Protocol for estimating the willingness-to-pay-based value for a quality-adjusted life year to aid health technology assessment in India: a cross-sectional study.

INTRODUCTION: To ensure that the evidence generated by health technology assessment (HTA) is translated to policy, it is important to generate a threshold value against which the outcomes of HTA studies can be compared. In this context, the present study delineates the methods that will be deployed to estimate such a value for India. METHODS AND ANALYSIS: The proposed study will deploy a multistage sampling approach considering economic and health status for selection of states, followed by selection of districts based on Multidimensional Poverty Index (MPI) and identification of primary sampling units (PSUs) using the 30-cluster approach. Further, households within PSU will be identified using systematic random sampling and block randomisation based on gender will be done to select respondent from the household. A total of 5410 respondents will be interviewed for the study. The interview schedule will comprise of three sections including background questionnaire to elicit socioeconomic and demographic characteristics, followed by assessment of health gains, and willingness to pay (WTP). To assess the health gains and corresponding WTP, the respondent will be presented with hypothetical health states. Using time trade off method, the respondent will indicate the amount of time he/she is willing to give up at the end of life to avoid morbidities in the hypothetical health condition. Further, respondents will be interviewed about their WTP for treatment of respective hypothetical conditions using contingent valuation technique. These estimates of health gains and corresponding WTP will then be combined to ascertain the value of WTP per quality-adjusted life year. ETHICS AND DISSEMINATION: The ethical approval has been obtained from the Institutional Ethics Committee (IEC) of Postgraduate Institute of Medical Education and Research, Chandigarh, India. The study outcomes will be made available for general use and interpretation of HTA studies commissioned by India's central HTA Agency.

Development of an EQ-5D Value Set for India Using an Extended Design (DEVINE) Study: The Indian 5-Level Version EQ-5D Value Set.

OBJECTIVES: This study aimed to develop the Indian 5-level version EQ-5D (EQ-5D-5L) value set, which is a key input in health technology assessment for resource allocation in healthcare. METHODS: A cross-sectional survey using the EuroQol Group's Valuation Technology was undertaken in a representative sample of 3548 adult respondents, selected from 5 different states of India using a multistage stratified random sampling technique. The participants were interviewed using a computer-assisted personal interviewing technique. This study adopted a novel extended EuroQol Group's Valuation Technology design that included 18 blocks of 10 composite time trade-off (c-TTO) tasks, comprising 150 unique health states, and 36 blocks of 7 discrete choice experiment (DCE) tasks, comprising 252 DCE pairs. Different models were explored for their predictive performance. Hybrid modeling approach using both c-TTO and DCE data was used to estimate the value set. RESULTS: A total of 2409 interviews were included in the analysis. The hybrid heteroscedastic model with censoring at -1 combining c-TTO and DCE data yielded the most consistent results and was used for the generation of the value set. The predicted values for all 3125 health states ranged from -0.923 to 1. The preference values were most affected by the pain/discomfort dimension. CONCLUSIONS: This is the largest EQ-5D-5L valuation study conducted so far in the world. The Indian EQ-5D-5L value set will promote the effective conduct of health technology assessment studies in India, thereby generating credible evidence for efficient resource use in healthcare.

Experiences and challenges in accessing hospitalization in a government-funded health insurance scheme: Evidence from early implementation of Pradhan Mantri Jan Aarogya Yojana (PM-JAY) in India.

INTRODUCTION: Government-sponsored health insurance schemes can play an important role in improving the reach of healthcare services. Launched in 2018 in India, Pradhan Mantri Jan Aarogya Yojana (PM-JAY) is one of the world's largest government-sponsored health insurance schemes. The objective of this study is to understand beneficiaries' experience of availing healthcare services at the empaneled hospitals in PM-JAY. This study examines the responsiveness of PM-JAY by measuring the prompt attention in service delivery, and access to information by the beneficiaries; financial burden experienced by the beneficiaries; and beneficiary's satisfaction with the experience of hospitalization under PMJAY and its determinants. METHODS: The study was conducted during March-August 2019. Data were obtained through a survey conducted with 200 PM-JAY beneficiaries (or their caregivers) in the Indian states of Gujarat and Madhya Pradesh. The study population comprised of patients who received healthcare services at 14 study hospitals in April 2019. Prompt attention was measured in the form of a) effectiveness of helpdesk, and b) time taken at different stages of hospitalization and discharge events. Access to information by the beneficiaries was measured using the frequency and purpose of text messages and phone calls from the scheme authorities to the beneficiaries. The financial burden was measured in terms of the incidence and magnitude of out-of-pocket payments made by the beneficiaries separate from the cashless payment provided to hospitals by PMJAY. Beneficiaries' satisfaction was measured on a five-point Likert scale. RESULTS: Socio-economically weaker sections of the society are availing healthcare services under PM-JAY. In Gujarat, the majority of the beneficiaries were made aware of the scheme by the government official channels. In Madhya Pradesh, the majority of the beneficiaries got to know about the scheme from informal sources. For most of the elements of prompt attention, access to information, and beneficiaries' satisfaction, hospitals in Gujarat performed significantly better than the hospitals in Madhya Pradesh. Similarly, for most of the elements of prompt attention, access to information, and beneficiaries' satisfaction, public hospitals performed significantly better than private hospitals. Incidence and magnitude of out-of-pocket payments were significantly higher in Madhya Pradesh as compared to Gujarat, and in private hospitals as compared to the public hospitals. CONCLUSION: There is a need to focus on Information, Education, and Communication (IEC) activities for PM-JAY, especially in Madhya Pradesh. Capacity-building efforts need to be prioritized for private hospitals as compared to public hospitals, and for Madhya Pradesh as compared to Gujarat. There is a need to focus on enhancing the responsiveness of the scheme, and timely exchange of information with beneficiaries. There is also an urgent need for measures aimed at reducing the out-of-pocket payments made by the beneficiaries.

Improving hospital-based processes for effective implementation of Government funded health insurance schemes: evidence from early implementation of PM-JAY in India.

BACKGROUND: Government-sponsored health insurance schemes (GSHIS) aim to improve access to and utilization of healthcare services and offer financial protection to the population. India's Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY) is one such GSHIS. This paper aims to understand how the processes put in place to manage hospital-based transactions, from the time a beneficiary arrives at the hospital to discharge are being implemented in PM-JAY and how to improve them to strengthen the scheme's operation. METHODS: Guidelines were reviewed for the processes associated with hospital-based transactions, namely, beneficiary authentication, treatment package selection, preauthorization, discharge, and claims payments. Across 14 hospitals in Gujarat and Madhya Pradesh states, the above-mentioned processes were observed, and using a semi-structured interview guide fifty-three respondents were interviewed. The study was carried out from March 2019 to August 2019. RESULTS: Average turn-around time for claim reimbursement is two to six times higher than that proposed in guidelines and tender. As opposed to the guidelines, beneficiaries are incurring out-of-pocket expenditure while availing healthcare services. The training provided to the front-line workers is software-centric. Hospital-based processes are relatively more efficient in hospitals where frontline workers have a medical/paramedical/managerial background. CONCLUSIONS: There is a need to broaden capacity-building efforts from enabling frontline staff to operate the scheme's IT platform to developing the technical, managerial, and leadership skills required for them. At the hospital level, an empowered frontline worker is the key to efficient hospital-based processes. There is a need to streamline back-end processes to eliminate the causes for delay in the processing of claim payment requests. For policymakers, the most important and urgent need is to reduce out-of-pocket expenses. To that end, there is a need to both revisit and streamline the existing guidelines and ensure adherence to the guidelines.

Valuing health-related quality of life among the Indian population: a protocol for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study.

INTRODUCTION: Quality-adjusted life year (QALY) has been recommended by the government as preferred outcome measure for Health Technology Assessment (HTA) in India. As country-specific health-related quality of life tariff values are essential for accurate measurement of QALYs, the government of India has commissioned the present study. The aim of this paper is to describe the methods for the Development of an EQ-5D Value set for India using an Extended design (DEVINE) Study. Additionally, this study aspires to establish if the design of 10-time trade-off (TTO) blocks is enough to generate valid value sets. METHODS AND ANALYSIS: A cross-sectional survey using the EuroQol Group's Valuation Technology (EQ-VT) will be undertaken in a sample of 2700 respondents selected from six different states of India using a multistage stratified random sampling technique. The participants will be interviewed using computer-assisted personal interviewing technique. The TTO valuation will be done using 10 composite TTO (c-TTO) tasks and 7 discrete choice experiment (DCE) tasks. Hybrid modelling approach using both c-TTO and DCE data to estimate the potential value set will be applied. Values of all 3125 health states will be predicted using both the conventional EQ-VT design of 10 blocks of 10 TTO tasks, and an extended design of 18 blocks of 10 TTO tasks. The potential added value of the eight additional blocks in overall validity will be tested. The study will deliver value set for India and assess the adequacy of existing 10-blocks design to be able to correctly predict the values of all 3125 health states. ETHICS AND DISSEMINATION: The ethical approval has been obtained from Institutional Ethics Committee of PGIMER, Chandigarh, India. The anonymised EQ-5D-5L value set will be available for general use and in the HTAs commissioned by India's central HTA Agency.

Role of insurance in determining utilization of healthcare and financial risk protection in India.

BACKGROUND: Universal health coverage has become a policy goal in most developing economies. We assess the association of health insurance (HI) schemes in general, and RSBY (National Health Insurance Scheme) in particular, on extent and pattern of healthcare utilization. Secondly, we assess the relationship of HI and RSBY on out-of-pocket (OOP) expenditures and financial risk protection (FRP). METHODS: A cross-sectional study was undertaken to interview 62335 individuals among 12,134 households in 8 districts of three states in India i.e. Gujarat, Haryana and Uttar Pradesh (UP). Data on socio-demographic characteristics, assets, education, occupation, consumption expenditure, illness in last 15 days or hospitalization during last 365 days, treatment sought and its OOP expenditure was collected. We computed catastrophic health expenditures (CHE) as indicator for FRP. Hospitalization rate, choice of care provider and CHE were regressed to assess their association with insurance status and type of insurance scheme, after adjusting for other covariates. RESULTS: Mean OOP expenditures for outpatient care among insured and uninsured were INR 961 (USD 16) and INR 840 (USD 14); and INR 32573 (USD 543) and INR 24788 (USD 413) for an episode of hospitalization respectively. The prevalence of CHE for hospitalization was 28% and 26% among the insured and uninsured population respectively. No significant association was observed in multivariate analysis between hospitalization rate, choice of care provider or CHE with insurance status or RSBY in particular. CONCLUSION: Health insurance in its present form does not seem to provide requisite improvement in access to care or financial risk protection.

Inequity & burden of out-of-pocket health spending: District level evidences from India.

BACKGROUND & OBJECTIVES: Numerous studies have highlighted the regressive and immiserating impact of out-of-pocket (OOP) health spending in India. However, most of these studies have explored this issue at the national or up to the State level, with an associated risk of overlooking intra-State diversities in the health system and health-seeking behaviour and their implication on the financial burden of healthcare. This study was aimed to address this issue by analyzing district level diversities in inequity, financial burden and impoverishing impact of OOP health spending. METHODS: A household survey of 62,335 individuals from 12,134 households, covering eight districts across three States, namely Gujarat, Haryana and Rajasthan was conducted during 2014-2015. Other than general household characteristics, the survey collected information on household OOP [sum total of expenditure on doctor consultation, drugs, diagnostic tests etc. on inpatient depatment (IPD), outpatient depatment (OPD) or chronic ailments] and household monthly consumption expenditure [sum total of monthly expenditure on food, clothing, education, healthcare (OOP) and others]. Gini index of consumption expenditure, concentration index and Kakwani index (KI) of progressivity of OOP, catastrophic burden (at 20% threshold) and poverty impact (using district-level poverty thresholds) were computed, for these eight districts using the survey data. The concentration curve (of OOP expenditure) and Lorenz curve (of consumption expenditure) for the eight districts were also drawn. RESULTS: The distribution of OOP was found to be regressive in all the districts, with significant inter-district variations in equity parameters within a State (KI ranges from -0.062 to -0.353). Chhota Udepur, the only tribal district within the sample was found to have the most regressive distribution (KI of -0.353) of OOP. Furthermore, the economic burden of OOP was more pronounced among the rural sample (CB of 19.2% and IM of 8.9%) compared to the urban sample (CB of 9.4% and IM of 3.7%). INTERPRETATION & CONCLUSIONS: The results indicate that greater decentralized planning taking into account district-level health financing patterns could be an effective way to tackle inequity and financial vulnerability emerging out of OOP expenses on healthcare.

Out-of-Pocket Spending on Out-Patient Care in India: Assessment and Options Based on Results from a District Level Survey.

Out-of-pocket spending at out-patient departments (OPD) by households is relatively less analyzed compared to hospitalization expenses in India. This paper provides new evidence on the levels and drivers of expenditure on out-patient care, as well as choice of providers, using household survey data from 8 districts in 3 states of India. Results indicate that the economically vulnerable spend more on OPD as a proportion of per capita consumption expenditure, out-patient care remains overwhelmingly private and switches of providers-while not very prevalent-is mostly towards private providers. A key result is that choice of public providers tend to lower OPD spending significantly. It indicates that an improvement in the overall quality and accessibility of government facilities still remain an important tool that should be considered in the context of financial protection.

Diabetes knowledge and self-efficacy among rural women in Gujarat, India.

INTRODUCTION: Type II diabetes has risen dramatically among rural women in India, specifically in the states of Gujarat, Karnataka, Tamil Nadu and Uttar Pradesh. Recent studies suggest that rural Indian women's low level of self-efficacy, or confidence in their ability to carry out tasks, such as managing diabetes, is a key reason for this increase. Therefore, this study utilizes the Health Belief Model to analyze whether increased awareness of diabetes leads to a positive increase in levels of self-efficacy among diabetic women in two rural villages of Gujarat. METHODS: A cross-sectional study of 126 known cases of women with diabetes was carried out in the villages of Rajpur and Valam in the Mehsana District in the state of Gujarat, India, to assess the relationship between diabetes knowledge and self-efficacy. The instrument was adapted from the Michigan Diabetes Research and Training Center's Diabetes Empowerment Scale-Short Form and Knowledge, Attitudes and Practices Assessment of the Indian Institute of Public Health Gandhinagar. RESULTS: Participants' mean knowledge score was 10.77±2.86 out of a possible 24 points, for a mean percentage of 45%. The median self-efficacy score for the women was 7 with an interquartile range of 3. The age-adjusted multiple regression analysis demonstrated a significant positive correlation between knowledge and self-efficacy (p<0.001). CONCLUSIONS: The observations of this study suggest a positive correlation between diabetes knowledge and self-efficacy. Future diabetes educational interventions in India should place a greater emphasis on increasing knowledge among rural women. Specifically, these interventions should emphasize the major gaps in knowledge regarding causes of diabetes, complications and treatment procedures. Educational interventions that are catered more towards rural women will be critical for improving their self-efficacy.

Willingness to pay for health insurance among HIV-positive patients in India.

BACKGROUND: Standard health insurance products in India currently exclude conditions related to HIV. Although antiretroviral (ARV) drugs are now publicly funded, the burden of treatment due to hospitalization on people living with HIV and AIDS (PLHIV) continues to be high. Unlike many countries, India is yet to eliminate the exclusion clause in standard health insurance products. OBJECTIVE: The overall aim of this study was to understand if PLHIV would be willing to participate in and purchase commercial health insurance, if it were offered to them. METHODS: This study uses primary survey data to analyse the burden of treatment due to hospitalization and estimates the willingness to pay (WTP) for health insurance based on the contingent valuation approach. RESULTS: The average WTP per year was in the range of Indian rupee (R) 1,145-1,355 or $US20-24, with hospitalization and economic status significantly affecting the WTP. CONCLUSION: The findings of the study can serve as evidence for possible changes to policy on health insurance that would allow PLHIV to purchase health insurance.

Factors determining intention to quit tobacco: exploring patient responses visiting public health facilities in India.

INTRODUCTION: Intention to quit and setting a quit date are key steps in the process towards improving quit rates and are thus an integral part of tobacco cessation efforts. The present study examined various motivating factors of "intention to quit" and "setting a quit date" in patients visiting public health facilities in two states of India. METHODS: A total of 1569 tobacco-users visiting public health facilities in 12 districts of the states of Andhra Pradesh and Gujarat were assessed through an interviewer-administered questionnaire. Bivariate and multivariable logistic regression was performed to assess the effect of socio-demographic characteristics, nicotine dependence, previous quit attempts and motivational factors on "intention to quit within 30 days" and "setting a quit date". RESULTS: Only 12% of patients intended to quit tobacco within 30 days and about 11% of them were ready to set a quit date. Respondents aged above 25 years were 53% less likely to quit tobacco within 30 days when compared to those below 25 years (95% Confidence Intervals [CI]: 0.22 to 0.99). Smokeless tobacco users were associated with an odds ratio (OR) of 2.05 (95% CI: 1.15 to 3.65) for "setting a quit date" when compared to smokers. Those with 1 to 5 previous quit attempts (in the past twelve months) were associated with an OR of 2.2 (95% CI: 1.38 to 3.51) for "intention to quit" and 2.46 (95% CI: 1.52 to 3.96) for "setting a quit date". "Concern for personal health" and "setting an example for children" were associated with ORs of 3.42 (95% CI: 1.35 to 8.65) and 2.5 (95% CI: 1.03 to 6.03) respectively for "setting a quit date". CONCLUSIONS: This study is amongst the first in India to explore factors associated with the "intention to quit" and "setting a quit date" among patients visiting public health facilities. Our findings suggest that socio-economic and individual-level factors are important factors depicting intention to quit and setting a quit date. We recommend the need for well-defined studies to understand the long term effects of factors influencing tobacco cessation for patients visiting public health facilities in India.

Promoting universal financial protection: evidence from the Rashtriya Swasthya Bima Yojana (RSBY) in Gujarat, India.

BACKGROUND: India's health expenditure is met mostly by households through out-of-pocket (OOP) payments at the time of illness. To protect poor families, the Indian government launched a national health insurance scheme (RSBY). Those below the national poverty line (BPL) are eligible to join the RSBY. The premium is heavily subsidised by the government. The enrolled members receive a card and can avail of free hospitalisation care up to a maximum of US$ 600 per family per year. The hospitals are reimbursed by the insurance companies. The objective of our study was to analyse the extent to which RSBY contributes to universal health coverage by protecting families from making OOP payments. METHODS: A two-stage stratified sampling technique was used to identify eligible BPL families in Patan district of Gujarat, India. Initially, all 517 villages were listed and 78 were selected randomly. From each of these villages, 40 BPL households were randomly selected and a structured questionnaire was administered. Interviews and discussions were also conducted among key stakeholders. RESULTS: Our sample contained 2,920 households who had enrolled in the RSBY; most were from the poorer sections of society. The average hospital admission rate for the period 2010-2011 was 40/1,000 enrolled. Women, elderly and those belonging to the lowest caste had a higher hospitalisation rate. Forty four per cent of patients who had enrolled in RSBY and had used the RSBY card still faced OOP payments at the time of hospitalisation. The median OOP payment for the above patients was US$ 80 (interquartile range, $16-$200) and was similar in both government and private hospitals. Patients incurred OOP payments mainly because they were asked to purchase medicines and diagnostics, though the same were included in the benefit package. CONCLUSIONS: While the RSBY has managed to include the poor under its umbrella, it has provided only partial financial coverage. Nearly 60% of insured and admitted patients made OOP payments. We plea for better monitoring of the scheme and speculate that it is possible to enhance effective financial coverage of the RSBY if the nodal agency at state level would strengthen its stewardship and oversight functions.

The new patent regime and disease priorities in India.

The World Trade Organization (WTO) and Trade-Related Aspects of Intellectual Property Rights (TRIPS), which made product patents compulsory for countries to follow, meant that the entire market for generic drugs was out of bounds for manufacturing till the time the products went off-patent. The TRIPS has generated widespread discussions and debates around the costs and benefits of new patent regimes on countries such as India. This article analyses whether the post-WTO system was consistent with, and conducive to, improved public health in India. It is a first-of-its-kind effort in which the data on pharmaceutical patents applications were collected, collated, cleaned and classified according to IPC codes, to enable preliminary understanding of the nature and type of the applications. The patent applications that are filed in India are not found to be consistent with the disease burden of the country.

Third Angle of RSBY: Service Providers' Perspective to RSBY-operational Issues in Gujarat.

CONTEXT: Government of India in 2008, launched its flagship health insurance scheme for the poor. The Rashtriya Swasthya Bima Yojana (RSBY) combines cutting edge technology with an unusual reliance on incentives to provide inpatient insurance coverage. The scheme allows for cashless hospitalization services at any of the empaneled hospitals. Stakeholders in RSBY include members of the community, Insurance Company and the service provider. AIM: The study manuscript is an attempt to get an insight to understand the bottle necks in faced by the service providers with an overall goal to understand issues in complete roll out of RSBY and its successful implementation across country. It was conducted to undertake the stakeholder analysis and understand the service providers' perspective to RSBY. SETTING AND DESIGN: The present study was conducted in the Patan district of Gujarat state. Qualitative tool mainly in-depth interview of service providers of RSBY in Patan district of Gujarat state was utilized for the data collection. RESULTS AND CONCLUSION: Service providers opined an ineffective IEC around the utility of the RSBY service in the community. In spite of the claim that scheme relies heavily on technology to ensure paperless cashless services, on field, it was observed in the present study that the claim settlements are done through physical documents. The service providers had a perceived threat of being suspended from the list/de-empanelment of the provider by the insurance company. There is an urgent need for improved and effective IEC for the service and possibilities of an arrangement for to settle the case of grievances around suspensions ao that genuine hospitals can have fair deal as well. There definitely remains a greater and more serious role of government, which ranges from ownership to larger issue of governance.

The outcome of treating ESBL infections with carbapenems vs. non carbapenem antimicrobials.

BACKGROUND: In India where the prevalence of extended spectrum beta lactamase (ESBL) producing organisms among gram negative organisms is 60-70% and Ertapenem was unavailable at the beginning of this study, exclusive use of Group 2 Carbapenems (Imipenem and Meropenem) for treatment raises issues of cost and development of resistance. Therefore the role of non-Carbapenem alternatives, chiefly Betalactam + Betalactamase inhibitors (BL-BLI) was explored in this prospective observational study at a private tertiary care teaching hospital. PATIENTS AND METHODS: 522 consecutive in door patients from the period between June 2006 to March 2007and June 2008 to December 2008, who had true infections with ESBL producing organisms were enrolled in the study. Antimicrobials were prescribed or changed by the treating physicians on the basis of the nature and severity of infection, the susceptibility of the organism and the affordability of the patient. Patients who received a Carbapenem at any time during treatment were considered in the Carbapenem group. Those who never received a Carbapenem at any time during treatment were considered in the non-Carbapenem group. RESULTS: Of the 522 infections, 287 were urinary tract infections, 60 were skin structure infections, 60 were bacteremias, 55 were hospital acquired pneumonias, 31 were intra-abdominal infections and 29 were other infections. There were 351 E. coli, 119 K. pneumoniae, 23 K. oxytoca, 16 Enterobacter aerogenes, 5 Kozoanae, 4 Enterobacter agglomerans, 3 Citrobacter freundi, 1 E. cloacae, 1 Enterobacterspp. and 1 Morgenella morganii isolates. Clinical outcomes were available for 486 patients. 339 patients who were in the non-Carbapenem group and who might have had less serious infections had a clinical success rate of 79.6%. 147 patients who were in the Carbapenem group and who might have had more serious infections had a clinical success rate of 85.71%. CONCLUSIONS: It is possible to successfully treat at least the less serious infections due to ESBL producing gram negative organisms with non-Carbapenem antimicrobials. This will not compromise outcomes but will likely result in restricting the use of Carbapenems which may help preserve their efficacy against increasingly resistant organisms.

Serum concentrations of substance P in cholestasis.

Substance P (SP) is an excitatory neuropeptide that acts via the neurokinin-1 receptor (NK-1) in the nervous system. Pruritus, a complication of cholestasis, is a nociceptive stimulus; thus, we hypothesized that cholestasis would be associated with increased neurotransmission via SP as evidenced, in part, by increased serum concentrations of this neuropeptide. Accordingly, the aim of this study was to determine the serum concentration of SP in patients with pruritus secondary to cholestasis and in the serum of rats with cholestasis secondary to bile duct resection (BDR). The mean serum SP concentration of patients with chronic liver disease (CLD) and pruritus was 9.09 pg/mL SD +/- 6.5, significantly higher than 0.74 pg/mL SD +/- 0.77, the mean serum concentration of SP from patients with CLD without pruritus (p = 0.0001), and from that of the control group, which was 0.65 pg/mL SD +/- 0.37 (p = 0.0001). The mean serum SP concentration from six rats with cholestasis secondary to BDR six and fourteen days after surgery was 57.9 pg/mL, SD +/- 17.3, and 56.3 pg/mL, SD +/- 21.4, respectively, as compared to the concentration from the sham resected control group, which was 3.5 pg/mL SD +/- 0.59 (p = 0.002) at six days post surgery. In conclusion, in cholestasis, there is increased availability of SP. These data provide a rationale for the study of SP release and metabolism in cholestasis, and in the mediation of the pruritus.