was the main approach to identify value attributes in 36 VAFs. Patient or public was engaged through the development of only 11 VAFs. Weighting has been used to score 29 VAFs, of which 19 used the methods of multicriteria decision analysis. CONCLUSIONS: There are substantial variations in defining and measuring value. A noticeable weakness of existing VAFs is that patient or public engagement was generally very limited or missing in framework development process. Existing VAFs tend to aggregate multiple value attributes into a single index for decision making.

Estimating and Comparing Health and Financial Risk Protection Outcomes in Economic Evaluations.

OBJECTIVES: Improving health and financial risk protection (FRP, the prevention of medical impoverishment) and their distributions is a major objective of national health systems. Explicitly describing FRP and disaggregated (eg, across socioeconomic groups) impact of health interventions in economic evaluations can provide decision makers with a broader set of health and financial outcomes to compare and prioritize interventions against each other. METHODS: We propose methods to synthesize such a broader set of outcomes by estimating and comparing the distributions in both health and FRP benefits procured by health interventions. We build on benefit-cost analysis frameworks and utility-based models, and we illustrate our methods with the case study of universal public finance (financing by government regardless of whom an intervention is targeting) of disease treatment in a low- and middle-income country setting. RESULTS: Two key findings seem to emerge: FRP is critical when diseases are less lethal (eg, case fatality rates <1% or so), and quantitative valuation of inequality aversion across income groups matters greatly. We recommend the use of numerous sensitivity analyses and that all distributional health and financial outcomes be first presented in a disaggregated form (before potential subsequent aggregation). CONCLUSIONS: Estimation approaches such as the one we propose provide explicit disaggregated considerations of equity, FRP, and poverty impact for the development of health sector policies, with high relevance for population-based preventive measures.

Time Costs and Out-of-Pocket Costs in Patients With Chronic Hepatitis C in a Publicly Funded Health System.

OBJECTIVES: Chronic hepatitis C (CHC) infection affects more than 70 million people worldwide and imposes considerable health and economic burdens on patients and society. This study estimated 2 understudied components of the economic burden, patient out-of-pocket (OOP) costs and time costs, in patients with CHC in a tertiary hospital clinic setting and a community clinic setting. METHODS: This was a multicenter, cross-sectional study with hospital-based (n = 174) and community-based (n = 101) cohorts. We used a standardized instrument to collect healthcare resource use, time, and OOP costs. OOP costs included patient-borne costs for medical services, nonprescription drugs, and nonmedical expenses related to healthcare visits. Patient and caregiver time costs were estimated using an hourly wage value derived from patient-reported employment income and, where missing, derived from the Canadian census. Sensitivity analysis explored alternative methods of valuing time. Costs were reported in 2020 Canadian dollars. RESULTS: The mean 3-month OOP cost was $55 (95% confidence interval [CI] $21-$89) and $299 (95% CI $170-$427) for the community and hospital cohorts, respectively. The mean 3-month patient time cost was $743 (95% CI $485-$1002) (community) and $465 (95% CI $248-$682) (hospital). The mean 3-month caregiver time cost was $31 (95% CI $0-$63) (community) and $277 (95% CI $174-$380) (hospital). Patients with decompensated cirrhosis bore the highest costs. CONCLUSIONS: OOP costs and patient and caregiver time costs represent a considerable economic burden to patient with CHC, equivalent to 14% and 21% of the reported total 3-month income for the hospital-based and community-based cohorts, respectively.

Treatment of Chronic Hepatitis C in Young Children Reduces Adverse Outcomes and Is Cost-Effective Compared with Deferring Treatment to Adulthood.

OBJECTIVE: To evaluate the cost-effectiveness of treating young children with chronic hepatitis C virus (HCV) with new direct-acting antivirals. STUDY DESIGN: A state-transition model of chronic HCV was developed to conduct a cost-effectiveness analysis comparing treatment at age 6 years vs delaying treatment until age 18 years. Model inputs were derived from recently conducted systematic reviews, published literature, and government statistics. Medical care costs were obtained from linked population level laboratory and administrative data (Ontario, Canada). Outcomes are expressed in expected quality-adjusted life-years and costs (CAD$). Analysis included a base-case to estimate the expected value and one-way and probabilistic sensitivity analyses to evaluate the impact of uncertainty of the model inputs. RESULTS: After 20 years, treating 10 000 children early would prevent 330 cases of cirrhosis, 18 cases of hepatocellular carcinoma, and 48 liver-related deaths. The incremental cost-effectiveness ratio of early treatment compared to delayed treatment was approximately $12 690/quality-adjusted life-years gained and considered cost-effective. Model results were robust to variation in fibrosis progression rates, disease state-based costs, treatment costs, and utilities. CONCLUSIONS: Delaying treatment until age 18 years results in an increased lifetime risk of late-stage liver complications. Early treatment in children is cost effective. Our work supports clinical and health policies that broaden HCV treatment access to young children.

Pharmacological Acromegaly Treatment: Cost-Utility and Value of Information Analysis.

OBJECTIVES: To conduct a cost-utility analysis comparing drug strategies involving octreotide, lanreotide, pasireotide, and pegvisomant for the treatment of patients with acromegaly who have failed surgery, from a Brazilian public payer perspective. METHODS: A probabilistic cohort Markov model was developed. One-year cycles were employed. The patients started at 45 years of age and were followed lifelong. Costs, efficacy, and quality of life parameters were retrieved from the literature. A discount rate (5%) was applied to both costs and efficacy. The results were reported as costs per quality-adjusted life year (QALY), and incremental cost-effectiveness ratios (ICERs) were calculated when applicable. Scenario analyses considered alternative dosages, discount rate, tax exemption, and continued use of treatment despite lack of response. Value of information (VOI) analysis was conducted to explore uncertainty and to estimate the costs to be spent in future research. RESULTS: Only lanreotide showed an ICER reasonable for having its use considered in clinical practice (R$ 112,138/US$ 28,389 per QALY compared to no treatment). Scenario analyses corroborated the base-case result. VOI analysis showed that much uncertainty surrounds the parameters, and future clinical research should cost less than R$ 43,230,000/US$ 10,944,304 per year. VOI also showed that almost all uncertainty that precludes an optimal strategy choice involves quality of life. CONCLUSIONS: With current information, the only strategy that can be considered cost-effective in Brazil is lanreotide treatment. No second-line treatment is recommended. Significant uncertainty of parameters impairs optimal decision-making, and this conclusion can be generalized to other countries. Future research should focus on acquiring utility data.

Health outcomes and cost-effectiveness of diversion programs for low-level drug offenders: A model-based analysis.

BACKGROUND: Cycles of incarceration, drug abuse, and poverty undermine ongoing public health efforts to reduce overdose deaths and the spread of infectious disease in vulnerable populations. Jail diversion programs aim to divert low-level drug offenders toward community care resources, avoiding criminal justice costs and disruptions in treatment for HIV, hepatitis C virus (HCV), and drug abuse. We sought to assess the health benefits and cost-effectiveness of a jail diversion program for low-level drug offenders. METHODS AND FINDINGS: We developed a microsimulation model, calibrated to King County, Washington, that captured the spread of HIV and HCV infections and incarceration and treatment systems as well as preexisting interventions such as needle and syringe programs and opiate agonist therapy. We considered an adult population of people who inject drugs (PWID), people who use drugs but do not inject (PWUD), men who have sex with men, and lower-risk heterosexuals. We projected discounted lifetime costs and quality-adjusted life years (QALYs) over a 10-year time horizon with and without a jail diversion program and calculated resulting incremental cost-effectiveness ratios (ICERs) from the health system and societal perspectives. We also tracked HIV and HCV infections, overdose deaths, and jail population size. Over 10 years, the program was estimated to reduce HIV and HCV incidence by 3.4% (95% CI 2.7%-4.0%) and 3.3% (95% CI 3.1%-3.4%), respectively, overdose deaths among PWID by 10.0% (95% CI 9.8%-10.8%), and jail population size by 6.3% (95% CI 5.9%-6.7%). When considering healthcare costs only, the program cost $25,500/QALY gained (95% CI $12,600-$48,600). Including savings from reduced incarceration (societal perspective) improved the ICER to $6,200/QALY gained (95% CI, cost-saving $24,300). Sensitivity analysis indicated that cost-effectiveness depends on diversion program participants accessing community programs such as needle and syringe programs, treatment for substance use disorder, and HIV and HCV treatment, as well as diversion program cost. A limitation of the analysis is data availability, as fewer data are available for diversion programs than for more established interventions aimed at people with substance use disorder. Additionally, like any model of a complex system, our model relies on simplifying assumptions: For example, we simplified pathways in the healthcare and criminal justice systems, modeled an average efficacy for substance use disorder treatment, and did not include costs associated with homelessness, unemployment, and breakdown in family structure. CONCLUSIONS: We found that diversion programs for low-level drug offenders are likely to be cost-effective, generating savings in the criminal justice system while only moderately increasing healthcare costs. Such programs can reduce incarceration and its associated costs, and also avert overdose deaths and improve quality of life for PWID, PWUD, and the broader population (through reduced HIV and HCV transmission).

An Economic Analysis of the Implementation of Team-based Collaborative Care in Outpatient General Mental Health Clinics.

BACKGROUND: Collaborative Chronic Care Models represent an evidence-based way to structure care for chronic conditions, including mental health conditions. Few studies, however, have examined the cost implications of collaborative care for mental health. OBJECTIVE: We aimed to conduct an economic analysis of implementing collaborative care in 9 outpatient general mental health clinics. RESEARCH DESIGN: Analyses were derived from a stepped wedge hybrid implementation-effectiveness trial. We conducted cost-minimization analyses from the health system perspective, incorporating implementation costs, outpatient costs, and inpatient costs for the year before collaborative care implementation and the implementation year. We used a difference-in-differences approach and conducted 1-way sensitivity analyses to determine the robustness of results to variations ±15% in model parameters, along with probabilistic sensitivity analysis using Monte Carlo simulation. SUBJECTS: Our treatment group included 5507 patients who were initially engaged in care within 9 outpatient general mental health teams that underwent collaborative care implementation. We compared costs for this group to 45,981 control patients who received mental health treatment as usual at the same medical centers. RESULTS: Collaborative care implementation cost about $40 per patient and was associated with a significant decrease in inpatient costs and a nonsignificant increase in outpatient mental health costs. This implementation was associated with $78 in cost savings per patient. Monte Carlo simulation suggested that implementation was cost saving in 78% of iterations. CONCLUSIONS: Collaborative care implementation for mental health teams was associated with significant reductions in mental health hospitalizations, leading to substantial cost savings of about $1.70 for every dollar spent for implementation.

Cost-utility of individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy compared with treatment as usual in reducing psychological distress in cancer patients.

OBJECTIVE: It was previously determined that group-based face-to-face Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) are equally efficacious compared with treatment as usual (TAU) in reducing psychological distress. In this study, the incremental cost-utility of both interventions compared with TAU was assessed. METHODS: This cost-utility study included 245 self-referred heterogeneous cancer patients with psychological distress who were randomized to MBCT, eMBCT or TAU. Healthcare costs and (informal) work-related productivity losses were assessed by interview. Outcomes were expressed in EuroQol-5D-3L utility scores and quality-adjusted life years (QALY). An economic evaluation with a time-horizon of 3 months was conducted from the societal perspective in the intention-to-treat sample. In addition, secondary explorative analyses of costs and quality of life during the 9-month follow-up were conducted based on linear extrapolation of TAU. RESULTS: Paid work-related productivity losses and societal costs were lower in both intervention conditions compared with TAU during the 3-month intervention period. Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53). At a willingness to pay of €20000 per QALY, the mean incremental net monetary benefit was €1916 (SD=€783) in eMBCT and €2365 (SD=€796) in MBCT versus TAU. Exploration of costs demonstrated an equal pattern of eMBCT and MBCT being superior to TAU. Quality of life at 9-month follow-up remained improved in both interventions. CONCLUSIONS: Results indicate that eMBCT and MBCT are cost-saving treatments whilst simultaneously improving quality of life for distressed cancer patients.

Cost-Utility Analysis of Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Genotype 1 and 6 in Vietnam.

OBJECTIVE: Very few cost-utility analyses have either evaluated direct-acting antivirals (DAAs) on hepatitis C virus (HCV) genotype 6 patients or undertaken societal perspective. Recently, DAAs have been introduced into the Vietnamese health insurance drug list for chronic hepatitis C (CHC) treatment without empirical cost-effectiveness evidence. This study was conducted to generate these data on DAAs among CHC patients with genotypes 1 and 6 in Vietnam. METHODS: A hybrid decision-tree and Markov model was employed to compare costs and quality-adjusted life-years (QALYs) of available DAAs, including (1) sofosbuvir/ledipasvir, (2) sofosbuvir/velpatasvir, and (3) sofosbuvir plus daclatasvir, with pegylated-interferon plus ribavirin (PR). Primary data collection was conducted in Vietnam to identify costs and utility values. Incremental cost-effectiveness ratios were estimated from societal and payer perspectives. Uncertainty and scenario analyses and value of information analyses were performed. RESULTS: All DAAs were cost-saving as compared with PR in CHC patients with genotypes 1 and 6 in Vietnam, and sofosbuvir/velpatasvir was the most cost-saving regimen, from both societal and payer perspectives. From the societal perspective, DAAs were associated with the increment of quality-adjusted life-years by 1.33 to 1.35 and decrement of costs by $6519 to $7246. Uncertainty and scenario analyses confirmed the robustness of base-case results, whereas the value of information analyses suggested the need for further research on relative treatment efficacies among DAA regimens. CONCLUSIONS: Allocating resources for DAA treatment for HCV genotype 1 and 6 is surely a rewarding public health investment in Vietnam. It is recommended that the government rapidly scale up treatment and enable financial accessibility for HCV patients.

Identifying Outcome Measures for Migraine Value-Based Contracting Using the Delphi Method.

OBJECTIVE: To identify meaningful migraine outcome measures among key stakeholders to inform value-based contracts for migraine medications. BACKGROUND: Value-based contracts linking medication payments to predefined performance metrics aim to promote value through aligned incentives and shared risk between manufacturers and payers. The emergence of new and expensive pharmaceuticals for migraine presents an opportunity for value-based contract development. However, uncertainty remains around which outcomes are most meaningful to all migraine stakeholders. METHODS: This study utilized a Delphi survey to incorporate views from 82 stakeholders, including patients (n = 21), providers (n = 23), payers (n = 10), employers (n = 18), and pharmaceutical company representatives (n = 10). A list of 15 migraine-related outcomes was created from a literature review and subject matter expert consultation. Stakeholders reported on the value of these outcomes through a 5-point Likert scale and selection of their top 3 most meaningful outcomes. All participants except patients and employers also used a 5-point Likert scale to rate the feasibility of collecting each outcome measure. Consensus was defined as ≥75% agreement on the importance and feasibility of an outcome (Likert scores ≥4/5 or selection of an outcome as most meaningful). RESULTS: After 2 rounds, consensus was achieved for importance of 9 outcomes on the Likert scale. "Decrease in migraine frequency" reached 100% agreement (82/82), followed by "increased ability to resume normal activities" (96%, 79/82). When asked to choose the 3 most meaningful outcomes, stakeholders selected "decrease in migraine frequency" (88%, 72/82) followed by "decrease in migraine severity" (80%, 66/82). The 2 measures rated as most feasibly collected were "decrease in emergency department/urgent care visits" (95%, 40/42) and "decrease in migraine frequency" (90%, 38/42). There were statistically significant differences between non-patient and patient stakeholders in selection of "decrease in emergency department/urgent care visits" [20% (12/61) vs 0% (0/21), P = .031]; and employer and patient stakeholders in selection of "decrease in work days missed" [44% (8/18) vs 5% (1/21), P = .006] and "decrease in emergency department/urgent care visits" [22% (4/18) vs 0% (0/21), P = .037] as most meaningful outcomes. CONCLUSIONS: The measures "decrease in migraine frequency" followed by "decrease in migraine severity" were identified as top priority migraine outcome measures.

How Effective Is Palliative Care in Improving Patient Outcomes?

OPINION STATEMENT: As palliative care (PC) continues its rapid growth, an emerging body of evidence is demonstrating that its approach of interdisciplinary supportive care benefits many patient populations, including in the oncology setting. As studies and data proliferate, however, questions persist about who, what, why, when, and how PC as well as the ideal time for a PC consult and length of involvement. When comparing outcomes from chemotherapy trials, it is important to consider the dosing regimens used in the various studies. In the same way, it is important to account for the "dose" of the PC interventions utilized across studies, and apples to apples comparisons are needed in order to draw accurate conclusions about PC's benefits. Studies which include a true interdisciplinary PC intervention consistently show improvements in patient quality of life, as well as cost savings, with further study needed for other outcomes. These benefits cannot be extrapolated to care which may be labeled "palliative care," but which does not meet the standard of true interdisciplinary PC. The ultimate question is: Does PC indeed improve outcomes?

Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial.

AIM: This study compared the cost-effectiveness of botulinum neurotoxin A (BoNT-A) injections with two-duct ligation of the submandibular glands as treatment for severe drooling after one treatment cycle. METHOD: The study was part of a larger, partly single-blinded, randomized clinical trial (trialregister.nl identifier NTR3537). Data were collected between 2012 and 2017. Evaluation was at 32 weeks after one treatment cycle. Fifty-seven patients with cerebral palsy or other neurological, non-progressive disorders and severe drooling classified as having a drooling frequency ≥3 or a drooling severity ≥2, in whom conservative treatment was deemed ineffective, were randomized to treatment by BoNT-A or two-duct ligation. An incremental cost-effectiveness ratio (ICER) was calculated using the success rates as the measure of benefit. Treatment success was defined as a decrease ≥50% from baseline to 32 weeks in the subjective visual analogue scale for the severity of drooling or the objective drooling quotient. RESULTS: Fifty-three patients were analysed (22 females, 31 males; mean age 11y, range 8-22y). Average costs for one treatment cycle, which included one BoNT-A injection, were €1929 (standard error 62) for BoNT-A and €3155 (standard error 99) for two-duct ligation. Treatment success was in favour of two-duct ligation (63% vs 27%; number needed to treat 3). The ICER was €34 per 1% gain in treatment success in favour of two-duct ligation versus BoNT-A. INTERPRETATION: The additional cost of two-duct ligation is to some extent offset by a larger treatment success rate compared with BoNT-A. WHAT THIS PAPER ADDS: Botulinum neurotoxin A (BoNT-A) is less expensive per percentage of success than two-duct ligation. The additional cost of two-duct ligation over BoNT-A is offset by greater treatment success.

Cost-benefit of outcome adjudication in nine randomised stroke trials.

BACKGROUND: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. METHODS: We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators' time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. RESULTS: The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). CONCLUSIONS: Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.

Cost-Utility Analysis of Electroconvulsive Therapy and Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Depression in Ontario.

OBJECTIVES: To evaluate the cost-effectiveness of repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT), and combining both treatments in a stepped care pathway for patients with treatment-resistant depression (TRD) in Ontario. METHODS: A cost-utility analysis evaluated the lifetime costs and benefits to society of rTMS and ECT as first-line treatments for TRD using a Markov model, which simulates the costs and health benefits of patients over their lifetime. Health states included acute treatment, maintenance treatment, remission, and severe depression. Treatment efficacy and health utility data were extracted and synthesized from randomized controlled trials and meta-analyses evaluating these techniques. Direct costing data were obtained from national and provincial costing databases. Indirect costs were derived from government records. Scenario, threshold, and probabilistic sensitivity analyses were performed to test robustness of the results. RESULTS: rTMS dominated ECT, as it was less costly and produced better health outcomes, measured in quality-adjusted life years (QALYs), in the base case scenario. rTMS patients gained an average of 0.96 additional QALYs (equivalent to approximately 1 year in perfect health) over their lifetime with costs that were $46,094 less than ECT. rTMS remained dominant in the majority of scenario and threshold analyses. However, results from scenarios in which the model's maximum lifetime allowance of rTMS treatment courses was substantially limited, the dominance of rTMS over ECT was attenuated. The scenario that showed the highest QALY gain (1.19) and the greatest cost-savings ($46,614) was when rTMS nonresponders switched to ECT. CONCLUSION: From a societal perspective utilizing a lifetime horizon, rTMS is a cost-effective first-line treatment option for TRD relative to ECT, as it is less expensive and produces better health outcomes. The reduced side effect profile and greater patient acceptability of rTMS that allow it to be administered more times than ECT in a patient's lifetime may contribute to its cost-effectiveness.

The Impact of Corporate Payments on Robotic Surgery Research: A Systematic Review.

OBJECTIVE: To quantify the influence of financial conflict of interest (COI) payments on the reporting of clinical results for robotic surgery. DATA SOURCES AND STUDY SELECTION: A systematic search (Ovid MEDLINE databases) was conducted (May 2017) to identify randomized controlled trials (RCTs) and observational studies comparing the efficacy of the da Vinci robot on clinical outcomes. Financial COI data for authors (per study) were determined using open payments database. MAIN OUTCOMES AND MEASURES: Primary outcomes assessed were receipt of financial COI payments and overall conclusion reported between robotic versus comparative approach. Quality/risk of bias was assessed using Newcastle-Ottawa Scale (NOS)/Cochrane risk of bias tool. Disclosure discrepancies were also analyzed. DATA EXTRACTION AND SYNTHESIS: Study characteristics, surgical subspecialty, methodological assessment, reporting of disclosure statements, and study findings dual abstracted. The association of the amount of financial support received as a predictor of reporting positive findings associated robotic surgery was assessed at various cut-offs of dollar amount received by receiver operating curve (ROC). RESULTS: Thirty-three studies were included, 9 RCTs and 24 observational studies. There was a median, 111 patients (range 10 to 6420) across studies. A little more than half (17/33) had a conclusion statement reporting positive results in support of robotic surgery, with 48% (16/33) reporting results not in favor [equivocal: 12/33 (36%), negative: 4/33 (12%)]. Nearly all (91%) studies had authors who received financial COI payments, with a median of $3364.46 per study (range $9 to $1,775,378.03). ROC curve demonstrated that studies receiving greater than $9557.31 (cutpoint) were more likely to report positive robotic surgery results (sensitivity: 0.65, specificity: 0.81, area under the curve: 0.73). Studies with financial COI payment greater than this amount were more likely to report beneficial outcomes with robotic surgery [(78.57% vs 31.58%, P = 0.013) with an odds ratio of 2.07 (confidence interval: 0.47-3.67; P = 0.011)]. Overall, studies were high quality/low risk of bias [median NOS: 8 (range 5 to 9)]; Cochrane risk: "low risk" (9/9, 100%)]. CONCLUSION AND RELEVANCE: Financial COI sponsorship appears to be associated with a higher likelihood of studies reporting a benefit of robotic surgery. Our findings suggest a dollar amount where financial payments influence reported clinical results, a concept that challenges the current guidelines, which do not account for the amount of COI funding received.

Children Learning About Secondhand Smoke (CLASS II): A Pilot Cluster Randomized Controlled Trial.

INTRODUCTION: Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children. METHODS: In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children's salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577. RESULTS: Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm-a mean difference of -1.31 ng/ml (95% CI = -2.86 to 0.24). CONCLUSION: It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials. IMPLICATIONS: In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children's exposure to SHS-an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.

A cost effectiveness analysis of maintenance cognitive stimulation therapy (MCST) for people with dementia: examining the influence of cognitive ability and living arrangements.

OBJECTIVES: Identify if cost-effectiveness of Maintenance Cognitive Simulation Therapy (MCST) differs by type of living arrangement and cognitive ability of the person with dementia. Next, a value of information analysis is performed to inform decisions about future research. METHODS: Incremental cost-effectiveness analysis applying seemingly unrelated regressions using data from a multicentre RCT of MCST versus treatment as usual in a population which had already received 7 weeks of CST for dementia (ISRCTN: 26286067). The findings from the cost-effectiveness analysis are used to inform a value of information analysis. RESULTS: The results are dependent upon how quality adjusted life years (QALYs) are measured. MCST might be cost-effective compared to standard treatment for those who live alone and those with higher levels of cognitive functioning. If a further RCT was to be conducted for this sub-group of the population, value of information analysis suggests a total sample of 48 complete cases for both sub-groups would be required for a two-arm trial. The expected net gain of conducting this future research is £920 million. CONCLUSION: Preliminary results suggest that MCST may be most cost-efficient for people with dementia who live alone and/or who have higher cognition. Future research in this area is needed.

A Systematic Review of Asynchronous, Provider-to-Provider, Electronic Consultation Services to Improve Access to Specialty Care Available Worldwide.

BACKGROUND: Electronic consultation (eConsult) is an asynchronous electronic communication tool allowing primary care providers to obtain a specialist consultant's expert opinion in a timely manner, thereby offering a potential solution to excessive wait times for specialist care, which remain a serious concern in many countries. INTRODUCTION: Our 2014 review of eConsult services demonstrated feasibility and high acceptability among patients and providers. However, gaps remain in knowledge regarding eConsult's impact on system costs and patient outcomes. MATERIALS AND METHODS: Following the PRISMA guidelines, we conducted a systematic review in May 2017 of English and French literature on OVID Medline, EMBASE, ERIC, and CINAHL databases, examining all studies on eConsult services published since our previous review. The Quadruple Aim Framework was used to synthesize outcomes. Articles reporting on the impact of eConsult on access, patient safety and satisfaction, utilization rates, clinical workflow, and continuing medical education were analyzed using a narrative synthesis approach. RESULTS: The initial search yielded 1,021 results, 50 of which were included on abstract and received a quality assessment and full text review. Of these, 43 were included in our final analysis. Results demonstrated the worldwide presence of eConsult services in North America and countries beyond, including Brazil, Australia, Spain, and The Netherlands. The breadth of specialty services offered has greatly expanded beyond dermatology and includes cardiology, nephrology, and hematology among others. Overall impact on access measures, acceptability, cost, and provider satisfaction remain positive. There is limited research on population health outcomes of morbidity and mortality. CONCLUSIONS: The availability of eConsult services has spread both geographically and in terms of specialty services offered. By allowing for a greater population to be served, access to care is being improved; however, long-term impact should continue to be assessed with a focus on patient safety, morbidity, mortality, and cost effectiveness metrics.

Interventions to Reduce Intraoperative Costs: A Systematic Review.

OBJECTIVE: The aim of this study was to systematically review the risks and benefits of interventions designed to reduce intraoperative costs. SUMMARY BACKGROUND DATA: Episode-based payments shift financial risk from insurers onto hospitals and providers. The operating room (OR) is a resource dense environment and there is growing interest in identifying ways to reduce intraoperative costs while maintaining patient safety. METHODS: We searched PubMed, Cochrane, and CINAHL for articles published between 2001 and March 2017 that assessed interventions designed to reduce intraoperative costs. We grouped interventions into 6 categories: standardization of instruments, switching to reusable instruments or removing instruments from trays, wound closure comparisons, cost feedback to surgeons, head-to-head instrument trials, and timely arrival of surgeon to the OR. RESULTS: Of 43 included studies, 12 were randomized trials and 31 were observational studies. Gross cost estimates ranged from -$413 (losses) to $3154 (savings) per operation, with only 2 studies reporting losses; however, studies had significant methodologic limitations related to cost data. Studies evaluating standardization and cost feedback were the most robust with estimated cost savings between $38 and $732/case, with no change in OR time, length of stay, or adverse events. CONCLUSIONS: Almost all studies assessing interventions to reduce intraoperative costs have demonstrated cost savings with no apparent increase in adverse effects. Methodologic limitations, especially related to cost data, weaken the reliability of these estimates for most intervention categories. However, hospitals seeking to reduce costs may be able to do so safely by standardizing operative instruments or providing cost feedback to surgeons.