Their independence is essential because the university provides knowledge not only to its students, but also to the public agency in need of expert guidance and the general society in need of greater knowledge;... these latter clients have a stake in disinterested professional opinion, stated without fear or favor, which the institution is morally required to respect.” — American Association of University Professors Public skepticism about the timeliness, accuracy, and completeness of reporting clinical trial results has never been more pervasive. The topic continues to attract attention from the media and the United States Congress ,3. Recenhttp://www.clinicaltrials.gov . It is essential that the P&A committee be independent of the sponsor's control, have access to the full data set, understand and implement the prespecified analysis plan, and have the resources and skills both to interpret that analysis and perform additional analysis if required. In order to prevent any appearance of undue influence by the sponsor, the P&A committee should contain a majority of participating, non-sponsor-employed investigators, with appropriate skills in analysis and interpretation of clinical trials. The P&A committee and the steering committee may have the same membership.11. The P&A committee in multisite clinical trials , through a qualified expert of its choosing, preferably a member of that committee, should have the right to access any data generated during the study that the committee deems necessary to ensure the integrity and validity of the study and its full reporting.12. The P&A committee in multisite clinical trials  should require that the sponsor of the study perform its analysis of trial data in a defined period of time. The committee (or PI) should be able to conduct its own analysis through an expert selected by it, to the extent it deems this necessary. Whenever feasible, the expert should be agreed upon by the P&A committee and the sponsor.13. The sponsor should share with the P&A committee all analyses called for by the study that the sponsor conducts of any biological materials it receives during the course of the study.14. The P&A committee or PI should make a good faith effort to disseminate the results of the study through peer reviewed mechanisms.only after review and comment by the P&A committee and only after publication of the study as a whole, or, in the absence of acceptance of the full publication, within 2 years from the specified end points or earlier termination of the study.15. Site-specific publications in multisite trials have an unavoidable potential for bias. Because they are almost never part of the original analytic plan, they are often misleading, and should be strongly discouraged. However, to respect an academic institution's commitment to academic freedom, site-specific analyses should nonetheless be permitted with conditions. Accordingly, an individual site investigator in a multisite trial should be free to analyze and publish data from the individual site, consistent with sound principles of science and analysis, but 16. Ghost or guest authorship is unacceptable. Authorship implies independent, substantial, and fully disclosed participation in the study and in the preparation of the manuscript. It is acceptable for employees of the sponsor to participate in drafting and publication activity, but only if their roles are fully disclosed.17. Institutions conducting clinical trials should adopt as policy the standards of authorship defined by the ICMJE.18. Where applicable, investigators should use the CONSORT principles ,30 as gu19. Investigators should fully disclose, and journals should publish, the existence of all relevant financial interests, including consultancies of any investigator, in all communications of trial results.20. Any manuscript submitted for publication should accurately disclose the role of each author in conducting the study and preparing the manuscript. Such information should also be disclosed in any public presentation of study results, to the extent practicable.21. Manuscripts submitted for publication should disclose all previous publications involving the same protocol or database.22. Manuscripts submitted for publication should be accompanied by the protocol and pre-specified analysis plan and all dated amendments to them, and any deviations to the pre-specified plan should be identified and discussed.There is growing public skepticism about the accuracy and completeness of reporting of clinical trial results.Academic medical institutions and their faculty often play leading roles in performing and reporting clinical trials.Clinical research in humans can only be justified ethically when it leads to generalizable knowledge, which means results should be disclosed.AAMC has developed principles for conducting and reporting clinical research that ensure to investigators full right of independent access to and analysis of the underlying data.The principles aim to ensure that the conduct and reporting of clinical research conform to the highest standards of scientific and ethical integrity.For the biopharmaceutical industry, widely publicized concerns about “dry pipelines” , expirinFor academic investigators eager to participate in industry-sponsored trials to help create new medical knowledge and advance their own professional development and for their healthcare institutions that find hosting such trials important marketing assets, the universities' efforts to protect academic freedom often lead to protracted negotiations over the fine language of clinical trials contracts, and the process breeds discouragement, cynicism, and frustration in all parties. And, of course, the patients who might wish to participate in the trials are the ultimate victims of these clashing institutional interests.Notwithstanding these formidable impediments, we are optimistic that the principles outlined here will be adopted widely across the professional community as expressions of long-endorsed values and practices. We also hope they will be championed by patients, potential research participants, and their advocacy groups, for whom this effort to strengthen the integrity and credibility of clinical trials results and the evidentiary base of medical practice can only be beneficial.Both industry and academia have been punished in the last decade by harsh publicity and congressional rebukes over revelations of questionable (or worse) practices in conducting and reporting clinical research, hidden financial conflicts of interest, and tragic clinical research mishaps. Both sectors may welcome the opportunity to reaffirm more confidently that their partnership in clinical research, so vital for translating scientific advancements into better health care and improved public health, is “principled, protective of research subjects, and capable of withstanding intense public scrutiny” . We argu


New and explosive HIV epidemics are being witnessed in certain countries of Eastern Europe, including Ukraine, as well as a rapid and dramatic increase in the supply, use, and negative public health consequences of illicit drugs. A majority of registered HIV cases in Ukraine occur among injection drug users (IDUs), large numbers of whom report HIV risk behaviors such as needle sharing. The purpose of this study was to apply the World Health Organization's Rapid Assessment and Response on Injection Drug Use (IDU-RAR) guide to create a situational picture in the Vinnitsya Oblast, Ukraine, a region with very scarce information about the HIV/AIDS and injection drug use (IDU) epidemics.The IDU-RAR uses a combination of qualitative data collection techniques commonly employed in social science and evaluation research to quickly depict the extent and nature of the given health problem and propose locally relevant recommendations for improvement. The investigators focused their assessment on the contextual factors, drug use, and intervention and policy components of the IDU-RAR. A combination of network and block sampling techniques was used. Data collection methods included direct observation, review of existing data, structured and unstructured interviews, and focus group discussions. Key informants and locations were visited until no new information was being generated.The number of registered HIV cases in Vinnitsya has increased from 3 (1987–1995) to 860 (1999–10/2004), 57 of whom have already died. Ten percent of annual admissions to the area's Regional Narcological Dispensary were for opiate disorders, and the number of registered IDUs rose by 20% from 1999 to 2000. The level of HIV/AIDS awareness is generally poor among the general population but high among high-risk populations. Both HIV/AIDS and injection drug use carry a strong stigma in the community, even among medical professionals. There was very little evidence of primary HIV/AIDS prevention efforts, and IDU prevention efforts focused on promotion of anti-drug messages in the schools.Given that Ukraine has sparse resources to be devoted to this problem, action recommendations should be prioritized, realistic, and initially targeted to persons in greatest need. The following action recommendations are prioritized by the following categories: First priority: Voluntary Counseling and Testing; Second Priority: Prevention and Education; and Third Priority: Harm Reduction and Treatment. They are provided in this sequence based on what response can realistically be implemented first with limited additional resources and can make the greatest immediate impact. The persons at greatest risk, HIV positive persons and IDUs, should be attended to first. New and explosive HIV epidemics are being witnessed in certain countries of Eastern Europe: Russia, Moldova, Belarus, and Ukraine -6. AccorPolitical independence in Ukraine and surrounding Eastern European countries in the 1990s has been associated with a rapid and dramatic increase in the supply, use, and negative public health consequences of illicit drugs -10,16. WThe majority of reported HIV infections in Ukraine were diagnosed in IDUs from 1987 to 2004 ,15. A toThe proportion of total cases acquiring HIV through opiate IDU in certain areas of Ukraine dropped from 72.7% in 1997 to 56.7% in 2004, suggesting expansion of the epidemic to the general population . Data inAt the time of this study, information about the HIV epidemic came mainly from the most heavily affected Ukrainian cities, such as Odessa, Kharkiv, and Mykolaiv . The attThis project builds on a successful three-year joint collaboration between public health, HIV/AIDS, and drug addiction researchers and clinicians from the University of Alabama at Birmingham (UAB), The Regional Narcological Dispensary (RND) in Vinnitsya, Ukraine , and the Vinnitsya National Pirogov Medical University (PMU). This collaboration was initiated by the UAB John J. Sparkman Center for International Public Health Education and an International Clinical, Operational and Health Services Research and Training Award (ICOHRTA) awarded by the National Institutes of Health Fogarty International Center to UAB in 2001.The fieldwork phase of this study was completed from May through July of 2001.This study utilized rapid assessment and response (RAR) methodology developed by the World Health Organization (WHO) in 1998. The RAR method uses a combination of qualitative data collection techniques commonly employed in social science and evaluation research to quickly depict the extent and nature of the given health problem and propose locally relevant recommendations for improvement. One of the key principles of RAR is that data are collected from different sources, which allows continuous examination of the reliability and consistency of the data and enables investigators to make better informed decisions about what evidence should be sought in the next stage of the assessment. RAR is designed to rapidly assess a current problem situation (e.g. IDU) in a community. This information is then used to make informed decisions about the development of interventions needed to reduce the adverse health and social consequences of the targeted condition. The WHO Rapid Assessment and Response guide on injection drug use (IDU-RAR) , includiDue to limited financial resources and a short time frame, we directed our focus to three areas of the IDU-RAR when assessing the IDU situation: Contextual Assessment, Drug Use Assessment, and Intervention and Policy Assessment. The Contextual Assessment identifies factors that influence the current and potential situations regarding drug injection and its adverse health consequences, as well as opportunities for the development of interventions. Key areas for assessment include factors for spread of IDU, exacerbation versus amelioration of adverse health consequences of injecting, and factors that are likely to hinder or enable the development of interventions. The Drug Use Assessment focuses on the nature and extent of drug use – who is injecting drugs and where this occurs, as well as trends in injection drug use over time. Finally, the Intervention and Policy Assessment is designed to assess existing interventions and policy responses aimed at reducing drug use and its consequences while allowing the assessment team to examine their effectiveness and develop recommendations. Our study also included an assessment of the HIV/AIDS situation, which incorporated the nature and extent of the epidemic, HIV/AIDS awareness, attitudes toward individuals living with HIV/AIDS, and existing prevention/control measures.As a first step of the rapid assessment, the principal investigator met with key collaborators in Vinnitsya to assemble an assessment team and identify key informants. Immediately following the initial consultation, a conceptual map of the Vinnitsya community was developed. The map captured key locations for the needs assessment including major gathering points for IDUs, areas where drugs are sold, needle exchange sites, treatment facilities, transportation routes, and other key locations. The investigator traveled to all key locations to develop a physical map, noting activities that would help to provide some insight into the nature of IDU.network and block sampling techniques was used. The network sampling method involved a chain of referrals initiated by the key informants. All key informants were asked to provide a list of individuals who would be able to offer additional information on a given area of the needs assessment. These individuals were then contacted for further information and asked to provide another list of informants. This approach was used until no new information was being generated. The block sampling technique was similar to the networking sampling, but instead of using key informants as the starting point, the needs assessment team traveled to key locations (identified by the mapping exercise) to identify new informants. As an example, the leading investigator frequently traveled to a local market in the Vishinka district (identified as a gathering point for IDUs) to develop rapport with IDUs and gain access to new informants who would be willing to provide information on the IDU situation in Vinnitsya.In order to create a representative sample of informants, a combination of Data were collected using a combination of rapid assessment methods, including direct observation, review of existing data , structured and unstructured interviews, and focus group discussions. An important component of the needs assessment was the triangulation of information, or cross-checking of collected data through the multiple sources. This allowed for collection of more representative data with higher confidence in its accuracy.The first occurrences of HIV infection in the Vinnitsya region were officially registered with the Sanitation and Epidemiological Service between 1987 and 1995. At this point, only 3 HIV infections were registered. By 1996, the number of new HIV infections rose to 46 , including the first officially registered AIDS case. Between 1999 and 2001, there was a sharp increase in the number of new HIV infections in the region (at approximately 130%) that brought the total number of HIV infections to 431. At the end of 2001, a total of 112 new HIV infections, 26 AIDS cases, and 17 AIDS-related deaths were recorded for the Vinnitsya region. The regional Sanitation and Epidemiological Service statistics for the year 2001 revealed that the largest proportion of HIV infections occurred through injection drug use , followed by sexual transmission . Individuals in the 20–29 age group accounted for the largest proportion of HIV infections (69.6 %). Within this age group, the male to female ratio was 3 to 1. The most heavily affected areas within the Vinnitsya Oblast were Gaisyn, Ladyzhyn, and the city of Vinnitsya with 29.5%, 20.5%, 15.1% of the total number of new HIV infections in 2001 respectively. By October 2004, there were 783 cases of HIV infection and 57 AIDS deaths registered in Vinnitsya Oblast. In 2004 for the first time heterosexual route of transmission has prevailed with 54.1% of newly registered cases .Information gathered from NGOs and local researchers suggests similar trends. However, accurate prevalence rates at the present time are difficult to assess due to lack of testing resources and fear and mistrust among those who may be at risk of having HIV/AIDS.Data collected through personal interviews with key informants and focus group discussions suggest that residents of Vinnitsya have heard of HIV/AIDS, but the level of knowledge and perception of risk vary among different groups. A focus group discussion with students from local universities in Vinnitsya revealed that young people in the community were likely to perceive HIV/AIDS as something that is found exclusively in the West and thus is not a real threat to their community. Many of the students were surprised to learn that HIV cases were reported in Vinnitsya and admitted that they were not as well informed about the disease as they needed to be. Discussions with IDU at a needle exchange program in the Vishenka District, on the other hand, revealed a much different outlook on the HIV/AIDS situation. These individuals were well aware of the presence of HIV in the community, and some even knew someone who had already contracted the virus. They felt that they were well informed about HIV/AIDS and how to protect themselves against the virus. Interviews with Vinnitsya city service providers and representatives from local NGOs confirmed that the level of HIV/AIDS awareness among high-risk populations was high. The same level of HIV/AIDS awareness, however, did not appear to extend to the rural communities. According to information from rural health providers working with IDUs, many of their patients lacked information about HIV/AIDS and did not perceive themselves as being at risk. A director of a government program focusing on the social welfare of youth in the Vinnitsya region also attested to low HIV/AIDS awareness among young adults in the rural communities.Vinnitsya residents living with HIV face a great deal of stigma and lack a widespread support system within their community. According to infectious disease treatment providers at a local hospital in Vinnitsya, HIV positive patients tend to stay secluded and often are very concerned that other people not learn about their infection. It is not unlikely for someone diagnosed with HIV infection to seek treatment and consultation with a physician during evening hours or at other times when they would be less likely to be seen by other people at the medical facility. Though many physicians seemed compassionate toward HIV positive patients , direct observations and interviews with medical staff revealed that HIV positive individuals were stigmatized within treatment facilities. Test results that were to be kept confidential were openly shared in patient charts, and HIV patients were placed in isolation blocks. Interviews with nurses and other clinical staff revealed that some of the staff were reluctant to treat HIV infected patients. HIV positive patients at a local narcological dispensary stayed in an isolation block consisting of a small single-bed patient room, a nurse's cabinet, and a small waiting area. Anyone in the facility could easily determine who was staying in the isolation block and why he or she was there (as the restricted area was clearly labeled). It was not until recently (at the time of writing this paper) that the isolation block was discontinued and persons diagnosed with HIV/AIDS mainstreamed into the hospital.Aside from counseling provided by some physicians who work with HIV-positive patients, there was very little evidence of routine counseling and follow-up for individuals who are tested for HIV. An important concern expressed by a physician at a hospital-based HIV/AIDS center was the lack of a support system that would allow patients diagnosed with HIV to speak openly about their condition and gain more information on living with the virus.Prevention activities found in the area were classified according to the three categories: primary (prevention of occurrence), secondary (diagnostics and treatment), and tertiary (minimization of adverse consequences). With the exception of a school-based educational program and some media efforts, there was very little evidence of primary HIV/AIDS prevention. The school-based program, organized by a local NGO, was implemented at only one of the 40 local elementary schools. The program (modeled after the American Project Hope) utilized innovative educational methods, through which children took part in skill building exercises (including self-efficacy building) and learned through peer-education. This program, however, did not have a built-in evaluation or measures to ensure sustainability. The local media were known to disseminate HIV/AIDS information through newspaper articles, but none of the information concentrated on the prevention of HIV/AIDS. At the time of the study, Peace Corps volunteers based in Vinnitsya were planning to develop and implement an HIV/AIDS education program through UNAIDS-Kyiv, which would serve as a great opportunity to create more educational programs at local schools in Vinnitsya and surrounding rural areas.Primary prevention efforts carried out by a local NGOs reached out to high-risk populations, including commercial sex workers and IDUs, in the city of Vinnitsya and surrounding smaller cities. Outreach workers at needle/syringe exchange sites distributed condoms and information about HIV/AIDS and other sexually transmitted diseases. Educational booklets included information on safer sex practices and where to go for treatment. IDUs participating in the needle-exchange program were referred to a local hospital that had a special hepatitis and HIV/AIDS center within its facility. Some referrals to substance abuse treatment also were made. The program provided opportunities for HIV, HBV, and HCV testing free of charge. This effort, however, was fully funded through a time-bound grant, and it was not clear whether it would be sustained.The AIDS Center at the local hospital provided HIV infected individuals with necessary medical attention and some counseling services and linked them with other sources of information. There were limited resources, however, for secondary prevention activities, such as screening, analysis, and HIV/AIDS disease monitoring. Availability of antiretroviral therapy was limited due to high cost. Patients had to make arrangements to buy their own medications. This situation was likely to change with the Ukrainian government's intention to provide subsidized antiretroviral therapy in the near future, supported by the grant from the Global Fund. The AIDS Center also worked closely with local NGOs to recruit individuals from high-risk populations for testing and treatment.During the Soviet era, IDU was largely hidden and mostly limited to individuals from wealthy families. The drugs that were consumed during that time usually included "clean" drugs such as morphine and heroin. Substance abuse treatment providers who treated patients during the Soviet era indicated that the nature of drug use in Vinnitsya has changed dramatically over the past decade. In the years following Ukraine's independence, drug use has increased rapidly and shifted from purer, more expensive drugs to drugs that can be made at home. According to recovering IDUs from a local church, raw materials became easily accessible, and preparation procedures were passed around like cooking recipes. One especially potent amphetamine-like injectible drug, commonly referred to as "vint," was prepared using readily available chemicals that could be purchased at drug stores and local pharmacies. Though this particular recipe came at a price, IDUs could easily learn how to prepare a homemade opiate solution ("hanka" or "shirka") from their peers.Individuals who were new to IDU could purchase ready-filled syringes or small medicine containers with the opiate solution at a local market. According to informants at a market in the Vishinka District of Vinnitsya city, drug dealers (often IDUs themselves) were able to do their business there without getting much attention from law enforcement while having good access to new customers. An inexperienced person might be invited to the dealer's apartment or a nearby garage, as attested by social workers at a local needle exchange program, where the dealer would help him or her to inject the drug.There were no reliable epidemiological studies available to estimate the prevalence rates of opiate IDU in Vinnitsya and surrounding areas. Ten percent of the annual admissions to the area's only RND for drug and alcohol treatment were diagnosed with opiate disorders, but the actual prevalence rate in Vinnitsya was estimated to be more than ten times that figure or 2,000 persons with opiate disorders . Dr. Slobodyenyuk also reported that the number of registered IDUs from rural areas during the year 2000 rose by 20% from the previous year. According to reports from the regional Sanitation and Epidemiology Service, rural areas were the most heavily affected in terms of opiate IDU and reportedly include the regions of Koziatyn, Zhmerynka, Trostyanets, Ladyzhyn and Illinitsi, as well as various small towns such as Hnivan and Vapniarka.hanka quickly became a prosperous business. The drug production was not difficult, the raw material was grown in the area, and the demand for opiates was increasing. The cultivation of poppies has been part of the Ukrainian culture for many generations. Consequently, there was fairly easy access to poppies in the Vinnitsya region, especially in the rural areas. IDUs were able to gather poppy straws directly from the fields or purchase them from babushkas (grannies) at the local market. A 1-ml dose of hanka sold for about 5.00 grivnas (about $0.95 US) during the poppy season and for about 8.00 grivnas (about $1.50 US) out of season according to local IDUs. Selling a liter of hanka in a day allowed one to make more than ten times the income an average person makes in a month.Results from this study indicated a combination of numerous factors that encouraged the spread of opiate IDU, including Ukraine's economic situation, social changes following the country's independence, easy access to poppy plants, and lack of knowledge. As Ukraine transitioned from the old (i.e. Soviet) system, many people were left without jobs or ones that pay on average US $30–50 a month as revealed by community informants. The sale of There did not appear to be a single driving force behind the increase in drug use among young adults. Discussions with IDUs at local treatment facilities and needle exchange programs revealed that people turn to drugs for different reasons. Some people sold drugs to make money while others were drawn to use IDU out of boredom, curiosity, or an attempt to be part of a social circle. As graduates from universities and technical colleges, young adults often had to travel to larger cities to find employment. When they first arrived they would try to find a social circle and a place to belong. This was how many people were introduced to people who inject drugs, according to IDUs and substance abuse treatment providers. They would then introduce their friends to IDU upon returning home and consequently form small IDU communities. Furthermore, the consumption of alcohol is a very important part of the Ukrainian culture. With the economic situation under strain, people turned to alcohol to escape the harsh realities of everyday life. IDU is slowly becoming the mechanism of abuse among young people who wished to do the same. Though information collected through different sources did not contradict this observation, more research is needed to confirm that there is indeed an association between alcohol use and illicit drug use.Another important factor that was indicated as a possible facilitator of drug use, and one that should also be explored through further research, is the changing social environment among school-aged children. As the economy began to crumble, many parents were forced to take on additional jobs to compensate for low income. Their children were under less supervision, and some community representatives speculate that they became more vulnerable to exploring drugs. Extracurricular activities such as sports and various special interest clubs were free-of-charge during the Soviet era. Following the fall of the Soviet Union, however, local schools no longer had the necessary financial resources to sponsor extracurricular activities, and thus children were left with more free time and less to do. These are factors that may play a role in the increasing IDU epidemic. However, more research is needed in this area.While young people from the Vinnitsya community were exposed to various forms of pro-drug messages  on practically a daily basis, the effort to counteract the influence of these messages by informing the public about the dangerous consequences of substance abuse was minimal. Aside from the recent implementation of school-based anti-drug programs and a special radio program that reaches out to the Vinnitsya city residents, there was very little evidence of anti-drug propaganda . Furthermore, not much was said about the association between alcohol abuse and HIV/AIDS. This was especially true in the rural areas, where the information was needed the most.The promotion of anti-drug messages in schools tended to be the most favored primary prevention approach toward controlling the spread of IDU in this area. The RND has been active in launching several school-based anti-drug prevention programs in all 40 local schools in Vinnitsya, as well as schools in the surrounding areas. Most schools and teachers were surprisingly open to this type of intervention. Students were also quite open and interested in the topics presented and actively asked and answered questions. These programs, however, did not appear to be carried out to their fullest potential. They were not theory-based or standardized in their delivery. The focus of the sessions was primarily on IDU and excluded more common substances such as tobacco and alcohol. The programs were mostly didactic with no experiential components. Teaching materials and information were not always age appropriate, and there were no hand-out materials or resources to obtain help or further information about drug abuse. Furthermore, the programs did not have a built-in evaluation system.st–4th grades self-efficacy skills  through fairy tales, games, and various fun activities. Teachers also were provided with guides on how to conduct interactive sessions and ideas on how to get parents involved. Older children were encouraged to participate in a voluntary Children's Club, in which children taught each other about the negative consequences of drug, alcohol and tobacco use and sexual activity, as well as sexually transmitted diseases. This program, however, was being implemented at only one school in the Vinnitsya area, and no information on its efficacy has been presented.Another school-based primary prevention program implemented by a local NGO, titled Project Hope, was modeled after a project that started in the United States and has been implemented in many areas around the world – including Moscow and three Ukrainian cities . The goal of the program was to teach children in 1The local media also were involved in primary prevention. The public radio aired a special program on drugs, during which various substance-abuse specialists talked about the consequences of drug abuse and how to deal with addiction. The program also included individuals who had personal experience with substance abuse and were willing to share their story with others. The goal of the program was to provide people with the necessary information to encourage young people not to take drugs or encourage individuals who use drugs to seek treatment. The local newspaper also has created a special section with information about drug use . Most of this information, however, was limited to individuals who live in Vinnitsya and did not reach the rural areas, where the information also was needed.In the area of tertiary IDU prevention, a local NGO has been carrying out a needle/syringe exchange program (NEP/SEP) at various sites in the Vinnitsya area over the past three years. There were two NEP/SEP sites in Vinnitsya, as well as sites in Kalynovka, Ladyzhyn, Zhmerynka, and Haysin, with one being planned for Kaziatin. IDUs in the area were able to exchange used needles and syringes for new, sterile needles and syringes at no cost. The goal of the program was to reduce the potential harm of IDU by reaching out to individuals who put themselves at risk for physical injuries, nerve damage, and infection with sexually transmitted diseases and various blood-borne viruses including HIV, Hepatitis B and Hepatitis C. Educational booklets distributed included information on safer injection practices (to avoid serious injuries such as nerve damage), safer sex practices, and information on where to go for treatment.Though the authorities have supported harm reduction programs such as this, needle exchange was not yet fully accepted within the community. There was still some doubt as to the effectiveness of such a program, and there was even some suspicion that NEP/SEP served as a place to purchase drugs. According to the social workers from the Vyshenka District NEP, the local police had been suspicious that the social workers were involved in the drug trade. The police had been known to send in undercover agents, for instance, to see whether they could purchase drugs or poppy straws from the social workers. The program was advertised through "word of mouth" due to the stigma placed on IDUs. There tended to be a lack of coordination between the NGO and other organizations in the community, all of which would help to make the program more effective. No empirical information on the effectiveness of this program has been presented to the research or local community over the three years of program operation.The RND  is the only facility for the diagnostics and medical treatment of alcohol and drug related disorders in Vinnitsya. Located in the south Leninsky district, it is staffed by medical doctors, psychologists, social workers, and nurses. It also carries out the expert assessment of substance use disorders for local road police and the criminal justice system and provides educational lectures to local and rural elementary schools. There were more 24 thousand persons "registered" as patients of the RND. The patient population was primarily male and approximately 60 percent from the city of Vinnitsya and 40 percent from rural areas. Most patients were being treated for alcohol-related disorders. Only 10 percent were opiate IDUs, despite the increasing demand for treatment of this problem. Treatment was organized into three stages: medical, psychotherapy, and rehabilitation. Primary emphasis was placed on medical treatment.Though the RND is a public health facility, the government covers only a small portion of the total cost of treatment, which barely covers staff salaries. Treatment in public institutions is considered free, which means that patients do not pay any hospital or physician charges. However, since the breakdown of the Soviet system, the state budget does not make provisions for medication. Consequently, patients were responsible for covering the cost of medicines and various medical supplies, which usually added up to about 150 grivnas ($28) for the minimum length of stay – an amount that exceeded some people's monthly salary. The RND provided treatment primarily for the patients' physical dependency  with very little aftercare, and it was plausibly reported that many patients have short remission times and return to alcohol or drug abuse just a few months following the completion of the treatment. Each patient is recommended to follow up with a psychologist or a regional narcologist after discharge; however no monitoring system is in place, which prevents valid outcome assessment. According to the treatment providers' personal experience, very few patients do see their psychologist or narcologist before the next full-blown relapse. Factors that may hinder the effectiveness of the treatment include: high cost and short length of treatment, lack of evidenced-based interventions, lack of outpatient treatment and drug use monitoring, and absence of narcotic substitution medication therapies. There are essentially no eligibility criteria for admission; any resident of Vinnitsya oblast could enter the RND if diagnosed with a substance use disorder. High costs of medication and little faith in the efficacy of available treatment among potential patients further decrease the attractiveness of drug treatment in Vinnitsya.There was a great amount of prejudice toward IDUs both within the community and among medical professionals that presented another barrier to the effective treatment of IDUs. Interviews with medical practitioners revealed discriminatory attitudes toward IDUs. They were perceived to be criminals and/or individuals who lack moral values. Furthermore, IDUs were not the most "liked" patients, even at the RND, where patients with alcohol dependency were said to get preferential treatment. Alcohol dependency may be more acceptable due to the strong cultural role of alcohol in this society. Some medical professionals viewed IDUs as "hopeless cases" or as individuals who are "impossible to treat." It is commonly believed that IDUs generally were not willing to change their lifestyle and came for treatment only in order to lower their tolerance level (as it becomes too expensive for them to inject) or avoid a prison sentence. Furthermore, some health professionals explained that IDUs are so mentally disturbed (due to brain damage) that they are no longer receptive to any treatment. Direct observations at the treatment center revealed that it was not unlikely to see a physician on duty refuse treatment to HIV positive IDUs and send them to another facility . The director and staff of the RND, however, were highly compassionate and motivated to improve the state of treatment services for alcohol and drug related disorders at the RND.A response designed to positively impact mortality and morbidity associated with HIV and IDU in this part of the world must be swift and comprehensive. Given that Ukraine has sparse resources to be devoted to this problem, action recommendations should be prioritized, realistic, and initially targeted to persons in greatest need. The following action recommendations are prioritized by the following categories: First priority: Voluntary Counseling and Testing; Second Priority: Prevention and Education; and Third Priority: Harm Reduction and Treatment. They are provided in this sequence based on what response can realistically be implemented first with limited additional resources and can make the greatest immediate impact. The persons at greatest risk, HIV positive persons and IDUs, should be attended to first.The existing ICOHRTA has a four-year history of training health care providers, medical students, and drug addiction specialists and has a relationship with existing agencies capable of responding to the HIV and IDU epidemic. As such, we recommend using the resources and staff of ICOHRTA for initiating and sustaining the implementation of the following priorities. IROHRTA resources and staff can link in-country stakeholders with educational materials, risk assessments, skill building protocols, and evidence-based prevention and intervention protocols, training. They also can offer assistance with writing grants to procure funds for HIV testing supplies, condoms, bleach kits, educational materials, research, and salary support for prevention staff.Voluntary counseling and testing for HIV (VCT) is often used as the first step in addressing HIV transmission and prevention. Most people who have HIV do not know they have it. Furthermore, many people at risk are afraid to be tested because of the stigma associated with IDU and HIV and fear of testing positive. One way to address the AIDS epidemic is to give people an opportunity to know their HIV status so that they can take precautions to avoid further spread and seek treatment if they are infected ,26. ApprIdentification of those in need of help through effective outreach, motivational enhancement, risk assessment, and VCT must be the first priority to make an immediate impact on those at greatest risk in Vinnitsya. Vinnitsya has various locations appropriate for VCT sites. For example, the RND, the Infectious Disease Hospital, PMU, the STEPS program , and the NEP NGO are existing organizations that could offer VCT services. Training of agency staff is recommended in effective peer outreach strategies, risk assessment, motivational enhancement, and VCT protocols. Immediate diversion of agency funds and applications for small grants are recommended to fund the purchasing of HIV test kits. Successful outreach and VCT will immediately break down the first barrier to assessing the problem through anonymous testing, epidemiological prevalence surveys, and provision of prevention, education, and treatment to those most in need.As a result of effective outreach and VCT, four high risk populations will emerge, in order of severity: HIV positive IDUs, HIV positive non-IDUs, HIV negative IDUs, and HIV negative non-IDUs. The second priority is the prevention of HIV transmission among high risk populations through education, skills development, and distribution of free condoms with support from the ICOHRTA. Secondary prevention or the prevention of the spread of HIV by persons who are HIV positive IDUs or HIV non-IDUs should be given the greatest attention. Since only persons with HIV can spread HIV, reducing risk behaviors among persons who are HIV positive can make the most immediate impact on transmission rates.HIV positive IDUs should be targeted first for secondary prevention by VCT providers via education about their risk of transmitting HIV to others and how to prevent transmission through abstinence or reduce it through condom use. They should first have access to free condoms and be trained in correct condom use and then interpersonal sexual negotiation skills to practice safer sex or abstinence. HIV positive IDUs should then be educated about the HIV transmission risks associated with IDU and the dangers associated with sharing needles, syringes, paraphernalia, or drug solutions. Drug and alcohol use in general reduces the practice of safer sex and drug use behaviors, but IDU is the most risky behavior due to the opportunity to spread the virus by sharing needles, syringes or other contaminated drug use paraphernalia. Therefore, training in needle and syringe cleaning with bleach should be given high priority.Persons who are HIV positive may be suffering from despair and depression and be less motivated than high risk populations to practice safer sex or IDU behaviors. It is recommended that VCT prevention staff be adequately trained in the areas of coping with HIV diagnosis, apathy, depression, and even suicidal ideation. Finally, prevention staff should work on identification and notification of sexual and IDU partners. HIV positive IDUs represent a significant risk to their sex and drug use partners. HIV positive IDUs should be encouraged to inform partners of their HIV status so the partners can have the opportunity to practice HIV prevention themselves.The next two high risk populations in order of severity are HIV negative IDUs and HIV negative non-IDUs. They should be targeted next for prevention and education. Many of the prevention strategies proposed above for HIV positive persons apply to these groups. HIV negative IDUs should be given the first priority because of their risky practice of IDU. They should be provided with the abovementioned programs to prevent drug use prevention, teach sexual negotiation skills and provide condoms. They also should be encouraged to return for re-testing after three months. Finally, HIV negative non-IDUs are the next target population. This group should be assessed for unsafe sex behaviors and non-IDU risky drug and or alcohol use. They should be provided with condoms, HIV prevention education, risk reduction skills, and information about the use of drugs and alcohol and practicing unsafe sex.Once high risk populations are identified and tested for HIV, and prevention and education have been implemented, attention should be given to reducing harm from existing risky behaviors and enhancing opportunities for treatment. The philosophy of harm reduction, as opposed to abstinence, should guide the initial delivery of tertiary prevention. While abstinence from both sex and IDU behaviors is the only safe way to prevent HIV transmission, this advice is often met with resistance, takes a long time to achieve, and is not realistic for many persons. The most commonly practiced harm reduction method to limit the spread of HIV among IDUs is implemention of NEP/SEP. Vinnitsya has had an NEP funded by a NGO for the past several years. This NEP reaches out to the community from two street sites, offering clean needle exchange and alcohol swabs. The concept of NEPs in Vinnitsya is not fully accepted by the police, and the NEP sites are regularly monitored for any illegal practices. It is recommended that the ICOHRTA investigators meet with the leader of this NGO and discuss ideas of offering free condoms and prevention literature, making referrals for treatment, site expansion, and additional funding. Strategies should be discussed about how to link the NEP with treatment providers in the community to refer persons needing and motivated to seek out drug addiction treatment or medical services related to IDU or HIV/AIDS.Treatment for IDU and HIV/AIDS is limited in Vinnitsya. However, since the beginning of the ICOHRTA approximately four years ago, training, research opportunities, and grant funding for treatment of both IDU and HIV/AIDS has increased. Assessment of drug addiction treatment model preferences was assessed among providers and patients of the RND in preparation for the technology transport of behavioral, HIV prevention, motivational enhancement, and relapse prevention interventions . The NatIt has been stated that in order to control the HIV/AIDS epidemic, one must first understand the cultural, political, economic, and religious context in which populations, individuals, and their behaviors are situated . An incrThough the Vinnitsya Oblast is not the most severely affected region in terms of HIV infection, the assessment of the current state of the HIV/AIDS in this area of the country does shed some light on what is going on there. First, we have learned that there is a great shortage of resources for testing of HIV/AIDS  and low HIV/AIDS awareness in the general population. It is therefore possible that the statistics from these areas may be inadequate due to underreporting. Thus, there may not be such a large difference between the heavily affected regions  and other regions of the country. The most heavily infected regions may simply have better reporting systems and resources for HIV testing.Second, while the statistics for Ukraine as a whole seem to indicate that there is a shift toward heterosexual transmission of HIV, a great majority of the HIV infections reported prior to 2004 in the Vinnitsya region were among IDUs. It seemed plausible, that the HIV/AIDS epidemic in the Vinnitsya region was a few years behind. In fact, there were no officially registered HIV infections in this region until the year 1996, and the current distribution of HIV infections by risk group actually resembles the national statistics for that same year. Unexpectedly, the majority of newly registered HIV cases in Vinnitsya in 2004 were attributed to heterosexual transmission (54.1%). It can be explained either by a true shift in the epidemic dynamics or by improved surveillance after the establishment of the Regional AIDS Centre; however, there are no sufficient data to document either explanation. In any case given that the great bulk of existing HIV cases are among IDUs it is reasonable to conclude that high, significant problems lie ahead without enhanced prevention and treatment efforts.There also is a shift in the nature of drug use and the demographics of individuals who abuse drugs in this part of the country. Currently, individuals who abuse drugs tend to be younger, and the drugs tend to be more potent and riskier than they were when Ukraine was a part of the Soviet Union. Drug abuse appears to start with the use of alcohol and smoking of cannabis among children as young as 10 years of age, which may help to explain the earlier onset of IDU. Konoplya, a strong cannabis-based substance that was not as common among teenagers during the Soviet era (perhaps due to a stricter regulation at the borders), may serve as a gateway drug, leading the way to experimentation with more risky drugs (i.e. homemade stimulants and opiates). Because many IDUs make the opiate solution themselves in non-sterile home-laboratories, they have control over its strength; face a greater chance of contaminating the solution (i.e. by using unclean works and solvents); and present great risks of HIV transmission through needle and drug sharing. Prevention and treatment efforts have been attempted with limited success due to inadequate resources, training, and the burgeoning IDU problem in the area. Avenues for change in the drug addiction prevention and treatment fields are open due to caring and motivated health care providers and public health officials. In order to control the HIV/AIDS and IDU epidemics, one needs to consider a great deal of factors that fuel these epidemics. Changes may have to be made at the levels of individuals, services, communities, environments, and policies. Consequently, it will take a collective effort to make significant progress.ICOHRTA – International Clinical, Operational and Health Services Research and Training AwardIDU – Injection Drug UseIDUs – Injection Drug UsersIDU-RAR – Rapid Assessment and Response in Injection Drug UseNEP/SEP – Needle/Syringe Exchange ProgramNGO – Non-governmental OrganizationPMU – Vinnitsya National Pirogov Medical UniversityRND – Regional Narcological DispensaryUAB – University of Alabama at BirminghamWHO – World Health OrganizationThe author(s) declare that they have no competing interests.Katerina Barcal, MPH conceived of the study and its design, the collection of data, organizing the data for qualitative analysis, drafting the article and making final edits, and giving final approval for publication.Joseph E. Schumacher, PhD mentored Ms. Barcal in the study conceptualization, design, data analysis, manuscript preparation, giving final approval for publication.Kostyantyn Dumchev, MD, MPH participated in the design and methodology of the study, collection of the data, organization of the data, editing the manuscript, and giving final approval for publication.Larisa Vasiliyevna Moroz, MD, PhD participated in the acquisition and interpretation of the data, editing the manuscript, and giving final approval for publication.


With the recognition that public hospitals are often productively inefficient, reforms have taken place worldwide to increase their administrative autonomy and financial responsibility. Reforms in China have been some of the most radical: the government budget for public hospitals was fixed, and hospitals had to rely on charges to fill their financing gap. Accompanying these changes was the widespread introduction of performance-related pay for hospital doctors – termed the "bonus" system. While the policy objective was to improve productivity and cost recovery, it is likely that the incentive to increase the quantity of care provided would operate regardless of whether the care was medically necessary.The primary concerns of this study were to assess the effects of the bonus system on hospital revenue, cost recovery and productivity, and to explore whether various forms of bonus pay were associated with the provision of unnecessary care. The study drew on longitudinal data on revenue and productivity from six panel hospitals, and a detailed record review of 2303 tracer disease patients (1161 appendicitis patients and 1142 pneumonia patients) was used to identify unnecessary care.The study found that bonus system change over time contributed significantly to the increase in hospital service revenue and hospital cost recovery. There was an increase in unnecessary care and in the probability of admission when the bonus system switched from one with a weaker incentive to increase services to one with a stronger incentive, suggesting that improvement in the financial health of public hospitals was achieved at least in part through the provision of more unnecessary care and drugs and through admitting more patients.There was little evidence that the performance-related pay system as designed by the sample of Chinese public hospitals was socially desirable. Hospitals should be monitored more closely by the government, and regulations applied to limit opportunistic behaviour. Otherwise, the containment of government financing for public facilities may result in an increase in the provision of unnecessary care, an increase in health costs to society, and a waste in social resources. Health policy researchers and policy makers have increasingly recognized that health care providers have a powerful influence on health care provision and the use of health care resources. With the recognition that public hospitals are often productively inefficient, reforms have taken place worldwide to increase the administrative autonomy and financial responsibility of public hospitals ,2. ReforThe bonus system is widespread and used by almost all hospitals in China. The types of hospital bonus system can be summarized into three different forms: flat bonus, quantity-related bonus and revenue-related bonus -12. A flA survey of bonus systems in all county hospitals in Shandong province in 1997  found thThe objectives of the study reported here were to assess the effects of the bonus system on hospital revenue, cost recovery and productivity, and to explore whether bonus pay was associated with the provision of unnecessary care. The primary hypothesis tested in the study was that the impact of a bonus system on revenue, cost recovery, productivity and unnecessary care would depend on the strength and direction of the economic incentive of different bonus systems, and doctors' responses to these incentives. It was assumed that an increase in provision of necessary care would provide utility gains for doctors in the form of income and a utility loss in the form of greater effort, and that the provision of unnecessary care would also provide income utility gains, but at a utility loss stemming from ethical concerns as well as greater effort. Thus the behaviour of doctors would be determined by the trade-off of utility gains and losses, and the motivation for doctors to provide unnecessary care would be constrained by their desire for leisure and for ethical behaviour.It was hypothesized that a flat bonus might motivate doctors to provide necessary care but would be less likely to motivate them to provide unnecessary care. If there is enough demand, the effort of an individual doctor to provide more necessary care would benefit patients, the hospital and the doctor as well. Productivity, cost recovery and quality of care could all improve. If there is insufficient demand, the doctor could induce demand but might be less motivated to do so because the bonus income would be distributed throughout the hospital. A quantity-related bonus would provide a stronger economic incentive for doctors to provide a greater quantity of services, and might help to improve productivity, cost recovery and quality of care if there is sufficient demand. But when demand is insufficient, doctors may be motivated to induce demand by providing more care, regardless of need. What types of service would be overprovided would depend on how quantity is defined and measured. Finally, a revenue-related bonus provides the strongest incentive for doctors to induce patient demand for both services and drugs.o compared with the n hospitals in the data set is:Productivity is generally defined as the ratio of a hospital's output to its input. This study employed both unidimensional ratio analysis ; and Data Envelopment Analysis, a linear programming method that measures the technical efficiency of production  and has o represents the hospital being evaluated in the set of j = 1,...,n hospitals; E is the efficiency score; ur is the weight for the rth output; yro is the rth output for the oth hospital; s is the number of outputs; vi is the weight of the ith input; xio is the ith input for the oth hospital; m is the number of inputs. The DEA efficiency score was calculated using software developed by Warwick Business School [where s School , assuminCost recovery was defined as service revenue expressed as a percentage of recurrent and total costs. Unnecessary care was defined as services and drugs provided that were judged by a panel of doctors to lead to no improvement in patient outcomes. Unnecessary care can be assessed only in relation to the nature of the cases being treated, so appendicitis and child pneumonia were selected as tracer diseases on the basis that they were common so there were enough cases for each hospital and year; they had clear-cut diagnoses so the sample would be homogeneous; and both had a standard plan of treatment, so variation in treatment would not be due to treatment uncertainty. Six surgeons (for appendicitis cases) and six paediatricians (for pneumonia cases) worked together with the investigators to develop guidelines for appropriate management of the two tracer diseases and for identification of unnecessary care. These guidelines were positive lists of types and quantities of services and drugs necessary for the improvement of the health outcomes of patients. The unnecessary care indicator was unnecessary care expenditure as a percent of total expenditure. A detailed description of the methodology is in Liu and Mills .Based on a census of all 127 county general hospitals in Shandong province , 25 hospInpatient records were collected from the six panel hospitals for each change of bonus system and encompassing the year of the switch and the two years before and after. Inpatient records for each year, disease and hospital were drawn from the beginning of the year until the sample size reached 30 or until there were no more records available. Altogether the study included 1161 appendicitis patients and 1142 pneumonia patients.Patient files were randomly distributed to the relevant doctors who reviewed the files and recorded the types and quantities of services and drugs actually used, and the types and quantities of unnecessary services and drugs. If the removal of unnecessary items was considered to result in inadequate treatment, substitute necessary services and drugs were added in. Finally, actual expenditures and unnecessary expenditures were computed by accountants according to the 1997 provincial fee schedule.ps of t-tests were less than 0.05 and most were very close to 1.Because of the burden of work, each record was reviewed by only one doctor, but to check for consistency, 61 patient records for appendicitis and 57 for pneumonia were selected and randomly distributed to the panel doctors for re-reviews, without their knowledge, and the results compared. Means were very similar: none of the In the data analysis, we first described the historical changes in bonus system, hospital revenue, productivity and cost recovery, and then analysed the level of unnecessary care.Trend analysis was performed to examine the changes in hospital revenue, cost recovery, productivity, and the rate of unnecessary expenditure following the bonus switches. In the trend analysis, the indicators were assessed for a continuous five years for each of the hospital bonus switches, including the year of bonus switch and the two years before and the two years after the switch.In correlation and regression analysis, we examined the relationships of the bonus system with the four key variables . First, the interrelationships among these four variables were examined through correlation analysis of each pair of variables. The observation units were hospital-years. The type of bonus was measured by a dummy variable with values reflecting the expected strength of economic incentives to overprovide . Cost recovery was measured by the rate of recovery of recurrent cost, and hospital productivity by the DEA efficiency score.The subsequent set of analyses used stepwise regression analysis to examine whether and how hospital revenue, cost recovery, unnecessary care and productivity were related to each other, and to what extent they were explained by the bonus system. Each of the four variables was taken in turn as a dependent variable, and the factors that might explain the variations in the dependent variable examined . Besides indicators of revenue, cost recovery, unnecessary care and productivity, the year, names of hospitals and bonus type were put into the regression models as independent variables. The six hospital names were arranged into five dummy variables. The year measured all the factors that changed with time . The names of hospitals measured all the factors that were related to each hospital .All six panel hospitals had experienced bonus switches from no-bonus to flat-bonus and then to revenue-related bonus Table . None haCoinciding with the change in bonus systems, over the period 1978–97, there was a remarkable increase in hospital revenue, an increase in hospital cost recovery, a doubling of admissions, a decrease in visits and a tripling of operations Table . The aveThere was a large amount of unnecessary expenditure for both tracer diseases. The average expenditure (1997 prices) for an appendicitis patient was 774 yuan (USD 95), of which 18% was considered unnecessary. For a pneumonia patient these figures were 559 yuan (USD 68) and 19%. Further analyses showed that more than one third of the expenditure for drugs was deemed unnecessary for both appendicitis (38%) and pneumonia (34%), and this made up 49% (appendicitis) and 73% (pneumonia) of total unnecessary expenditure. Unnecessary expenditure for doctors' and nurses' services, associated with excessive lengths of stay, made up the second largest share of unnecessary expenditure, accounting for 43% (appendicitis) and 21% (pneumonia). In terms of expenditure for doctors' and nurses' services, 13% (appendicitis) and 9% (pneumonia) of this was unnecessary. Although more than 50% of the expenditure for examinations for appendicitis patients was unnecessary, it made up only about 1% of the total unnecessary expenditure since little was spent on examinations. Unnecessary expenditure for laboratory tests was small in terms of both its contribution to total unnecessary expenditure (1%), and its percentage of expenditure for tests (7%).The above data show that there had been considerable changes over time in hospital revenue and productivity, and also that there was a considerable amount of unnecessary care. But were these features related? This section examines this question through analysis of trends; the subsequent section examines the question through correlation and regression analysis.Table • the rate of growth of revenue increased in all three;• cost recovery increased in all three;• two hospitals out of three showed a decrease in the visits/admission ratio, meaning that more patients were admitted out of those attending for outpatient care;• one hospital out of three showed a decrease in the admissions/operation ratio, meaning that a higher share of inpatients were operated on;• productivity decreased in all three;• unnecessary care increased in two out of three.When hospitals conducted a further switch from flat bonus to revenue-related bonus:• all six hospitals increased their rate of growth of revenue• the majority (4/6) showed a decrease in cost recovery• all six hospitals showed a decrease in the visits/admission ratio• all six hospitals showed a decrease in the admissions/operation ratio• five of the six hospitals experienced increases in productivity• half showed an increase in unnecessary care.Despite some inconsistent results, likely to reflect location-specific factors, an overall pattern emerges. First, the implementation of a flat bonus where previously there had been no bonus system seemed to be associated with an increase in hospital revenue and cost recovery, a decrease in hospital productivity and an increase in unnecessary care. Second, the implementation of a revenue-related bonus following a flat bonus system appeared to have increased hospital revenue and cost recovery, encouraged higher admissions and operations rates, and increased hospital productivity, with an unclear effect on unnecessary care.p values for the null hypothesis that the correlation coefficients are zero) are shown in Table p < 0.01) but positively correlated with unnecessary care (p < 0.05), with service revenue (p < 0.01) and the rate of cost recovery (p < 0.01). These results mean that with a change in the bonus payment from non-bonus to flat bonus and to revenue-related bonus, hospital revenue increased and cost recovery improved. However, the improvement in financial status was associated with reductions in hospital productivity and increase in unnecessary care.Results of correlation analysis (the correlation coefficients and their p < 0.01) and hospital productivity and hospital revenue (p < 0.01) are consistent with the previous trend analysis, which showed an increase in cost recovery (and revenue) but a decrease in hospital productivity over time. Reduction in hospital productivity may have resulted from increased competition between providers, which encouraged county hospitals to provide more drugs and services per patient and to charge them more in order to increase revenue, and/or the increasing cost may have deterred people from seeking care.The negative correlations between hospital productivity and cost recovery (p < 0.05). This relationship implies that if hospitals provide less unnecessary care and the expenditure of patients is therefore less, the hospital will be able to attract more patients. This is theoretically as expected because reduction in price will lead to increase in patient demand.Hospital productivity and unnecessary care were negatively correlated (p > 0.05 for both). Individual hospital analysis showed that when the bonus switched from non-bonus to flat bonus or from flat bonus to revenue-related bonus, both unnecessary care and cost recovery tended to increase. In theory, there should indeed be a positive relationship between unnecessary care and hospital cost recovery. The reason why the relationship was not statistically significant may be explained by the sample size  and large variations in both unnecessary care and rates of cost recovery.The relationships were not statistically significant between unnecessary care and hospital revenue, and unnecessary care and cost recovery . Bonus type was selected into the model and was statistically significant (p < 0.01), explaining about 6% of the total variation in hospital service revenue. On average, as the parameter estimate shows, a switch to a bonus system with an expected stronger economic incentive increased hospital revenue by about two million yuan. The DEA efficiency score was not statistically significant and the unnecessary care indicator was not even selected into the model at the level of p = 0.15, implying that the relationship between revenue and productivity and the relationship between revenue and unnecessary care  are in fact the effect of the bonus type. In other words, bonus type may have affected hospital revenue through increases in hospital productivity and unnecessary care.Table 2 shows, the year, which was selected with p = 0.0001, explained 70% of the total variation in hospital revenue. This is not surprising, given the change in revenue over time described earlier. The two hospital dummy variables jointly explained 9% of the revenue variation. These results imply that a dominant proportion of the revenue variation among years and hospitals can be explained by factors related to time and individual hospital characteristics. Although bonus type mattered, it could explain only a small portion of the variation.As the partial R2 of 0.6084. As with the regression on hospital revenue, the DEA efficiency score and unnecessary care were not selected into the model at the p = 0.15 level, and the bonus type was selected with a p value of 0.0129. The bonus type explained more than 3% of the variation in the rate of cost recovery, and on average a bonus switch to one with an expected stronger economic incentive contributed a two percentage-point increase to the rate of cost recovery. In contrast to the regression on hospital revenue, the year variable was no longer statistically significant and a dominant proportion (55%) of the variation in the rate of cost recovery was explained by hospital characteristics.Table p < 0.01) and the R2 of the model was 0.3371. Bonus type was selected as a significant factor (p = 0.05) with a partial R2 of 0.058, meaning that the difference in bonus system explained about 6% of the variation in unnecessary care. As the parameter shows, with a change in bonus type from non-bonus to flat or from flat bonus to revenue-related bonus, the unnecessary care indicator increased by about one percentage point – not as much as had been expected. After controlling for bonus type and hospital characteristics, the year and DEA efficiency score were not selected as significant factors explaining the difference in unnecessary care. The difference in characteristics of individual hospitals explained 27% of the total difference in unnecessary care and more than 60% of the variance was unexplained by this model.Table p < 0.001) with an R2of 0.35. Unnecessary care was selected as a significant factor affecting hospital productivity, and the difference in unnecessary care explained 8.6% of the total variation in hospital productivity. A decrease in unnecessary care was associated with an increase in hospital productivity. This finding, and the fact that the DEA efficiency score was not selected as a significant factor explaining the difference in unnecessary care, imply that the relationship between unnecessary care and hospital productivity is such that the increase in unnecessary care reduced hospital productivity, rather than that the reduction in hospital productivity forced hospitals to provide more unnecessary care. Bonus type in this model was not found to be a significant factor, suggesting that the historical reduction in hospital productivity was not caused by switches in bonus system and that bonus switches failed to improve hospital productivity. Although the descriptive data showed that hospital productivity fell over time, year was not statistically significant in this model.Table Given the absence of computerized information systems, this study was constrained by what data could feasibly be collected by hand. In particular this limited the study of unnecessary care, which was extremely time-consuming. If inpatient records had covered more years and more hospital years had been employed in the regression analyses, the factors that were not significant might have been statistically significant, and the goodness of fit of the models might have improved. Moreover, only two tracer conditions were studied, and only inpatient care was assessed. These conditions allow for only a limited degree of overprovision, especially in terms of lab tests and drugs, and so are likely to have underestimated the amount of unnecessary care.Productivity assessment, for both unidimensional ratio analysis and DEA, had two major shortcomings: changes in the quality of care (other than the component of unnecessary care) were ignored, and changes in case mix were not adjusted for. Over time it is likely that the quality of care improved, and that case mix changed; thus this study is likely to have exaggerated the degree to which productivity declined over time. However, these points do not necessarily affect the finding that there was a lack of a statistically significant relationship between bonus type and hospital productivity. It is possible that hospital expansion and increased numbers of staff per hospital may have obscured any increase in quantity stimulated by the bonus payment.The effect of bonus payment is likely to depend on both the type and the amount of bonus. However, data on the amount of bonus was a sensitive question, and panel hospitals either refused to provide data or provided data that were not considered reliable. In a related hospital census survey , it was In the analyses of individual hospitals and of trends, it was found that for some hospitals, the changes in indicators happened in the year of switch and for others the following year. There are two possible reasons. First, when hospitals responded to the bonus switch would depend on whether the bonus switch happened early or late in the year. Second, the speed of effects would also depend on how hospitals responded. Some may have responded quickly by admitting more patients, providing more existing services and prescribing more and costlier drugs. Others may have had to wait for the purchase of equipment (e.g. CT scanner) or the training of personnel (e.g. for open-heart surgery).It was clear from the analysis that the increase in hospital cost recovery was not a result of improvement in hospital productivity, since between 1978 and 1997, cost recovery increased from 71% to 96% and the DEA efficiency score decreased from 97% to 73%. Apart from the increase in the proportion of unnecessary expenditure and the bonus system changes, there are at least four additional factors that may have affected the increase in hospital cost recovery.First, over the previous 20 years the Chinese government had been raising medical care prices. Although these on average were set at about 50% of total cost , prices Second, due to the liberalization of the pharmaceutical market, the prices of drugs had increased considerably, doubling from 1980 to 1990 [Third, the development of new technologies encouraged the introduction of new treatments and drugs that usually had much higher regulated prices than traditional treatments and drugs. For example, before 1980, imported drugs accounted for less than 1% of the Chinese drug market, while by 1993 the sale of imported drugs made up 30%–55% of the market in major cities such as Beijing and Shanghai . Before Finally, government budget reform increased the financial accountability of public hospitals. Reducing waste and saving costs became a major management concern, helping to improve hospital cost recovery. However, this study suggests that hospital characteristics explained around 55% of the variation in hospital cost recovery, implying that hospital management capacity and ability to control cost varied a great deal.Between 1978 and 1997, the visits/admission ratio and admissions/operation ratio went down. The analysis showed that a bonus switch from one with a weaker economic incentive to one with a stronger incentive was one of the factors explaining the decreases in the visits/admission ratio and in the admissions/operation ratio, suggesting there must be other factors affecting these ratios. The number of visits to county hospitals was increasing until around the middle of the 1980s, and then started falling. Beginning at the end of the 1970s, rural economic reform brought about a rapid increase in peasants' income, which could have encouraged an increased demand for health care . This maIt is difficult to explain fully the steady increase in the number of admissions and the number of operations. Since inpatients can be admitted only through the outpatient department and only inpatients can be operated on, it is obvious that the hospitals admitted more and more from among the outpatients and performed more and more operations for the inpatients. There are several possible reasons for this. First, the case mix may have changed so that more patients needed to be admitted and operated on. Second, the development of technology and changes in medical criteria for admissions and operations may have led to more patients' being admitted and operated on. Third, the increase in the numbers of beds and doctors may have permitted needed admissions and operations that had not been possible before due to lack of inputs. Finally, related to the major hypothesis of this research, the changes in doctor payment system may have motivated staff to provide more unnecessary admissions and surgical operations. The study has shown that a bonus switch appeared to bring about an increase in the visits/admission ratio, but case notes did not permit a judgement as to whether an admission was necessary or unnecessary.Although the DEA efficiency score decreased when panel hospitals switched from non-bonus to flat bonus, this does not mean that the bonus switch helped to decrease hospital productivity. This is, first, because the DEA efficiency score was generally decreasing over time; and second, because in two of the three hospitals (Liangshan and Changyi), the bonus switch appears to have helped to slow down the rate of decrease in the DEA efficiency score.Based on these analyses, we can draw several conclusions. First, there was a steady increase in hospital revenue, and bonus type was a significant factor explaining its variation across hospitals and years.Second, a considerable proportion of unnecessary expenditure out of total expenditure was identified, and there was a relationship between the bonus system and unnecessary care. Analyses showed that the bonus system was positively correlated with the unnecessary care indicator, implying that the higher the expected incentive of the bonus system, the higher the proportion of unnecessary expenditure.Third, although hospital productivity decreased over time, a bonus switch from flat bonus to revenue-related bonus appeared to increase hospital productivity in the year of the switch. A bonus switch from non-bonus to flat bonus was not similarly able to reverse the trend of hospital productivity, but it seemed that the rate of decrease in hospital productivity was slowed down by a bonus switch.Fourth, hospital cost recovery increased over time. The study suggests that the bonus switch brought about an increase in cost recovery and that the bonus system was positively correlated with hospital cost recovery.Last and in general, the research suggests that the bonus change over time contributed significantly to the increase in hospital service revenue and hospital cost recovery. The increase in unnecessary care and increase in the number of admissions out of the existing number of outpatients, with the bonus system switching from one with a weaker incentive to one with a stronger incentive, suggests that the improvement in hospital cost recovery was achieved at least in part through the provision of more unnecessary care and drugs and through admitting more patients.There are two policy implications from this study. First, there is little evidence that the performance-related pay system as designed by Chinese public hospitals is socially desirable. It could improve hospital financial sustainability, but did not necessarily lead to improvements in efficiency from a social perspective. The key barrier to achieving the social objectives of performance-related pay was the inappropriate link (whether direct or indirect) between bonus payment and hospital revenue. Hospital bonus distribution should be based on doctor performance measured by indicators that are in line with the desired overall performance of the health care system.Second, reforms in various countries are characterized by increased exposure of public hospitals to financial risk, in order to increase financial accountability, efficiency and productivity. However there is a risk of encouraging revenue maximization and rent-seeking. Chinese experiences show that when increasing public hospital autonomy, hospitals should be monitored closely by the government, and regulations applied to limit opportunistic behaviour. Otherwise, the containment of government financing to public facilities may result in an increase in the provision of unnecessary care, an increase in health costs to society and a waste in social resources.The author(s) declare that they have no competing interests.XL designed the study, carried out the fieldwork, undertook the data analysis and wrote the initial draft. AM guided and supervised the design and data analysis and participated in writing and finalizing the paper. Both authors read and approved the final manuscript.