Guo, Wudong2020-01-162020-01-162020-01-162019-10-17http://hdl.handle.net/10012/15492INTRODUCTION Given the challenge of addressing a growing non-communicable disease burden with limited health resources in developing countries, clinical pathways (CP) have been proposed as a strategy to optimize resource allocation in a climate of increasing healthcare costs. Ongoing reforms to China’s county-level public hospitals have generated an interest in developing evidence-based CP with a focus on controlling unreasonable medical costs, while at the same time raising the overall quality of healthcare services provided. An intervention project of evidence-informed CP on two selected disease areas (chronic obstructive pulmonary disease (COPD) and stroke) was conducted by China National Development Research Center (CNHDRC) in 2014. Since then, the implementation of CP project has received significant government interest, and has been seen as a model for replication across the country by the national health authority. However, the real impact of CP intervention in the short and long term is not yet clear. Therefore, an impact evaluation was considered necessary to identify the effectiveness and cost-effectiveness of implementing the CP in the pilot setting before being scaled up in other parts of the country and for other conditions. Stroke incidence has declined by over 40% in the past four decades in high-income countries, but over the same period, incidence has doubled in low and middle-income countries. Taking cerebral infarction (CI, a type of stroke) as an example, this study aims to understand the impact of the CP intervention on treatment effectiveness, and the use of resources in both short and long term. The study not only adds valuable evidence to the literature of CP management of CI, but also seeks to demonstrate the potential effectiveness and cost-effectiveness of CP intervention in the real setting of rural China taking into account contextually appropriate solutions to enable continuous improvement in intervention effectiveness. LITERATURE REVIEW A literature review focusing on effectiveness and cost-effectiveness of CP in management of in-hospital CI patients was undertaken by thesis author and a second reviewer, using a number of key databases (PubMed, Medline, Embase, Cochrane library and CINAHL) applying pre-defined keywords and subject headings. The Cochrane collaboration’s tool for assessing risk of bias was used to document the internal validity of individual studies. In addition, forest plots of selected outcomes across different studies were performed where heterogeneity was not judged to be a concern. Since there are high levels of variation in the nature of the disease and treatment depends greatly on local circumstances, the application of CP in management of in-hospital CI patients in the studies reviewed reveals conflicting evidence given the variety of settings studied, the diversity of aims, and variation in reporting outcomes. Some studies reported that the introduction of CP for a broad range of conditions can reduce the length of stay (LOS), in-patient complications, and total costs of acute hospital admissions while maintaining quality of care, improving patients’ outcomes, interdisciplinary cooperation and staff satisfaction. Conversely, there are studies reporting no or minimal measurable benefits regarding LOS, readmission to hospital, mortality rates and total costs, and no positive “return on investment”. Overall, the result of literature review does not provide a clear justification and firm conclusion for the implementation of CP for hospital-based CI management. A larger population scale study assessing the effectiveness and cost-effectiveness of CP is needed. METHODOLOGY The study analysis was performed using quantitative data collected from a pilot site-Hanbin county (in Shannxi province of China). First, descriptive statistics of the entire dataset and of selected subsets were provided, and data were examined to see if outcomes were distributed normally. Next, three major type of analysis were processed, namely: difference in difference (DID) after propensity score matching (PSM); interrupted time series (ITS); and Markov modeling. DID study design is commonly applied to evaluating observational data in order to address the problem of time-dependent trends in outcomes unrelated to the policy change, and PSM can balance the variation of patients’ characteristics using matching skills. ITS is an intuitive, practical and powerful analytical approach which is used here for evaluating longitudinal effectiveness of a time-limited intervention before and after a specific time point, using routinely collected longitudinal data. In terms of the ITS analysis, overall intervention effectiveness, based on a number of outcomes, was explored over a period covering 12 months before the intervention was introduced, and 36 months after the intervention was performed. For both the DID and ITS analysis, the primary outcomes of total hospitalization expenses and its components (medication expenses, radiology expenses, laboratory test expenses, diagnostic expenses and consultation expenses), LOS and utility value were analyzed. The Markov model is a routinely analytical tool in cost-effectiveness to simulate the disease trajectory and compare the relative costs and outcomes of an intervention against a relevant alternative. In this study, two Markov models were developed to identify the cost-effectiveness of CP management for patients admitted into hospital and discharged after CP management. Estimations of the incremental cost-effectiveness were generated, supported by comprehensive sensitivity analysis. Ethical approval was obtained from the University of Waterloo Research Ethics Committee (ORE#22396) for this research. RESULTS After several rounds of screening with specified selection criteria, 2,533 CI patients’ records were obtained and grouped into 4 subgroups. DID analyses result shows the impact of CP intervention is generally positive after removing potential confounding factors using PSM. Total hospitalization cost decreased, as did LOS, while European Quality of Life Scale-5 dimensions-3 Levels (EQ-5D-3L) based utility value increased. For ITS, the general tendency is similar for all primary outcomes. Results show that CP implementation slowed down the rate of increase of costs and LOS. However, most of the parameters were not statistically significant based on t-tests. For the Markov model-based cost-effectiveness analyses, the impact of CP intervention was observed to be not cost-effective in short term (21 days), but appeared to be cost-effective in long term (lifelong). For patients who are at stage of hospitalization, CP intervention of CI patients was not cost effective, and the ICER value was higher than the pre-defined threshold. However, the intervention of CP led to better health-related quality of life as indicated by higher utility value. For patients who are at the stable stage, namely being discharged by hospital, CP intervention of CI patients was the dominant strategy, whose ICER was much lower than the pre-defined threshold. In conclusion, combing both acute and stable stages, the CP intervention is cost-effective as ¥30,071.79/QALY with higher costs and Quality-adjusted life year (QALYs), comparing to the 1 time local GDP in 2014 (¥46,929.00/QALY). DISCUSSION In the literature, the application of hospital-based CP in management of acute stroke CI is associated with positive and negative effects, but this study reported more likely positive results in terms of selected primary outcomes and cost-effectiveness. The impact of the intervention could not only be attributed to the application of CP itself, but also its integration with awareness of standardized treatment among clinical practitioners, extensive training and support, and incentive management approaches. All these were combined with extensive stakeholder engagement given the ongoing China’s nationwide healthcare reform. It is clear and significant that the perceived importance of using evidence to inform practice has changed. But results of DID and ITS analysis should be regarded as provisional and a complex causal chain requires further investigation over a longer time period, with the collection of additional data. Development of the Markov model was a means to assess the long term effectiveness and cost-effectiveness of such a complex intervention to support evidence-based decision making. Much more can still be done in re-directing resources away from the county hospital sector towards community care in rural China. Further refinement is also possible using information technology innovations, including electronic pathways plug-ins into clinical decision support and patients’ health record systems, that can better monitor baseline activity and link compliance with preferred activities to appropriate reimbursement. The strength of the study is in applying statistical skills of DID, PSM, ITS and Markov model in analyzing the impact of CP effects. The limitation of the study is identifying confounding factors in explaining the casual chain between intervention and observed primary outcomes. CONCLUSION The evaluation findings and lessons learned from the pilot will be widely discussed and disseminated to policy-makers to enable evidence-based decision-making for CP implementation in China.enclinical pathwayscost-effectivenessacute strokeDoctoral Thesis