Impact of a protein-based assay that predicts prostate cancer aggressiveness on urologists' recommendations for active treatment or active surveillance: a randomized clinical utility trial.

BACKGROUND: Of the more than 1.1 million men diagnosed worldwide annually with prostate cancer, the majority have indolent tumors. Distinguishing between aggressive and indolent cancer is an important clinical challenge. The current approaches for assessing tumor aggressiveness are recognized as insufficient. A validated protein-based assay has been shown to predict tumor aggressiveness from prostate biopsy. The main objective of this study was to measure the clinical utility of this new assay in the management of early-stage prostate cancer. METHODS: One hundred twenty nine board-certified urologists were asked to participate in a randomized, two-arm experiment. We collected data over 2 rounds using simulated clinical cases administered via an online platform. The cases were all newly diagnosed Gleason 3 + 3 or 3 + 4 prostate camcer patients. Urologists in the intervention arm received a 15-min webinar on this protein-based assay and given assay test results for their simulated patients in round 2. Each case had a preferred recommendation of either active surveillance or active treatment. The measured outcome was rate of preferred recommendation, defined as urologists who recommended the proper treatment course. Analyses were done using difference-in-difference estimations. RESULTS: Using multinomial logistical regression, urologists who were given the assay results were significantly more likely to choose the preferred recommendation (active surveillance or active treatment) compared to controls (p = 0.004). These urologists were also significantly more likely to involve their patients in the treatment decision compared to controls (p = 0.001). CONCLUSIONS: By providing additional information to inform the physician's treatment plan, a protein-based assay shows demonstrable clinical utility confirmed through a rigorous randomized controlled study design and regression analyses to test for effects.

Do Health Reforms to Improve Quality Have Long-Term Effects? Results of a Follow-Up on a Randomized Policy Experiment in the Philippines.

We tracked doctors who had previously participated in a randomized policy experiment in the Philippines. The original experiment involved 30 district hospitals divided equally into one control site and two intervention sites that increased insurance payments (full insurance support for children under 5 years old) or made bonus payments to hospital staff. During the 3 years of the intervention, quality-as measured by clinical performance and value vignettes-improved and was sustained in both intervention sites compared with controls. Five years after the interventions were discontinued, we remeasured the quality of care of the doctors. We found that the intervention sites continued to have significantly higher quality compared with the control sites. The previously documented quality improvement in intervention sites appears to be sustained; moreover, it was subject to a very low (less than 1% per year) rate of decay in quality scores.

Variations and practice in the care of patients with rheumatoid arthritis: quality and cost of care.

INTRODUCTION: Variability in treatment is linked to lower quality of care and higher costs. Rheumatoid arthritis (RA) is a chronic inflammatory disease for which care and management may vary considerably among rheumatologists. The extent of this variability and its cost ramifications have not been widely studied. This prospective study evaluated the quality and variability in care and quantified the potential cost implications. METHODS: We used Clinical Performance and Value® vignettes to measure the quality of RA care among community-based rheumatologists. Three online Clinical Performance and Value® vignettes--representing patients likely seen in practice with mild disease activity (case A), worsening disease activity (case B), and stable disease with a complicating comorbidity (case C)--were administered to each rheumatologist. Responses were scored against evidence-based criteria. Costs were computed using current (2011) Medicare pricing. Data were analyzed using t test and fixed-effects analysis of variance. RESULTS: One hundred eight board-certified rheumatologists (72% were male; mean age, 49.1 years) completed the study. Overall quality scores averaged 61.3%. Those employed by a health system or in a multispecialty practice were more likely to score higher. Highest combined scores for diagnosis and treatment were evident with case A (61.7%) and lowest with case C (46.7%). Up to 79% of rheumatologists ordered at least 1 laboratory test that was considered unnecessary by study protocol criteria, incurring a mean excess cost of $37.85 per physician per case. Up to 26.9% rheumatologists prescribed biologic agents that were not indicated based on American College of Rheumatology treatment guidelines, resulting in additional costs of $2041 per patient per month. CONCLUSION: In this study, we observed a wide range of reported practice variability by rheumatologists in the management of RA. This included unnecessary testing and use of biologic agents that increased the costs of treatment. Opportunities for quality improvement and cost control exist in the management of RA.

Correction: Expansion of social protection is necessary towards zero catastrophic costs due to TB: The first national TB patient cost survey in the Philippines.

[This corrects the article DOI: 10.1371/journal.pone.0264689.].

Expansion of social protection is necessary towards zero catastrophic costs due to TB: The first national TB patient cost survey in the Philippines.

BACKGROUND: Tuberculosis (TB) is a disease associated with poverty. Moreover, a significant proportion of TB patients face a substantial financial burden before and during TB care. One of the top targets in the End TB strategy was to achieve zero catastrophic costs due to TB by 2020. To assess patient costs related to TB care and the proportion of TB-affected households that faced catastrophic costs, the Philippines National TB Programme (NTP) conducted a national TB patient cost survey in 2016-2017. METHODS: A cross-sectional survey of 1,912 TB patients taking treatment in health facilities engaged with the NTP. The sample consists of 786 drug-sensitive TB (DS-TB) patients in urban facilities, 806 DS-TB patients in rural facilities, and 320 drug-resistant TB (DR-TB) patients. Catastrophic cost due to TB is defined as total costs, consisting of direct medical and non-medical costs and indirect costs net of social assistance, exceeding 20% of annual household income. RESULTS: The overall mean total cost including pre- and post-diagnostic costs was US$601. The mean total cost was five times higher among DR-TB patients than DS-TB patients. Direct non-medical costs and income loss accounted for 42.7% and 40.4% of the total cost of TB, respectively. More than 40% of households had to rely on dissaving, taking loans, or selling their assets to cope with the costs. Overall, 42.4% (95% confidence interval (95% CI): 40.2-44.6) of TB-affected households faced catastrophic costs due to TB, and it was significantly higher among DR-TB patients (89.7%, 95%CI: 86.3-93.0). A TB enabler package, which 70% of DR-TB patients received, reduced catastrophic costs by 13.1 percentage points (89.7% to 76.6%) among DR-TB patients, but only by 0.4 percentage points (42.4% to 42.0%), overall. CONCLUSIONS: TB patients in the Philippines face a substantial financial burden due to TB despite free TB services provided by the National TB Programme. The TB enabler package mitigated catastrophic costs to some extent, but only for DR-TB patients. Enhancing the current social and welfare support through multisectoral collaboration is urgently required to achieve zero catastrophic costs due to TB.

Evidence of a causal link between health outcomes, insurance coverage, and a policy to expand access: experimental data from children in the Philippines.

In this paper, we present evidence on the health effects of a health insurance intervention targeted to poor children using data from a randomized policy experiment known as the Quality Improvement Demonstration Study. Among study participants, using a difference-in-difference regression model, we estimated a 9-12 and 4-9 percentage point reduction in the likelihood of wasting and having an infection, respectively, as measured by a common biomarker C-reactive Protein. Interestingly, these benefits were not apparent at the time of discharge; the beneficial health effects were manifest several weeks after release from the hospital.

Quality variation and its impact on costs and satisfaction: evidence from the QIDS study.

BACKGROUND: Improving the quality of inpatient hospital care is increasingly attainable in a variety of settings. However, the relationship between rising quality and costs is unclear; similarly the relationship between varying levels of quality and a patient's satisfaction remains poorly defined. METHODS: We use data from the Quality Improvement Demonstration Study (QIDS) based in 30 district hospitals in the Philippines. There were 974 children in the study; these children were cared for by 43 physicians. To measure quality of care, the physicians completed vignettes, a valid and inexpensive measure. Patient exit surveys were given to parents of children on the day of discharge, collecting information on services and hospital charges for the inpatient stay, payment sources for the hospitalization, and the Patient Satisfaction Survey (PSQ-18). RESULTS: We found a nonlinear relationship between quality and hospital charges: at low levels of quality improvements are linked to lower hospital charges. However, as quality improves further, these changes lead to higher charges. Higher quality also demonstrated a similar nonlinear relationship with patient satisfaction. CONCLUSIONS: The U-shaped association between quality and hospital charges suggests that targeting the lowest quality providers may decrease costs. The similar relationship between patient-reported satisfaction and quality improvement suggests that investments in quality will raise satisfaction, perhaps even when charges are increased.

The health and cost impact of care delay and the experimental impact of insurance on reducing delays.

OBJECTIVE: To examine whether delays in seeking care are associated with worse health outcomes or increased treatment costs in children, and then assess whether insurance coverage reduces these delays. STUDY DESIGN: We use data on 4070 children younger than 5 years from the Quality Improvement Demonstration Study, a randomized controlled experiment assessing the effects of increasing insurance coverage. We examined whether delay in care, defined as greater than 2 days between the onset of symptoms and admission to the study district hospitals, is associated with wasting or having positive C-reactive protein levels on discharge, and with total charge for hospital admission; we also evaluated whether increased benefit coverage and enrollment reduced the likelihood of delay. RESULTS: Delay is associated with 4.2% and 11.2% percentage point increases in the likelihood of wasting (P = .08) and having positive C-reactive protein levels (P = .03), respectively, at discharge. On average, hospitalization costs were 1.9% higher with delay (P = .04). Insurance intervention results in 5 additional children in 100 not delaying going to the hospital (P = .02). CONCLUSIONS: In this population, delayed care is associated with worse health outcomes and higher costs. Access to insurance reduced delays; thus insurance interventions may have positive effects on health outcomes.

An evaluation of the cost-effectiveness of policy navigators to improve access to care for the poor in the Philippines.

OBJECTIVES: Even when health insurance coverage is available, health policies may not be effective at increasing coverage among vulnerable populations. New approaches are needed to improve access to care. We experimentally introduced a novel intervention that uses Policy Navigators to increase health insurance enrollment in a poor population. METHODS: We used data from the Quality Improvement Demonstration Study (QIDS), a randomized experiment taking place at the district level in the Visayas region of the Philippines. In two arms of the study, we compared the effects of introducing Policy Navigators to controls. The Policy Navigators advocated for improved access to care by providing regular system-level expertise directly to the policy-makers, municipal mayors and governors responsible for paying for and enrolling poor households into the health insurance program. Using regression models, we compared levels of enrollment in our intervention versus control sites. We also assessed the cost-effectiveness of marginal increases in enrollment. RESULTS: We found that Policy Navigators improved enrollment in health insurance between 39% and 102% compared to the controls. Policy navigators were cost-effective at 0.86 USD per enrollee. However, supplementary national government campaigns, which were implemented to further increase coverage, attenuated normal enrollment efforts. CONCLUSION: Policy Navigators appear to be effective in improving access to care and their success underscores the importance of local-level strategies for improving enrollment.

Comparative effectiveness of two disparate policies on child health: experimental evidence from the Philippines.

BACKGROUND: Should health systems invest more in access to care by expanding insurance coverage or in health care services including improving the quality of care? Comparing these options experimentally would shed light on the impact and cost-effectiveness of these strategies. METHODS: The Quality Improvement Demonstration Study (QIDS) was a randomized policy experiment conducted across 30 districts in the Philippines. The study had a control group and two policy intervention groups intended to improve the health of young children. The demand-side intervention in QIDS was universal health insurance coverage (UHC) for children aged 5 years or younger, and a supply-side intervention, a pay-for-performance (P4P) bonus for all providers who met pre-determined quality levels. In this paper, we compare the impacts of these policies from the QIDS experiment on childhood wasting by calculating DALYs averted per US$spent. RESULTS: The direct per capita costs to implement UHC and P4P are US$4.08 and US$1.98 higher, respectively, compared to control. DALYs due to wasting were reduced by 334,862 in UHC and 1,073,185 in P4P. When adjustments are made for the efficiency of higher quality, the DALYS averted per US$ spent is similar in the two arms, 1.56 and 1.58 for UHC and P4P, respectively. Since the P4P quality improvements touches all patients seen by qualifying providers (32% in UHC versus 100% in P4P), there is a larger reduction in DALYs. With similar programmatic costs for either intervention, in this study, each US$spent under P4P yielded 1.52 DALYs averted compared to the standard program, while UHC yielded only a 0.50 DALY reduction. CONCLUSION: P4P had a greater impact and was more cost-effective compared to UHC as measured by DALYs averted. While expanded insurance benefit ceilings affected only those who are covered, P4P incentivizes practice quality improvement regardless of whether children are insured or uninsured.

Improving Clinical Practice Using a Novel Engagement Approach: Measurement, Benchmarking and Feedback, A Longitudinal Study.

BACKGROUND: Poor clinical outcomes are caused by multiple factors such as disease progression, patient behavior, and structural elements of care. One other important factor that affects outcome is the quality of care delivered by a provider at the bedside. Guidelines and pathways have been developed with the promise of advancing evidence-based practice. Yet, these alone have shown mixed results or fallen short in increasing adherence to quality of care. Thus, effective, novel tools are required for sustainable practice change and raising the quality of care. METHODS: The study focused on benchmarking and measuring variation and improving care quality for common types of breast cancer at four sites across the United States, using a set of 12 Clinical Performance and Value(®) (CPV(®)) vignettes per site. The vignettes simulated online cases that replicate a typical visit by a patient as the tool to engage breast cancer providers and to identify and assess variation in adherence to evidence-based practice guidelines and pathways. RESULTS: Following multiple rounds of CPV measurement, benchmarking and feedback, we found that scores had increased significantly between the baseline round and the final round (P < 0.001) overall and for all domains. By round 4 of the study, the overall score increased by 14% (P < 0.001), and the diagnosis with treatment plan domain had an increase of 12% (P < 0.001) versus baseline. CONCLUSION: We found that serially engaging breast cancer providers with a validated clinical practice engagement and measurement tool, the CPVs, markedly increased quality scores and adherence to clinical guidelines in the simulated patients. CPVs were able to measure differences in clinical skill improvement and detect how fast improvements were made.

Clinical Utility of a Comprehensive, Whole Genome CMA Testing Platform in Pediatrics: A Prospective Randomized Controlled Trial of Simulated Patients in Physician Practices.

BACKGROUND: Developmental disorders (DD), including autism spectrum disorder (ASD) and intellectual disability (ID), are a common group of clinical manifestations caused by a variety of genetic abnormalities. Genetic testing, including chromosomal microarray (CMA), plays an important role in diagnosing these conditions, but CMA can be limited by incomplete coverage of genetic abnormalities and lack of guidance for conditions rarely seen by treating physicians. METHODS: We conducted a longitudinal, randomized controlled trial investigating the impact of a higher resolution 2.8 million (MM) probe-CMA test on the quality of care delivered by practicing general pediatricians and specialists. To overcome the twin problems of finding an adequate sample size of multiple rare conditions and under/incorrect diagnoses, we used standardized simulated patients known as CPVs. Physicians, randomized into control and intervention groups, cared for the CPV pediatric patients with DD/ASD/ID. Care responses were scored against evidence-based criteria. In round one, participants could order diagnostic tests including existing CMA tests. In round two, intervention physicians could order the 2.8MM probe-CMA test. Outcome measures included overall quality of care and quality of the diagnosis and treatment plan. RESULTS: Physicians ordering CMA testing had 5.43% (p<0.001) higher overall quality scores than those who did not. Intervention physicians ordering the 2.8MM probe-CMA test had 7.20% (p<0.001) higher overall quality scores. Use of the 2.8MM probe-CMA test led to a 10.9% (p<0.001) improvement in the diagnosis and treatment score. Introduction of the 2.8MM probe-CMA test led to significant improvements in condition-specific interventions including an 8.3% (p = 0.04) improvement in evaluation and therapy for gross motor delays caused by Hunter syndrome, a 27.5% (p = 0.03) increase in early cognitive intervention for FOXG1-related disorder, and an 18.2% (p<0.001) improvement in referrals to child neurology for Dravet syndrome. CONCLUSION: Physician use of the 2.8MM probe-CMA test significantly improves overall quality as well as diagnosis and treatment quality for simulated cases of pediatric DD/ASD/ID patients, and delivers additional clinical utility over existing CMA tests.

Low Rates of Genetic Testing in Children With Developmental Delays, Intellectual Disability, and Autism Spectrum Disorders.

To explore the routine and effective use of genetic testing for patients with intellectual disability and developmental delay (ID/DD), we conducted a prospective, randomized observational study of 231 general pediatricians (40%) and specialists (60%), using simulated patients with 9 rare pediatric genetic illnesses. Participants cared for 3 randomly assigned simulated patients, and care responses were scored against explicit evidence-based criteria. Scores were calculated as a percentage of criteria completed. Care varied widely, with a median overall score of 44.7% and interquartile range of 36.6% to 53.7%. Diagnostic accuracy was low: 27.4% of physicians identified the correct primary diagnosis. Physicians ordered chromosomal microarray analysis in 55.7% of cases. Specific gene sequence testing was used in 1.4% to 30.3% of cases. This study demonstrates that genetic testing is underutilized, even for widely available tests. Further efforts to educate physicians on the clinical utility of genetic testing may improve diagnosis and care in these patients.

Understanding predictors of postdischarge deaths: a prospective evaluation of children 5 years and younger discharged from Philippine district hospitals.

BACKGROUND: Factors that increase likelihood of readmission or mortality postdischarge from diarrhea and pneumonia cases among children is less understood. METHODS: This study investigated the deaths of 24 children from a cohort of 3275. Using logistic regression, the authors compared data from those who survived with those who died to estimate the determinants of mortality in the study population. The authors also analyzed the hospital charts and completed mortality interviews with families of the deceased children. RESULTS: Poor quality of care significantly increased the likelihood of mortality. Sicker children, those born to less-educated mothers, and those who had longer lengths of stay also had a higher likelihood of mortality. Hospital charts corroborated findings from clinical vignettes. The mortality interviews revealed delays in seeking care from onset of symptoms. CONCLUSION: Quality of care contributes to postdischarge mortality and that clinical vignettes are an effective means to identify where quality can be improved.

Financial incentives and measurement improved physicians' quality of care in the Philippines.

The merits of using financial incentives to improve clinical quality have much appeal, yet few studies have rigorously assessed the potential benefits. The uncertainty surrounding assessments of quality can lead to poor policy decisions, possibly resulting in increased cost with little or no quality improvement, or missed opportunities to improve care. We conducted an experiment involving physicians in thirty Philippine hospitals that overcomes many of the limitations of previous studies. We measured clinical performance and then examined whether modest bonuses equal to about 5 percent of a physician's salary, as well as system-level incentives that increased compensation to hospitals and across groups of physicians, led to improvements in the quality of care. We found that both the bonus and system-level incentives improved scores in a quality measurement system used in our study by ten percentage points. Our findings suggest that when careful measurement is combined with the types of incentives we studied, there may be a larger impact on quality than previously recognized.

A novel method for measuring health care system performance: experience from QIDS in the Philippines.

OBJECTIVES: Measuring and monitoring health system performance is important albeit controversial. Technical, logistic and financial challenges are formidable. We introduced a system of measurement, which we call Q, to measure the quality of hospital clinical performance across a range of facilities. This paper describes how Q was developed, implemented in hospitals in the Philippines and how it compares with typical measures. METHODS: Q consists of measures of clinical performance, patient satisfaction and volume of physician services. We evaluate Q using experimental data from the Quality Improvement Demonstration Study (QIDS), a randomized policy experiment. We determined its responsiveness over time and to changes in structural measures such as staffing and supplies. We also examined the operational costs of implementing Q. RESULTS: Q was sustainable, minimally disruptive and readily grafted into existing routines in 30 hospitals in 10 provinces semi-annually for a period of 2(1/2) years. We found Q to be more responsive to immediate impacts of policy change than standard structural measures. The operational costs totalled USD2133 or USD305 per assessment per site. CONCLUSION: Q appears to be an achievable assessment tool that is a comprehensive and responsive measure of system level quality at a limited cost in resource-poor settings.

Underutilization of social insurance among the poor: evidence from the Philippines.

BACKGROUND: Many developing countries promote social health insurance as a means to eliminate unmet health needs. However, this strategy may be ineffective if there are barriers to fully utilizing insurance. METHODS: We analyzed the utilization of social health insurance in 30 hospital districts in the central regions of the Philippines between 2003 and 2007. Data for the study came from the Quality Improvement Demonstration Study (QIDS) and included detailed patient information from exit interviews of children under 5 years of age conducted in seven waves among public hospital districts located in the four central regions of the Philippines. These data were used to estimate and identify predictors of underutilization of insurance benefits--defined as the likelihood of not filing claims despite having legitimate insurance coverage--using logistic regression. RESULTS: Multivariate analyses using QIDS data from 2004 to 2007 reveal that underutilization averaged about 15% throughout the study period. Underutilization, however, declined over time. Among insured hospitalized children, increasing length of stay in the hospital and mother's education, were associated with less underutilization. Being in a QIDS intervention site was also associated with less underutilization and partially accounts for the downward trend in underutilization over time. DISCUSSION: The surprisingly high level of insurance underutilization by insured patients in the QIDS sites undermines the potentially positive impact of social health insurance on the health of the marginalized. In the Philippines, where the largest burden of health care spending falls on households, underutilization suggests ineffective distribution of public funds, failing to reach a significant proportion of households which are by and large poor. Interventions that improve benefit awareness may combat the problem of underutilization and should be the focus of further research in this area.