Differences in health outcomes for high-need high-cost patients across high-income countries.

OBJECTIVE: This study explores variations in outcomes of care for two types of patient personas-an older frail person recovering from a hip fracture and a multimorbid older patient with congestive heart failure (CHF) and diabetes. DATA SOURCES: We used individual-level patient data from 11 health systems. STUDY DESIGN: We compared inpatient mortality, mortality, and readmission rates at 30, 90, and 365 days. For the hip fracture persona, we also calculated time to surgery. Outcomes were standardized by age and sex. DATA COLLECTION/EXTRACTION METHODS: Data was compiled by the International Collaborative on Costs, Outcomes and Needs in Care across 11 countries for the years 2016-2017 (or nearest): Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States. PRINCIPAL FINDINGS: The hip sample across ranged from 1859 patients in Aragon, Spain, to 42,849 in France. Mean age ranged from 81.2 in Switzerland to 84.7 in Australia, and the majority of hip patients across countries were female. The congestive heart failure (CHF) sample ranged from 742 patients in England to 21,803 in the United States. Mean age ranged from 77.2 in the United States to 80.3 in Sweden, and the majority of CHF patients were males. Average in-hospital mortality across countries was 4.1%. for the hip persona and 6.3% for the CHF persona. At the year mark, the mean mortality across all countries was 25.3% for the hip persona and 32.7% for CHF persona. Across both patient types, England reported the highest mortality at 1 year followed by the United States. Readmission rates for all periods were higher for the CHF persona than the hip persona. At 30 days, the average readmission rate for the hip persona was 13.8% and 27.6% for the CHF persona. CONCLUSION: Across 11 countries, there are meaningful differences in health system outcomes for two types of patients.

Mapping expanded prostate cancer index composite to EQ5D utilities to inform economic evaluations in prostate cancer: Secondary analysis of NRG/RTOG 0415.

PURPOSE: The Expanded Prostate Cancer Index Composite (EPIC) is the most commonly used patient reported outcome (PRO) tool in prostate cancer (PC) clinical trials, but health utilities associated with the different health states assessed with this tool are unknown, limiting our ability to perform cost-utility analyses. This study aimed to map EPIC tool to EuroQoL-5D-3L (EQ5D) to generate EQ5D health utilities. METHODS AND MATERIALS: This is a secondary analysis of a prospective, randomized non-inferiority clinical trial, conducted between 04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland. Eligible patients included men >18 years with a known diagnosis of low-risk PC. Patient HRQoL data were collected using EPIC and health utilities were obtained using EQ5D. Data were divided into an estimation sample (n = 765, 70%) and a validation sample (n = 327, 30%). The mapping algorithms that capture the relationship between the instruments were estimated using ordinary least squares (OLS), Tobit, and two-part models. Five-fold cross-validation (in-sample) was used to compare the predictive performance of the estimated models. Final models were selected based on root mean square error (RMSE). RESULTS: A total of 565 patients in the estimation sample had complete information on both EPIC and EQ5D questionnaires at baseline. Mean observed EQ5D utility was 0.90±0.13 (range: 0.28-1) with 55% of patients in full health. OLS models outperformed their counterpart Tobit and two-part models for all pre-determined model specifications. The best model fit was: "EQ5D utility = 0.248541 + 0.000748*(Urinary Function) + 0.001134*(Urinary Bother) + 0.000968*(Hormonal Function) + 0.004404*(Hormonal Bother)- 0.376487*(Zubrod) + 0.003562*(Urinary Function*Zubrod)"; RMSE was 0.10462. CONCLUSIONS: This is the first study to identify a comprehensive set of mapping algorithms to generate EQ5D utilities from EPIC domain/ sub-domain scores. The study results will help estimate quality-adjusted life-years in PC economic evaluations.

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.

The use of genomic tests in patients with breast cancer in Lombardy: a successful healthcare model.

BACKGROUND: The accurate identification of patients with early breast cancer (eBC) suitable for adjuvant chemotherapy is essential in order to avoid overtreatment or undertreatment. For eBC patients with luminal (HR+/HER2-) intermediate risk disease, multigene assays (MGAs) have been convincingly reported to be useful in guiding treatment decisions. The most recently published data and recommendations from main International Guidelines and Heath Technology Assessment reports confirmed the benefit of MGAs in guiding treatment decisions for clinically intermediate risk patients, and led several countries to test reimbursement. PURPOSE: This article describes the process followed by the Lombardy region in Italy regarding the reimbursement of MGAs for patients with eBC, based on the results of a prospective clinical trial. RESULTS: The study shows that the use of Oncotype DX allowed avoiding the use of unnecessary adjuvant chemotherapy in 50% of patients for whom chemotherapy was initially recommended according to traditional clinical practice. On the basis of these data, a group of oncologists in collaboration with a pathologist regional board formally requested authorization for MGA reimbursement in Lombardy. Acknowledging the strategic importance of the proposal, the Lombardy region approved the reimbursement of MGAs for resident patients with luminal eBC at intermediate clinical risk. It can be assumed that about 1500 patients will be tested in Lombardy per year and this should allow the Regional Health Service to save more than 750 chemotherapies/year. CONCLUSION: The introduction of MGAs in the clinical evaluation of patients with luminal eBC with intermediate risk is economically sustainable and contributes towards preserving quality of life of eligible women.

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.

Analysis of 102 Fully Robotic Pancreaticoduodenectomies: Clinical and Financial Outcomes.

OBJECTIVES: The value of robotic pancreaticoduodenectomy (RPD) remains undefined. The aim of this retrospective study was to compare and assess clinical outcomes and financial variables of patients undergoing RPD versus open pancreaticoduodenectomy (OPD) at a single high-volume center. METHODS: The study design is a retrospective analysis of a prospectively maintained database of consecutive PD patients from 2013 to 2019. Clinical variables and total hospital charges were evaluated as an unadjusted and adjusted intention-to-treat analysis. RESULTS: A total of 156 patients (54 OPD, 102 RPD) were identified. In the RPD group, patients were significantly older (P = 0.0304) and had shorter length of stay (mean, 7 vs 11.8 days; P < 0.0001) and longer operative times (mean, 352.7 vs 211.5 minutes; P < 0.0001) compared with OPD. There was no significant difference in 90-day readmissions, bleeding, or complications between OPD and RPD. Adjusted charge analyses show no difference in total charges (P = 0.057). CONCLUSIONS: Robotic pancreaticoduodenectomy is safe, feasible, and valid alternative to OPD. Because of comparable results within each group, randomized trials may be indicated. High-volume RPD centers should collaborate to better understand the differences and advantages over laparoscopic or OPD.

Cost-Effectiveness Analysis of Xpert MTB/RIF for Multi-Outcomes of Patients With Presumptive Pulmonary Tuberculosis in Thailand.

OBJECTIVES: The cost-effectiveness of screening adult patients for pulmonary tuberculosis is not clear. As such, this study aims to identify the cost-effectiveness between the Xpert MTB/RIF assay and the sputum acid-fast bacilli (AFB) smear. Multi-outcomes were correct diagnosis, time to achieve correct diagnosis, and gain in quality-adjusted life-years (QALYs). METHODS: A decision tree model was constructed to reveal a possible clinical pathway of tuberculosis diagnosis. The researchers used a clinical study to establish the probability of all clinical pathways for input into this model. The sample size was calculated following the correct diagnosis. Participants were randomly divided into 2 groups. A structural questionnaire and the Thai version of quality of life (EQ-5D-5L) were used for interviewing. RESULTS: The results showed that the time to achieve the correct diagnosis for the group using Xpert MTB/RIF was shorter than that for the group using the sputum AFB smear. Both the correct diagnosis and QALYs of the base case analysis presented the Xpert MTB/RIF method as dominant. A Monte Carlo model, which analyzed the Xpert MTB/RIF method, revealed that the average number of patients who were correctly diagnosed was 673, the QALYs were 945.85 years, and the total cost was $143 110.64. For the sputum AFB smear method, the average number who received a correct diagnosis was 592, the QALYs were 940.40 years, and the total cost was $196 666.84. Probabilistic and one-way sensitivity analysis confirmed that the Xpert MTB/RIF remained dominant. CONCLUSIONS: These results provide useful information for the National Strategic Plan to screen all adult patients for pulmonary tuberculosis.

Cost-effectiveness Applications of Patient-reported Outcome Measures (PROMs) in Spine Surgery.

Because of the rising health care costs in the United States, there has been a focus on value-based care and improving the cost-effectiveness of surgical procedures. Patient-reported outcome measures (PROMs) can not only give physicians and health care providers immediate feedback on the well-being of the patients but also be used to assess health and determine outcomes for surgical research purposes. Recently, PROMs have become a prominent tool to assess the cost-effectiveness of spine surgery by calculating the improvement in quality-adjusted life years (QALY). The cost of a procedure per QALY gained is an essential metric to determine cost-effectiveness in universal health care systems. Common patient-reported outcome questionnaires to calculate QALY include the EuroQol-5 dimensions, the SF-36, and the SF-12. On the basis of the health-related quality of life outcomes, the cost-effectiveness of various spine surgeries can be determined, such as cervical fusions, lumbar fusions, microdiscectomies. As the United States attempts to reduce costs and emphasize value-based care, PROMs may serve a critical role in spine surgery moving forward. In addition, PROM-driven QALYs may be used to analyze novel spine surgical techniques for value-based improvements.

Efficacy, patient-doctor relationship, costs and benefits of utilizing telepsychiatry for the management of post-traumatic stress disorder (PTSD): a systematic review

Abstract Introduction Post-traumatic stress disorder (PTSD) is one of the most common psychiatric disorders found among victims of disaster, kidnapping, accidents, sexual assaults and war in Indonesia. However, lacking and unequal distribution of psychiatric medical personnel remains a barrier to its management. This review aims to introduce and evaluate the potential contribution of telepsychiatry to the management of PTSD based on published literature. Methods Original studies were obtained from PubMed, Science Direct, ProQuest, High Wire, and Elsevier Clinical Key databases. Results A total of 125 articles were found, of which 15 articles (12 randomized controlled trials, 2 open trials and 1 pilot study) fulfilled the inclusion criteria. A total of 991 subjects were found with a follow-up period ranging between 5 weeks and 18 months. Telepsychiatry is an innovative use of technology to aid the delivery of PTSD treatments in areas difficult to reach. The quality of care given by telepsychiatry both through video conferencing as well as web- and application-based is comparable to that of face-to-face therapy. Patient satisfaction, quality of doctor-patient relationship also remains high, with lower costs and shorter therapeutic time when compared to face-to-face therapy. Conclusion Various studies have shown that telepsychiatry is an effective solution for the management of PTSD. Studies have also reported that the quality of treatment through telepsychiatry is as effective as face-to-face therapy, with greater efficiency. Countries, especially those with a low patient-to-mental health professional ratio, should be encouraged to develop telepsychiatry systems to manage PTSD.

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-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.

Health outcomes, utility and costs of returning incidental results from genomic sequencing in a Canadian cancer population: protocol for a mixed-methods randomised controlled trial.

INTRODUCTION: Genomic sequencing has rapidly transitioned into clinical practice, improving diagnosis and treatment options for patients with hereditary disorders. However, large-scale implementation of genomic sequencing faces challenges, especially with regard to the return of incidental results, which refer to genetic variants uncovered during testing that are unrelated to the primary disease under investigation, but of potential clinical significance. High-quality evidence evaluating health outcomes and costs of receiving incidental results is critical for the adoption of genomic sequencing into clinical care and to understand the unintended consequences of adoption of genomic sequencing. We aim to evaluate the health outcomes and costs of receiving incidental results for patients undergoing genomic sequencing. METHODS AND ANALYSIS: We will compare health outcomes and costs of receiving, versus not receiving, incidental results for adult patients with cancer undergoing genomic sequencing in a mixed-methods randomised controlled trial. Two hundred and sixty patients who have previously undergone first or second-tier genetic testing for cancer and received uninformative results will be recruited from familial cancer clinics in Toronto, Ontario. Participants in both arms will receive cancer-related results. Participants in the intervention arm have the option to receive incidental results. Our primary outcome is psychological distress at 2 weeks following return of results. Secondary outcomes include behavioural consequences, clinical and personal utility assessed over the 12 months after results are returned and health service use and costs at 12 months and 5 years. A subset of participants and providers will complete qualitative interviews about utility of incidental results. ETHICS AND DISSEMINATION: This study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System that provides ethical review and oversight for multiple sites participating in the same clinical trial in Ontario.Results from the trial will be shared through stakeholder workshops, national and international conferences, and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03597165.

Expanding Access to Home-Based Palliative Care: A Randomized Controlled Trial Protocol.

Introduction: Studies show that home-based palliative care (HBPC) improves participant outcomes and satisfaction with care while also decreasing hospitalizations and emergency department visits. U.S. health care payment reforms create financial opportunities to offer HBPC. Consequently, more HBPC programs are emerging, heightening the need to evaluate their effectiveness. Methods: This randomized, controlled trial is comparing the effectiveness of an evidence-based model of HBPC and enhanced usual primary care for participants who receive primary care from medical groups and clinics organized under an accountable care organization or Medicare Advantage plan. Palliative care services are reimbursed by our partnering health plan provider. The five-year trial will enroll 1155 seriously ill participants (and ∼884 of their caregivers) with heart failure, chronic obstructive pulmonary disease, or advanced cancer. We are collecting data via telephone surveys with participants at baseline and one and two months postenrollment and with caregivers at baseline, one and two months postenrollments, and following the death of a loved one. We are collecting participant-reported outcome measures of pain, symptoms, anxiety, depression, participant-provider communication, and hope. Caregiver outcome measures include caregiver burden, communication with providers, anxiety, and depression. Additional outcomes are participant survival time and participants' emergency department visits and hospitalizations. Study Implementation: Challenges and Contributions: Our research team has encountered several significant challenges in early study implementation. These include engaging primary care providers in the study and coordinating logistics with a health plan. Both challenges have contributed to a lag in participant enrollment. Despite these challenges, our study holds tremendous promise to accelerate adoption and spread of an evidence-based HBPC model across the country.

Treatment Patterns and Clinical and Economic Outcomes in Patients With Newly Diagnosed Multiple Myeloma Treated With Lenalidomide- and/or Bortezomib-containing Regimens Without Stem Cell Transplant in a Real-world Setting.

BACKGROUND: Real-world data in patients with newly diagnosed multiple myeloma (NDMM) are sparse. Using United States claims databases, we analyzed treatment patterns, clinical outcomes, and health care utilization and costs in patients receiving lenalidomide- and/or bortezomib-containing therapy. MATERIALS AND METHODS: Patient claims were obtained from a large commercial and Medicare database (October 2009 to May 2015). Patients with NDMM who received lenalidomide- and/or bortezomib-containing therapy and did not receive stem cell transplant (SCT) were analyzed. Duration of treatment (DOT), time to next treatment (TTNT), and health care utilization and costs were evaluated. RESULTS: Of 3075 patients, 1767 received doublet therapy (814 lenalidomide-dexamethasone [Rd], 953 bortezomib-dexamethasone [Vd]) and 464 received triplet therapy (318 lenalidomide-bortezomib-dexamethasone [RVd], 146 cyclophosphamide-bortezomib-dexamethasone [CyBord]). Rd versus Vd resulted in longer median DOT (12.0 vs. 5.9 months; P < .0001) and median TTNT (36.7 vs. 24.4 months; P = .0005). Year 1 costs were greater with Rd versus Vd (Δ = $14,964; P = .0009), primarily owing to higher pharmacy costs; outpatient physician visits and chemotherapy administration costs were lower. Median DOT (14.8 vs. 9.0 months; P < .0001) and median TTNT (35.7 vs. 22.3 months; P = .0007) were longer with RVd versus CyBord; year 1 costs were comparable. CONCLUSIONS: In this study of patients with NDMM ineligible for transplant, the median duration of therapy was approximately 70% of that in clinical trial observations. Lenalidomide therapy versus Vd and CyBord resulted in longer DOT, which correlated with longer TTNT, and higher pharmacy costs, which were partially offset by lower outpatient and chemotherapy administration costs.

Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany.

Aim: This study evaluated the occurrence and associated costs of pacemaker complications in Germany from 2010 to 2013. Patients & methods: Patients with a de novo or replacement implantation of a single or dual chamber pacemaker between 2010 and 2013 were followed for 12 months post-implant using German health insurance claims data. A case-control analysis was performed using propensity score matching to estimate the costs of complications. Results: Out of 12,922 implanted patients, 12.0% had a complication in the year following the implant. Complications related to lead and pocket were found in 10.2% of all implanted patients; infections occurred in 1.7% patients. Healthcare costs up to 36 months post complication were on average €4627 higher than for pacemaker patients without a complication. Conclusion: Pacemaker complications are common and represent a burden for patients and healthcare systems generating substantial costs. Most of the pacemaker complications involved the pacing lead or pacemaker pocket.

Implications of the introduction of new criteria for the diagnosis of gestational diabetes: a health outcome and cost of care analysis.

OBJECTIVE: To identify effects on health outcomes from implementing new criteria diagnosing gestational diabetes mellitus(GDM) and to analyse costs-of-care associated with this change. DESIGN: Quasi-experimental study comparing data from the calendar year before (2014) and after (2016) the change. SETTING: Single, tertiary-level, university-affiliated, maternity hospital. PARTICIPANTS: All women giving birth in the hospital, excluding those with pre-existing diabetes or multiple pregnancy. MAIN OUTCOME MEASURES: Primary outcomes were caesarean section, birth weight >90th percentile for gestation, hypertensive disorder of pregnancy and preterm birth less than 37 weeks. A number of secondary outcomes reported to be associated with GDM were also analysed.Care packages were derived for those without GDM, diet-controlled GDM and GDM requiring insulin. The institutional Business Reporting Unit data for average occasions of service, pharmacy schedule for the costs of consumables and medications, and Medicare Benefits Schedule ultrasound services were used for costing each package. All costs were estimated in figures from the end of 2016 negating the need to adjust for Consumer Price Index increases. RESULTS: There was an increase in annual incidence of GDM of 74% without overall improvements in primary health outcomes. This incurred a net cost increase of AUD$560 093. Babies of women with GDM had lower rates of neonatal hypoglycaemia and special care nursery admissions after the change, suggesting a milder spectrum of disease. CONCLUSION: New criteria for the diagnosis of GDM have increased the incidence of GDM and the overall cost of GDM care. Without obvious changes in short-term outcomes, validation over other systems of diagnosis may require longer term studies in cohorts using universal screening and treatment under these criteria.

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.